Vir Biotechnology, Inc S-1, filed Jul 6, 2020
Vir Biotechnology, Inc. (VIR)
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As filed with the Securities and Exchange Commission on July 6, 2020.
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Vir Biotechnology, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 2836 | 81-2730369 | ||
| (State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) 499 Illinois Street, Suite 500 San Francisco, California 94158 (415) 906-4324 |
(I.R.S. Employer Identification Number) |
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
George Scangos, Ph.D.
President and Chief Executive Officer
Vir Biotechnology, Inc.
499 Illinois Street, Suite 500
San Francisco, California 94158
(415) 906-4324
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
| Laura A. Berezin Charles S. Kim Kristin VanderPas Cooley LLP 3175 Hanover Street Palo Alto, California 94304 (650) 843-5000 |
Brian J. Cuneo B. Shayne Kennedy Drew Capurro Latham & Watkins LLP 140 Scott Drive Menlo Park, California 94025 (650) 328-4600 |
Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box. ☐
If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
| Non-accelerated filer | ☒ | Smaller reporting company | ☐ | |||
| Emerging growth company | ☒ | |||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
CALCULATION OF REGISTRATION FEE
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| Title of securities being registered |
Proposed maximum aggregate offering price(1)(2) |
Amount of registration fee (2) | ||
| Common Stock, $0.0001 par value per share |
$287,500,000 | $37,317.50 | ||
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| (1) | Includes additional shares that the underwriters have the option to purchase. |
| (2) | Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended. |
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
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The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED JULY 6, 2020
PRELIMINARY PROSPECTUS
6,200,000 Shares
Common Stock
We are offering 6,200,000 shares of our common stock.
Our common stock is listed on The Nasdaq Global Select Market under the trading symbol “VIR.” The last reported sale price of our common stock on The Nasdaq Global Select Market on July 2, 2020 was $40.32 per share.
We are an “emerging growth company” as defined under the federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements.
Investing in our common stock involves a high degree of risk. See the section titled “Risk Factors” beginning on page 17.
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Total | |||||||
| Public offering price |
$ | $ | ||||||
| Underwriting discounts and commissions(1) |
$ | $ | ||||||
| Proceeds to us before expenses |
$ | $ | ||||||
| (1) | See the section titled “Underwriting” for additional information regarding compensation payable to the underwriters. |
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities, or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
We have granted the underwriters an option for a period of 30 days to purchase up to 930,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions.
The underwriters expect to deliver the shares against payment in New York, New York on , 2020.
| Goldman Sachs & Co. LLC | BofA Securities | Cowen | Barclays | |||
| Needham & Company | ||||||
Prospectus dated , 2020
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Neither we nor the underwriters have authorized anyone to provide any information or to make any representations other than those contained or incorporated by reference in this prospectus or in any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained or incorporated by reference in this prospectus or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of shares of our common stock. Our business, financial condition, results of operations and prospects may have changed since that date.
For investors outside the United States: Neither we nor the underwriters have done anything that would permit this offering or possession or distribution of this prospectus or any free writing prospectus we may provide to you in connection with this offering in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus and any such free writing prospectus outside the United States.
Unless the context otherwise requires, the terms “Vir,” “the company,” “we,” “us,” “our” and similar references in this prospectus refer to Vir Biotechnology, Inc. and its consolidated subsidiaries.
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This summary highlights selected information contained elsewhere in this prospectus or incorporated by reference herein. Before investing in our common stock, you should carefully read this entire prospectus, including the information incorporated by reference herein, especially the matters discussed in the information set forth under the sections titled “Risk Factors” in this prospectus and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, each of which are incorporated by reference herein.
Business Summary
Our mission is to create a world without infectious disease
We are a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Infectious diseases are one of the leading causes of death worldwide and can cause trillions of dollars of direct and indirect economic burden each year – as evidenced by the current coronavirus disease 2019, or COVID-19, pandemic. We believe that now is the time to apply the recent and remarkable advances in immunology to combat infectious diseases. Our approach begins with identifying the limitations of the immune system in combating a particular pathogen, the vulnerabilities of that pathogen and the reasons why previous approaches have failed. We then bring to bear powerful technologies that we believe, individually or in combination, will lead to effective therapies.
We have assembled four technology platforms, focused on antibodies, T cells, innate immunity and small interfering ribonucleic acid, or siRNA, through internal development, collaborations and acquisitions. Our current development pipeline consists of product candidates targeting severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, the virus that causes COVID-19, hepatitis B virus, or HBV, influenza A, human immunodeficiency virus, or HIV, and tuberculosis, or TB. For SARS-CoV-2, VIR-7831, a SARS-CoV-2- neutralizing monoclonal antibody, or mAb, is planned to start a Phase 2/3 clinical trial program in August 2020 and we anticipate initial clinical data to be available before the end of the year. VIR-7832, a vaccinal SARS-CoV-2-neutralizing mAb, is planned to initiate a Phase 2 clinical trial later this year. VIR-2703, a SARS-CoV-2-targeting siRNA, is in preclinical studies. For HBV, VIR-2218, an HBV-targeting siRNA, is currently in an ongoing Phase 2 clinical trial. Initial Phase 2 data have demonstrated substantial, durable, and dose dependent reduction of hepatitis B virus surface antigen, or HBsAg, and VIR-2218 has been generally well-tolerated. We recently initiated a Phase 2 clinical trial to combine VIR-2218 with pegylated interferon-alpha, or PEG-IFN-α, an approved immune modulatory agent. In addition, we recently initiated a Phase 1 clinical trial for VIR-3434, an HBV-neutralizing mAb. For influenza A, VIR-2482, a mAb designed for the prevention of influenza A, is currently in a Phase 1/2 clinical trial and has been generally well-tolerated. For HIV, VIR-1111, an HIV T cell vaccine based on HCMV, is planned to initiate a Phase 1 trial in the second half of this year. We have built an industry-leading team that has deep experience in immunology, infectious diseases and product development. Given the global impact of infectious diseases, we are committed to developing cost-effective treatments that can be delivered at scale.
Our Technology Platforms
Our four current technology platforms are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. We are using our platforms to advance our current product candidates and generate additional product candidates for multiple indications.
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Antibody Platform: We have established a robust method for capitalizing on unusually successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases. We identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving and/or previously untreatable pathogens via direct pathogen neutralization and immune system stimulation. The fully-human antibodies that we discover may also be modified to enhance their therapeutic potential. We have applied these methods to identify mAbs for a range of pathogens including Ebola, HBV, influenza A and influenza B virus, SARS-CoV-2, RSV and malaria, and bacterial pathogens, including clostridium difficile, Staphylococcus aureus, Klebsiella pneumoniae, and Acinetobacter spp.
T Cell Platform: We are exploiting the unique immunology of human cytomegalovirus, or HCMV, a commonly occurring virus in humans, as a vaccine vector to potentially treat and prevent infection by pathogens refractory to current vaccine technologies. This approach is based on fundamental observations made in non-human primates, or NHPs, with rhesus cytomegalovirus, or RhCMV. We believe that this platform may also have applicability beyond infectious diseases, to areas such as cancer.
Innate Immunity Platform: Moving beyond more traditional approaches that are used to evoke adaptive immunity or that directly target pathogens, where the development of resistance can occur, we plan to target host proteins as a means of creating host-directed therapies with high barriers to resistance. We believe that by leveraging the power of innate immunity, we can create medicines that break the “one-drug-for-one-bug” paradigm to produce “one-drug-for-multiple-bugs.”
siRNA Platform: We are harnessing the power of siRNA to inhibit pathogen replication, eliminate key host factors necessary for pathogen survival and remove microbial immune countermeasures. Our collaboration with Alnylam Pharmaceuticals, Inc., or Alnylam, includes VIR-2218 for HBV, VIR-2703 for SARS-CoV-2 and up to seven additional programs for infectious diseases.
Our Development Pipeline
Our current product candidates are summarized in the chart below:
| * | VIR-1111 is a vaccine designed to establish proof of concept in Phase (Ph) 1 clinical trial to determine whether unique immune response observed in NHPs can be replicated in humans; ultimately, any candidates we advance as a potential HIV vaccine will require modifications to VIR-1111 before further clinical development. |
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SARS-CoV-2: The substantial impact of viral outbreaks and the need for global preparedness have been highlighted by the current COVID-19 pandemic. As of June 19, 2020, the virus had spread to 188 countries, there were over 8.5 million recorded infections and over 450,000 recorded deaths. We have moved rapidly to address this global health challenge. Our focus is on treating and preventing SARS-CoV-2, as well as potential future coronavirus outbreaks. To do so, we are taking multiple approaches: antibodies (VIR-7831 and VIR-7832), siRNA (VIR-2703), applying our innate immunity platform to identify cellular host genes necessary for virus replication, and vaccines. We anticipate that the initial registration populations for our product candidates will include those at high risk of contracting COVID-19 and those in need of treatment for COVID-19.
VIR-7831 and VIR-7832 are SARS-CoV-2-neutralizing mAbs. For VIR-7831, we plan to submit an Investigational New Drug Application, or IND, and thereafter commence a Phase 2/3 clinical trial program in August 2020. VIR-7832 is planned to initiate a Phase 2 clinical trial later this year. Both VIR-7831 and VIR-7832 are based on a parent antibody, S309, which was derived from samples previously gathered for research on pan-coronavirus-neutralizing mAbs. S309 has demonstrated high affinity and avidity for the SARS-CoV-2 spike protein and the ability to potently neutralize SARS-CoV-2 in multiple live-virus cellular assays. S309 binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also commonly known as ‘SARS’), indicating that the epitope is highly conserved. We believe the conservation of this epitope will make it more difficult for escape mutants to develop and result in a high barrier to resistance. S309 also exhibits potent effector function in vitro, potentially allowing the engagement and recruitment of immune cells to kill off already infected cells. VIR-7831 and VIR-7832 have both been engineered with “LS” mutations within the Fc region of the mAbs, for the purpose of increasing lung tissue bioavailability and extending their half-life. VIR-7832 has been further engineered with “XX2” mutations in the Fc region of the mAb to potentially allow it to function as a T cell vaccine. We anticipate initial clinical data from our Phase 2/3 trial of VIR-7831 to be available before the end of the year.
Our Phase 2/3 trial program for VIR-7831 will be comprised of the following:
To accelerate the progress of VIR-7831 and VIR-7832, we have signed a number of collaboration agreements to aid in their manufacture and potential commercialization. Specifically, we are collaborating on clinical manufacturing with WuXi Biologics (Hong Kong) Limited, or WuXi, and Biogen Inc., or Biogen. We are collaborating on commercial manufacturing with WuXi and Samsung Biologics Co., Ltd., or Samsung, and we anticipate commercial supply of approximately 10-15 million doses in 2021, depending on titer, yield and dose amount. And we are collaborating on potential commercialization with WuXi for greater China and GlaxoSmithKline plc, or GSK, for all other countries. See the section titled “Recent SARS-CoV-2 Activities” for a description of these and other collaborations.
VIR-2703 is an inhaled SARS-CoV-2-targeting siRNA for which we are conducting preclinical studies that are expected to be completed by the end of 2020. In vitro, VIR-2703 has demonstrated the ability to significantly reduce SARS-CoV-2 live virus replication. It is designed to degrade the viral genome, leading to inhibition of viral protein synthesis and blocking the production of infectious virus. It targets a nucleic acid sequence in the SARS-CoV-2 genome that is highly conserved amongst currently available viral sequences and is also conserved in SARS-CoV-1. VIR-2703 leverages Alnylam’s latest advances in lung delivery of siRNAs and is the first development candidate selected in our expanded collaboration with Alnylam for SARS-CoV-2 and other coronaviruses.
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HBV: Approximately 290 million people globally are chronically infected with HBV and approximately 900,000 of them die from HBV-associated complications each year. There is a significant unmet medical need for more effective therapies that lead to life-long control of the virus after a finite duration of therapy, which is the definition of a functional cure. For a registrational trial to demonstrate a functional cure, the formal endpoint accepted by the U.S. Food and Drug Administration, or the FDA, is undetectable HBsAg, defined as less than 0.05 international units per milliliter, or IU/ml, as well as HBV DNA less than the lower limit of quantification, in the blood six months after the end of therapy.
We are developing VIR-2218 and VIR-3434 for the functional cure of HBV. Each of these product candidates has the potential to stimulate an effective immune response and also has direct antiviral activity against HBV. We believe that a functional cure for HBV will require an effective immune response, in addition to antiviral activity, based on the observation that severe immunosuppression can reactivate HBV disease. While monotherapy with VIR-2218 and VIR-3434 may provide a functional cure in some patients, we believe combination therapy will be necessary for a functional cure in many patients. We are planning trials that combine VIR-2218 and VIR-3434, which we believe have the potential to act in concert by removing potentially tolerogenic HBV proteins and stimulating new HBV specific T cells. We also recently initiated a trial that combines VIR-2218 with PEG-IFN-α and are evaluating additional combinations with other immunotherapy agents and direct acting antiviral agents. We anticipate that the initial registration population for these product candidates will be patients chronically infected with HBV.
VIR-2218 is a subcutaneously administered HBV-targeting siRNA that is currently in a Phase 2 clinical trial. By targeting a conserved region of the HBV genome, it is designed to inhibit the production of all HBV proteins: X, polymerase, S, and core. Suppression of HBV proteins, particularly HBsAg, is hypothesized to remove the inhibition of T cell and B cell activity directed against HBV, allowing VIR-2218 to potentially result in a functional cure. VIR-2218 was the first siRNA in the clinic to include Alnylam’s ESC+ technology, which has the potential to enhance the therapeutic index. In total, 37 healthy volunteers have received VIR-2218 and 12 healthy volunteers have received placebo. In addition, 24 patients with chronic HBV on nucleotide/nucleoside reverse transcriptase inhibitors, or NRTIs, have received VIR-2218, and eight patients with chronic HBV on NRTIs have received placebo. The data suggest that VIR-2218 is generally well-tolerated in healthy volunteers given as a single dose up to 900 mg and in patients given as two doses of 20 mg, 50 mg, 100 mg or 200 mg each dose. The data also demonstrate substantial, dose dependent reductions in HBsAg in patients at doses ranging from 20 mg to 200 mg, which are durable at the higher doses for at least six months. We recently initiated a Phase 2 combination trial of VIR-2218 and PEG-IFN-α, and anticipate initial clinical data to be available in 2021.
The trial design for the Phase 2 combination trial of VIR-2218 and PEG-IFN-α is shown below:
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VIR-3434 is a subcutaneously administered HBV-neutralizing mAb currently in a Phase 1 clinical trial. By targeting a conserved region of HBsAg, it is designed to block entry of all 10 genotypes of HBV into liver cells called hepatocytes and reduce the level of virions and subviral particles in the blood. We have also engineered VIR-3434 to have an extended half-life and to potentially function as a therapeutic T cell vaccine for chronic HBV infection. These modifications are intended to enhance its potential to result in an HBV functional cure. We anticipate clinical data from our Phase 1 trial will enable us to initiate a Phase 2 clinical trial of VIR-3434 in combination with VIR-2218 in 2021.
Influenza: On average, each year the influenza virus infects 5% to 10% of the world’s population and results in an estimated 500,000 deaths. In the 2017-2018 flu season, it is now estimated that 61,000 people died from influenza in the United States alone. Influenza vaccines have historically had limited success, with an average efficacy of 40%. This limited efficacy results from incomplete coverage against seasonal strains and the lack of an effective immune response in many individuals after receiving the vaccine. We are developing VIR-2482 as a universal prophylactic for influenza A and have designed it to overcome both limitations of flu vaccines, which we believe will lead to meaningfully higher levels of protection. We anticipate that the initial registration population for VIR-2482 will be individuals at high risk of influenza A complications, such as the elderly with chronic lung disease or congestive heart failure.
VIR-2482 is an intramuscularly administered influenza A-neutralizing mAb currently in a Phase 1/2 clinical trial. In vitro, VIR-2482 has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. We believe that VIR-2482 has the potential to provide superior protection to flu vaccines and be able to be used year after year because it has broad strain coverage as opposed to the limited strain coverage generated by vaccines. We also believe that it provides passive immunity rather than relying on a person to generate active immunity via a functional immune response, an ability that is known to decline with age. VIR-2482 has been engineered to increase lung tissue bioavailability and to extend its half-life so that a single intramuscular dose has the potential to last the entire flu season, which is typically five to six months long. VIR-2482 is estimated to have a half-life of 58 days based on preliminary data. VIR-2482 has been generally well-tolerated in the approximately 100 healthy volunteers dosed in the Phase 1 portion of the clinical trial. We anticipate initiating the Phase 2 portion of the clinical trial in the northern hemisphere in the fourth quarter of 2020, followed by a second northern hemisphere season if necessary. Data from an interim analysis of the first flu season of the Phase 2 clinical trial are anticipated to be available in the first half of 2021.
HIV: Each year there are approximately 1.8 million new cases of HIV and approximately 1.0 million HIV-related deaths globally. Current prevention approaches such as behavioral modification and pharmacological intervention have had only a modest effect on HIV transmission globally, leaving a high unmet medical need for a safe and effective vaccine for the billions of individuals who are or may become sexually active. VIR-1111 is a proof of concept HIV vaccine designed to elicit a type of immune response that is different from other vaccines. We anticipate the initial registration population for our eventual HIV vaccine will be individuals at high risk of contracting HIV.
VIR-1111 is a subcutaneously administered HIV T cell vaccine based on HCMV for which we plan to submit an IND in the second half of 2020 and thereafter commence a Phase 1 clinical trial. VIR-1111 has been designed to elicit T cells that recognize HIV epitopes that are different from those recognized by prior HIV vaccines and to stimulate a different and specific type of T cell immune response to HIV, known as an HLA-E restricted immune response. An HLA-E restricted immune response has been shown to be associated with protection of NHPs from simian immunodeficiency virus, or SIV, the NHP equivalent of HIV. VIR-1111 is a vaccine designed solely to establish proof of concept in a Phase 1 clinical trial to determine whether the unique immune response observed in NHPs can be replicated in humans.
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TB: Globally, nearly two billion people are latently infected with TB, and each year there are approximately 10 million new active cases of TB and approximately 1.6 million TB-related deaths. There is a high unmet medical need for a safe and effective vaccine that prevents active pulmonary TB in adolescents and adults, as they represent the key sources of TB transmission and are the primary contributors to overall disease burden. VIR-2020 is a vaccine designed to provide a type of immune response that is different from other vaccines and lead to meaningful levels of protection from active TB. We anticipate that the initial registration population for VIR-2020 will be people at high risk of developing active TB, such as those who have latent TB infection.
VIR-2020 is a subcutaneously administered TB T cell vaccine based on HCMV for which we plan to submit an IND in 2023 and thereafter commence a Phase 1 clinical trial. VIR-2020 is designed to stimulate T cells that reside in the lung and to recognize TB epitopes that are different from those recognized by prior TB vaccines. In preclinical studies, a T cell vaccine based on RhCMV has been shown to provide protection of NHPs from TB.
Recent SARS-CoV-2 Activities
Since February 2020, we have entered into a number of collaboration agreements to accelerate the development, manufacture, and potential commercialization of therapies to treat and prevent SARS-CoV-2 and other coronaviruses. We have also made substantial efforts to protect our intellectual property in this area, as evidenced by our recent expansion of our patent portfolio.
Development and Commercialization
GSK Collaboration Agreement
In June 2020, we entered into a definitive collaboration agreement with Glaxo Wellcome UK Limited and Beecham S.A. of GSK (and collectively referred to as GSK), pursuant to which we agreed to collaborate to research, develop and commercialize products for the prevention, treatment and prophylaxis of diseases caused by SARS-CoV-2 and potentially other coronaviruses. The collaboration is focused on the development and commercialization of three types of collaboration products under three programs: (1) antibodies targeting SARS-CoV-2, and potentially other coronaviruses, or the Antibody Program; (2) vaccines targeting SARS-CoV-2, and potentially other coronaviruses, or the Vaccine Program, and (3) products based on genome-wide CRISPR screening of host targets expressed in connection with exposure to SARS-CoV-2, or the Functional Genomics Program. The initial antibodies under the Antibody Program will be VIR-7831 and VIR-7832, which have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralizing SARS-CoV-2 in live-virus cellular assays.
We are primarily responsible for the development and clinical manufacturing activities for the Antibody Program, and for conducting the initial development activities directed to a vaccine in the Vaccine Program. GSK will be primarily responsible for the commercialization activities for the Antibody Program (except in connection with sales of antibody products licensed to WuXi in greater China), the later-stage development, manufacturing and commercialization activities for the Vaccine Program and the development, manufacturing and commercialization activities for the Functional Genomics Program. We and GSK are required to use commercially reasonable efforts to conduct the activities assigned to each party under each development plan and to seek and obtain regulatory approval for collaboration products that arise from such activities in the United States and specified major markets. Subject to an opt-out mechanism, we and GSK will share all development costs, manufacturing costs and costs and expenses for the commercialization of the collaboration products, with us bearing 72.5% of such costs for the antibody products, 27.5% of such costs for the vaccine products, and we and GSK sharing equally all such costs for the functional genomics products, and all profits will be shared in the same ratios. If we and GSK elect to conduct a technology transfer of manufacturing technology under our agreements with WuXi (as further described below) and Biogen, we will bear 72.5% of the costs related to such
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manufacturing technology transfer and for commercial manufacturing of the antibody products under such agreements with WuXi and Biogen, and GSK will bear 27.5% of such costs. The parties will also share the committed costs for the reservation of manufacturing capacity for the drug substance for antibody products in the foregoing ratio under our agreement with Samsung as well as such costs relating to committed manufacturing capacity for antibody products as are approved by the joint steering committee from time to time.
On an antibody product-by-antibody product basis, we have a co-promotion right with respect to such antibody product in the United States, pursuant to which we will have the right to perform up to 20% of details in connection with such antibody product. GSK will lead commercialization and book all sales and is required to use commercially reasonable efforts to commercialize each collaboration product following regulatory approval in the United States and specified major markets. This definitive agreement superseded and replaced the April 2020 preliminary agreement with GSK. In connection with the GSK collaboration, we also entered into a stock purchase agreement in April 2020, pursuant to which we issued 6,626,027 shares of our common stock to an affiliate of GSK at a price per share of $37.73, for an aggregate purchase price of approximately $250.0 million.
Expansion of Alnylam Collaboration and License Agreement
In March and April 2020, we entered into two further amendments to our collaboration and license agreement with Alnylam, dated October 16, 2017, to expand our existing collaboration of five infectious disease targets to nine, including one targeting SARS-CoV-2 and potentially other coronaviruses, and up to three targeting human host factors for SARS-CoV-2.
Pursuant to both recent amendments, we and Alnylam will each be responsible for pre-clinical development costs incurred by such party in performing its allocated responsibilities under an agreed-upon initial pre-clinical development plan for each of the four new targets. We and Alnylam will equally share costs incurred in connection with the manufacture of non-GMP drug product required for pre-clinical development prior to filing of an IND. Following the completion of initial pre-clinical development activities, if we exercise our option to progress one or more candidates arising from the coronavirus program into further development, we will be responsible for conducting all development, manufacturing and commercialization activities at our sole expense, subject to Alnylam’s right to opt-in, during a specified period, to share equally with us the profits and losses in connection with development and commercialization of a coronavirus product.
Manufacturing
Consistent with our corporate manufacturing strategy of building internal capabilities in chemistry, manufacturing and control, or CMC, and working with contract development and manufacturing organizations, or CDMOs, to supply clinical and commercial batches of our product candidates, we have entered into the following agreements to date in support of our SARS-CoV-2 program:
WuXi Manufacturing Agreements
In February 2020, we entered into a development and manufacturing collaboration agreement with WuXi, for the clinical development, manufacturing, and commercialization of our proprietary antibodies developed for SARS-CoV-2. Under the agreement, WuXi will conduct cell-line development, process and formulation development, and initial manufacturing for clinical development. WuXi will have the right to commercialize products incorporating such antibodies in greater China pursuant to an exclusive license granted for the selected antibodies that have been developed. We will have the right to commercialize such products in all other markets worldwide.
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WuXi will perform mutually agreed development and manufacturing activities, under individual statements of work. In addition, the parties agreed that WuXi will pay us tiered royalties at percentages ranging from the high single-digits to mid-teens on annual net sales of all products sold by WuXi in greater China.
On June 15, 2020, we entered into a binding letter of intent with WuXi, pursuant to which WuXi will perform certain development and manufacturing services for our SARS-CoV-2 antibody program. Under the terms of the letter of intent, we have committed to purchase a firm and binding capacity reservation for the manufacture of a specified number of batches of drug substance of our SARS-CoV-2 antibody in 2020 and 2021. In addition, we have the right to order an additional specified number of batches of drug substance, provided we make such election by a specified date in the fourth calendar quarter in 2020. WuXi is obligated to reserve such manufacturing slots on a non-cancellable basis, and will manufacture the agreed number of batches of drug substance in accordance with an agreed manufacturing schedule. We are obligated to pay a total of approximately $130.0 million for such capacity reservation, if all batches are manufactured, inclusive of estimated raw material costs, with between 70% and 80% of the batch production fees owed to WuXi on a take-or-pay basis regardless of whether we utilize such manufacturing slots. The amounts will be payable during 2020 and 2021 and invoiced on a per-batch basis. The SARS-CoV-2 antibody drug substance contemplated to be manufactured in accordance with the terms of the letter of intent will be utilized in connection with progressing the development and commercialization of the SARS-CoV-2 antibody product under our collaboration with GSK.
We and WuXi will continue to negotiate additional terms in a definitive commercial manufacturing and supply agreement and will use commercially reasonable efforts to execute such definitive agreement before July 30, 2020.
We will bear 72.5% of the costs under the development and manufacturing collaboration agreement and letter of intent with WuXi and GSK will bear 27.5% of such costs pursuant to our collaboration agreement with GSK, subject to certain conditions and exceptions.
Biogen Clinical Development and Manufacturing Agreement
In May 2020, we entered into a clinical development and manufacturing agreement with Biogen pursuant to which Biogen will perform process development activities and specified manufacturing services under agreed statements of work for certain pre-commercial and clinical supply of our SARS-CoV-2 mAbs. We also agreed to collaborate with Biogen to develop highly productive clonal cell lines and clinical and commercial manufacturing processes for our SARS-CoV-2 mAbs. These processes are designed to be transferrable to global biomanufacturing facilities designed for advanced biologics production. Under the agreement, Biogen will conduct cGMP clinical manufacturing in the United States and provide technical support to facilitate process transfer to Samsung, and potentially other large-scale biomanufacturing facilities in the United States and other regions of the world to enable us to obtain reliable supply of a potential commercial product.
Under the terms of the Biogen agreement, we have agreed to pay fees for Biogen’s performance of services as provided in each applicable statement of work, including costs to third parties on a pass-through basis. We entered into three statements of work with Biogen for the process development and certain clinical manufacturing services simultaneously with the execution of the agreement, with the cost of activities under such agreed statements of work totaling approximately $13.8 million.
The Biogen agreement provides us the right to request a technology transfer of all manufacturing technology and processes developed under the agreement to us or any third party designated by us to conduct manufacturing of a SARS-CoV-2 antibody using such technology, including applicable licenses to us under Biogen’s relevant intellectual property rights. In connection with any such technology transfer, we have also agreed to pay an “access fee” to Biogen for each successful batch of SARS-CoV-2 antibody drug substance manufactured using
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certain improvements relating to increases in batch yield developed under the agreement, whether such manufacturing is performed by us, our affiliates, or third parties. If we successfully manufacture all batches of SARS-CoV-2 antibody drug substance for which we are currently committed under the Samsung letter agreement, based on our current working assumptions of manufacturing yield per batch, the access fee payable to Biogen in connection with the Samsung manufacturing will total approximately $100.0 million.
We will bear 72.5% of the costs under the Biogen agreement and GSK will bear 27.5% of such costs pursuant to our collaboration agreement with GSK, subject to certain conditions and exceptions.
Samsung Manufacturing Agreement
In April 2020, we entered into a binding letter agreement with Samsung pursuant to which Samsung will perform development and manufacturing services for our SARS-CoV-2 mAbs. Under the terms of the letter agreement, we have committed to purchase a firm and binding capacity reservation for a specified number of drug substance manufacturing slots in 2021 and 2022. Samsung will reserve such manufacturing slots on a non-cancellable, non-adjustable basis and will not offer such manufacturing slots under our capacity reservation to third parties. We are obligated to pay a total of approximately $362.0 million for such capacity reservation on a take-or-pay basis regardless of whether such manufacturing slots are utilized by us. The amounts will be payable during 2021 and 2022 and invoiced on a per-batch basis, with shortfalls invoiced at the end of the year in which such shortfall occurs. Samsung began performing services for us upon execution of the letter agreement, and we agreed to pay fees and out-of-pocket costs for the services performed thereunder. Samsung is expected to commence manufacturing on our behalf as early as October 2020 with the first engineering run.
We will bear 72.5% of the costs under the Samsung letter agreement and GSK will bear 27.5% of such costs pursuant to our collaboration agreement with GSK, subject to certain conditions and exceptions.
We continue to negotiate a definitive agreement with Samsung, to expand upon the letter agreement, and agreed to use best efforts to execute such definitive agreement before July 31, 2020.
Intellectual Property
VIR-7831
Our VIR-7831 intellectual property portfolio includes multiple United States provisional patent applications. These applications include composition of matter claims, pharmaceutical composition claims, and method of treatment claims. The 20-year term of any patents issuing from these provisional patent applications is presently estimated to expire in 2041, absent any available patent term adjustments or extensions.
Licensed Patents
Our VIR-7831 intellectual property portfolio also includes patents and patent applications that we have non- exclusively licensed from Xencor, Inc., or Xencor. As of February 15, 2020, these patents and applications include seven issued patents in the United States directed to composition of matter claims, methods of extending antibody serum half-life claims, pharmaceutical composition claims and process (methods of producing) claims. The 20-year term of these patents is presently estimated to expire between 2021 and 2025, absent any available patent term adjustments or extensions. Additionally, as of February 15, 2020, these patents and applications include 70 issued patents in Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, South Korea, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Poland, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom directed to composition of matter claims, pharmaceutical composition claims, method of
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treatment claims, composition for use in treatment claims and process (methods of producing) claims. The 20-year term of these patents is presently estimated to expire between 2021 and 2028, absent any available patent term adjustments or extensions.
The patents and applications we have non-exclusively licensed from Xencor also include, as of February 15, 2020, a pending patent application in the United States and five patent applications pending in Brazil, Canada, China, Europe and Russia directed to composition of matter claims, pharmaceutical composition claims, composition for use in treatment claims, and process (methods of producing) claims. The 20-year term of any patents issuing from these patent applications is presently estimated to expire between 2021 and 2028, absent any available patent term adjustments or extensions.
VIR-7832
Our VIR-7832 intellectual property portfolio includes multiple United States provisional patent applications. These applications include composition of matter claims, pharmaceutical composition claims, and method of treatment claims. The 20-year term of any patents issuing from these provisional patent applications is presently estimated to expire in 2041, absent any available patent term adjustments or extensions.
Licensed Patents
Our VIR-7832 intellectual property portfolio includes a patent family that we have exclusively licensed from Rockefeller, which includes, as of February 15, 2020, one pending patent application in the United States, one pending PCT patent application and one pending patent application in Europe. The applications in this family include composition of matter claims, pharmaceutical composition claims, method of treatment claims, composition for use in treatment claims and process (methods of producing) claims. The 20-year term of any patents issuing from the application in this family is presently estimated to expire in 2038, absent any available patent term adjustments or extensions.
Our VIR-7832 intellectual property portfolio also includes patents and patent applications that we have non- exclusively licensed from Xencor. As of February 15, 2020, these patents and applications include seven issued patents in the United States directed to composition of matter claims, methods of extending antibody serum half-life claims, pharmaceutical composition claims and process (methods of producing) claims. The 20-year term of these patents is presently estimated to expire between 2021 and 2025, absent any available patent term adjustments or extensions. Additionally, as of February 15, 2020, these patents and applications include 70 issued patents in Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, South Korea, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Poland, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom directed to composition of matter claims, pharmaceutical composition claims, method of treatment claims, composition for use in treatment claims and process (methods of producing) claims. The 20-year term of these patents is presently estimated to expire between 2021 and 2028, absent any available patent term adjustments or extensions.
The patents and applications we have non-exclusively licensed from Xencor also include, as of February 15, 2020, a pending patent application in the United States and five patent applications pending in Brazil, Canada, China, Europe and Russia directed to composition of matter claims, pharmaceutical composition claims, composition for use in treatment claims, and process (methods of producing) claims. The 20-year term of any patents issuing from these patent applications is presently estimated to expire between 2021 and 2028, absent any available patent term adjustments or extensions.
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VIR-2703
Licensed Patents
Our VIR-2703 intellectual property portfolio includes multiple United States provisional patent applications that we have exclusively licensed from Alnylam. These applications include composition of matter claims, pharmaceutical composition claims, and method of treatment claims. The 20-year term of any patents issuing from these provisional patent applications is presently estimated to expire in 2041, absent any available patent term adjustments or extensions.
Risks Associated with Our Business
Our business is subject to a number of risks of which you should be aware before making a decision to invest in our common stock. These risks are more fully described in the section titled “Risk Factors” immediately following this prospectus summary. These risks include, among others, the following:
| • | We have incurred significant net losses since inception and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve or maintain profitability. |
| • | Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability. |
| • | Even after this offering, we will require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations. |
| • | Our pursuit of a potential therapy for COVID-19, the disease caused by the virus SARS-CoV-2, is at an early stage, and we are committing substantial financial resources and personnel and making substantial capital commitments with third parties in furtherance thereof. |
| • | Our future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of our product candidates in a timely manner. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates and our ability to generate product revenue will be adversely affected. |
| • | We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates. We also intend to explore additional strategic collaborations, which may never materialize or may require that we relinquish rights to and control over the development and commercialization of our product candidates. |
| • | Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials and we cannot assure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals. |
| • | Clinical product development involves a lengthy and expensive process. We may incur additional costs and encounter substantial delays or difficulties in our clinical trials. |
| • | Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the current COVID-19 pandemic and future outbreaks of the disease. |
| • | We intend to rely on third parties to produce clinical and commercial supplies of our product candidates. |
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| • | If we are unable to obtain and maintain patent protection for our product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected. |
| • | We are highly dependent on our key personnel, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business will be harmed. |
Our Corporate Information
We were incorporated under the laws of the State of Delaware on April 7, 2016. Our principal executive offices are located at 499 Illinois Street, Suite 500, San Francisco, California 94158, and our telephone number is (415) 906-4324. Our corporate website address is www.vir.bio. Information contained on or accessible through our website is not a part of this prospectus or the registration statement of which it forms a part, and the inclusion of our website address in this prospectus is an inactive textual reference only.
“Vir Biotechnology,” “Vir Bio,” “Vir.Bio,” the Vir logo and other trademarks, trade names or service marks of Vir Biotechnology, Inc. appearing in this prospectus or the documents incorporated by reference herein are the property of Vir Biotechnology, Inc. All other trademarks, trade names and service marks appearing in this prospectus or incorporated by reference herein are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus or the documents incorporated by reference herein may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.
Implications of Being an Emerging Growth Company
We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, enacted in April 2012. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. In particular, in this prospectus, we have provided only two years of audited consolidated financial statements and have not included all of the executive compensation-related information that would be required if we were not an emerging growth company. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock.
We would cease to be an “emerging growth company” upon the earliest to occur of: (i) December 31, 2024; (ii) the last day of the fiscal year in which we have $1.07 billion or more in annual revenue; (ii) the date on which we first qualify as a large accelerated filer under the rules of the U.S. Securities and Exchange Commission, or the SEC; and (iii) the date on which we have, in any three-year period, issued more than $1.0 billion in non-convertible debt securities. We may choose to take advantage of some but not all of these reduced reporting burdens.
In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this exemption from new or revised accounting standards, and therefore we will not be subject to the same requirements to adopt new or revised accounting standards as other public companies that are not emerging growth companies.
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The Offering
| Common stock to be offered by us |
6,200,000 shares |
| Underwriters’ option to purchase additional shares |
930,000 shares |
| Common stock to be outstanding immediately after this offering |
122,499,280 shares (or approximately 123,429,280 shares if the underwriters exercise in full their option to purchase additional shares of common stock) |
| Use of proceeds |
We estimate that the net proceeds from this offering will be approximately $234.0 million (or approximately $269.2 million if the underwriters exercise in full their option to purchase up to 930,000 additional shares of common stock), based on the assumed public offering price of $40.32 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on July 2, 2020, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
| We currently intend to use the net proceeds from this offering, together with our existing cash, cash equivalents and short-term investments, to fund the research and development of our product candidates and development programs, including VIR-7831, VIR-7832, VIR-2703, VIR-2218, VIR-2218 with PEG-IFN-α, VIR-3434 and VIR-2482, and the remainder for commercial manufacturing and launch preparation for our SARS-CoV-2 antibodies, our other clinical trials and preclinical programs, as well as for working capital and other general corporate purposes. |
| The intended uses set forth above include any related milestone payments that may be due from us under the applicable license and collaboration agreements. In addition, we expect that the current grants from the Bill & Melinda Gates Foundation will fund the manufacture and early clinical development of VIR-1111 and VIR-2020. |
See the section titled “Use of Proceeds” for additional information.
| Risk factors |
You should read the section titled “Risk Factors” for a discussion of factors to consider carefully, together with all the other information included in this prospectus and incorporated by reference herein, before deciding to invest in our common stock. |
| Nasdaq Global Select Market symbol |
“VIR” |
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The number of shares of our common stock to be outstanding after this offering is based on 116,299,280 shares of common stock (excluding 1,457,432 shares of unvested restricted common stock) outstanding as of March 31, 2020 on a pro forma basis, and after giving effect to the subsequent issuances after March 31, 2020 of an aggregate of 7,948,912 shares of our common stock as described below, and excludes:
| • | 7,959,416 shares of our common stock issuable upon the exercise of outstanding stock options as of March 31, 2020, with a weighted-average exercise price of $7.30 per share; |
| • | 1,884,693 shares of our common stock issuable upon the exercise of outstanding stock options granted subsequent to March 31, 2020, with a weighted-average exercise price of $30.36 per share; |
| • | 7,611,513 shares of our common stock reserved for future issuance under our 2019 Equity Incentive Plan, or the 2019 Plan, as of March 31, 2020; and |
| • | 2,377,244 shares of our common stock reserved for future issuance under our 2019 Employee Stock Purchase Plan, or ESPP, as of March 31, 2020. |
Unless otherwise indicated, all information contained in this prospectus, including the number of shares of common stock that will be outstanding after this offering, assumes or gives effect to:
| • | the issuance of 6,626,027 shares of our common stock to Glaxo Group Limited, or GGL, on April 29, 2020 at a purchase price per share of $37.73, or approximately $250.0 million; |
| • | the issuance of 1,111,111 shares of our common stock to Alnylam on May 6, 2020 upon the achievement of a development milestone pursuant to a collaboration and license agreement; |
| • | the issuance of 211,774 shares of common stock to Takeda Ventures, Inc., or Takeda, on May 26, 2020 upon the cashless exercise of a warrant to purchase 244,444 shares; |
| • | no exercise of the outstanding options after March 31, 2020; and |
| • | no exercise by the underwriters of their option to purchase up to 930,000 additional shares of our common stock. |
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Summary Consolidated Financial Data
The following tables summarize our consolidated financial data for the periods and as of the dates set forth below. You should read the following summary consolidated financial data together with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the related notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, each of which are incorporated by reference herein. We have derived the summary consolidated statements of operations data for the years ended December 31, 2018 and 2019 from our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2019, which are incorporated by reference herein. We derived the summary consolidated statements of operations data for the three months ended March 31, 2019 and 2020, and the summary consolidated balance sheet data as of March 31, 2020, from our unaudited interim condensed consolidated financial statements included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which are incorporated by reference herein. Our unaudited consolidated interim financial statements were prepared on a basis consistent with our audited consolidated financial statements and include, in management’s opinion, all adjustments, consisting of normal recurring adjustments, that we consider necessary for a fair presentation of the financial information set forth in those financial statements. Our historical results are not necessarily indicative of the results that may be expected in the future and our results for the three months ended March 31, 2020 are not necessarily indicative of results to be expected for the full fiscal year or any other period.
| Year Ended December 31, |
Three Months Ended March 31, |
|||||||||||||||
| 2018 | 2019 | 2019 | 2020 | |||||||||||||
| (in thousands, except share and per share data) |
||||||||||||||||
| Consolidated Statements of Operations Data: |
||||||||||||||||
| Revenue: |
||||||||||||||||
| Grant revenue |
$ | 9,800 | $ | 7,380 | $ | 3,644 | $ | 5,231 | ||||||||
| Contract revenue |
868 | 711 | 17 | 487 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total revenue |
10,668 | 8,091 | 3,661 | 5,718 | ||||||||||||
| Operating expenses: |
||||||||||||||||
| Research and development |
100,229 | 148,472 | 25,872 | 64,979 | ||||||||||||
| General and administrative |
29,131 | 37,598 | 8,559 | 12,649 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating expenses |
129,360 | 186,070 | 34,431 | 77,628 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss from operations |
(118,692 | ) | (177,979 | ) | (30,770 | ) | (71,910 | ) | ||||||||
| Other income (expense): |
||||||||||||||||
| Interest income |
2,540 | 8,511 | 2,245 | 1,755 | ||||||||||||
| Other income (expense), net |
(212 | ) | (5,061 | ) | (145 | ) | (7,069 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total other income (expense) |
2,328 | 3,450 | 2,100 | (5,314 | ) | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss before benefit from (provision for) income taxes |
(116,364 | ) | (174,529 | ) | (28,670 | ) | (77,224 | ) | ||||||||
| Benefit from (provision for) income taxes |
480 | (154 | ) | — | (16 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ | (115,884 | ) | $ | (174,683 | ) | $ | (28,670 | ) | $ | (77,240) | |||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss per share, basic and diluted(1) |
$ | (15.12) | $ | (5.76) | $ | (3.19) | $ | (0.71) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Weighted-average shares outstanding, basic and diluted(1) |
7,666,463 | 30,349,920 | 9,001,158 | 108,387,913 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| (1) | See Notes 2 and 13 to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2019 and Note 12 to our unaudited condensed consolidated financial statements included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, each of which are incorporated by reference herein, for explanations of the |
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| calculations of our basic and diluted net loss per share and the weighted-average number of shares outstanding used in the computation of the per share amounts. |
| As of March 31, 2020 | ||||||||||||
| Actual | Pro Forma(1) | Pro Forma As Adjusted(2)(3) |
||||||||||
| (in thousands) | ||||||||||||
| Consolidated Balance Sheet Data: |
||||||||||||
| Cash, cash equivalents and short-term investments |
$ | 355,611 | $ | 605,611 | $839,596 | |||||||
| Working capital(4) |
321,145 | 571,145 | 805,130 | |||||||||
| Total assets |
477,114 | 727,114 | 961,099 | |||||||||
| Accumulated deficit |
(445,759 | ) | (445,759 | ) | (445,759) | |||||||
| Total stockholders’ equity |
380,333 | 630,333 | 864,318 | |||||||||
| (1) | The pro forma column reflects: (i) the issuance of 6,626,027 shares of our common stock to GGL on April 29, 2020 at a purchase price per share of $37.73, or approximately $250.0 million; (ii) the issuance of 1,111,111 shares of our common stock to Alnylam on May 6, 2020 upon the achievement of a development milestone pursuant to a collaboration and license agreement; and (iii) the issuance of 211,774 shares of common stock to Takeda on May 26, 2020 upon the cashless exercise of a warrant to purchase 244,444 shares. |
| (2) | The pro forma as adjusted column reflects (i) the pro forma adjustments set forth in footnote (1) above and (ii) the sale of 6,200,000 shares of our common stock in this offering at the assumed public offering price of $40.32 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on July 2, 2020, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
| (3) | The pro forma as adjusted information discussed above is illustrative only and will depend on the actual public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed public offering price of $40.32 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on July 2, 2020, would increase or decrease, as applicable, each of our pro forma as adjusted cash, cash equivalents and short-term investments, working capital, total assets and total stockholders’ equity by approximately $5.8 million, assuming the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares of common stock offered by us would increase or decrease, as applicable, each of our pro forma as adjusted cash, cash equivalents and short-term investments, working capital, total assets and total stockholders’ equity by approximately $37.9 million, assuming the assumed public offering price of $40.32 per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
| (4) | We define working capital as current assets less current liabilities. See our unaudited condensed consolidated financial statements and the related notes included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which is incorporated by reference herein, for further details regarding our current assets and current liabilities. |
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Investing in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below, as well as the risks and uncertainties set forth under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which is incorporated by reference herein, and all of the other information in this prospectus and the documents incorporated by reference herein before deciding whether to purchase shares of our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. If any of the following risks are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected. In that event, the price of our common stock could decline, and you could lose part or all of your investment.
Risks Related to This Offering
We have broad discretion in the use of our cash, cash equivalents and short-term investments, including the net proceeds from this offering, and may use them ineffectively, in ways with which you do not agree or in ways that do not increase the value of your investment.
Our management will have broad discretion in the application of our cash, cash equivalents and short-term investments, including the net proceeds from this offering, and could spend the proceeds in ways that do not improve our results of operations or enhance the value of our common stock. The failure by our management to apply these funds effectively could result in additional operating losses that could have a negative impact on our business, cause the price of our common stock to decline and delay the development of our product candidates. Pending their use, we may invest our cash, cash equivalents and short-term investments, including the net proceeds from this offering, in a manner that does not produce income or that loses value. See the section titled “Use of Proceeds” for additional information.
We will require substantial additional funding to finance our operations. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.
Based on our current operating plan, we expect our operating expenses to increase in future periods relative to our historical spend, and we believe that the net proceeds from this offering, together with our existing cash, cash equivalents and short-term investments, will fund our operations through at least the next 12 months. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned. Moreover, it is particularly difficult to estimate with certainty our future expenses given the dynamic and rapidly evolving nature of our business and the COVID-19 pandemic environment generally. The expected net proceeds from this offering, together with our cash, cash equivalents and short-term investments, will not be sufficient for us to fund any of our product candidates through regulatory approval, and we will need to raise additional capital to complete the development and commercialization of our product candidates and fund certain of our existing manufacturing and other commitments. We expect to finance our cash needs through public or private equity or debt financings, third-party (including government) funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. Our future capital requirements will depend on many factors, including:
| • | the timing, progress and results of our ongoing preclinical studies and clinical trials of our product candidates; |
| • | the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials of other product candidates that we may pursue; |
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| • | our ability to establish and maintain collaboration, license, grant and other similar arrangements, and the financial terms of any such arrangements, including timing and amount of any future milestones, royalty or other payments due thereunder; |
| • | the costs, timing and outcome of regulatory review of our product candidates; |
| • | the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; |
| • | the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; |
| • | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; |
| • | any expenses needed to attract, hire and retain skilled personnel; |
| • | the costs of operating as a public company; and |
| • | the extent to which we acquire or in-license other companies’ product candidates and technologies. |
Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenue, if any, will be derived from sales of products that we do not expect to be commercially available for several years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives.
The COVID-19 pandemic continues to rapidly evolve and has already resulted in a significant disruption of global financial markets. If the disruption persists and deepens, we could experience an inability to access additional capital, which could in the future negatively affect our capacity for certain corporate development transactions or our ability to make other important, opportunistic investments. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or altogether terminate our research and development programs or future commercialization efforts, which may adversely affect our business, financial condition, results of operations and prospects. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
If you purchase shares of common stock in this offering, you will suffer immediate dilution of your investment.
The public offering price of our common stock will be substantially higher than the pro forma, as adjusted net tangible book value per share of our common stock as of March 31, 2020. Therefore, if you purchase shares of our common stock in this offering, you will pay a price per share that substantially exceeds our pro forma, as adjusted net tangible book value per share immediately after this offering. Based on the assumed public offering price of $40.32 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on July 2, 2020, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, you will experience immediate dilution of $33.69 per share, representing the difference between our pro forma, as adjusted net tangible book value per share after this offering and the public offering price per share. After this offering, we will also have outstanding options to purchase common stock. To the extent these outstanding options are exercised, there will be further dilution to investors in this offering. See the section titled “Dilution” for additional information.
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Future sales and issuances of our capital stock or rights to purchase capital stock could result in additional dilution of the percentage ownership of our stockholders and could cause the price of our common stock to decline.
We may issue additional securities following the closing of this offering. Future sales and issuances of our capital stock or rights to purchase our capital stock could result in substantial dilution to our existing stockholders. We may sell common stock, convertible securities, and other equity securities in one or more transactions at prices and in a manner as we may determine from time to time. If we sell any such securities in subsequent transactions, investors may be materially diluted. New investors in such subsequent transactions could gain rights, preferences, and privileges senior to those of holders of our common stock.
Future sales of our common stock in the public market could cause the market price of our common stock to decline.
Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that such sales may have on the prevailing market price of our common stock.
As of March 31, 2020, we had outstanding a total of 108,350,368 shares of common stock (without giving effect to any of the share issuances that occurred after March 31, 2020). All of our outstanding shares as of such date were eligible for sale in the public market, other than shares and options held by directors, executive officers, and other affiliates that are subject to volume limitations under Rule 144 of the Securities Act of 1933, as amended, or the Securities Act, and various vesting agreements.
Future sales also could cause the trading price of our common stock to decline and make it more difficult for investors to sell shares of our common stock.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents we have filed with the SEC that are incorporated by reference herein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. All statements other than statements of historical facts contained in this prospectus or in the documents incorporated by reference herein, including statements regarding our strategy, future financial condition, future operations, research and development, planned clinical trials and preclinical studies, technology platforms, the timing and likelihood of regulatory filings and approvals for our product candidates, our ability to commercialize our product candidates, the potential benefits of collaborations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.
We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions described in the section titled “Risk Factors” and in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section in our Annual Report on Form 10-K for the year ended December 31, 2019 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which are incorporated by reference herein, and elsewhere in this prospectus and the documents incorporated by reference herein. Other sections of this prospectus and the documents incorporated by reference herein may include additional factors that could harm our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.
In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this prospectus or the documents incorporated by reference herein, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the section titled “Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. The Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act do not protect any forward-looking statements that we make in connection with this offering.
You should read this prospectus and the documents that we incorporate by reference in this prospectus and the documents that we have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this prospectus and in the documents incorporated by reference herein by these cautionary statements.
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Certain market, industry and competitive data contained or incorporated by reference in this prospectus were obtained from our own internal estimates and research, as well as from publicly available information, reports of governmental agencies and industry publications and surveys. In some cases, we do not expressly refer to the sources from which this data is derived. All of the market and industry data used in this prospectus is inherently subject to uncertainties and involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such information. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Risk Factors” in this prospectus. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.
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We estimate that the net proceeds to us from this offering will be approximately $234.0 million (or approximately $269.2 million if the underwriters exercise in full their option to purchase up to 930,000 additional shares of common stock), based on the assumed public offering price of $40.32 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on July 2, 2020, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
Each $1.00 increase or decrease in the assumed public offering price of $40.32 per share would increase or decrease, as applicable, the net proceeds to us from this offering by approximately $5.8 million, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares of common stock offered by us, would increase or decrease, as applicable, the net proceeds to us by approximately $37.9 million, assuming the assumed public offering price of $40.32 per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
We currently intend to use the net proceeds from this offering, together with our existing cash, cash equivalents and short-term investments, as follows:
| • | to fund the following clinical trials through completion: |
| • | VIR-7831 – our planned IND for SARS-CoV-2 and assuming regulatory clearance, subsequent Phase 2/3 clinical trial, |
| • | VIR-7832 – our planned IND or equivalent submission for SARS-CoV-2 and assuming regulatory clearance, subsequent Phase 2 |
| • | VIR-2703 – our ongoing preclinical studies for SARS-CoV-2, |
| • | VIR-2218 – our ongoing Phase 2 clinical trial of VIR-2218 and Phase 2 combination trial of VIR-2218 and PEG-IFN-α for HBV, |
| • | VIR-3434 – our ongoing Phase 1 clinical trial for HBV, and |
| • | VIR-2482 – our ongoing Phase 1/2 clinical trial for influenza A, including the Phase 2 portion of the trial in the northern hemisphere that we anticipate initiating in the fourth quarter of 2020; and |
| • | any remainder for commercial manufacturing and launch preparation for our SARS-CoV-2 antibodies, our other clinical trials and preclinical programs, as well as for working capital and other general corporate purposes. |
The intended uses set forth above include any related milestone payments that may be due from us under the applicable license and collaboration agreements. In addition, we expect that the current grants from the Bill & Melinda Gates Foundation will fund the manufacture and early clinical development of VIR-1111 and VIR-2020.
Based on our current operating plan, we expect our operating expenses to increase in future periods relative to our historical spend, and we believe that the net proceeds from this offering, together with our existing cash, cash equivalents and short-term investments, will fund our operations through at least the next 12 months.
This expected use of the net proceeds from this offering represents our intentions based on our current plans and business conditions, which could change in the future as our plans and business conditions evolve. Further, due to the uncertainties inherent in the drug development process, it is difficult to estimate with certainty the amounts of the net proceeds from this offering that may be used for the above purposes. Moreover, it is particularly difficult to estimate with certainty our future expenses given the dynamic and rapidly evolving nature of our business and the COVID-19 pandemic environment generally.
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Our management will have broad discretion over the use of the net proceeds from this offering, and our investors will be relying on the judgment of our management regarding the application of the net proceeds of this offering. The amounts and timing of our expenditures will depend upon numerous factors including the results of our research and development efforts, the timing and success of preclinical studies and any ongoing clinical trials or clinical trials we may commence in the future, the timing of regulatory submissions and the amount of cash obtained through current and any future collaborations.
The expected net proceeds from this offering, together with our cash, cash equivalents and short-term investments, will not be sufficient for us to fund any of our product candidates through regulatory approval and commercialization, and we will need to raise additional capital to complete the development and commercialization of our product candidates and fund certain of our existing manufacturing and other commitments. We expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaborations, and license and development agreements. We have based these estimates on assumptions that may prove to be incorrect, and we could expend our available capital resources at a rate greater than we currently expect.
Pending the use of the net proceeds from this offering as described above, we intend to invest the net proceeds in a variety of capital preservation instruments, including short-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.
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We have never declared or paid cash dividends on our capital stock, and we do not currently intend to pay any cash dividends on our capital stock in the foreseeable future. We currently intend to retain all available funds and any future earnings, if any, to fund the development and expansion of our business. Any future determination related to dividend policy will be made at the discretion of our board of directors, subject to applicable laws, and will depend upon, among other factors, our results of operations, financial condition, contractual restrictions and capital requirements. In addition, our ability to pay cash dividends on our capital stock in the future may be limited by the terms of any future debt or preferred securities we issue or any credit facilities we enter into.
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The following table sets forth our cash, cash equivalents and short-term investments, and our capitalization as of March 31, 2020 on:
| • | an actual basis; |
| • | a pro forma basis to reflect: (i) the issuance of 6,626,027 shares of our common stock to GGL on April 29, 2020 at a purchase price per share of $37.73, or approximately $250.0 million, (ii) the issuance of 1,111,111 shares of our common stock to Alnylam on May 6, 2020 upon the achievement of a development milestone pursuant to a collaboration and license agreement, and (iii) the issuance of 211,774 shares of common stock to Takeda on May 26, 2020 upon the cashless exercise of a warrant to purchase 244,444 shares; and |
| • | a pro forma as adjusted basis giving effect to the pro forma adjustments discussed above, and giving further effect to the sale of 6,200,000 shares of our common stock in this offering at the assumed public offering price of $40.32 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on July 2, 2020, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
You should read this table together with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” our consolidated financial statements and the related notes included in our condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which are incorporated by reference herein.
| As of March 31, 2020 | ||||||||||||
| Actual | Pro Forma | Pro Forma As Adjusted(1) |
||||||||||
| (in thousands, except share and per share amounts) |
||||||||||||
| Cash, cash equivalents and short-term investments |
$ | 355,611 | $ | 605,611 | $ | 839,596 | ||||||
|
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|
|
|
|
|
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| Stockholders’ equity: |
||||||||||||
| Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized as of March 31, 2020; no shares issued or outstanding, actual, pro forma, or pro forma as adjusted |
— | — | — | |||||||||
| Common stock, $0.0001 par value per shares; 300,000,000 shares authorized as of March 31, 2020; 108,350,368 shares issued and outstanding as of March 31, 2020, actual; 116,299,280 shares issued and outstanding, pro forma, and 122,499,280 shares issued and outstanding, pro forma as adjusted |
11 | 12 | 12 | |||||||||
| Additional paid-in capital |
825,833 | 1,075,832 | 1,309,817 | |||||||||
| Accumulated other comprehensive income |
248 | 248 | 248 | |||||||||
| Accumulated deficit |
(445,759 | ) | (445,759 | ) | (445,759 | ) | ||||||
|
|
|
|
|
|
|
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| Total stockholders’ equity |
380,333 | 630,333 | 864,318 | |||||||||
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|
|
|
|
|
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| Total capitalization |
$ | 380,333 | $ | 630,333 | $ | 864,318 | ||||||
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|
|
|
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| (1) | The pro forma as adjusted information discussed above is illustrative only and will depend on the actual public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed public offering price of $40.32 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on July 2, 2020, would increase or decrease, as applicable, each of our pro forma as adjusted cash, cash equivalents and short-term investments, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $5.8 million, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares of common stock offered by us would increase or decrease, as applicable, each of our pro forma as adjusted cash, cash equivalents and |
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| short-term investments, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $37.9 million, assuming that the assumed public offering price of $40.32 per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
The number of shares of our common stock to be outstanding after this offering is based on 116,299,280 shares of common stock (excluding 1,457,432 shares of unvested restricted common stock) outstanding as of March 31, 2020 on a pro forma basis, and after giving effect to the subsequent issuances after March 31, 2020 of an aggregate of 7,948,912 shares of our common stock as described above, and excludes:
| • | 7,959,416 shares of our common stock issuable upon the exercise of outstanding stock options as of March 31, 2020, with a weighted-average exercise price of $7.30 per share; |
| • | 1,884,693 shares of our common stock issuable upon the exercise of outstanding stock options granted subsequent to March 31, 2020, with a weighted-average exercise price of $30.36 per share; |
| • | 7,611,513 shares of our common stock reserved for future issuance under the 2019 Plan as of March 31, 2020; and |
| • | 2,377,244 shares of our common stock reserved for future issuance under the ESPP as of March 31, 2020. |
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If you invest in our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the public offering price per share of our common stock and the pro forma as adjusted net tangible book value per share of our common stock after this offering.
Our historical net tangible book value as of March 31, 2020 was $328.0 million, or $3.03 per share of our common stock. Our historical net tangible book value represents our total tangible assets less total liabilities. Historical net tangible book value per share is our historical net tangible book value divided by the number of shares of our common stock (excluding 1,457,432 shares of unvested restricted common stock) outstanding as of March 31, 2020.
Our pro forma net tangible book value as of March 31, 2020 was $578.0 million, or $4.97 per share of our common stock, based on the total number of shares of our common stock outstanding as of March 31, 2020 on a pro forma basis to reflect issuances of our common stock after March 31, 2020 as described below. Pro forma net tangible book value per share represents our total tangible assets less our total liabilities, divided by the number of shares of our common stock (excluding 1,457,432 shares of unvested restricted common stock) outstanding as of March 31, 2020 after giving effect to:
| • | the issuance of 6,626,027 shares of our common stock to GGL on April 29, 2020 at a purchase price per share of $37.73, or approximately $250.0 million; |
| • | the issuance of 1,111,111 shares of our common stock to Alnylam on May 6, 2020 upon the achievement of a development milestone pursuant to a collaboration and license agreement; and |
| • | the issuance of 211,774 shares of common stock to Takeda on May 26, 2020 upon the cashless exercise of a warrant to purchase 244,444 shares. |
After giving effect to the sale of 6,200,000 shares of common stock in this offering at the assumed public offering price of $40.32 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on July 2, 2020, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of March 31, 2020 would have been $812.0 million, or $6.63 per share. This represents an immediate increase in pro forma as adjusted net tangible book value of $1.66 per share to our existing stockholders and an immediate dilution of $33.69 per share to new investors participating in this offering.
The following table illustrates this dilution on a per share basis:
| Assumed public offering price per share |
$ | 40.32 | ||||||
| Historical net tangible book value per share as of March 31, 2020 |
$ | 3.03 | ||||||
| Pro forma increase in net tangible book value per share as of March 31, 2020 attributable to the pro forma transactions described above |
1.94 | |||||||
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|
|
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| Pro forma net tangible book value per share as of March 31, 2020 |
4.97 | |||||||
| Increase in pro forma net tangible book value per share attributable to new investors participating in this offering |
1.66 | |||||||
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| Pro forma as adjusted net tangible book value per share after this offering |
6.63 | |||||||
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| Dilution per share to new investors participating in this offering |
$ | 33.69 | ||||||
|
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|
The pro forma as adjusted information discussed above is illustrative only and will depend on the actual public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed public offering price of $40.32 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on July 2, 2020, would increase or decrease, as applicable, our pro
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forma as adjusted net tangible book value per share after this offering by $0.05 per share and the dilution per share to new investors participating in this offering by $0.95 per share, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, an increase of 1.0 million in the number of shares of common stock offered by us would increase the pro forma as adjusted net tangible book value after this offering by $0.25 per share and decrease the dilution per share to new investors participating in this offering by $0.25 per share, and a decrease of 1.0 million shares of common stock offered by us would decrease the pro forma as adjusted net tangible book value by $0.26 per share, and increase the dilution per share to new investors in this offering by $0.26 per share, assuming that the assumed public offering price of $40.32 per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
If the underwriters exercise in full their option to purchase up to 930,000 additional shares of common stock from us, the pro forma as adjusted net tangible book value per share after giving effect to this offering would be $6.86 per share, representing an immediate increase to existing stockholders of $1.89 per share, and dilution to new investors participating in this offering of $33.46 per share.
The foregoing discussion and tables above are based on 116,299,280 shares of common stock (excluding 1,457,432 shares of unvested restricted common stock) outstanding as of March 31, 2020 on a pro forma basis, and after giving effect to the subsequent issuances after March 31, 2020 of an aggregate of 7,948,912 shares of our common stock as described above, and excludes:
| • | 7,959,416 shares of our common stock issuable upon the exercise of outstanding stock options as of March 31, 2020, with a weighted-average exercise price of $7.30 per share; |
| • | 1,884,693 shares of our common stock issuable upon the exercise of outstanding stock options granted subsequent to March 31, 2020, with a weighted-average exercise price of $30.36 per share; |
| • | 7,611,513 shares of our common stock reserved for future issuance under the 2019 Plan as of March 31, 2020; and |
| • | 2,377,244 shares of our common stock reserved for future issuance under the ESPP as of March 31, 2020. |
To the extent that any outstanding options are exercised, new options or other equity awards are issued under our equity incentive plans, or we issue additional equity or convertible debt securities in the future, there will be further dilution to new investors participating in this offering.
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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
The following includes a summary of transactions since January 1, 2017 and any currently proposed transactions, to which we were or are to be a participant, in which (i) the amount involved exceeded or will exceed $120,000 and (ii) any of our directors, executive officers or holders of more than 5% of our capital stock, or any affiliate or member of the immediate family of the foregoing persons, had or will have a direct or indirect material interest, other than compensation and other arrangements that are described under the sections titled “Executive Compensation” and “Director Compensation” included in our Definitive Proxy Statement on Schedule 14A for our 2020 Annual Meeting of Stockholders, which is incorporated by reference herein.
We believe the terms obtained or consideration that we paid or received, as applicable, in connection with the transactions described below were comparable to terms available or the amounts that we would pay or receive, as applicable, in arm’s-length transactions.
Convertible Preferred Stock Financings
Series A-1 Convertible Preferred Stock Financing
In September 2016, we entered into a Series A-1 preferred stock purchase agreement with various investors, pursuant to which we issued shares of our Series A-1 convertible preferred stock at a price per share of $4.50. We held a second closing in March 2017, at which time we issued an additional 3,333,333 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $15.0 million. Two additional closings occurred in June 2017, at which time we issued an aggregate of 24,571,107 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $110.6 million. The fifth closing occurred in July 2017, at which time we issued an additional 6,641,111 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $29.9 million.
In August 2017, the Series A-1/B Purchase Agreement was amended and restated, or the A&R Purchase Agreement, pursuant to which we issued an aggregate of 25,843,330 shares of Series A-1 convertible preferred stock at $4.50 per share for gross proceeds of $116.3 million in five closings. The first two closings occurred in August 2017, at which time we issued an aggregate of 21,111,110 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $95.0 million. Two additional closings occurred in September 2017, at which time we issued an aggregate of 3,968,270 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $17.9 million. The fifth closing occurred in October 2017, at which time we issued an aggregate of 763,950 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $3.4 million. In June 2018, the A&R Purchase Agreement was amended, or the Amended A&R Purchase Agreement, pursuant to which we issued an aggregate of 3,222,220 shares of Series A-1 convertible preferred stock at $4.50 per share for gross proceeds of $14.5 million in two closings. The first closing occurred in June 2018, at which time we issued an additional 2,777,776 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $12.5 million. The second closing occurred in July 2018, at which time we issued an additional 444,444 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $2.0 million.
The table below sets forth the number of shares of our Series A-1 convertible preferred stock purchased by our executive officers, directors, holders of more than 5% of our capital stock and their affiliated entities or immediate family members. Each share of Series A-1 convertible preferred stock in the table below converted into one share of our common stock in October 2019 upon the closing of our initial public offering.
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| Name | Series A-1 Convertible Preferred Stock (#) |
Aggregate Cash Purchase Price ($) |
||||||
| Entities affiliated with ARCH Venture Partners(1) |
24,444,442 | 110,000,000 | ||||||
| SVF Endurance (Cayman) Limited(2) |
15,555,555 | 70,000,000 | ||||||
| Alta Partners NextGen Fund I, L.P.(3) |
1,666,666 | 7,500,000 | ||||||
| (1) | Kristina Burow and Robert Nelsen, members of our Board of Directors, were designated to our Board in 2016 by ARCH Venture Fund IX, L.P., or ARCH IX, which is an affiliate of ARCH Venture Fund IX Overage, L.P., or ARCH Overage, and their affiliated funds. ARCH Venture Partners IX, L.P., or ARCH IX LP, is the sole general partner of ARCH IX, and ARCH IX Overage LP is the sole general partner of ARCH Overage. Mr. Nelsen is a managing director of ARCH Venture Partners IX, LLC, or ARCH IX LLC, the sole general partner of ARCH IX LP and ARCH IX Overage LP. Ms. Burow holds an interest in each of ARCH IX LP and ARCH IX Overage LP. Dr. Daniel, a former member of our Board of Directors, is a venture partner of ARCH, which is an affiliate of ARCH IX and ARCH Overage, and their affiliated funds. Dr. Parrish, our Chief Business Officer, is a venture partner of ARCH, which is an affiliate of ARCH IX and ARCH Overage, and their affiliated funds. |
| (2) | SVF Endurance (Cayman) Limited is a wholly owned subsidiary of SoftBank Vision Fund (AIV M1) L.P., SVF. Dipchand Nishar, a member of our Board of Directors, was designated to our Board in 2017 by SVF. Mr. Nishar is Senior Managing Partner at SoftBank Investment Advisers, an affiliate of SVF. |
| (3) | Robert More, a member of our board of directors, is a managing director of Alta Partners NextGen Fund I Management, LLC, or APNG I Management. APNG I Management is the general partner of Alta Partners NextGen Fund I, L.P., or APNG I. |
Series B Convertible Preferred Stock Financing
In January 2019, we issued an aggregate of 18,202,213 shares of Series B convertible preferred stock at $18.00 per share for gross proceeds of $327.6 million in two closings pursuant to an Amended and Restated Series A-1 and Series B Preferred Stock Purchase Agreement. Both closings occurred in January 2019.
The table below sets forth the number of shares of our Series B convertible preferred stock purchased by our executive officers, directors, holders of more than 5% of our capital stock and their affiliated entities or immediate family members. Each share of Series B convertible preferred stock in the table below converted into one share of our common stock upon the completion of our initial public offering.
| Name |
Series B Convertible Preferred Stock (#) |
Aggregate Cash Purchase Price ($) |
||||||
| Entities affiliated with ARCH Venture Partners(1) |
2,777,777 | 50,000,000 | ||||||
| SVF Endurance (Cayman) Limited(2) |
6,111,111 | 110,000,000 | ||||||
| Alta Partners NextGen Fund I, L.P.(3) |
277,777 | 5,000,000 | ||||||
| (1) | Ms. Burow and Mr. Nelsen, members of our Board of Directors, were designated to our Board in 2016 by ARCH IX, which is an affiliate of ARCH Overage, and their affiliated funds. ARCH IX LP, is the sole general partner of ARCH IX, and ARCH IX Overage LP is the sole general partner of ARCH Overage. Mr. Nelsen is a managing director of ARCH IX LLC, the sole general partner of ARCH IX LP and ARCH IX Overage LP. Ms. Burow holds an interest in each of ARCH IX LP and ARCH IX Overage LP. Dr. Daniel, a former member of our Board of Directors, is a venture partner of ARCH, which is an affiliate of ARCH IX and ARCH Overage, and their affiliated funds. Dr. Parrish, our Chief Business Officer, is a venture partner of ARCH, which is an affiliate of ARCH IX and ARCH Overage, and their affiliated funds. |
| (2) | SVF Endurance (Cayman) Limited is a wholly owned subsidiary of SVF. Mr. Nishar, a member of our Board of Directors, was designated to our Board in 2017 by SVF. Mr. Nishar is Senior Managing Partner at SoftBank Investment Advisers, an affiliate of SVF. |
| (3) | Mr. More, a member of our Board of Directors, is a managing director of APNG I Management. APNG I Management is the general partner of APNG I. |
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Relationships with Klaus Frueh
In June 2016, we entered into a consulting agreement with Klaus Frueh, Ph.D., a former member of our Board of Directors and a stockholder, pursuant to which Dr. Frueh agreed to provide certain consulting, advisory and related services within the field of immune programming on an exclusive basis, in exchange for a consulting fee of $150,000 per year. Unless we terminate the agreement earlier, the consulting agreement will terminate in September 2021. We paid Dr. Frueh an aggregate of $150,000 pursuant to the consulting agreement during 2019.
Investors’ Rights, Management Rights, Voting and Co-Sale Agreements
In connection with our convertible preferred stock financings, we entered into investors’ rights, management rights, voting and right of first refusal and co-sale agreements containing registration rights, information rights, rights of first offer, voting rights and rights of first refusal, among other things, with certain holders of our capital stock. The holders of more than 5% of our capital stock that are party to these agreements are entities affiliated with ARCH Venture Partners and SVF. In connection with our acquisition of TomegaVax, former stockholders of TomegaVax became parties to the investors’ rights, voting and right of first refusal and co-sale agreements. Our directors who are parties to these agreements are Dr. Frueh, who resigned from our Board in October 2019, and Mr. More.
These stockholder agreements terminated upon the closing of our initial public offering in October 2019, except for the registration rights granted under our investors’ rights agreement, which will terminate upon the earliest of (i) the closing of a deemed liquidation event, as defined in our amended and restated certificate of incorporation as currently in effect; (ii) with respect to each stockholder, the date when such stockholder can sell all of its registrable shares without limitation during a three-month period without registration pursuant to Rule 144 of the Securities Act, or Rule 144, or another similar exemption under the Securities Act; and (iii) five years after the completion of our initial public offering.
Certain Loan Transactions
In January 2017, we issued two promissory notes to Dr. Scangos, our President, Chief Executive Officer and a member of our Board of Directors, and Vicki Sato, Ph.D., Chairman of our Board of Directors, for principal amounts of $2.9 million and $0.2 million, respectively, with an interest rate of 1.97% per annum, to allow Dr. Scangos and Dr. Sato to purchase 3,338,222 shares and 286,133 shares of our restricted stock, respectively, pursuant to their respective restricted stock purchase agreements. The principal and accrued interest outstanding on each of these promissory notes was approximately $3.0 million and $0.3 million for Dr. Scangos and Dr. Sato, respectively, as of July 31, 2019. These loans were repaid in full in August 2019.
Employment of an Immediate Family Member
Jennifer Scangos, the daughter of Dr. Scangos, our President, Chief Executive Officer and a member of our board of directors, is employed by us as a legal counsel. For the years ended December 31, 2017 and 2018, Ms. Scangos earned $9,394 and $153,282, respectively, in base salary and bonus which was in line with similar roles at the Company. For the year ended December 31, 2019, Ms. Scangos earned $139,000 and $24,325, respectively, in base salary and bonus, which was in line with compensation we pay to employees in similar roles. Ms. Scangos has received and continues to be eligible to receive equity awards and benefits on the same general terms and conditions as applicable to unrelated employees in similar positions.
Collaboration with Brii Biosciences
In May 2018, we entered into an option and license agreement with Brii Bio Parent and Brii Bio, pursuant to which we granted, and were granted, an exclusive option with respect to up to four collaboration programs for the development and commercialization of therapeutic products for infectious diseases. Dr. Scangos, our
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President, Chief Executive Officer and a member of our Board of Directors, and Mr. Nelsen, a member of our Board of Directors, served at the time and currently serve as directors of Brii Bio Parent and Brii Bio. We agreed to pay Brii Bio an option exercise fee for each licensed Brii Bio program up to $50.0 million, and milestone payments and royalties for net sales of licensed products in the United States arising from the selected collaboration programs. Brii Bio agreed to pay us an option exercise fee for each licensed Vir program up to $20.0 million, and milestone payments and royalties for net sales of licensed products in greater China arising from the selected collaboration programs. On June 12, 2020, following our achievement of proof of concept for VIR-2218, Brii Bio notified us of the exercise of its option to obtain exclusive rights to develop and commercialize compounds and products arising from VIR-2218 in greater China. Brii Bio paid us a $20.0 million option exercise fee in connection with the option exercise, half of which we will pay to Alnylam in connection with our collaboration and license agreement with Alnylam.
Other Transactions
We have entered into offer letter agreements with our executive officers that, among other things, provide for certain compensatory and change in control benefits, as well as severance benefits. For a description of these agreements with our named executive officers, see the sections titled “Executive Compensation” and “Director Compensation” included in our Definitive Proxy Statement on Schedule 14A for our 2020 Annual Meeting of Stockholders, which is incorporated by reference herein.
We have also granted stock options and restricted stock to our executive officers and certain of our directors. For a description of these equity awards, see the sections titled “Executive Compensation” and “Director Compensation” included in our Definitive Proxy Statement on Schedule 14A for our 2020 Annual Meeting of Stockholders, which is incorporated by reference herein.
Indemnification Agreements
We have entered into indemnification agreements with each of our current directors and executive officers. Our amended and restated certificate of incorporation and our amended and restated bylaws provide that we will indemnify our directors and officers to the fullest extent permitted by applicable law.
Other than as described above under this section “Certain Relationships and Related Party Transactions” and in the documents incorporated by reference herein, since January 1, 2017, we have not entered into any transactions, nor are there any currently proposed transactions, between us and a related person where the amount involved exceeds, or would exceed, $120,000, and in which any related person had or will have a direct or indirect material interest. We believe the terms of the transactions described above were comparable to terms we could have obtained in arm’s length dealings with unrelated third parties.
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The following description of our capital stock is based upon our amended and restated certificate of incorporation and our amended and restated bylaws. This summary does not purport to be complete and is subject to, and is qualified in its entirety by express reference to, the applicable provisions of our amended and restated certificate of incorporation and our amended and restated bylaws, which are filed as exhibits to the registration statement of which this prospectus is part. We encourage you to read our amended and restated certificate of incorporation, our amended and restated bylaws and the applicable provisions of the Delaware General Corporation Law, or the DGCL for more information.
General
Our amended and restated certificate of incorporation states that our authorized capital stock consists of 300,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.
Common Stock
Voting Rights
Each holder of common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders. The affirmative vote of holders of at least 66 2/3% of the voting power of all of the then-outstanding shares of capital stock, voting as a single class, is required to amend certain provisions of our amended and restated certificate of incorporation, including provisions relating to amending our amended and restated bylaws, the classified structure of our board of directors, the size of our board of directors, removal of directors, director liability, vacancies on our board of directors, special meetings, stockholder notices, actions by written consent and exclusive jurisdiction.
Dividends
The holders of our common stock are entitled to receive ratably any dividends that our board of directors may declare out of funds legally available for that purpose on a non-cumulative basis.
Liquidation
In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities.
Rights and Preferences
Holders of our common stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to our common stock.
Preferred Stock
Under our amended and restated certificate of incorporation, our board of directors has the authority, without further action by the stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each such series, to fix the rights, preferences and privileges of the shares of each wholly unissued series and any qualifications, limitations or restrictions thereon and to increase or decrease the number of shares of any such series, but not below the number of shares of such series then outstanding. Our board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of the common stock. The issuance of preferred stock, while providing flexibility in connection with possible
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acquisitions and other corporate purposes, could, among other things, have the effect of delaying, deferring or preventing a change in our control that may otherwise benefit holders of our common stock and may adversely affect the market price of the common stock and the voting and other rights of the holders of common stock.
Registration Rights Under Amended and Restated Investors’ Rights Agreement
Certain holders of shares of our common stock issued upon conversion of previously outstanding convertible preferred stock are entitled to certain rights with respect to registration of such shares under the Securities Act. These shares are referred to as registrable securities. The holders of these registrable securities possess registration rights pursuant to the terms of our amended and restated investors’ rights agreement and are described in additional detail below. The registration of shares of our common stock pursuant to the exercise of the registration rights described below would enable the holders to trade these shares without restriction under the Securities Act when the applicable registration statement is declared effective. We will pay the registration expenses, other than underwriting discounts, selling commissions and stock transfer taxes, of the shares registered pursuant to the piggyback and Form S-3 registrations described below.
Generally, in an underwritten offering, the managing underwriter, if any, has the right, subject to specified conditions and limitations, to limit the number of shares the holders may include. The demand, piggyback and Form S-3 registration rights described below will expire no later than five years after the completion of our initial public offering, or with respect to any particular holder, at such time that such holder can sell its shares under Rule 144 of the Securities Act during any three-month period.
Demand Registration Rights
Certain holders of our common stock issued upon conversion of previously outstanding convertible preferred stock are entitled to certain demand registration rights. Certain major investors holding, collectively, a majority of registrable securities may, on not more than two occasions, request that we register all or a portion of their shares, subject to certain specified exceptions.
Piggyback Registration Rights
Certain holders of our common stock issued upon conversion of previously outstanding convertible preferred stock are entitled to their rights to notice of this offering and to include their shares of registrable securities in this offering. The requisite percentage of these stockholders have waived all such stockholders’ rights to notice of this offering and to include their shares of registrable securities in this offering. In the event that we propose to register any of our securities under the Securities Act in another offering, either for our own account or for the account of other security holders, the holders of registrable securities will be entitled to certain “piggyback” registration rights allowing them to include their shares in such registration, subject to specified conditions and limitations.
S-3 Registration Rights
Certain holders of our common stock issued upon conversion of previously outstanding convertible preferred stock will be entitled to certain Form S-3 registration rights. Certain major investors holding at least 10% of registrable securities may, on not more than two registrations on Form S-3 within any 12-month period, request that we register all or a portion of their shares on Form S-3 if we are qualified to file a registration statement on Form S-3, subject to specified exceptions. Such request for registration on Form S-3 must cover securities with an aggregate offering price which equals or exceeds $5.0 million, net of selling expenses. The right to have such shares registered on Form S-3 is further subject to other specified conditions and limitations.
Stock Purchase Agreement with Glaxo Group Limited
On April 5, 2020, concurrently with the execution of the Preliminary Collaboration Agreement, we entered into a stock purchase agreement, or the Stock Purchase Agreement, with GGL, an affiliate of GSK, pursuant to
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which GGL purchased 6,626,027 shares of our common stock on April 29, 2020, or the GGL Shares, at a purchase price of $37.73 per share, or approximately $250.0 million.
Pursuant to the terms of the Stock Purchase Agreement, GGL has agreed not to, without our prior written consent and subject to certain conditions and exceptions, among other things, directly or indirectly acquire additional shares of our common stock, seek or propose a tender or exchange offer, merger or other business combination involving us, solicit proxies or consents with respect to any matter, or undertake other specified actions related to the potential acquisition of additional equity interests in us. Such restrictions will expire on the one-year anniversary of the effective date of the Stock Purchase Agreement.
The Stock Purchase Agreement also provides that until the first anniversary of the effective date of such agreement, GGL will hold and not sell any of the GGL Shares, subject to certain exceptions. We agreed to register the GGL Shares for resale following expiration of the one-year lock-up period if Rule 144 under the Securities Act is not available for such resale without any volume or manner of sale restrictions.
Anti-Takeover Provisions of Delaware Law and Our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws
Section 203 of the Delaware General Corporation Law
We are subject to Section 203 of the DGCL, which prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years after the date that such stockholder became an interested stockholder, with the following exceptions:
| • | before such date, the board of directors of the corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder; |
| • | upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
| • | on or after such date, the business combination is approved by the board of directors and authorized at an annual or special meeting of the stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned by the interested stockholder. |
Section 203 defines a “business combination” to include the following:
| • | any merger or consolidation involving the corporation and the interested stockholder; |
| • | any sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder; |
| • | subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder; |
| • | any transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class or series of the corporation beneficially owned by the interested stockholder; and |
| • | the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits by or through the corporation. |
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In general, Section 203 defines an “interested stockholder” as an entity or person who, together with the person’s affiliates and associates, beneficially owns, or within three years prior to the time of determination of interested stockholder status did own, 15% or more of the outstanding voting stock of the corporation.
The statute could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above the prevailing market price.
Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws
Among other things, our amended and restated certificate of incorporation and amended and restated bylaws will:
| • | permit our board of directors to issue up to 10,000,000 shares of preferred stock, with any rights, preferences and privileges as they may designate, including the right to approve an acquisition or other change in control; |
| • | provide that the authorized number of directors may be changed only by resolution of our board of directors; |
| • | provide that our board of directors will be classified into three classes of directors; |
| • | provide that, subject to the rights of any series of preferred stock to elect directors, directors may only be removed for cause, which removal may be effected, subject to any limitation imposed by law, by the holders of at least 66 2/3% of the voting power of all of our then-outstanding shares of the capital stock entitled to vote generally at an election of directors; |
| • | provide that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum; |
| • | require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent or electronic transmission; |
| • | provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder’s notice; |
| • | provide that special meetings of our stockholders may be called only by the chairman of our board of directors, our chief executive officer or president or by our board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors, and not by our stockholders; and |
| • | not provide for cumulative voting rights, therefore allowing the holders of a majority of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so choose. |
The amendment of any of these provisions would require approval by the holders of at least 66 2/3% of the voting power of all of our then-outstanding common stock entitled to vote generally in the election of directors, voting together as a single class.
The combination of these provisions will make it more difficult for our existing stockholders to replace our board of directors as well as for another party to obtain control of us by replacing our board of directors. Because our board of directors has the power to retain and discharge our officers, these provisions could also make it more difficult for existing stockholders or another party to effect a change in management. In addition, the authorization of undesignated preferred stock makes it possible for our board of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change our control.
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These provisions are intended to enhance the likelihood of continued stability in the composition of our board of directors and its policies and to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to reduce our vulnerability to hostile takeovers and to discourage certain tactics that may be used in proxy fights. However, such provisions could have the effect of discouraging others from making tender offers for our shares and may have the effect of delaying changes in our control or management. As a consequence, these provisions may also inhibit fluctuations in the market price of our stock that could result from actual or rumored takeover attempts. We believe that the benefits of these provisions, including increased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our company, outweigh the disadvantages of discouraging takeover proposals, because negotiation of takeover proposals could result in an improvement of their terms.
Choice of Forum
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware (or, if and only if the Court of Chancery of the State of Delaware lacks subject matter jurisdiction, any state court located within the State of Delaware or, if and only if all such state courts lack subject matter jurisdiction, the federal district court for the District of Delaware) is the sole and exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf; (ii) any action or proceeding asserting a claim of breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders; (iii) any action or proceeding asserting a claim against us or any of our current or former directors, officers or other employees, arising out of or pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws; (iv) any action or proceeding to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws; and (v) any action asserting a claim against us or any of our directors, officers or other employees governed by the internal affairs doctrine. This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the U.S. federal courts have exclusive jurisdiction. Nothing in our amended and restated certificate of incorporation precludes stockholders that assert claims under the Securities Act from bringing such claims in state or federal court, subject to applicable law. Our amended and restated certificate of incorporation further provides that the federal district courts of the United States is the exclusive forum for resolving any complaint asserting a cause of action under the Securities Act, unless we consent in writing to the selection of an alternative forum.
Listing
Our common stock is listed on The Nasdaq Global Select Market under the trading symbol “VIR.”
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Computershare Trust Company, N.A. The transfer agent’s address is 250 Royall Street, Canton, Massachusetts 02021.
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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS
The following is a general discussion of the material U.S. federal income tax consequences applicable to non-U.S. holders (as defined herein) with respect to their purchase, ownership and disposition of shares of our common stock issued pursuant to this offering. All prospective non-U.S. holders of our common stock should consult their own tax advisors with respect to the U.S. federal, state, local and non-U.S. tax consequences of the purchase, ownership and disposition of our common stock. In general, a non-U.S. holder means a beneficial owner of our common stock (other than a partnership or an entity or arrangement treated as a partnership for U.S. federal income tax purposes) that is not, for U.S. federal income tax purposes:
| • | an individual who is a citizen or resident of the United States; |
| • | a corporation, or an entity treated as a corporation for U.S. federal income tax purposes, created or organized in the United States or under the laws of the United States or of any state thereof or the District of Columbia; |
| • | an estate, the income of which is subject to U.S. federal income tax regardless of its source; or |
| • | a trust if (i) a U.S. court can exercise primary supervision over the trust’s administration and one or more U.S. persons have the authority to control all of the trust’s substantial decisions or (ii) the trust has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a U.S. person. |
We assume in this discussion that a non-U.S. holder holds shares of our common stock as a capital asset within the meaning of Section 1221 of the Code (generally, property held for investment). This discussion does not address all aspects of U.S. federal income taxation that may be relevant to a particular non-U.S. holder in light of that non-U.S. holder’s individual circumstances, nor does it address any estate or gift tax consequences, or any aspects of U.S. state, local or non-U.S. taxes. This discussion also does not consider any specific facts or circumstances that may apply to a non-U.S. holder and does not address the special tax rules applicable to particular non-U.S. holders, such as holders that own, or are deemed to own, more than 5% of our capital stock (except to the extent specifically set forth below), corporations that accumulate earnings to avoid U.S. federal income tax, tax-exempt or governmental organizations, banks, financial institutions, insurance companies, brokers, dealers or traders in securities, commodities or currencies, tax-qualified retirement plans, holders subject to the alternative minimum tax or the Medicare contribution tax on net investment income, holders holding our common stock as part of a hedge, straddle or other risk reduction strategy, conversion transaction, synthetic security or other integrated investment, holders deemed to sell our common stock under the constructive sale provisions of the Code, controlled foreign corporations, passive foreign investment companies, accrual method taxpayers subject to special tax accounting rules under Section 451(b) of the Code, and U.S. expatriates and certain former U.S. citizens or long-term residents.
In addition, this discussion does not address the tax treatment of partnerships (or entities or arrangements that are treated as partnerships for U.S. federal income tax purposes) or persons that hold their common stock through such partnerships. If a partnership, including any entity or arrangement treated as a partnership for U.S. federal income tax purposes, holds shares of our common stock, the U.S. federal income tax treatment of a partner in such partnership will generally depend upon the status of the partner, the activities of the partnership and certain determinations made at the partner level. Such partners and partnerships should consult their own tax advisors regarding the tax consequences of the purchase, ownership and disposition of our common stock.
There can be no assurance that a court or the Internal Revenue Service, or the IRS, will not challenge one or more of the tax consequences described herein, and we have not obtained, nor do we intend to obtain, a ruling with respect to the U.S. federal income tax consequences to a non-U.S. holder of the purchase, ownership or disposition of our common stock.
Distributions on Our Common Stock
As described in the section titled “Dividend Policy,” we do not currently intend to pay any cash dividends on our capital stock in the foreseeable future. If we do make distributions of cash or property on our common
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stock, such distributions generally will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. If a distribution exceeds our current and accumulated earnings and profits, the excess will be treated as a tax-free return of the non-U.S. holder’s investment, up to such holder’s adjusted tax basis in the common stock. Any remaining excess will be treated as capital gain from the sale or exchange of such common stock subject to the tax treatment described below in “Gain on Sale, Exchange or Other Disposition of Our Common Stock.” Any distributions will also be subject to the discussion below under the heading “Foreign Accounts.”
Dividends paid to a non-U.S. holder will generally be subject to withholding of U.S. federal income tax at a 30% rate or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’s country of residence.
Dividends that are treated as effectively connected with a trade or business conducted by a non-U.S. holder within the United States and, if an applicable income tax treaty so provides, that are attributable to a permanent establishment or a fixed base maintained by the non-U.S. holder within the United States, are generally exempt from the 30% withholding tax if the non-U.S. holder satisfies applicable certification and disclosure requirements. However, such U.S. effectively connected income, net of specified deductions and credits, is taxed at the U.S. federal income tax rates applicable to “United States persons” (as defined in the Code). Any U.S. effectively connected income received by a non-U.S. holder that is a corporation may also, under certain circumstances, be subject to an additional “branch profits tax” at a 30% rate or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’s country of residence.
To claim a reduction or exemption from withholding, a non-U.S. holder of our common stock generally will be required to provide (i) a properly executed IRS Form W-8BEN (in the case of individuals) or IRS Form W-8BEN-E (in the case of entities), or successor form, and satisfy applicable certification and other requirements to claim the benefit of an applicable income tax treaty between the United States and such holder’s country of residence, or (ii) a properly executed IRS Form W-8ECI stating that dividends are not subject to withholding because they are effectively connected with such non-U.S. holder’s conduct of a trade or business within the United States. The tax forms referred to above must be provided to us or our paying agent prior to the payment of dividends and must be updated periodically. In the case of a non-U.S. holder that is an entity, Treasury Regulations and any relevant tax treaty provide rules to determine whether, for purposes of determining the applicability of a tax treaty, dividends will be treated as paid to the entity or to those holding an interest in that entity. If a non-U.S. Holder holds stock through a financial institution or other agent acting on the holder’s behalf, the holder will be required to provide appropriate documentation to such agent. The holder’s agent will then be required to provide certification to us or our paying agent, either directly or through other intermediaries. Non-U.S. holders are urged to consult their tax advisors regarding their entitlement to benefits under a relevant income tax treaty.
A non-U.S. holder that is eligible for a reduced rate of U.S. withholding tax under an income tax treaty may obtain a refund or credit of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS.
Gain on Sale, Exchange or Other Disposition of Our Common Stock
Subject to the discussion below regarding backup withholding, in general, a non-U.S. holder will not be subject to any U.S. federal income or withholding tax on any gain realized upon such holder’s sale, exchange or other disposition of shares of our common stock unless:
| • | the gain is effectively connected with a U.S. trade or business of the non-U.S. holder and, if an applicable income tax treaty so provides, is attributable to a permanent establishment or a fixed base maintained in the United States by such non-U.S. holder, in which case the non-U.S. holder generally will be taxed at the U.S. federal income tax rates applicable to “United States persons” (as defined in the Code) and, if the non-U.S. holder is a foreign corporation, the branch profits tax described above in “Distributions on Our Common Stock” may also apply; |
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| • | the non-U.S. holder is a nonresident alien individual who is present in the United States for 183 days or more in the taxable year of the disposition and certain other conditions are met, in which case the non-U.S. holder will be subject to a 30% tax (or such lower rate as may be specified by an applicable income tax treaty) on the net gain derived from the disposition, which may be offset by U.S. source capital losses of the non-U.S. holder, if any (even though the individual is not considered a resident of the United States), provided the non-U.S. holder has timely filed U.S. federal income tax returns with respect to such losses; or |
| • | our common stock constitutes a U.S. real property interest because we are, or have been, at any time during the five-year period preceding such disposition (or the non-U.S. holder’s holding period, if shorter) a U.S. real property holding corporation. Generally, a corporation is a U.S. real property holding corporation only if the fair market value of its U.S. real property interests equals or exceeds 50% of the sum of the fair market value of its worldwide real property interests plus the fair market value of its other assets used or held for use in a trade or business. We do not believe that we are, or have been, a U.S. real property holding corporation, or that we are likely to become one in the future. However, because the determination of whether we are a U.S. real property holding corporation depends on the fair market value of our U.S. real property relative to the fair market value of our other business assets, there can be no assurance that we will not become a U.S. real property holding corporation in the future. Even if we are or become a U.S. real property holding corporation, provided that our common stock is “regularly traded” (as defined by applicable Treasury Regulations), on an established securities market, our common stock will be treated as a U.S. real property interest only with respect to a non-U.S. holder that holds more than 5% of our outstanding common stock, actually or constructively, during the shorter of the five-year period ending on the date of the disposition or the period that the non-U.S. holder held our common stock. In such case, such non-U.S. holder generally will be taxed on its net gain derived from the disposition at the U.S. federal income tax rates applicable to “United States persons” (as defined in the Code). No assurance can be provided that our common stock will continue to be regularly traded on an established securities market for purposes of the rules described above. |
Backup Withholding and Information Reporting
We must report annually to the IRS and to each non-U.S. holder the gross amount of the distributions on our common stock paid to such holder and the tax withheld, if any, with respect to such distributions. Non-U.S. holders will have to comply with specific certification procedures to establish that the holder is not a “United States person” (as defined in the Code) in order to avoid backup withholding at the applicable rate with respect to dividends on our common stock. A non-U.S. holder generally will not be subject to U.S. backup withholding with respect to payments of dividends on our common stock if it certifies its non-U.S. status by providing a valid IRS Form W-8BEN (in the case of individuals), IRS Form W-8BEN-E (in the case of entities) or IRS Form W-8ECI, or successor form, or otherwise establishes an exemption; provided the applicable withholding agent does not have actual knowledge or reason to know such non-U.S. holder is a “United States person,” as defined in the Code.
Information reporting and backup withholding will generally apply to the proceeds of a disposition of our common stock by a non-U.S. holder effected by or through the U.S. office of any broker, U.S. or foreign, unless the holder certifies its status as a non-U.S. holder and satisfies certain other requirements, or otherwise establishes an exemption. Generally, information reporting and backup withholding will not apply to a payment of disposition proceeds to a non-U.S. holder where the transaction is effected outside the United States through a non-U.S. office of a broker. However, for information reporting purposes, dispositions effected through a non-U.S. office of a broker with substantial U.S. ownership or operations generally will be treated in a manner similar to dispositions effected through a U.S. office of a broker. Information reporting and backup withholding requirements may, however, apply to a payment of disposition proceeds if the broker has actual knowledge, or reason to know, that the holder is, in fact, a U.S. person. Non-U.S. holders should consult their own tax advisors regarding the application of the information reporting and backup withholding rules to them.
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Copies of information returns that are filed with the IRS may be made available under the provisions of a specific treaty or agreement to the tax authorities of the country in which the non-U.S. holder resides or is incorporated.
Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules from a payment to a non-U.S. holder may be allowed as a credit against the non-U.S. holder’s U.S. federal income tax liability, if any, and may entitle such holder to a refund, provided that the required information is timely furnished to the IRS.
Foreign Accounts
Withholding taxes may be imposed under Sections 1471 to 1474 of the Code (such Sections commonly referred to as the Foreign Account Tax Compliance Act, or FATCA) on certain types of payments made to non-U.S. financial institutions and certain other non-U.S. entities. Specifically, a 30% withholding tax may be imposed on dividends on our common stock paid to a “foreign financial institution” (as specifically defined for this purpose), unless such institution enters into an agreement with the U.S. government to, among other things, withhold on certain payments and to collect and provide to the U.S. tax authorities substantial information regarding U.S. account holders of such institution (which includes certain equity and debt holders of such institution, as well as certain account holders that are foreign entities with U.S. owners) or otherwise qualifies for an exemption from these rules. A U.S. federal withholding tax of 30% also applies to dividends on our common stock paid to a “non-financial foreign entity” (as defined in the Code), unless such entity provides the withholding agent with either a certification that it does not have any substantial direct or indirect U.S. owners or provides information regarding substantial direct and indirect U.S. owners of the entity, or otherwise qualifies for an exemption from these rules. The withholding provisions described above currently apply to dividends paid on our common stock. Under the applicable Treasury Regulations and administrative guidance, withholding under FATCA would have applied to payments of gross proceeds from the sale or other disposition of stock on or after January 1, 2019, although under proposed Treasury Regulations (the preamble to which specifies that taxpayers are permitted to rely on such proposed Treasury Regulations pending finalization), no withholding applies with respect to payments of gross proceeds. Under certain circumstances, a non-U.S. holder might be eligible for refunds or credits of such taxes. An intergovernmental agreement between the United States and an applicable foreign country may modify the requirements described in this paragraph.
EACH PROSPECTIVE INVESTOR SHOULD CONSULT ITS TAX ADVISOR REGARDING THE PARTICULAR U.S. FEDERAL, STATE AND LOCAL AND NON-U.S. TAX CONSEQUENCES OF PURCHASING, HOLDING AND DISPOSING OF OUR COMMON STOCK, INCLUDING THE CONSEQUENCES OF ANY RECENT AND PROPOSED CHANGE IN APPLICABLE LAWS.
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We and the underwriters named below have entered into an underwriting agreement with respect to the shares being offered. Subject to certain conditions, each underwriter has severally agreed to purchase the number of shares indicated in the following table. Goldman Sachs & Co. LLC is the sole representative of the underwriters.
| Underwriters | Number of Shares |
|||
| Goldman Sachs & Co. LLC |
||||
| BofA Securities, Inc. |
||||
| Cowen and Company, LLC |
||||
| Barclays Capital Inc. |
||||
| Needham & Company, LLC |
||||
|
|
|
|||
| Total |
6,200,000 | |||
|
|
|
|||
The underwriters are committed to take and pay for all of the shares being offered, if any are taken, other than the shares covered by the option described below unless and until this option is exercised.
The underwriters have an option to buy up to an additional 930,000 shares from us to cover sales by the underwriters of a greater number of shares than the total number set forth in the table above. They may exercise that option for 30 days. If any shares are purchased pursuant to this option, the underwriters will severally purchase shares in approximately the same proportion as set forth in the table above.
The following table shows the per share and total underwriting discounts and commissions to be paid to the underwriters by us. Such amounts are shown assuming both no exercise and full exercise of the underwriters’ option to purchase additional shares.
| Paid by Us | No Exercise | Full Exercise | ||||||
| Per Share |
$ | $ | ||||||
| Total |
$ | $ | ||||||
Shares sold by the underwriters to the public will initially be offered at the initial public offering price set forth on the cover of this prospectus. Any shares sold by the underwriters to securities dealers may be sold at a discount of up to $ per share from the initial public offering price. After the initial offering of the shares, the representative may change the offering price and the other selling terms. The offering of the shares by the underwriters is subject to receipt and acceptance and subject to the underwriters’ right to reject any order in whole or in part.
We and our directors, our executive officers and certain affiliated stockholders have agreed with the underwriters, subject to certain limited exceptions, not to dispose of or hedge any of their common stock or securities convertible into or exchangeable for shares of common stock during the period from the date of this prospectus continuing through the date 90 days after the date of this prospectus, except with the prior written consent of Goldman Sachs & Co. LLC.
Our common stock is listed on The Nasdaq Global Select Market under the trading symbol “VIR.”
In connection with the offering, the underwriters may purchase and sell shares of common stock in the open market. These transactions may include short sales, stabilizing transactions and purchases to cover positions created by short sales. Short sales involve the sale by the underwriters of a greater number of shares than they are required to purchase in the offering, and a short position represents the amount of such sales that have not been covered by subsequent purchases. A “covered short position” is a short position that is not greater than the amount of additional shares for which the underwriters’ option described above may be exercised. The underwriters may cover any covered short position by either exercising their option to purchase additional shares or purchasing shares in the open market. In determining the source of shares to cover the covered short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase additional shares pursuant to the option described above.
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“Naked” short sales are any short sales that create a short position greater than the amount of additional shares for which the option described above may be exercised. The underwriters must cover any such naked short position by purchasing shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of the common stock in the open market after pricing that could adversely affect investors who purchase in the offering. Stabilizing transactions consist of various bids for or purchases of common stock made by the underwriters in the open market prior to the completion of the offering.
The underwriters may also impose a penalty bid. This occurs when a particular underwriter repays to the underwriters a portion of the underwriting discount received by it because the representative has repurchased shares sold by or for the account of such underwriter in stabilizing or short covering transactions.
Purchases to cover a short position and stabilizing transactions, as well as other purchases by the underwriters for their own accounts, may have the effect of preventing or retarding a decline in the market price of our common stock, and together with the imposition of the penalty bid, may stabilize, maintain or otherwise affect the market price of the common stock. As a result, the price of the common stock may be higher than the price that otherwise might exist in the open market. The underwriters are not required to engage in these activities and may end any of these activities at any time. These transactions may be effected on the New York Stock Exchange, The Nasdaq Global Select Market or relevant exchange, in the over-the-counter market or otherwise. In connection with the offering, underwriters and selling group members may engage in passive market making transactions in the common stock on The Nasdaq Global Select Market in accordance with Rule 103 of Regulation M under the Exchange Act during the period before the commencement of offers or sales of common stock and extending through the completion of distribution. A passive market maker must display its bids at a price not in excess of the highest independent bid of the security. However, if all independent bids are lowered below the passive market maker’s bid that bid must be lowered when specified purchase limits are exceeded.
We estimate that our share of the total expenses of the offering, excluding underwriting discounts and commissions, will be approximately $1,000,000. We will reimburse the underwriters for certain of their expenses incurred in connection with this offering in an amount up to $25,000.
We have agreed to indemnify the several underwriters against certain liabilities, including liabilities under the Securities Act.
The underwriters and their respective affiliates are full service financial institutions engaged in various activities, which may include sales and trading, commercial and investment banking, advisory, investment management, investment research, principal investment, hedging, market making, brokerage and other financial and non-financial activities and services. Certain of the underwriters and their respective affiliates have provided, and may in the future provide, a variety of these services to the issuer and to persons and entities with relationships with the issuer, for which they received or will receive customary fees and expenses.
In the ordinary course of their various business activities, the underwriters and their respective affiliates, officers, directors and employees may purchase, sell or hold a broad array of investments and actively trade securities, derivatives, loans, commodities, currencies, credit default swaps and other financial instruments for their own account and for the accounts of their customers, and such investment and trading activities may involve or relate to assets, securities and/or instruments of the issuer (directly, as collateral securing other obligations or otherwise) and/or persons and entities with relationships with the issuer. The underwriters and their respective affiliates may also communicate independent investment recommendations, market color or trading ideas and/or publish or express independent research views in respect of such assets, securities or instruments and may at any time hold, or recommend to clients that they should acquire, long and/or short positions in such assets, securities and instruments.
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Selling Restrictions
European Economic Area and United Kingdom
In relation to each Member State of the European Economic Area and the United Kingdom (each a “Relevant State”), no shares have been offered or will be offered pursuant to this offering to the public in that Relevant State prior to the publication of a prospectus in relation to the shares which has been approved by the competent authority in that Relevant State or, where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that offers of shares may be made to the public in that Relevant State at any time under the following exemptions under the Prospectus Regulation:
| • | to any legal entity which is a qualified investor as defined in the Prospectus Regulation; |
| • | to fewer than 150 natural or legal persons (other than qualified investors as defined under the Prospectus Regulation), subject to obtaining the prior consent of the representative for any such offer; or |
| • | in any other circumstances falling within Article 1(4) of the Prospectus Regulation, provided that no such offer of shares shall require us or any underwriter to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation and each person who initially acquires any shares or to whom any offer is made will be deemed to have represented, acknowledged and agreed to and with each of the underwriters and the company that it is a “qualified investor” within the meaning of Article 2(e) of the Prospectus Regulation. In the case of any shares being offered to a financial intermediary as that term is used in the Prospectus Regulation, each such financial intermediary will be deemed to have represented, acknowledged and agreed that the shares acquired by it in the offer have not been acquired on a non-discretionary basis on behalf of, nor have they been acquired with a view to their offer or resale to, persons in circumstances which may give rise to an offer of any shares to the public other than their offer or resale in a Relevant State to qualified investors as so defined or in circumstances in which the prior consent of the underwriters have been obtained to each such proposed offer or resale. |
For the purposes of this provision, the expression an “offer to the public” in relation to shares in any Relevant State means the communication in any form and by any means of sufficient information on the terms of the offer and any shares to be offered so as to enable an investor to decide to purchase or subscribe for any shares, and the expression “Prospectus Regulation” means Regulation (EU) 2017/1129.
This European Economic Area selling restriction is in addition to any other selling restrictions set out below.
United Kingdom
In the United Kingdom, this prospectus is only addressed to and directed as qualified investors who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order); or (ii) high net worth entities and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). Any investment or investment activity to which this prospectus relates is available only to relevant persons and will only be engaged with relevant persons. Any person who is not a relevant person should not act or relay on this prospectus or any of its contents.
Canada
The securities may be sold in Canada only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument
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31-103 Registration Requirements, Exemptions, and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with an exemption form, or in a transaction not subject to, the prospectus requirements of applicable securities laws.
Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory of these rights or consult with a legal advisor.
Pursuant to section 3A.3 of National Instrument 33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection with this offering.
Hong Kong
The shares may not be offered or sold in Hong Kong by means of any document other than (i) in circumstances which do not constitute an offer to the public within the meaning of the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32 of the Laws of Hong Kong) (“Companies (Winding Up and Miscellaneous Provisions) Ordinance”) or which do not constitute an invitation to the public within the meaning of the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong) (“Securities and Futures Ordinance”), or (ii) to “professional investors” as defined in the Securities and Futures Ordinance and any rules made thereunder, or (iii) in other circumstances which do not result in the document being a “prospectus” as defined in the Companies (Winding Up and Miscellaneous Provisions) Ordinance, and no advertisement, invitation or document relating to the shares may be issued or may be in the possession of any person for the purpose of issue (in each case whether in Hong Kong or elsewhere), which is directed at, or the contents of which are likely to be accessed or read by, the public in Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to shares which are or are intended to be disposed of only to persons outside Hong Kong or only to “professional investors” in Hong Kong as defined in the Securities and Futures Ordinance and any rules made thereunder.
Singapore
This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus and any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of the shares may not be circulated or distributed, nor may the shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional investor (as defined under Section 4A of the Securities and Futures Act, Chapter 289 of Singapore, or the SFA) under Section 274 of the SFA, (ii) to a relevant person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of the SFA, or any person pursuant to Section 275(1A) of the SFA, and in accordance with the conditions specified in Section 275 of the SFA, or (iii) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA, in each case subject to conditions set forth in the SFA.
Where the shares are subscribed or purchased under Section 275 of the SFA by a relevant person which is a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor, the securities (as defined in Section 239(1) of the SFA) of that corporation shall not be transferable for six months after that corporation has acquired the shares under Section 275 of the SFA except: (i) to an institutional investor under Section 274 of the SFA or to a relevant person (as defined in Section 275(2) of the SFA), (ii) where such transfer arises from an offer in that corporation’s securities pursuant
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to Section 275(1A) of the SFA, (iii) where no consideration is or will be given for the transfer, (iv) where the transfer is by operation of law, (v) as specified in Section 276(7) of the SFA, or (vi) as specified in Regulation 32 of the Securities and Futures (Offers of Investments) (Shares and Debentures) Regulations 2005 of Singapore (“Regulation 32”).
Where the shares are subscribed or purchased under Section 275 of the SFA by a relevant person which is a trust (where the trustee is not an accredited investor (as defined in Section 4A of the SFA)) whose sole purpose is to hold investments and each beneficiary of the trust is an accredited investor, the beneficiaries’ rights and interest (howsoever described) in that trust shall not be transferable for six months after that trust has acquired the shares under Section 275 of the SFA except: (i) to an institutional investor under Section 274 of the SFA or to a relevant person (as defined in Section 275(2) of the SFA), (ii) where such transfer arises from an offer that is made on terms that such rights or interest are acquired at a consideration of not less than S$200,000 (or its equivalent in a foreign currency) for each transaction (whether such amount is to be paid for in cash or by exchange of securities or other assets), (iii) where no consideration is or will be given for the transfer, (iv) where the transfer is by operation of law, (v) as specified in Section 276(7) of the SFA, or (vi) as specified in Regulation 32.
Singapore Securities and Futures Act Product Classification—Solely for the purposes of its obligations pursuant to Sections 309B(1)(a) and 309B(1)(c) of the SFA, we have determined, and hereby notify all relevant persons (as defined in Section 309A of the SFA) that the common shares are “prescribed capital markets products” (as defined in the Securities and Futures (Capital Markets Products) Regulations 2018) and Excluded Investment Products (as defined in MAS Notice SFA 04-N12: Notice on the Sale of Investment Products and MAS Notice FAA-N16: Notice on Recommendations on Investment Products).
Japan
The securities have not been and will not be registered under the Financial Instruments and Exchange Act of Japan (Act No. 25 of 1948, as amended), or the FIEA. The securities may not be offered or sold, directly or indirectly, in Japan or to or for the benefit of any resident of Japan (including any person resident in Japan or any corporation or other entity organized under the laws of Japan) or to others for reoffering or resale, directly or indirectly, in Japan or to or for the benefit of any resident of Japan, except pursuant to an exemption from the registration requirements of the FIEA and otherwise in compliance with any relevant laws and regulations of Japan.
Israel
In the State of Israel this prospectus shall not be regarded as an offer to the public to purchase shares of common stock under the Israeli Securities Law, 5728 – 1968, which requires a prospectus to be published and authorized by the Israel Securities Authority, if it complies with certain provisions of Section 15 of the Israeli Securities Law, 5728–1968, including, inter alia, if: (i) the offer is made, distributed or directed to not more than 35 investors, subject to certain conditions (“Addressed Investors”); or (ii) the offer is made, distributed or directed to certain qualified investors defined in the First Addendum of the Israeli Securities Law, 5728 – 1968, subject to certain conditions (“Qualified Investors”). The Qualified Investors shall not be taken into account in the count of the Addressed Investors and may be offered to purchase securities in addition to the 35 Addressed Investors. The company has not and will not take any action that would require it to publish a prospectus in accordance with and subject to the Israeli Securities Law, 5728 – 1968. We have not and will not distribute this prospectus or make, distribute or direct an offer to subscribe for our common stock to any person within the State of Israel, other than to Qualified Investors and up to 35 Addressed Investors.
Qualified Investors may have to submit written evidence that they meet the definitions set out in of the First Addendum to the Israeli Securities Law, 5728 – 1968. In particular, we may request, as a condition to be offered common stock, that Qualified Investors will each represent, warrant and certify to us and/or to anyone acting on our behalf: (i) that it is an investor falling within one of the categories listed in the First Addendum to the Israeli Securities Law, 5728 – 1968; (ii) which of the categories listed in the First Addendum to the Israeli Securities
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Law, 5728 – 1968 regarding Qualified Investors is applicable to it; (iii) that it will abide by all provisions set forth in the Israeli Securities Law, 5728 – 1968 and the regulations promulgated thereunder in connection with the offer to be issued common stock; (iv) that the shares of common stock that it will be issued are, subject to exemptions available under the Israeli Securities Law, 5728 – 1968: (1) for its own account; (2) for investment purposes only; and (3) not issued with a view to resale within the State of Israel, other than in accordance with the provisions of the Israeli Securities Law, 5728 – 1968; and (v) that it is willing to provide further evidence of its Qualified Investor status. Addressed Investors may have to submit written evidence in respect of their identity and may have to sign and submit a declaration containing, inter alia, the Addressed Investor’s name, address and passport number or Israeli identification number.
Switzerland
The securities will not be offered, directly or indirectly, to the public in Switzerland and this prospectus does not constitute a public offering prospectus as that term is understood pursuant to article 652a or 1156 of the Swiss Federal Code of Obligations.
Australia
No placement document, prospectus, product disclosure statement or other disclosure document has been lodged with the Australian Securities and Investments Commission, or ASIC, in relation to the offering. This prospectus does not constitute a prospectus, product disclosure statement or other disclosure document under the Corporations Act 2001, or the Corporations Act, and does not purport to include the information required for a prospectus, product disclosure statement or other disclosure document under the Corporations Act.
Any offer in Australia of the shares may only be made to persons, or the Exempt Investors, who are “sophisticated investors” (within the meaning of section 708(8) of the Corporations Act), “professional investors” (within the meaning of section 708(11) of the Corporations Act) or otherwise pursuant to one or more exemptions contained in section 708 of the Corporations Act so that it is lawful to offer the shares without disclosure to investors under Chapter 6D of the Corporations Act.
The shares applied for by Exempt Investors in Australia must not be offered for sale in Australia in the period of 12 months after the date of allotment under the offering, except in circumstances where disclosure to investors under Chapter 6D of the Corporations Act would not be required pursuant to an exemption under section 708 of the Corporations Act or otherwise or where the offer is pursuant to a disclosure document which complies with Chapter 6D of the Corporations Act. Any person acquiring shares must observe such Australian on-sale restrictions.
This prospectus contains general information only and does not take account of the investment objectives, financial situation or particular needs of any particular person. It does not contain any securities recommendations or financial product advice. Before making an investment decision, investors need to consider whether the information in this prospectus is appropriate to their needs, objectives and circumstances, and, if necessary, seek expert advice on those matters.
Dubai International Financial Centre
This prospectus relates to an Exempt Offer in accordance with the Offered Securities Rules of the Dubai Financial Services Authority, or DFSA. This prospectus is intended for distribution only to persons of a type specified in the Offered Securities Rules of the DFSA. It must not be delivered to, or relied on by, any other person. The DFSA has no responsibility for reviewing or verifying any documents in connection with Exempt Offers. The DFSA has not approved this prospectus nor taken steps to verify the information set forth herein and has no responsibility for the prospectus. The shares to which this prospectus relates may be illiquid and/or subject to restrictions on their resale. Prospective purchasers of the shares offered should conduct their own due diligence on the shares. If you do not understand the contents of this prospectus you should consult an authorized financial advisor.
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The validity of the issuance of our common stock offered in this prospectus will be passed upon for us by Cooley LLP, Palo Alto, California. Certain legal matters in connection with this offering will be passed upon for the underwriters by Latham & Watkins LLP, Menlo Park, California.
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2019, as set forth in their report, which is incorporated by reference in this prospectus and elsewhere in the registration statement. Our financial statements are incorporated by reference in reliance on Ernst & Young LLP’s report, given on their authority as experts in accounting and auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We have filed with the SEC a registration statement on Form S-1, including exhibits and schedules, under the Securities Act, with respect to the shares of common stock being offered by this prospectus. This prospectus, which constitutes part of the registration statement, does not contain all of the information in the registration statement and its exhibits. For further information with respect to us and the common stock offered by this prospectus, we refer you to the registration statement and its exhibits. Statements contained in this prospectus as to the contents of any contract or any other document referred to are not necessarily complete, and in each instance, we refer you to the copy of the contract or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects by this reference.
You may read our SEC filings, including this registration statement, over the Internet at the SEC’s website at www.sec.gov. We are subject to the information reporting requirements of the Exchange Act and have filed reports, proxy statements and other information with the SEC. These reports, proxy statements and other information will be available for review on the web site of the SEC referred to above. We also maintain a website at www.vir.bio, at which you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Information contained on or accessible through our website is not a part of this prospectus or the registration statement of which it forms a part, and the inclusion of our website address in this prospectus is an inactive textual reference only.
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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to “incorporate by reference” information from other documents that we file with it, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus. Information in this prospectus supersedes information incorporated by reference that we filed with the SEC prior to the date of this prospectus. We incorporate by reference into this prospectus and the registration statement of which this prospectus is a part the information or documents listed below that we have filed with the SEC (File No. 001-39083):
| • | our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 26, 2020; |
| • | the portions of our Definitive Proxy Statement on Schedule 14A for our 2020 Annual Meeting of Stockholders specifically incorporated by reference into our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 6, 2020 and as supplemented on May 8, 2020; |
| • | our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on May 12, 2020; |
| • | our Current Reports on Form 8-K (File No. 001-39083) filed with the SEC on January 23, 2020, January 30, 2020, February 12, 2020, March 9, 2020, April 6, 2020, April 7, 2020, April 10, 2020, April 30, 2020, May 22, 2020, May 29, 2020, June 15, 2020, June 19, 2020 and July 6, 2020; and |
| • | the description of the Common Stock contained in our Registration Statement on Form 8-A filed with the SEC on October 9, 2019, including any amendments or reports filed for the purpose of updating such description. |
Notwithstanding the statements in the preceding paragraphs, no document, report or exhibit (or portion of any of the foregoing) or any other information that we have “furnished” to the SEC pursuant to the Exchange Act shall be incorporated by reference into this prospectus.
We will furnish without charge to you, on written or oral request, a copy of any or all of the documents incorporated by reference in this prospectus, including exhibits to these documents. You should direct any requests for documents to Vir Biotechnology, Inc., Attn: Investor Relations, 499 Illinois Street, Suite 500, San Francisco, California 94158.
You also may access these filings on our website at www.vir.bio. Information contained on or accessible through our website is not a part of this prospectus or the registration statement of which it forms a part, and the inclusion of our website address in this prospectus is an inactive textual reference only.
Any statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus will be deemed modified, superseded or replaced for purposes of this prospectus to the extent that a statement contained in this prospectus modifies, supersedes or replaces such statement.
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6,200,000 Shares
Common Stock
PRELIMINARY PROSPECTUS
| Goldman Sachs & Co. LLC | BofA Securities | Cowen | Barclays | |||
| Needham & Company | ||||||
, 2020
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PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution.
The following table sets forth the costs and expenses, other than the underwriting discounts and commissions, payable by Vir Biotechnology, Inc., or the Registrant, in connection with the sale of our common stock being registered. All amounts are estimates except for the Securities and Exchange Commission, or SEC, registration fee, and the Financial Industry Regulatory Authority, or FINRA, filing fee.
| Item | Amount Paid or to Be Paid |
|||
| SEC registration fee |
$ | 37,318 | ||
| FINRA filing fee |
43,625 | |||
| Printing expenses |
75,000 | |||
| Legal fees and expenses |
600,000 | |||
| Accounting fees and expenses |
175,000 | |||
| Miscellaneous expenses |
69,057 | |||
|
|
|
|||
| Total |
$ | 1,000,000 | ||
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|
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Item 14. Indemnification of Directors and Officers.
As permitted by Section 102 of the Delaware General Corporation Law, we have adopted provisions in our amended and restated certificate of incorporation and amended and restated bylaws that limit or eliminate the personal liability of our directors for a breach of their fiduciary duty of care as a director. The duty of care generally requires that, when acting on behalf of the corporation, directors exercise an informed business judgment based on all material information reasonably available to them. Consequently, a director will not be personally liable to us or our stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for:
| • | any breach of the director’s duty of loyalty to us or our stockholders; |
| • | any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; |
| • | any act related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or |
| • | any transaction from which the director derived an improper personal benefit. |
These limitations of liability do not affect the availability of equitable remedies such as injunctive relief or rescission. Our amended and restated certificate of incorporation also authorizes us to indemnify our officers, directors and other agents to the fullest extent permitted under Delaware law.
As permitted by Section 145 of the Delaware General Corporation Law, our amended and restated bylaws provide that:
| • | we may indemnify our directors, officers and employees to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions; |
| • | we may advance expenses to our directors, officers and employees in connection with a legal proceeding to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions; and |
| • | the rights provided in our bylaws are not exclusive. |
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Our amended and restated certificate of incorporation and our amended and restated bylaws provide for the indemnification provisions described above and elsewhere herein. We have entered or will enter into, and intend to continue to enter into, separate indemnification agreements with our directors and officers that may be broader than the specific indemnification provisions contained in the Delaware General Corporation Law. These indemnification agreements generally require us, among other things, to indemnify our officers and directors against certain liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct. These indemnification agreements also generally require us to advance any expenses incurred by the directors or officers as a result of any proceeding against them as to which they could be indemnified. These indemnification provisions and the indemnification agreements may be sufficiently broad to permit indemnification of our officers and directors for liabilities, including reimbursement of expenses incurred, arising under the Securities Act of 1933, as amended, or the Securities Act.
The Registrant has purchased and currently intends to maintain insurance on behalf of each and every person who is or was a director or officer of the Registrant against any loss arising from any claim asserted against him or her and incurred by him or her in any such capacity, subject to certain exclusions.
The form of underwriting agreement for this public offering provides for indemnification by the underwriters of us and our officers and directors who sign this registration statement for specified liabilities, including matters arising under the Securities Act.
Item 15. Recent Sales of Unregistered Securities.
Since May 31, 2017, we have made the following sales of unregistered securities:
Equity Plan-Related Issuances
| 1. | Since May 31, 2017, we have granted to certain of our directors, employees and consultants options to purchase 7,714,906 shares of our common stock with per share exercise prices ranging from $1.49 to $10.40 under our 2016 Equity Incentive Plan, as amended or 2016 Plan. |
| 2. | Since May 31, 2017, we have issued to certain of our directors, employees and consultants an aggregate of 1,902,016 shares of our common stock at per share purchase prices ranging from $0.86 to $10.40 pursuant to exercises of options under the 2016 Plan for an aggregate purchase price of $3.7 million. |
| 3. | In October 2019, we granted to certain of our directors and employees options to purchase 306,441 shares of our common stock with a per share exercise price of $20.00 under our 2019 Equity Incentive Plan. |
Sale of Common Stock
| 4. | In October 2017, we issued 1,111,111 shares of our common stock to one accredited investor as partial consideration for entry into a collaboration and license agreement and the investor granting us certain license rights. |
| 5. | In August 2019, we issued 38,888 shares of our common stock to one accredited investor as partial consideration for entry into a license agreement and the investor granting us certain license rights. |
| 6. | In April 2020, we issued and sold 6,626,027 shares of our common stock to one accredited investor pursuant to a stock purchase agreement at a cash purchase price per share of $37.73, or approximately $250.0 million. |
| 7. | In May 2020, we issued 1,111,111 shares of our common stock to one accredited investor as consideration for achieving a specified development milestone under a collaboration and license agreement. |
| 8. | In May 2020, we issued 211,774 shares of our common stock to one accredited investor upon the exercise of an outstanding warrant to acquire 244,444 shares pursuant to the cashless exercise provisions contained therein. |
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Sale of Preferred Stock
| 9. | Between May 2017 and July 2018, we issued and sold an aggregate of 60,277,749 shares of Series A-1 convertible preferred stock to 13 accredited investors at a purchase price per share of $4.50 for an aggregate purchase price of $271.3 million. |
| 10. | In January 2019, we issued and sold an aggregate of 18,202,213 shares of Series B convertible preferred stock to 20 accredited investors at a purchase price per share of $18.00 for an aggregate purchase price of $327.6 million. |
Acquisitions
| 11. | In August 2017, we issued to 23 accredited investors, including certain of our employees and consultants, 1,666,656 shares of our common stock in connection with our acquisition of a company. |
| 12. | In January 2018, we issued to 35 accredited investors, including certain of our consultants, an aggregate of 555,537 shares of Series A-2 convertible preferred stock in connection with our acquisition of a company. |
| 13. | In February 2018, we issued to two accredited investors an aggregate of 188,333 shares of Series A-2 convertible preferred stock in connection with our acquisition of a company. |
The offers, sales and issuances of the securities described in paragraphs (1) through (3) were deemed to be exempt from registration under Rule 701 promulgated under the Securities Act as transactions under compensatory benefit plans and contracts relating to compensation, or under Section 4(a)(2) of the Securities Act as a transaction by an issuer not involving a public offering. The recipients of such securities were our directors, employees or bona fide consultants and received the securities under our equity incentive plans. Appropriate legends were affixed to the securities issued in these transactions. Each of the recipients of securities in these transactions had adequate access, through employment, business or other relationships, to information about us.
The offers, sales and issuances of the securities described in paragraphs (4) through (13) were deemed to be exempt under Section 4(a)(2) of the Securities Act or Rule 506 of Regulation D under the Securities Act as a transaction by an issuer not involving a public offering. The recipients of securities in each of these transactions acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the securities issued in these transactions. Each of the recipients of securities in these transactions was an accredited investor within the meaning of Rule 501 of Regulation D under the Securities Act and had adequate access, through employment, business or other relationships, to information about us. No underwriters were involved in these transactions.
Item 16. Exhibits and Financial Statement Schedules.
(a) Exhibits.
The exhibits listed below are filed as part of this registration statement.
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| + | Indicates a management contract or compensatory plan. |
| † | Certain portions of this exhibit (indicated by “[***]”) have been omitted pursuant to confidential treatment. |
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(b) Financial Statement Schedules.
Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the consolidated financial statements or notes thereto, which are incorporated herein by reference.
Item 17. Undertakings.
The undersigned Registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
The undersigned Registrant hereby undertakes that:
1. For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective.
2. For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
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Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this registration statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Francisco, State of California on July 6, 2020.
| VIR BIOTECHNOLOGY, INC. | ||
| By: | /s/ George Scangos | |
| George Scangos, Ph.D. | ||
| President and Chief Executive Officer | ||
POWER OF ATTORNEY
KNOW ALL BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints George Scangos, Ph.D., and Howard Horn, and each of them, as his or her true and lawful attorneys-in-fact and agents, each with the full power of substitution, for him or her and in his or her name, place or stead, in any and all capacities, to sign any and all amendments to this registration statement (including post-effective amendments), and to sign any registration statement for the same offering covered by this registration statement that is to be effective upon filing pursuant to Rule 462(b) promulgated under the Securities Act, and all post-effective amendments thereto, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or their, his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement on Form S-1 has been signed by the following persons in the capacities and on the dates indicated.
| Signature |
Title |
Date | ||
| /s/ George Scangos George Scangos, Ph.D. |
President, Chief Executive Officer and Director (Principal Executive Officer) | July 6, 2020 | ||
| /s/ Howard Horn Howard Horn |
Chief Financial Officer and Secretary (Principal Financial and Accounting Officer) |
July 6, 2020 | ||
| /s/ Vicki Sato, Ph.D. Vicki Sato, Ph.D. |
Chairman of the Board of Directors | July 6, 2020 | ||
| /s/ Kristina Burow Kristina Burow |
Director | July 6, 2020 | ||
| /s/ Robert More Robert More |
Director | July 6, 2020 | ||
| /s/ Robert Nelsen Robert Nelsen |
Director | July 6, 2020 | ||
| /s/ Dipchand Nishar Dipchand Nishar |
Director | July 6, 2020 | ||
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| Signature |
Title |
Date | ||
| /s/ Robert Perez Robert Perez |
Director | July 6, 2020 | ||
| /s/ Saira Ramasastry Saira Ramasastry |
Director | July 6, 2020 | ||
| /s/ Phillip Sharp Phillip Sharp, Ph.D. |
Director | July 6, 2020 | ||
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Exhibit 1.1
Vir Biotechnology, Inc.
Common Stock
Underwriting Agreement
July [ ● ], 2020
Goldman Sachs & Co. LLC
As representative (the “Representative”) of the several Underwriters
named in Schedule I hereto,
c/o Goldman Sachs & Co. LLC
200 West Street
New York, NY 10282-2198
Ladies and Gentlemen:
Vir Biotechnology, Inc., a Delaware corporation (the “Company”), proposes, subject to the terms and conditions stated in this agreement (this “Agreement”), to issue and sell to the underwriters named in Schedule I hereto (the “Underwriters”) an aggregate of [ ● ] shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”, and such shares the “Firm Shares”) and, at the election of the Underwriters, up to [ ● ] additional shares (the “Optional Shares”) of Common Stock (the Firm Shares and the Optional Shares that the Underwriters elect to purchase pursuant to Section 2 hereof being collectively called the “Shares”).
1. The Company represents and warrants to, and agrees with, each of the Underwriters that:
(a) A registration statement on Form S-1 (File No. 333-[ ● ]) (the “Initial Registration Statement”) in respect of the Shares has been filed with the Securities and Exchange Commission (the “Commission”); the Initial Registration Statement and any post-effective amendment thereto, each in the form heretofore delivered to you, have been declared effective by the Commission in such form; other than a registration statement, if any, increasing the size of the offering (a “Rule 462(b) Registration Statement”), filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended (the “Act”), which became effective upon filing, no other document with respect to the Initial Registration Statement or document incorporated by reference therein has been filed with the Commission; and no stop order suspending the effectiveness of the Initial Registration Statement, any post-effective amendment thereto or the Rule 462(b) Registration Statement, if any, has been issued and no proceeding for that purpose or pursuant to Section 8A of the Act has been initiated or, to the Company’s knowledge, threatened by
the Commission (any preliminary prospectus included in the Initial Registration Statement or filed with the Commission pursuant to Rule 424(a) of the rules and regulations of the Commission under the Act is hereinafter called a “Preliminary Prospectus”; the various parts of the Initial Registration Statement and the Rule 462(b) Registration Statement, if any, including all exhibits thereto and including the information contained in the form of final prospectus filed with the Commission pursuant to Rule 424(b) under the Act in accordance with Section 5(a) hereof and deemed by virtue of Rule 430A under the Act to be part of the Initial Registration Statement at the time it was declared effective, each as amended at the time such part of the Initial Registration Statement became effective or such part of the Rule 462(b) Registration Statement, if any, became or hereafter becomes effective, are hereinafter collectively called the “Registration Statement”; the Preliminary Prospectus relating to the Shares that was included in the Registration Statement immediately prior to the Applicable Time (as defined in Section 1(c) hereof) is hereinafter called the “Pricing Prospectus”; such final prospectus, in the form first filed pursuant to Rule 424(b) under the Act, is hereinafter called the “Prospectus”; any reference herein to the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus shall be deemed to refer to and include the documents incorporated by reference therein pursuant to Item 12 of Form S-1 under the Act, as of the effective date of the Registration Statement or the date of such prospectus, as the case may be; any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Act or Rule 163B under the Act is hereinafter called a “Testing-the-Waters Communication”; any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405 under the Act is hereinafter called a “Testing-the-Waters Writing”; and any “issuer free writing prospectus” as defined in Rule 433 under the Act relating to the Shares is hereinafter called an “Issuer Free Writing Prospectus”);
(b) (i) No order preventing or suspending the use of any Preliminary Prospectus or any Issuer Free Writing Prospectus has been issued by the Commission, and (ii) each Preliminary Prospectus, at the time of filing thereof, conformed in all material respects to the requirements of the Act and the rules and regulations of the Commission thereunder, and did not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided, however, that this representation and warranty shall not apply to any statements or omissions made in reliance upon and in conformity with the Underwriter Information (as defined in Section 9(b) of this Agreement);
(c) For the purposes of this Agreement, the “Applicable Time” is [ ● ] [p.m.] (Eastern time) on the date of this Agreement. The Pricing Prospectus, as supplemented by the information listed on Schedule II(c) hereto, taken together (collectively, the “Pricing Disclosure Package”), as of the Applicable Time, did not, and as of each Time of Delivery (as defined in Section 4(a) of this Agreement) (as supplemented by any post-effective amendment thereto) will not, include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; and each Issuer Free Writing Prospectus and each Testing-the-Waters Writing does not conflict with the information contained in the Registration Statement, the Pricing Prospectus or the Prospectus and each Issuer Free Writing Prospectus and each Testing-the-Waters Writing, as
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supplemented by and taken together with the Pricing Disclosure Package, as of the Applicable Time, did not, and as of each Time of Delivery (as supplemented by any post-effective amendment thereto) will not, include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided, however, that this representation and warranty shall not apply to statements or omissions (i) made in reliance upon and in conformity with the Underwriter Information or (ii) which are updated or supplemented by the Pricing Prospectus;
(d) The documents incorporated by reference in the Registration Statement, the Pricing Prospectus and the Prospectus, when they became effective or were filed with the Commission, as the case may be, conformed in all material respects to the requirements of the Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as applicable, and the rules and regulations of the Commission thereunder, and none of such documents contained an untrue statement of a material fact or omitted to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading;
(e) The Registration Statement conforms, and the Prospectus and any further amendments or supplements to the Registration Statement and the Prospectus will conform, in all material respects to the requirements of the Act and the rules and regulations of the Commission thereunder and do not and will not, as of the applicable effective date as to each part of the Registration Statement, as of the applicable filing date as to the Prospectus and any amendment or supplement thereto, and as of each Time of Delivery, contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading; provided, however, that this representation and warranty shall not apply to any statements or omissions made in reliance upon and in conformity with the Underwriter Information;
(f) Other than as set forth or contemplated in the Pricing Prospectus, neither the Company nor any of its subsidiaries has, since the date of the latest audited financial statements included or incorporated by reference in the Pricing Prospectus, (i) sustained any material loss or interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor dispute or court or governmental action, order or decree or (ii) entered into any transaction or agreement (whether or not in the ordinary course of business) that is material to the Company and its subsidiaries taken as a whole or incurred any liability or obligation, direct or contingent, that is material to the Company and its subsidiaries taken as a whole; and, since the respective dates as of which information is given in the Registration Statement and the Pricing Prospectus, there has not been (x) any change in the capital stock of the Company (other than as a result of (i) the exercise, if any, of stock options or the award, if any, of stock options, restricted stock or other awards in the ordinary course of business pursuant to the Company’s equity plans that are described in the Pricing Prospectus and the Prospectus or (ii) the issuance, if any, of shares of Common Stock upon conversion of Company securities as described in the Pricing Prospectus and the Prospectus) or (y) any Material Adverse Effect (as defined below); as used in this Agreement, “Material Adverse Effect” shall mean any material adverse change or effect, or any development involving a prospective material adverse change or effect, in or affecting (i) the business, properties,
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general affairs, management, financial position, stockholders’ equity, results of operations or prospects of the Company and its subsidiaries, taken as a whole, except as set forth or contemplated in the Pricing Prospectus, or (ii) the ability of the Company to issue and sell the Shares;
(g) Neither the Company nor any of its subsidiaries owns any real property and the Company and its subsidiaries have good and marketable title to all personal property owned by them (other than with respect to Intellectual Property (as defined below), which is addressed exclusively in subsection (gg) below), in each case free and clear of all liens, encumbrances and defects except such as are described in the Pricing Prospectus or such as do not materially affect the value of such property and do not interfere with the use made and proposed to be made of such property by the Company and its subsidiaries; and any real property and buildings held under lease by the Company and its subsidiaries are, to the Company’s knowledge, held by them under valid, subsisting and enforceable leases with such exceptions as are not material and do not materially interfere with the use made and proposed to be made of such property and buildings by the Company and its subsidiaries;
(h) The Company has been (i) duly organized and is validly existing and in good standing under the laws of its jurisdiction of organization, with power and authority (corporate and other) to own and/or lease its properties and conduct its business as described in the Pricing Prospectus, and (ii) duly qualified as a foreign corporation for the transaction of business and is in good standing (where such concept exists) under the laws of each other jurisdiction in which it owns or leases properties or conducts any business so as to require such qualification, except, in the case of this clause (ii), where the failure to be so qualified or in good standing (where such concept exists) would not, individually or in the aggregate, have a Material Adverse Effect. Each of the Company’s subsidiaries (i) has been, to the Company’s knowledge, duly organized, and is validly existing and in good standing (where such concept exists) under the laws of its jurisdiction of organization, with power and authority (corporate and other) to own and/or lease its properties and conduct its business as described in the Pricing Prospectus, and (ii) has been duly qualified as a foreign corporation for the transaction of business and is in good standing (where such concept exists) under the laws of each other jurisdiction in which it owns or leases properties or conducts any business so as to require such qualification, except, in the case of this clause (ii), where the failure to be so qualified or in good standing (where such concept exists) would not, individually or in the aggregate, have a Material Adverse Effect, and each subsidiary of the Company has been included in exhibit 21.1 to the Registration Statement, other than as permitted by Item 601(b)(21) of Regulation S-K;
(i) The Company has an authorized capitalization as set forth in the Pricing Prospectus and all of the issued shares of capital stock of the Company have been duly and validly authorized and issued and are fully paid and non-assessable and conform in all material respects to the description of the Common Stock contained in the Pricing Disclosure Package and Prospectus; to the Company’s knowledge, all of the issued shares of capital stock of each subsidiary of the Company have been duly and validly authorized and issued, and are fully paid and non-assessable (except, in the case of any foreign subsidiary, for directors’ qualifying shares); and all of the issued shares of capital stock of each subsidiary of the Company are owned directly or indirectly by the Company, free and clear of all liens, encumbrances, equities or claims, except for such liens and encumbrances described in the Pricing Prospectus and the Prospectus;
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(j) The Shares to be issued and sold by the Company to the Underwriters hereunder have been duly and validly authorized and, when issued and delivered against payment therefor as provided herein, will be duly and validly issued and fully paid and non-assessable and will conform in all material respects to the description of the Common Stock contained in the Pricing Disclosure Package and the Prospectus; and the issuance of the Shares is not subject to any preemptive or similar rights except as have been validly waived or complied with;
(k) The issue and sale of the Shares and the compliance by the Company with this Agreement and the consummation of the transactions contemplated in this Agreement and the Pricing Prospectus will not conflict with or result in a breach or violation of any of the terms or provisions of, or constitute a default under, (i) any indenture, mortgage, deed of trust, loan agreement, lease or other agreement or instrument to which the Company or any of its subsidiaries is a party or by which the Company or any of its subsidiaries is bound or to which any of the property or assets of the Company or any of its subsidiaries is subject, (ii) the certificate of incorporation or by-laws (or other applicable organizational document) of the Company or any of its subsidiaries, or (iii) any statute or any judgment, order, rule or regulation of any court or governmental agency or body having jurisdiction over the Company or any of its subsidiaries or any of their properties, except, in the case of clauses (i) or (iii), for such defaults, breaches, or violations that would not, individually or in the aggregate, have a Material Adverse Effect; and no consent, approval, authorization, order, registration or qualification of or with any such court or governmental agency or body is required for the issue and sale of the Shares or the consummation by the Company of the transactions contemplated by this Agreement, except such as have been obtained under the Act, the approval by the Financial Industry Regulatory Authority, Inc. (“FINRA”) of the underwriting terms and arrangements and such consents, approvals, authorizations, registrations or qualifications as may be required under state securities or Blue Sky laws in connection with the purchase and distribution of the Shares by the Underwriters;
(l) Neither the Company nor any of its subsidiaries is (i) in violation of its certificate of incorporation or by-laws (or other applicable organizational document), (ii) in violation of any statute or any judgment, order, rule or regulation of any court or governmental agency or body having jurisdiction over the Company or any of its subsidiaries or any of their properties, or (iii) in default in the performance or observance of any obligation, agreement, covenant or condition contained in any indenture, mortgage, deed of trust, loan agreement, lease or other agreement or instrument to which it is a party or by which it or any of its properties may be bound, except, in the case of the foregoing clauses (ii) and (iii), for such violations or defaults as would not, individually or in the aggregate, have a Material Adverse Effect;
(m) The statements set forth in the Pricing Prospectus and Prospectus under the caption “Description of Capital Stock”, insofar as they purport to constitute a summary of the terms of the Common Stock, and under the caption “Material U.S. Federal Income Tax Consequences to Non-U.S. Holders”, insofar as they purport to describe the provisions of the laws and documents referred to therein, are accurate and fair in all material respects;
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(n) Other than as set forth in the Pricing Prospectus, there are no legal or governmental proceedings pending to which the Company or any of its subsidiaries or, to the Company’s knowledge, any officer or director of the Company, is a party or of which any property of the Company or any of its subsidiaries is the subject which, if determined adversely to the Company or any of its subsidiaries (or such officer or director), would individually or in the aggregate have a Material Adverse Effect; and, to the Company’s knowledge, no such proceedings are threatened or contemplated by governmental authorities or others;
(o) The Company is not and, after giving effect to the offering and sale of the Shares and the application of the proceeds thereof, will not be an “investment company”, as such term is defined in the Investment Company Act of 1940, as amended;
(p) At the time of filing the Initial Registration Statement and any post-effective amendment thereto, at the earliest time thereafter that the Company or any offering participant made a bona fide offer (within the meaning of Rule 164(h)(2) under the Act) of the Shares, and at the date hereof, the Company was not and is not an “ineligible issuer,” as defined under Rule 405 under the Act;
(q) Ernst & Young LLP, who have certified certain financial statements of the Company and its subsidiaries, are independent public accountants as required by the Act and the rules and regulations of the Commission thereunder;
(r) The Company maintains a system of internal control over financial reporting (as such term is defined in Rule 13a-15(f) under the Exchange Act) that (i) has been designed by the Company’s principal executive officer and principal financial officer, or under their supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and (ii) is designed to provide reasonable assurance that (A) transactions are executed in accordance with management’s general or specific authorization, (B) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain accountability for assets, (C) access to assets is permitted only in accordance with management’s general or specific authorization, (D) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences and (E) interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement, the Pricing Disclosure Package and the Prospectus fairly presents the information called for in all material respects and is prepared in accordance with the Commission’s rules and guidelines applicable thereto. The Company is not aware of any material weaknesses in its internal control over financial reporting (it being understood that this subsection shall not require the Company to comply with Section 404 of the Sarbanes Oxley Act of 2002 as of an earlier date than it would otherwise be required to so comply under applicable law);
(s) The interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement, the Pricing Disclosure Package and the Prospectus fairly presents the information called for in all material respects and has been prepared in accordance with the Commission’s rules and guidelines applicable thereto to the extent required;
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(t) Since the date of the latest audited financial statements included or incorporated by reference in the Pricing Prospectus, there has been no change in the Company’s internal control over financial reporting that has materially and adversely affected, or is reasonably likely to materially and adversely affect, the Company’s internal control over financial reporting;
(u) The Company maintains disclosure controls and procedures (as such term is defined in Rule 13a-15(e) under the Exchange Act) that have been designed to ensure that material information relating to the Company and its subsidiaries is made known to the Company’s principal executive officer and principal financial officer by others within the Company; and such disclosure controls and procedures are effective in all material respects;
(v) This Agreement has been duly authorized, executed and delivered by the Company;
(w) Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company, any director, officer, agent, employee, affiliate or other person associated with or acting on behalf of the Company or any of its subsidiaries has (i) made, offered, promised or authorized any unlawful contribution, gift, entertainment or other unlawful expense; (ii) made, offered, promised or authorized any direct or indirect unlawful payment; or (iii) violated or is in violation of any applicable provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended, the UK Bribery Act 2010 or any other applicable anti-bribery or anti-corruption law;
(x) The operations of the Company and its subsidiaries are and have been conducted at all times in compliance with the requirements of applicable anti-money laundering laws, including, but not limited to, the Bank Secrecy Act of 1970, as amended by the USA PATRIOT ACT of 2001, and the rules and regulations promulgated thereunder, and the anti-money laundering laws of the various jurisdictions in which the Company and its subsidiaries conduct business (collectively, the “Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its subsidiaries with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, threatened;
(y) Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company, any director, officer, agent, employee or affiliate of the Company or any of its subsidiaries is currently the subject or the target of any sanctions administered or enforced by the U.S. Government, including, without limitation, the Office of Foreign Assets Control of the U.S. Department of the Treasury (“OFAC”), or the U.S. Department of State and including, without limitation, the designation as a “specially designated national” or “blocked person,” the European Union, Her Majesty’s Treasury, the United Nations Security Council, or other relevant sanctions authority (collectively, “Sanctions”), nor is the Company or any of its subsidiaries located, organized or resident in a country or territory that is the subject or target of Sanctions, and the Company will not directly or indirectly use the proceeds of
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the offering of the Shares hereunder, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity (i) to fund or facilitate any activities of or business with any person, or in any country or territory (currently Cuba, Iran, North Korea, Syria and the Crimea Region of the Ukraine) that, at the time of such funding, is the subject or the target of Sanctions, or (ii) in any other manner that will result in a violation by any person (including any person participating in the transaction, whether as underwriter, advisor, investor or otherwise) of Sanctions;
(z) The financial statements included or incorporated by reference in the Registration Statement, the Pricing Prospectus and the Prospectus, together with the related schedules and notes, present fairly in all material respects the financial position of the Company and its subsidiaries at the dates indicated and the statement of operations, stockholders’ equity and cash flows of the Company and its subsidiaries for the periods specified; said financial statements have been prepared in conformity with U.S. generally accepted accounting principles applied on a consistent basis throughout the periods involved. The selected financial data and the summary financial information included in the Registration Statement, the Pricing Prospectus and the Prospectus present fairly in all material respects the information shown therein and have been compiled on a basis consistent with that of the audited financial statements included or incorporated by reference therein. Except as included or incorporated by reference therein, no historical or pro forma financial statements or supporting schedules are required to be included in the Registration Statement, the Pricing Prospectus or the Prospectus under the Act or the rules and regulations promulgated thereunder;
(aa) There are (and prior to the Time of Delivery, will be) no debt securities or preferred stock issued or guaranteed by the Company or any of its subsidiaries that are rated by a “nationally recognized statistical rating organization”, as such term is defined under Section 3(a)(62) under the Exchange Act;
(bb) From the time of initial confidential submission of a registration statement relating to the Shares with the Commission (or, if earlier, the first date on which a Testing-the-Waters Communication was made) through the date hereof, the Company has been and is an “emerging growth company” as defined in Section 2(a)(19) of the Act (an “Emerging Growth Company”);
(cc) Except as described in the Registration Statement and the Prospectus, the Company: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the Health Care Laws (as defined below) of the Food and Drug Administration (“FDA”), the Department of Health and Human Services (“HHS”) and any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s product candidates or any product manufactured or distributed by the Company; (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or the Applicable Regulatory Authorities alleging or asserting non-compliance with any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by
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any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or the Applicable Regulatory Authorities or any other third party alleging that any product operation or activity is in material violation of any Health Care Laws and has no knowledge that the Applicable Regulatory Authorities or any other third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received notice that any of the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the Applicable Regulatory Authorities is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vii) is not a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Applicable Regulatory Authority; and (viii) along with its employees, officers and directors, has not been excluded, suspended or debarred from participation in any government health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.
The term “Health Care Laws” means Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287 and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the Exclusion Laws, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations;
(dd) None of the Company’s product candidates have received marketing approval from any Applicable Regulatory Authority. All clinical and pre-clinical studies and trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Registration Statement and the Prospectus, or
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the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, to the Company’s knowledge, being conducted in all material respects in accordance with all applicable Health Care Laws of the Applicable Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions in the Registration Statement, Pricing Disclosure Package and the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; the Company has no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus; the Company has not received any written notices, correspondence or other communications from the Applicable Regulatory Authorities or any other governmental entity requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. No investigational new drug application or comparable submission filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA or any other Applicable Regulatory Authority. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct;
(ee) The Company is, and at all prior times was, in material compliance with all applicable data privacy and security laws and regulations, including without limitation, as applicable, HIPAA, as amended, and the Company has taken any required and necessary actions to comply in all material respects with the European Union General Data Protection Regulation (“GDPR”) (EU 2016/679) (and all other applicable laws and regulations with respect to Personal Data that have been announced as of the date hereof as becoming effective within 12 months after the date hereof, and for which any non-compliance with the same would be reasonably likely to create a material liability) as soon as they take effect (collectively, the “Privacy Laws”). To ensure material compliance with the Privacy Laws, the Company has in place and is in material compliance with commercially reasonable policies and procedures relating to data privacy and security and the collection, storage, use, disclosure, handling, and analysis of Personal Data (the “Policies”) as applicable. “Personal Data” means (i) a natural person’s name, street address, telephone number, e-mail address, photograph, social security number or tax identification number, driver’s license number, passport number, credit card number, bank information, or customer or account number; (ii) any information which would qualify as “personally identifying information” under the Federal Trade Commission Act, as amended; (iii) Protected Health Information as defined by HIPAA; (iv) “personal data” as defined by GDPR; and (v) any other piece of information that allows the identification of such natural person or permits the collection or analysis of any data related to an identified person’s health or sexual orientation. The Company has since inception made all disclosures to users or customers required by applicable laws and regulatory rules or requirements, and has provided
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accurate notice of its Policies then in effect to its customers, employees, third party vendors and representatives as required by applicable laws and regulatory rules or requirements, except where the failure to do so would not, individually or in the aggregate, have a Material Adverse Effect. None of such disclosures made or contained in any of the Policies have been inaccurate, misleading, deceptive or in violation of any Privacy Laws or Policies in any material respect. The execution, delivery and performance of this Agreement or any other agreement referred to in this Agreement will not result in a breach of violation of any Privacy Laws or Policies. The Company further certifies that it: (i) has not received notice of any actual or potential liability under or relating to, or actual or potential violation of, any of the Privacy Laws, and has no knowledge of any event or condition that would reasonably be expected to result in any such notice; (ii) is not currently conducting or paying for, in whole or in part, any investigation, remediation, or other corrective action pursuant to any Privacy Law; or (iii) is a party to any order, decree, or agreement that imposes any obligation or liability under any Privacy Law;
(ff) Except as would not reasonably be expected to have a Material Adverse Effect, the Company and its subsidiaries’ information technology assets and equipment, computers, systems, networks, hardware, software, websites, applications, and databases (collectively, “IT Systems”) are (i) adequate for, and operate and perform as required in connection with the operation of the business of the Company and its subsidiaries as currently conducted, and (ii) to the Company’s knowledge, free and clear of all bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants. The Company and its subsidiaries have implemented and maintained commercially reasonable controls, policies, procedures, and safeguards to maintain and protect their material confidential information and the integrity, continuous operation, redundancy and security of all IT Systems and data (including all personal, personally identifiable, sensitive, confidential or regulated data (“Personal Data”)) used in connection with their businesses, and, except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, there have been no breaches, violations, outages or known unauthorized uses of or known accesses to the same, except for those that have been remedied without material cost or liability or the duty to notify any other person, nor any incidents under internal review or investigations relating to the same and except as would not reasonably be expected to have a Material Adverse Effect. The Company and its subsidiaries are presently in compliance with all applicable laws or statutes and all judgments, orders, rules and regulations of any court or arbitrator or governmental or regulatory authority, internal policies and contractual obligations relating to the privacy and security of IT Systems and Personal Data and to the protection of such IT Systems and Personal Data from unauthorized use, access, misappropriation or modification, except where the failure to be in compliance would not reasonably be expected to have a Material Adverse Effect;
(gg) Except as disclosed in the Pricing Prospectus, the Company and its subsidiaries own or have obtained valid and enforceable licenses for, the inventions, patent applications, patents, trademarks, trade names, service names, copyrights, trade secrets and other intellectual property described in the Registration Statement and the Pricing Prospectus as being owned or licensed by them or which are necessary for the conduct of their respective businesses as currently conducted or as currently proposed to be conducted in the Registration Statement and the Pricing Prospectus (collectively, “Intellectual Property”). Except as disclosed in the Pricing Prospectus, to the Company’s
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knowledge: (i) there are no third parties who have rights to any Intellectual Property, except for customary reversionary rights of third-party licensors with respect to Intellectual Property that is disclosed in the Registration Statement and the Prospectus as licensed to the Company or any of its subsidiaries; (ii) there is no infringement or misappropriation by third parties of any Intellectual Property; (iii) neither the Company nor any of its subsidiaries is infringing or misappropriating the intellectual property rights of third parties; and (iv) the Company and each of its subsidiaries is either the sole owner or the co-owner of the Intellectual Property owned by it and has the valid right to use such Intellectual Property. There is no pending or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others: (A) challenging the Company’s or any of its subsidiaries’ rights in or to any Intellectual Property; (B) challenging the validity, enforceability or scope of any Intellectual Property; or (C) asserting that either the Company or any of its subsidiaries infringes or otherwise violates, or would, upon the commercialization of any product or service described in the Registration Statement and the Prospectus as under development, infringe, misappropriate or violate, any patent, trademark, trade name, service name, copyright, trade secret or other proprietary rights of others. The Company and each of its subsidiaries have complied with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company or such subsidiary, and all such agreements are in full force and effect;
(hh) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, all patents and patent applications owned by or licensed to the Company or its subsidiaries under which the Company or any of its subsidiaries has rights have, to the knowledge of the Company, been duly and properly filed and maintained; to the knowledge of the Company, the parties prosecuting such applications have complied with their duty of candor and disclosure to the U.S. Patent and Trademark Office (the “USPTO”) in connection with such applications; and the Company is not aware of any facts required to be disclosed to the USPTO that were not disclosed to the USPTO and which would preclude the grant of a patent in connection with any such application or would reasonably be expected to form the basis of a finding of invalidity with respect to any patents that have been issued with respect to such applications;
(ii) There are no persons with registration rights or other similar rights to have any securities registered pursuant to the Registration Statement or otherwise registered by the Company under the Act except as have been validly waived or complied with;
(jj) No labor disturbance by or dispute with the employees of the Company or any of its subsidiaries exists or, to the knowledge of the Company or any of its subsidiaries, is contemplated or threatened, and the Company and its subsidiaries are not aware of any existing or imminent labor disturbance by, or dispute with, the employees of any of its principal suppliers, manufacturers, customers or contractors, which, in either case, would, individually or in the aggregate, result in a Material Adverse Effect;
(kk) Except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect: (i) each employee benefit plan, within the meaning of Section 3(3) of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), for which the Company or any member of its “Controlled Group” (defined as any entity, whether or not incorporated, that is under common control with the
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Company within the meaning of Section 4001(a)(14) of ERISA or any entity that would be regarded as a single employer with the Company under Section 414(b),(c),(m) or (o) of the Internal Revenue Code of 1986, as amended (the “Code”)) would have any liability (each, a “Plan”) has been maintained in compliance with its terms and the requirements of any applicable statutes, orders, rules and regulations, including but not limited to ERISA and the Code and no prohibited transaction, within the meaning of Section 406 of ERISA or Section 4975 of the Code, has occurred with respect to any Plan, excluding transactions effected pursuant to a statutory or administrative exemption; (ii) none of the Plans are subject to the funding rules of Section 412 of the Code or Section 302 of ERISA; (iii) none of the Plans are “multiemployer plans” within the meaning of Section 4001(a)(3) of ERISA; and (iv) each Plan that is intended to be qualified under Section 401(a) of the Code is so qualified, and nothing has occurred, whether by action or failure to act, which would cause the loss of such qualification;
(ll) The Company and its subsidiaries have paid all federal, state, local and foreign taxes and filed all tax returns required to be paid or filed through the date hereof; and except as otherwise disclosed in each of the Registration Statement, the Pricing Disclosure Package and the Prospectus, there is no tax deficiency that has been asserted against the Company or any of its subsidiaries or any of their respective properties or assets;
(mm) (i) The Company and its subsidiaries (x) are in compliance with all, and have not violated any, applicable federal, state, local and foreign laws, rules, regulations, requirements, decisions, judgments, decrees, orders and other legally enforceable requirements relating to pollution or the protection of human health or safety, the environment, natural resources, hazardous or toxic substances or wastes, pollutants or contaminants (collectively, “Environmental Laws”); (y) have received and are in compliance with all, and have not violated any, permits, licenses, certificates or other authorizations or approvals required of them under any Environmental Laws to conduct their respective businesses; and (z) have not received written notice of any actual or potential liability or obligation under or relating to, or any actual or potential violation of, any Environmental Laws, including for the investigation or remediation of any disposal or release of hazardous or toxic substances or wastes, pollutants or contaminants, and have no knowledge of any event or condition that would reasonably be expected to result in any such notice, and (ii) there are no costs or liabilities associated with Environmental Laws of or relating to the Company or its subsidiaries, except in the case of each of (i) and (ii) above, for any such matter as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and (iii) except as described in each of the Registration Statement, the Pricing Disclosure Package and the Prospectus, (x) there is no proceeding that is pending, or that is known by the Company to be contemplated, against the Company or any of its subsidiaries under any Environmental Laws in which a governmental entity is also a party, other than such proceeding regarding which the Company reasonably believes no monetary sanctions of $100,000 or more will be imposed, (y) the Company and its subsidiaries are not aware of any facts or issues regarding compliance with Environmental Laws, or liabilities or other obligations under Environmental Laws or concerning hazardous or toxic substances or wastes, pollutants or contaminants, that would, individually or in the aggregate, reasonably be excepted to have a Material Adverse Effect, and (z) none of the Company or its subsidiaries anticipates material capital expenditures relating to any Environmental Laws;
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(nn) There are no business relationships or related-party transactions involving the Company or any subsidiary or any other person required to be disclosed in the Pricing Prospectus or the Prospectus that have not been described as required;
(oo) The Company and its subsidiaries have insurance covering their respective properties, operations, personnel and businesses, including business interruption insurance, which insurance is in amounts and insures against such losses and risks as are generally maintained by similarly situated companies and which the Company believes are reasonably adequate to protect the Company and its subsidiaries and their respective businesses; and neither the Company nor any of its subsidiaries has (i) received notice from any insurer or agent of such insurer that capital improvements or other expenditures are required or necessary to be made in order to continue such insurance or (ii) any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage at reasonable cost from similar insurers as may be necessary to continue its business;
(pp) Neither the Company nor any of its subsidiaries is a party to any contract, agreement or understanding with any person (other than this Agreement) that would give rise to a valid claim against any of them or any Underwriter for a brokerage commission, finder’s fee or like payment in connection with the offering and sale of the Shares; and
(qq) Nothing has come to the attention of the Company that has caused the Company to believe that the statistical and market-related data included or incorporated by reference in each of the Registration Statement, the Pricing Disclosure Package and the Prospectus is not based on or derived from sources that are reliable and accurate in all material respects.
2. Subject to the terms and conditions herein set forth, (a) the Company agrees to issue and sell to each of the Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, at a purchase price per share of $[ ● ], the number of Firm Shares set forth opposite the name of such Underwriter in Schedule I hereto and (b) in the event and to the extent that the Underwriters shall exercise the election to purchase Optional Shares as provided below, the Company agrees to issue and sell to each of the Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, at the purchase price per share set forth in clause (a) of this Section 2 (provided that the purchase price per Optional Share shall be reduced by an amount per share equal to any dividends or distributions declared by the Company and payable on the Firm Shares but not payable on the Optional Shares), that portion of the number of Optional Shares as to which such election shall have been exercised (to be adjusted by the Representative so as to eliminate fractional shares) determined by multiplying such number of Optional Shares by a fraction, the numerator of which is the maximum number of Optional Shares which such Underwriter is entitled to purchase as set forth opposite the name of such Underwriter in Schedule I hereto and the denominator of which is the maximum number of Optional Shares that all of the Underwriters are entitled to purchase hereunder.
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The Company hereby grants to the Underwriters the right to purchase at their election up to [ ● ] Optional Shares, at the purchase price per share set forth in the paragraph above, for the sole purpose of covering sales of shares in excess of the number of Firm Shares, provided that the purchase price per Optional Share shall be reduced by an amount per share equal to any dividends or distributions declared by the Company and payable on the Firm Shares but not payable on the Optional Shares. Any such election to purchase Optional Shares may be exercised only by written notice from the Representative to the Company, given within a period of 30 calendar days after the date of this Agreement, setting forth the aggregate number of Optional Shares to be purchased and the date on which such Optional Shares are to be delivered, as determined by the Representative but in no event earlier than the First Time of Delivery (as defined in Section 4 hereof) or, unless the Representative and the Company otherwise agree in writing, earlier than two or later than ten business days after the date of such notice.
3. Upon the authorization by you of the release of the Firm Shares, the several Underwriters propose to offer the Firm Shares for sale upon the terms and conditions set forth in the Pricing Prospectus and the Prospectus.
4. (a) The Shares to be purchased by each Underwriter hereunder, in book-entry form, and in such authorized denominations and registered in such names as the Representative may request upon at least forty-eight hours’ prior notice to the Company shall be delivered by or on behalf of the Company to the Representative, through the facilities of the Depository Trust Company (“DTC”), for the account of such Underwriter, against payment by or on behalf of such Underwriter of the purchase price therefor by wire transfer of Federal (same-day) funds to the account specified by the Company to the Representative at least forty-eight hours in advance. The time and date of such delivery and payment shall be, with respect to the Firm Shares, 9:30 a.m., New York City time, on July [ ● ], 2020 or such other time and date as the Representative and the Company may agree upon in writing, and, with respect to the Optional Shares, 9:30 a.m., New York time, on the date specified by the Representative in the written notice given by the Representative of the Underwriters’ election to purchase such Optional Shares, or such other time and date as the Representative and the Company may agree upon in writing. Such time and date for delivery of the Firm Shares is herein called the “First Time of Delivery”, such time and date for delivery of the Optional Shares, if not the First Time of Delivery, is herein called the “Second Time of Delivery”, and each such time and date for delivery is herein called a “Time of Delivery”.
(b) The documents to be delivered at each Time of Delivery by or on behalf of the parties hereto pursuant to Section 8 hereof, including the cross receipt for the Shares and any additional documents requested by the Underwriters pursuant to Section 8(l) hereof, will be delivered at the offices of Latham & Watkins LLP, 140 Scott Drive, Menlo Park, CA 94025 (the “Closing Location”), and the Shares will be delivered at the office of DTC or its designated custodian (the “Designated Office”), all at such Time of Delivery. A meeting will be held at the Closing Location at 4:00 p.m., New York City time, on the New York Business Day next preceding such Time of Delivery, at which meeting the final drafts of the documents to be delivered pursuant to the preceding sentence will be available for review by the parties hereto. For the purposes of this Section 4, “New York Business Day” shall mean each Monday, Tuesday, Wednesday, Thursday and Friday which is not a day on which banking institutions in New York City are generally authorized or obligated by law or executive order to close.
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5. The Company agrees with each of the Underwriters:
(a) To prepare the Prospectus in a form approved by you and to file such Prospectus pursuant to Rule 424(b) under the Act not later than the Commission’s close of business on the second business day following the execution and delivery of this Agreement, or, if applicable, such earlier time as may be required by Rule 430A(a)(3) under the Act; to make no further amendment or any supplement to the Registration Statement or the Prospectus prior to the last Time of Delivery which shall be disapproved by you promptly after reasonable notice thereof; to advise you, promptly after it receives notice thereof, of the time when any amendment to the Registration Statement has been filed or becomes effective or any amendment or supplement to the Prospectus has been filed and to furnish you with copies thereof; to file promptly all material required to be filed by the Company with the Commission pursuant to Rule 433(d) under the Act; to advise you, promptly after it receives notice thereof, of the issuance by the Commission of any stop order or of any order preventing or suspending the use of any Preliminary Prospectus or other prospectus in respect of the Shares, of the suspension of the qualification of the Shares for offering or sale in any jurisdiction, of the initiation or threatening of any proceeding for any such purpose, including pursuant to Section 8A under the Act, or of any request by the Commission for the amending or supplementing of the Registration Statement or the Prospectus or for additional information; and, in the event of the issuance of any stop order or of any order preventing or suspending the use of any Preliminary Prospectus or other prospectus or suspending any such qualification, to promptly use its best efforts to obtain the withdrawal of such order;
(b) Promptly from time to time to take such action as you may reasonably request to qualify the Shares for offering and sale under the securities laws of such jurisdictions as you may request and to comply with such laws so as to permit the continuance of sales and dealings therein in such jurisdictions for as long as may be necessary to complete the distribution of the Shares, provided that in connection therewith the Company shall not be required to qualify as a foreign corporation (where not otherwise required) or to file a general consent to service of process in any jurisdiction (where not otherwise required);
(c) Prior to 10:00 a.m., New York City time, on the New York Business Day next succeeding the date of this Agreement (or such other time as may be agreed to by the Representative and the Company) and from time to time, to furnish the Underwriters with written and electronic copies of the Prospectus in New York City in such quantities as you may reasonably request, and, if the delivery of a prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Act) is required at any time prior to the expiration of nine months after the time of issue of the Prospectus in connection with the offering or sale of the Shares and if at such time any event shall have occurred as a result of which the Prospectus as then amended or supplemented would include an untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made when such Prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Act) is
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delivered, not misleading, or, if for any other reason it shall be necessary during such same period to amend or supplement the Prospectus in order to comply with the Act, to notify you and upon your request to prepare and furnish without charge to each Underwriter and to any dealer in securities as many written and electronic copies as you may from time to time reasonably request of an amended Prospectus or a supplement to the Prospectus which will correct such statement or omission or effect such compliance; and in case any Underwriter is required to deliver a prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Act) in connection with sales of any of the Shares at any time nine months or more after the time of issue of the Prospectus, upon your request but at the expense of such Underwriter, to prepare and deliver to such Underwriter as many written and electronic copies as you may request of an amended or supplemented Prospectus complying with Section 10(a)(3) of the Act;
(d) To make generally available to its securityholders as soon as practicable (which may be satisfied by filing with the Commission’s Electronic Data Gathering Analysis and Retrieval System (“EDGAR”)), but in any event not later than sixteen months after the effective date of the Registration Statement (as defined in Rule 158(c) under the Act), an earnings statement of the Company and its subsidiaries (which need not be audited) complying with Section 11(a) of the Act and the rules and regulations of the Commission thereunder (including, at the option of the Company, Rule 158);
(e) During the period beginning from the date hereof and continuing to and including the date 90 days after the date of the Prospectus (the “Lock-Up Period”), not to (i) offer, sell, contract to sell, pledge, lend, grant any option to purchase, make any short sale or otherwise transfer or dispose of, directly or indirectly, or file with or confidentially submit to the Commission a registration statement under the Act relating to, any securities of the Company that are substantially similar to the Shares, including but not limited to any options or warrants to purchase shares of Common Stock or any securities that are convertible into or exchangeable for, or that represent the right to receive, Common Stock or any such substantially similar securities, or publicly disclose the intention to make any offer, sale, pledge, loan, disposition, confidential submission or filing or (ii) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the Common Stock or any such other securities, whether any such transaction described in clauses (i) or (ii) above is to be settled by delivery of Common Stock or such other securities, in cash or otherwise, or (iii) publicly disclose the intention to do any of the foregoing, in each case, without the prior written consent of the Representative; provided, however, that the foregoing restrictions shall not apply to (1) the Shares to be sold hereunder, (2) any shares of Common Stock or any securities or other awards (including without limitation options, restricted stock or restricted stock units) convertible into, exercisable for, or that represent the right to receive, shares of Common Stock pursuant to any stock option plan, incentive plan or stock purchase plan of the Company (collectively, “Company Stock Plans”) or otherwise in equity compensation arrangements described in the Registration Statement and the Prospectus, provided that any directors or officers who are the recipients thereof have provided to the Representative a signed lock-up letter substantially in the form of Annex I hereto, (3) any shares of Common Stock issued upon the conversion, exercise or exchange of convertible, exercisable or exchangeable securities, including convertible notes, outstanding on the date of this Agreement, in each case if such convertible, exercisable or exchangeable
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securities is described in the Registration Statement and the Prospectus and the holders of such convertible, exercisable or exchangeable securities have provided to the Representative a signed lockup-letter substantially in the form of Annex I hereto, (4) the filing by the Company of any registration statement on Form S-8 or a successor form thereto relating to any Company Stock Plan described in the Registration Statement and the Prospectus, and (5) any shares of Common Stock or any securities convertible into or exchangeable for, or that represent the right to receive, shares of Common Stock issued in connection with any joint venture, commercial or collaborative relationship or the acquisition or license by the Company of the securities, businesses, property or other assets of another person or entity or pursuant to any employee benefit plan assumed by the Company in connection with any such acquisition, provided that in the case of clause (5), the aggregate number of shares that the Company may sell or issue or agree to sell or issue pursuant to clause (5), (x) shall not exceed 10.0% of the total number of shares of Common Stock issued and outstanding immediately following the completion of the transactions contemplated by this Agreement and (y) the recipients thereof provide to the Representative a signed lock-up letter substantially in the form of Annex I hereto.
(f) During a period of three years from the effective date of the Registration Statement, for so long as the Company is subject to the reporting requirements of either Section 13 or Section 15(d) of the Exchange Act, to furnish to its stockholders as soon as practicable after the end of each fiscal year an annual report (including a balance sheet and statements of income, stockholders’ equity and cash flows of the Company and its consolidated subsidiaries certified by independent public accountants) and, as soon as practicable after the end of each of the first three quarters of each fiscal year (beginning with the fiscal quarter ending after the effective date of the Registration Statement), to make available to its stockholders consolidated summary financial information of the Company and its subsidiaries for such quarter in reasonable detail, provided, that no reports, documents or other information needs to be furnished pursuant to this Section 5(f) to the extent they are available on EDGAR;
(g) During a period of three years from the effective date of the Registration Statement, to furnish to you copies of all reports or other communications (financial or other) furnished to stockholders, and to deliver to you (i) as soon as they are available, copies of any reports and financial statements furnished to or filed with the Commission or any national securities exchange on which any class of securities of the Company is listed; and (ii) such additional information concerning the business and financial condition of the Company as you may from time to time reasonably request (such financial statements to be on a consolidated basis to the extent the accounts of the Company and its subsidiaries are consolidated in reports furnished to its stockholders generally or to the Commission), provided, that no reports, documents or other information needs to be furnished pursuant to this Section 5(g) to the extent they are available on EDGAR;
(h) To use the net proceeds received by it from the sale of the Shares pursuant to this Agreement in the manner specified in the Pricing Prospectus under the caption “Use of Proceeds”;
(i) To use its best efforts to list, subject to notice of issuance, the Shares on the Nasdaq Stock Market (the “Nasdaq”);
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(j) If the Company elects to rely upon Rule 462(b), the Company shall file a Rule 462(b) Registration Statement with the Commission in compliance with Rule 462(b) by 10:00 p.m., Washington, D.C. time, on the date of this Agreement, and the Company shall at the time of filing either pay to the Commission the filing fee for the Rule 462(b) Registration Statement or give irrevocable instructions for the payment of such fee pursuant to Rule 111(b) under the Act;
(k) Upon request of any Underwriter, to furnish, or cause to be furnished, to such Underwriter an electronic version of the Company’s trademarks, servicemarks and corporate logo for use on the website, if any, operated by such Underwriter for the purpose of facilitating the on-line offering of the Shares (the “License”); provided, however, that the License shall be used solely for the purpose described above, is granted without any fee and may not be assigned or transferred;
(l) To promptly notify you if the Company ceases to be an Emerging Growth Company at any time prior to the later of (i) completion of the distribution of the Shares within the meaning of the Act and (ii) the last Time of Delivery; and
(m) The Company will not take, directly or indirectly, without giving effect to activities by the Underwriters, any action designed to or that would reasonably be expected to cause or result in any stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Shares.
6. (a) The Company represents and agrees that, without the prior consent of the Representative, it has not made and will not make any offer relating to the Shares that would constitute a “free writing prospectus” as defined in Rule 405 under the Act; each Underwriter represents and agrees that, without the prior consent of the Company and the Representative, it has not made and will not make any offer relating to the Shares that would constitute a free writing prospectus required to be filed with the Commission; any such free writing prospectus the use of which has been consented to by the Company and the Representative is listed on Schedule II(a) or Schedule II(c) hereto;
(b) The Company has complied and will comply with the requirements of Rule 433 under the Act applicable to any Issuer Free Writing Prospectus, including timely filing with the Commission or retention where required and legending; and the Company represents that it has satisfied and agrees that it will satisfy the conditions under Rule 433 under the Act to avoid a requirement to file with the Commission any electronic road show;
(c) The Company agrees that if at any time following issuance of an Issuer Free Writing Prospectus or any Testing-the-Waters Writing prepared or authorized by it any event occurred or occurs as a result of which such Issuer Free Writing Prospectus or Testing-the-Waters Writing prepared or authorized by it would conflict with the information in the Registration Statement, the Pricing Prospectus or the Prospectus or would include an untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances then prevailing, not misleading, the Company will give prompt notice thereof to the Representative and, if requested by the Representative, will prepare and furnish without charge to each Underwriter an Issuer Free Writing Prospectus, Testing-the-Waters Writing or other
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document which will correct such conflict, statement or omission, provided, however, that this representation and warranty shall not apply to any statements or omissions in an Issuer Free Writing Prospectus or Testing-the-Waters Writing prepared or authorized by it made in reliance upon and in conformity with the Underwriter Information;
(d) The Company represents and agrees that (i) it has not engaged in, or authorized any other person to engage in, any Testing-the-Waters Communications, other than Testing-the-Waters Communications with the prior consent of the Representative with entities that are qualified institutional buyers as defined in Rule 144A under the Act or institutions that are accredited investors as defined in Rule 501(a) under the Act; and (ii) it has not distributed, or authorized any other person to distribute, any Testing-the-Waters Writings, other than those distributed with the prior consent of the Representative that are listed on Schedule II(d) hereto; and the Company reconfirms that the Underwriters have been authorized to act on its behalf in engaging in Testing-the-Waters Communications; and
(e) Each Underwriter represents and agrees that any Testing-the-Waters Communications undertaken by it were with entities that are qualified institutional buyers as defined in Rule 144A under the Act or institutions that are accredited investors as defined in Rule 501(a) under the Act.
7. The Company covenants and agrees with the several Underwriters that the Company will pay or cause to be paid the following: (i) the fees, disbursements and expenses of the Company’s counsel and accountants in connection with the registration of the Shares under the Act and all other expenses in connection with the preparation, printing, reproduction and filing of the Registration Statement, any Preliminary Prospectus, any Testing-the-Waters Writing, any Issuer Free Writing Prospectus and the Prospectus and amendments and supplements thereto and the mailing and delivering of copies thereof to the Underwriters and dealers; (ii) the cost of printing or producing any Agreement among Underwriters, this Agreement, the Blue Sky Memorandum, closing documents (including any compilations thereof) and any other documents in connection with the offering, purchase, sale and delivery of the Shares; (iii) all expenses in connection with the qualification of the Shares for offering and sale under state securities laws as provided in Section 5(b) hereof, including the fees and disbursements of counsel for the Underwriters in connection with such qualification and in connection with the Blue Sky survey (iv) all fees and expenses in connection with listing the Shares on the Nasdaq; (v) the filing fees incident to, and the fees and disbursements of counsel for the Underwriters in connection with, any required review by FINRA of the terms of the sale of the Shares; (vi) the cost of preparing stock certificates; (vii) the cost and charges of any transfer agent or registrar; and (viii) all other costs and expenses incident to the performance of its obligations hereunder which are not otherwise specifically provided for in this Section; provided, however, that the amounts payable by the Company pursuant to clauses (iii) and (v) for fees and disbursements of counsel to the Underwriters described in clauses (iii) and (v) shall not exceed $25,000 in the aggregate. It is understood, however, that, (x) except as provided in this Section, and Sections 9 and 11 hereof, the Underwriters will pay all of their own costs and expenses, including the fees of their counsel, stock transfer taxes on resale of any of the Shares by them, and any advertising expenses connected with any offers they may make and all travel and lodging expenses of the Underwriters and their representatives
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and counsel; and (y) subject to the Company’s and Representative’s prior written approval of each such expense, the Underwriters and the Company shall each pay 50% of the cost of chartering any aircraft to be used by the directors and officers of the Company and the employees of the Representative in connection with the road show or any testing-the-waters meetings by the Company and the Underwriters, provided that both directors and officers of the Company and employees of the Representative are on board the aircraft.
8. The obligations of the Underwriters hereunder, as to the Shares to be delivered at each Time of Delivery, shall be subject, in their discretion, to the condition that all representations and warranties and other statements of the Company herein are, at and as of the Applicable Time and such Time of Delivery, true and correct, the condition that the Company shall have performed all of its obligations hereunder theretofore to be performed, and the following additional conditions:
(a) The Prospectus shall have been filed with the Commission pursuant to Rule 424(b) under the Act within the applicable time period prescribed for such filing by the rules and regulations under the Act and in accordance with Section 5(a) hereof; all material required to be filed by the Company pursuant to Rule 433(d) under the Act shall have been filed with the Commission within the applicable time period prescribed for such filing by Rule 433; if the Company has elected to rely upon Rule 462(b) under the Act, the Rule 462(b) Registration Statement shall have become effective by 10:00 p.m., Washington, D.C. time, on the date of this Agreement; no stop order suspending the effectiveness of the Registration Statement or any part thereof shall have been issued and no proceeding for that purpose or pursuant to Section 8A of the Act shall have been initiated or threatened by the Commission; no stop order suspending or preventing the use of the Pricing Prospectus, Prospectus or any Issuer Free Writing Prospectus shall have been initiated or threatened by the Commission; and all requests for additional information on the part of the Commission shall have been complied with to your reasonable satisfaction;
(b) Latham & Watkins LLP, counsel for the Underwriters, shall have furnished to you such written opinion and negative assurance letter, each dated for such Time of Delivery, in form and substance satisfactory to the Representative, and such counsel shall have received such papers and information as they may reasonably request to enable them to pass upon such matters;
(c) Cooley LLP, corporate and regulatory counsel for the Company, shall have furnished to you their written opinion and negative assurance letter, each dated for such Time of Delivery, in form and substance satisfactory to the Representative;
(d) Seed IP, intellectual property counsel for the Company, shall have furnished to you their written opinion and negative assurance letter, each dated for such Time of Delivery, in form and substance satisfactory to the Representative;
(e) On the date of the Prospectus at a time after the execution of this Agreement, at 9:30 a.m., New York City time, on the effective date of any post-effective amendment to the Registration Statement filed subsequent to the date of this Agreement and also at each Time of Delivery, Ernst & Young LLP shall have furnished to you a letter or letters, dated the respective dates of delivery thereof, in form and substance satisfactory to the Representative;
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(f) (i) Neither the Company nor any of its subsidiaries shall have sustained since the date of the latest audited financial statements included or incorporated by reference in the Pricing Prospectus any loss or interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor dispute or court or governmental action, order or decree, otherwise than as set forth or contemplated in the Pricing Prospectus, and (ii) since the respective dates as of which information is given in the Pricing Prospectus there shall not have been any change in the capital stock (other than as a result of the exercise of stock options or the award of stock options or restricted stock in the ordinary course of business pursuant to the Company’s equity plans that are described in the Pricing Prospectus) or long-term debt of the Company or any of its subsidiaries or any dividend or distribution of any kind declared, set aside for payment, paid or made by the Company on any class of capital stock or any change or effect, or any development involving a prospective change or effect, in or affecting (x) the business, properties, general affairs, management, financial position, stockholders’ equity or results of operations of the Company and its subsidiaries, taken as a whole, except as set forth or contemplated in the Pricing Prospectus and the Prospectus, or (y) the ability of the Company to perform its obligations under this Agreement, including the issuance and sale of the Shares, or to consummate the transactions contemplated in the Pricing Prospectus and the Prospectus, the effect of which, in any such case described in clause (i) or (ii), is in your judgment so material and adverse as to make it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares being delivered at such Time of Delivery on the terms and in the manner contemplated in the Pricing Prospectus and the Prospectus;
(g) On or after the Applicable Time there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange or on the Nasdaq; (ii) a suspension or material limitation in trading in the Company’s securities on the Nasdaq; (iii) a general moratorium on commercial banking activities declared by either Federal or New York State authorities or a material disruption in commercial banking or securities settlement or clearance services in the United States; (iv) the outbreak or escalation of hostilities involving the United States or the declaration by the United States of a national emergency or war or (v) the occurrence of any other calamity or crisis or any change in financial, political or economic conditions in the United States or elsewhere, if the effect of any such event specified in clause (iv) or (v) in your judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares being delivered at such Time of Delivery on the terms and in the manner contemplated in the Pricing Prospectus and the Prospectus;
(h) The Shares to be sold at such Time of Delivery shall have been duly listed for quotation on the Nasdaq;
(i) FINRA shall have raised no objection to the fairness and reasonableness of the underwriting terms and arrangements;
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(j) The Company shall have obtained and delivered to the Underwriters executed copies of an agreement from all officers and directors of the Company and certain affiliated stockholders of the Company, substantially to the effect set forth in Annex I hereof in form and substance satisfactory to you;
(k) The Company shall have complied with the provisions of Section 5(c) hereof with respect to the furnishing of prospectuses on the New York Business Day next succeeding the date of this Agreement (or such other time as may be agreed to by the Representative and the Company);
(l) The Company shall have furnished or caused to be furnished to you at such Time of Delivery certificates of officers of the Company satisfactory to you as to the accuracy of the representations and warranties of the Company herein at and as of such Time of Delivery, as to the performance by the Company of all of its obligations hereunder to be performed at or prior to such Time of Delivery, as to the matters set forth in subsections (a) and (f) of this Section and as to such other matters as you may reasonably request; and
(m) At each Time of Delivery, the Representative shall have received a certificate of the Secretary of the Company, as to such matters as the Representative may reasonably request.
9. (a) The Company will indemnify and hold harmless each Underwriter against any losses, claims, damages or liabilities, joint or several, to which such Underwriter may become subject, under the Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, any Issuer Free Writing Prospectus, any “roadshow” as defined in Rule 433(h) under the Act (a “roadshow”), any “issuer information” filed or required to be filed pursuant to Rule 433(d) under the Act or any Testing-the-Waters Writing prepared or authorized by the Company, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, and will reimburse each Underwriter for any legal or other expenses reasonably incurred by such Underwriter in connection with investigating or defending any such action or claim as such expenses are incurred; provided, however, that the Company shall not be liable in any such case to the extent that any such loss, claim, damage or liability arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission made in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, or any Issuer Free Writing Prospectus or any Testing-the-Waters Writing, in reliance upon and in conformity with the Underwriter Information.
(b) Each Underwriter, severally and not jointly, will indemnify and hold harmless the Company against any losses, claims, damages or liabilities to which the Company may become subject, under the Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, any
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Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, or any Issuer Free Writing Prospectus, or any roadshow or any Testing-the-Waters Writing, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, in each case to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, or any Issuer Free Writing Prospectus, or any roadshow or any Testing-the-Waters Writing, in reliance upon and in conformity with the Underwriter Information; and will reimburse the Company for any legal or other expenses reasonably incurred by the Company in connection with investigating or defending any such action or claim as such expenses are incurred. As used in this Agreement with respect to an Underwriter and an applicable document, “Underwriter Information” shall mean the written information furnished to the Company by such Underwriter through the Representative expressly for use therein; it being understood and agreed upon that the only such information furnished by any Underwriter consists of the following information in the Prospectus furnished on behalf of each Underwriter: the concession and reallowance figures appearing in the fifth paragraph under the caption “Underwriting”, and the information contained in the eighth, ninth and tenth paragraphs under the caption “Underwriting”.
(c) Promptly after receipt by an indemnified party under subsection (a) or (b) above of notice of the commencement of any action, such indemnified party shall, if a claim in respect thereof is to be made against the indemnifying party under such subsection, notify the indemnifying party in writing of the commencement thereof; provided that the failure to notify the indemnifying party shall not relieve it from any liability that it may have under the preceding paragraphs of this Section 9 except to the extent that it has been materially prejudiced (through the forfeiture of substantive rights or defenses) by such failure; and provided further that the failure to notify the indemnifying party shall not relieve it from any liability that it may have to an indemnified party otherwise than under the preceding paragraphs of this Section 9. In case any such action shall be brought against any indemnified party and it shall notify the indemnifying party of the commencement thereof, the indemnifying party shall be entitled to participate therein and, to the extent that it shall wish, jointly with any other indemnifying party similarly notified, to assume the defense thereof, with counsel reasonably satisfactory to such indemnified party (who shall not, except with the consent of the indemnified party, be counsel to the indemnifying party), and, after notice from the indemnifying party to such indemnified party of its election so to assume the defense thereof, the indemnifying party shall not be liable to such indemnified party under such subsection for any legal expenses of other counsel or any other expenses, in each case subsequently incurred by such indemnified party, in connection with the defense thereof other than reasonable costs of investigation. No indemnifying party shall, without the written consent of the indemnified party, effect the settlement or compromise of, or consent to the entry of any judgment with respect to, any pending or threatened action or claim in respect of which indemnification or contribution may be sought hereunder (whether or not the indemnified party is an actual or potential party to such action or claim) unless such settlement, compromise or judgment (i) includes an unconditional release of the indemnified party from all liability arising out of such action or claim and (ii) does not include a statement as to or an admission of fault, culpability or a failure to act, by or on behalf of any indemnified party.
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(d) If the indemnification provided for in this Section 9 is unavailable to or insufficient to hold harmless an indemnified party under subsection (a) or (b) above in respect of any losses, claims, damages or liabilities (or actions in respect thereof) referred to therein, then each indemnifying party shall contribute to the amount paid or payable by such indemnified party as a result of such losses, claims, damages or liabilities (or actions in respect thereof) in such proportion as is appropriate to reflect the relative benefits received by the Company on the one hand and the Underwriters on the other from the offering of the Shares. If, however, the allocation provided by the immediately preceding sentence is not permitted by applicable law, then each indemnifying party shall contribute to such amount paid or payable by such indemnified party in such proportion as is appropriate to reflect not only such relative benefits but also the relative fault of the Company on the one hand and the Underwriters on the other in connection with the statements or omissions which resulted in such losses, claims, damages or liabilities (or actions in respect thereof), as well as any other relevant equitable considerations. The relative benefits received by the Company on the one hand and the Underwriters on the other shall be deemed to be in the same proportion as the total net proceeds from the offering (before deducting expenses) received by the Company bear to the total underwriting discounts and commissions received by the Underwriters, in each case as set forth in the table on the cover page of the Prospectus. The relative fault shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company on the one hand or the Underwriters on the other and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission. The Company and the Underwriters agree that it would not be just and equitable if contribution pursuant to this subsection (d) were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation which does not take account of the equitable considerations referred to above in this subsection (d). The amount paid or payable by an indemnified party as a result of the losses, claims, damages or liabilities (or actions in respect thereof) referred to above in this subsection (d) shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim. Notwithstanding the provisions of this subsection (d), no Underwriter shall be required to contribute any amount in excess of the amount by which the total price at which the Shares underwritten by it and distributed to the public were offered to the public exceeds the amount of any damages which such Underwriter has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. The Underwriters’ obligations in this subsection (d) to contribute are several in proportion to their respective underwriting obligations and not joint.
(e) The obligations of the Company under this Section 9 shall be in addition to any liability which the Company may otherwise have and shall extend, upon the same terms and conditions, to each employee, officer and director of each Underwriter and each
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person, if any, who controls any Underwriter within the meaning of the Act and each broker-dealer or other affiliate of any Underwriter; and the obligations of the Underwriters under this Section 9 shall be in addition to any liability which the respective Underwriters may otherwise have and shall extend, upon the same terms and conditions, to each officer and director of the Company (including any person who, with his or her consent, is named in the Registration Statement as about to become a director of the Company) and to each person, if any, who controls the Company within the meaning of the Act.
10. (a) If any Underwriter shall default in its obligation to purchase the Shares which it has agreed to purchase hereunder at a Time of Delivery, the Representative may in the Representative’s discretion arrange for the Representative or another party or other parties to purchase such Shares on the terms contained herein. If within thirty-six hours after such default by any Underwriter the Representative does not arrange for the purchase of such Shares, then the Company shall be entitled to a further period of thirty-six hours within which to procure another party or other parties satisfactory to the Representative to purchase such Shares on such terms. In the event that, within the respective prescribed periods, the Representative notifies the Company that the Representative has so arranged for the purchase of such Shares, or the Company notifies the Representative that it has so arranged for the purchase of such Shares, the Representative or the Company shall have the right to postpone such Time of Delivery for a period of not more than seven days, in order to effect whatever changes may thereby be made necessary in the Registration Statement or the Prospectus, or in any other documents or arrangements, and the Company agrees to file promptly any amendments or supplements to the Registration Statement or the Prospectus which in your opinion may thereby be made necessary. The term “Underwriter” as used in this Agreement shall include any person substituted under this Section with like effect as if such person had originally been a party to this Agreement with respect to such Shares.
(b) If, after giving effect to any arrangements for the purchase of the Shares of a defaulting Underwriter or Underwriters by the Representative and the Company as provided in subsection (a) above, the aggregate number of such Shares which remains unpurchased does not exceed one-eleventh of the aggregate number of all the Shares to be purchased at such Time of Delivery, then the Company shall have the right to require each non-defaulting Underwriter to purchase the number of shares which such Underwriter agreed to purchase hereunder at such Time of Delivery and, in addition, to require each non-defaulting Underwriter to purchase its pro rata share (based on the number of Shares which such Underwriter agreed to purchase hereunder) of the Shares of such defaulting Underwriter or Underwriters for which such arrangements have not been made; but nothing herein shall relieve a defaulting Underwriter from liability for its default.
(c) If, after giving effect to any arrangements for the purchase of the Shares of a defaulting Underwriter or Underwriters by you and the Company as provided in subsection (a) above, the aggregate number of such Shares which remains unpurchased exceeds one-eleventh of the aggregate number of all the Shares to be purchased at such Time of Delivery, or if the Company shall not exercise the right described in subsection (b) above to require non-defaulting Underwriters to purchase Shares of a defaulting Underwriter or Underwriters, then this Agreement (or, with respect to the Second Time of Delivery, the obligations of the Underwriters to purchase and of the Company to sell the
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Optional Shares) shall thereupon terminate, without liability on the part of any non-defaulting Underwriter or the Company, except for the expenses to be borne by the Company and the Underwriters as provided in Section 7 hereof and the indemnity and contribution agreements in Section 9 hereof; but nothing herein shall relieve a defaulting Underwriter from liability for its default.
11. The respective indemnities, agreements, representations, warranties and other statements of the Company and the several Underwriters, as set forth in this Agreement or made by or on behalf of them, respectively, pursuant to this Agreement, shall remain in full force and effect, regardless of any investigation (or any statement as to the results thereof) made by or on behalf of any Underwriter or any controlling person of any Underwriter, or the Company, or any officer or director or controlling person of the Company, and shall survive delivery of and payment for the Shares.
12. If this Agreement shall be terminated pursuant to Section 10 hereof, the Company shall not then be under any liability to any Underwriter except as provided in Sections 7 and 9 hereof; but, if for any other reason, any Shares are not delivered by or on behalf of the Company as provided herein, the Company will reimburse the Underwriters through the Representative for all out-of-pocket expenses approved in writing by the Representative, including fees and disbursements of counsel, reasonably incurred by the Underwriters in making preparations for the purchase, sale and delivery of the Shares not so delivered, but the Company shall then be under no further liability to any Underwriter except as provided in Sections 7 and 9 hereof.
13. In all dealings hereunder, you shall act on behalf of each of the Underwriters, and the parties hereto shall be entitled to act and rely upon any statement, request, notice or agreement on behalf of any Underwriter made or given by you as the Representative. All statements, requests, notices and agreements hereunder shall be in writing, and if to the Underwriters shall be delivered or sent by mail, telex or facsimile transmission to you as the Representative in care of Goldman Sachs & Co. LLC, 200 West Street, New York, New York 10282-2198, Attention: Registration Department; and if to the Company shall be delivered or sent by mail, telex or facsimile transmission to the address of the Company set forth in the Registration Statement, Attention: Secretary; provided, however, that any notice to an Underwriter pursuant to Section 9(c) hereof shall be delivered or sent by mail, telex or facsimile transmission to such Underwriter at its address set forth in its Underwriters’ Questionnaire, or telex constituting such Questionnaire, which address will be supplied to the Company by you upon request. Any such statements, requests, notices or agreements shall take effect upon receipt thereof.
In accordance with the requirements of the USA Patriot Act (Title III of Pub. L. 107-56 (signed into law October 26, 2001)), the Underwriters are required to obtain, verify and record information that identifies their respective clients, including the Company, which information may include the name and address of their respective clients, as well as other information that will allow the Underwriters to properly identify their respective clients.
14. This Agreement shall be binding upon, and inure solely to the benefit of, the Underwriters, the Company and, to the extent provided in Sections 9 and 11 hereof, the officers and directors of the Company and each person who controls the Company or any
27
Underwriter, and their respective heirs, executors, administrators, successors and assigns, and no other person shall acquire or have any right under or by virtue of this Agreement. No purchaser of any of the Shares from any Underwriter shall be deemed a successor or assign by reason merely of such purchase.
15. Time shall be of the essence of this Agreement. As used herein, the term “business day” shall mean any day when the Commission’s office in Washington, D.C. is open for business.
16. The Company acknowledges and agrees that (i) the purchase and sale of the Shares pursuant to this Agreement is an arm’s-length commercial transaction between the Company, on the one hand, and the several Underwriters, on the other, (ii) in connection therewith and with the process leading to such transaction each Underwriter is acting solely as a principal and not the agent or fiduciary of the Company, (iii) no Underwriter has assumed an advisory or fiduciary responsibility in favor of the Company with respect to the offering contemplated hereby or the process leading thereto (irrespective of whether such Underwriter has advised or is currently advising the Company on other matters) or any other obligation to the Company except the obligations expressly set forth in this Agreement and (iv) the Company has consulted its own legal and financial advisors to the extent it deemed appropriate. The Company agrees that it will not claim that the Underwriters, or any of them, has rendered advisory services of any nature or respect, or owes a fiduciary or similar duty to the Company, in connection with such transaction or the process leading thereto.
17. This Agreement supersedes all prior agreements and understandings (whether written or oral) between the Company and the Underwriters, or any of them, with respect to the subject matter hereof.
18. This Agreement and any transaction contemplated by this Agreement shall be governed by and construed in accordance with the laws of the State of New York without regard to principles of conflict of laws that would results in the application of any other law than the laws of the State of New York. The Company agrees that any suit or proceeding arising in respect of this Agreement or any transaction contemplated by this Agreement will be tried exclusively in the U.S. District Court for the Southern District of New York or, if that court does not have subject matter jurisdiction, in any state court located in The City and County of New York and the Company agrees to submit to the jurisdiction of, and to venue in, such courts.
19. The Company and each of the Underwriters hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby.
20. This Agreement may be executed by any one or more of the parties hereto in any number of counterparts, each of which shall be deemed to be an original, but all such counterparts shall together constitute one and the same instrument.
21. The words “execution,” “execute”, “signed,” “sign,” “signature,” and words of like import in or related to any document to be signed in connection with this Agreement and
28
the transactions contemplated hereby shall be deemed to include electronic signatures, or the keeping of records in electronic form, each of which shall be of the same legal effect, validity or enforceability as a manually executed signature or the use of a paper-based recordkeeping system, as the case may be, to the extent and as provided for in any applicable law, including the Federal Electronic Signatures in Global and National Commerce Act, the New York State Electronic Signatures and Records Act, or any other similar state laws based on the Uniform Electronic Transactions Act.
22. Recognition of the U.S. Special Resolution Regimes.
(a) In the event that any Underwriter that is a Covered Entity becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer from such Underwriter of this Agreement, and any interest and obligation in or under this Agreement, will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement, and any such interest and obligation, were governed by the laws of the United States or a state of the United States.
(b) In the event that any Underwriter that is a Covered Entity or a BHC Act Affiliate of such Underwriter becomes subject to a proceeding under a U.S. Special Resolution Regime, Default Rights under this Agreement that may be exercised against such Underwriter are permitted to be exercised to no greater extent than such Default Rights could be exercised under the U.S. Special Resolution Regime if this Agreement were governed by the laws of the United States or a state of the United States.
(c) As used in this section:
“BHC Act Affiliate” has the meaning assigned to the term “affiliate” in, and shall be interpreted in accordance with, 12 U.S.C. § 1841(k).
“Covered Entity” means any of the following:
(i) a “covered entity” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 252.82(b);
(ii) a “covered bank” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 47.3(b); or
(iii) a “covered FSI” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 382.2(b).
“Default Right” has the meaning assigned to that term in, and shall be interpreted in accordance with, 12 C.F.R. §§ 252.81, 47.2 or 382.1, as applicable.
“U.S. Special Resolution Regime” means each of (i) the Federal Deposit Insurance Act and the regulations promulgated thereunder and (ii) Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act and the regulations promulgated thereunder.
29
If the foregoing is in accordance with your understanding, please sign and return to us an executed facsimile or executed scanned copy of this Agreement and such delivery hereof shall constitute a binding agreement between each of the Underwriters and the Company. It is understood that your acceptance of this letter on behalf of each of the Underwriters is pursuant to the authority set forth in a form of Agreement among Underwriters, the form of which shall be submitted to the Company for examination upon request, but without warranty on your part as to the authority of the signers thereof.
| Very truly yours, | ||
| Vir Biotechnology, Inc. | ||
| By: |
||
| Name: | ||
| Title: | ||
Accepted as of the date hereof:
Goldman Sachs & Co. LLC
| By: |
| |
| Name: | ||
| Title: |
On behalf of each of the Underwriters
[Signature Page to Underwriting Agreement]
SCHEDULE I
| Underwriter |
Total Number of Firm Shares to be Purchased |
Number of Optional Shares to be Purchased if Maximum Option Exercised | ||
| Goldman Sachs & Co. LLC |
[ ● ] | [ ● ] | ||
| BofA Securities, Inc. |
[ ● ] | [ ● ] | ||
| Cowen and Company, LLC |
[ ● ] | [ ● ] | ||
| Barclays Capital Inc. |
[ ● ] | [ ● ] | ||
| Needham & Company, LLC |
[ ● ] | [ ● ] | ||
|
|
| |||
| Total |
[ ● ] | [ ● ] | ||
|
|
|
SCHEDULE II
| (a) | Issuer Free Writing Prospectuses not included in the Pricing Disclosure Package: |
None
| (b) | Additional Documents Incorporated by Reference: |
None
| (c) | Information other than the Pricing Prospectus that comprise the Pricing Disclosure Package: |
The initial public offering price per share for the Shares is $[ ● ].
The number of Shares purchased by the Underwriters is [ ● ].
| (d) | Testing-the-Waters Writings: |
[ ● ]
ANNEX I
Form of Lock-Up Agreement
Vir Biotechnology, Inc.
Lock-Up Agreement
, 2020
Goldman Sachs & Co. LLC
As representative of the several Underwriters
named in Schedule I to the
Underwriting Agreement referred to below
c/o Goldman Sachs & Co. LLC
200 West Street
New York, NY 10282-2198
| Re: | Vir Biotechnology, Inc. - Lock-Up Agreement |
Ladies and Gentlemen:
The undersigned understands that you, as representative (the “Representative”), propose to enter into an underwriting agreement (the “Underwriting Agreement”) on behalf of the several underwriters named in Schedule I to such agreement (collectively, the “Underwriters”), with Vir Biotechnology, Inc., a Delaware corporation (the “Company”), providing for a public offering (the “Public Offering”) of shares of common stock, par value $0.0001 per share (the “Common Stock”), of the Company (the “Shares”) pursuant to a Registration Statement on Form S-1 (the “Registration Statement”) to be filed with the Securities and Exchange Commission (the “SEC”).
In consideration of the agreement by the Underwriters to offer and sell the Shares, and of other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the undersigned agrees that, during the period beginning from the date of this Lock-Up Agreement and continuing to and including the date 90 days after the date set forth on the final prospectus used to sell the Shares (the “Lock-Up Period”), the undersigned shall not, and shall not cause or direct any of its affiliates to, (i) offer, sell, contract to sell, pledge, grant any option to purchase, lend or otherwise dispose of any shares of Common Stock of the Company, or any options or warrants to purchase any shares of Common Stock of the Company, or any securities convertible into, exchangeable for or that represent the right to receive shares of Common Stock of the Company (such options, warrants or other securities together with the Common Stock, “Lock-Up Securities”), including without limitation any Lock-Up Securities now owned or hereafter acquired by the undersigned, or publicly disclose the intention to make any offer, sale, pledge or other disposition or (ii) engage in any hedging or other transaction or arrangement (including, without limitation, any short sale or the purchase or sale of, or entry into, any put or call option, or combination thereof, forward, swap, or any other derivative transaction or instrument, however described or defined) which is designed to or which reasonably could be expected to lead to or result in a sale or disposition (whether by the undersigned or someone other than the undersigned), or transfer of any of the economic consequences of ownership, in whole or in part, directly or indirectly, of any Lock-
Up Securities, whether any such transaction or arrangement (or instrument provided for thereunder) would be settled by delivery of Common Stock or other securities, in cash or otherwise (any such sale, disposition or transfer of economic consequences as described in this clause (ii), “Prohibited Activity”). The undersigned represents and warrants that the undersigned is not, and has not caused or directed any of its affiliates to be or become, currently a party to any agreement or arrangement that is designed to or which reasonably could be expected to lead to or result in any Prohibited Activity during the Lock-Up Period.
If the undersigned is not a natural person, the undersigned represents and warrants that no single natural person, entity or “group” (within the meaning of Section 13d-3 of the Securities Exchange Act of 1934, as amended, the “Exchange Act”) beneficially owns, directly or indirectly, 50% or more of the common equity interests, or 50% or more of the voting power, in the undersigned.
Notwithstanding the foregoing, the undersigned may transfer or otherwise dispose of the undersigned’s Lock-Up Securities (collectively, the “Undersigned’s Shares”):
| i. | as a bona fide gift or gifts, provided that the donee or donees thereof agree to be bound in writing by the restrictions set forth herein; |
| ii. | to any trust for the direct or indirect benefit of the undersigned or the immediate family (as defined below) of the undersigned, or if the undersigned is a trust, to a trustor, trustee (or co-trustee) or beneficiary of the trust or to the estate of the beneficiary of such trust, provided that the transferee agrees to be bound in writing by the restrictions set forth herein, and provided further that any such transfer shall not involve a transfer for value; and provided further that any filing under Section 16 of the Exchange Act shall indicate in the footnotes thereto that the filing relates to the applicable circumstances described in this clause, and no other public announcement shall be required or shall be made voluntarily in connection with such transfer; |
| iii. | in connection with the sale of any of the Undersigned’s Shares acquired (a) in the Public Offering or (b) in open market transactions after the Public Offering; |
| iv. | if the undersigned is a corporation, partnership, limited liability company, trust or other business entity (a) to another corporation, partnership, limited liability company, trust or other business entity that is an affiliate (as defined in Rule 405 promulgated under the Securities Act of 1933, as amended) of the undersigned or the immediate family of the undersigned, or to any investment fund or other entity controlling, controlled by, managing or managed by or under common control with the undersigned or affiliates or immediate family of the undersigned (including, for the avoidance of doubt, where the undersigned is a partnership, to its general partner or a successor partnership or fund, or any other funds managed by such partnership), or (b) as part of a distribution, transfer or disposition without consideration by the undersigned to its stockholders, partners, members, beneficiaries or other equity holders; provided, however, that in the case of any transfer or disposition contemplated by (a) or (b) above, it shall be a condition to the transfer or disposition that the transferee agrees to be bound in writing by the restrictions set forth herein; |
| v. | to the Company in connection with the exercise or settlement of options, warrants or other rights to acquire shares of Common Stock or any securities convertible into, exercisable or exchangeable for or that represent the right to receive shares of Common Stock in accordance with their terms (including the vesting or settlement of restricted stock units and including, in each case, by way of net exercise and/or to cover withholding tax obligations |
| in connection with such exercise, vesting or settlement) pursuant to an employee benefit plan, option, warrant or other right disclosed in the final prospectus for the Public Offering (including the documents incorporated by reference therein), provided that any such shares issued upon exercise, vesting or settlement, as applicable, of such option, warrant, restricted stock unit or other right shall be subject to the restrictions set forth herein, and provided further that any filing under Section 16 of the Exchange Act shall indicate in the footnotes thereto that the filing relates to the applicable circumstances described in this clause, and no other public announcement shall be required or shall be made voluntarily in connection with such transfer; |
| vi. | by will or intestacy, provided that the transferee agrees to be bound in writing by the restrictions set forth herein; |
| vii. | to any immediate family member of the undersigned, provided that such family member agrees to be bound by the restrictions set forth herein; |
| viii. | to the Company pursuant to agreements under which the Company has (a) the option to repurchase such shares upon termination of service of the undersigned or (b) a right of first refusal with respect to transfers of such shares; |
| ix. | pursuant to a court order or settlement agreement related to the distribution of assets in connection with the dissolution of a marriage, domestic partnership or civil union; provided that any required filing under Section 16 of the Exchange Act shall indicate in the footnotes thereto that the filing relates to the circumstances described in this clause and no other public announcement shall be required or shall be made voluntarily by the undersigned in connection with such transfer or disposition; |
| x. | pursuant to a trading plan that complies with Rule 10b5-1 under the Exchange Act (“10b5-1 Trading Plan”) that is existing as of the date hereof, provided that to the extent a public announcement or filing under the Exchange Act is required of the undersigned or the Company regarding the sale, such announcement or filing shall include a statement to the effect that the sale occurred pursuant to such 10b5-1 Trading Plan; and |
| xi. | with the prior written consent of Goldman Sachs & Co. LLC on behalf of the Underwriters. |
For purposes of this Lock-Up Agreement, “immediate family” shall mean any relationship by blood, marriage, domestic partnership, civil union or adoption, not more remote than first cousin. Notwithstanding anything to the contrary, in the case of clauses (i), (iii), (iv), (vii) and (viii)(b) above, no filing under the Exchange Act or any other public filing or disclosure of such transfer by or on behalf of the undersigned shall be required or voluntarily made during the Lock-up Period (other than a filing on a Form 5 after the expiration of the Lock-Up Period and other than a filing under Section 13 of the Exchange Act).
Furthermore, notwithstanding the restrictions imposed by this Lock-Up Agreement, the undersigned may exercise an option or other equity award to purchase shares of Common Stock or exercise warrants (pursuant to an employee benefit plan, option, warrant or other right disclosed in the final prospectus for the Public Offering (including the documents incorporated by reference therein)) on a cash basis, provided that any such shares issued upon such exercise shall be subject to the restrictions set forth herein, and provided further that any filing under Section 16 of the Exchange Act shall indicate in the footnotes thereto that the filing relates to the applicable circumstances described in this paragraph, and no other public announcement shall be required or shall be made voluntarily in connection with such exercise.
Further, this Lock-Up Agreement shall not restrict any sale, disposal or transfer of the Undersigned’s Shares to a bona fide third party pursuant to a tender offer for securities of the Company or any merger, consolidation or other business combination involving a Change of Control (as defined below) of the Company occurring after the settlement of the Public Offering, that, in each case, has been approved by the board of directors of the Company; provided that all of the Undersigned’s Shares subject to this Lock-Up Agreement that are not so transferred, sold, tendered or otherwise disposed of remain subject to this Lock-Up Agreement; and provided, further, that it shall be a condition of transfer, sale, tender or other disposition that if such tender offer or other transaction is not completed, any of the Undersigned’s Shares subject to this Lock-Up Agreement shall remain subject to the restrictions on transfer set forth herein. For the purposes of this paragraph, “Change of Control” means the consummation of any bona fide third party tender offer, merger, consolidation or other similar transaction, the result of which is that any “person” (as defined in Rule 13d-3 of the Exchange Act), or group of persons, other than the Company or its subsidiaries, becomes the beneficial owner (as defined in Rule 13d-3 and 13d-5 of the Exchange Act) of at least 50% of the total voting power of the voting share capital of the Company.
Additionally, the undersigned may establish or amend a 10b5-1 Trading Plan for the transfer of the Undersigned’s Shares, provided that such 10b5-1 Trading Plan does not provide for any transfers of Common Stock during the Lock-Up Period and no filing under the Exchange Act nor any other public filing or disclosure of such 10b5-1 Trading Plan shall be made during the Lock-Up Period.
The undersigned now has, and, except as contemplated above, for the duration of this Lock-Up Agreement will have, good and marketable title to the Undersigned’s Shares, free and clear of all liens, encumbrances, and claims whatsoever. The undersigned also agrees and consents to the entry of stop transfer instructions with the Company’s transfer agent and registrar against the transfer of the Undersigned’s Shares except in compliance with the foregoing restrictions. The undersigned hereby waives any and all notice requirements and rights with respect to the registration of securities pursuant to any agreement, understanding or anything otherwise setting forth the terms of any security of the Company held by the undersigned, including any registration rights agreement or investors’ rights agreement to which the undersigned and the Company may be party; provided, however, that such waiver shall apply only to the proposed Public Offering, and any other action taken by the Company in connection with the proposed Public Offering.
This Lock-Up Agreement (and for the avoidance of doubt, the Lock-Up Period described herein) and related restrictions shall automatically terminate upon the earliest to occur, if any, of (i) the Company advising Goldman Sachs & Co. LLC in writing prior to the execution of the Underwriting Agreement that it has determined not to proceed with the Public Offering, (ii) the termination of the Underwriting Agreement before the sale of any Shares to the Underwriters, (iii) the Registration Statement is withdrawn or (iv) July 31, 2020, in the event the closing of the Public Offering shall not have occurred on or before such date.
This Lock-Up Agreement and any claim, controversy or dispute arising under or related to this Lock-Up Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to the conflict of laws principles thereof.
[Signature Page Follows]
The undersigned understands that the Company and the Underwriters are relying upon this Lock-Up Agreement in proceeding toward consummation of the Public Offering. The undersigned further understands that this Lock-Up Agreement is irrevocable and shall be binding upon the undersigned’s heirs, legal representatives, successors, and assigns. This Lock-Up Agreement may be delivered via facsimile, electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com or www.echosign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.
| Very truly yours, | ||
| IF AN INDIVIDUAL: | ||
|
| ||
| [Name of Undersigned (Print exact name)] | ||
| By: |
| |
| Signature | ||
| IF NOT SIGNING IN AN INDIVIDUAL CAPACITY: | ||
|
| ||
| [Name of Undersigned (Print exact name)] | ||
| By: |
| |
| Signature | ||
|
| ||
| [Name of Authorized Signatory (Print full name)] | ||
|
| ||
| Title of Authorized Signatory (Print full title) | ||
| (indicate capacity of person signing if signing as custodian, trustee, or on behalf of an entity) | ||
[Signature Page to Lock-Up Agreement]
Exhibit 5.1
Laura A. Berezin
+1 650 843 5128
lberezin@cooley.com
July 6, 2020
Vir Biotechnology, Inc.
499 Illinois Street, Suite 500
San Francisco, California 94158
Ladies and Gentlemen:
We have represented Vir Biotechnology, Inc., a Delaware corporation (the “Company”), in connection with the filing by the Company of a Registration Statement on Form S-1 (the “Registration Statement”) with the Securities and Exchange Commission, including a related prospectus filed with the Registration Statement (the “Prospectus”), covering an underwritten public offering of up to 7,130,000 shares (the “Shares”) of the Company’s common stock, par value $0.0001, which includes up to 930,000 shares that may be sold pursuant to the exercise of an option to purchase additional shares.
In connection with this opinion, we have (i) examined and relied upon (a) the Registration Statement and the Prospectus, (b) the Company’s Amended and Restated Certificate of Incorporation, as amended, and Bylaws, as amended, each as currently in effect, and (c) originals or copies certified to our satisfaction of such records, documents, certificates, memoranda and other instruments as in our judgment are necessary or appropriate to enable us to render the opinion expressed below, and (ii) assumed that the Shares will be sold at a price established by the Board of Directors of the Company or a duly authorized committee thereof. We have undertaken no independent verification with respect to such matters.
We have assumed the genuineness and authenticity of all documents submitted to us as originals, and the conformity to originals of all documents submitted to us as copies thereof, the accuracy, completeness and authenticity of the certificates of public officials and the due authorization, execution and delivery of all documents, other than by the Company, where authorization, execution and delivery are a prerequisite to the effectiveness thereof. As to certain factual matters, we have relied upon a certificate of an officer of the Company and have not independently verified such matters.
Our opinion is expressed only with respect to the General Corporation Law of the State of Delaware. We express no opinion to the extent that any other laws are applicable to the subject matter hereof and express no opinion and provide no assurance as to compliance with any federal or state securities law, rule or regulation.
On the basis of the foregoing, and in reliance thereon, we are of the opinion that the Shares, when sold and issued against payment therefor as described in the Registration Statement and the Prospectus, will be validly issued, fully paid and non-assessable.
We consent to the reference to our firm under the caption “Legal Matters” in the Prospectus included in the Registration Statement and to the filing of this opinion as an exhibit to the Registration Statement.
| Sincerely, | ||
| Cooley LLP | ||
| By: | /s/ Laura A. Berezin | |
| Laura A. Berezin | ||
Cooley LLP 3175 Hanover Street Palo Alto, CA 94304-1130
t: (650) 843-5000 f: (650) 849-7400 cooley.com
Exhibit 10.21
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
| CONFIDENTIAL | EXECUTION VERSION |
AMENDMENT NO. 3 TO THE COLLABORATION AND LICENSE AGREEMENT
THIS AMENDMENT NO. 3 TO THE COLLABORATION AND LICENSE AGREEMENT (“Amendment”) is made and entered into, effective as of April 1, 2020 (“Amendment No. 3 Effective Date”), by and between Vir Biotechnology, Inc., a Delaware corporation with offices at with an office at 499 Illinois Street, San Francisco, California 94158 (“Vir”), and Alnylam Pharmaceuticals, Inc., a Delaware corporation located at 675 West Kendall Street – Henri A. Termeer Square, Cambridge, Massachusetts 02142 (“Alnylam”). Each of Vir and Alnylam are referred to in this Amendment as a “Party” and together, the “Parties”.
BACKGROUND
WHEREAS, the Parties have entered into that certain Collaboration and License Agreement effective as of October 16, 2017 (as amended by Letter Agreement dated November 13, 2018 and by Amendment No. 1 to the Collaboration and License Agreement effective December 17, 2019 and Amendment No. 2 to the Collaboration and License Agreement effective March 3, 2020, the “Collaboration Agreement”) pursuant to which the Parties entered into a collaboration to develop and commercialize certain compounds and products based on Alnylam’s RNAi technology, in connection with Hepatitis B and other infectious diseases;
WHEREAS, pursuant to Section 3.1(b) and 3.1(c) of the Collaboration Agreement Vir has selected five (5) ID Collaboration Targets;
WHEREAS, the Parties desire to add three additional ID Collaboration Targets to the Collaboration, bringing the total number of ID Collaboration Targets to eight (8) on the terms and conditions described in this Amendment; and
WHEREAS, Section 14.4 of the Collaboration Agreement provides that the Collaboration Agreement may only be modified by a written instrument duly executed by an authorized representative of each Party.
NOW, THEREFORE, the Parties desire, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, to amend the Collaboration Agreement as set forth in this Amendment.
ARTICLE 1
DEFINITIONS
1.1 Capitalized Terms. Capitalized terms used in this Amendment shall have the meanings set forth in the Collaboration Agreement unless otherwise defined and set forth in this Amendment. Except as expressly modified by this Amendment, the remainder of the Collaboration Agreement shall remain in force in accordance with its terms and without any modification.
ARTICLE 2
AMENDMENTS
2.1 Addition of New Section 1.1.54B: Article 1 of the Collaboration Agreement is hereby amended by adding a new Section 1.1.54B immediately after Section 1.1.54A as follows:
1.1.54B “Coronaviruses” shall mean any coronavirus, or isolate or isoform thereof, that causes severe acute respiratory syndrome in humans, including SARS-CoV-2, SARS-CoV and MERS-CoV.
1
2.2 Amendment to Section 1.1.77: Section 1.1.77 of the Collaboration Agreement is hereby amended in its entirety as follows:
1.1.77 “Field” shall mean (a) for all Collaboration Targets other than the Host Factor Targets, all uses and purposes, including the treatment, palliation, diagnosis or prevention of any human disease, disorder or condition, and (b) for the Host Factor Targets, the treatment, palliation, diagnosis or prevention of Coronaviruses, but in each case ((a)-(b)) excluding applications in agriculture, horticulture, forestry, aquaculture, and/or residential markets relating to plants, fish, arthropods and/or pests and pathogens thereof (e.g., home, lawn and/or garden).
2.3 Addition of New Section 1.1.90A: Article 1 of the Collaboration Agreement is hereby amended by adding a new Section 1.1.90A immediately after Section 1.1.90 as follows:
1.1.90A “Host Factor” shall mean a human trait that affects susceptibility to disease.
2.4 Addition of New Section 1.1.90B: Article 1 of the Collaboration Agreement is hereby amended by adding a new Section 1.1.90B immediately after Section 1.1.90A as follows:
90B “Host Factor Targets” shall mean (a) the two Initial Host Factor Targets, (b) an additional Host Factor selected by the Parties in accordance with Section 3.1(d)(i), and (iii) a replacement Host Factor selected by the Parties in accordance with Section 3.1(d)(i).
2.5 Amendment to Section 1.1.92: Section 1.1.92 of the Collaboration Agreement is hereby amended in its entirety as follows:
1.1.92 “ID Collaboration Target” shall mean an ID Target that is designated for an ID Program pursuant to Section 3.1(b), 3.1(c) or 3.1(d).
2.6 Amendment to Section 1.1.97: Section 1.1.97 of the Collaboration Agreement is hereby amended in its entirety as follows:
1.1.97 “ID Target” shall mean (a) for all Targets other than the Host Factor Targets, a Target primarily for intervention in the treatment, palliation, diagnosis or prevention of Infectious Disease in humans or animals, and (b) for the Host Factor Targets, a Target for intervention in the treatment, palliation, diagnosis or prevention of Coronaviruses in humans or animals.
2.7 Addition of Section 1.1.99A: Article 1 of the Collaboration Agreement is hereby amended by adding a new Section 1.1.99A immediately after Section 1.1.99 as follows:
1.1.99A “Initial Host Factor Targets” shall mean (a) angiotensin converting enzyme 2 (ACE2) and (b) transmembrane serine protease 2 (TMPRSS2).
2.8 Amendment to Section 1.1.182: Section 1.1.182 of the Collaboration Agreement is hereby amended in its entirety as follows:
1.1.182 “Vir Improvements” means any patented improvement, discovery or Know-How that (a) is first conceived or reduced to practice, or with respect to inventions and discoveries other than patentable inventions, otherwise identified, discovered, made or developed, solely by individuals who are employees, agents or consultants of Vir or its Affiliates in the course of conducting Development, Manufacturing or Commercialization activities with respect to Licensed Products under this Agreement, (b) is Controlled by Vir or its Affiliates, and (c) constitutes an improvement that would otherwise be dominated by Alnylam Core Technology Patent Rights, including, as applicable, formulation technology. Vir Improvements excludes [***].
2
2.9 Amendment of Section 3.1: Section 3.1(d) of the Collaboration Agreement is hereby amended to add the following Section 3.1(d):
(a) Host Factor Targets.
(i) Host Factor Targets. Notwithstanding the provisions of Section 3.1(b) or 3.1(c) above, the Parties agree to collaborate in a program to Develop RNAi Products Directed to the Host Factor Targets for use in the Field, which program may include the use of [***], until Development Candidate selection pursuant to Section 3.3 below. The program shall be directed to the Initial Host Factor Targets, and the Parties may mutually agree to the selection of up to one (1) additional Host Factor as an ID Collaboration Target. Once mutually agreed by the Parties, the new Host Factor Target shall be added to the list of ID Collaboration Targets listed on Schedule D. The Host Factor Targets shall be ID Collaboration Targets and shall be in addition to, and not in lieu of, the five (5) ID Collaboration Targets described in Sections 3.1(b) and 3.1(c). Notwithstanding any provision of Section 3.3(b) to the contrary, if Alnylam has not commenced work pursuant to a DC Workplan for a given Host Factor Target, Vir shall have the right to propose to replace such Host Factor Target with a replacement Host Factor pursuant to this Section 3.1(d), provided that such proposed replacement Host Factor is discussed and mutually agreed upon by the Parties (which discussions may occur via the JSC). If the Parties mutually agree to designate the proposed replacement Host Factor as a Host Factor Target, then Schedule D shall be updated to include such new Host Factor Target as an ID Collaboration Target, and the Parties shall develop an ID Development Plan for such new ID Collaboration Target in accordance with Section 3.2(a). The Host Factor Target that is replaced shall be classified as an “Abandoned ID Target” and shall cease to be an ID Collaboration Target under this Agreement, Vir’s Program Option and other rights with respect to such Abandoned ID Target and any RNAi Products Directed to such Abandoned ID Target shall terminate and the provisions of Section 4.1(b) shall apply to the Abandoned ID Target and the ID Program for such Abandoned IT Target. Unless otherwise mutually agreed by the Parties, the Parties shall not replace more than one (1) Host Factor Target and, for clarity, at no time during the Term shall there be more than three (3) Host Factor Targets.
(ii) ID Development Plan. The initial ID Development Plan for the Host Factor Targets developed by the JSC pursuant to Section 3.2(a) shall include the following responsibilities of the Parties and unless otherwise agreed by the Parties, Alnylam’s DC Workplan for the Host Factor Targets shall be limited to the following responsibilities of Alnylam:
| Host Factor Target ID Development Plan
Activities |
Responsible | |
| [***] |
[***] | |
| [***] |
[***] | |
| [***] |
[***] | |
| [***] |
[***] | |
| [***] |
[***] | |
| [***] |
[***] | |
| [***] |
[***] | |
| [***] |
[***] |
2.10 Amendment of Section 3.4(b). Section 3.4(b) of the Collaboration Agreement is hereby amended in its entirety as follows:
(b) ID Programs. Subject to the exercise by Alnylam of its Profit-Sharing Option pursuant to Section 4.2, with respect to an ID Licensed Product, Vir shall bear 100% of the Program Costs incurred by the Parties during the Collaboration Term for each ID Program in conducting each ID Program pursuant to the Development Plan for such ID Program, including ID Licensed Product supplied by Alnylam pursuant to Section 5.1(a)(ii); provided, however, that Alnylam shall bear the Program Costs incurred by Alnylam [***]
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under the DC Workplan for the COV Target ID Program and the Host Factor Target ID Programs. In addition, (i) [***], and (ii) the Parties shall each bear fifty percent (50%) of all Program Costs in connection with the Manufacture of non-GMP Drug Product required for nonclinical use prior to filing of an IND for the first Licensed Product in each of the COV Target ID Program and the Host Factor Target ID Programs. In no event shall any of the Host Factor Target ID Programs be conducted outside of the Field.
2.11 Amendment of Section 3.5(c). Section 3.5(c) of the Collaboration Agreement is hereby amended in its entirety as follows:
(c) ID Programs. After exercise of its Program Option with respect to an ID Program, Vir shall use Commercially Reasonable Efforts to Develop, obtain Regulatory Approval and following Regulatory Approval Commercialize [***] ID Licensed Product Directed to the ID Collaboration Target in such ID Program in the Field in [***] Major Markets, provided that solely with respect to the COV Target ID Program and the Host Factor Target Programs, [***], Vir may [***]; provided, however, that [***] with respect to the COV Target ID Program or such Host Factor Target ID Program (as applicable).
2.12 Amendment of Section 4.1(a). Section 4.1(a) of the Collaboration Agreement is hereby amended in its entirety, as follows:
(a) With respect to each ID Program, Alnylam hereby grants Vir an exclusive option (“Program Option”) to obtain a Program License for such ID Program. Vir may exercise its Program Option with respect to an ID Program by written notice to Alnylam (“Program Option Notice”) at any time prior to the date that is [***] after the earlier of (i) [***] and (ii) the date that is [***] after [***] (“Program Option Period”). Upon Vir’s giving a Program Option Notice to Alnylam, Vir shall pay Alnylam (x) the Program Option Exercise Fee, which is payable within [***] after Vir’s exercise of such Program Option for such ID Program, and (y) any outstanding undisputed Program Costs due to Alnylam for such ID Program, within [***] after receipt by Vir of any invoice therefor. Upon payment in full of the Program Option Exercise Fee and any outstanding undisputed Program Costs as set forth above, (i) Alnylam shall and hereby does grant to Vir the Program License with respect to such ID Program as set forth in Section 6.1(b)(ii), and (ii) subject to the exercise by Alnylam of its Profit-Sharing Option pursuant to Section 4.2 with respect to an ID Licensed Product and Alnylam’s responsibilities for ID Licensed Product Manufacturing [***] pursuant to Section 5.1(a), [***], for the further Development, Manufacture and Commercialization of the ID Licensed Products in such ID Program. Notwithstanding anything herein to the contrary, no Program Option Exercise Fee shall be payable with respect to the COV Target ID Program or the Host Factor Target ID Programs, and the licenses granted to Vir in Sections 6.1(b)(i) and (ii) shall become effective for the COV Target ID Program and a given Host Factor Target ID Program automatically upon Vir’s delivery to Alnylam of a Program Option Notice for such COV Target ID Program or such Host Factor Target ID Program (as applicable) and payment of all undisputed Program Costs reimbursable to Alnylam for such COV Target ID Program or such Host Factor Target ID Program (as applicable).
2.13 Amendment of Section 6.1(d). Section 6.1(d) of the Collaboration Agreement is hereby amended in its entirety, as follows:
(d) Retained Rights. Notwithstanding the license grants in Sections 6.1(a) and 6.1(b), Alnylam retains the rights under Alnylam Intellectual Property (a) to Develop and Manufacture Licensed Products in the Field in the Territory solely for the purpose and only to the extent necessary for the performance of its obligations under this Agreements, and (b) subject to Alnylam’s obligations under Section 10.5(a), for [***]. Notwithstanding anything herein to the contrary, (i) with respect to the COV Target and each Host Factor Target, neither Vir nor its Affiliates, directly or indirectly (alone or with an affiliate or Third Party), shall have any right or license under this Agreement to any Licensed Product for the COV Target or such Host Factor Target to [***].
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2.14 Amendment of Section 7.3(a)(ii). Section 7.3(a)(ii) of the Collaboration Agreement is hereby amended in its entirety as follows:
(ii) ID Licensed Products other than ID Licensed Products Directed to the COV Target or the Host Factor Targets, with respect to which Vir has exercised its Program Option:
| Milestone Event |
Milestone Payment | |
| [***] |
[***] | |
| [***] |
[***] | |
| [***] |
[***] | |
| [***] |
[***] | |
| [***] |
[***] |
2.15 Amendment of Section 7.3(a). Section 7.3(a) of the Collaboration Agreement is hereby amended to add the following Section 7.3(a)(iv) to the end of such Section:
(iv) ID Licensed Products Directed to each Host Factor Target with respect to which Vir has exercised its Program Option:
| Milestone Event |
Milestone Payment | |
| [***] |
[***] | |
| [***] |
[***] |
2.16 Amendment of Section 7.5(b). Section 7.5(b) of the Collaboration Agreement is hereby amended by inserting the following at the end of such Section:
; provided, however, that solely with respect to an ID Licensed Product Directed to the COV Target or a Host Factor Target, if (i) Vir or its Related Parties sell such ID Licensed Product to a Biodefense Authority in a country, (ii) such sale is for the purposes of [***], and (iii) the aggregate amount of such Net Sales of such ID Licensed Product to such Biodefense Authority during such Calendar Year is [***] of such ID Licensed Product on which such Net Sales are based, then (1) Vir shall pay Alnylam a [***] royalty on such Net Sales [***] by Alnylam or its Affiliates to Third Parties under any applicable Alnylam In-License with respect to such ID Licensed Product sales, (2) such royalty shall [***], and (3) such Net Sales shall not be [***] Net Sales of such ID Licensed Product.
2.17 Amendment of Section 10.5(d). Section 10.5(d) of the Collaboration Agreement is hereby amended in its entirety as follows:
(d) [***].
2.18 Amendment of Section 10.5. Section 10.5 of the Collaboration Agreement is hereby amended to add the following Section 10.5(e) to the end of such Section:
(e) for each Host Factor Target, neither Vir nor its Affiliates shall: (i) alone or with or for any Third Party, research, develop, manufacture or commercialize any Licensed Product Directed to such Host Factor Target outside of the Field; (ii) grant a license, sublicense or other rights to any Third Party to conduct any of the activities in the foregoing clause (i) with respect to any Licensed Product Directed to such Host Factor Target outside of the Field; or (iii) transfer, assign, convey or otherwise sell any Licensed Product Directed to such Host Factor Target outside of the Field.
2.19 Amendment of Schedule A (Existing Alnylam Third Party Agreements). Schedule A (Existing Alnylam Third Party Agreements) of the Collaboration Agreement is hereby amended as follows. [***]:
[***]
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2.20 Amendment of Schedule D (ID Targets, Reserved Targets and ID Collaboration Targets). Schedule D (ID Targets, Reserved Targets and ID Collaboration Targets) of the Collaboration Agreement is hereby amended by adding the [***].
ARTICLE 3
MISCELLANEOUS
3.1 No Waiver. Nothing in this Amendment is intended to operate as a waiver of any claims either Party may have against the other Party arising prior to the date of this Amendment, including any claims arising prior to the date of this Amendment with respect to the performance of the Parties under the Collaboration Agreement. Any delay in enforcing a party’s rights under this Amendment or the Collaboration Agreement, or any waiver as to a particular default or other matter, will not constitute a waiver of such party’s rights to the future enforcement of its rights under this Amendment or the Collaboration Agreement, except with respect to an express written waiver relating to a particular matter for a particular period of time signed by an authorized representative of the waiving Party, as applicable.
3.2 Miscellaneous. This Amendment shall be governed by and interpreted in accordance with the law of the State of New York, U.S.A., without reference to any principles of conflicts of laws to the contrary. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to the transactions contemplated by this Amendment. Except as specifically amended by this Amendment, the terms and conditions of the Collaboration Agreement shall remain in full force and effect. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Signatures transmitted by PDF shall be treated as original signatures. Except to the extent expressly provided herein, the Collaboration Agreement, as amended by this Amendment, together with the Commitment Letter between the Parties entered into on the Commitment Letter Date and the Stock Purchase Agreement, including all appendices, exhibits and schedules to each of the foregoing, constitute the entire agreement between the Parties relating to the subject matter of the Collaboration Agreement and supersedes all previous oral and written communications, including all previous agreements, between the Parties.
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IN WITNESS WHEREOF, on the Amendment No. 3 Effective Date Vir and Alnylam have caused this Amendment to be duly executed by their authorized representatives.
| Vir Biotechnology, Inc. | ||
| Name: |
/s/ George Scangos | |
| Title: |
George Scangos | |
| Date: |
Chief Executive Officer | |
| Alnylam Pharmaceuticals, Inc. | ||
| Name: |
/s/ Yvonne Greenstreet | |
| Title: |
Yvonne Greenstreet | |
| Date: |
Chief Operating Officer | |
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Exhibit 10.53
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
EXECUTION VERSION
CONFIDENTIAL
Preliminary Collaboration Agreement
This Preliminary Collaboration Agreement (“Preliminary Collaboration Agreement”) is entered into as of April 5, 2020 (the “Execution Date”), by and between GlaxoSmithKline Intellectual Property Development Limited, a limited liability company incorporated under the laws of England having an office at 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK, and GlaxoSmithKline Biologicals SA, a limited liability company incorporated under the laws of Belgium having its registered place of business at rue de l’Institut 89, 1330 Rixensart, Belgium, registered with the Legal Entity Register (RPM Nivelles) under number 0440.72.918 (together, “GSK”), and Vir Biotechnology, Inc., a Delaware corporation having an office at 499 Illinois Street, Suite 500, San Francisco, CA 94158 (“Vir”) (each GSK and Vir, a “Party” and together, the “Parties”). The capitalized terms used herein and not otherwise defined have the meanings given to them in the Stock Purchase Agreement.
| 1. Binding Nature of this Preliminary Collaboration Agreement | The Parties hereby enter into this Preliminary Collaboration Agreement, which constitutes a binding obligation of both Parties. This Section 1 and Sections 2, 15, 16, 17, 18, 19(a), 20, 21, 22, 23, 24 and 25 of this Preliminary Collaboration Agreement (together with the appendices referenced in such sections) shall be effective as of the Execution Date; all other terms shall be automatically effective as of the Closing (as defined in the Stock Purchase Agreement) without any further action on the part of any person. The terms of this Preliminary Collaboration Agreement shall remain in effect until the earlier of (a) valid termination of the Stock Purchase Agreement or (b) the effectiveness of the Definitive Collaboration Agreement. The Parties shall execute an agreement containing a more detailed set of terms governing the collaboration established under this Preliminary Collaboration Agreement (which agreement shall be consistent with the terms of this Preliminary Collaboration Agreement) (such expanded version of such terms, the “Definitive Collaboration Agreement”), subject to Section 17 of this Preliminary Collaboration Agreement. If the Stock Purchase Agreement is validly terminated in accordance with Section 10 thereof such that the Closing does not occur, this Preliminary Collaboration Agreement and if entered into, the Definitive Collaboration Agreement, shall terminate, both effective as of the termination date of the Stock Purchase Agreement. [***], Vir shall [***]. Following the date hereof, the capitalized terms used in the appendices hereto and not otherwise defined therein have the meanings given to them in this Preliminary Collaboration Agreement.
“Collaboration Products” means (a) the 309 Antibody and any Antibodies developed against any coronavirus under the Antibody Program (“Antibody Products”), (b) Vaccines that |
| are developed under the Vaccine Program (“Vaccine Products”), and (c) such products that the JRC agrees to include in the Functional Genomics Program based on the results of the genomic screens conducted under the Functional Genomics Program (which may be any modality) (“Functional Genomics Products”).
[***].
“Development Plan” means a detailed plan and budget mutually agreed to govern the conduct of the applicable Program. The agreed Development Plan for clinical elements of the Development activities for the Antibody Program directed to the 309 Antibody and a high level version of the budget therefor (the “309 Antibody Program”) is attached hereto as Appendix A.
“Collaboration” means (a) research activities conducted under the Development Plans, and (b) the Development, Manufacture and Commercialization activities with respect to the Collaboration Products during the Term pursuant to and in accordance with the terms of this Preliminary Collaboration Agreement or the Definitive Collaboration Agreement. For the avoidance of doubt, neither Party’s assets (targets or compounds), including those discovered, licensed or acquired by such Party outside of the Collaboration, shall be included at any time as part of the Collaboration unless otherwise agreed by such Party in the applicable Development Plan; provided that, for clarity, [***].
“Field” means the prevention, treatment and prophylaxis of diseases caused by coronaviruses, (including SARS-COV-2 [***]) in humans, including the disease known as CoVID-19, [***].
The Collaboration will be directed to three programs (each a “Collaboration Program”) for the Development and Commercialization of separate types of Collaboration Products as set forth below, in each case pursuant to mutually agreed Development and Commercialization plans, including budgets:
(a) Antibodies, including the 309 Antibody, as further described below (the “Antibody Program”).
(b) Vaccines, which may include the development of Vaccines directed against SARS-COV-2 and other specific coronaviruses (the “Vaccine Program”).
(c) Genome-wide CRISPR screening activities and other functional genomic screens as are mutually agreed, including [***] (“Functional Genomics Program”). If the Parties mutually agree, they may include in the Functional Genomics Program, drug discovery, development and commercialization of Functional Genomics Products. [***]. |
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| Vir’s existing collaboration with Alnylam Pharmaceuticals in connection with development, manufacture and commercialization of RNAi products in the Field is excluded from the Collaboration. | ||
| 2. Certain Definitions | “Antibody” means any monoclonal antibodies that bind to coronaviruses and [***]. For clarity, Antibodies shall not include any Vaccine. [***].
“Commercialization” (and corresponding terms) means any and all activities directed to the preparation for sale of (but excluding Commercial Manufacture), offering for sale of, or sale of a Collaboration Product, including activities related to marketing, promoting, selling, distributing, importing and exporting such Collaboration Product, and interacting with regulatory authorities regarding any of the foregoing.
“Commercial Manufacture” means Manufacture for commercial sale, including use of contract manufacturers for such commercial sale, and the following activities, whenever required during the Term for a given Collaboration Product (a) selection of the facility(ies) for commercial Manufacturing of Collaboration Product (including for pivotal trials) (“Commercial Facilities”); (b) subject to the terms of any existing Third Party agreements, technology transfer of the Manufacturing process for Collaboration Product to Commercial Facilities; (c) conduct of process performance qualification (“PPQ”) batches and other process qualification and validation activities required for Regulatory Approval for commercial Manufacturing of Collaboration Product at the Commercial Facility(ies); and (d) obtaining pre-approval inspection and required licenses and permits for Commercial Facilities.
“Control” means, with respect to any material, information, or intellectual property, the possession (whether by ownership or license, other than the licenses granted hereunder) of the ability to grant a license or sublicense or other right to exploit, as provided herein, without violating the terms of any agreement or other arrangement with any Third Party, or any applicable law.
“Development” means all activities related to research, pre- clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, quality assurance/quality control, clinical trials, including manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of applications for marketing approval, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a regulatory authority as a condition or in support of obtaining or maintaining a regulatory approval. When used as a verb, “Develop” means to engage in Development. | |
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“Development Costs” has the meaning set forth on Appendix C.
“GSK Licensed Technology” means, on a Collaboration Program-by-Collaboration Program basis, all patents and know-how that are both (a) [***], and (b) [***], provided that GSK Licensed Technology shall not include (i) any GSK Program Technology or (ii) [***]. If GSK includes any patents or know-how in the GSK Licensed Technology, such inclusion shall be subject to any Third Party agreements and any limitations on use imposed by GSK at the time of the inclusion. For clarity, [***].
“GSK Program Technology” means, on a Collaboration Program-by-Collaboration Program basis, GSK’s right and interest in any patent and know-how generated under such Collaboration Program.
“Manufacture” (and corresponding terms) means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of any Collaboration Product, or any component or intermediate thereof, including process development, process qualification and validation, scale-up, qualification, validation, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control.
“Program Antibodies” means (a) any Antibody [***] that is directed against any coronaviruses, including the Antibody known as the 309 Antibody [***] (the “309 Antibody”); (b) any Antibody created, discovered, conceived or reduced to practice by either Party or both Parties jointly during the conduct of activities under an Antibody Development Plan during the Initial Development Term, and (c) any Antibody Controlled by either Party that the Parties agree during the Initial Development Term, through the JRC, to include as the subject of Development activities under an Antibody Development Plan.
“Third Party” means a person or entity other than (a) Vir and its Affiliates, and (b) GSK and its Affiliates.
“U.S. Territory” means the United States and its territories and possessions.
“Vaccine” means any biological product, including nucleic acid(s), protein(s), peptide(s), polysaccharide(s), conjugated polysaccharide(s), live, live-attenuated or inactivated microorganism(s) including replication-competent and replication defective virus(es), bacteriophages(s) and bacteria, in each case comprising or encoding an antigen derived from |
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| the pathogen or the disease to be prevented or treated, optionally in combination with one or more biological or non-biological product(s) and that when administered to an subject induces, increases, decreases or qualitatively modifies, an immune response intended to prevent or treat the target disease or condition.
“Vir Licensed Technology” means, on a Collaboration Program-by-Collaboration Program basis, all patents and know-how that are (i) (a) [***], and (b) [***], and (ii) [***]; provided that Vir Licensed Technology shall not include any Vir Program Technology.
“Vir Licensed Technology” shall [***]. If Vir includes any patents or know-how in the Vir Licensed Technology for the Vaccine Program or the Functional Genomics Program, such inclusion shall be subject to any Third Party agreements and any limitations on use imposed by Vir at the time of the inclusion. For clarity, any technology that Vir includes within Vir Licensed Technology for a given Collaboration Program shall not be deemed included in Vir Licensed Technology for any other Collaboration Program, unless Vir expressly agrees to such inclusion in the applicable Development Plan for such other Collaboration Program, and specifically, [***].
“Vir Program Technology” means, on a Collaboration Program-by-Collaboration Program basis, Vir’s right and interest in any patent and know-how generated under such Collaboration Program.
“WuXi Agreement” means the Development and Manufacturing Collaboration Agreement by and between WuXi Biologics (Hong Kong) Limited and Vir dated 25 February, 2020.
“WuXi Territory” means solely with respect to Collaboration Programs and Collaboration Products that are subject to the WuXi Agreement, (as of the date hereof) the People’s Republic of China, Hong Kong and Macau and Taiwan, for so long as such Collaboration Programs and Collaboration Products is subject to the WuXi Agreement. [***]. | ||
| 3. Exclusivity | During the Initial Development Term, neither Vir nor its Affiliates (either internally or through enabling a Third Party) will (a) create or generate Antibodies for the purpose of developing or commercializing any Antibody directed to SARS-COV-2 or any other coronaviruses; or (b) conduct functional genomics screens (including genome-wide screens using CRISPR) for SARS-COV-2 or any other coronaviruses to discover novel targets or progress such targets into drug discovery and development, in each case ((a) and (b)), except pursuant to the Collaboration. | |
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| During the Initial Development Term, neither GSK nor its Affiliates (either internally or through enabling a Third Party ) will (a) create or generate Antibodies for the purpose of developing or commercializing any antibody product directed to SARS-COV-2 or any other coronaviruses; or (b) conduct functional genomics screens (including genome-wide screens using CRISPR) for SARS-COV-2 or any other coronaviruses to discover novel targets or progress such targets into drug discovery and development, in each case ((a) and (b)), except pursuant to the Collaboration; provided, however, [***].
For the avoidance of doubt, the foregoing exclusivity obligation shall not apply to, with respect to GSK, [***].
Notwithstanding the foregoing, if during the Initial Development Term, either Party or its Affiliates wishes to pursue a new program that falls within the exclusivity obligations above (whether alone or with a Third Party), then such Party shall first offer to include any such program under the Collaboration. If the other Party declines to include such program under the Collaboration, then the offering Party or its Affiliates shall have the right to pursue such program outside of the Collaboration, regardless of its obligations under this Section 3.
Each Party will be free to pursue by itself or through the grant of rights to or from a Third Party, other therapeutic or prophylactic approaches to the prevention, treatment and prophylaxis of diseases caused by coronaviruses that do not fall within the exclusivity obligations above, including with respect to Vir, RNAi products with Alnylam. | ||
| 4. Collaboration Programs; Lead Party | For a period of four (4) years from the Closing (the “Initial Development Term”), the Parties will collaborate, under mutually agreed upon research and development plans (and associated budgets) for each of the (a) Antibody Program, (b) Vaccine Program, and (c) Functional Genomics Program (each a “Development Plan”), to generate and evaluate potential clinical candidates under each Collaboration Program. Each Development Plan will set out the allocation of responsibilities, as between the Parties, for Development (including related CMC activities) under the applicable Collaboration Program. The Parties agree that, any activities under a Development Plan to be conducted by or with WuXi or any additional counterparty in China shall be expressly agreed and set forth in such Development Plan and that [***].
With respect to each Collaboration Program (and any Collaboration Product generated therefrom), the Party that is designated as the lead party in accordance with a Development Plan or specified in this Preliminary Collaboration Agreement or the Definitive Collaboration Agreement (the “Lead Party”) shall be primarily responsible for Development (including | |
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| research), regulatory, or Manufacturing in accordance with the Development Plan, unless expressly provided otherwise herein or in the Definitive Collaboration Agreement.
The Lead Party for each Collaboration Program shall have the final decision-making right with respect to Development or clinical Manufacturing of the Collaboration Products under the applicable Collaboration Program. With respect to each Antibody Product under the Antibody Program, Vir shall be the Lead Party for such Program Antibody until the first filing for Regulatory Approval for such Antibody Product; provided that [***]. GSK shall become the Lead Party for such Antibody Product upon the first filing for Regulatory Approval.
The Parties will be responsible for activities under each Collaboration Program as follows:
1. Antibody Program.
• The Antibody Program will be the first Collaboration Program to be progressed by the Parties, and will build on Vir’s ongoing activities in the Field, including under Vir’s collaboration with WuXi and Biogen. For clarity, Vir will be permitted to continue to perform activities under (a) the WuXi Agreement (in accordance with its terms), and (b) the agreement currently under negotiation between Vir and Biogen Inc. in connection with the manufacture (including the development of manufacturing processes) of Antibodies for use in the Field (the “Biogen Draft Agreement”), in each case ((a) and (b)) solely in connection with manufacturing for clinical supply of Antibodies for use in the Field, as further set forth in Section 9 below.
• In connection with the negotiation of the Definitive Collaboration Agreement, the Parties will agree upon the clinical Development Plan (including the budget therefor) for the Antibody Program (which shall include the 309 Development Plan) (the “Antibody Development Plan”), which will be included as an exhibit to the Definitive Collaboration Agreement.
• Vir will be primarily responsible for and shall be the Lead Party for Development and clinical Manufacturing activities for the Antibody Program, under the oversight of the JSC and any other governance committees as further described in Section 8 below.
• GSK will be primarily responsible for Commercialization and, where applicable, Commercial Manufacturing activities for such Antibody Product, under the oversight of the JSC and any other governance committees as further described in Section 8 below.
• Subject to the opt-out provisions and any other provisions expressly set forth in this Preliminary Collaboration Agreement, the Parties will share all Development Costs associated with |
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| activities under the Antibody Development Plan, in accordance with the budget therefor, with Vir bearing 72.5% and GSK bearing 27.5% of such Development Costs. Any Development Costs incurred in excess of the agreed upon budget (including any pre-agreed overage percentage) in the Antibody Development Plan will be subject to the terms set forth in Section 5 below.
• The Definitive Collaboration Agreement will set forth the operational terms for reconciliation of Development Costs as between the Parties in accordance with the above cost-sharing ratios.
2. Vaccine Program
• The Vaccine Program will commence promptly following adoption of the Development Plan for the Vaccine Program and will include such proprietary technology of Vir and GSK, in case as contributed by the applicable Party in [***] and set forth in the Development Plan. The Development Plan will set forth the expected timing for the commencement of activities under the Vaccine Program.
• In connection with the negotiation of the Definitive Collaboration Agreement, the Parties will negotiate in good faith an initial draft of the Development Plan (including the budget therefor) for the Vaccine Program (the “Vaccine Development Plan”); provided that if the Development Plan is not attached to the Definitive Collaboration Agreement then, the Parties will continue such negotiation.
• GSK will be the Lead Party and the LCP and it is anticipated that the research work will be conducted predominantly by Vir. [***]. If the research is successful, then the Parties may take forward the project in accordance with the terms of this Preliminary Collaboration Agreement or, once executed, the Definitive Collaboration Agreement. In the event that GSK does not elect to take the applicable Vaccine Product forward (i.e., exercises its Opt-Out Rights), then Vir may take the project forward, subject to the terms and conditions of this Preliminary Collaboration Agreement and Definitive Collaboration Agreement, once executed; [***].
• If GSK determines that a development candidate from such program was not successful or otherwise wished to opt out from further Development, Manufacturing or Commercialization, GSK shall have the right to do so. [***].
• The Parties will share all Development Costs associated with activities under the Vaccine Development Plan, in accordance with the budget therefor, with GSK bearing 72.5% and Vir bearing 27.5% of such Development Costs. Any Development Costs incurred in excess of the agreed upon budget (including any pre-agreed overage percentage) in the Vaccine Development Plan will be subject to the terms set forth in Section 5 below. |
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| • The Definitive Collaboration Agreement will set forth the operational terms for reconciliation of Development Costs as between the Parties in accordance with the above cost-sharing ratios, which shall be [***] except as otherwise agreed in the Definitive Collaboration Agreement.
3. Functional Genomics Program
• The Functional Genomics Program will commence promptly following the adoption of the Development Plan for the Functional Genomics Program, or if later, the date specified in the Development Plan for the commencement of the Functional Genomics Program. Any databases and data mining technologies [***] shall be included solely as specified in the Functional Genomics Program Development Plan, and in each case subject to any applicable Third Party agreements.
• The Parties will mutually agree upon the timing for drafting and negotiating a Development Plan (including the budget therefor) for the Functional Genomics Program (the “Functional Genomics Development Plan”), which Development Plan shall specify the date on which the Functional Genomics Program shall commence.
• GSK will be primarily responsible for and shall be the Lead Party for Development and Manufacturing activities for the Functional Genomics Program, under the oversight of the JSC and any other governance committees as further described in Section 8 below.
• The Parties will share equally all Development Costs associated with activities under the Functional Genomics Development Plan, in accordance with the budget therefor, with each of GSK and Vir bearing 50% of such Development Costs. Any Development Costs incurred in excess of the agreed upon budget (including any pre-agreed overage percentage) in the Genomics Development Plan would be subject to the terms set forth in Section 5 below.
• The Definitive Collaboration Agreement will set forth the operational terms for reconciliation of Development Costs as between the Parties in accordance with the above cost-sharing ratios, which reconciliation shall be [***] except as otherwise agreed by the Parties.
Diligence
Each Party will use commercially reasonable efforts to conduct the activities assigned to it under each Development Plan and to enable GSK to seek and obtain regulatory approval for any Collaboration Product progressed thereunder in the United States, the European Union, and the United Kingdom. The Parties further agree that, with respect to a Collaboration Product, the Parties will discuss and agree on [***]. |
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Regulatory Matters
In general, the Lead Party for a given Collaboration Program shall have the right to prepare and file for, in its own name, and will own all regulatory applications and approvals for any Collaboration Product under such Collaboration Program. The Parties will discuss and seek to agree upon the appropriate regulatory strategy for each Collaboration Product, taking into account any accelerated pathways to regulatory approval that may be available in connection with CoVID-19 and other diseases associated with coronavirus infection, provided that the Lead Party will have the right to make a final decision in connection with regulatory activities and strategy for Collaboration Products for which it is the Lead Party.
Notwithstanding the foregoing, with respect to any Collaboration Product for which Vir is the Lead Party, unless GSK has exercised its Opt-Out Right, any NDA or BLA for such Collaboration Product shall be filed in the name of GSK, and [***]. | ||
| 5. Development Cost Overruns | Neither Party will be liable to the other for Development Costs incurred by such other Party in an amount in excess of [***] of the then-approved budget for such Collaboration Program, without approval of the JSC for so long as it remains a Collaboration Program (i.e. as long as neither Party has exercised its opt-out rights for such Collaboration Program). Any expenditure in excess of [***] of the then-approved budget for such Collaboration Program will be subject to mutual agreement through the JSC. Subject to the overage provision set forth above, if the Parties are not able to agree on a proposed increase to a Development Plan budget, then [***]. | |
| 6. Third Party Technologies | The Parties, through the JSC, would discuss and mutually agree upon any third party technologies (other than the Vir Licensed Technology and the GSK Licensed Technology) they feel are appropriate to include within a Collaboration Program, as well as the terms associated therewith. To the extent applicable to the activities under a given Collaboration Program, any costs associated with obtaining and use of technology under Third Party licenses (including costs under any such licenses existing as of the effective date of the Preliminary Collaboration Agreement) would be borne as a Development Cost under the applicable Collaboration Program and subject to the Opt-Out provisions, allocated between the Parties in accordance with the cost-sharing ratios applicable thereto. | |
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| 7. Collaboration Governance | The Parties would establish, [***], a Joint Steering Committee (the “JSC”) consisting of an equal number of representatives of each Party. The JSC will, among other things:
• oversee and guide the strategic direction of the Collaboration;
• facilitate communication between the Parties regarding the identification and evaluation of Collaboration Products;
• establish, as appropriate, sub-committees or working groups responsible for managing specific aspects of the Collaboration, which shall include a joint research committee (the “JRC”), a joint development committee, and/or a joint manufacturing committee and such other committees as mutually agreed by the Parties;
• delegate its decision making authority to the applicable subcommittees, provided that any material dispute shall be elevated to the JSC;
• serve as a forum for each Party to communicate at certain points in time its decisions regarding continuation of its participation in the development of each Collaboration Product;
• resolve issues elevated to it by any other subcommittee or working group the JSC may establish; and
• Perform such other functions as the Parties may mutually agree in writing.
Meetings of the JSC would be held [***] initially, with at least [***] per year, and the JSC would have the right to change such frequency as it determines appropriate. Meetings would alternative between each party’s facilities, to the extent conducted in person. All decisions of the JSC would be made by consensus of the Parties. In the event of dispute within the JSC’s jurisdiction, [***], will attempt to resolve such dispute within [***]. If senior management cannot resolve the dispute, then, such dispute shall be resolved as follows:
(a) With respect to research activities:
• Any such unresolved disputes shall [***].
(b) With respect to each Collaboration Product prior to the first filing for Regulatory Approval of such Collaboration Product:
• With regard to [***], the Lead Party shall have the final decision making authority, except for budget increases and assignment of activities to the other Party, in which case consent of the other Party shall be required.
• Thereafter, GSK will have final decision-making except for assignment of activities to Vir, in which case consent of Vir shall be required.
• In addition, GSK will have final decision-making with regard to any matter relating to [***]. | |
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| (c) With respect to each Collaboration Product, after the first filing for regulatory approval of such Collaboration Product:
• GSK shall have the final decision-making authority.
Notwithstanding the foregoing, (i) neither Party may exercise its final decision-making authority to impose additional obligations upon the other Party without such Party’s consent, and (ii) if a Party elects its Opt-Out Right at any time in a Collaboration Program, then thereafter, to the extent such opt-out Party would have the final decision-making authority pursuant to (a)-(c) above, then, such opt-out Party shall no longer have such decision-making authority, and dispute that would be subject to such opt-out Party’s final decision-making authority shall then be subject to the non opt-out Party’s final decision-making authority. Matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Preliminary Collaboration Agreement, are outside the jurisdiction and authority of the JSC, including amendment, modification or waiver of compliance with the Preliminary Collaboration Agreement or the Definitive Collaboration Agreement.
Matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of the JSC, including amendment, modification or waiver of compliance with the Preliminary Collaboration Agreement or the Definitive Collaboration Agreement.
[***], each Party shall designate an individual to serve as the main point of contact for each Party for the Antibody Program and upon agreement on a Development Plan for the Vaccine Program and Functional Genomics Program, respectively each such Collaboration Program to exchange information, facilitate communication and coordinate the Parties’ activities under the Definitive Collaboration Agreement (each, an “Alliance Manager”).
The Alliance Managers shall attend JSC meetings (or designate an appropriate representative to attend JSC meetings on the Alliance Manager’s behalf). | ||
| 8. Collaboration Programs –Right to Opt-Out | For each Collaboration Program, all Development Costs will be shared by the Parties in the cost-sharing ratios set forth in Section 4 above unless and until a Party opts-out of co-funding (as provided below).
Opt-Out Right
On a Collaboration Product-by-Collaboration Product basis, either Party would have the right, at each of the specified milestones set forth below (each, an “Opt-Out Point”), to elect to “opt out” of its co-funding obligation (the “Opt-Out Right”):
• [***] | |
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|
If a Party elects to opt-out of its participation at any of the indicated points for a Collaboration Product, it would communicate in writing to the other Party that it desires to cease all further funding for such Collaboration Product, provided that such opting-out Party shall continue to be liable for its allocation of costs [***]. For clarity, if a Party does not elect to exercise its Opt-Out Right at one of the above specified points in time, it will be obligated to continue to co-fund all Development Costs until such time as the next Opt-Out Right event occurs, if any; provided, that [***].
Upon receipt of any opt-out notice from a Party the other Party will have the right to elect either to:
• pursue such program unilaterally, in which case the opting-out Party’s rights to share in future net profits shall cease and instead it shall be entitled to royalties and as to be further set forth in the Definitive Collaboration Agreement, and a certain percentage of Sublicense Revenue [***] from the other Party on Net Sales [***] of the applicable Collaboration Product(s).
• also cease the conduct and funding of such Collaboration Product and if so, the Parties may agree to out-license or otherwise divest such Collaboration Product, in which case the [***] shall take the lead in negotiations, and the reasonable and properly incurred costs associated with such negotiations and entry into any agreements with a Third Party, and any revenue arising from such outlicensing or divestment shall be shared in accordance with the cost-sharing ratios. | ||
| 9. Manufacture and Supply | For each Collaboration Program the Parties will jointly through a Joint Manufacturing Committee or the JSC (and subject to each Party’s applicable final decision-making authority) determine a, Manufacturing strategy with respect to the Manufacture and supply of Collaboration Product drug substance or drug product, which may as appropriate include manufacturing capabilities of both Parties, or contract manufacturer.
During the [***], Vir will remain the Lead Party for all Manufacturing activities for the Antibody Program, provided that [***].
In consultation with GSK, following the execution date hereof, Vir will [***].
Vir shall be the Lead Party and responsible for Manufacturing for clinical supply, and GSK shall be the Lead Party and responsible for the Commercial Manufacture of Antibody Product, including any scale-up activities for Commercial Manufacture. | |
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| If the Parties agree to seek a contract manufacturer, the Lead Party for such Collaboration Program will be the lead contracting party for the applicable drug substance or drug product. To the extent one Party supplies the other with drug substance or drug product for such Collaboration Program the costs to supply such drug substance or drug product shall be deemed part of the overall Development Costs, or commercial costs, as the case may be, as they are incurred.
Any supply agreement for commercial supply during the Term shall include [***].
With respect to [***]. | ||
| 10. Commercialization of Collaboration Products | Unless a Party has opted-out prior to such time, the Parties will share in all profits and losses arising from any Collaboration Product in the same ratios in which the Parties bore Development Costs for such Collaboration Program.
In general, except for the Antibody Program, as set forth below, the Lead Party for Development will continue to act as the “Lead Commercialization Party” or “LCP” for such Collaboration Program. The LCP will conduct its activities in accordance with an agreed upon commercialization plan (the “Commercial Plan”) and budget (“Commercial Budget”) (with a [***] overage provision) for such countries.
For each Antibody Product, following the filing for Regulatory Approval (i.e. an NDA or MAA, as applicable), GSK will assume the role of LCP for the Commercialization of each such Antibody Product, and will be responsible for booking all sales of such Antibody Product.
GSK will be responsible for all Commercialization activities worldwide with respect to each Collaboration Product, except (a) for detailing conducted by Vir in the US Territory under the Co-Promotion Agreement, if agreed by the Parties, for so long as the Co-Promotion Agreement is in effect, and (b) in connection with sales in the WuXi Territory for Antibody Products arising or licensed to WuXi under the WuXi Agreement and directed to SARs-COV-2. GSK will be required to use commercially reasonable efforts to Commercialize each Collaboration Product in the US following regulatory approval in the US, in [***] following regulatory approval in the European Union, and the United Kingdom, following regulatory approval in the United Kingdom.
Except in the case of an Opt-Out, for each Collaboration Product, Vir and GSK will share net profits and net losses, to be defined in the Definitive Collaboration Agreement from commercialization of any Collaboration Product worldwide. | |
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| 11. Vir Co-Promotion Right for Antibody Products | On an Antibody Product-by-Antibody Product basis, Vir shall have the right to opt in to co-detail such Antibody Product in the United States subject to [***] and an agreed Co-Promotion Agreement (the “Co-Promotion Option”), which will include provisions around [***]. Vir’s detail percentage shall not exceed twenty percent (20%), and subject to [***], and as otherwise may be reasonably agreed by the Parties in the Co-Promotion Agreement.
The Definitive Collaboration Agreement shall set forth (which may be in an appendix or separate form of co-promotion or similar agreement) the timing of Vir’s right to exercise the Co- Promotion Option, and the nature of Vir’s rights and responsibilities in connection with the Commercialization of the applicable Antibody Product. | |
| 12. Economic Terms a. Collaboration Programs |
The Definitive Collaboration Agreement will include a financial terms exhibit or appendix setting forth the financial terms, including definitions, consistent with any financial terms and definitions set forth herein: (a) such more detailed definitions [***], (b) the rules for calculating net profits and net losses, and (c) the operational provisions governing payment/reimbursement as between the Parties of net profits and net losses. Without limiting the foregoing, the Parties agree that the following specific costs will be included as either Development Costs or in the net profits and net losses calculation (subject to the applicable budget and overage provisions) as well as other customary cost categories:
• Costs of Third Party licenses necessary for the Development, Manufacture or Commercialization of any Collaboration Product.
• Costs of Manufacturing technology transfer to either Party or to a designated contract manufacturer in connection with activities to be conducted under the WuXi Agreement or any agreement between Vir and Biogen relating to the development of manufacturing processes for Antibody Products in the Field.
• For the Antibody Program, costs incurred by Vir in connection with the Development and Manufacture of Antibody Products under the WuXi Agreement, provided that [***]. | |
| b. Programs subject to Opt-Out Right | For each Collaboration Product as to which a Party exercises its Opt-Out Right as described herein, the commercializing Party will pay to the opting out Party royalties on Net Sales (to be defined in the Definitive Collaboration Agreement) of the applicable Collaboration Product at commercially reasonable rates to be agreed in good faith in the Definitive Collaboration | |
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| Agreement, taking into account, among other relevant commercial factors (a) the development stage of the Collaboration Product at the time of the exercise of the Opt-Out Right, (b) [***], and (c) whether the Party exercising the Opt-Out Right is the Lead Party or Non-Lead Party.
If, following the Opt-Out by one Party, the other Party does not continue the further Development of the applicable Collaboration Product, then the non Opt-Out Party shall have the right to take the lead on sublicensing or otherwise divesting rights to the applicable Collaboration Product (consistent with the terms of this Preliminary Collaboration Agreement or Definitive Collaboration Agreement and subject to any applicable limitations applicable to sublicensing); provided, however, that in such case the non Opt-Out Party shall pay to the original Opt-Out Party a portion of Sublicense Revenue at rates to be agreed in the Definitive Collaboration Agreement. For clarity, [***].
The term of any royalties and Sublicense Revenue due to the Opt-Out Party shall be paid on Net Sales and Sublicense Revenue received prior to the end of the Term for the applicable Collaboration Product.
[***]:
In the event that [***] with respect to a Collaboration Product:
(a) if neither Party has exercised Opt-Out Right with respect to such Collaboration Product, then [***];
(b) if one Party has exercised Opt-Out Right, then [***]. | ||
| 13. Change of Control of Vir | The Definitive Collaboration Agreement will include provisions setting forth the consequences for any ongoing Collaboration Program as a result of a change of control of Vir, which consequences shall [***]. | |
| 14. Intellectual Property | Except as otherwise set forth in the Definitive Collaboration Agreement, ownership of inventions arising in the conduct of activities under the Collaboration will follow inventorship in accordance with United States patent laws.
On a Collaboration Program-by-Collaboration Program basis, and subject to the terms and conditions of this Preliminary Collaboration Agreement (or the Definitive Collaboration Agreement once executed), including the profit-sharing terms thereof:
(a) Vir hereby grants to GSK effective as of the Closing:
(i) a co-exclusive (with Vir), worldwide (excluding the WuXi Territory to the extent such rights have been granted to WuXi for so long as the Wuxi Agreement is in effect), sublicenseable license under the Vir Licensed Technology and Vir Program Technology to Develop and Manufacture Collaboration Products arising from such Collaboration Program; | |
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| (ii) an exclusive, worldwide (excluding the WuXi Territory for so long as the Wuxi Agreement is in effect), sublicenseable license under the Vir Licensed Technology and Vir Program Technology to Commercialize Collaboration Products arising from such Collaboration Program, provided that for clarity, where Vir exercises the Co-Promotion Option, under the Co-Promotion Agreement, GSK will grant back to Vir such licenses under the Vir Licensed Technology and Vir Program Technology as are necessary for Vir to perform its activities under the “Co-Promotion Agreement” to be entered into by the Parties; and
(iii) [***].
(b) GSK will grant to Vir:
(i) a non-exclusive, worldwide, sublicenseable [***] license under the GSK Licensed Technology to Develop and Manufacture Collaboration Products in accordance to the applicable Development Plan and to Manufacture in accordance with this Preliminary Collaboration Agreement (or the Definitive Collaboration Agreement, once executed), subject to any obligations to Third Parties with respect to the applicable GSK Licensed Technology;
(ii) a co-exclusive, worldwide, sublicenseable [***] license under the GSK Program Technology to Develop, Manufacture Collaboration Products arising from such Collaboration Program, and, solely with respect to any Antibody Product for which Vir has exercised the Co- Promotion Option, Commercialize such Antibody Product solely in accordance with Vir’s rights under the Preliminary Collaboration Agreement (or the Definitive Collaboration Agreement, once executed) in connection with the exercise of such Co-Promotion Option; and
(iii) [***].
All licenses granted by a Party to the other Party hereunder shall be subject to the licensing restrictions set forth in the existing agreements between such Party and any Third Party existing as of the signing date.
Provisions relating to patent prosecution, maintenance, enforcement, and defense rights for the Collaboration will be set forth in the Definitive Collaboration Agreement. | ||
| 15. Indemnification; Limitation of Liability | Each Party shall indemnify, defend and hold harmless the other Party and its Affiliates and their respective directors, officers, | |
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| employees and agents, and the respective successors and assigns (any of the foregoing “Indemnitees”), from and against any and all suits, claims, actions, demands, losses, damages, liabilities, settlements, penalties, fines, costs and expenses (including reasonable attorneys’ fees and other expenses of litigation) (collectively, “Losses”) asserted by a Third Party arising from [***].
The Definitive Collaboration Agreement shall include the indemnities set forth above and other customary indemnities to be agreed by the Parties.
NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS PRELIMINARY COLLABORATION AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 15 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY SET FORTH ABOVE, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF ITS OBLIGATIONS HEREUNDER RELATING TO CONFIDENTIALITY. THE DEFINITIVE COLLABORATION AGREEMENT WILL INCLUDE ANALOGOUS LANGUAGE. | ||
| 16. Term and Termination | This Preliminary Collaboration Agreement shall terminate upon execution of the Definitive Collaboration Agreement. For clarity, the Definitive Collaboration Agreement will supersede the Preliminary Collaboration Agreement and will remain in effect in perpetuity, unless earlier terminated as set forth below (including on a Collaboration Program or Collaboration Product basis, as the case may be) (the term of this Preliminary Collaboration Agreement and the Definitive Collaboration Agreement, collectively, the “Term”).
This Preliminary Collaboration Agreement shall terminate in the event of a valid termination of the Stock Purchase Agreement pursuant to Section 10 thereof.
Additionally, either Party shall have the right to terminate this Preliminary Collaboration Agreement or the Definitive Collaboration Agreement, (a) in the case of the insolvency of the other Party (as termination for insolvency is customarily defined), (b) in the case of a material breach with respect to the Preliminary Collaboration Agreement or the Definitive Collaboration Agreement as a whole by the other Party with respect to the applicable Collaboration Program or Collaboration Product, subject to a reasonable cure period, and (c) in the case of the Definitive Collaboration Agreement, in the case of such other events that both Parties agree shall be included in the Definitive Collaboration Agreement. | |
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| In the case of a termination of this Preliminary Collaboration Agreement or the Definitive Collaboration Agreement (including in the case of an opt-out), the terminated Party shall reasonably support the transition to the continuing Party of all Development and Commercialization activities related to the applicable Collaboration Product, including the reasonable grant of licenses to any Vir Licensed Technology or GSK Licensed Technology, as the case may be, that is [***] at the time of termination, including Commercialization of the applicable Collaboration Products, subject to the agreement upon reasonable license terms (including any financial terms for such licenses) and any rights granted to a Third Party. In addition, [***].
In the case of a termination for material breach with respect to the Agreement as a whole or insolvency by a Party, [***]. | ||
| 17. Governing Law; Dispute Resolution | This Preliminary Collaboration Agreement and the Definitive Collaboration Agreement are and will be governed by and construed under the laws of the State of Delaware, without reference to conflicts of law principles.
If the Parties are unable to reach agreement on the final terms of the Preliminary Collaboration Agreement within 45 days of the execution of the Preliminary Collaboration Agreement (a “Definitive Agreement Terms Dispute”), the Parties agree that any dispute regarding the final terms of the Preliminary Collaboration Agreement shall be finally resolved by “baseball- style” arbitration pursuant to the provisions set forth on Appendix E. The Parties further agree that during the pendency of a Definitive Agreement Terms Dispute, any dispute regarding the interpretation of any term of the Preliminary Collaboration Agreement and its implementation in the Definitive Collaboration Agreement shall also be finally resolved in accordance with Appendix E and shall be consolidated into any pending arbitration.
The Parties further agree that it is intended that the “baseball- style” arbitration pursuant to the provisions set forth on Appendix E controls all disputes among the Parties related to resolving gaps or indefinite terms in the Preliminary Collaboration Agreement and each Party agrees not to bring such claims pursuant to the arbitration procedures set forth in Appendix F, but, rather, to resolve such claims through the “baseball-style” arbitration pursuant to the provisions set forth on Appendix E even if such claims arise prior to the commencement of a Definitive Agreement Terms Dispute.
Except for a Definitive Agreement Terms Dispute or any dispute contemplated by the preceding paragraph, which arises prior to the commencement of a Definitive Agreement Terms | |
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| Dispute, any dispute arising out of or relating to this Preliminary Collaboration Agreement or Definitive Collaboration Agreement, or the breach, termination or validity thereof (a “Dispute”), shall be finally resolved pursuant to the provisions set forth on Appendix F. | ||
| 18. Assignment of the Agreement | The Preliminary Collaboration Agreement (or the Definitive Collaboration Agreement if executed) shall not be assignable by either Party in whole or in part to any Third Party without the prior written consent of the other Party hereto.
Notwithstanding the foregoing, [***]. | |
| 19. (a) Representations and Warranties; Pre-Closing Covenants | Vir hereby makes, and in the Definitive Collaboration Agreement shall make, the representations and warranties and agrees to the pre-closing covenants in each case, as set forth in Appendix D. The Definitive Collaboration Agreement will contain required representations and warranties relating to human rights, anti-bribery and corruption, human tissue samples, and animal welfare that are adequate to meet both Parties’ corporate standards. | |
| 19. (b) Additional Covenant | [***]. | |
| 20. Confidentiality | The confidentiality provisions set forth on Appendix G shall apply with respect to this Preliminary Collaboration Agreement. | |
| 21. Counterparts; Electronic Signatures | This Preliminary Collaboration Agreement may be executed and delivered (including by facsimile transmission or PDF or any other electronically transmitted signatures) in two counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. | |
| 22. Severability | If any provision of this Preliminary Collaboration Agreement should be held invalid, illegal or unenforceable in any jurisdiction, the Parties will negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof will remain in full force and effect in such jurisdiction and will be liberally construed in order to carry out the intentions of the Parties as nearly as may be possible.
Such invalidity, illegality or unenforceability will not affect the validity, legality or enforceability of such provision in any other jurisdiction. | |
| 23. Entire Agreement; Amendments | This Preliminary Collaboration Agreement, the Stock Purchase Agreement and, once entered into, the Definitive Collaboration Agreement (including any schedules, appendices and exhibits hereto or thereto and any certificates delivered hereunder or thereunder) constitute the entire agreement between the Parties with respect to the subject matter hereof and thereof. There are no restrictions, promises, warranties or undertakings, other than those set forth or referred to herein or therein. This Preliminary Collaboration Agreement supersedes all prior agreements and | |
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| understandings between the Parties with respect to the subject matter hereof. No provision of this Preliminary Collaboration Agreement may be waived or amended other than by an instrument in writing signed by the Party to be charged with enforcement. Any amendment or waiver effected in accordance with this Section 23 will be binding upon GSK and Vir. | ||
| 24. Third Party Beneficiaries | This Preliminary Collaboration Agreement is intended for the benefit of the Parties, their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other Person. | |
| 25. Miscellaneous | The Definitive Collaboration Agreement will include other reasonable and customary terms and conditions for an agreement of its type, including with respect to Termination, Indemnification, Insurance, Representations and Warranties, and Confidentiality (including Press Release). Section 11.5 (Rules of Construction) of the Stock Purchase Agreement shall apply, mutandis mutatis, to this Preliminary Collaboration Agreement (including the appendices hereto) and the Definitive Collaboration Agreement. | |
SIGNATURES FOLLOW
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IN WITNESS WHEREOF, GSK and Vir have caused this Preliminary Collaboration Agreement to be duly executed as of the date first above written.
| GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LIMITED | ||
| By: | /s/ Victoria Whyte | |
| for and on behalf of Glaxo Group Ltd. | ||
| Its: | Corporate Director | |
| GLAXOSMITHKLINE BIOLOGICALS SA | ||
| By: | /s/ Antoon Loomans | |
| Name: | Antoon Loomans | |
| Its: | SVP GC, Director | |
| VIR BIOTECHNOLOGY, INC. | ||
| By: | /s/ George Scangos | |
| Name: | George Scangos | |
| Its: | President and Chief Executive Officer | |
[Signature page to Preliminary Collaboration Agreement]
Appendix A
309 Antibody Program Development Plan
[***]
Appendix B
Listed Program Antibodies
Vir mAb-S309 [***]
[***]
Appendix C
Development Costs
“Development Costs” means the following costs incurred by the Parties following the Effective Date in conducting Development under the applicable Collaboration Programs, in each case to the extent incurred in accordance with this Preliminary Collaboration Agreement or the Definitive Collaboration Agreement and the applicable Development Plan, and without any additional mark-up: [***].
Appendix D
REPRESENTATIONS AND WARRANTIES
1.1. Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as of the Execution Date and the Effective Date as follows:
(a) such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority and legal right to enter into this Preliminary Collaboration Agreement and to carry out the provisions hereof;
(b) such Party has the right to grant the licenses to the other Party purported to be granted pursuant to this Preliminary Collaboration Agreement;
(c) such Party has taken all necessary action on its part required to authorize the execution and delivery of this Preliminary Collaboration Agreement and the performance of its obligations hereunder;
(d) such Party has received all necessary laboratory licenses and certificates with respect to facilities within such Party’s ownership or control sufficient to allow such Party to conduct the activities assigned to such Party under this Preliminary Collaboration Agreement, and such Party is in compliance with the requirements of such licenses and certificates;
(e) this Preliminary Collaboration Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with the terms and conditions hereof, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity);
(f) the execution, delivery and performance of this Preliminary Collaboration Agreement by such Party (i) will not constitute a default under, or conflict with, any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound; (ii) violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party; and (iii) is not prohibited or limited by, and shall not result in the breach of or a default under, any provision of the certificate or articles of incorporation or bylaws of such Party;
(g) Except for any filings that may be required to comply with the HSR Act , no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality , domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Preliminary Collaboration Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Preliminary Collaboration Agreement and such other agreements;
(h) such Party and its Affiliates have not employed (and, to its knowledge, has not used a (sub)contractor or consultant that has employed) and, during the Term, will not knowingly employ (or, to its knowledge, use any (sub)contractor or consultant that employs, provided that such Party may reasonably rely on a representation made by such (sub)contractor or consultant) any Person debarred by the FDA (or subject to a similar sanction of EMA or foreign equivalent), or any Person which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA or foreign equivalent); and
(i) Each Party and its Affiliates performing activities under the Collaboration has in place or will have in place prior to its conduct of its activities under the Collaboration a written agreement with its employees and other personnel it appoints to perform such activities hereunder sufficient to ensure that such Party has sufficient ownership or license rights to any Program Technology developed or created by such Party to grant the rights to the other Party as required to be granted under the Preliminary Collaboration Agreement;
1.2. Representations and Warranties of Vir. Vir hereby represents and warrants to GSK, as of the Execution Date and the Effective Date as follows:
(a) Vir or one of its Affiliates solely owns or exclusively licenses and Controls the Existing Antibodies and Vir Licensed Technology;
(b) neither Vir nor any of its Affiliates has entered into any agreement (other than agreements with subcontractors) granting any right, interest or claim in or to, any Existing Antibodies or Vir Licensed Technology that would conflict with the rights and licenses to GSK as required to be granted in the Preliminary Collaboration Agreement;
(c) neither Vir nor any of its Affiliates has previously entered into any agreement, whether written or oral, to assign, transfer, license, convey or otherwise encumber its right, title or interest in or to any Patent or other know-how that is necessary for the Development, Manufacture, or Commercialization of Antibody Products, in each case, where such Patent or other know-how would be Vir Licensed Technology but for such assignment, transfer, license, conveyance or encumbrance;;
(d) [***];
(e) Vir has not, and will not, after the Execution Date and during the Term, grant any right to any Third Party that would conflict with the rights granted to GSK hereunder;
(f) [***];
(g) all Patents that are included in the Vir Licensed Technology (“Vir Licensed Patents”) are subsisting and all Vir Licensed Patents for which Vir controls prosecution and maintenance activities are being diligently prosecuted in the patent offices in accordance with applicable law and, to Vir’s Knowledge, are not invalid or unenforceable in whole or in part;
(h) to Vir’s Knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate any Vir Licensed Technology and there are no activities by Third Parties that would constitute infringement or misappropriation of the Vir Licensed Technology;
(i) no claim or litigation has been brought or threatened in writing by any Person against Vir or any of its Affiliates alleging, and Vir has no Knowledge of any reasonable basis for any such claim or allegation, whether or not asserted, that (A) any Vir Licensed Patents are invalid or unenforceable, or (B) the use or practice of any Vir Licensed Technology, or the disclosing, copying, making, assigning or licensing of any Vir Licensed Technology, or the exploitation of the Existing Antibodies, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any Third Party;
(j) [***];
(k) Vir has provided or made available to GSK all material adverse information with respect to the safety and efficacy of the Existing Antibodies of which Vir is aware and is or could be reportable to the Applicable Regulatory Authorities;
(l) [***];
(m) [***];
(n) [***];
(o) Vir or one of its Affiliates has obtained the right (including under any Patents and other intellectual property rights) to use all information and all other materials (including any formulations and manufacturing processes and procedures) developed or delivered by any Third Party under any agreements between Vir or one of its Affiliates and any such Third Party with respect to any Existing Antibodies to the extent necessary to provide GSK with the rights granted to it hereunder, and Vir or one of its Affiliates has the rights to grant GSK the right to use such information or other materials in the Development or Commercialization of the Program Antibodies (e.g., 309 Antibody) as contemplated in the Preliminary Collaboration Agreement;
(p) Vir is in material compliance with (i) all applicable laws relating to data privacy and data security, including with respect to the collection, use, storage, sharing, transfer, disposition, protection and processing of personally identifiable information (PII); (ii) all privacy policies and other related policies, programs and other notices of Vir relating to the privacy, protection and security of PII; and (iii) all contractual and other legal requirements to which Vir is subject with respect to the privacy, protection, and security of PII; and has in place reasonable safeguards to protect the confidentiality and security of PII, including from unauthorized access or misuse, based on applicable law;
(q) [***];
(r) [***];
(s) [***]; and
(t) [***].
1.3. Disclaimer of Warranty. EXCEPT AS EXPRESSLY SET FORTH IN THIS PRELIMINARY COLLABORATION AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND, AND BOTH PARTIES EXPRESSLY DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT.
CERTAIN COVENANTS
1.1 Mutual Covenants.
(a) Immediately following the Execution Date, Vir and GSK shall commence negotiations with the intent to enter into the Definitive Collaboration Agreement. Vir and GSK shall use their respective best efforts to negotiate diligently and agree upon final terms for the Definitive Collaboration Agreement as promptly as practicable following the Execution Date and in no event later than the later of (x) the Antitrust Clearance Date (as defined in the Stock Purchase Agreement) and (y) forty-five (45) days following the Execution Date (or such longer period as Vir and GSK may mutually agree in writing) (the “Negotiation Period”). For the avoidance of doubt, entry into the Definitive Collaboration Agreement is not a condition to the effectiveness of this Preliminary Collaboration Agreement. If the Definitive Collaboration Agreement has not been finalized and executed, but the Closing (as defined in the Stock Purchase Agreement) occurs in accordance with the terms thereof, then this Preliminary Collaboration Agreement, which is binding and governs the Parties’ collaboration relationship, shall continue in full force and effect and Vir and GSK shall continue to negotiate or otherwise finalize the Definitive Collaboration Agreement in accordance with Appendix E of this Preliminary Collaboration Agreement.
(b) Each of Vir and GSK shall duly execute and deliver the Definitive Collaboration Agreement, on final terms as are (a) mutually agreed by Vir and GSK within the Negotiation Period, or (b) in the absence of such mutual agreement, determined in accordance with Appendix E of this Preliminary Collaboration Agreement.
(c) Upon execution by the Parties, this Preliminary Collaboration Agreement shall be a fully integrated and binding agreement and in full force and effect, subject only to the satisfaction of the conditions set forth therein. Neither Party, nor any of their respective Affiliates shall seek to assert that this Preliminary Collaboration Agreement or any term thereof is unenforceable for vagueness, or for not having sufficiently clear or defined terms, for failure of consideration or because it lacks any essential term for enforcement and each of Vir and GSK, on behalf of themselves and their Affiliates, hereby waive any right to make such an assertion. To the extent that any material term has not been included in this Preliminary Collaboration Agreement, Vir and GSK agree that such term (or terms) will be provided through the process set forth in Appendix E of this Preliminary Collaboration Agreement and will be binding and enforceable as if it had been included in this Preliminary Collaboration Agreement.
1.2 Pre-Closing Negative Covenants of Vir. During the period beginning on the Execution Date and ending on the Effective Date, Vir shall not, and shall cause its Affiliates not to, without the prior written consent of GSK (such consent not to be unreasonably withheld, conditioned or delayed):
(a) enter into any agreement with any Third Party, whether written or oral, with respect to, or otherwise assign, transfer, license or convey its right, title or interest in or to, the Vir Licensed Technology relating to the Antibody Program in connection with the 309 Antibody (the “309 Antibody Program”) or any Program Antibodies Controlled by Vir as of the Execution Date (“Existing Antibodies”), in each case, in a manner that creates a material conflict with the rights granted or purported to be granted by Vir to GSK under this Preliminary Collaboration Agreement;
(b) (i) sell, out-license or otherwise dispose of any assets or rights relating to the 309 Antibody Program or any Existing Antibodies, in each case, in a manner that creates a material conflict with the rights granted or purported to be granted by Vir to GSK under this Preliminary Collaboration Agreement, (ii) amend any agreements, licenses or other rights of Vir or any of its Affiliates relating to the 309 Antibody Program or any Existing Antibodies, in each case, in a manner that creates a material conflict with the rights granted or purported to be granted by Vir to GSK under this Preliminary Collaboration Agreement, or (iii) grant any security interest or otherwise encumber material assets and properties (including Vir Licensed Technology), relating to the 309 Antibody Program or any Existing Antibodies;
(c) (i) compromise, settle or agree to settle any litigation, dispute, action or other proceeding or institute any such litigation, dispute, action or other proceeding, in each case, concerning any Vir Licensed Technology that is material to the 309 Antibody Program or any Existing Antibodies, or (ii) fail to take any action necessary or advisable to protect or maintain any Vir Licensed Technology that is material to the 309 Antibody Program or any Existing Antibodies; provided that none of the foregoing shall be interpreted as requiring Vir or any of its Affiliates to commence any such litigation, dispute, action or other proceeding;
(d) (i) enter into any material agreement relating to the 309 Antibody Program or any Existing Antibodies or (ii) enter into any agreement pertaining to a merger, sale, acquisition, licensing, development, manufacturing, distribution, co-development, marketing or co-marketing arrangement, or any contract containing exclusivity provisions or restrictive covenants relating to the 309 Antibody Program or any other Existing Antibodies, in each case ((i) and (ii)), that creates a conflict with the rights granted or purported to be granted by Vir under this Preliminary Collaboration Agreement; or
(e) enter into any agreement with any Third Party, whether written or oral, with respect to contract manufacturing arrangements related to the Antibody Program if the costs of supply thereunder would be shared by the Parties pursuant to the Collaboration.
1.3 Pre-Closing Affirmative Covenants of Vir. During the period beginning on the Execution Date and ending on the Effective Date, Vir covenants that:
(a) [***];
(b) Vir shall, and shall cause its Affiliates and its and their respective contractors, licensees and consultants to, conduct the 309 Antibody Program and all other activities relating to the Existing Antibodies undertaken pursuant to this Preliminary Collaboration Agreement in accordance with Applicable Law;
(c) with respect to all intellectual property that it purports to license to GSK under this Preliminary Collaboration Agreement that is, may be or becomes subject to the Bayh-Dole Act, Vir shall, and shall cause its Affiliates and the relevant research partners to, continue to comply with the applicable provisions of the Bayh-Dole Act, in a manner that protects and preserves Vir’s right, title and interest in the subject intellectual property to the maximum extent permitted by Applicable Law; and
(d) Vir shall [***] notify GSK of the occurrence of a Key Product Event, and in no event more than [***] after such occurrence. “Key Product Event” means any event with respect to the 309 Antibody Program or Existing Antibodies, that: (a) is determined by an independent safety review committee overseeing the safety of the relevant clinical trial to be directly related to the 309 Antibody or any other Existing Antibody in such program and (i) to have resulted in death, (ii) been life-threatening, (iii) required inpatient hospitalization or a significant prolongation of existing hospitalization, (iv) resulted in persistent or significant disability or incapacity, (v) resulted in a congenital anomaly or birth defect or (vi) required significant intervention to prevent permanent impairment or damage; and (b) results in any Applicable Regulatory Authority (as defined in the Stock Purchase Agreement) placing a clinical hold on such program.
1.4 Nothing contained in this Preliminary Collaboration Agreement shall be deemed to give GSK, directly or indirectly, the right to control or direct the business of Vir prior to the Closing. Prior to
the Closing, Vir and its subsidiaries shall exercise, consistent with the terms and conditions of this Preliminary Collaboration Agreement and the Stock Purchase Agreement, complete control over their businesses and operations.
Appendix E
Arbitration for Failure to Agree on Final Collaboration Terms
If the Parties cannot reach agreement and enter into the Definitive Collaboration Agreement within 45 days following the execution date of the Preliminary Collaboration Agreement, then the Parties will communicate their respective positions to the [***], in the case of GSK, and [***], in the case of Vir (or their respective designee with power and authority to resolve such dispute) (“Senior Officials”), who will use good faith efforts to resolve the matter within [***] following the date of such referral. If the Senior Officials are not able to agree upon any unresolved terms to be included in the Definitive Collaboration Agreements referred to them [***] from the date of the Preliminary Collaboration Agreement, then the final terms and conditions of the Definitive Collaboration Agreement will be determined through the mediation and binding arbitration procedures set forth below:
[***]
Appendix F
Dispute Resolution
Any dispute arising out of or relating to the Agreement, or the breach, termination or validity thereof (a “Dispute”), shall be finally resolved pursuant to the following provision:
In the event a Dispute arises, the parties agree that they shall attempt in good faith to resolve the Dispute by negotiation between GSK’s [***] and Vir’s [***] (or their respective designee with power and authority to resolve such dispute). Either party may refer a Dispute to the applicable officers in the preceding sentence by serving notice that Dispute has arisen and demand that negotiations commence. If the parties are unable for any reason to resolve a Dispute within [***] of service of the notice, either party shall have the right to refer the Dispute for mediation as set forth in below.
[***].
Appendix G
Confidentiality Provisions
Confidentiality Obligations. The Definitive Collaboration Agreement will provide for confidentiality and use restrictions in respect of information disclosed by each Party to the other Party that are customary for arrangements such as the Collaboration and similar to the terms set forth herein.
In general, during the term of the Collaboration and for a period of [***] following termination or expiration thereof each Party will be obligated to keep confidential and not publish or otherwise disclose to a third party, and not to use, directly or indirectly, for any purpose other than the Collaboration, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Preliminary Collaboration Agreement or is reasonably necessary or useful for the performance of, or the exercise of such Party’s rights under, the Preliminary Collaboration Agreement. “Confidential Information” will be defined to mean any technical, business, or other information provided by or on behalf of one Party to the other Party in connection with the Preliminary Collaboration Agreement or the Collaboration, whether prior to, on, or after the effective date of the Preliminary Collaboration Agreement, including information relating to the GSK Licensed Technology, where GSK is the disclosing Party, and information relating to the Vir Licensed Technology, where Vir is the disclosing Party, any inventions, know-how or other information developed in connection with the Collaboration with respect thereto by or on behalf of the disclosing Party (including GSK Program Technology, where GSK is the disclosing Party, and Vir Program Technology, where Vir is the disclosing Party), or the scientific, regulatory or business affairs or other activities of the disclosing Party. The confidentiality and non-use obligations with respect to either Party’s Confidential Information will not include any information that:
(a) is or becomes part of the public domain through no wrongful act, fault or negligence on the part of the receiving Party;
(b) can be demonstrated by competent proof to have been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information;
(c) is subsequently received by the receiving Party from a third party who is not bound by any obligation of confidentiality with respect to such information;
(d) has been published by a third party or otherwise enters the public domain through no fault of the receiving Party in breach of its contractual obligations to the disclosing Party; or
(e) can be demonstrated by competent proof to have been independently developed by or for the receiving Party without reference to the disclosing Party’s Confidential Information.
Permitted Disclosures. The receiving Party may disclose Confidential Information of the disclosing Party to the extent that such disclosure is:
(a) made in response to a valid order of a court or other governmental authority or, if in the reasonable opinion of the receiving Party’s legal counsel, such disclosure is otherwise required by law, including by reason of filing with securities regulators; provided, however, that the receiving Party shall first have given notice to the disclosing
Party and given the disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment; and provided further that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;
(b) made by or on behalf of the receiving Party to regulatory authorities as required in connection with any filing, application or request for marketing or other regulatory approval; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information to the extent practicable and consistent with applicable law;
(c) made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a patent; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available; or
(d) made by the receiving Party to its attorneys, auditors, advisors, consultants, contractors, existing or prospective collaboration partners, licensees, sublicensees, existing or prospective investors, prospective acquirers, or other third parties as may be necessary or useful in connection with exploitation of Collaboration Products as contemplated by the Collaboration or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by the Preliminary Collaboration Agreement; provided, however, that such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party set forth herein.
Publication. The Collaboration will be subject to, and the Preliminary Collaboration Agreement will reflect, provisions for publication of papers regarding results of, and other information regarding, activities under the Collaboration in a form customary for arrangements like the Collaboration. In general, the Parties will maintain the confidentiality of any Confidential Information included in any invention disclosure or draft patent application until such patent application has been filed. Each Party will accordingly have the right to review and approve any paper or other presentation proposed for publication or disclosure by a Party that contains clinical data or clinical results in respect of Collaboration activities or that includes Confidential Information of the other Party. The publishing or presenting Party will comply with the other Party’s request to delete references to such other Party’s Confidential Information in any such paper or presentation and will withhold publication of any such paper or presentation for a reasonable period (at least [***]) in order to permit the Parties to obtain patent protection. Any publication or presentation by a Party will recognize the contributions of the other Party according to standard practice for assigning scientific credit.
Return of Confidential Information. Upon the termination of the Collaboration, either Party may request the return or destruction by the other Party of the requesting Party’s Confidential Information. Except for retention of an appropriate archival copy of any such Confidential Information, the Party requested to effect such return or destruction shall promptly comply.
Exhibit 10.54
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
| CONFIDENTIAL | EXECUTION VERSION |
DEFINITIVE COLLABORATION AGREEMENT
By and Among
GLAXO WELLCOME UK LIMITED;
BEECHAM S.A.;
And
VIR BIOTECHNOLOGY, INC.
TABLE OF CONTENTS
| Page | ||||||
| ARTICLE 1 |
DEFINITIONS | 1 | ||||
| ARTICLE 2 |
EFFECTIVENESS; OVERVIEW; EXCLUSIVITY | 22 | ||||
| 2.1 |
Effectiveness of the Agreement | 22 | ||||
| 2.2 |
Overview | 22 | ||||
| 2.3 |
Exclusivity | 23 | ||||
| ARTICLE 3 |
MANAGEMENT OF THE COLLABORATION | 25 | ||||
| 3.1 |
Joint Steering Committee | 25 | ||||
| 3.2 |
Joint Research and Development Committee | 26 | ||||
| 3.3 |
Joint Commercialization Committee | 27 | ||||
| 3.4 |
Joint Patent Committee | 28 | ||||
| 3.5 |
Joint Manufacturing Committee | 29 | ||||
| 3.6 |
Financial Working Group | 30 | ||||
| 3.7 |
Other Subcommittees | 30 | ||||
| 3.8 |
Membership, Meetings and Meeting Minutes | 30 | ||||
| 3.9 |
Decision-Making | 32 | ||||
| 3.10 |
Alliance Managers | 33 | ||||
| 3.11 |
Most Conservative Approach and Internal Policies | 34 | ||||
| ARTICLE 4 |
COLLABORATION PROGRAMS | 34 | ||||
| 4.1 |
Collaboration Program Leads | 34 | ||||
| 4.2 |
Antibody Program | 35 | ||||
| 4.3 |
Vaccine Program | 35 | ||||
| 4.4 |
Functional Genomics Program | 35 | ||||
| 4.5 |
Compassionate Use Programs. | 36 | ||||
| 4.6 |
Parties’ Assets; Products | 36 | ||||
| 4.7 |
Compliance with Applicable Law | 36 | ||||
| ARTICLE 5 |
DEVELOPMENT | 36 | ||||
| 5.1 |
Development Plans | 36 | ||||
| 5.2 |
Development Efforts | 38 | ||||
| 5.3 |
Development Records; Exchange of Information | 38 | ||||
| 5.4 |
Performance by Affiliates; Subcontracting | 39 | ||||
| 5.5 |
Clinical Studies | 39 | ||||
| 5.6 |
Rights to Opt-Out | 40 | ||||
| ARTICLE 6 |
REGULATORY ACTIVITIES | 43 | ||||
| 6.1 |
Generally | 43 | ||||
| 6.2 |
Meetings and Communications | 43 | ||||
- i -
TABLE OF CONTENTS
(continued)
| Page | ||||||
| 6.3 |
Regulatory Submissions | 44 | ||||
| 6.4 |
Exchange of Development Data | 44 | ||||
| 6.5 |
Lead Party Opt-Out | 45 | ||||
| ARTICLE 7 |
COMMERCIALIZATION | 45 | ||||
| 7.1 |
General | 45 | ||||
| 7.2 |
Commercialization Plan | 45 | ||||
| 7.3 |
Commercialization Efforts | 46 | ||||
| 7.4 |
Co-Promotion Option of Vir | 46 | ||||
| 7.5 |
Right to Subcontract Commercialization Activities; Distribution | 47 | ||||
| 7.6 |
Commercialization Reports | 47 | ||||
| 7.7 |
GSK Opt-Out | 47 | ||||
| ARTICLE 8 |
PHARMACOVIGILANCE AND MEDICAL AFFAIRS | 48 | ||||
| 8.1 |
Pharmacovigilance Technical Agreement | 48 | ||||
| 8.2 |
Costs | 48 | ||||
| 8.3 |
Medical Inquiries | 48 | ||||
| ARTICLE 9 |
FINANCIAL PROVISIONS | 48 | ||||
| 9.1 |
Development Costs | 48 | ||||
| 9.2 |
Profit/Loss Sharing | 49 | ||||
| 9.3 |
Adjustment of Actual Profits | 49 | ||||
| 9.4 |
Reconciliation Procedures | 49 | ||||
| 9.5 |
Opt-Out Royalties and Payments | 51 | ||||
| 9.6 |
Third Party Technologies and Government Funding | 52 | ||||
| 9.7 |
Audits | 54 | ||||
| 9.8 |
Tax Matters | 54 | ||||
| 9.9 |
General Payment Terms | 56 | ||||
| 9.10 |
Blocked Payments | 56 | ||||
| 9.11 |
Reporting; Financial Records | 56 | ||||
| 9.12 |
Cooperation on Inter-Party Structure | 56 | ||||
| 9.13 |
Resolution of Financial Disputes | 56 | ||||
| 9.14 |
Specific Finance Disputes | 57 | ||||
| ARTICLE 10 |
LICENSES | 57 | ||||
| 10.1 |
Collaboration Programs | 57 | ||||
| 10.2 |
Following Opt-Out Option | 58 | ||||
| 10.3 |
Rejected Collaboration Product License | 58 | ||||
- ii -
TABLE OF CONTENTS
(continued)
| Page | ||||||
| 10.4 |
Sublicenses | 59 | ||||
| 10.5 |
Licensing Program Technology | 59 | ||||
| 10.6 |
No Implied Licenses | 59 | ||||
| 10.7 |
Retained Rights | 59 | ||||
| 10.8 |
Rights in Bankruptcy | 60 | ||||
| 10.9 |
Existing Third Party Agreements | 60 | ||||
| ARTICLE 11 |
MANUFACTURING AND SUPPLY | 61 | ||||
| 11.1 |
General | 61 | ||||
| 11.2 |
Manufacturing Party | 61 | ||||
| 11.3 |
Antibody Program | 61 | ||||
| 11.4 |
Other Collaboration Programs | 62 | ||||
| 11.5 |
Transition of Manufacturing and Supply | 63 | ||||
| ARTICLE 12 |
SCIENTIFIC PUBLICATIONS AND PRESENTATIONS | 63 | ||||
| 12.1 |
Research and Pre-Clinical Publications | 63 | ||||
| 12.2 |
Clinical Development Publications | 63 | ||||
| 12.3 |
Review by the Parties | 64 | ||||
| 12.4 |
Third Parties | 64 | ||||
| 12.5 |
Lead Party Publication | 64 | ||||
| 12.6 |
Publication after Opt-Out | 65 | ||||
| ARTICLE 13 |
MATERIALS TRANSFER; INTELLECTUAL PROPERTY; INFORMATION TECHNOLOGY | 65 | ||||
| 13.1 |
Materials Transfer | 65 | ||||
| 13.2 |
Ownership of Intellectual Property | 67 | ||||
| 13.3 |
Prosecution, Maintenance and Defense | 68 | ||||
| 13.4 |
Enforcement Rights | 69 | ||||
| 13.5 |
Joint Patent Committee | 71 | ||||
| 13.6 |
Third Party Technologies | 71 | ||||
| 13.7 |
Infringement Claims by Third Parties | 72 | ||||
| 13.8 |
Product Marks | 72 | ||||
| 13.9 |
Information Technology Requirements | 73 | ||||
| ARTICLE 14 |
TERM AND TERMINATION | 74 | ||||
| 14.1 |
Term | 74 | ||||
| 14.2 |
Mutual Termination | 74 | ||||
| 14.3 |
Termination for Cause | 74 | ||||
| 14.4 |
Termination for Insolvency | 75 | ||||
- iii -
TABLE OF CONTENTS
(continued)
| Page | ||||||
| ARTICLE 15 |
EFFECTS OF EXPIRATION OR TERMINATION | 75 | ||||
| 15.1 |
Accrued Obligations | 75 | ||||
| 15.2 |
Effects of Termination by Mutual Agreement | 75 | ||||
| 15.3 |
Effects of Termination for Material Breach or Insolvency | 76 | ||||
| 15.4 |
Other Termination Consequences | 76 | ||||
| 15.5 |
Survival | 77 | ||||
| 15.6 |
Termination Not Sole Remedy | 77 | ||||
| ARTICLE 16 |
CONFIDENTIALITY | 78 | ||||
| 16.1 |
Confidentiality | 78 | ||||
| 16.2 |
Authorized Disclosure | 78 | ||||
| 16.3 |
Injunctive Relief | 79 | ||||
| 16.4 |
Return of Confidential Information | 79 | ||||
| 16.5 |
Press Releases and Other Public Statements | 79 | ||||
| ARTICLE 17 |
REPRESENTATIONS AND WARRANTIES AND COVENANTS | 80 | ||||
| 17.1 |
Mutual Representations and Warranties | 80 | ||||
| 17.2 |
Representations and Warranties of Vir | 82 | ||||
| 17.3 |
Post-Closing Covenants of Vir | 84 | ||||
| 17.4 |
Disclaimer of Warranty | 85 | ||||
| ARTICLE 18 |
INDEMNIFICATION | 85 | ||||
| 18.1 |
Indemnification | 85 | ||||
| 18.2 |
Insurance | 86 | ||||
| 18.3 |
LIMITATION OF CONSEQUENTIAL DAMAGES | 86 | ||||
| ARTICLE 19 |
ANTI-BRIBERY AND ANTI-CORRUPTION | 87 | ||||
| ARTICLE 20 |
MISCELLANEOUS | 87 | ||||
| 20.1 |
Dispute Resolution | 87 | ||||
| 20.2 |
Equitable Relief | 87 | ||||
| 20.3 |
Governing Law | 87 | ||||
| 20.4 |
Assignment | 88 | ||||
| 20.5 |
Change of Control of Vir | 88 | ||||
| 20.6 |
Force Majeure | 89 | ||||
| 20.7 |
Notices | 89 | ||||
- iv -
TABLE OF CONTENTS
(continued)
| Page | ||||||
| 20.8 |
Export Clause | 90 | ||||
| 20.9 |
Waiver | 90 | ||||
| 20.10 |
Severability | 90 | ||||
| 20.11 |
Entire Agreement | 90 | ||||
| 20.12 |
Independent Contractors | 91 | ||||
| 20.13 |
Headings | 91 | ||||
| 20.14 |
Further Actions | 91 | ||||
| 20.15 |
Books and Records | 91 | ||||
| 20.16 |
Construction of Agreement | 91 | ||||
| 20.17 |
Supremacy | 91 | ||||
| 20.18 |
Counterparts | 91 | ||||
| 20.19 |
No Third Party Beneficiaries | 91 | ||||
- v -
TABLE OF CONTENTS
(continued)
| SCHEDULES | ||
| Schedule 1.1 | 309 Antibody [***] | |
| Schedule 1.100 | Financial Schedule | |
| Schedule 1.122 | GSK Specified Internal Policies | |
| Schedule 1.250 | Vir Functional Genomics Targets | |
| Schedule 2.3.1 | Existing Vir Third Party Agreements | |
| Schedule 4.2.2 | Existing Antibody Development Plan | |
| Schedule 5.6.5 | Animal Welfare | |
| Schedule 8.1 | Key Terms for Pharmacovigilance Technical Agreement | |
| Schedule 9.5.2 | Royalties following Opt-Out | |
| Schedule 9.5.3 | [***] | |
| Schedule 10.9 | Existing Third Party IP Agreements | |
| Schedule 13.1.1 | Form of Material Transfer Record | |
| Schedule 20.1 | Arbitration |
- vi -
DEFINITIVE COLLABORATION AGREEMENT
This Definitive Collaboration Agreement (“Agreement”) is made and entered into as of June 9, 2020 (“Execution Date”) and is effective as of the Effective Date (as defined below), by and among Glaxo Wellcome UK Limited, a private company limited by shares organized under the laws of England having an office at [***]; and Beecham S.A., a private company limited by shares organized under the laws of Belgium having its registered place of business at [***] (together, “GSK”), and Vir Biotechnology, Inc., a Delaware corporation having an office at 499 Illinois Street, Suite 500, San Francisco, CA 94158 (“Vir”). GSK and Vir are sometimes referred to herein, individually, as a “Party” and, collectively, as the “Parties.”
BACKGROUND
WHEREAS, GSK, among other things, conducts programs to discover, develop, manufacture and commercialize innovative pharmaceutical medicines, vaccines and consumer healthcare products;
WHEREAS, Vir, among other things, conducts programs to develop and commercialize therapeutic products for the treatment and prevention of serious infectious diseases;
WHEREAS, an Affiliate (as defined below) of GSK and Vir have entered into a Stock Purchase Agreement, dated April 5, 2020 (the “SPA”), pursuant to which it has purchased certain voting shares of Vir;
WHEREAS, in connection with the SPA, Affiliates of GSK and Vir entered into a binding Preliminary Collaboration Agreement, dated April 5, 2020 (the “Preliminary Collaboration Agreement”), outlining the transactions contemplated therein to discover, develop and commercialize preventatives and treatment products for diseases caused by SARS-COV-2 (as defined below) and other Coronaviruses (as defined below);
WHEREAS, as contemplated under the SPA and the Preliminary Collaboration Agreement, GSK and Vir desire to enter into this Agreement containing a more detailed set of terms governing the collaboration established under the Preliminary Collaboration Agreement, consistent with the terms and conditions set forth therein.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
Capitalized terms used in this Agreement, whether used in the singular or plural, shall have the meanings set forth below, unless otherwise specifically indicated herein.
1.1 “309 Antibody” means the Antibody having the amino acids sequence listed on Schedule 1.1, and [***].
1.2 “309 Antibody Product” has the meaning set forth in Section 5.6.1.
1.3 “Accounting Standards” means, with respect to GSK, IFRS, and with respect to Vir, GAAP, in each case as consistently applied by the applicable Party and its Affiliates, as the same may be changed from time to time by the Parties; provided that each Party shall promptly notify the other Party in the event that such Party changes its Accounting Standards pursuant to which such Party’s records are maintained, and it being understood that each Party may only use internationally recognized accounting principles (e.g., IFRS, GAAP).
1.4 “[***]” has the meaning set forth in [***].
1.5 “[***]” has the meaning set forth in [***].
1.6 “[***]” has the meaning set forth in [***].
1.7 “Adverse Event” means any untoward medical occurrence in a patient or subject who is administered a product, whether or not considered related to such product, including any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such product.
1.8 “Affiliate” means, with respect to a given Party or Third Party, any corporation, firm, limited liability company, partnership or other entity which directly or indirectly controls, or is controlled by, or is under common control with such Party or such Third Party, respectively. For the purposes of this Section 1.8, “control” means ownership, directly or indirectly through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, or status as a general partner in the case of any partnership, or any other arrangement whereby a corporation or other entity controls or has the right to control the Board of Directors or equivalent governing body or management of another corporation or other entity.
1.9 “Agreement” has the meaning set forth in the preamble.
1.10 “Alliance Manager” has the meaning set forth in Section 3.10.
1.11 “Allowable Expenses” has the meaning set forth in the Financial Schedule.
1.12 “[***]” has the meaning set forth in [***].
1.13 “Alnylam Agreement” means the Collaboration and License Agreement between Vir and Alnylam Pharmaceuticals, Inc. (“Alnylam”), dated October 16, 2017 and amended December 17, 2019, March 3, 2020 and April 1, 2020.
1.14 “Antibody” means any monoclonal antibody that binds to a Coronavirus and [***]. For clarity, Antibodies shall not include any Vaccine. [***].
1.15 “Antibody Development Plan” has the meaning set forth in Section 4.2.2.
1.16 “Antibody Product” has the meaning set forth in Section 2.2.
- 2 -
1.17 “Antibody Program” means the Collaboration Program for Antibodies, including the 309 Antibody and other Program Antibodies, as further described in Section 4.2.
1.18 “Applicable Internal Policies” means those Internal Policies of either Party applicable to a Party by virtue of application of Section 3.11.
1.19 “Bankruptcy Code” means Title 11 of the United States Code.
1.20 “Balancing Payment” has the meaning set forth in Section 9.4.3(b).
1.21 “Biogen Agreement” means that certain Clinical Development and Manufacturing Agreement between Vir and Biogen, Inc. (“Biogen”), dated May 22, 2020.
1.22 “Biologic” means any composition of matter comprising proteins, nucleic acids, carbohydrates, or any combination of these substances, including antibodies (derivatives or fragments thereof), other binding proteins, peptide molecules, RNA molecules, DNA molecules, viruses, gene therapy vectors, genetically engineered cells, and chemically modified cells.
1.23 “Biosimilar” means, with respect to a Collaboration Product or Sole Development Product, any product containing a Biologic sold in a country by a Third Party that receives Regulatory Approval (including via Emergency Use Authorization) and is claimed to be biosimilar to, or interchangeable with, such Collaboration Product or Sole Development Product (including a product that is the subject of an application submitted under Section 351(k) of the Public Health Service Act in the United States or under Article 10(4) of Directive 2001/83/EC in the European Union or any member state thereof, in each case citing such Collaboration Product or Sole Development Product as the reference product) or for which the BLA otherwise references or relies on such Collaboration Product or Sole Development Product, including any product containing an active substance with the same core nonproprietary name as the active substance in the Collaboration Product or Sole Development Product.
1.24 “BLA” means a Biologics License Application (as defined in 21 C.F.R. 600 et. seq.) or an equivalent application for marketing authorization with respect to a Collaboration Product or Sole Development Product in any jurisdiction in the world.
1.25 “Blocking Third Party IP Agreement” has the meaning set forth in Section 9.6.1.
1.26 “Blocking Third Party IP Costs” has the meaning set forth in the Financial Schedule.
1.27 “BPCIA” has the meaning set forth in Section 13.4.1.
1.28 “Business Day” means a day, other than (a) Saturday or Sunday, or any other day on which banking institutions in New York, New York, London, England and Brussels, Belgium are not open for business, (b) [***], or (c) [***], provided that in the case of (b) and (c), [***].
1.29 “[***]” has the meaning set forth in [***].
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1.30 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.31 “Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.
1.32 “Change of Control” means, with respect to either Party, an event or transaction or series of events or transactions by which: (a) any Third Party (or group of Third Parties acting in concert) becomes the beneficial owner, directly or indirectly, of more than fifty percent (50%) of the outstanding securities of such Party or the total voting power of such securities normally entitled to vote in elections of directors; (b) (i) such Party reorganizes, consolidates or comes under common control with, or merges into another entity, or (ii) any entity reorganizes, consolidates or comes under common control with, or merges into such Party, in either event of the foregoing ((i) or (ii)) where more than fifty percent (50%) of the total voting power of the securities outstanding of the surviving entity normally entitled to vote in elections of directors is not held by the parties holding at least fifty percent (50%) of the outstanding shares of such Party immediately preceding such consolidation or merger; (c) such Party conveys, transfers or leases to a Third Party (A) all or substantially all of its assets or the control thereof, or (B) all or substantially all of its assets or business relating to this Agreement or the control thereof; or (d) any other arrangement whereby a Third Party (or group of Third Parties acting in concert) obtains control or the right to control the board of directors or equivalent governing body that has the ability to cause the direction of the management, policies or affairs of such Party.
1.33 “Change of Control Group” means, with respect to a Party, the Person, or group of Persons, that is the acquirer of, or successor to, such Party in connection with a Change of Control of such Party, together with all of the Affiliates of such Persons, in each case that are not Affiliates of such Party immediately prior to the closing of such Change of Control of such Party.
1.34 “China” means mainland China, Hong Kong and Macau.
1.35 “Clinical Development Publication Strategy” has the meaning set forth in Section 12.2.
1.36 “Clinical Study” means any human clinical study, including any Phase I Clinical Study, Phase I/IIa Clinical Study, Phase II Clinical Study, Phase II/III Clinical Study, Phase III Clinical Study, Pivotal Clinical Study, or Phase IV Clinical Study.
1.37 “Closing Date” means the closing of the transactions with respect to stock purchase outlined in the Stock Purchase Agreement, which occurred on April 29, 2020.
1.38 “CMO” has the meaning set forth in Section 11.2.
1.39 “[***]” has the meaning set forth in [***].
1.40 “[***]” has the meaning set forth in [***].
1.41 “[***]” has the meaning set forth in [***].
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1.42 “[***]” [***].
1.43 “[***]” has the meaning set forth in [***].
1.44 “[***]” has the meaning set forth in [***].
1.45 “[***]” has the meaning set forth in [***].
1.46 “Co-Chair” has the meaning set forth in Section 3.8.1.
1.47 “Collaboration” means (a) any Research activities conducted under the Development Plans, and (b) the Development, Manufacture and Commercialization activities with respect to the Collaboration Products during the Term pursuant to and in accordance with the terms of this Agreement and the Development Plans and Commercialization Plans.
1.48 “Collaboration Product” means (a) an Antibody Product, (b) a Vaccine Product, or (c) a Functional Genomics Product, in each case ((a) - (c)), for which a Party has not exercised its Opt-Out Option. For clarity, (i) [***]; and (ii) a Collaboration Product shall not include a Sole Development Product.
1.49 “Collaboration Program” means a Development, Manufacturing and Commercialization program with respect to a separate type of Collaboration Products, in each case pursuant to mutually agreed Development and Commercialization plans, including budgets as further specified herein. The Collaboration Programs include: (a) Antibody Program; (b) Vaccine Program; and (c) Functional Genomics Program.
1.50 “Commercialization” means any and all activities directed to the preparation for sale of (but excluding Development, Commercial Manufacture or other Manufacture), offering for sale of, or sale of a Collaboration Product, including activities related to obtaining pricing and reimbursement approvals, as applicable, marketing, promoting, selling, distributing, importing and exporting such Collaboration Product, and interacting with Regulatory Authorities regarding any of the foregoing. “Commercialize” and “Commercializing” shall have their correlative meanings.
1.51 “Commercialization Budget” means the annual budget for conducting Commercialization pursuant to a Collaboration Program for a given Collaboration Product as prepared by the LCP and reviewed by the JCC pursuant to Section 3.3.2(a) and approved by the JSC in accordance with Section 3.1.2(j), and as updated on a Calendar Year basis by the LCP concurrently with the Commercialization Plan in accordance with Sections 3.3.2(a), 3.1.2(j), and 7.2. Each annual Commercialization Budget shall include (a) a budget, [***], for the estimated FTE Costs and out-of-pocket external costs and expenses expected to be incurred by each Party in the given Calendar Year with respect to such Commercialization Plan, including [***], and (b) a good faith non-binding forecasted budget, [***], for the [***] period following the Calendar Year covered by the budget in (a), of the estimated FTE Costs and out-of-pocket external costs and expenses expected to be incurred by each Party in connection with activities under the applicable Commercialization Plan during such [***] period.
1.52 “Commercialization Plan” has the meaning set forth in Section 7.2.
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1.53 “Commercially Reasonable Efforts” means, such efforts that are consistent with the efforts and resources normally used by GSK (in the case of GSK) or a biopharmaceutical company (in the case of Vir) in the exercise of its reasonable business discretion relating to a research program, pharmaceutical product or target owned by it or to which it has exclusive rights, with similar product characteristics, which is of similar market potential at a similar stage in its development or product life as the Collaboration Program, Collaboration Product, Target, or, where applicable, Sole Development Product, taking into account issues of [***].
1.54 “Commercial Facility” means a facility for Commercial Manufacture of any Collaboration Product.
1.55 “Commercial Manufacture” means Manufacture for commercial sale, including (a) reservation of Manufacturing capacity for use in Manufacture for commercial sale; (b) selection and use of contract manufacturers; (c) selection of the Commercial Facilities; (d) subject to the terms of any existing Third Party agreements, technology transfer of the Manufacturing process for Collaboration Product to Commercial Facilities; (e) conduct of process performance qualification batches and other process qualification and validation activities required for Regulatory Approval for Commercial Manufacture of Collaboration Product at the Commercial Facility(ies); and (f) obtaining pre-approval inspection and required licenses and permits for Commercial Facilities.
1.56 “[***]” has the meaning set forth in [***].
1.57 “Committee” means, individually, the JSC, JRDC, JMC, JCC, JPC, the Financial Working Group and the Program Team or any other Subcommittee established as set forth in Section 3.7.
1.58 “Committee Deadlock” has the meaning set forth in Section 3.9.1.
1.59 “Companion Diagnostic” means a product designed for use in a diagnostic biomarker assay tailored or optimized for use with a Collaboration Product or a Sole Development Product, for predicting or monitoring the suitability of such Collaboration Product for prophylactic or therapeutic use in human patients or defined subpopulations thereof. A Companion Diagnostic shall be intended for use (a) as a means to select or monitor the patient population for the conduct of Clinical Studies of such Collaboration Product or Sole Development Product, (b) to predict predisposition to treatment in clinical use with such Collaboration Product or Sole Development Product, or (c) to predict or monitor potential safety considerations in clinical use with such Collaboration Product or Sole Development Product. Use of a Companion Diagnostic to guide use of the Collaboration Product will be contingent on appropriate Regulatory Approvals for such uses as deemed necessary by the FDA or other similar Regulatory Authority with appropriate jurisdiction.
1.60 “[***]” has the meaning set forth in [***].
1.61 “Confidential Information” means any technical, business, or other information provided by or on behalf of one Party of any of its Affiliates (the “Disclosing Party”) to the other Party or any of its Affiliates (the “Receiving Party”) in connection with this
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Agreement or the Collaboration, whether prior to, on, or after the Effective Date of this Agreement, including information relating to the GSK Licensed Technology, where GSK is the Disclosing Party, and information relating to the Vir Licensed Technology, where Vir is the Disclosing Party, any inventions, Know-How or other information developed in connection with the Collaboration with respect thereto by or on behalf of the Disclosing Party (including GSK Program Technology, where GSK is the Disclosing Party, Vir Program Technology, where Vir is the Disclosing Party, and Joint Program Technology, where both Parties will be deemed to be both Disclosing Party and Receiving Party), or the scientific, regulatory or business affairs or other activities of the Disclosing Party. For clarity, Confidential Information regarding any Collaboration Product shall be Confidential Information of both Parties.
1.62 “Control” (including variations such as “Controlled,” “Controlling” and the like) means, with respect to any material, information, or intellectual property, the possession (whether by ownership or license, other than the licenses granted hereunder) of the ability to grant a license or sublicense or other right to exploit, as provided herein, without violating the terms of any agreement or other arrangement with any Third Party, or any applicable Law.
1.63 “Controlling Party” has the meaning set forth in Section 13.4.3.
1.64 “Co-Promote Exercise Date” has the meaning set forth in Section 7.4.2.
1.65 “Co-Promotion Agreement” has the meaning set forth in Section 7.4.2.
1.66 “Co-Promotion Option” has the meaning set forth in Section 7.4.1.
1.67 “Co-Promotion Product” has the meaning set forth in Section 7.4.1.
1.68 “Coronavirus” means any spherical or pleomorphic enveloped virus of the family Coronaviridae containing single-stranded (positive-sense) RNA associated with a nucleoprotein within a capsid comprised of matrix protein, including SARS-COV-2.
1.69 “CoVID-19” means the Coronavirus disease-2019 caused by SARS-COV-2.
1.70 “CRISPR” means the gene editing and engineering technology known as “clustered regularly interspaced short palindromic repeats.”
1.71 “CRO” has the meaning set forth in Section 5.4.2.
1.72 “Currency Gains and Losses” means the gain or loss resulting from changes in exchange rates between the functional currency and the foreign currency in which the transaction is denominated, to the extent specifically identifiable to a Collaboration Product and shall only include the currency gains and losses realized between the end of a Calendar Quarter and the date of invoice payment for that Calendar Quarter.
1.73 “Data” means preclinical data (including computational validation, genetic data (including genotype, phenotype and genetic sequencing data), in vitro and in vivo data), clinical data (including broad data sets, study and investigator reports, both preliminary and final,
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statistical analyses, expert opinions and reports, safety and other electronic databases), and regulatory, Manufacturing, marketing, pricing, biological, chemical, pharmacological, toxicological, pharmaceutical, physical, analytical, safety and quality control data, information and documentation, whether in written or electronic form.
1.74 “[***]” has the meaning set forth in [***].
1.75 “Defending Party” means any Party participating in the defense of a Third Party Infringement Claim.
1.76 “[***]” means, [***].
1.77 “Development” means any and all Research and development activities conducted to develop or seek, obtain or maintain Regulatory Approvals for the Collaboration Products, which include Non-Clinical GLP Studies, Clinical Studies, quality of life assessments, pharmacoeconomics, regulatory affairs, and such other activities related to the Collaboration Products as are set forth in the applicable Development Plan approved by the JSC. “Develop” and “Developing” shall have their correlative meanings.
1.78 “Development Budget” means on a Collaboration Program-by-Collaboration Program basis, the budget of Development Costs for conducting activities under such Collaboration Program pursuant to the applicable Development Plan during a given Calendar Year, as prepared by the applicable Lead Party, with input from the other Party with respect to Development Costs to be borne by the other Party, and reviewed by the JRDC in accordance with Section 3.2.2(c) and approved by the JSC in accordance with Section 3.1.2(i), which budget shall be updated and amended (if necessary) on a Calendar Year basis concurrently with the Development Plan in accordance with Sections 3.2.2(c) and 3.1.2(i), and at any other time in accordance with Section 5.1.3(a). Each Development Budget shall include (a) a budget, [***], for the estimated Development FTE Costs and out-of-pocket external costs and expenses expected to be incurred by each Party in the given Calendar Year with respect to such Development Plan, and (b) a nonbinding good faith forecasted budget, [***], of the estimated Development Costs to be incurred in connection with activities under the applicable Development Plan, (i) with respect to [***], for the [***], and (ii) with respect to [***], for the time period [***].
1.79 “Development Candidate” means, (a) with respect to an Antibody Program or a Vaccine Program, an Antibody Product or Vaccine Product selected by the JRDC as suitable to progress into further Development, including in Non-Clinical GLP Studies, and (b) with respect to the Functional Genomics Program, a construct, molecule or compound directed to such Target selected by the JRDC as suitable to progress into further Development as a Functional Genomics Product.
1.80 “Development Costs” has the meaning set forth in the Financial Schedule.
1.81 “[***]” has the meaning set forth in the Financial Schedule.
1.82 “[***]” has the meaning set forth in the Financial Schedule.
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1.83 “Development Plan” means a detailed plan and budget mutually agreed to govern the conduct of Development activities for the applicable Collaboration Program. For clarity, the Parties intend that there will be one Development Plan for all Collaboration Products in a given Collaboration Program, for a total of three Development Plans, but there may be sub-plans for individual Collaboration Products.
1.84 “Development Summary” has the meaning set forth in Section 5.6.2.
1.85 “Disclosing Party” has the meaning set forth in the definition of “Confidential Information.”
1.86 “Drug Approval Application” means a BLA, NDA or any corresponding application in the applicable country or jurisdiction outside of the United States, including, with respect to the European Union, an application for marketing authorization approval (“MAA”) filed with the EMA pursuant to the centralized approval procedure, or with the applicable national Regulatory Authority of a country in the European Union with respect to the mutual recognition procedure, decentralized procedure or any other national approval.
1.87 “[***]” has the meaning set forth in [***].
1.88 “Effective Date” shall have the meaning set forth in Section 2.1.
1.89 “EMA” means the European Medicines Agency, or any successor entity thereto performing similar functions.
1.90 “Entity” has the meaning set forth in Section 9.8.4.
1.91 “European Union” means the economic, scientific and political organization of member states in Europe, as it may be constituted from time to time.
1.92 “Excess Costs” has the meaning set forth in Section 9.4.2(c)(i).
1.93 “Execution Date” has the meaning set forth in the preamble.
1.94 “Existing Program Antibodies” means the 309 Antibody and [***].
1.95 “Existing Third Party IP Agreement” has the meaning set forth in the Financial Schedule.
1.96 “[***]” has the meaning set forth in [***].
1.97 “FDA” means the U.S. Food and Drug Administration, or any successor entity thereto performing similar functions.
1.98 “Field” means the prevention, treatment and prophylaxis of diseases caused by Coronaviruses, (including SARS-COV-2) in humans, including the disease known as CoVID-19, [***]. [***].
1.99 “Financial Report” has the meaning set forth in Section 9.4.1(a).
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1.100 “Financial Schedule” means the schedule set forth in Schedule 1.100 attached hereto, as the same may be amended from time to time by the written agreement of the Parties.
1.101 “Financial Working Group” has the meaning set forth in Section 3.6.
1.102 “First Commercial Sale” means, with respect to a given product in a country, the first commercial sale for use or consumption by the general public in an arms-length transaction of such product by or on behalf of a Party, its Affiliate or its licensee or Sublicensee in such country following receipt of all applicable Regulatory Approvals of such product in such country; provided that the following shall not constitute a First Commercial Sale: (a) any sale or inter-company transfers to an Affiliate or sublicensee unless the Affiliate or sublicensee is the last entity in the distribution chain of such product, (b) any use of such product in Clinical Studies, preclinical activities or other research or Development activities, or (c) disposal or transfer of such products for a bona fide charitable purpose, compassionate use, so called “treatment IND sales” and “named patient sales” or use under the Temporary Authorisation for Use system in France or other equivalent systems.
1.103 “Force Majeure” means any event beyond the reasonable control of the affected Party including: embargoes; war or acts of war, including terrorism; insurrections, riots, or civil unrest; strikes, lockouts or other labor disturbances; epidemics (including pandemics), fire, floods, earthquakes or other acts of nature; unavailability of drug substance, receipt of warning letters, or loss, infection or failure of cell banks (in each case due to reasons other than the affected Party’s negligence or willful misconduct or any other cause within the reasonable control of the affected Party); or acts, omissions or delays in acting by any Governmental Authority (including the refusal of any Regulatory Authority to issue required Regulatory Approvals due to reasons other than the affected Party’s negligence or willful misconduct or any other cause within the reasonable control of the affected Party), and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances).
1.104 “FTE” means, with respect to a Person who is an employee or an individual who is an independent contractor of a Party or its Affiliates, the equivalent of the work of one (1) such Person directly engaged in performing Development, Commercialization or Manufacturing activities under this Agreement full time for one (1) year (consisting of a total of [***] hours per year, or such other number as may be agreed to by the Parties). [***].
1.105 “FTE Costs” has the meaning set forth in the Financial Schedule.
1.106 “Functional Genomics Development Plan” has the meaning set forth in Section 4.4.1.
1.107 “Functional Genomics Product” has the meaning set forth in Section 2.2.
1.108 “Functional Genomics Program” means the Collaboration Program for genome-wide CRISPR screening activities and other functional genomic screens as are mutually agreed, as further described in Section 4.4, including [***].
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1.109 “GAAP” means United States generally accepted accounting principles applied on a consistent basis.
1.110 “GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable, (a) FDA regulations and guidelines for good clinical practice, as promulgated by the FDA under 21 CFR Parts 50, 54, 56, 312 and 812, (b) as set forth in European Commission Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, and brought into law by European Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice for investigational medicinal products, (c) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the EU, (d) the Declaration of Helsinki (2008), and (e) any further amendments or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which pre-clinical or clinical studies of a product are conducted.
1.111 “General Principles” means the General Principles set forth in Section 1 of the Financial Schedule.
1.112 “Generic Product” means, with respect to a Collaboration Product or Sole Development Product in a country in the Territory, any product sold by a Third Party (not licensed, supplied or otherwise authorized by a Party or its Affiliates or Sublicensees) that (a) contains the same active ingredient as such Collaboration Product or Sole Development Product, (b) is sold under a Regulatory Approval that (i) is based upon or relies upon the Regulatory Approval granted to a Party or any of its Affiliates or Sublicensees for such Collaboration Product or Sole Development Product or (ii) is otherwise granted by a Regulatory Authority pursuant to an expedited or abbreviated approval process, and (c) is categorized by the applicable Regulatory Authority in such country to be therapeutically equivalent to, or interchangeable with such Collaboration Product or Sole Development Product.
1.113 “GLP” means all applicable Good Laboratory Practice standards, including, as applicable: (a) FDA regulations and guidelines for good laboratory practice, as promulgated by the FDA under 21 CFR Part 58; (b) European Commission Directive 2004/10/EC relating to the application of the principles of good laboratory practices, as may be amended from time to time as well as any Rules Governing Medicinal Products in the European Community Vol. III, ISBN 92.825 9619-2 (ex - OECD principles of GLP); and (c) any further amendments or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which pre-clinical or clinical studies of a product are conducted.
1.114 “GMP” means all applicable Good Manufacturing Practices, including: (a) the applicable part of quality assurance to ensure that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use, as defined in European Commission Directive 2003/94/EC laying down the principals and guidelines of good manufacturing practice; (b) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601, 610 and 820; (c) the Rules Governing Medicinal
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Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products; (d) the principles detailed in the ICH Q7A guidelines; and (e) the equivalent Laws in any relevant country, each as may be amended and applicable from time to time.
1.115 “Governmental Authority” means any federal, state, provincial, local, municipal, foreign or other governmental or quasi-governmental authority, including any arbitrator and applicable securities exchanges, or any department, minister, agency, commission, commissioner, board, subdivision, bureau, agency, instrumentality, court or other tribunal of any of the foregoing.
1.116 “[***]” has the meaning set forth in [***].
1.117 “GSK Indemnitees” has the meaning set forth in Section 18.1.1.
1.118 “[***]” means [***].
1.119 “GSK Licensed Patent” has the meaning set forth in Section 13.3.2(b).
1.120 “GSK Licensed Technology” means, on a Collaboration Program-by-Collaboration Program basis, all Patents and Know-How that are both (a) Controlled by GSK or its Affiliates as of the Effective Date or during the Term, and (b) [***] provided that GSK Licensed Technology shall not include (i) any GSK Program Technology, (ii) [***], or (iii) [***]. For clarity, any technology that GSK includes within GSK Licensed Technology for a given Collaboration Program shall not be deemed included in GSK Licensed Technology for any other Collaboration Program, unless GSK expressly agrees to such inclusion in the applicable Development Plan for such other Collaboration Program.
1.121 “GSK Program Technology” means, on a Collaboration Program-by-Collaboration Program basis, GSK’s right and interest in any Program Technology generated under such Collaboration Program.
1.122 “GSK Specified Internal Policies” means the Internal Policies set forth in Schedule 1.122 herein, and such other Relevant Internal Policies of GSK as are provided to Vir during the Term.
1.123 “Hatch-Waxman Act” has the meaning set forth in Section 13.4.1.
1.124 “IFRS” means the International Financial Reporting Standards, the set of accounting standards and interpretations and the framework in force on the Effective Date and adopted by the European Union or the United Kingdom, as applicable, as issued by the International Accounting Standards Board (IASB) and the International Financial Reporting Interpretations Committee (IFRS IC), and as adopted by the European Union or the United Kingdom, as applicable, as such accounting standards may be amended from time to time.
1.125 “[***]” has the meaning set forth in [***].
1.126 “IND” means an Investigational New Drug Application (including any amendments thereto) filed with the FDA pursuant to 21 CFR Part 312 before the Initiation of Clinical Studies of a product, or any equivalent filing with any relevant Regulatory Authority in any jurisdiction.
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1.127 “[***]” has the meaning set forth in [***].
1.128 “Indemnifying Party” has the meaning set forth in Section 18.1.3.
1.129 “Indemnitee” has the meaning set forth in Section 18.1.3.
1.130 “Infringement” has the meaning set forth in Section 13.4.1.
1.131 “Infringement Notice” has the meaning set forth in Section 13.4.1.
1.132 “[***]” has the meaning set forth in [***].
1.133 “Initial Development Term” means the period from the Effective Date through the fourth (4th) anniversary thereof.
1.134 “Initiation” means, with respect to a Clinical Study, the first dosing of the first human subject in such Clinical Study. “Initiating” means the act of Initiating a Clinical Study.
1.135 “Institutional Review Board” means an institutional review board (“IRB”) or independent ethics committee (“IEC”) that reviews the methods proposed for research and development activities to ensure such methods satisfy ethical requirements.
1.136 “Intellectual Property Rights” means Patents, design rights, copyrights, trademarks, services marks, trade secret rights, or other rights in Know-How, database rights, and all other intellectual property rights or similar proprietary rights of whatever nature, whether registered or not, and including applications to register or rights to apply for registration or renewals or extensions of, and rights to claim priority from, which may now or in the future subsist anywhere in the world.
1.137 “Internal Policies” means, with respect to a Party, such Party’s health care compliance, ethical, reputational, anti-bribery and corruption and other policies applicable to such Party’s activities under this Agreement, and any standard operating procedures implementing such policies, including the codes of conduct of any self-regulatory body of which that Party is a member. Internal Policies includes the Vir Specified Internal Policies and the GSK Specified Internal Policies.
1.138 “[***]” means [***].
1.139 “Joint Commercialization Committee” or “JCC” has the meaning set forth in Section 3.3.1.
1.140 “Joint Manufacturing Committee” or “JMC” has the meaning set forth in Section 3.5.
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1.141 “Joint Patent Committee” or “JPC” has the meaning set forth in Section 3.4.1.
1.142 “Joint Research and Development Committee” or “JRDC” has the meaning set forth in Section 3.2.1.
1.143 “Joint Steering Committee” or “JSC” has the meaning set forth in Section 3.1.1.
1.144 “Joint Technology” means any and all Program Technology that is jointly owned by the Parties pursuant to Section 13.2.2.
1.145 “Key Product Event” means any event with respect to the Collaboration Program or any Collaboration Product, that: (a) is determined by an independent safety review committee overseeing the safety of the relevant clinical trial to be directly related to the Collaboration Product, and (i) to have resulted in death, (ii) been life-threatening, (iii) required inpatient hospitalization or a significant prolongation of existing hospitalization, (iv) resulted in persistent or significant disability or incapacity, (v) resulted in a congenital anomaly or birth defect or (vi) required significant intervention to prevent permanent impairment or damage; and (b) results in a clinical hold being imposed on such program by the FDA or any comparable state, foreign or other Regulatory Authority to which the Collaboration Program or Collaboration Products are subject.
1.146 “Know-How” means proprietary and confidential trade secrets, models, discoveries, ideas, Data and other types of data, databases, results, assays, instructions, processes, techniques, formulas, algorithms, Materials, inventions, computational models, human-relevant disease models, computer software (including source code), predictive model implementations, data analytic tools, biotechnology hardware and associated algorithms and methodologies, methods of use, expert knowledge and information.
1.147 “Knowledge” means, with respect to a particular fact or matter and a Party, the knowledge [***].
1.148 “Law” means, individually and collectively, any and all laws, ordinances, rules, directives and regulations of any kind whatsoever of any governmental or regulatory authority within the applicable jurisdiction.
1.149 “LCP” has the meaning set forth in Section 4.1.1.
1.150 “Lead Party” means (a) with respect to any Antibody Product under the Antibody Program, (i) prior to the first filing of the Drug Approval Application for such Antibody Product, Vir, and (ii) following the first filing of the Drug Approval Application for such Antibody Product, GSK; and (b) with respect to a Vaccine Program or a Functional Genomics Program, GSK.
1.151 “Legal Requirement” has the meaning set forth in Section 16.5.
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1.152 “Licensed Technology” means (a) GSK Licensed Technology or (b) Vir Licensed Technology, as applicable.
1.153 “Losses” has the meaning set forth in Section 18.1.1.
1.154 “Major Market” has the meaning set forth in Section 7.3.
1.155 “Malwares” has the meaning set forth in Section 13.9.
1.156 “Manufacturing” means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of any Collaboration Product, or any component or intermediate thereof, and all activities performed in support of the CMC (chemistry, manufacturing and controls, or equivalent) section of an IND, NDA or BLA and other Regulatory Filing, including process and formulation development, process qualification and validation, scale-up, qualification, validation, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control. “Manufacture” shall have a correlative meaning.
1.157 “Manufacturing Party” has the meaning set forth in Section 11.2.
1.158 “Material Receiving Party” means the Party receiving Materials from the other Party as contemplated in Section 13.1.
1.159 “Materials” means any chemical or biological substances, including any biological or chemical compounds, drug products, human samples, or other materials, regardless of the route of transfer, which are supplied by a Party or its nominee to the other Party or its nominee for use in the conduct of activities under this Agreement, including any applicable Development Plan. For clarity, clinical supplies delivered pursuant to a Supply Agreement shall not constitute “Materials” for purposes of this Agreement.
1.160 “Materials Transferring Party” has the meaning set forth in Section 13.1.1.
1.161 “Medical Affairs Activities” means activities directed to interacting with physicians and other healthcare professionals who utilize or conduct research related to a drug or biological product, including [***]. For the avoidance of doubt, Medical Affairs Activities do not include any activities involving the marketing, promotion or sale of any Collaboration Product.
1.162 “[***]” has the meaning set forth in [***].
1.163 “Most Conservative Approach” means the approach or position offered by a Party in its Internal Policies, which approach or position, in the aggregate, is [***].
1.164 “MTR” or “Material Transfer Record” has the meaning set forth in Section 13.1.
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1.165 “NDA” means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq. or its successor regulation) and all amendments and supplements thereto filed with the FDA.
1.166 “Net Sales” has the meaning set forth in the Financial Schedule.
1.167 “Non-Clinical GLP Studies” means those studies conducted under GLP to produce data intended for inclusion in an IND, including IND-enabling toxicology studies.
1.168 “Non-Lead Party” means, with respect to a given Collaboration Program, the Party that is not the Lead Party.
1.169 “Non Opt-Out Notice” has the meaning set forth in Section 5.6.4(a).
1.170 “Non Opt-Out Party” has the meaning set forth in Section 5.6.4(a).
1.171 “Opt-Out Effective Date” has the meaning set forth in Section 5.6.3(a).
1.172 “Opt-Out Notice” has the meaning set forth in Section 5.6.1.
1.173 “Opt-Out Option” has the meaning set forth in Section 5.6.1.
1.174 “Opt-Out Party” has the meaning set forth in Section 5.6.1.
1.175 “Opt-Out Point” has the meaning set forth in Section 5.6.1.
1.176 “Orange Book” means the FDA publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations.”
1.177 “[***]” has the meaning set forth in [***].
1.178 “[***]” has the meaning set forth in [***].
1.179 “[***]” has the meaning set forth in [***].
1.180 “[***]” has the meaning set forth in the [***].
1.181 “Patents” means all patents and pending patent applications (including inventor’s certificates and utility models) and any patents issuing therefrom, in any country in the Territory, including any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisional and other continuing applications, supplementary protection certificates, renewals, and any and all reissues, extensions, registrations, reexaminations, extensions, confirmations, registrations and patents of addition on any of the foregoing.
1.182 “Payee” has the meaning set forth in Section 9.8.2.
1.183 “Payor” has the meaning set forth in Section 9.8.2.
1.184 “PCA Execution Date” means April 5, 2020.
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1.185 “Permitted Overage” has the meaning set forth in Section 9.4.2(b).
1.186 “Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof.
1.187 “Personally Identifiable Information” or “PII” means information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual, including: (a) a first and last name; (b) a home or other physical address, including street name and name of city or town; (c) an email address or other online contact information, such as an instant messaging user identifier or a screen name that reveals an individual’s email address; (d) a telephone number; (e) a social security number; (f) a bank, loan, or credit card account number; or (g) a persistent identifier, such as a customer number held in a “cookie” or processor serial number, that is combined with other available data that identifies an individual consumer.
1.188 “Pharmacovigilance Technical Agreement” has the meaning set forth in Section 8.1.
1.189 “Phase I Clinical Study” means, with respect to a given product, any clinical study administering such product to humans, whether healthy volunteers or patients, for the first time as a single or repeated dose for a given indication.
1.190 “[***]” has the meaning set forth in [***].
1.191 “Phase I/IIa Clinical Study” means, with respect to a given product, any clinical study of such product, for the purpose of studying pharmacology/pharmacodynamics effects or mechanism of action when administered to humans, whether healthy volunteers or patients, preliminarily determining dose or a range of doses or evaluating preliminary safety and which is not a Phase I Clinical Study.
1.192 “Phase II Clinical Study” means, with respect to a given product, any clinical study of such product, which provides for the trial of such product on a limited number of patients for the purpose of determining dose or a range of doses and evaluating safety and preliminary efficacy in the proposed therapeutic indication.
1.193 “[***]” has the meaning set forth in [***].
1.194 “Phase II/III Clinical Study” means, with respect to a given product, any clinical study of such product, for the purpose of determining a dose or dose ranges of such product and evaluating safety and effectiveness of dose ranges of such product in patients with the disease or condition being studied for the purposes of filing for Regulatory Approval with the FDA or other applicable Regulatory Authority.
1.195 “Phase III Clinical Study” means, with respect to a given product, any Pivotal Clinical Study of such product for the purpose of establishing to establish safety and efficacy of such product in patients with the disease or condition being studied for purposes of filing for Regulatory Approval with the FDA or other applicable Regulatory Authority, as described under 21 C.F.R. §312.21(c) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study.
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1.196 “Phase IV Clinical Study” means of such product for the purpose of establishing any clinical study conducted for such product after such product has received Regulatory Approval for marketing in a particular jurisdiction, including trials the principal purpose of which is to (a) continue testing such product to collect information about (i) its safety or efficacy to provide comprehensive data confirming the benefit-risk balance is positive to convert to a standard Regulatory Approval for marketing in broader or various populations, (ii) its long term safety and side effects associated with long term use, or (iii) its use in additional diseases or conditions other than those for which Regulatory Approval was previously granted where the product is likely to be used “off label” in the disease or condition as a result of a similar mechanism of action, (b) obtain or widen reimbursement coverage, (c) improve the product’s competitive position, or (d) improve the standard of care. For clarity, Phase IV Clinical Studies do not include investigator-initiated trials.
1.197 “Pivotal Clinical Study” means, with respect to a product, a Clinical Study for the purpose of establishing any randomized, well-controlled, appropriately powered study of product as described in 21 C.F.R. §312.21(c) that is either a Phase II Clinical Study (including any Phase II Clinical Study as described in 21 C.F.R. §312.84(b)), Phase II/III Clinical Study or any Phase III Clinical Study, the results of which, if the pre-defined primary endpoint(s) is met or where the weight of evidence or totality of data provide sufficient data on safety and effectiveness to support a marketing approval (including any conditional approval) of the relevant product in the Territory.
1.198 “Plan” means any Development Plan or Commercialization Plan.
1.199 “[***]” has the meaning set forth in Section [***].
1.200 “Pre-Tax Profit or Loss” has the meaning set forth in the Financial Schedule.
1.201 “Product Mark Controlling Party” has the meaning set forth in Section 13.8.1.
1.202 “Product Mark Non-Controlling Party” has the meaning set forth in Section 13.8.1.
1.203 “Product Marks” means the trademarks for use in connection with the Commercialization of any Collaboration Product or Sole Development Product, including trademarks, generic names, international nonproprietary names, trade dress, style of packaging and Internet domain names used in connection with the Commercialization of such Collaboration Product or Sole Development Product.
1.204 “Program Antibody” means (a) any Antibody [***] that is directed against any Coronaviruses, including the 309 Antibody; (b) any Antibody created, discovered, conceived or reduced to practice by either Party or both Parties jointly during the conduct of activities under the Antibody Development Plan during the Initial Development Term; and (c) to the extent not
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included in the foregoing subclause (a) or (b), any Antibody Controlled by either Party that the Parties agree during the Initial Development Term, through the JDC, to include as the subject of Development activities under an Antibody Development Plan.
1.205 “Program Technology” means, on a Collaboration Program-by-Collaboration Program basis, all Patents and Know-How generated under such Collaboration Program.
1.206 “Program Teams” has the meaning set forth in Section 3.2.2(n).
1.207 “Public Statement” has the meaning set forth in Section 16.5.
1.208 “Receiving Party” has the meaning set forth in the definition of “Confidential Information.”
1.209 “Regulatory Approval” means, with respect to a country or jurisdiction in the Territory, all approvals, licenses, registrations or authorizations of any Regulatory Authority (including approvals of Drug Approval Applications), necessary for the Manufacturing, use, storage, import, export, transport, marketing and sale of a product, as applicable, in such country or jurisdiction.
1.210 “Regulatory Authority” means the FDA, the EMA or any regulatory body with similar regulatory authority in any other jurisdiction anywhere in the world.
1.211 “[***]” has the meaning set forth in the [***].
1.212 “Regulatory Filing” means any filing or regulatory application or submission related to a product with the FDA or any other Regulatory Authority within or outside the United States, including authorizations, approvals or clearances arising from the foregoing, and all correspondence with a Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with such Regulatory Authority in each case with respect to such product.
1.213 “Relevant Internal Policies” has the meaning set forth in Section 3.11.
1.214 “Research” means non-clinical and pre-clinical research activities, excluding any Clinical Studies or other clinical Development activities.
1.215 “Research and Pre-Clinical Publication Strategy” has the meaning set forth in Section 12.1.
1.216 “[***]” means [***].
1.217 “[***]” means, [***].
1.218 “[***]” has the meaning set forth in [***].
1.219 “[***]” has the meaning set forth in [***].
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1.220 “Samsung DS Letter Agreement” means the binding letter agreement dated April 9, 2020 by and between Vir and Samsung BioLogics Co., Ltd. (“Samsung”).
1.221 “SARS-COV-2” means the severe acute respiratory syndrome Coronavirus 2.
1.222 “Senior Managers” has the meaning set forth in Section 20.1.1.
1.223 “[***]” means, [***].
1.224 “[***]” has the meaning set forth in [***].
1.225 “[***]” has the meaning set forth in the [***].
1.226 “Sole Development Product” means (a) an Antibody Product, (b) a Vaccine Product, or (c) a Functional Genomics Product, in each case ((a) - (c)), upon which one Party has exercised its Opt-Out Option and the Non Opt-Out Party has elected to pursue such product unilaterally pursuant to Section 5.6.4(b). In the event GSK has exercised its Opt-Out Option and Vir has elected to pursue such product unilaterally, such product thereafter becomes a “Vir Sole Development Product” and ceases to be a Collaboration Product. Similarly, in the event Vir has exercised its Opt-Out Option and GSK has elected to pursue such product unilaterally, such Collaboration Product becomes a “GSK Sole Development Product” and ceases to be a Collaboration Product.
1.227 “Subcommittee” has the meaning set forth in Section 3.7.
1.228 “Subcommittee Deadlock” has the meaning set forth in Section 3.9.1.
1.229 “Sublicensee” has the meaning set forth in Section 10.4.
1.230 “Target” means a biological or chemical molecule, including a protein, having a biological or chemical activity or function that may be modulated by one or more active compounds (including small molecules, monoclonal antibodies, oligonucleotides, gene therapies, or other biomolecules or modalities) or by exposure to pathogens such as viruses. A Target may reside on or may be otherwise expressed in or associated with either the applicable virus or a host cell.
1.231 “Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including interest, penalties and additions thereto), but not including any taxes, levies, imposts, duties, charges, assessments or fees taken into account in the determination of Pre-Tax Profit or Loss pursuant to the Financial Schedule.
1.232 “Term” has the meaning set forth in Section 14.1.
1.233 “Terminated Collaboration Product(s)” has the meaning set forth in Section 15.3.1.
1.234 “Terminated Party” has the meaning set forth in Section 15.3.1.
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1.235 “Terminating Party” has the meaning set forth in Section 15.3.1.
1.236 “Territory” means all countries and territories in the world.
1.237 “Third Party” means a person or entity other than (a) Vir and its Affiliates, and (b) GSK and its Affiliates.
1.238 “Third Party Infringement Claim” has the meaning set forth in Section 13.7.1.
1.239 “Third Party Patent Rights” means any Patents owned or controlled by a Third Party.
1.240 “United States” or “U.S.” means the United States and its territories and possessions.
1.241 “USD”, “United States Dollar” or “$” means the official currency of the United States of America.
1.242 “Vaccine” means any biological product, including nucleic acid(s), protein(s), peptide(s), polysaccharide(s), conjugated polysaccharide(s), live, live-attenuated or inactivated microorganism(s) including replication-competent and replication defective virus(es), bacteriophages(s) and bacteria, in each case comprising or encoding an antigen derived from the pathogen or the disease to be prevented or treated, optionally in combination with one or more biological or non-biological product(s) and that when administered to an subject induces, increases, decreases or qualitatively modifies, an immune response intended to prevent or treat the target disease or condition.
1.243 “Vaccine Development Plan” has the meaning set forth in Section 4.3.1.
1.244 “Vaccine Product” has the meaning set forth in Section 2.2.
1.245 “Vaccine Program” means the Collaboration Program for Vaccines as further described in Section 4.3, including, the Development of Vaccines Products directed against SARS-COV-2 and other specific Coronaviruses, in each case that is expressly set out in and is the subject of a Vaccine Development Plan.
1.246 “[***]” has the meaning set forth in [***].
1.247 “[***]” has the meaning set forth in [***].
1.248 “[***]” means, [***].
1.249 “[***]” has the meaning set forth in [***].
1.250 “Vir Functional Genomics Target” means (a) any Target Controlled by Vir or its Affiliates that (i) [***], or (ii) [***], and (b) any other Target the Parties agree to include in a Functional Genomics Program Development Plan.
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1.251 “Vir Indemnitees” has the meaning set forth in Section 18.1.2.
1.252 “Vir License Agreements” means all license and other agreements regarding [***], as amended, as of the applicable date.
1.253 “Vir Licensed Technology” means, on a Collaboration Program-by-Collaboration Program basis, all Patents and Know-how that are (a) [***], (b) [***], and (c) [***]; provided that in each case ((a) through (c)), Vir Licensed Technology shall not include any Vir Program Technology. For clarity, any technology that Vir includes within Vir Licensed Technology for a given Collaboration Program shall not be deemed included in Vir Licensed Technology for any other Collaboration Program, unless Vir expressly agrees to such inclusion in the applicable Development Plan for such other Collaboration Program, and specifically, [***].
1.254 “[***]” has the meaning set forth in [***].
1.255 “[***]” means [***].
1.256 “Vir Program Technology” means, on a Collaboration Program-by-Collaboration Program basis, Vir’s right and interest in any Patent and Know-How generated under such Collaboration Program.
1.257 “[***]” has the meaning set forth in [***].
1.258 “Vir Specified Internal Policies” means Relevant Internal Policies of Vir as are provided by Vir to GSK during the Term.
1.259 “WuXi Agreement” means that certain Development and Manufacturing Collaboration Agreement by and between WuXi Biologics (Hong Kong) Limited (“WuXi”) and Vir, dated February 25, 2020, which incorporates by reference the amendment dated February 25, 2020 to the Cell Line License Agreement between WuXi and Vir dated February 3, 2019 to address license terms relating to products directed to the Specified Virus (as defined therein).
1.260 “WuXi LOI” has the meaning set forth in Section 11.3.1(b).
1.261 “WuXi Territory” means solely with respect to Collaboration Programs and Collaboration Products that are subject to the WuXi Agreement (as of the PCA Execution Date) the People’s Republic of China, Hong Kong and Macau and Taiwan, for so long as such Collaboration Programs and Collaboration Products are subject to the WuXi Agreement.
ARTICLE 2
EFFECTIVENESS; OVERVIEW; EXCLUSIVITY
2.1 Effectiveness of the Agreement. This Agreement is effective as of the Closing Date (the “Effective Date”).
2.2 Overview. Generally, the Parties shall collaborate to Develop pharmaceutical or biological products or Vaccines for the prevention, treatment and prophylaxis of diseases caused by SARS-COV-2 and potentially other Coronaviruses, each, in accordance with
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an applicable Development Plan and shall collaborate to further Manufacture and Commercialize such Collaboration Products under the terms set forth herein and in accordance with an applicable Commercialization Plan. The Collaboration is comprised of the following three Collaboration Programs for the Development, Manufacture and Commercialization of three types of products: (a) an Antibody Program for the Development, Manufacture and Commercialization of products containing Antibodies targeted against SARS-COV-2 and, where applicable, other Coronaviruses, including any Program Antibodies (each, an “Antibody Product”), provided that, for clarity, (i) if an Antibody arises from the Functional Genomics Program rather than the Antibody Program, such Antibody shall not be considered an Antibody Product and shall be considered as Functional Genomics Product, and (ii) [***]; (b) a Vaccine Program for the Development, Manufacture and Commercialization of products containing any Vaccine mutually agreed by the Parties that targets against SARS-COV-2 and, where applicable, other Coronaviruses(each, a “Vaccine Product”); provided that, for clarity, [***]; and (c) a Functional Genomics Program for the Development, Manufacture and Commercialization of other products in any modality, as mutually agreed by the Parties, based on genome-wide CRISPR screening of host Targets expressed in connection with exposure to SARS-COV-2, and, where applicable, other Coronaviruses (each a “Functional Genomics Product”). During the Initial Development Term, the Parties will collaborate, under mutually agreed Development Plan(s) for each Collaboration Program, to generate and evaluate Development Candidates under such Collaboration Program. With respect to each Collaboration Product under an applicable Collaboration Program, the Parties will conduct Development, Manufacturing, and regulatory activities in accordance with a Development Plan and Commercialization activities in accordance with a Commercialization Plan.
2.3 Exclusivity.
2.3.1 Exclusivity Obligations of Vir. During the Initial Development Term, neither Vir nor its Affiliates (either internally or through intentionally enabling a Third Party) shall (a) create or generate Antibodies for the purpose of Developing or Commercializing any Antibody directed to SARS-COV-2 or any other Coronavirus(es); or (b) conduct genome-wide screens using CRISPR or gene editing screens for SARS-COV-2 or any other Coronavirus(es) to discover Targets or progress such Targets into drug discovery and development, in each case ((a) and (b)), except pursuant to the Collaboration under this Agreement, provided that, the exclusivity obligations under this Section 2.3.1 shall not apply to (i) Vir’s continued conduct of activities (A) under its agreements with Third Parties existing as of the PCA Execution Date and set forth on Schedule 2.3.1 (“Existing Vir Third Party Agreements”), or (B) [***]; or (ii) subject to Section 11.3.1(c), Vir’s activities under (A) the WuXi Agreement (in accordance with its terms), (B) the Biogen Agreement, (C) [***], and (D) the Samsung DS Letter Agreement, in each case ((A) through (D)) solely in connection with (x) the negotiation of the terms of definitive agreements with Biogen and Samsung, or (y) Development and Manufacturing for clinical and commercial supply of Antibodies. [***].
2.3.2 Exclusivity Obligations of GSK. During the Initial Development Term, neither GSK nor its Affiliates (either internally or through intentionally enabling a Third Party) shall (a) create or generate Antibodies for the purpose of Developing or Commercializing any Antibody directed to SARS-COV-2 or any other Coronavirus(es); or (b) conduct genome-wide screens using CRISPR or gene editing screens for SARS-COV-2 or any other Coronaviruses to discover Targets or progress such Targets into drug discovery and development, in each case
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((a) and (b)), except pursuant to the Collaboration under this Agreement; provided that, the exclusivity obligations under this Section 2.3.2 shall not apply to any activities or enablement (including funding) conducted by GSK or its Affiliates pursuant to a written agreement with a Third Party entered into prior to the PCA Execution Date, either (x) for the purpose of discovering any Antibody directed to SARS-COV-2 or other Coronaviruses, or conducting genome-wide screens using CRISPR or gene editing screens for SARS-COV-2 or any other Coronaviruses, or (y) that are not for the purposes described in subclause (x) but [***] (each, an “Existing GSK Third Party Agreement”), provided further, for clarity, that the foregoing exception shall not include any amendment of an Existing GSK Third Party Agreement that expands the scope thereof with respect to any Antibody directed to, or conducting genome-wide screens using CRISPR or gene editing screens for, SARS-COV-2 or other Coronaviruses; or (ii) [***].
2.3.3 Activities Outside Collaboration. For the avoidance of doubt, during the Initial Development Term, each Party shall have the right to pursue by itself or through the grant of rights to or from a Third Party, other therapeutic or prophylactic approaches to the prevention, treatment and prophylaxis of diseases caused by Coronaviruses that do not fall within the exclusivity obligations under Section 2.3.1 or Section 2.3.2 including with respect to Vir, any RNAi products generated from its collaboration with Alnylam under the Alnylam Agreement.
2.3.4 Inclusion of Competing Programs. Notwithstanding Section 2.3.1 and Section 2.3.2, if during the Initial Development Term, either Party or its Affiliates wishes to conduct any activities under a program, including generating or advancing a new Antibody, that would constitute a breach by such Party of its exclusivity obligations under Section 2.3.1 or Section 2.3.2, as applicable (whether alone or with a Third Party), then such Party shall, prior to initiation of such program, first notify the other Party in writing, and offer to include any such program under the Collaboration (an “Inclusion Notice”), [***]. The other Party shall have [***] from the date on which it receives the Inclusion Notice to determine whether or not it will accept such offer to include such program in the Collaboration and to notify the offering Party of its decision. If such other Party notifies the offering Party in writing within such [***] period, then such program shall be included in the Collaboration, the scope of which will be included in the Antibody Development Plan or the Functional Genomics Development Plan, as applicable, and shall constitute part of the Antibody Program or the Functional Genomics Program, as the case may be and the terms and conditions of this Agreement shall apply. If such other Party declines, or fails to notify the offering Party in writing within such [***] period that it wishes to include such program in the Collaboration, then the offering Party or its Affiliates shall have the right to exploit such program outside of the Collaboration, and such exploitation shall not constitute a breach of Section 2.3.1 or Section 2.3.2 by such offering Party. Notwithstanding the foregoing, during the Initial Development Term, neither Party nor its Affiliates (either internally or through enabling a Third Party) shall Develop or Commercialize any Program Antibody [***] outside of this Agreement without the other Party’s prior written consent.
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ARTICLE 3
MANAGEMENT OF THE COLLABORATION
3.1 Joint Steering Committee.
3.1.1 Establishment of JSC. Prior to the Execution Date, the Parties established a Joint Steering Committee (“Joint Steering Committee” or “JSC”), which is constituted in accordance with Section 3.8. The JSC shall operate in accordance with the provisions of Section 3.8 and Section 3.9. At its meetings, the JSC shall discuss the matters described below and such other matters as are reasonably requested by either Party’s Alliance Managers.
3.1.2 Responsibilities of the JSC. The JSC shall perform the following functions:
(a) oversee, guide and approve the overall strategic direction of the Collaboration (but without modifying or limiting the rights or obligations of either Party as otherwise set forth herein);
(b) facilitate communications between the Parties regarding the identification and evaluation of Collaboration Products;
(c) establish, as appropriate, additional sub-committees or working groups responsible for managing specific aspects of the Collaboration as contemplated herein;
(d) delegate decision-making authority with respect to specified issues to the applicable subcommittees, provided that any such delegated decision-making shall remain subject to Section 3.9;
(e) oversee and supervise the subcommittees and resolve issues or Dispute elevated to it by any subcommittee, Program Team or working group the JSC may establish;
(f) serve as a forum for each Party to communicate regarding each Party’s interest in participation in further Development of each Collaboration Product, including approval of proposals from the JRDC for the inclusion of, and terms for, Third Party assets or Intellectual Property Rights within a given Collaboration Program;
(g) serve as a forum for the Parties to discuss any proposal from either Party for a competing program in accordance with Section 2.3.4;
(h) [***];
(i) for each Collaboration Product, review and approve the initial Development Plan (and the Development Budget therein) in accordance with Section 5.1.2 and any material updates or amendments thereto in accordance with Section 5.1.3;
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(j) for each Collaboration Product [***] the initial Commercialization Plan (including the associated Commercialization Budget) and proposed material updates and amendments thereto (including any updates to the Commercialization Budget [***];
(k) [***];
(l) [***]; and
(m) perform such other functions as are assigned to the JSC in this Agreement, or otherwise agreed by the Parties in writing.
3.2 Joint Research and Development Committee.
3.2.1 Establishment of JRDC. The Parties shall, [***], establish a joint research and development committee (“Joint Research and Development Committee” or “JRDC”) to oversee Development of Collaboration Products and to coordinate Development activities of both Parties with respect to such Collaboration Products.
3.2.2 Responsibilities of the JRDC. The JRDC shall perform the following functions:
(a) oversee, review and coordinate the conduct, implementation and progress of the Development (including any Research) activities of each Collaboration Product with respect thereto under this Agreement, as described in the applicable Development Plan;
(b) discuss and develop the Development (including Research) strategy for the Collaboration, including any next-generation Collaboration Products;
(c) review and approve the applicable initial Development Plan and proposed updates and amendments thereto, in each case, as prepared by the Lead Party in conjunction with the Program Teams with respect to clinical Development of any Collaboration Product, including the applicable Development Budget and the allocation of responsibilities between the Parties, from time to time, and submit such Development Plan, updates, and other amendments to the JSC for review and approval in accordance with Section 5.1.2 or Section 5.1.3, as applicable;
(d) review and evaluate any results or reports delivered to the JRDC with respect to the Research activities, including validation and designation of each Development Candidate;
(e) review and evaluate any results or reports delivered to the JRDC with respect to further Development activities in addition to Research activities under the Development Plans, including the protocol concepts for Clinical Studies of the Collaboration Products and any revision of such protocols with respect to issues that are referred to the JRDC, in each case pursuant and subject to Section 5.5.3;
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(f) address issues escalated from Program Teams, including [***], and oversee risk mitigation plans proposed by Program Teams;
(g) [***];
(h) approve CROs and other subcontractors in accordance with Section 5.4.2, excluding manufacturing subcontractors, which shall be approved by the JMC;
(i) [***];
(j) for each Collaboration Program, discuss each Party’s interest in participation in further Development activities in connection with the applicable Opt-Out Points;
(k) review and approve any Research and Pre-Clinical Publication Strategy or Clinical Development Publication Strategy proposed by the Lead Party of a Collaboration Program, pursuant to Section 12.1 or Section 12.2;
(l) [***];
(m) provide periodic updates to the JSC and otherwise supporting the JSC’s decision-making;
(n) establish a working functional teams for each Collaboration Program (each, a “Program Team”) to oversee the Development activities under each Collaboration Program, and delegate one or more of its functions under this Section 3.2.2 to such Program Team, with the supervision of the JRDC; and
(o) perform such other functions as are specifically designated to the JRDC in this Agreement, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement.
3.3 Joint Commercialization Committee.
3.3.1 Establishment of JCC. The Parties shall establish a joint commercialization committee (“Joint Commercialization Committee” or “JCC”), [***], to oversee and review progress of Commercialization activities with respect to such Collaboration Products.
3.3.2 Responsibilities of the JCC. The JCC shall perform the following functions:
(a) [***] the initial Commercialization Plan, including the associated Commercialization Budget, and proposed material updates thereto proposed by either Party (including any updates to the Commercialization Budget), in each case, [***], with respect to Commercialization of each Collaboration Product, and, [***], [***] of the then-existing approved Commercialization Budget) to the JSC for review and approval in accordance with Section 7.2;
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(b) provide a forum for discussing the need for significant updates to Commercialization Plan [***], as applicable;
(c) review and discuss the [***] forecast for the Commercialization Budget, in conjunction with the Finance Working Group;
(d) following exercise of the Co-Promotion Option by Vir, oversee and review Vir’s proposed sales force and sales force activities, and provide a forum for the exchange of information in relation thereto;
(e) review reports delivered to the JCC with respect to [***] and, [***];
(f) following Vir’s exercise of the Co-Promotion Option, (i) set direction for sales training, compliance procedures, use of GSK promotional materials, and other relevant matters in connection with the Parties’ negotiation and entry into the Co-Promotion Agreement, and (ii) oversee, review and coordinate the conduct and progress of the Commercialization activities with respect to each Antibody Product for which Vir has exercised its Co-Promotion Option, including activities under the Co-Promotion Agreement;
(g) to the extent not addressed by a Program Team, [***]; and
(h) perform such other functions as are specifically designated to the JCC in this Agreement or the Co-Promotion Agreement, as applicable, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement or the Co-Promotion Agreement, as applicable.
3.4 Joint Patent Committee.
3.4.1 Establishment of JPC. [***], the Parties shall establish a joint patent committee (“Joint Patent Committee” or “JPC”) to oversee patent matters relating to the Collaboration, as more specifically described below.
3.4.2 Responsibilities of the JPC. The JPC shall perform the following functions.
(a) serve as a forum for the discussion of the overall intellectual property strategies for the Collaboration, including the prosecution, maintenance, defense and enforcement of Program Patents, GSK Licensed Patents and Vir Licensed Patents, and submission of patent information to the FDA for listing in the Orange Book, “Purple Book” (or Orange Book-equivalent framework document for Biologics) or any foreign equivalents thereof;
(b) [***];
(c) [***];
(d) review proposed publication by the Parties for any Patent-related issues;
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(e) [***]; and
(f) perform such other functions regarding Patents included in the Program Patents, GSK Licensed Patents and Vir Licensed Patents, that are specifically designated to the JPC in this Agreement, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement.
3.4.3 Decision-Making of the JPC. For matters relating to prosecution, maintenance or defense of a Patent, the Party [***] with Section 13.3. For matters relating to submission of patent information for listing in the Orange Book or any foreign equivalents thereof, [***] shall have the final decision-making authority pursuant to Section 6.3. For matters relating to whether to enter into a Blocking Third Party IP Agreement (and the agreement on the material terms thereof), any dispute shall be resolved in accordance with Section 9.6.1. For matters relating to whether to include any Third Party Intellectual Property Rights under a Third Party IP Agreement, any dispute shall be resolved in accordance with Section 10.9.2. [***]. For all other matters under the JPC authority, if the JPC cannot resolve a dispute with respect to such matter, the JPC shall be submitted such dispute to the JSC for resolution in accordance with Section 3.9.
3.5 Joint Manufacturing Committee.
3.5.1 Establishment of the JMC. [***], the Parties shall establish a joint Manufacturing committee (“Joint Manufacturing Committee” or “JMC”) to oversee matters relating to Manufacturing (including Commercial Manufacturing and technology transfer) of any Collaboration Product under the Collaboration. The JMC shall be chaired by [***].
3.5.2 Responsibilities of the JMC. The JMC shall perform the following functions:
(a) serve as a forum for the discussion of the overall Manufacturing strategies and plans for the Collaboration, including [***];
(b) review and approve the Manufacturing plans included in a Development Plan or Commercialization Plan, including with respect to Manufacturing process, physical product, Manufacturing and technology transfer, supply chain for launch and commercial supply and solutions for technical issues;
(c) assist the JRDC, and where applicable, the JCC and JSC, in review and approval of the Development Budget or Commercialization Budget to the extent relating to Manufacturing activities;
(d) provide recommendations to JSC for the selection of CMOs for Commercial Manufacturing and the terms and conditions of the proposed CMO agreement; and
(e) perform such other functions as are specifically designated to the JMC in this Agreement, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement.
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3.5.3 Decision-Making of the JMC. The JMC shall operate in accordance with Section 3.8, and the JMC shall make decisions generally in accordance with Section 3.9. If the JMC is unable, despite the good faith efforts of all members, to resolve any dispute relating to matters within the JMC’s authority within [***] after a disputed issue has been referred to the JMC by either Party, the disputed issue shall be referred to the JRDC, and shall be resolved in accordance with Section 3.9.
3.6 Financial Working Group. Within thirty (30) days following the Effective Date, the JSC will establish a financial working group subcommittee (“Financial Working Group”) that will be responsible for initially reviewing all budgets included as part of the Development Plans and Commercialization Plans, and for overseeing the operational aspects of all co-funding and payment activities under this Agreement. The JSC shall determine the appropriate number of representatives of each Party that will constitute the Financial Working Group. Promptly following the Effective Date, each Party shall designate their respective initial representatives to the Financial Working Group to allow such Financial Working Group to begin organizing information for the initial meetings of each of the JRDC and JSC. Unless otherwise specified by the JSC, the Financial Working Group shall operate generally in accordance with the provisions of Section 3.8, and shall have no authority to alter or amend the terms and conditions of this Agreement. Both Parties’ representatives on the Financial Working Group shall make decisions and act in accordance with the General Principles.
3.7 Other Subcommittees. From time to time, the JSC and the JRDC may establish other subcommittees to oversee particular projects or activities under this Agreement, and such subcommittees shall be constituted and have such responsibility as the JSC or JRDC approves (such subcommittees, along with the other subcommittees established hereunder, each referred to herein as a “Subcommittee”). The Subcommittees shall operate in accordance with the provisions of Section 3.8, and shall have no authority to alter or amend the terms and conditions of this Agreement.
3.8 Membership, Meetings and Meeting Minutes.
3.8.1 Membership. Except as otherwise stated herein, each Committee shall be composed of at least [***] representatives ([***]) in each case from each of Vir and GSK, or such other equal number of representatives as the Parties may agree. As of the Effective Date, the Parties anticipate that the JSC will be composed of [***] of each Party, and the JRDC will be composed of [***] of each Party. Either Party may replace its respective Committee representatives at any time with prior written notice to the other Party, provided that such replacement is of comparable authority and scope of functional responsibility within that Party’s organization as the person he or she is replacing. Each Party’s representatives to each Committee shall be individuals suitable in seniority and experience and amongst such representatives shall be [***] from each Party with relevant decision-making authority to make decisions within the scope of the applicable Committee’s responsibilities, provided that it is understood that [***]. For each Committee, or where applicable, Subcommittees, each Party shall designate one of its representatives on such Committee to co-chair the meetings for such Committee (each, a “Co-Chair”). The Co-Chairs shall, with and through the assistance of the Alliance Managers, coordinate and prepare the agenda for, and ensure the orderly conduct of, the meetings of such Committee. The Co-Chairs shall, with and through the assistance of the Alliance Managers, solicit
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agenda items from Committee members and provide an agenda, along with appropriate information for such agenda, reasonably in advance of any meeting, including [***]. Such agenda shall include all items requested by either Co-Chair for inclusion therein. In the event the Co-Chairs or another Committee member from either Party is unable to attend or participate in a meeting of such Committee, the Party whose Co-Chair or member is unable to attend may designate a substitute co-chair or other representative for the meeting. For clarity, while the Alliance Managers may attend meetings of all Committees, the Alliance Managers shall not: (a) serve as a voting member of any such Committee; nor (b) be counted towards either Party’s representation on any such Committee.
3.8.2 Meetings. The JSC shall meet at least [***] per year, or at a frequency determined by the JSC, for so long as the Parties are engaging in Development activities as part of the Collaboration or a Collaboration Product is in Development or being Commercialized, in each case, for clarity, not as a Sole Development Product, and JSC meetings can be called at other times to resolve Committee Deadlocks in accordance with Section 3.9.1. At least [***] per year will be in-person, unless the JSC members agree to meet by an alternative mechanism (e.g., telephone or videoconference). The JRDC and the JCC, once formed, shall meet at least [***], and thereafter at least [***], or in each case at a frequency determined by the JRDC or JCC, as applicable. The Financial Working Group, Program Teams and other Subcommittees, if any, shall each meet at least [***] after the Subcommittee is formed, or as more or less often as otherwise agreed by the applicable Subcommittee; provided that the Financial Working Group will meet as and when necessary to carry out its responsibilities set forth in Section 9.3. [***]. Committee meetings may be conducted by telephone, videoconference or in person. Any in-person Committee meetings shall be held on an alternating basis between Vir’s and GSK’s facilities, unless otherwise agreed by the Parties. Each Party shall be responsible for its own expenses in attending such meetings. As appropriate, the Committee may [***]. Each Party may also call for special meetings of a Committee to discuss particular matters requested by such Party. The Alliance Managers shall provide the members of each Committee with no less than [***] notice of each regularly scheduled meeting and, to the extent reasonably practicable under the circumstances, no less than [***] notice of any special meetings called by either Party.
3.8.3 Meeting Minutes. Minutes will be kept of all Committee meetings by one of the Alliance Managers (or his or her designees), or by one of the Co-Chairs (if an Alliance Manager is not present) on a rotating basis (commencing with GSK’s representative) and sent to all members of the Committee by facsimile or e-mail for review and approval within [***] after each meeting. If a Party’s Alliance Manager (or his or her designee) is not present at a Committee meeting and that Party is responsible for keeping minutes, such Party shall designate one of its Committee members to keep minutes. Minutes shall record all action items and decisions of the applicable Committee. The Committee shall formally accept the minutes of the previous Committee meeting [***]. Minutes will be deemed approved unless any member of the Committee objects to the accuracy of such minutes by [***]. Minutes shall list action items and shall designate any issues that need to be resolved by the JSC or applicable dispute resolution process. In the event of any such objection to the minutes that is not resolved by mutual agreement of the Parties, such minutes will be amended to reflect such unresolved dispute.
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3.9 Decision-Making.
3.9.1 Committee Decision Making. Decisions of each Committee shall be made by unanimous vote, with each Party having one vote. To the extent a Party has voted in favor of a particular action, after commencement of the implementation of such action it shall not be permitted to reverse such vote absent changed facts and circumstances that were not present at the time of the initial vote. [***]. Representatives of each Party under each Committee shall use reasonable efforts to resolve any dispute within the authority of such Committee in good faith. If (a) the JRDC, the JCC, the Financial Working Group, or the JPC (subject to Section 3.4.3) cannot or does not reach consensus with respect to a bona fide dispute within the authority of such Subcommittee (a “Subcommittee Deadlock”) after endeavoring for [***] to do so, such matter shall be referred to the JSC for discussion and attempted resolution, and (b) any Program Team or other Subcommittee cannot or does not reach consensus with respect to Subcommittee Deadlock after endeavoring for [***] to do so, then such Subcommittee Deadlock shall be first referred to the JRDC (in case of Program Teams and the JMC) or the applicable establishing Committee for resolution before they are submitted to the JSC pursuant to subsection (a). In the event that the JSC does not reach a decision with respect to a Subcommittee Deadlock, or if the JSC cannot or does not reach consensus with respect to any other matter within its authority, in each case, after endeavoring for [***] to do so, then such matter (a “Committee Deadlock”) shall be decided by the Parties in accordance with Section 3.9.2 below. For clarity, all commitments and other matters decided by the JSC or any other Committee between the Effective Date and the Execution Date (inclusive), to the extent that such commitments and other matters are actually approved and documented in the JSC meeting minutes, shall be deemed to be approved by and mutually agreed through the JSC and such other Committee, respectively, for purposes of this Agreement.
3.9.2 Decision Making Authority. The Committee Deadlock shall be submitted by either Party to the Senior Managers of both Parties. Then, the Senior Managers of each Party or their respective designees, shall attempt to resolve such Committee Deadlock within [***] after submission. If the Senior Managers (or their respective designees) cannot resolve the Committee Deadlock, then, such Committee Deadlock shall be resolved as follows:
(a) if such Committee Deadlock is with respect to the Research activities for any Collaboration Program, [***];
(b) prior to the first filing for Drug Approval Application of any Collaboration Product, if such Committee Deadlock is with respect to Development (other than Research) and regulatory matters regarding such Collaboration Product, including clinical Manufacturing and supply of clinical trial material for Clinical Studies, the Lead Party for such Collaboration Product shall have the final decision making authority, except that,
(i) [***];
(ii) [***]; and
(iii) [***].
(c) [***];
(d) after the first filing for Drug Approval Application of any Collaboration Product, if such Committee Deadlock is with respect to Development, including
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regulatory matters regarding such Collaboration Product, the LCP shall have the final decision-making authority, except for assignment of any activities to the other Party, in which case consent of such other Party shall be required, provided that [***]; and
(e) after the first filing for Drug Approval Application of any Collaboration Product, if such Committee Deadlock is with respect to matters other than those described in Section 3.9.2(d) above, then the LCP shall have the final decision-making authority, provided that [***].
3.9.3 Limits on Decision-Making Authority. Notwithstanding Section 3.9.2, (a) neither Party may exercise its final decision-making authority to (i) impose additional obligations upon the other Party without such Party’s consent, (ii) cause the other Party to violate any applicable Law, or the terms of any agreement it may have with any Third Party entered into prior to the Execution Date, or (iii) modify, violate, breach or waive compliance with this Agreement, or cause the other Party to do so, (b) a Party may only exercise its final decision-making authority with respect to a matter after giving good faith consideration to the other Party’s comments (through its JSC members or its Senior Manager, as applicable) on such matter, and (c) if a Party elects its Opt-Out Option at any time with respect to a Collaboration Product, then thereafter, to the extent such Opt-Out Party would have the final decision-making authority pursuant to Sections 3.9.2(a)-(e), then, such Opt-Out Party shall no longer have such final decision-making authority with respect to such Collaboration Product and any dispute that would be subject to such Opt-Out Party’s final decision-making authority shall then be subject to the Non Opt-Out Party’s final decision-making authority.
3.9.4 Day-to-Day Decision-Making Authority. Each Party shall have decision-making authority with respect to the day-to-day activities of such Party (and such Party’s employees, agents and subcontractors) under this Agreement in accordance with this Agreement, including applicable Development Plan or Commercialization Plan, provided that such decisions are not inconsistent with the terms and conditions of this Agreement (including any applicable Plan) or the decisions and actions of the JSC, the JRDC, the JCC, the JMC, the Financial Working Group or any other Subcommittee, as applicable. Subject to the foregoing, each Party shall keep the relevant Committees reasonably informed of material developments regarding the Collaboration Products.
3.9.5 Limitation of Powers. Each Committee will have only the powers as are specifically delegated to it under this Agreement. The JSC is not a substitute for the rights of the Parties under this Agreement and is intended to coordinate and facilitate the activities of the Parties during the Term. The JSC will not be involved with the day-to-day management of activities to be performed by a Party under this Agreement. Matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of the JSC, including amendment, modification or waiver of compliance with the Agreement, which shall be made by the Parties in accordance with Section 20.11.
3.10 Alliance Managers. [***], each Party shall designate an individual to serve as the main point of contact for each Party [***], to exchange information, facilitate communication and coordinate the Parties’ activities hereunder (each, an “Alliance Manager”).
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Each Party may designate an Alliance Manager for each specific Collaboration Program. The applicable Alliance Managers shall attend the JSC meetings (or designate an appropriate representative to attend JSC meetings on the Alliance Manager’s behalf). For all other Committees, the Alliance Managers may participate in meetings but are not required to participate. The Alliance Managers shall not be counted as members of any Committee (and shall not vote on matters discussed at any Committee meeting). Each Party may change its designated Alliance Manager from time to time upon written notice to the other Party.
3.11 Most Conservative Approach and Internal Policies. For all activities with respect to Collaboration Products, each Party will provide the other with copies of Internal Policies that are relevant and material to the activities being conducted by the Parties hereunder (the “Relevant Internal Policies”) [***], and will provide updates of such Relevant Internal Policies as appropriate. [***]. If there is a conflict between the Relevant Internal Policies with respect to a particular issue, the Parties shall [***], and, except as otherwise set forth in an applicable Development Plan or Co-Promotion Agreement, each Party shall [***] with respect to Development, Manufacturing and Commercialization activities hereunder.
ARTICLE 4
COLLABORATION PROGRAMS
4.1 Collaboration Program Leads.
4.1.1 Lead Party. Generally, (a) the Lead Party for a Collaboration Program shall be primarily responsible for Development activities with respect to each Collaboration Product under such Collaboration Program, and each, under the oversight of the JRDC, the JSC and other applicable Committees, and, subject to Section 3.9.2 and Section 11.3.1(d), shall have the final decision-making authority with respect to the Development and Manufacturing (other than Commercial Manufacture) activities under such Collaboration Program; and (b) the Lead Party for Commercialization and Commercial Manufacture of each Collaboration Program (the “LCP”) shall be primarily responsible for Commercialization and Commercial Manufacture activities with respect to each Collaboration Product under such Collaboration Program, each, under the oversight of the JCC, the JSC and other applicable Committees, and, subject to Section 3.9.2 and Section 11.3.1(d), shall have the final decision-making authority with respect to the Commercialization and Commercial Manufacture under such Collaboration Program.
4.1.2 Parties’ Roles. Subject to Section 5.6, (a) for the Vaccine Program and the Functional Genomics Program, GSK shall be the Lead Party for Development activities, and the LCP for Commercialization and Commercial Manufacture of each Collaboration Product under such Collaboration Program; and (b) for the Antibody Program, subject to Section 4.2.3, Vir shall be the Lead Party for Development activities and GSK shall be the LCP for Commercialization and Commercial Manufacture of each Antibody Product under the Antibody Program.
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4.2 Antibody Program.
4.2.1 General. The Antibody Program shall be the first Collaboration Program to be progressed by the Parties following the Effective Date, and is partly based upon Vir’s ongoing Development activities with respect to Antibodies in the Field, including under Vir’s collaboration with WuXi and Biogen. During the Term, the Parties shall discuss and agree, through the JRDC and the JSC, on Development Plans for Antibody Products under the Antibody Program in accordance with Section 5.1 (each, an “Antibody Development Plan”). Without limiting the foregoing, the Antibody Development Plan will set forth (a) [***]; (b) [***]; (c) [***]; and (d) [***]. As the initial Lead Party, Vir shall be primarily responsible for the Development and clinical Manufacturing activities for the Antibody Program, under the oversight of the JRDC and the JSC.
4.2.2 Existing Program Antibody. With respect to the Existing Program Antibody(ies), the initial Antibody Development Plan (including the mutually agreed initial Development Budget therefor) for such Existing Program Antibody(ies) is set forth in Schedule 4.2.2 (“Existing Antibody Development Plan”). Following the Effective Date, the Parties shall promptly start conducting Development activities assigned to it as set forth in the Existing Antibody Development Plan, in accordance with the associated Development Budget.
4.2.3 Change of Lead Party. Subject to Section 11.3.1 and [***] with respect to Manufacturing, for each Antibody Product under the Antibody Program, Vir shall be the Lead Party for such Antibody Product until the first filing of the Drug Approval Application (including BLA or MAA) for such Antibody Product; [***]. GSK shall become the Lead Party for such Antibody Product upon the first filing for Regulatory Approval of such Antibody Product.
4.3 Vaccine Program
4.3.1 General. [***], the Parties will, through the JRDC, discuss and mutually agree on the Development Plan for each Vaccine Product under the Vaccine Program in accordance with Section 5.1 (the “Vaccine Development Plan”). Without limiting the foregoing, the Vaccine Development Plan will set forth (a) [***]; (b) [***]; (c) [***]; (d) [***]; and (e) [***].
4.3.2 Lead Party. GSK shall be the Lead Party for the Vaccine Program, provided that it is anticipated that the initial Research activities will be conducted predominantly by Vir, as set forth in the Development Plan for the Vaccine Program. [***], as set forth in the Development Plan for the Vaccine Program.
4.3.3 [***]. The JRDC shall determine whether a designated Vaccine has met all the criteria for a Development Candidate, and if so, shall designate such Development Candidate for further Development as a Vaccine Product. If any Vaccine has not met the criteria for the Development Candidate, as determined by the JRDC, then, neither Party shall have the right to further Develop, Manufacture or commercialize any product containing such Vaccine under the Collaboration. [***].
4.4 Functional Genomics Program
4.4.1 General. [***], the Parties will, through the JRDC, discuss and mutually agree on the Development Plan for each Functional Genomics Product under the Functional Genomics Program in accordance with Section 5.1 (the “Functional Genomics Development Plan”). Without limiting the foregoing, the Functional Genomics Development Plan will include (a) [***], (b) [***], (c) [***]; (d) [***], and (e) [***].
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4.4.2 Lead Party. GSK as the Lead Party will be primarily responsible for Development and Manufacturing activities for the Functional Genomics Program, under the oversight of the JSC and any other applicable Committees.
4.4.3 Database Technology. Any databases and data mining technologies [***] shall only be included in the Functional Genomics Program to the extent specified as included within GSK Licensed Technology or Vir Licensed Technology in the applicable Functional Genomics Program Development Plan, in accordance with Section 4.4.1, and in each case shall be subject to any applicable Third Party agreements, [***] prior to inclusion in the Functional Genomics Program Development Plan. [***].
4.5 Compassionate Use Programs. With respect to each Collaboration Product, the Parties shall, through the JRDC and the JSC, discuss and agree on [***].
4.6 Parties’ Assets; Products. Unless otherwise agreed by such Party in the applicable Development Plan, neither Party’s assets (Targets, compounds or other products), including those discovered, licensed or acquired by such Party outside of the Collaboration, shall be included at any time as part of the Collaboration; provided that the foregoing shall not exclude [***].
4.7 Compliance with Applicable Law. Each Party shall, and shall cause their Affiliates, Sublicensees, permitted subcontractors and distributors to conduct its or their activities under this Agreement in compliance with applicable Law. Without limiting the foregoing, any information exchanged between the Parties under this Agreement shall be subject to, and limited to the extent permitted by any applicable Law, including any applicable competition Law.
ARTICLE 5
DEVELOPMENT
5.1 Development Plans.
5.1.1 Each Development Plan shall (a) provide a framework for the applicable Collaboration Program, and (b) set forth (i) the objectives of the Collaboration Program, (ii) the specific Development activities to be undertaken by either Party to achieve those objectives, with anticipated timelines, (iii) the Development Budget, (iv) [***], (v) Manufacturing plan in support of Development activities, and (v) any other items applicable to Development activities that the Parties may agree to include in the Development Plan. [***].
5.1.2 The JRDC, [***], shall review and approve each initial Development Plan (to the extent not approved prior to the Execution Date) within [***], and shall submit such Development Plan to the JSC for the JSC to review and approve, except that the JMC shall review and approve any Manufacturing plan (and associated budget) included in the Development Plan [***] prior to submission to the JSC for review and approval. If the JRDC or the JMC, as applicable, cannot agree on the Development Plan within such [***], then such dispute shall also be submitted to the JSC. If the JSC cannot agree on such proposed Development Plan
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submitted by the JRDC within [***] after being submitted by the JRDC or the JMC, whichever is later, then such dispute shall be resolved in accordance with Section 3.9.2. The proposed final Development Plan (including the initial Development Budget that is part of the Development Plan) will go into effect once approved by the JSC in accordance with Section 3.9. For clarity, the initial Vaccine Development Plan and initial Functional Genomics Development Plan or any material amendment to the Existing Antibody Development Plan as set forth on Schedule 4.2.2, shall not go into effect until finalized pursuant to the process set forth in this Section 5.1.2 and approved by the JSC. Once approved by the JSC, the Parties shall conduct Development activities under the Development Plan in accordance with this Agreement. All such Development activities shall be conducted under the supervision of the JRDC, as applicable and in accordance with the approved Development Plan. Activities of a Party’s Affiliates, licensees or Sublicensees shall be considered activities of such Party for purposes of this Agreement.
5.1.3 Following approval by the JSC of the initial Development Plan (including the associated Development Budget) for a Collaboration Program in accordance with Section 5.1.2, such Development Plan shall be updated or amended as follows:
(a) the JRDC [***] shall review each Development Plan not less frequently than annually and the Lead Party shall prepare detailed and specific Development Plan updates, which shall include, as applicable, updates to the existing Development Budget, including to provide for the Development Budget for the next Calendar Year and the applicable non-binding budget forecast (as defined in the definition of Development Budget) following such Calendar Year for the particular Collaboration Program. The Lead Party shall submit all such updates to the JRDC ([***]) for review and approval no later than [***] of each Calendar Year and the JRDC shall submit such updated Development Plan to the JSC for review and approval. If the JSC cannot agree on such proposed updated Development Plan submitted by the JRDC within [***], then such dispute shall be resolved in accordance with Section 3.9.2. Upon the JSC’s preliminary approval, such updates shall be submitted to each Party for its internal budgeting process with a target for final approval no later than [***] of each Calendar Year, at which time any such approved updates shall be appended to the Development Plan, provided that, [***].
(b) The Lead Party may also develop and submit to the JRDC [***]) from time to time other proposed amendments to the Development Plan, which the JRDC [***] will review and approve. The JRDC shall submit all material amendments to the Development Plan to the JSC for review and approval and, if the JRDC cannot agree with respect to any matter in any other proposed amendments to the Development Plan within [***], the JRDC shall submit such amendments to the JSC for review and approval. If the JSC cannot agree on such proposed amendments to the Development Plan referred by the JRDC within [***], then such dispute shall be resolved in accordance with Section 3.9.2. Proposed amendments to the Development Plan shall not go into effect until approved by the JRDC or, if applicable, the JSC, at which time such approved amendments shall be appended to the Development Plan.
(c) For clarity, when providing the JRDC with information regarding the projected Development Budget anticipated to be expended under a particular Collaboration Program, the Lead Party shall provide to the JRDC the level and quality of information that the Parties have agreed through the Financial Working Group, which level and quality of information shall be agreed to by the Financial Working Group within [***].
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5.1.4 The Development Plan may include [***], solely if the Parties mutually agree to include such product in the applicable Development Plan or an amendment to such Development Plan (each agreed product, an “Additional Products”). For clarity, with respect to any portion of an Additional Product [***] the Development Plan for such Additional Product. [***]. The Development Plan may also include [***] the Development and Commercialization of Collaboration Products, for which the Parties will mutually agree on any Development activities associated therewith. For clarity, unless otherwise agreed by the Parties, the sharing of Development Costs applicable to [***] such Development Plan. If the Parties agree to include in the Collaboration an Additional Product that is [***].
5.2 Development Efforts. Each Party shall use its Commercially Reasonable Efforts to (a) perform the obligations assigned to it under each Development Plan, and (b) enable GSK to seek and obtain regulatory approval for any Collaboration Product progressed thereunder in the United States, the European Union, and the United Kingdom. [***]. Each Party shall conduct its Development activities in good scientific manner and in compliance with all applicable Law, including Laws regarding the environment, safety and industrial hygiene, and GMP, GLP, GCP, informed consent and Institutional Review Board regulations, current standards for pharmacovigilance practice, and all applicable requirements relating to the protection of human subjects.
5.3 Development Records; Exchange of Information.
5.3.1 Each Party shall maintain, in good scientific manner, complete and accurate books and records pertaining to its activities under each Development Plan, in sufficient detail to verify compliance with its obligations under this Agreement and which books and records shall (a) be appropriate for Patent and regulatory purposes, (b) be kept and maintained in compliance with applicable Law, (c) properly reflect all work done and results achieved in the performance of its activities hereunder and (d) record only such activities and not include or be commingled with records of activities outside the scope of this Agreement (such books and records, “Program Records”). As part of keeping the Program Records, each Party shall maintain records in sufficient detail as will properly reflect all work done, in the performance of activities arising out of, in conducting, or otherwise in connection with the Development Plan. Such Program Records shall be retained by the applicable Party for at least [***] after the expiration or termination of the applicable Collaboration Program or for such longer period as may be required by applicable Law. With respect to any Collaboration Programs for which the Opt-Out Party has not exercised its Opt-Out Option, the JRDC shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all Program Records kept by a Party. Each Party shall provide the JRDC with detailed reports relating to its activities under each Collaboration Program each Calendar Quarter for the applicable Collaboration Program.
5.3.2 With respect to any Collaboration Program, within [***] of each year, each Party shall prepare and provide to the other Party a written report that summarizes the Development activities (including Manufacturing-related development activities) performed and the status of activities and progress with respect to the information included the Development Plan, and shall identify any issues or circumstances of which it is aware that may prevent or adversely affect in a material manner its future performance of activities assigned to it under the then-current Development Plan. The Parties may agree that minutes or presentations from Committee meetings
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may be used to satisfy this reporting requirement. Each Party shall have the right to review all reports related to any Clinical Studies for a Collaboration Product, whether such reports are generated by or on behalf of GSK, Vir or a CRO or subcontractor, provided that such Party has not exercised its Opt-Out Option.
5.4 Performance by Affiliates; Subcontracting.
5.4.1 Each Party conducting any Development activities under each Development Plan shall have the right to subcontract any of the activities assigned to it under any Development Plan to any of its Affiliates without further approval of the JRDC or the other Party; provided that no such permitted subcontracting shall relieve the subcontracting Party of any obligation hereunder and the subcontracting Party shall cause its permitted subcontractors to comply with its applicable obligations under this Agreement.
5.4.2 Subject to Section 5.4.3, each Party conducting any Development activities under each Development Plan may subcontract any of the activities assigned to it under any Development Plan to a Third Party subcontractor, including clinical research organizations (“CROs”), contract manufacturing organizations, subject to the following terms and conditions: (a) any such subcontracting to a Third Party shall be approved by the JRDC; (b) none of the rights of the other Party hereunder are diminished or otherwise adversely affected as a result of such subcontract; (c) such Third Party subcontractor shall be bound by a written agreement that is consistent with terms and conditions of this Agreement, including applicable confidentiality, publication and intellectual property ownership provisions; and (d) such Party shall remain responsible under this Agreement for ensuring, and shall be liable to the other Party for, the compliance of such Third Party subcontractor with this Agreement. Notwithstanding the foregoing, at the time of preparation of the Development Plan for a given Collaboration Product, where reasonably practicable, the Parties will discuss through the JRDC and agree upon any Third Party subcontractors that the Non-Lead Party anticipates it may wish to use to perform activities for or on behalf of such Non-Lead Party. Such pre-approved Third Party subcontractors will be listed in the Development Plan, and, no separate approval by the JRDC shall be required for the Non-Lead Party to use such Third Parties to perform activities with respect to any Collaboration Product under the same Collaboration Program. [***].
5.4.3 [***].
5.5 Clinical Studies.
5.5.1 Generally. All Clinical Studies of the Collaboration Products conducted by the applicable Party shall be conducted only pursuant to this Agreement and the applicable Development Plan. Any Clinical Studies of the Collaboration Product will be conducted in accordance with the Applicable Internal Policies and GCP standards and involve investigators of recognized competence. If agreed to by the Parties in writing or approved by the JRDC, or if a Party has a reasonable basis to believe a violation of applicable Law has occurred with respect to a given Clinical Study, each Party shall have the right, at its own expense and subject to the terms and conditions of any applicable agreements, to audit all Clinical Study sites used by the other Party, and have all other audit rights to ensure that any necessary compliance standards are upheld. Such audit shall be made at reasonable times during regular business hours
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and upon [***] prior notice to such other Party and the Clinical Study site. Summaries of results of all Clinical Studies conducted by either Party with respect to any Collaboration Product shall be published on GSK’s clinical trial register, unless GSK has exercised its Opt-Out Option and is not conducting or funding any activity with regard to the applicable program.
5.5.2 Investigator-Initiated Studies. The Lead Party shall determine, and the Development Plan shall set forth any sponsorship of investigator-initiated studies of the Collaboration Products. All sponsorship of such investigator-initiated studies shall be subject to approval by the JRDC or, where applicable, the JSC.
5.5.3 Clinical Study Protocol. All Clinical Studies conducted under a Development Plan will first be approved in concept by the JRDC. For any Clinical Studies that are to be conducted solely by a Party (including through an affiliated entity or a subsidiary) or its contractors, the protocol and related investigator’s brochures shall be designed by such Party in accordance with the approved Development Plan with review and input from the other Party within [***] after submission to the JRDC of the draft protocol; provided, that if the other Party identifies a material issue in the protocol, it may refer the issue to the JRDC for revision. Except as otherwise specified in the applicable Development Plan, the Lead Party will secure any required approvals from any IRBs, safety boards or the like. Notwithstanding the foregoing, the Party conducting the Clinical Study may make modifications to the protocol on an emergency basis for patient safety reasons and in such case, shall notify the JRDC and the other Party as promptly as practical.
5.6 Rights to Opt-Out
5.6.1 Opt-Out Points. On a Collaboration Product-by-Collaboration Product basis, each Party (whether the Lead Party or the Non-Lead Party, such Party, an “Opt-Out Party”) will have the one-time right to elect, pursuant to the procedures set forth in this Section 5.6 to cease funding its share of the Development Costs for such Collaboration Product in its entirety (the “Opt-Out Option”), with such right exercisable by providing the required written notice (an “Opt-Out Notice”) to the other Party, as further provided in this Section 5.6, at or prior to the following milestones (each, an “Opt-Out Point”):
(a) [***]
(b) [***];
(c) [***]; and
(d) [***].
For clarity, with respect to the Antibody Product containing the 309 Antibody under the existing Antibody Program (the “309 Antibody Product”), [***].
5.6.2 Share of Data and Materials. Within [***] for a Collaboration Product, the Lead Party (and the Non-Lead Party if applicable) conducting Development activities with respect to such Collaboration Product shall submit to the JRDC [***] conducted by such Party for such Collaboration Product from last Opt-Out Point (if any) to such Opt-Out Point (the “Development Summary”). The Development Summary shall include, where applicable, [***].
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Following presentation and discussion between the Parties, and within [***] after submission of the Development Summary to the JRDC, [***] shall be provided by the Party conducting the Development activities upon reasonable request by the other Party, provided that [***]. For clarity, this Section 5.6.2 shall apply even if [***].
5.6.3 Exercise of Opt-Out Option.
(a) A Party may exercise an Opt-Out Option by delivering an Opt-Out Notice at any time prior to, and no later than [***] with respect to such Collaboration Product ([***]). The Opt-Out Option shall be deemed to be exercised upon (i) [***], or (ii) [***] (such date in (i) or (ii), the “Opt-Out Effective Date”).
(b) If a Party exercises an Opt-Out Option in accordance with Section 5.6.3(a), then:
(i) The Opt-Out Party shall be responsible for its allocation of all Development Costs and Manufacturing Costs for Development and Commercialization with respect to such Collaboration Product that are (A) incurred in connection with (x) Development, or (y) Manufacturing for Development or Commercialization activities up to the Opt-Out Effective Date, or (B) non-cancelable and, prior to the Opt-Out Effective Date, committed for such Collaboration Product in connection with [***] prior to the Opt-Out Effective Date, in each case, [***].
(ii) Notwithstanding the foregoing, an Opt-Out Party [***]. For clarity, [***].
(iii) The Opt-Out Party shall also be responsible for [***].
(c) If a Party does not elect to exercise its Opt-Out Option at one of the above Opt-Out Points within the specified time periods in accordance with Section 5.6.3(a), it will be obligated to continue to fund all Development Costs for such Collaboration Product in accordance with Section 9.1.1, Section 9.1.2, or Section 9.1.3, as applicable, until such time as the next Opt-Out Point becomes available, if any; provided, that the share of Development Costs for which it is responsible shall not exceed the Development Costs set forth in the Development Plan and associated existing Development Budget (including Permitted Overage, or such other additional overage as the Parties have mutually agreed as of such time).
5.6.4 Parties’ Rights after Opt-Out.
(a) Upon receipt of any Opt-Out Notice timely delivered by the Opt-Out Party in accordance with Section 5.6.3, the other Party (the “Non Opt-Out Party”) shall have the right, at any time after the Opt-Out Effective Date with respect to a Collaboration Product, to elect either to (i) continue with the Development and Commercialization of such Collaboration Product, at its own cost; or (ii) subject to the remainder of this Section 5.6.4, cease bearing Development Costs for future Development activities with respect to such Collaboration Product, in which case the Non Opt-Out Party may wind down the Development activities with respect to such Collaboration Product, or (iii) propose to out-license or otherwise divest such Collaboration
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Product, subject to the Opt-Out Party’s agreement. After the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, the Non Opt-Out Party shall notify the Opt-Out Party of its decision to elect subsection (i), (ii) or (iii) in the foregoing within [***] following the Opt-Out Effective Date for such Collaboration Product (the “Non Opt-Out Notice”), provided that, [***], the election by the Non Opt-Out Party of subsections (i), (ii) or (iii) in the Non Opt-Out Notice shall not [***]. The Opt-Out Party shall, upon reasonable request by the Non Opt-Out Party, discuss with the Non Opt-Out Party in good faith, and cooperate to facilitate its decision-making, including by [***].
(b) If, after the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, the Non Opt-Out Party elects to continue with the Development and Commercialization of such Collaboration Product (which shall thereafter become a Sole Development Product and cease being a Collaboration Product), then:
(i) the Opt-Out Party’s rights to share any Pre-Tax Profit or Loss in such Collaboration Product pursuant to Section 9.2 shall cease upon receipt of the Non Opt-Out Notice and the Opt-Out Party shall be entitled to receive royalties from the Non Opt-Out Party on Net Sales of such Sole Development Product in accordance with Section 9.5;
(ii) the Non Opt-Out Party shall [***] perform such activities;
(iii) the Opt-Out Party shall, subject to Section 10.2, provide reasonable assistance requested by the Non Opt-Out Party to (A) transfer or transition to the Non Opt-Out Party (or wind down, if applicable) all activities for which such Opt-Out Party was responsible prior to the exercise of the Opt-Out Option, [***]; (B) transfer to the Non Opt-Out Party relevant Data, information and materials [***], in each case ((A) or (B)), to the extent necessary for the Non Opt-Out Party’s continued conduct of Development, Manufacturing and Commercialization of such Sole Development Product, [***];
(iv) with respect to [***], the Opt-Out Party shall, at the Non Opt-Out Party’s request [***], if the Opt-Out Party is required to [***] with respect to the Development, Manufacture and Commercialization of any Sole Development Product, then [***]; and
(v) the JRDC, the JSC or other Committees shall no longer have authority over such Sole Development Product, and the applicable Development Plan and Development Budget will be of no further effect with respect to such Sole Development Product other than with respect to costs incurred prior to the Opt-Out Effective Date.
(c) If, after the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, the Non Opt-Out Party elects, [***] [***], to cease and wind down the Development activities with respect to such Collaboration Product, the Non Opt-Out Party shall conduct winding down activities in accordance with all applicable Law, and the Opt-Out Party shall, upon Non Opt-Out Party’s reasonable request, provide reasonable assistance with such winding down activities. [***].
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(d) If, (i) after the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, the Non Opt-Out Party elects, [***], or (ii) after the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, [***] and the Non Opt-Out Party elects to, [***], in either case ((i) or (ii)), cease any further funding of, or Development or Commercialization activities with respect to such Collaboration Product, and out-license or otherwise divest such Collaboration Product, then (A) [***], (B) [***], and (C) [***].
(e) If, after the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, (i) the Non Opt-Out Party elects to, [***], cease any further funding of, or Development or Commercialization activities with respect to such Collaboration Product, and out-license or otherwise divest such Collaboration Product, and (ii) [***], then (A) [***], (B) [***] and (C) [***].
5.6.5 Animal Welfare. With respect to any Development activities conducted by either Party under this Agreement that involve the use of animals, including any animal studies, such Party agrees to comply with the terms of Schedule 5.6.5. For the avoidance of doubt, during the Term, neither Vir nor its Affiliates (either internally or through enabling a Third Party) shall Develop or Commercialize any Antibody Product for purposes of veterinary use.
ARTICLE 6
REGULATORY ACTIVITIES
6.1 Generally. Generally, the Parties will discuss and seek to agree upon the appropriate regulatory strategy for each Collaboration Product, taking into account any accelerated pathways to Regulatory Approval that may be available in connection with CoVID-19 and other diseases associated with Coronavirus infection.
6.2 Meetings and Communications. During the Term, each Party shall keep the other Party reasonably informed of any material communications from, or meetings with, any Regulatory Authority pertaining to such Party’s Development activities performed under this Agreement. To the extent relating to a Collaboration Product, the Party that is the regulatory sponsor or, following the release of headline data of the relevant Clinical Study, the applicant for the Drug Approval Application with respect to such Collaboration Product, shall provide the other Party with: (a) to the extent allowable by applicable Laws and the relevant Regulatory Authority and to the extent practicable, an opportunity to have one or more of its representatives attend and observe [***] in substantive discussions and meetings with the FDA or any other Regulatory Authority with respect to any Clinical Studies or other matters (e.g., CMC or non-clinical issues); (b) a copy of any material documents, reports or correspondence submitted to the FDA or any other Regulatory Authority; and (c) reasonable advanced notice (to the extent practicable) of substantive meetings, scheduled or unscheduled, with the FDA or any other Regulatory Authority. All such documents or reports described in subclause (b) above shall be provided to the JRDC at least [***] prior to their submission to the applicable Regulatory Authority (or such later date as the Parties may reasonably agree). To the extent a Party receives material written or oral communications from the FDA or any other Regulatory Authority relating to a Collaboration Product or activities under this Agreement with respect to a Collaboration Product, such Party shall notify the other Party and provide a copy of any such written communications to the other Party [***]. In addition, upon a reasonable request from the other Party, each Party shall provide copies of other documents, reports or communications from or to Regulatory Authorities relating to Collaboration Products.
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6.3 Regulatory Submissions.
6.3.1 Regulatory Filings.
(a) For Collaboration Programs other than the Antibody Program, the Lead Party (and the LCP) for such Collaboration Program shall, in its own name, obtain and maintain all Regulatory Filings and Regulatory Approvals for Development, Manufacture and Commercialization of such Collaboration Products, including INDs, NDAs, BLAs, Regulatory Approvals for product labeling or promotional materials and other items filed with the FDA or other Regulatory Authorities with respect to any Collaboration Product under such Collaboration Program.
(b) For the Antibody Program Vir, as the initial Lead Party, shall, in its own name, obtain and maintain Regulatory Filings for an Antibody Product prior to the filing of the first Drug Approval Application for such Antibody Product. [***]. After filing of the first Drug Approval Application for any Antibody Product, GSK shall be responsible for all subsequent Regulatory Filings and Regulatory Approvals for Development, Manufacture and Commercialization of such Antibody Product, in GSK’s name. The rights of GSK under this ARTICLE 6 with respect to an Antibody Product is subject to WuXi’s right with respect to Antibodies against SARS-COV-2 under the WuXi Agreement.
6.3.2 Other Filings. The Parties may discuss, through the JPC, regarding submission of patent information to the FDA as required for listing in the Orange Book (as required by 21 C.F.R. §214.53 (d)(2) and 35 U.S.C. §156 (Hatch-Waxman Act)), the “Purple Book” (or other Orange Book-equivalent database or listing for Biologics), or any foreign equivalents thereof, provided that the LCP shall have the decision-making authority and shall be responsible for such submission. Additionally, the LCP shall be responsible for all acts required of the reference product sponsor under the US Biologicals Price Competition and Innovation Act of 2009 (42 U.S.C. § 262) (“Biologics Act”), or any foreign equivalents thereof. Specifically, (a) for the Vaccine Program and the Functional Genomics Program, the LCP, and (b) for the Antibody Program, Vir (provided that Vir will reasonably consult with GSK through the JPC and shall consider in good faith GSK’s comments relating thereto), will control all of the actions, filings, and communications with any follow-on biologic applicant under the Biologics Act with respect to Collaboration Products including generating the following documents: [***].
6.4 Exchange of Development Data. Without limiting the other provisions of this Agreement, at the request of the Lead Party, or upon direction by the JSC or JRDC, the Non-Lead Party shall provide to the Lead Party [***] pertinent Data developed by or on behalf of the Non-Lead Party, as applicable, in connection with the Development of a Collaboration Product this Agreement or the performance of other activities under the Plans [***] for the Lead Party to satisfy Regulatory Approval requirements for application or maintenance of Regulatory Approvals of such Collaboration Product. The format of, and media for exchanging, such Data shall be decided by the JRDC. Each Party shall have the right, without obtaining the approval of the other
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Party and without additional payment to such other Party (other than payments expressly provided in this Agreement), to reference, access and use such Data, and all reports, documents and other information developed by any Party that is derived from such Data, (a) for purposes of preparing and submitting INDs, NDAs, BLAs and other Regulatory Filings for the Collaboration Products in the applicable Collaboration Program, and (b) preparing and filing patent applications, in each case ((a) and (b)) in accordance with this Agreement, and, with respect to such Data, reports, documents and other information developed by the other Party, solely to the extent permitted under this Agreement.
6.5 Lead Party Opt-Out. If the Lead Party exercises its Opt-Out Option with respect to a Collaboration Product pursuant to Section 5.6, and the Non-Lead Party elects to continue with the Development and Commercialization of such Collaboration Product as a Sole Development Product, then the Non-Lead Party shall notify the Lead Party in writing of such election, and thereafter shall be solely responsible for any Regulatory Filing or other regulatory activities with respect to such product. The Lead Party shall, upon reasonable request of the Non-Lead Party and to the extent permissible under applicable Law, transfer all regulatory documentation, including any Regulatory Filing or Regulatory Approval for such product Controlled by such Lead Party to the Non-Lead Party, and the Parties shall share the cost of such regulatory transfer in accordance with the profit-share percentages set forth in Section 9.2.1, as applicable. To the extent that such regulatory transfer is not permissible under applicable Law, the Parties shall discuss in good faith, and agree on a regulatory strategy to maintain such regulatory documentation for such Collaboration Product.
ARTICLE 7
COMMERCIALIZATION
7.1 General. Subject to the remainder of this ARTICLE 7, and any applicable Co-Promotion Agreement between the Parties, GSK shall be the LCP for each Collaboration Product, and GSK or its Affiliates shall have the sole right and responsibility for (a) Commercializing all Collaboration Products in the Territory, including [***]; and (b) all decisions for all Commercialization activities relating to each Collaboration Product, including [***]; provided that GSK’s right to Commercialize any Collaboration Product shall be subject to rights granted to WuXi in the WuXi Territory for Antibody directed to SARS-COV-2. [***].
7.2 Commercialization Plan.
7.2.1 With respect to each Collaboration Product, in connection with the determination to file the first Drug Approval Application for such Collaboration Product, the LCP shall prepare and provide to the JCC a commercialization plan (the “Commercialization Plan”) for such Collaboration Product. The LCP shall provide the initial Commercialization Plan for each Collaboration Product to the JCC [***]. Each such initial Commercialization Plan shall include, (a) [***]; (b) [***]; (c) [***]; (e) [***]; and (f) [***].
(a) With respect to the initial Commercialization Plan (including the associated Commercialization Budget) [***], the JCC shall review and approve such Commercialization Plan and shall submit such Commercialization Plan to the JSC for the JSC to review and approve, with the exception of the portion relating to plans for Commercial
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Manufacture and supply for Commercialization, which shall be submitted to the JMC for review and approval prior to submission to the JSC for review and approval. If the JSC cannot agree on the Commercialization Plan submitted by the JCC within [***] after being submitted by the JCC or the JMC, whichever is later, then such dispute shall be resolved in accordance with Section 3.9.2. Each initial Commercialization Plan and associated Commercialization Budget [***] will go into effect once approved by the JSC in accordance with Section 3.9.
(b) With respect to the initial Commercialization Plan (including the associated Commercialization Budget) [***], the JCC and the JSC shall review and discuss, and [***].
7.2.2 The LCP shall prepare and submit to the JCC for review and approval, on an annual basis, any material changes to each Commercialization Plan, including any updates to the Commercialization Budget for each Collaboration Product, no later than [***] of each Calendar Year.
(a) With respect to the Commercialization Plan (including the associated Commercialization Budget) [***], the JCC shall review and approve such annual updates and shall submit such updates to the JSC for review and approval. If the JSC cannot agree on such updates submitted by the JCC within [***], then such dispute shall be resolved in accordance with Section 3.9.2. Upon the JSC’s preliminary approval, such updates shall be submitted to each Party for its internal budgeting process with a target for final approval no later than [***] of each Calendar Year, at which time any such approved update shall be appended to the Commercialization Plan [***], provided that, [***]. Any material updates to the Commercialization Plans, including any updates to the associated Commercialization Budgets, for the Antibody Products and Functional Genomics Products shall not be effective without the approval of the JSC, subject to the terms and conditions of Section 3.9.
(b) With respect to the Commercialization Plan (including the associated Commercialization Budget) [***], the JCC and the JSC shall review and discuss all annual updates to such Commercialization Plans, and [***].
7.3 Commercialization Efforts. The LCP, by itself or through its Affiliates or Sublicensees, shall, following the receipt of Regulatory Approval for each Collaboration Product by the applicable Regulatory Authority in the applicable jurisdiction, use Commercially Reasonable Efforts to seek pricing and reimbursement approvals for and Commercialize such Collaboration Product in accordance with the Commercialization Plan in the United States, [***] (each, a “Major Market”). With respect to any Collaboration Product, the LCP shall be responsible for and have the exclusive right to seek and attempt to obtain pricing and reimbursement approvals for each Collaboration Product.
7.4 Co-Promotion Option of Vir.
7.4.1 On an Antibody Product-by-Antibody Product basis, Vir shall have the right to elect to co-detail a Collaboration Product that is an Antibody Product in the United States (the “Co-Promotion Option”) in accordance with an agreed Co-Promotion Agreement, as set forth in Section 7.4.2. The Co-Promotion Option shall only apply to each Collaboration Product that is an Antibody Product (“Co-Promotion Product”), and shall not apply to any other Collaboration Products, or Commercialization of any Collaboration Product outside the United States.
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7.4.2 Vir may exercise a Co-Promotion Option [***] (the “Co-Promote Exercise Date”). Vir shall, by delivery of a written exercise notice, indicate whether it desires to exercise the Co-Promotion Option with respect to such Antibody Product. [***]. If Vir [***] exercises its Co-Promotion Option, then the Parties shall discuss in good faith and agree on a co-promotion agreement with respect to the corresponding Co-Promotion Product (each a “Co-Promotion Agreement”). In such written notice, Vir shall elect a percentage of detailing for the applicable Co-Promotion Product in the United States, which percentage in each Co-Promotion Agreement in the United States shall not exceed twenty percent (20%) of all details of the Co-Promotion Product in the United States for any applicable period (as such percentage is implemented in the Co-Promotion Agreement). Vir may engage or employ a sales force [***], to conduct such details (or as otherwise may be reasonably agreed by the Parties), [***]. The Co-Promotion Agreement shall include provisions relating to [***]. Vir and its permitted sales force contractors shall conduct co-detailing activities with respect to the applicable Co-Promotion Product under the Co-Promotion Agreement [***].
7.4.3 Except for the conduct of detailing pursuant to a Co-Promotion Agreement with respect to a Co-Promotion Product in the United States and except as permitted by the WuXi Agreement in the WuXi Territory, Vir and its Affiliates shall not market, promote or otherwise Commercialize a Co-Promotion Product anywhere in the Territory.
7.5 Right to Subcontract Commercialization Activities; Distribution. GSK shall have the right to (sub) contract, license or sublicense to its Affiliates or Third Parties with respect to the performance of any or all of its Commercialization activities, provided that GSK may not, without the consent of Vir [***] grant a sublicense to a Third Party to conduct marketing and promotional activities in the United States for any Antibody Product for which Vir has exercised its Co-Promotion Option. Except as otherwise set forth in the Co-Promotion Agreement between the Parties, (a) GSK and its Affiliates shall book all sales of Collaboration Products and [***]; and (b) Vir and its Affiliates shall not accept orders for any Collaboration Products or sell any Collaboration Products for its or their own account or for GSK’s or its Affiliate’s account, and if Vir or its Affiliates receive any order for Collaboration Products in the Territory, they shall refer such orders to GSK or its designated Affiliate(s) for acceptance or rejection.
7.6 Commercialization Reports. GSK shall provide a written report to the JCC describing material Commercialization activities with respect to all Collaboration Products Commercialized by GSK or any of its Affiliates, Sublicensees or distributors [***]. Such reports shall include [***].
7.7 GSK Opt-Out. If GSK exercises its Opt-Out Option with respect to a Collaboration Product pursuant to Section 5.6, and if Vir, as the Non Opt-Out Party, elects to continue with Commercialization of such Collaboration Product, then, notwithstanding anything to the contrary in this ARTICLE 7, Vir shall be the LCP for such Collaboration Product, and the rights and obligations of GSK set forth in this ARTICLE 7 (other than with respect to the Co-Promotion Agreement), shall apply to Vir mutatis mutandis.
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ARTICLE 8
PHARMACOVIGILANCE AND MEDICAL AFFAIRS
8.1 Pharmacovigilance Technical Agreement. For each Collaboration Product the Parties shall enter into, no later than such date as required to comply with applicable Law, an appropriate agreement setting forth the processes and procedures for the collection, management, assessment and reporting of Adverse Event with respect to such Collaboration Product and [***] (each, a “Pharmacovigilance Technical Agreement”), which shall include the terms set forth on Schedule 8.1.
8.2 Costs. The incremental portion of the Parties’ costs and expenses incurred in maintaining the databases described in Section 8.1 attributable to the Collaboration Product and the Parties’ costs and expenses incurred in conducting audits pursuant to a Pharmacovigilance Technical Agreement shall [***].
8.3 Medical Inquiries. The Lead Party for a Collaboration Product shall handle all medical questions or inquiries from members of the medical profession for such Collaboration Product. In the event a Non-Lead Party receives any medical questions or inquiries, the Non-Lead Party shall refer the question or inquiry to the Lead Party within [***] (or such other timeframe as the Parties may agree in writing) in accordance with the relevant policies of the Lead Party as provided to the Non-Lead Party from time to time.
ARTICLE 9
FINANCIAL PROVISIONS
9.1 Development Costs
9.1.1 Antibody Development Costs. Subject to Section 5.6 and any other provisions expressly set forth in this Agreement, the Parties will share all Development Costs associated with activities under the Antibody Development Plan in accordance with the existing Development Budget therefor, with Vir bearing 72.5% and GSK bearing 27.5% of such Development Costs. Any Development Costs incurred in excess of the agreed upon Development Budget (including any Permitted Overage and Excess Costs) in the Antibody Development Plan will be subject to the terms set forth in Section 9.3.
9.1.2 Vaccine Development Costs. Subject to Section 5.6 and any other provisions expressly set forth in this Agreement, the Parties will share all Development Costs associated with activities under the Vaccine Development Plan, in accordance with the existing Development Budget therefor, with GSK bearing 72.5% and Vir bearing 27.5% of such Development Costs. Any Development Costs incurred in excess of the agreed upon Development Budget (including any Permitted Overage and Excess Costs) in the Vaccine Development Plan will be subject to the terms set forth in Section 9.3.
9.1.3 Functional Genomics Development Costs. Subject to Section 5.6 and any other provisions expressly set forth in this Agreement, the Parties will share equally all Development Costs associated with activities under the Functional Genomics Development Plan, in accordance with the existing Development Budget therefor, with each of GSK and Vir bearing 50% of such Development Costs. Any Development Costs incurred in excess of the agreed upon Development Budget (including any Permitted Overage and Excess Costs) in the Functional Genomics Program will be subject to the terms set forth in Section 9.3.
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9.1.4 Development Costs After Opt-Out. In the event that either Party exercises its Opt-Out Option for a particular Collaboration Program pursuant to Section 5.6, the Opt-Out Party shall remain liable for its share of Development Costs following the delivery of an Opt-Out Notice to the extent provided in Section 5.6.3.
9.2 Profit/Loss Sharing.
9.2.1 Subject to either Party becoming an Opt-Out Party pursuant to Section 5.6.1 in respect of a particular Collaboration Product, the Parties shall, [***], share in all Pre-Tax Profit or Loss for such Collaboration Product in the Territory, in accordance with the following percentages:
(a) for any Antibody Program, 72.5% for Vir and 27.5% for GSK;
(b) for any Vaccine Program, 72.5% for GSK and 27.5% for Vir; and
(c) for any Functional Genomics Program, 50% for each Party.
9.2.2 The calculation of the Pre-Tax Profit or Loss shall be in accordance with the provisions set out in the Financial Schedule.
9.3 [***]. [***]:
9.3.1 Vir’s share of Pre-Tax Profit or Loss shall first be calculated in accordance with Section 9.2.1(a), using SG&A Expenses as incurred, provided that, for purposes of this calculation, the SG&A Expenses for such Calendar Year shall not exceed the Initial Budget Cap or Increased Budget Cap or any greater amount of SG&A Expenses that Vir elects to bear for such Calendar Year, as applicable (“Calculated Net Profit”);
9.3.2 [***];
9.3.3 [***];
9.3.4 [***];
9.3.5 [***].
[***].
9.4 Reconciliation Procedures.
9.4.1 Reporting.
(a) Reporting Generally. On a Collaboration Product-by-Collaboration Product basis, within [***], each Party shall provide to the Financial Working Group a report of its actual Development Costs incurred with respect to such Collaboration Product for
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such [***] and, beginning with the first [***] in which the First Commercial Sale of such Collaboration Product occurs, a report of its calculation of actual Pre-Tax Profit or Loss with respect to such Collaboration Product for such [***] (each, a “Financial Report”), [***] in accordance with its Accounting Standards; provided, that the Financial Report of a Party’s calculation of Pre-Tax Profit or Loss for the [***] in which the First Commercial Sale of a Collaboration Product occurs will include any Allowable Expenses incurred by such Party with respect to such Collaboration Product prior to such [***]. Each Financial Report shall specify in reasonable detail, as applicable, [***] for such Collaboration Product in the corresponding [***] received and incurred by the reporting Party or any of its Affiliates or (sub)licensees in accordance with this Agreement in such [***]. [***].
(b) Net Sales Reporting. Without limiting the generality of Section 9.4.1(a), within [***] after the end of each [***], GSK shall provide the Financial Working Group with a report of the Net Sales for the preceding [***].
(c) [***].
(d) [***].
(e) Vir Reporting. In the event that Vir exercises its Co-Promotion Option pursuant to Section 7.4, or GSK exercises its Opt-Out Option with respect to a Collaboration Product pursuant to Section 5.6, the reporting obligations set out in this Section 9.4.1 shall apply to Vir mutatis mutandis in respect of those Collaboration Products for which Vir undertakes Commercialization.
9.4.2 Overruns.
(a) Each Party shall notify the other Party [***] that the anticipated Development Costs or Allowable Expenses to be incurred by such Party for a Collaboration Product for a given Calendar Year shall be in excess of the applicable approved Development Budget or Commercialization Budget, respectively, for such Collaboration Product for such Calendar Year.
(b) Following such notification, the Financial Working Group shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of Development Costs or Allowable Expenses, as applicable. To the extent, based on this discussion, the Financial Working Group concludes that the anticipated amount of the concerned category of Development Costs or Allowable Expenses is likely not to exceed [***] of the aggregate annual amounts budgeted (the “Permitted Overage”) to be incurred by or on behalf of the concerned Party for its activities for the Collaboration Product in such Calendar Year as set forth in the then-current applicable Development Budget or Commercialization Budget, respectively, such anticipated costs or expenses shall be included in the calculation of the applicable Development Costs or applicable Allowable Expenses for the purposes of calculating the Development Cost sharing pursuant to Section 9.1 or calculating the profit or loss sharing pursuant to Section 9.2, provided that:
(i) [***]; and
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(ii) [***].
(c) If the Financial Working Group concludes that:
(i) the anticipated amount of the applicable Development Costs or Allowable Expenses is likely to exceed the Permitted Overage (such amount the “Excess Costs”); and
(ii) there are no mitigation measures to prevent such Excess Costs, the JSC shall discuss in good faith a corresponding amendment of the concerned Development Budget or Commercialization Budget, as applicable, to reflect the anticipated Excess Costs. [***].
(d) [***].
(e) [***].
(f) [***].
9.4.3 Reconciliation and Payment.
(a) Reconciliation Discussion. In the event that either Party has any questions or concerns regarding the Development Costs or calculation of Pre-Tax Profit or Loss reported by the other Party in a Financial Report pursuant to Section 9.4.1, the Financial Working Group shall endeavor to resolve such questions and concerns of either Party within [***]. Additionally, the Financial Working Group may by mutual agreement adjust the timing for notification or payment of any reconciliation payments hereunder.
(b) [***]. Unless such timing is otherwise modified by the Financial Working Group, [***] after receipt of each Party’s Financial Report provided pursuant to Section 9.4.1, the Financial Working Group shall confer and agree in writing on a reconciliation report setting out the calculation of any payment to be paid by Vir to GSK or by GSK to Vir, as the case may be, (“Balancing Payment”) in order to effect the sharing of Development Costs in accordance Section 9.1 and the sharing of Pre-Tax Profit or Loss in accordance with Section 9.2, [***]. In the event of any dispute regarding any Balancing Payment due, the Parties shall use good faith efforts to resolve the dispute provided that, if not so resolved within [***], such dispute shall be resolved pursuant to Section 9.12. Each Party that is owed a Balancing Payment shall invoice the other Party for the amount of the Balancing Payment due and the other Party shall pay such invoiced amount within [***] after delivery of such invoice; provided that, in the event of any dispute regarding the Balancing Payment due, the undisputed portion of such Balancing Payment shall be paid in accordance with the foregoing timetable by the applicable Party, and the remaining, disputed portion shall be paid in accordance with Section 9.12.
9.5 Opt-Out Royalties and Payments.
9.5.1 In the event that a Party exercises its Opt-Out Option in respect of a Collaboration Product pursuant to Section 5.6, from the date the applicable Opt-Out Option becomes effective, the Opt-Out Party’s rights to share in future Pre-Tax Profit or Loss in respect of such Collaboration Product shall cease, and the Opt-Out Party shall be entitled to royalties and payments pursuant to this Section 9.5.
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9.5.2 Net Sales Royalties. With respect to any Sole Development Product, on a country-by-country basis, commencing on the First Commercial Sale of the applicable Sole Development Product in the Territory, [***], the Non Opt-Out Party shall pay to the Opt-Out Party royalties (determined by the timing of the exercise of the Opt-Out Option) on Net Sales of such Sole Development Product in the Territory during each Calendar Year at the rates set forth in Schedule 9.5.2.
9.5.3 Royalty Step-Down.
(a) [***]. [***], the Parties will discuss, [***], an equitable reduction to the royalties payable to the Opt-Out Party pursuant to Section 9.5.2, taking into account [***].
(b) [***]. If, with respect to a Sole Development Product in a country in the Territory, [***], the royalty rates set forth in Section 9.5.2 for such Sole Development Product in such country (after giving effect to any reductions pursuant to Section 9.5.3) shall be reduced in such country by [***], as determined by [***].
9.5.4 Royalty Payment and Reporting. The paying Party shall, within [***], pay to the receiving Party the royalties due for such [***]. At the same time as such payment, the paying Party shall furnish to the receiving Party a written report showing on a Sole Development Product-by-Sole Development Product and country-by-country basis the total Net Sales of a Sole Development Product in a country in the Territory for that [***] stated in U.S. Dollars and the royalties due thereon. The paying Party will keep complete and accurate records in sufficient detail to enable the royalties payable to be determined and the information provided to be verified. With respect to Net Sales of Sole Development Products invoiced in a currency other than U.S. Dollars, such amounts and the royalty amounts payable under this Agreement shall be expressed in U.S. Dollar equivalent calculated using [***].
9.6 Third Party Technologies and [***].
9.6.1 If, during the Term, in connection with a Collaboration Program, either Party determines, in its reasonable judgment, that it is [***] to obtain rights under any Third Party Intellectual Property Rights in order to Develop, Manufacture or Commercialize any Collaboration Products pursuant to this Agreement, then it shall notify the JPC of such Third Party Intellectual Property Rights, along with (where reasonably practical) a proposal of the terms upon which such Third Party Intellectual Property Rights are available to license or acquire for use in connection with the applicable Collaboration Products. The JPC, and if the JPC cannot agree, then upon escalation, the JSC, shall determine whether or not to seek a license under or to acquire such Third Party Intellectual Property Rights for purposes of Developing, Manufacturing or Commercializing such Collaboration Products. If the JPC or the JSC, as applicable, determines to seek such a license or acquisition, then, the Lead Party shall take the lead in negotiating the agreement pursuant to which a license under or acquisition of such Third Party Intellectual Property Rights would be obtained (the “Blocking Third Party IP Agreement”), provided that [***].
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9.6.2 If a Blocking Third Party IP Agreement is entered into in accordance with Section 9.6.1 with respect to a Collaboration Product, any amounts paid by the Lead Party to any Third Party under such Blocking Third Party IP Agreement that are attributable or allocable to such Collaboration Product shall be deemed Blocking Third Party IP Costs and included within Development Costs (to the extent applicable to Development or Manufacturing for Development) for purposes of Development Cost sharing or included within Allowable Expenses (to the extent applicable to Commercialization and Commercial Manufacture) for calculating Pre-Tax Profits or Loss pursuant to the Financial Schedule.
9.6.3 Notwithstanding Sections 9.6.1 and 9.6.2, the Parties acknowledge and agree that if they elect to conduct a technology transfer of Manufacturing technology arising as a result of activities conducted under [the WuXi Agreement or the Biogen Agreement, in order to have Commercial Manufacture performed by Vir, GSK or any Third Party, then such Commercial Manufacture will be subject to the terms of licenses granted by WuXi or Biogen, as applicable, to Vir under certain Intellectual Property Rights Controlled by WuXi or Biogen, respectively, including certain rights relating to (a) use of cell lines under the WuXi Agreement, and (b) Manufacturing yield improvements by Biogen (the “Biogen Yield Improvements”), which licenses granted by Biogen require the payment of specified “access fees” to Biogen in connection with Manufacturing yield improvements obtained in such Commercial Manufacture (the “Biogen Access Fees”). For the purposes of this Agreement, if the Parties mutually agree, through the JSC, to conduct a Manufacturing technology transfer from Biogen to any Third Party (or to GSK or Vir), then [***]. If the Parties mutually agree, through the JSC, to conduct a Manufacturing technology transfer from WuXi to any Third Party (or to GSK or Vir), then [***].
9.6.4 If, following the Opt-Out Effective Date for a Collaboration Product, the Non Opt-Out Party has elected to continue with the Development and Commercialization of such Collaboration Product in accordance with Section 5.6.4(a), then:
(a) If, with respect to a Sole Development Product, the Non Opt-Out Party determines, [***], that it is [***] to obtain rights under any Third Party Intellectual Property Rights in order to Develop, Manufacture or Commercialize such Sole Development Product, the Non Opt-Out Party shall have right, but not the obligation, to take the lead in negotiating the agreement pursuant to which a license under such Third Party Intellectual Property Rights would be obtained. If the Non Opt-Out Party (i) obtains a license to or acquires any such Third Party Intellectual Property Rights that are [***] for the Development, Manufacture or Commercialization of a Sole Development Product (i.e. where the Opt-Out Party is receiving only royalties in the Territory and not a share of Pre-Tax Profits or Loss) or (ii) is required to make payments under (A) any Existing Third Party IP Agreement, or (B) any Blocking Third Party IP Agreement existing as of the effective date of the applicable Opt-Out Option, in each case ((A) and (B)) with respect to a Sole Development Product, then the Non Opt-Out Party shall be permitted to offset [***] of the amounts paid to the applicable Third Party in consideration for the grant of such a license [***], against [***] payable to the Opt-Out Party [***], provided that, in each case ((i) or (ii)), [***].
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(b) If the Opt-Out Party is required to make payments under any Existing Third Party IP Agreement or any Blocking Third Party IP Agreement entered into by the Opt-Out Party prior the effective date of the applicable Opt-Out Option with respect to the Development, Manufacture or Commercialization of the Non Opt-Out Party’s Sole Development Product, then the Non Opt-Out Party shall reimburse the Opt-Out Party for all such payments and the Non Opt-Out Party shall be permitted to offset [***] of such amounts reimbursed to the Opt-Out Party ([***]) against [***] payable to the Opt-Out Party [***] with respect to such Sole Development Product, provided that, [***].
9.6.5 If, during the Term on a Collaboration Program-by-Collaboration Program basis, either Party wishes to [***], unless such Party exercises its Opt-Out Options with respect to a Collaboration Program, it shall [***].
9.7 Audits. Each Party shall, and shall ensure that its Affiliates and licensees and Sublicensees, keep complete and accurate records of [***]. Each Party will have the right, at its own expense and [***], to have an independent, certified public accountant, selected by such Party [***], review any such records of the other Party in the location(s) where such records are maintained by the other Party upon [***] prior written notice and during regular business hours and under obligations of confidentiality, for the sole purpose of verifying the basis and accuracy of payments made under this Agreement, with respect to any Calendar Year ending not more than [***] prior to the request of the auditing Party. If the review of such records reveals that the other Party has failed to accurately report financial information required to be reported hereunder, or to make any payment (or portion thereof) required under this Agreement, then the other Party shall pay, within [***], to the auditing Party any underpaid amounts due hereunder, together with interest calculated in the manner provided in Section 9.9. If any such discrepancies are greater than [***] of the amounts actually due for the audited period, the other Party shall pay all reasonable costs incurred in conducting such review. Once a Party has conducted a review and audit of the other Party pursuant to this Section 9.7 in respect of any given period, it may not subsequently re-inspect the other Party’s records in respect of such period, unless [***]. For clarity, however, if a discrepancy is identified by the accountant during the course of an audit and the Parties do not agree upon a resolution of such discrepancy, then the auditing Party’s accountant may re-inspect the books and records to the extent reasonably relevant to resolving such discrepancy.
9.8 Tax Matters. Each Party will make all payments to each other under this Agreement without deduction or withholding for Taxes (as that term is defined below) except to the extent that any such deduction or withholding is required by applicable Law in effect at the time of payment. The Parties shall [***] cooperate with one another to reduce or minimize any such deduction or withholding required by applicable Law, including by providing reasonable advance notice of such deduction or withholding by providing any forms or other certifications necessary to reduce the amount of such withholding. Each Party (including successors and assignees) shall, [***], provide the other Parties [***].
9.8.1 Any amount payable by one Party to the other under this Agreement is deemed to be exclusive of any amount in respect of any VAT chargeable on the supply for which that sum is the consideration (in whole or in part) for VAT purposes. If anything done by one Party under this Agreement constitutes, for VAT purposes, the making of a supply to the other Party and VAT is or becomes chargeable on that supply, the Party receiving the supply shall pay the other
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Party, in addition to any amount otherwise payable under this Agreement by the Party receiving the supply, a sum equal to the amount of the VAT chargeable on that supply against delivery of a valid VAT invoice to the Party receiving the supply. “VAT” means any value added, goods and services, sales, use, purchase, turnover or consumption tax as may be applicable in any relevant jurisdiction, including but not limited to value added tax chargeable under legislation implementing EU Council Directive 2006/112/EC.
9.8.2 Any Tax required to be withheld on amounts payable under this Agreement will be [***] paid by the Party making the payment (the “Payor”) on behalf of the Party receiving the payment (the “Payee”) to the appropriate Governmental Authority, and Payor will furnish Payee with proof of payment of such Tax. Any such Tax required to be withheld will be an expense of and borne by Payee and any amounts withheld and paid to the applicable Tax authority shall be treated as paid to the applicable Party for purposes of this Agreement. Notwithstanding anything to the contrary in this Agreement, if a Payor redomiciles, assigns, transfers, sublicenses or otherwise disposes of some or all of its rights and obligations to any Person (without the prior written consent of the Payee) (including an assignment of this Agreement as permitted under Section 20.4 of this Agreement) and if, as a result of such action, the withholding or deduction of tax required by applicable Law with respect to payments under this Agreement is increased (the “Increased Withholding Taxes”), then any amount payable to the Payee under this Agreement shall be increased to take into account such Increased Withholding Taxes as may be necessary so that, after making all required withholdings (including withholdings on the withheld amounts), the Payee receives an amount equal to the sum it would have received had no such action occurred. [***].
9.8.3 The Parties will reasonably cooperate with respect to all documentation required by any taxing authority or reasonably requested by either Party to secure a reduction in the rate of applicable withholding Taxes or an exemption from withholding Taxes. Notwithstanding the foregoing, if a Party is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, or recovery of, applicable withholding tax, then it may deliver to the other Party or the appropriate Governmental Authority the prescribed forms necessary to reduce the applicable rate of withholding or to relieve the payor of its obligation to withhold tax. If a Payee [***] delivers to the Payor a validly executed form establishing a reduced rate or exemption from withholding, the Payor shall apply the reduced rate of withholding, or not withhold, as the case may be, provided that the Payor is in receipt of evidence, in a form reasonably satisfactory to the Payor. If, in accordance with the foregoing, the Payor withholds any amount, then it will pay to the Payee the balance when due, [***] remit to the proper taxing authority of the withheld amount, and send the Payee proof of such remittance within [***] following the Payee’s request for such proof of remittance.
9.8.4 No Partnership. Nothing contained in this Agreement shall be deemed or construed by the Parties, any of their Affiliates, a Third Party, or any third person to treat the relationship between the Parties contemplated by this Agreement as a partnership, joint venture or other business entity under Treasury Regulations Section 301.7701-1(a)(2) (or any corresponding provision under state, local or non-U.S. tax Law) (an “Entity”). Without the prior written consent of the Parties (such consent not to be unreasonably withheld, delayed or conditioned), no Party (or successor or assignee) shall, for Tax purposes, report the relationships established by this Agreement as an Entity, including either (a) making any disclosure that the
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relationships established by this Agreement may give rise to an Entity (whether on a U.S. Internal Revenue Service Form 8275 or otherwise) or (b) withholding any amounts from payments made to the other Party pursuant to Section 1446 of the Code (or any corresponding provision under state, local or non-U.S. tax law), unless required by a tax authority on audit or other examination.
9.8.5 Independent Parties. The Parties agree and acknowledge that they are acting for their own account and do not intend this Agreement to result in an Entity. Each Party is acting on its own behalf and has obtained its own legal, tax, and investment advice regarding the execution of this Agreement and the rights and obligations arising herein. The Parties shall not maintain joint bank accounts and shall not commingle funds. No Party shall hold itself out as being an agent of any other Party or as having the legal right to bind or act on behalf of any other Party.
9.9 General Payment Terms. Unless otherwise expressly set forth herein, including in respect of the payment of Balancing Payments (which shall be paid in accordance with Section 9.4.3(b)) and in respect of the payment of royalties (which shall be paid in accordance with Section 9.5), the invoicing Party shall invoice the paying Party for any amounts due hereunder, and the paying Party shall pay such invoiced amounts within [***] from receipt of such invoice.
9.9.1 Without limiting either Party’s remedies under this Agreement, if a Party fails to pay any amount due under this Agreement by the relevant payment date when such amounts are due, the other Party may, [***].
9.9.2 Except as otherwise agreed by the Parties, all payments to be made by either Party to the other Party under this Agreement shall be made by such Party or its Affiliate in U.S. Dollars to the account designated by the Party to which the relevant payment is due. In the case of any amounts designated in another currency, then each Party shall convert such foreign currency into U.S. Dollars using [***].
9.10 Blocked Payments. In the event that, by reason of applicable Laws in any country, it becomes impossible or illegal for a Party or its Affiliate, licensee or Sublicensee to transfer, or have transferred on its behalf, payments to the other Party, such Party shall [***] notify the other Party of the conditions preventing such transfer and such payments shall [***].
9.11 Reporting; Financial Records. Unless otherwise defined or stated, financial terms shall be calculated by the accrual method under the applicable Party’s Accounting Standards. Financial records shall be maintained (in such form as may be available) for a period of no less than [***] following the end of the period to which they pertain.
9.12 [***]. The Parties will [***].
9.13 Resolution of Financial Disputes. In the event there is a dispute, claim or controversy relating to any financial obligation by one Party to the other Party pursuant to this Agreement, such Party shall provide such other Party with a written notice setting forth in reasonable detail the nature and factual basis for such good-faith dispute and, unless the Financial Working Group has already attempted to resolve the dispute, each Party agrees that it shall seek to resolve such dispute within [***] within the Financial Working Group after the date such written
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notice is received. If no resolution is reached by the Financial Working Group, the dispute shall be referred to the JSC for resolution, and if the JSC is unable to reach resolution within [***], then (a) if such dispute relates to [***], (b) if such dispute relates to [***], then such dispute shall be subject to the dispute resolution process set forth in Section 9.14. Notwithstanding any other provision of this Agreement to the contrary, the obligation to pay any reasonably disputed amount shall not be deemed to have been triggered until such dispute is resolved hereunder, provided that any undisputed portion of such payment shall be paid by the paying Party in accordance with the payment terms set forth in this Agreement including in Section 9.9 ([***]). Any disputed portion of any payment shall be paid by the responsible Party within [***] after the date on which the Parties, using good faith efforts, or the JSC (as applicable) resolve the dispute or, if not so resolved within [***], within [***] after such dispute is resolved pursuant to Section 20.1.
9.14 Specific Finance Disputes. If the Parties are unable to reach a mutually acceptable resolution of any dispute falling within Section 9.13(b) within [***], the dispute shall be submitted for resolution to [***]. Any amounts owed by one Party to the other Party as a result of such resolution shall be paid or reimbursed by the owing Party within [***].
ARTICLE 10
LICENSES
10.1 Collaboration Programs.
10.1.1 License Grant to GSK. On a Collaboration Program-by-Collaboration Program basis, Vir hereby grants to GSK as of the Effective Date the following:
(a) a co-exclusive (with Vir), worldwide (subject to Section 10.9.1), sublicensable (subject to Section 10.4) license under the Vir Licensed Technology and Vir Program Technology to Develop and Manufacture Collaboration Products arising from such Collaboration Program subject to any obligations of Vir to Third Parties with respect to the applicable Vir Licensed Technology, ([***]);
(b) an exclusive, worldwide (subject to Section 10.9.1), sublicensable (subject to Section 10.4) license under the Vir Licensed Technology and Vir Program Technology to Commercialize Collaboration Products arising from such Collaboration Program subject to any obligations of Vir to Third Parties with respect to the applicable Vir Licensed Technology, ([***]); provided that, for clarity, if Vir exercises its Co-Promotion Option, GSK will grant back to Vir such licenses under the Vir Licensed Technology and Vir Program Technology to the extent necessary for Vir to perform activities for which it is responsible under the Co-Promotion Agreement to be entered into by the Parties; and
(c) a non-exclusive, worldwide, royalty-free, perpetual license under the Vir Program Technology for GSK’s internal Research purposes only.
10.1.2 License Grant to Vir. On a Collaboration Program-by-Collaboration Program basis, GSK hereby grants to Vir as of the Effective Date the following:
(a) a non-exclusive, worldwide, sublicensable (subject to Section 10.4 [***]) license under the GSK Licensed Technology (i) to Develop and Manufacture
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Collaboration Products arising from such Collaboration Program subject to any obligations of GSK to Third Parties with respect to the applicable GSK Licensed Technology ([***]); and (ii) with respect to any Antibody Product for which Vir has exercised the Co-Promotion Option, to Commercialize such Antibody Product to the extent necessary for Vir to perform activities for which it is responsible under the Co-Promotion Agreement to be entered into by the Parties;
(b) a co-exclusive (with GSK), worldwide, sublicensable (subject to Sections 5.4 and 7.4 and [***]) license under GSK Program Technology (i) to Develop and Manufacture Collaboration Products arising from such Collaboration Program ([***]), and (ii) with respect to any Antibody Product for which Vir has exercised the Co-Promotion Option, to Commercialize such Antibody Product to the extent necessary for Vir to perform activities for which it is responsible under the Co-Promotion Agreement to be entered into by the Parties; and
(c) a non-exclusive, worldwide, royalty-free, perpetual license under the GSK Program Technology for Vir’s internal Research purposes only, [***].
10.1.3 The licenses set forth in Sections 10.1.1(a) and (b) and Sections 10.1.2(a) and (b) above shall remain in effect for each Collaboration Program until termination of this Agreement with respect to such Collaboration Program (but shall be adjusted as specified above and in Section 10.2).
10.2 Following Opt-Out Option.
10.2.1 Vir Sole Development Product. [***], the licenses granted to Vir above with respect to any Vir Sole Development Product shall be automatically adjusted to include only any GSK Licensed Technology or GSK Program Technology that (a) was used to conduct Development, Manufacturing or Commercialization activities in connection with such Vir Sole Development Product prior to GSK exercising its Opt-Out Option for such Collaboration Product and such Collaboration Product being designated as a Vir Sole Development Product, and (b) is necessary for continued Development, Manufacturing or Commercialization of such Vir Sole Development Product, [***].
10.2.2 GSK Sole Development Product. The licenses granted to GSK above with respect to any GSK Sole Development Product shall be automatically adjusted to include only any Vir Licensed Technology or Vir Program Technology that (a) was used to conduct Development, Manufacturing or Commercialization activities in connection with such GSK Sole Development Product prior to Vir exercising its Opt-Out Option for such Collaboration Product and such Collaboration Product being designated as a GSK Sole Development Product, and (b) is necessary for continued Development, Manufacturing or Commercialization of such GSK Sole Development Product, [***].
10.3 Rejected Collaboration Product License. In the event that, following the exercise of the Opt-Out Option by one Party for a Collaboration Product, the other Party does not wish to continue the further Development, Manufacturing or Commercialization of the applicable Collaboration Product (“Rejected Collaboration Product”), then,
10.3.1 if the Non Opt-Out Party has elected to wind down Development activities and has the right to take the lead on winding down Development activities with respect
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to such Rejected Collaboration Product in accordance with Section 5.6.4(c), then, except to the extent necessary for the purposes of winding down all Development activities with respect to such Collaboration Product, neither Party or its Affiliates shall have the right to use, infringe or otherwise exploit the Program Technology, GSK Licensed Technology and Vir Licensed Technology with respect to the Rejected Collaboration Product, and neither such Party or its Affiliates shall grant the right to any Third Party to engage in any activities with respect to such Rejected Collaboration Product.
10.3.2 if the Non Opt-Out Party has proposed to out-license or otherwise divest such rejected Collaboration Product and has the right to take the lead on (sub)licensing or otherwise divesting rights to such Rejected Collaboration Product pursuant to Section 5.6.4(d), then neither Party or its Affiliates shall have the right to use, infringe or otherwise exploit the Program Technology, GSK Licensed Technology and Vir Licensed Technology with respect to the Rejected Collaboration Product, and, except for purposes of such (sub)licensing or divestiture, neither such Party or its Affiliates shall grant the right to any Third Party to engage in any activities with respect to such Rejected Collaboration Product, in each case without the consent of the other Party.
10.3.3 For clarity, with respect to any Collaboration Program, [***].
10.4 Sublicenses. Subject to Section 10.5, each Party shall have the right to grant sublicenses to its Affiliates. Any sublicenses granted to a Third Party under the licenses granted to a Party under this ARTICLE 10 (each, a “Sublicensee”) shall be subject to the conditions set forth in this ARTICLE 10 (including Section 10.1.2, [***]. Any and all sublicenses shall be in writing and shall be subject to, and consistent with, the terms and conditions of this Agreement (including the Development Plan) applicable to sublicensees. The Party granting the sublicense shall be responsible for ensuring the compliance of its Sublicensees with all obligations owed to the other Party under this Agreement.
10.5 Licensing Program Technology. For purposes of the licenses granted to Program Technology hereunder, unless otherwise agreed by the Parties in writing, such licenses are not intended to include any Program Technology arising from the other Party’s activities with respect to any Sole Development Product after the date on which the Opt-Out Option is exercised. For clarity, with respect to a Collaboration Program, solely to the extent agreed by the JPC and the JRDC, the licenses granted to Program Technology shall include Program Technology arising from any other Collaboration Program.
10.6 No Implied Licenses. Each Party acknowledges that the licenses granted under this ARTICLE 10 are limited to the scope expressly granted, and all other rights to Patents and Know-How licensed hereunder are expressly reserved to the Party granting the license to such Patents or Know-How. Without limiting the foregoing, it is understood that where an exclusive license under Patents or Know-How is granted to a Party under this ARTICLE 10 for a particular purpose, the Party granting such license retains all of its rights to such Patents or Know-How for all other purposes not expressly stated herein.
10.7 Retained Rights. Any rights of a Party not expressly granted to the other Party under the provisions of this Agreement will be retained by such first Party.
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10.8 Rights in Bankruptcy. The Parties intend to take advantage of the protections of Section 365(n) (or any successor provision) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction to the maximum extent permitted by law. All rights and licenses granted under or pursuant to this Agreement, but only to the extent they constitute licenses of a right to “intellectual property” as defined in Section 101 of the U.S. Bankruptcy Code, shall be deemed to be “intellectual property” for the purposes of Section 365(n) or any analogous provisions in any other country or jurisdiction. The Parties shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, including the right to obtain the intellectual property from another entity. In the event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the Party that is not subject to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropriate) all such intellectual property (including all embodiments of such intellectual property), which, if not already in the non-subject Party’s possession, shall be [***] delivered to it upon [***]. Unless and until the subject Party rejects this Agreement, the subject Party shall perform this Agreement or provide the intellectual property (including all embodiments of such intellectual property) to the non-subject Party, and shall not interfere with the rights of the non-subject party to such intellectual property, including the right to obtain the intellectual property from another entity. In the case of an insolvency that is governed by non-U.S. bankruptcy law, the Parties agree that, to the extent not prohibited by the applicable insolvency law, the non-subject Party will be entitled to at least the same rights and protections afforded by the U.S. Bankruptcy Code, including survival of the licenses granted hereunder even if the subject Party revokes or terminates this Agreement and a copy of the embodiments of such intellectual property, without conditions other than any legally required payment of royalties.
10.9 Existing Third Party Agreements.
10.9.1 All licenses granted by a Party to the other Party in this ARTICLE 10 shall be subject to the licensing restrictions set forth in the Third Party agreements between such Party and any Third Party existing as of the Execution Date. Without limiting the foregoing, the licenses granted by Vir to GSK under Section 10.1.1 shall for the Antibody Program be subject to WuXi’s rights with respect to Antibodies directed to SARS-COV-2 under the WuXi Agreement, for so long as the WuXi Agreement is in effect.
10.9.2 Each Party shall have the right to propose to include any Patents or Know-How licensed to it under an Existing Third Party IP Agreement in its Licensed Technology for any Collaboration Product in accordance with Section 5.1 (as further described in Section 4.2.1, Section 4.3.1, or Section 4.4.1, as applicable), and such inclusion shall be reviewed and approved by the JRDC and the JPC. If the Parties cannot agree through the JPC or the JSC on whether to include any Third Party Intellectual Property Rights under an Existing Third Party IP Agreement, then, (a) [***], and (b) [***]. Schedule 10.9 sets forth the Existing Third Party IP Agreements that the Parties have agreed, as of the Effective Date, are [***] for the Development, Manufacture or Commercialization of the 309 Antibody Product. Notwithstanding the foregoing or anything to the contrary hereunder, (A) [***], and (B) [***].
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10.9.3 Without limiting Section 10.9.2, with respect to the Existing Vir Third Party Agreements set forth on Schedule 2.3.1 [***], if any Intellectual Property Rights arise from activities under such agreements [***].
ARTICLE 11
MANUFACTURING AND SUPPLY
11.1 General. For each Collaboration Program, the Parties will jointly through the JMC (and subject to each Party’s applicable final decision-making authority) determine a Manufacturing strategy with respect to the Manufacture and supply of any Collaboration Product, which may as appropriate include Manufacturing capabilities of both Parties or contract manufacturers. Promptly following the Effective Date, or following commencement of a particular Collaboration Program, where applicable, the Parties shall negotiate in good faith and execute any supply agreements between GSK and Vir required for the supply from GSK to Vir, or vice versa (each, a “Supply Agreement”) for the applicable Collaboration Products under applicable Collaboration Program(s), each, in accordance with the terms set forth herein, [***]. Any Supply Agreement for Commercial Manufacture during the Term shall include [***]. The Parties will, in connection with each such Supply Agreement, enter into a quality agreement (each, a “Quality Agreement”) that governs the quality of the applicable Collaboration Products supplied by one Party to the other Party thereunder.
11.2 Manufacturing Party. The Party that has the right to conduct Manufacturing and supply for a particular Collaboration Product hereunder shall be referred to as the “Manufacturing Party” with respect to such Collaboration Program. Except as may be otherwise specified in a Supply Agreement, the Manufacturing Party may Manufacture and supply the applicable Collaboration Product by itself and through Affiliates or through one or more contract manufacturers (each, a “CMO”) provided that any such subcontracting to a CMO shall be approved by the JMC. The Manufacturing Party for a Collaboration Product shall keep the JMC apprised regarding any material developments relating to the Manufacture and supply of such Collaboration Product. [***].
11.3 Antibody Program.
11.3.1 Parties’ Roles.
(a) During the three (3)-month period following the PCA Execution Date, Vir shall be the Lead Party for all Manufacturing activities (including Commercial Manufacture) for the Antibody Program, [***]. Following such three (3)-month period, GSK shall be the LCP and responsible for Commercial Manufacture for the Antibody Program, including [***].
(b) Without limiting Section 11.3.1, GSK acknowledges that following the PCA Execution Date, in connection with Vir’s obligations under Section 11.3.3, (i) Vir entered into the Samsung DS Letter Agreement, pursuant to which Vir has agreed to reserve drug substance (“DS”) Commercial Manufacture capacity for supply of Antibody Products, at the 15,000 liter scale in Samsung’s Plant #3 DS manufacturing facility, and Vir provided written notice to GSK of such commitments, and [***]. The Parties hereby agree that the costs associated
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with (x) the binding commitments set forth in the Samsung DS Letter Agreement, [***], and if approved by the JSC (including any approval of the JSC prior to the Execution Date) and documented in the applicable JSC meeting minutes, shall be included in Development Costs for purposes of the Development Cost sharing pursuant to Section 9.1.1 or in Allowable Expenses for purposes of profit or loss sharing pursuant to Section 9.2.1(a), in each case, as and when incurred.
(c) Following the PCA Execution Date and for the three (3)-month period thereafter, Vir shall [***].
(d) Vir shall [***].
(e) Prior to the first filing of the Drug Approval Application for an Antibody Product, Vir shall be the Lead Party and during the Term, shall be responsible for Manufacturing of clinical supply of such Antibody Product; after the filing of the first Drug Approval Application for such Antibody Product, GSK shall be the LCP and responsible for all Commercial Manufacturing activities with respect to such Antibody Product.
11.3.2 Manufacturing Technology Transfer. In connection with transitioning from Manufacturing for clinical supply to Commercial Manufacture for an Antibody Product, Vir shall use reasonable efforts to facilitate a Manufacturing technology transfer to GSK or its designee to enable GSK to conduct Commercial Manufacture activities, [***], for such Antibody Product. Without limiting the foregoing, [***], Vir shall [***].
11.3.3 Reservation of Manufacturing Capacity. In consultation with GSK, following the PCA Execution Date, Vir will [***] to secure Manufacturing capacity for (a) [***] or (b) Commercial Manufacture for Antibody Products with Samsung, WuXi, Biogen or other Third Party contract manufacturers. [***]. To the extent approved by the JSC, the costs for any Manufacturing capacity procured by Vir pursuant to commitments made by Vir in securing capacity in accordance with this Section 11.3.3, including the capacity described above and secured in [***] pursuant to the Samsung DS Letter Agreement will be shared as Development Costs or Allowable Expenses, as applicable, whether incurred by Vir [***]. For clarity, to the extent such costs are approved by the JSC (including any approval of the JSC prior to the Execution Date) and documented in the applicable JSC meeting minutes, if either Party is required to pay Samsung for any unused reserved Manufacturing capacity under the terms of the Samsung DS Letter Agreement (or successor agreement thereto) [***], such costs shall be included in Development Costs for purposes of the Development Cost sharing pursuant to Section 9.1.1 or in Allowable Expenses for purposes of profit or loss sharing pursuant to Section 9.2.1(a).
11.4 Other Collaboration Programs.
11.4.1 Except as otherwise set forth in this Section 11.4, or otherwise pursuant to an applicable Supply Agreement for a particular Collaboration Product, for Collaboration Programs other than the Antibody Program, GSK shall have the sole right to Manufacture and supply all Collaboration Product for use in such Collaboration Programs. If Vir is performing any Clinical Studies under a Collaboration Program for which GSK is the Lead Party, the Supply Agreement shall include provisions for the supply of applicable Collaboration Product to Vir for such purpose and specifying which Party would perform packing and labeling.
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11.4.2 [***].
11.5 Transition of Manufacturing and Supply. If the Manufacturing Party for a Collaboration Product elects to exercise its Opt-Out Option pursuant to Section 5.6.4(b), then promptly following the exercise of such Opt-Out Option by the Manufacturing Party, the Parties shall discuss through the JRDC and agree upon a Manufacturing technology transfer plan, subject to Section11.3.2, including a reasonable allocation of costs, for (a) the transfer to the new Manufacturing Party of responsibility for Manufacture of the applicable Collaboration Product for Development and Commercialization, including the transfer of the required Manufacturing process, and transfer and assignment to the new Manufacturing Party of any existing agreement (or portion thereof) relating to the Manufacturing and supply of the Antibody Products pursuant to Section 11.3.2, (b) any technical assistance agreed in such technology transfer plan and assumption of Manufacturing by the new Manufacturing Party or its designee, and (c) [***], any licenses required to be granted to the new Manufacturing Party in connection with such Manufacturing. During the period following the exercise of the applicable Opt-Out Option by the Manufacturing Party, and until Manufacturing for the applicable Collaboration Product is transferred in accordance with the foregoing subclauses (a) through (c), but in no event for longer than a period of [***], the previous Manufacturing Party shall continue to Manufacture and supply (itself or through an Affiliate or Third Party) the applicable Collaboration Product to the new Manufacturing Party, [***].
ARTICLE 12
SCIENTIFIC PUBLICATIONS AND PRESENTATIONS
12.1 Research and Pre-Clinical Publications. For each Collaboration Program, the Lead Party shall propose to the JRDC a global publication strategy for the Research and pre-clinical Development activities conducted with respect to such Collaboration Program (the “Research and Pre-Clinical Publication Strategy”) that is consistent with the applicable Development Plan. The JRDC (with consultation from the JPC, where applicable) shall review and approve such Research and Pre-Clinical Publication Strategy for each Collaboration Program, and may amend it from time to time. The Parties shall have no right to publish in relation to any Research or pre-clinical Development activities conducted hereunder other than as specified in the Research and Pre-Clinical Publication Strategy; provided that either Party shall have the right to re-publish or reference any publication (or information therein) previously published in accordance with the Research and Pre-Clinical Publication Strategy and any publication (or information therein) published prior to the Execution Date. If a Party desires to make a publication relating to activities being conducted under the applicable Development Plan, then it shall make such request to the other Party through the JRDC, and such publication shall be subject to review under Section 12.3 and the consent of such other Party, which shall not be unreasonably withheld.
12.2 Clinical Development Publications. For each Collaboration Program, the Lead Party shall propose to the JRDC a global publication strategy for the clinical Development activities related to the Collaboration Product(s) Developed under such Collaboration Program (the “Clinical Development Publication Strategy”) that is consistent with the Development Plan. The JRDC (with consultation from the JPC, where applicable) shall review and approve such Clinical Development Publication Strategy, and may amend it from time to time upon mutual agreement of the Parties. The Parties shall have no right to publish in relation to any clinical
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Development activities other than as specified in the Clinical Development Publication Strategy; provided that either Party shall have the right to re-publish or reference any publication (or information therein) previously published in accordance with the Clinical Development Publication Strategy and any publication (or information therein) published prior to the Execution Date. If a Party desires to make a publication relating to a Clinical Study that is being conducted under the Development Plan, then it shall make such request to the other Party through the JDC, and such publication shall be subject to review under Section 12.3, and the consent of such other Party, which shall not be unreasonably withheld.
12.3 Review by the Parties. Except as required by applicable Law or court order, any proposed scientific or medical publications or public scientific or medical presentations covered by Section 12.1 or Section 12.2; shall be subject to the provisions of this Section 12.3. For any such publication or presentation, the publishing Party shall submit a copy of the proposed publication or presentation (including manuscripts, abstracts, posters, slides, scheduled interviews or the like) to the representative of the other Party designated to receive such proposed publications [***] prior to any submission or disclosure to any Third Party to allow the other Party to review such proposed publication or presentation. The reviewing Party shall provide the publishing Party with its comments, if any, in writing within [***] after receipt of such proposed publication. The publishing Party shall consider [***] any comments thereto provided by the reviewing Party and shall comply with the reviewing Party’s request to remove any and all of the reviewing Party’s Confidential Information from the proposed publication. In addition, upon the reviewing Party’s reasonable request, the publishing Party shall delay the submission for a period up to [***] to permit the preparation and filing of a patent application. If the reviewing Party fails to provide its comments to the publishing Party within such [***], the reviewing Party shall be deemed to not have any comments. Each Party shall not, and shall cause each of its Affiliates and its and their Sublicensees not to, from and after the Execution Date, make any publications or public disclosures regarding any Collaboration Product, Development Candidate or Target under the Collaboration Programs in accordance with this Section 12.3.
12.4 Third Parties. With respect to any agreements between a Party and Third Parties (including clinical investigators) that a Party enters into after the Effective Date relating to the Development of any Collaboration Product or otherwise relating to Development activities under this Agreement, such Party shall use reasonable efforts to include publication provisions regarding results of preclinical studies or Clinical Studies for such Collaboration Products that allow such Party to receive and provide a copy of any proposed publications or public presentations to the other Party, which such Party shall submit to the other Party with a reasonable amount of time for review as described in this ARTICLE 12.
12.5 Lead Party Publication. Notwithstanding the provisions of ARTICLE 16 and Sections 12.1 and 12.2, subject to the review process and each Party’s obligations set forth in Section 12.3, the Lead Party for a given Collaboration Program and Vir, in the case of the Antibody Program, at all times, whether or not it is the Lead Party at such time (such Party, as applicable, the “Lead Publication Party”) or its Affiliates shall have the right as required by applicable Law or the Lead Publication Party’s or its Affiliates’ policies and standard operating procedures to (a) publish protocol summaries, results summaries, protocols, clinical study reports, plain language summaries and other study documents of all Clinical Studies conducted by or on behalf of such Lead Publication Party with respect to any Collaboration Product during the Term of this
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Agreement in any clinical trial register; (b) publish the results at scientific congresses and in peer-reviewed journals; (c) publicly disclose results from other Clinical Studies where the Lead Party determines that the results are scientifically important or relevant for patient care; and (d) make any other public disclosures of clinical Data that become required of the Lead Publication Party due to its internal policies and procedures or applicable Laws. Any publication or disclosure made by either Party pursuant to this Section 12.5 shall contain appropriate acknowledgements of the contribution of the other Party or Third Party to the Research or Development activities that are the subject of such publication, in accordance with generally accepted academic practice.
12.6 Publication after Opt-Out. With respect to a Sole Development Product, the Opt-Out Party shall not have the right to make any publication following its delivery of an Opt-Out Notice with respect to such Sole Development Product without the Non Opt-Out Party’s prior written consent; provided that the Opt-Out Party shall have the right, without the Non Opt-Out Party’s prior written consent, to re-publish or reference any publication (or information therein) previously published in accordance with this ARTICLE 12 and any publication (or information therein) published prior to the Execution Date. The Non Opt-Out Party shall have the right to make any publication relating to the pre-clinical or clinical Development activities with respect to such Sole Development Product, subject to review in accordance with Section 12.3.
ARTICLE 13
MATERIALS TRANSFER; INTELLECTUAL PROPERTY; INFORMATION TECHNOLOGY
13.1 Materials Transfer.
13.1.1 During the course of a Collaboration Program, either Party (or such Party’s designee) (the “Materials Transferring Party”) may transfer to the other Party or its designee (the “Materials Receiving Party”) certain Materials for use in connection with activities contemplated under this Agreement. Such Materials will be provided under the terms and conditions of this Agreement and in such amount as described in the material transfer record for the particular transfer (“MTR”), in the form attached hereto as Schedule 13.1.1, which MTR shall set forth the type and name of the Materials transferred, the amount of the Materials transferred, the date of the transfer of such Materials and the proposed use of such Materials by the Material Receiving Party.
13.1.2 MATERIALS SUPPLIED BY THE MATERIALS TRANSFERRING PARTY HEREUNDER ARE SUPPLIED IN “AS IS” CONDITION WITH NO WARRANTY, EXPRESS, IMPLIED OR STATUTORY, INCLUDING WARRANTIES OF MERCHANTABILITY, TITLE, NON-INFRINGEMENT, EXCLUSIVITY, OR FITNESS FOR A PARTICULAR PURPOSE. ANY MATERIAL DELIVERED PURSUANT TO THIS AGREEMENT IS UNDERSTOOD TO BE EXPERIMENTAL IN NATURE AND MAY HAVE HAZARDOUS PROPERTIES. THE MATERIALS RECEIVING PARTY WILL HANDLE THE MATERIAL ACCORDINGLY AND WILL INFORM THE MATERIALS TRANSFERRING PARTY IN WRITING OF ANY ADVERSE EFFECTS EXPERIENCED BY PERSONS HANDLING THE MATERIAL.
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13.1.3 The Materials Receiving Party acknowledges that, except for the licenses and other express rights granted herein, it does not have any claim to the Materials supplied by the Materials Transferring Party, or any license or rights to any proprietary information or intellectual property rights in or to the Materials. For clarity, the Materials (and any Intellectual Property Rights, including Patents, relating thereto) shall remain the sole and exclusive property of the Materials Transferring Party and shall be returned or destroyed at the request of the Materials Transferring Party.
13.1.4 The Materials Receiving Party agrees that the Material(s):
(a) will be used solely for, and in compliance with, the applicable Development Plan or in the MTR, and to conduct analyses to confirm identity and purity as may be reasonable required for the purposes of the applicable Collaboration Program;
(b) will be used in compliance with all applicable Laws;
(c) will not be used in human subjects, in clinical trials, or for diagnostic purposes involving human subjects;
(d) will not be used in animals intended to be kept as domestic pets;
(e) will be used only by the Materials Receiving Party and only in the Materials Receiving Party’s laboratory, except with the prior written consent of the Materials Transferring Party; and
(f) will not be transferred to a Third Party without the prior written consent of the Materials Transferring Party.
The Materials Receiving Party shall not reverse engineer or attempt to determine the chemical structure, make-up or sequence of, or determine the chemical or biological properties of, or make or attempt to make any analogues, progeny or derivatives of, or modifications to, such Materials except as may be necessary to carry-out such Party’s obligations hereunder, including its activities pursuant to any Development Plan. In the event that the Materials Receiving Party identifies or reasonably believes that there are any safety concerns related to the Material provided by the Materials Transferring Party, the Materials Receiving Party shall promptly notify the Materials Transferring Party in writing of such concerns and upon receiving such notification, the Materials Receiving Party shall promptly conduct investigations to address such concerns and shall keep the Materials Receiving Party reasonably informed of such investigation.
13.1.5 The Materials Receiving Party assumes all liability for damages which may arise from its use, storage or disposal of the Materials. The Materials Transferring Party shall not be liable to the Materials Receiving Party for any loss, claim or demand made by the Materials Receiving Party, or made against the Materials Receiving Party by any Third Party, due to or arising from the use of the Materials, except to the extent permitted by applicable Law when caused by the gross negligence or willful misconduct of the Materials Transferring Party. Upon the expiration or the earlier termination of a Collaboration Program, as applicable, except for any continuing rights as set forth in this Agreement, the Materials Receiving Party shall discontinue its use of any Materials and shall, upon direction of the Materials Transferring Party, return or destroy (and certify destruction of) any remaining Material.
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13.2 Ownership of Intellectual Property.
13.2.1 Inventorship. For purposes of this Agreement, the determination of inventorship of any Know-How, whether or not patentable, first invented, discovered, created or developed in the course of performing activities under the Collaboration pursuant to this Agreement, and whether solely or jointly by or on behalf of a Party, including by its employees, Affiliates, agents or independent contractors, shall be made in accordance with United States patent Law.
13.2.2 Program Technology.
(a) As between the Parties, (i) all patentable inventions within the Program Technology, and all Patents claiming such inventions, and (ii) all other Know-How and other Intellectual Property Rights in such Program Technology, in each case ((i) and (ii)) discovered, created or developed solely by a Party’s employees, Affiliates, agents or independent contractors in connection with their activities under a Collaboration Program shall be owned solely by the inventing, discovering, creating or developing Party, and if discovered, created or developed jointly by both Party’s employees, Affiliates, agents or independent contractors shall be owned jointly and deemed Joint Technology. Notwithstanding the foregoing, [***].
(b) [***].
(c) [***].
(d) [***];
(e) [***];
(f) [***]; and
(g) [***].
13.2.3 Joint Technology. Subject to the licenses granted under this Agreement and Section 2.3 and any other express restrictions set forth in this Agreement, each Party (or its Affiliates):
(a) may assign and transfer its interest in the Joint Technology in connection with a divestiture of the applicable Collaboration Program to a Third Party or in the case of a permitted assignment of this Agreement with respect to the applicable Collaboration Program, but may not otherwise assign or transfer its interest in the Joint Technology, whether within or outside the Collaboration, without the prior written consent of the other Party;
(b) may license its interest in the Joint Technology to (i) a permitted Sublicensee pursuant to Section 10.4, (ii) a Third Party in accordance with Section 10.3 with respect to a Rejected Collaboration Product, or (iii) a Third Party as otherwise permitted under
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this Agreement (e.g., Section 5.4 and Section 7.5), but may not otherwise license or transfer its interest in the Joint Technology to a Third Party, whether within or outside the Collaboration, without the other Party’s prior written consent;
13.2.4 Licensed Technology. Each Party shall retain all right, title and interest to its respective Licensed Technology and, except as expressly set forth in this Agreement, no right or license to such Patents or, Know-How included in such Licensed Technology is granted by either Party to the other Party.
13.3 Prosecution, Maintenance and Defense.
13.3.1 Program Patents. As between the Parties, the Lead Party in respect of each Collaboration Program shall be entitled to direct the prosecution, maintenance and defense (including patent term extensions and supplementary protection certificates) of all Patents within the Program Technology (“Program Patents”) for the relevant Collaboration Program worldwide using mutually acceptable outside counsel appointed by the Parties. The Parties shall [***], through the JPC, to ensure that the Party not entitled to direct the prosecution, maintenance and defense of a particular Program Patent is kept reasonably informed on a regular basis regarding, and provided with reasonable opportunity to comment and consult on, all such activities in respect of such Program Patent. The costs associated with prosecution, maintenance and defense of Program Patents, including the fees of jointly-appointed outside counsel, shall be allocated between the Parties as set forth in Section 9.1 or Section 9.2 irrespective of which Party incurs such costs. The Party with the right to direct the prosecution, maintenance and defense of a particular Program Patent will give reasonable notice to the other Party before determining to abandon the prosecution, maintenance or defense of such Program Patent, and the other Party would, upon receipt of such notice or the other Party’s otherwise abandoning the prosecution, maintenance or defense of the Program Patent, be entitled to assume and thereafter direct such prosecution, maintenance or defense activities. In such circumstances, the Party relinquishing direction of the prosecution, maintenance or defense activities will still be kept reasonably informed on a regular basis regarding, and provided with reasonable opportunity to comment and consult on, all such activities.
13.3.2 Other Patents.
(a) Vir shall have the right to pursue and direct the prosecution, maintenance and defense of Patents within the Vir Licensed Technology (“Vir Licensed Patents”) (including patent term extensions and supplementary protection certificates), provided that Vir will keep GSK reasonably informed through the JPC on a regular basis regarding, and provided with reasonable opportunity to comment and consult on, all such activities. The costs associated with such activities will be allocated between the Parties as set forth in Section 9.1 or Section 9.2. [***].
(b) GSK shall have the right to pursue and direct, at its own cost, the prosecution, maintenance and defense of Patents within the GSK Licensed Technology (“GSK Licensed Patents”) (including patent term extensions and supplementary protection certificates), provided that with respect to GSK Licensed Patents applicable to [***], GSK will keep Vir reasonably informed through the JPC on a regular basis regarding, and provided with reasonable opportunity to comment and consult on, all such activities. The costs associated with such activities will be allocated between the Parties as set forth in Section 9.1 or Section 9.2.
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13.3.3 Cooperation. The Party not directing the prosecution, maintenance or defense of a particular Patent as set forth in this Section 13.3 will cooperate with the other Party, including furnishing a power of attorney, inventor declaration or assignment documentation, to allow such prosecution, maintenance or defense activities to be carried out effectively and expeditiously.
13.3.4 Patent Prosecution after Opt-Out. If a Party exercises its Opt-Out Option with respect to a Collaboration Product, and the Non Opt-Out Party elects to continue to Develop, Manufacture and Commercialize the corresponding Sole Development Product in accordance with Section 5.6.4(a), then with respect to any Program Patent Controlled by the Opt-Out Party that is solely related to such Sole Development Product, the Non Opt-Out Party shall have the right, but not the obligation to be responsible for the prosecution, maintenance and defense of such Program Patent, at its own cost and expense, in its sole discretion. The Non Opt-Out Party shall keep the Opt-Out Party [***] informed of any [***] development and communications with applicable intellectual property offices with respect to any such Program Patent solely or jointly owned by the Opt-Out Party, and in the event the Non Opt-Out Party determines to abandon the prosecution, maintenance or defense of any such Program Patent, the Non Opt-Out Party will give reasonable notice to the Opt-Out Party and Opt-Out Party would, upon receipt of such notice or the Non Opt-Out Party’s otherwise abandoning the prosecution, maintenance or defense of such Program Patent, be entitled to assume and thereafter direct such prosecution, maintenance or defense activities with respect to such Program Patents. For clarity, the Non Opt-Out Party shall have the sole right, but not the obligation, to be responsible for the prosecution, maintenance and defense of Program Patents that are solely owned by the Non Opt-Out Party, at its own cost and expense, in its sole discretion.
13.4 Enforcement Rights.
13.4.1 Notification of Infringement. If either Party learns of any infringement or threatened or suspected infringement, or misappropriation or threatened or suspected misappropriation, of any (i) Program Technology, Vir Licensed Technology, or GSK Licensed Technology, by the manufacture, use, development or commercialization by a Third Party of a product that competes with a Collaboration Product (“Competing Product”) or (ii) any Joint Technology, whether or not relating to a Competing Product (each of (i) and (ii), an “Infringement”), such Party shall promptly provide notice to the JPC describing such Infringement (each, an “Infringement Notice”) and, in the case of any certification filed under the “U.S. Drug Price Competition and Patent Term Restoration Act of 1984” (the “Hatch-Waxman Act”) or notification of the submission of an Abbreviated Biologics License Application wherein a Collaboration Product is the “Reference Product” under the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”) or receipt of manufacturing process from a subsection (k) applicant or other similar procedure where a response is required under applicable Law (in order to avoid waiving rights), such Party shall provide notice as quickly as possible and in no event later than thirty (30) days prior to the applicable deadline for filing a response. For clarity, any certification filed under the Hatch-Waxman Act or notification or submission under the BPCIA shall constitute an Infringement for the purposes of this Agreement.
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13.4.2 Enforcement and Recoveries.
(a) The Party having the right to direct the prosecution, maintenance and defense of Program Patents as set forth in Section 13.3.1 (the “Program Patent Controlling Party”) shall have the right, at its cost and expense, to pursue and direct enforcement of such Program Patents with respect to any Infringement, provided that such Program Patent Controlling Party would provide written notice to the other Party and consult with the other Party, in advance of commencing any enforcement activities in respect of a Program Patent with respect to the Collaboration, subject to Section 13.5. The Program Patent Controlling Party would keep the other Party reasonably informed on a regular basis regarding, and provide such other Party with reasonable opportunity to consult and comment on, all enforcement activities in respect of the Program Patents. The other Party shall have the right, to the extent permitted by applicable Laws and procedural rules to join, at its own cost and using its own counsel, as a party to the enforcement actions included in such enforcement activities. Any damages or other monetary awards recovered from the settlement of or judgment from such enforcement actions shall be allocated first to reimburse the Parties for the costs and expenses incurred by it in connection with such enforcement actions (excluding any cost of separate counsel engaged by the other Party pursuant to the preceding sentence). Any amounts remaining will be allocated between the Parties in a manner consistent with the applicable split of Pre-Tax Profit and Loss percentages as set forth in Section 9.2.1.
(b) Vir shall have the right to pursue and direct, at its own cost, enforcement of Vir Licensed Patents with respect to any Infringement, provided that Vir would provide written notice to GSK and consult with GSK, in advance of commencing any such enforcement activities with respect to the Collaboration, subject to Section 13.5. Vir shall keep GSK reasonably informed on a regular basis regarding, and provide GSK with reasonable opportunity to consult and comment on, all enforcement activities in respect of each Vir Licensed Patent with respect to the Collaboration. Any damages or other monetary awards recovered from the settlement of or judgment from such enforcement actions shall be allocated first to reimburse Vir for the costs and expenses incurred by it in connection with such enforcement actions. Any amounts remaining will be allocated between the Parties in a manner consistent with the applicable split of Pre-Tax Profit and Loss percentages as set forth in Section 9.2.1.
(c) GSK shall have the right to pursue and direct, at its own cost, enforcement of GSK Licensed Patents with respect to any Infringement, provided that GSK would provide written notice to Vir and consult with Vir, in advance of commencing any such enforcement activities with respect to the Collaboration, subject to Section 13.5. GSK shall keep Vir reasonably informed on a regular basis regarding, and provide Vir with reasonable opportunity to consult and comment on, all enforcement activities in respect of each GSK Licensed Patent with respect to the Collaboration. Any damages or other monetary awards recovered from the settlement of or judgment from such enforcement actions shall be allocated first to reimburse GSK for the costs and expenses incurred by it in connection with such enforcement actions. Any amounts remaining will be allocated between the Parties in a manner consistent with the applicable split of Pre-Tax Profit and Loss percentages as set forth in Section 9.2.1.
13.4.3 Cooperation. If the Party having the right to pursue and direct the enforcement as set forth in each of subclauses (a), (b) and (c) in Section 13.4.2 (collectively, the
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“Controlling Party”) brings an enforcement action or proceeding with respect to any Infringement in accordance with Section 13.4.2, then the other Party shall cooperate as reasonably requested, at such Controlling Party’s reasonable expense, in the pursuit of such enforcement action, including if necessary by joining as a party to any such enforcement action for which it is a necessary or indispensable party or taking such other actions as are necessary for standing, furnishing a power of attorney, or for the Controlling Party to otherwise maintain or pursue such enforcement action effectively and expeditiously.
13.4.4 Settlement with a Third Party. The Controlling Party for an enforcement action with respect to any Infringement shall also have the right to control the settlement of such enforcement action; provided that the Controlling Party shall not admit the unenforceability or invalidity of Patents Controlled by the other Party, or of Patents within the Joint Technology without such other Party’s prior written consent.
13.4.5 Invalidity and Unenforceability. For any invalidity and unenforceability claims arising in such enforcement action, the Controlling Party for the enforcement action shall control the response thereto (but may not admit invalidity or unenforceability of any Patent owned by the other Party). Any other proceeding involving an invalidity or unenforceability challenge, including inter partes review, post-grant review, and any other post-grant proceedings for any issued Patent within the Program Patents, Vir Licensed Patents or GSK Licensed Patents, including reexamination, reissue, opposition, revocation and other similar proceedings, shall be controlled by the Controlling Party that would have the right under this Section 13.4 if it were to have arisen in an enforcement action.
13.4.6 Other Enforcement Activities. The Non Opt-Out Party pursuing any Sole Development Product assumes responsibility for enforcement against any infringement of Program Patents to the extent it relates to such Sole Development Product at its own costs and expense, in its sole discretion.
13.5 Joint Patent Committee. GSK and Vir shall, in advance of taking any actions to enforce Program Patents, GSK Licensed Patents or Vir Licensed Patents with respect to a Competing Product, present the proposed enforcement to the JPC for discussion and reasonably consider comments from members of the JPC representing the other Party.
13.6 Third Party Technologies. For any in-licensed technologies of either Party, the foregoing provisions of this ARTICLE 13 shall be subject to and limited by the terms and conditions of the applicable existing agreements and any agreement entered into after the Effective Date pursuant to which the in-licensing Party has acquired rights to the applicable Patent. Each Party agrees with respect to such agreements as to which it is a party to take such actions and exercise such rights under any such agreements as reasonably necessary to give effect to the foregoing provisions of Section 13.3 and Section 13.4 and, where such agreements are inconsistent with any term of this Agreement, such Party shall notify the other Party in writing, including a description of the difference.
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13.7 Infringement Claims by Third Parties.
13.7.1 Notice; Control. Each Party shall promptly notify the other Party in writing of (a) any allegation by a Third Party that any Development, Manufacture or Commercialization or other activities with respect to any Collaboration Product pursuant to this Agreement infringes or misappropriates or may infringe or misappropriate the Intellectual Property Rights of such Third Party (a “Product Third Party Infringement Claim”), or (b) any allegation by a Third Party of infringement or misappropriation of its Intellectual Property Rights with respect to the activities hereunder that is not covered by subclause (a) of this Section 13.7.1 (a “Non-Product Third Party Infringement Claim”, and collectively with any Product Third Party Infringement Claim, “Third Party Infringement Claim”). For any Product Third Party Infringement Claim, the Lead Party shall be the “Defending Party” and shall have the right to control the defense of the Third Party Infringement Claim, but the other Party shall have the right to control its own defense of any such Third Party Infringement Claim brought against it, by counsel of its own choice. In such case, the Parties shall coordinate in good faith. For any Non-Product Third Party Infringement Claim, each Party that is a defendant in such claim shall be the “Defending Party” and shall have the right to defend itself against such claim. For clarity, the Non Opt-Out Party shall have the right to control the defense of any Product Third Party Infringement Claim alleged against a Sole Development Product.
13.7.2 Cooperation; Settlement. Except with respect to a Sole Development Product, each Defending Party shall keep the other Party reasonably informed of all material developments in connection with any Third Party Infringement Claim. Each Defending Party agrees to provide the other Party with copies of all pleadings filed in any suit or proceeding relating to such Third Party Infringement Claim. The Defending Party may enter into a settlement or compromise of any Third Party Infringement Claim, provided, that if such settlement or compromise would admit liability on the part of the non-Defending Party or any of its Affiliates or would otherwise have a material adverse effect on the rights or interests of the non-Defending Party or its Affiliates, the Defending Party shall not enter into such settlement or compromise without the prior written consent of the non-Defending Party. In the event a proposed settlement involves obtaining a license under Third Party Patent Rights, the applicable provisions of ARTICLE 10 shall apply. Any counterclaims of Infringement shall be handled as set forth in Section 13.4.
13.7.3 Costs; Recoveries. All out-of-pocket expenses incurred by a Defending Party in defending a Third Party Infringement Claim (including outside counsel fees), and all amounts payable by either Party as a judgment based on a Third Party Infringement Claim or in settlement of such Third Party Infringement Claim, shall be included in the Pre-Tax Profit or Loss calculation. For clarity, the terms of this Section 13.7.3 shall not apply to a Third Party Infringement Claim alleged against a Sole Development Product.
13.8 Product Marks
13.8.1 (a) GSK shall have the sole right to select, obtain and maintain any Product Marks for Collaboration Products and GSK Sole Development Products. (b) Vir shall have the sole right to select, obtain and maintain any Product Marks for Vir Sole Development Products. In the case of (a) and (b), respectively, GSK and Vir are each referred to as the “Product Mark Controlling Party”, while the other Party is referred to as the “Product Mark Non-Controlling Party.” The costs associated with such activities for the Collaboration Products shall
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be included in the Development Costs and Pre-Tax Profit or Loss calculations for the applicable Collaboration Product (excluding Sole Development Products). Upon reasonable request of the Product Mark Controlling Party, the Product Mark Non-Controlling Party shall provide reasonable assistance in the selection of Product Marks for a Collaboration Product. As between the Parties, GSK shall be the owner of the Product Marks for any Collaboration Product. In the case in which a Collaboration Product becomes a Vir Sole Development Product, then Vir may continue to use Product Marks selected by GSK and approved by the FDA or other applicable Regulatory Authority, provided that Vir shall not have the right to use any trademarks owned or controlled by GSK (other than the Product Marks), or that are confusingly similar to such trademarks owned or controlled by GSK.
13.8.2 If the Product Mark Non-Controlling Party has a reasonable basis to believe that a Third Party is engaging in infringement of a Product Mark, such Party shall promptly notify the Product Mark Controlling Party in writing and provide it with any evidence of such infringement that is reasonably available. As between the Parties, the Party owning the infringed Product Mark, or its designee, shall have the sole right and option, at its sole expense, to respond to any infringement or potential infringement with respect to such Product Mark by appropriate steps, including filing an infringement suit or taking other similar action. The non-owning Party shall provide reasonable assistance to the other Party, or the other Party’s designee, at such other (owning) Party’s expense, with respect to any enforcement activities with respect to such Product Mark, including providing access to relevant documents and other evidence, making its employees reasonably available during business hours, and joining the action to the extent necessary to maintain the action. Any amounts recovered pursuant to this Section 13.8 whether by settlement or judgment, shall first be used to reimburse the applicable Party(ies) for their costs and expenses in making such recovery, and any remaining recovery shall be retained by the Product Mark Controlling Party except to the extent included in the Pre-Tax Profit or Loss calculation. The Product Mark Controlling shall solely control any infringement claim brought by any Third Party with regard to the Product Marks and the costs thereof shall be included in the Pre-Tax Profit or Loss calculated.
13.9 Information Technology Requirements. Each Party shall use all reasonable efforts, including operating commercially available anti-virus applications (and maintaining up to date virus definitions for such applications), to ensure that no portion of the activities conducted under this Agreement comprising software will contain any unauthorized code, or virus, Trojan horse, worm, or any other software routine or hardware component designed to permit, either automatically or through externally applied controls, unauthorized access or use to disable, erase, or otherwise harm software, hardware, or data (collectively “Malwares”). To the extent that any Party, in conducting activities under this Agreement, uses any system or software belonging to the other Party, such Party shall use its best efforts to avoid the introduction of any Malwares into such systems or software.
13.9.1 To the extent that any Malwares are discovered in any deliverables provided under this Agreement or is introduced to a Party’s systems or software by the other Party (or is reasonably likely to have been so introduced), such other Party shall use all reasonable efforts to assist the Party to which the Malware was delivered in removing such Malware from the software in question and shall be responsible for the costs of such removal.
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13.9.2 Each Party shall ensure that it has up to date information on all personnel who have access to the other Party’s IT systems and agrees to provide periodic updates on the names of such personnel. Each Party shall, no more than [***] after any change in such information or any new information, notify the other Party promptly of any individual IT user access change.
13.9.3 Both Parties agree to maintain reasonable security measures, in line with industry best practices for systems storing, accessing, or otherwise processing any Data. The Parties agree to coordinate in good faith regarding any requested updates or modifications to the security practices of the other Party as applicable to the Collaboration.
ARTICLE 14
TERM AND TERMINATION
14.1 Term. This Agreement shall be effective as of the Effective Date and, unless terminated under this ARTICLE 14 (in its entirety, on a Collaboration Program basis or a Collaboration Product basis, as the case may be), shall remain in effect (a) with respect to the Antibody Program, unless and until such time as there is no Antibody Product being Developed or Commercialized by the Lead Party or the LCP, or in the case of a corresponding Sole Development Product, by the Non Opt-Out Party, (b) with respect to the Vaccine Program, unless and until such time as there is no Vaccine Product being Developed or Commercialized by the Lead Party or the LCP, or in the case of a corresponding Sole Development Product, by the Non Opt-Out Party, and (c) with respect to the Functional Genomics Program, unless and until such time as there is no Functional Genomics Product being Developed or Commercialized by the Lead Party or the LCP, or in the case of a corresponding Sole Development Product, by the Non Opt-Out Party (the “Term”).
14.2 Mutual Termination. The Parties may terminate this Agreement in its entirety or with respect to a particular Collaboration Program or Collaboration Product at any time by mutual written agreement.
14.3 Termination for Cause. In addition to any other remedies conferred by this Agreement or by applicable Law or in equity, either Party (the “Non-Breaching Party”) may terminate this Agreement with respect to a particular Collaboration Program or a particular Collaboration Product upon written notice to the other Party (the “Breaching Party”) if there is an uncured material breach by the Breaching Party that impacts such Collaboration Program or such Collaboration Product. To exercise its termination rights under this Section 14.3, the Non-Breaching Party shall provide the Breaching Party with written notice identifying the material breach [***] and indicating whether the Non-Breaching Party is intending to terminate this Agreement with respect to the applicable Collaboration Program or Collaboration Product. If the Breaching Party, upon receiving such written notice identifying such material breach in reasonable detail, fails to cure such material breach within [***] after the date of such notice of breach is received, then this Agreement with respect to such particular Collaboration Program or Collaboration Product shall terminate. Notwithstanding the foregoing, if such breach is curable but cannot reasonably be cured within such [***] period, such cure period shall be extended if the Breaching Party provides the Non-Breaching Party with a written plan for curing such breach and uses Commercially Reasonable Efforts to cure such breach in accordance with such written plan;
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provided that no such extension shall exceed [***] without the consent of the Non-Breaching Party. If the existence or materiality of such alleged breach or if the failure to cure is contested in good faith by the alleged Breaching Party in writing within [***] after the delivery of the breach notice, then the dispute resolution procedure pursuant to Section 20.1 may be initiated by either Party to determine whether a material breach or a failure to cure has actually occurred. If either Party so initiates the dispute resolution procedure, then the Non-Breaching Party shall not have the right to terminate this Agreement under this Section 14.3 until such time as (a) the dispute is resolved pursuant to Section 20.1 with a determination that the Breaching Party has materially breached this Agreement or has failed to cure such breach, and (b) the Breaching Party has failed to cure such material breach within [***] thereafter (or within such other cure period prescribed by the arbitrators). It is understood and agreed that, during the pendency of such dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder. For the avoidance of doubt, in the event of a material breach of a Co-Promotion Agreement (if entered into with respect to an Antibody Product), the non-breaching Party shall only have the right to terminate such Co-Promotion Agreement in accordance with the terms of the Co-Promotion Agreement and, notwithstanding such termination, this Agreement shall remain in full force and effect with respect to the Antibody Program and the Antibody Product that is the subject of such Co-Promotion Agreement.
14.4 Termination for Insolvency. Either Party may terminate this Agreement in its entirety or with respect to a Collaboration Program or Collaboration Product, effective immediately upon written notice to the other Party if, at any time such other Party (or any Affiliate that controls such Party) (a) files in any court or agency pursuant to any statute or regulation of any state or country a petition in bankruptcy or insolvency or for reorganization (except for solvent reorganization or solvent reconstruction) or for an arrangement or for the appointment of a receiver or trustee of the Party or of substantially all of its assets, (b) proposes a written agreement of composition or extension of substantially all of its debts, (c) is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition is not be dismissed within [***] after the filing thereof, (d) proposes to be a party to any dissolution or liquidation, (e) admits in writing its inability generally to meet its obligations as they fall due in the general course or (f) makes an assignment of substantially all of its assets for the benefit of creditors.
ARTICLE 15
EFFECTS OF EXPIRATION OR TERMINATION
15.1 Accrued Obligations. The expiration or termination of this Agreement (in whole or in part) for any reason shall not release either Party from any liability that, at the time of such expiration or termination, has already accrued to the other Party or that is attributable to a period prior to such expiration or termination, nor will any early termination of this Agreement preclude either Party from pursuing any and all rights and remedies it may have under this Agreement, or at law or in equity, with respect to breach of this Agreement.
15.2 Effects of Termination by Mutual Agreement. In the case of a termination under Section 14.2 of this Agreement with respect to a particular Collaboration Program or Collaboration Product by mutual written agreement, the Parties shall also agree on the consequences of such a termination, including winding down of any Development activities with respect to any Collaboration Products.
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15.3 Effects of Termination for Material Breach or Insolvency. If this Agreement is terminated, in whole or in part pursuant to Section 14.3 or Section 14.4, then:
15.3.1 Regardless whether the Party that is subject to such termination (the “Terminated Party”) is a Lead Party at the time of such termination, (a) except to the extent set forth in Section 15.3.2 below with respect to payments owed to the Terminated Party following such termination, such termination shall be treated as though the Terminated Party had exercised an Opt-Out Option with respect to the Collaboration Product(s) subject to such termination (the “Terminated Collaboration Product(s)”) on the effective date of such termination; (b) the licenses granted to the Party terminating this Agreement (the “Terminating Party”) under Section 10.1 shall remain in effect only to the extent actually used for or incorporated in such terminated Collaboration Product(s) on or prior to the effective date of such termination, and subject to the terms and conditions (including any financial terms for such licenses) and any rights granted to a Third Party in a Third Party agreement with respect to such Terminated Collaboration Product existing prior to the effective date of such termination; (c) [***]; (d) the Terminating Party may continue with the Development and Commercialization of such Terminated Collaboration Product(s) at its discretion, and shall retain the sole right to out-license or otherwise divest the Terminated Collaboration Product(s) at its discretion in accordance with Section 5.6.4, including by sublicensing to Third Parties, subject to any applicable terms in the license granted with respect to such Terminated Collaboration Product, (e) following the effective date of such termination, the Terminating Party shall [***], and (f) the Terminated Party shall [***].
15.3.2 If the Terminating Party elects to continue with the Development and Commercialization of the Terminated Collaboration Product(s), [***].
15.3.3 Without limiting Section 15.3.1, if the Party that is subject to the termination is the Lead Party, the Terminating Party shall have the right to assume the role of the Lead Party in the manner otherwise set forth in this Agreement with respect to any Terminated Collaboration Product(s). Subject to the proviso in Section 15.3.1(c), the terminated Party shall, in accordance with the terms of this Agreement, effect transfer of relevant regulatory documentation and Manufacturing solely with respect to the Terminated Collaboration Product(s) to the Terminating Party in accordance with Section 6.5 or Section 11.5, as applicable.
15.4 Other Termination Consequences. If this Agreement is terminated for any reason pursuant to Sections 14.2 through 14.4, then the following provisions shall apply:
15.4.1 Development Costs. There shall be a final accounting for any Development Costs that are required to be shared by the Parties hereunder for the Collaboration Program or Collaboration Product that is terminated, which shall include any such Development Costs that are incurred (a) prior to the effective date of such termination of this Agreement, in whole or in part, (b) after the effective date of termination of this Agreement, in whole or in part, but relating to activities conducted during the Term (including any non-cancellable commitments incurred pursuant to the terminated Collaboration Program(s) in accordance with this Agreement), and (c) after the effective date of termination of this Agreement, in whole or in part, and required to be conducted in order to wind-down activities under the terminated Collaboration Program(s) in a manner compliant with applicable Law.
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15.4.2 [***].
(a) If, upon (i) [***], (ii) [***], or (iii) [***], in each case ((i)-(iii)), with respect to an Antibody Product, there are [***], then [***], and [***].
(b) [***].
(c) In the case of [***] (i) [***] or (ii) [***], then, in each case ((i) or (ii)), [***], provided that, in the case of Section 15.4.2(c)(i), if [***], then [***].
15.4.3 Unaffected Programs or Products. If this Agreement is terminated only with respect to a particular Collaboration Program or Collaboration Product, then all unaffected Collaboration Programs and Collaboration Products shall remain in effect in accordance with and subject to the terms and conditions of this Agreement. Without limiting the foregoing, the rights granted by each Party to the other Party with respect to such Collaboration Programs and Collaboration Product that are not subject to the termination shall remain in effect in accordance with and subject to terms and conditions of this Agreement.
15.5 Survival. The following provisions shall survive expiration or termination of this Agreement in its entirety, or with respect to a particular Collaboration Program or Collaboration Product: Sections 5.3.1 (for the applicable time period set forth therein), 9.4.1 (for payment obligations accruing during the Term and for costs required to be shared hereunder following expiration or termination), 9.4.3 (only with respect to payment obligations accruing during the Term and for amounts accruing after expiration or termination that are required to be shared hereunder), 9.5 (as applied in connection with any final accounting and with respect to payment obligations accruing during the Term), 9.7 (for the applicable time period set forth therein), 9.8, 9.9 (only with respect to payment obligations accruing during the Term and for costs required to be shared hereunder following expiration or termination), 9.10 (solely with respect to payments owed as of the effective date of termination), 9.11, 9.13(b), 9.14, 10.1.1(c), 10.1.2(c) 10.4-10.5 (each, as relating to any surviving licenses hereunder), 10.6-10.8, 10.9.1 (as relating to any surviving licenses hereunder), 12.3 (solely with respect to the obligation to remove the other Party’s Confidential Information) 12.5 (last sentence), 13.1 (excluding 13.1.1), 13.2, 18.1, 18.2 (as required to stand-by any post-termination liabilities), 18.3, 20.1, 20.2, 20.3, 20.6 (solely with respect to the performance by a Party of its obligations under this Agreement that survive expiration or termination) 20.7, 20.9, 20.11, 20.12 and 20.13, ARTICLE 15, ARTICLE 16, ARTICLE 17 (with respect to claims for breaches occurring prior to the end of the Term), Schedule 1.100 (with respect to any post-termination calculations), and any applicable definitions of any capitalized terms. In the event of expiration or termination, each Party shall remain obligated to share in any costs as to which it is committed as of the date of expiration or termination and where applicable, Section 11.3.3 and Section 17.3.1 shall apply with respect to both Parties.
15.6 Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies at equity or law shall remain available to the Parties except as agreed to otherwise herein.
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ARTICLE 16
CONFIDENTIALITY
16.1 Confidentiality. Except to the extent expressly authorized by this Agreement or otherwise agreed by the Parties in writing, during the Term and for a period of [***] following termination or expiration thereof, each Party will be obligated to keep confidential and not publish or otherwise disclose to a Third Party, and not to use, directly or indirectly, for any purpose other than the Collaboration, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement or is reasonably necessary or useful for the performance of, or the exercise of such Party’s rights under, this Agreement. The confidentiality and non-use obligations with respect to a Party’s Confidential Information in this Section 16.1 will not include any information that:
(a) is or becomes part of the public domain through no wrongful act, fault or negligence on the part of the Receiving Party;
(b) can be demonstrated by competent proof to have been in the Receiving Party’s possession prior to disclosure by the Disclosing Party without any obligation of confidentiality with respect to such information;
(c) is subsequently received by the Receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information;
(d) has been published by a Third Party or otherwise enters the public domain through no fault of the Receiving Party in breach of its contractual obligations to the Disclosing Party; or
(e) can be demonstrated by competent proof to have been independently developed (outside the scope of the Collaboration) by or for the Receiving Party without reference to the Disclosing Party’s Confidential Information.
16.2 Authorized Disclosure. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such disclosure is:
(a) made in response to a valid order of a court or other Governmental Authority or, if in the reasonable opinion of the Receiving Party, such disclosure is otherwise required by Law, including by reason of filing with securities regulators; provided that the Receiving Party shall, to the extent permitted by Law, first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity, at the Disclosing Party’s expense, to quash such order or to obtain a protective order or confidential treatment; and provided further that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;
(b) made by or on behalf of the Receiving Party to Regulatory Authorities as required in connection with any filing, application or request for marketing or other Regulatory Approval; provided that reasonable measures shall be taken to assure confidential treatment of such information to the extent practicable and consistent with applicable Law;
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(c) made by or on behalf of the Receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a Patent; provided that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available; or
(d) made by the Receiving Party to its attorneys, auditors, advisors, consultants, contractors, existing or prospective collaboration partners, licensees, sublicensees, existing or prospective investors, prospective acquirers, or other Third Parties as may be necessary or useful in connection with exploitation of Collaboration Products as contemplated by the Collaboration or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the Receiving Party set forth herein.
16.3 Injunctive Relief. Each Party, as a Receiving Party, acknowledges and agrees that due to the unique nature of a Disclosing Party’s Confidential Information, there may be no adequate remedy at law for any breach of its obligations hereunder and that any such breach may allow a Receiving Party or Third Parties unfairly to compete with the Disclosing Party, resulting in irreparable harm to the Disclosing Party. Therefore, notwithstanding the provisions of Section 20.1, the Parties agree that upon any such breach or any threat thereof, the Disclosing Party shall be entitled to seek appropriate equitable relief at the Disclosing Party’s option in either (a) a court of competent jurisdiction where such Disclosing Party resides, or (b) as provided in Section 20.1, as applicable, in addition to whatever remedies it might have at law in connection with any breach or enforcement of a Receiving Party’s obligations hereunder for the unauthorized use or release of any such Confidential Information.
16.4 Return of Confidential Information. At the written request of the Disclosing Party promptly following the termination of this Agreement, the Receiving Party shall (and shall cause its Affiliates and their respective representatives to) return to the Disclosing Party or destroy all originals of documents (in paper or electronic form) and physical materials then in its possession, and copies thereof, containing Confidential Information received from the Disclosing Party and constituting its exclusive Confidential Information, and destroy all documents and other materials that it created including any such Confidential Information; provided that the Receiving Party may retain in confidence (a) one (1) archival copy of the Confidential Information in its legal files solely to permit the Receiving Party to determine compliance with its obligations hereunder; (b) any portion of the Confidential Information of the other Party which is contained in the Receiving Party’s laboratory notebooks; (c) any portion of the Confidential Information of the other Party which a Receiving Party is required by applicable Law to retain; and (d) any Confidential Information that the Receiving Party has the right to continue to use after the date of the Disclosing Party’s request after termination or expiration of this Agreement, as applicable. Notwithstanding the return or destruction of the documents and tangible items described above, the Parties will continue to be bound by their obligations under this ARTICLE 16.
16.5 Press Releases and Other Public Statements. Except for any publications or presentations that are made consistent with ARTICLE 12 and those certain press releases made
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in connection with the execution of the Stock Purchase Agreement and the Preliminary Collaboration Agreement, neither Party nor its Affiliates will make any public announcements, press releases, regulatory filing or other public disclosures, written or oral, whether to the public, the press, stockholders or otherwise, concerning this Agreement or the terms and conditions or the subject matter hereof, the performance hereof or the Parties’ activities hereunder, or any results or data arising hereunder (a “Public Statement”), except: (a) with the prior written consent of the other Party (which may be conditional upon certain restrictions as to the content or distribution of such Public Statement); or (b) for such Public Statements, as in the opinion of the Party intending to make such Public Statement, are required to comply with applicable Law, regulation, rule or legal process (including the regulations of any stock exchange) (a “Legal Requirement”) and which in any event contain only the minimum disclosure necessary to comply with the relevant Legal Requirement. Each Party agrees, to the extent permitted by Legal Requirements, in any event to provide the other Party with a copy of any proposed Public Statement as soon as reasonably practicable under the circumstances prior to its scheduled release. Except under extraordinary circumstances, when the following notice may not be possible but in which event the proposed Public Statement will still be provided to the other Party for comment before release (which the releasing Party shall use reasonable efforts to provide at least forty-eight (48) hours prior to the intended time of publication), and to the extent permitted by Legal Requirements, each Party shall provide the other Party with an advance copy of any such Public Statement at least seven (7) days prior to its scheduled release. Each Party furthermore shall have the right to review and recommend changes to any such announcement and, except as otherwise required by Legal Requirement, the Party whose announcement has been reviewed shall remove any Confidential Information of the reviewing Party that the reviewing Party reasonably deems to be inappropriate for disclosure, subject to the exceptions in Section 16.2(a). Each Party agrees in any event to give the other Party a reasonable opportunity (to the extent consistent with Legal Requirements) to review all [***] Public Statements required by Legal Requirements to be filed with the Securities and Exchange Commission or similar body prior to submission of such filings, and will give due consideration to any reasonable comments by the non-filing Party relating to such filing, including the provisions of this Agreement for which confidential treatment should be sought.
ARTICLE 17
REPRESENTATIONS AND WARRANTIES AND COVENANTS
17.1 Mutual Representations and Warranties. Each Party represents and warrants to the other Party as of the Execution Date and the Effective Date, that:
17.1.1 such Party is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation and has full corporate power and authority and legal right to enter into this Agreement and to carry out the provisions hereof;
17.1.2 such Party has the right to grant the licenses to the other Party purported to be granted pursuant to this Agreement;
17.1.3 such Party has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
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17.1.4 such Party has received all necessary laboratory licenses and certificates with respect to facilities within such Party’s ownership or control sufficient to allow such Party to conduct the activities assigned to such Party under this Agreement, and such Party is in compliance with the requirements of such licenses and certificates;
17.1.5 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with the terms and conditions hereof, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity);
17.1.6 the execution, delivery and performance of this Agreement by such Party (i) will not constitute a default under, or conflict with, any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, (ii) violate any Law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party; and (iii) is not prohibited or limited by, and shall not result in the breach of or a default under, any provision of the certificate or articles of incorporation or bylaws of such Party;
17.1.7 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable Laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements;
17.1.8 such Party and its Affiliates have not employed (and, to its knowledge, has not used a (sub)contractor or consultant that has employed) and, during the Term, will not knowingly employ (or, to its knowledge, use any (sub)contractor or consultant that employs, provided that such Party may reasonably rely on a representation made by such (sub)contractor or consultant) any Person debarred by the FDA (or subject to a similar sanction of EMA or foreign equivalent), or any Person which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA or foreign equivalent);
17.1.9 such Party and its Affiliates performing activities under the Collaboration has in place or will have in place prior to its conduct of its activities under the Collaboration a written agreement with its employees and other personnel it appoints to perform such activities hereunder sufficient to ensure that such Party has sufficient ownership or license rights to any Program Technology developed or created by such Party to grant the rights to the other Party as required to be granted under this Agreement;
17.1.10 with respect to any Research and Development activities conducted by such Party or its Affiliates under this Agreement that involve the use of animals, including any animal studies, such Party and its Affiliates agree to comply with the terms of Schedule 5.6.5;
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17.1.11 to the knowledge of such Party, as it is relevant to this Agreement:
(a) such Party respects the human rights of its staff and does not employ child labor, forced labor, unsafe working conditions, or cruel or abusive disciplinary practices in the workplace;
(b) such Party does not discriminate against any workers on any ground (including race, religion, disability, gender, sexual orientation or gender identity);
(c) such Party pays each employee at least the minimum wage, provides each employee with all legally mandated benefits, and complies with the laws on working hours and employment rights in the countries in which it operates; and
(d) such Party is respectful of its employees right to freedom of association; and
17.1.12 such Party is in [***] compliance with (a) all applicable Laws relating to data privacy and data security, including with respect to the collection, use, storage, sharing, transfer, disposition, protection and processing of PII; (b) all privacy policies and other related policies, programs and other notices of such Party relating to the privacy, protection and security of PII; and (c) all contractual and other legal requirements to which such Party is subject with respect to the privacy, protection, and security of PII; and has in place reasonable safeguards to protect the confidentiality and security of PII, including from unauthorized access or misuse, based on applicable Law.
17.2 Representations and Warranties of Vir. Vir represents and warrants to GSK, as of the Execution Date and the Effective Date, as follows:
17.2.1 [***];
17.2.2 Vir or one of its Affiliates solely owns or exclusively licenses and Controls the Existing Program Antibodies and Vir Licensed Technology;
17.2.3 neither Vir nor any of its Affiliates has entered into any agreement (other than agreements with subcontractors) granting any right, interest or claim in or to, any Existing Program Antibodies or Vir Licensed Technology that would conflict with the rights and licenses to GSK granted or required to be granted in this Agreement;
17.2.4 neither Vir nor any of its Affiliates has previously entered into any agreement, whether written or oral, to assign, transfer, license, convey or otherwise encumber its right, title or interest in or to any Patent or other Know-How that is necessary for the Development, Manufacture, or Commercialization of any Antibody Products, in each case, where such Patent or other Know-How would be Vir Licensed Technology but for such assignment, transfer, license, conveyance or encumbrance;
17.2.5 [***];
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17.2.6 Vir has not, and will not, grant any right to any Third Party that would conflict with the rights granted to GSK hereunder;
17.2.7 [***];
17.2.8 all Vir Licensed Patents are subsisting and all Vir Licensed Patents for which Vir controls prosecution and maintenance activities are being diligently prosecuted in the patent offices in accordance with applicable Law and, to Vir’s Knowledge, are not invalid or unenforceable in whole or in part;
17.2.9 to Vir’s Knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate any Vir Licensed Technology and there are no activities by Third Parties that would constitute infringement or misappropriation of the Vir Licensed Technology;
17.2.10 no claim or litigation has been brought or threatened in writing by any Person against Vir or any of its Affiliates alleging, and Vir has no Knowledge of any reasonable basis for any such claim or allegation, whether or not asserted, that (a) any Vir Licensed Patents are invalid or unenforceable, or (b) the use or practice of any Vir Licensed Technology, or the disclosing, copying, making, assigning or licensing of any Vir Licensed Technology, or the exploitation of the Existing Program Antibodies, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any Third Party;
17.2.11 [***];
17.2.12 Vir has provided or made available to GSK all material adverse information with respect to the safety and efficacy of the Existing Program Antibodies of which Vir is aware and is or could be reportable to the applicable Regulatory Authorities;
17.2.13 [***];
17.2.14 [***];
17.2.15 [***];
17.2.16 Vir or one of its Affiliates has obtained the right (including under any Patents and other intellectual property rights) to use all information and all other materials (including any formulations and manufacturing processes and procedures) developed or delivered by any Third Party under any agreements between Vir or one of its Affiliates and any such Third Party with respect to any Existing Program Antibodies to the extent necessary to provide GSK with the rights granted to it hereunder, and Vir or one of its Affiliates has the rights to grant GSK the right to use such information or other materials in the Development or Commercialization of the Program Antibodies as contemplated in this Agreement;
17.2.17 [***];
17.2.18 [***];
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17.2.19 [***]; and
17.2.20 [***].
17.3 Post-Closing Covenants.
17.3.1 Negative Covenants: After the Closing Date and during the Term, neither Party shall, and shall cause its Affiliates not to, without the prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned or delayed):
(a) enter into any agreement with any Third Party, whether written or oral, with respect to, or otherwise assign, transfer, license or convey its right, title or interest in or to, the Vir Licensed Technology or GSK Licensed Technology, as applicable, relating to any Collaboration Program or Collaboration Product, in each case, in a manner that creates a material conflict with the rights granted or purported to be granted by such Party to the other Party under this Agreement;
(b) (i) sell, out-license or otherwise dispose of any assets or rights relating to any Collaboration Program or Collaboration Product, in each case, in a manner that creates a material conflict with the rights granted or purported to be granted by such Party to the other Party under this Agreement, (ii) amend any agreements, licenses or other rights of such Party or any of its Affiliates relating to any Collaboration Program or Collaboration Product, in each case, in a manner that creates a material conflict with the rights granted or purported to be granted by such Party to the other Party under this Agreement, or (iii) grant any security interest or otherwise encumber material assets and properties (including Vir Licensed Technology or GSK Licensed Technology, as applicable), relating to any Collaboration Program or Collaboration Product;
(c) enter into any agreement with any Third Party, whether written or oral, with respect to contract manufacturing arrangements related to any Collaboration Program or Collaboration Product if the costs of supply thereunder shall be shared by the Parties pursuant to the Collaboration; provided that this covenant shall not apply to the Samsung DS Letter Agreement, the Biogen Agreement, or any other agreement to be entered into by Vir with WuXi, Biogen or Samsung as contemplated in this Agreement, subject to Section 11.3.1(c) and Section 11.3.1(d); [***]. For clarity, all costs associated with [***], shall be shared as Development Costs or Allowable Expenses, as applicable, in accordance with the terms of this Agreement.
17.3.2 Affirmative Covenants. After the Closing Date and during the Term, each Party covenants that:
(a) it shall, and shall cause its Affiliates and its and their respective contractors, licensees and consultants to, conduct the Collaboration Programs and all other activities undertaken pursuant to this Agreement in accordance with applicable Law;
(b) with respect to all intellectual property that it purports to license to the other Party under this Agreement that is, may be or becomes subject to the Bayh-Dole Act, it shall, and shall cause its Affiliates and the relevant research partners to, continue to comply with the applicable provisions of the Bayh-Dole Act, in a manner that protects and preserves such Party’s right, title and interest in the subject intellectual property to the maximum extent permitted by applicable Law;
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(c) it shall promptly notify the other Party of the occurrence of a Key Product Event, and in no event more than [***] after such occurrence;
(d) [***]; and
(e) [***].
17.4 Disclaimer of Warranty. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, EACH PARTY SPECIFICALLY DISCLAIMS ANY GUARANTEE THAT ANY PLAN WILL BE SUCCESSFUL, IN WHOLE OR IN PART. EXCEPT AS OTHERWISE EXPRESSLY STATED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND, AND BOTH PARTIES EXPRESSLY DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT.
ARTICLE 18
INDEMNIFICATION
18.1 Indemnification.
18.1.1 Indemnification by Vir. Vir hereby agrees to indemnify, defend and hold harmless GSK and its Affiliates and their respective directors, officers, employees and agents, and the respective successors and assigns any of the foregoing (“GSK Indemnitees”), from and against any and all suits, claims, actions, demands, losses, damages, liabilities, settlements, penalties, fines, costs and expenses (including reasonable attorneys’ fees and other expenses of litigation) (collectively, “Losses”) asserted by a Third Party to the extent arising from [***].
18.1.2 Indemnification by GSK. GSK hereby agrees to indemnify, defend and hold harmless Vir and its Affiliates and their respective directors, officers, employees and agents, and the respective successors and assigns of any of the foregoing (“Vir Indemnitees”), from and against any and all Losses asserted by a Third Party to the extent arising from [***].
18.1.3 Indemnification Procedures. Upon becoming aware or receipt of notice of any Third Party claim that may be subject to indemnification by the other Party (the “Indemnifying Party”) under this Section 18.1, any GSK Indemnitee or any Vir Indemnitee (each, an “Indemnitee”), as the case may be, shall [***] notify the Indemnifying Party in writing (it being understood and agreed, however, that the failure by an Indemnitee to timely give such notice shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that the Indemnifying Party is actually prejudiced as a result of such failure to give timely notice). The Indemnifying Party shall have the right, but not the obligation, to conduct and control, through counsel of its choosing, any action for which indemnification is sought, and if the Indemnifying Party elects to assume the defense thereof, the Indemnifying Party shall not be liable to the Indemnitee for any legal expenses of other legal
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counsel or any other expenses subsequently incurred by such Indemnitee in connection with the defense thereof. The Indemnifying Party may not settle any action, claim or suit for which the Indemnitee is seeking indemnification without such Indemnitee’s prior written approval, such approval not to be unreasonably withheld, conditioned or delayed. The Parties and their employees shall cooperate fully with each other and their legal representatives in the investigation, defense, prosecution, negotiation, or settlement of any such claim or suit. The Indemnitee shall not settle or compromise any action, claim or suit for which the Indemnitee is seeking indemnification without the prior written consent of the Indemnifying Party. In no event shall the Indemnifying Party settle or abate any Third Party claim in a manner that would diminish the rights or interests of the Indemnitee or obligate the Indemnitee to make any payment, take any action, or refrain from taking any action, without the prior written approval of the Indemnitee. Notwithstanding the foregoing, no party shall settle any action, claim, or suit with respect to Taxes that are indemnified pursuant to this Agreement without the prior written approval of the other Party, such approval not to be unreasonably withheld, conditioned or delayed.
18.2 Insurance.
18.2.1 Vir’s Insurance Obligations. Vir shall maintain, at its cost, reasonable insurance against liability and other risks associated with its activities contemplated by this Agreement, including its indemnification obligations herein, in such amounts and on such terms as are determined to be advisable by Vir, based on advice from insurance professionals, for companies of similar size and with similar resources for the activities to be conducted by Vir under this Agreement taking into account the scope of the activities for which Vir is responsible hereunder. [***]. Vir shall furnish to GSK evidence of such insurance, upon reasonable request.
18.2.2 GSK’s Insurance Obligations. GSK shall maintain, at its cost, insurance or self-insurance with respect to liabilities and other risks associated with its activities and obligations under this Agreement, including its indemnification obligations herein, in such amounts and on such terms as are customary for prudent practices for large companies in the pharmaceutical industry for the activities to be conducted by GSK under this Agreement. GSK shall furnish to Vir evidence of such insurance or self-insurance, upon reasonable request.
18.3 LIMITATION OF CONSEQUENTIAL DAMAGES. EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 18.1, [***], OR A BREACH OF A PARTY’S CONFIDENTIALITY OBLIGATIONS IN ARTICLE 16, NEITHER VIR NOR GSK, NOR ANY OF THEIR AFFILIATES OR SUBLICENSEES WILL BE LIABLE TO THE OTHER PARTY TO THIS AGREEMENT, ITS AFFILIATES OR ANY OF THEIR SUBLICENSEES, FOR ANY INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR OTHER INDIRECT DAMAGES, LOST PROFITS, OR LOST DATA WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY) OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.
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ARTICLE 19
ANTI-BRIBERY AND ANTI-CORRUPTION
19.1 Each Party shall comply fully at all times with all applicable Laws and regulations, including anti-corruption Laws. Neither Party has, and covenants that it will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify, offer to make, or take any act in furtherance of any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage, or improperly assisting it or the other Party in obtaining or retaining business, or in any way with the purpose or effect of public or commercial bribery, and each Party warrants that it has taken reasonable measures to prevent subcontractors, agents or any other Third Parties subject to its control or determining influence from doing so. For the avoidance of doubt, the foregoing includes facilitating payments which are unofficial, improper small payments or gifts offered or made to government officials to secure or expedite a routine or necessary action to which other Party is legally entitled.
ARTICLE 20
MISCELLANEOUS
20.1 Dispute Resolution. Except as otherwise pursuant to Section 3.9 or with respect to any matter for which a Party has a final-decision making authority as expressly provided herein, any dispute arising out of or relating to the Agreement, or the breach, termination or validity thereof (a “Dispute”), shall be finally resolved pursuant to the following provision:
20.1.1 In the event a Dispute arises, the parties agree that they shall attempt in good faith to resolve the Dispute by negotiation between [***] (or their respective designee with power and authority to resolve such dispute) (each, a “Senior Manager”). Either Party may refer a Dispute to the applicable Senior Manager of the other Party by serving notice that Dispute has arisen and demand that negotiations commence. If the Senior Managers of both Parties are unable for any reason to resolve a Dispute within [***] after service of the notice, either party shall [***].
20.1.2 The parties agree that they shall try in good faith to resolve the Dispute by [***] shall be finally resolved by arbitration in accordance with the procedures set forth on Schedule 20.1.
20.2 Equitable Relief. Notwithstanding anything in this Agreement to the contrary, each Party has the right to pursue provisional equitable relief from any court to avoid irreparable harm, maintain the status quo, or preserve the subject matter of any Dispute, prior to the commencement of, or while the Parties are engaged in, the escalation process or dispute resolution process set forth above.
20.3 Governing Law. This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed in accordance with the laws of the State of Delaware, without reference to conflicts of laws principles. The Parties acknowledge that this Agreement evidences a transaction involving interstate commerce and a foreign (non-U.S.) Party. Notwithstanding the provision in the preceding sentence with respect to the applicable substantive law, any arbitration, decision, or award rendered hereunder and the validity, effect, and interpretation of the arbitration provision shall be governed by the Federal Arbitration Act.
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20.4 Assignment. Subject to any restrictions in the case of subcontracting set forth herein, this Agreement shall not be assignable by either Party in whole or in part without the prior written consent of the other Party(ies) hereto. Notwithstanding the foregoing, and subject (in the case of Vir) to Section 20.5, (a) GSK may assign its rights and delegate its obligations under this Agreement, in whole or in part, without consent of Vir, to an Affiliate of GSK, or a Third Party that acquires all or substantially all of the business or assets of GSK to which the subject matter of this Agreement pertains (whether by merger, reorganization, acquisition, sale of assets or otherwise); (b) Vir may assign this Agreement, without consent of GSK, but with written notice to GSK, to an Affiliate of Vir, or a Third Party that acquires all or substantially all of the business or assets of Vir (whether by merger, reorganization, acquisition, sale of assets or otherwise). All validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and assigns of such Party.
20.5 Change of Control of Vir. If there is a Change of Control of Vir in which Vir is acquired by an acquirer, then Vir shall [***] notify GSK in writing of such Change of Control within [***] following the consummation of such Change of Control, and upon consummation of such Change of Control of Vir, the following provisions shall apply:
20.5.1 All Vir Licensed Technology and Vir Program Technology Controlled by Vir or any of its Affiliates immediately before such Change of Control shall continue to be Vir Licensed Technology and Vir Program Technology, as applicable, for purposes of this Agreement. The Intellectual Property Rights of such acquirer and its Affiliates that existed prior to the Change of Control transaction shall not be included within the Vir Licensed Technology or Vir Program Technology licensed to GSK hereunder and shall not otherwise become subject to this Agreement, except to the extent such Intellectual Property Rights were so included in or subject to this Agreement prior to the consummation of such Change of Control or are used by such acquirer after the consummation of such Change of Control in the Development, Manufacture or Commercialization of Collaboration Products pursuant to this Agreement.
20.5.2 Each of the Committees, subcommittees and working groups shall be disbanded, and ARTICLE 3 (except for Section 3.11) shall terminate and be of no further force and effect. Any matters within the authority of a Committee, subcommittee or working group shall be determined, approved or resolved solely by the Lead Party for the applicable Collaboration Program, subject to Section 20.5.3 with respect to the Antibody Program. [***]. Any functions assigned to the Committees, subcommittees or working groups under this Agreement shall be performed solely by the Lead Party.
20.5.3 [***].
20.5.4 [***].
20.5.5 [***].
20.5.6 [***].
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20.5.7 Any reports or information that one Party is obligated to provide to a Committee in connection with the Development and Commercialization of any Collaboration Product shall be provided instead to the other Party, provided that (a) [***], and (b) [***].
20.5.8 [***].
20.5.9 [***].
20.5.10 Vir may retain its existing rights to any Vir Sole Development Product following a Change of Control.
20.6 Force Majeure. Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by a Force Majeure and the nonperforming Party promptly provides notice to the other Party. Such excuse shall be continued so long as the condition constituting Force Majeure continues and the non-performing Party takes reasonable efforts to remove the condition, for up to a maximum of [***], after which time the Parties will negotiate in good faith any modifications of the terms and conditions of this Agreement that may be necessary to arrive at an equitable solution. To the extent possible, each Party shall use reasonable efforts to minimize the duration of any Force Majeure.
20.7 Notices. Any notice required or permitted to be given by either Party under this Agreement shall be in writing and shall be personally delivered or sent by a nationally recognized private express courier, or by first class mail (registered or certified), or by facsimile confirmed by first class mail (registered or certified), to the respective Parties as set forth below. Notices will be deemed effective (a) [***]; (b) [***]; or (c) [***]. Either Party may change its address for purposes hereof by written notice to the other in accordance with the provisions of this Section 20.7.
If to GSK:
[***]
If to Vir:
Vir Biotechnology, Inc.
499 Illinois Street, Suite 500
San Francisco, CA 94158
Attention: [***]
E-mail: [***]
and
Vir Biotechnology, Inc.
499 Illinois Street, Suite 500
San Francisco, CA 94158
Attention: [***]
E-mail: [***]
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With a copy (which shall not constitute notice) to:
Cooley LLP
3175 Hanover Street
Palo Alto, CA 94304-1130
Attention: [***]
E-mail: [***]
20.8 Export Clause. Each Party acknowledges that the Laws and regulations of the United States and other applicable Laws restrict the export and re-export of certain commodities and technical data. Each Party agrees that it will not export or re-export restricted commodities or technical data of the other Party in any form without the appropriate United States or foreign government licenses.
20.9 Waiver. The terms and conditions of this Agreement may be waived or released only by a written instrument executed by the Party or Parties waiving or releasing compliance. The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition. No waiver by either Party of any condition or term in any one or more instances shall be construed as a continuing waiver or subsequent waiver of such condition or term or of another condition or term.
20.10 Severability. If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction.
20.11 Entire Agreement. This Agreement, together with the Schedules attached hereto, the Supply Agreements, Quality Agreements, and the SPA constitute the entire agreement between the Parties with respect to the subject matter hereof and thereof. There are no restrictions, promises, warranties or undertakings, other than those set forth or referred to herein or therein. Except for the SPA, this Definitive Collaboration Agreement supersedes all prior agreements and understandings between the Parties with respect to the subject matter hereof, including the Preliminary Collaboration Agreement and the [***]; provided that the following provisions in the Preliminary Collaboration Agreement shall be incorporated by reference in this Agreement and shall only apply with respect to any acts, omissions or events occurring between the PCA Execution Date and the Effective Date: Section 1 and Sections 2, 15, 16, 17, 18, 19(a), 20, 21, 22, 23, 24 and 25 of the Preliminary Collaboration Agreement (together with the appendices referenced in such sections). No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of both Parties.
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20.12 Independent Contractors. Nothing herein shall be construed to create a partnership, or any relationship of employer and employee, agent and principal, or joint venture between the Parties. Each Party is an independent contractor. Neither Party shall assume, either directly or indirectly, any liability of or for the other Party. Neither Party shall have the authority to bind or obligate the other Party, and neither Party shall represent that it has such authority.
20.13 Headings. Headings used herein are for convenience only and shall not in any way affect the construction of or be taken into consideration in interpreting this Agreement.
20.14 Further Actions. Each Party shall execute, acknowledge and deliver such further instruments, and do all such other acts, as may be reasonably necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of this Agreement.
20.15 Books and Records.
20.15.1 Any books and records to be maintained under this Agreement by a Party or its Affiliates or Sublicensees shall be maintained in accordance with the Accounting Standards applicable to such Party or its Affiliates in the jurisdiction in which it operates and need not be audited.
20.15.2 In the event a legal matter arises requiring preservation of certain records, each Party will suspend the destruction of such records as requested by the other Party or as requested by any governmental body. During the Term and thereafter, in accordance with any such applicable records retention notice period(s), in the event that a Party has reasonable cause to conduct an audit of the other Party, such Party requesting the audit shall have the right upon reasonable notice (which shall be not less than [***] prior written notice) and during normal working hours to inspect, copy and audit such records. Each Party shall cooperate in any such inspection or audit of its records.
20.16 Construction of Agreement. Section 11.5 of the Stock Purchase Agreement is hereby incorporate herein, mutatis mutandis.
20.17 Supremacy. In the event of any express conflict or inconsistency between this Agreement and any Schedule hereto, the terms and conditions of this Agreement shall control. The Parties understand and agree that the Schedules hereto are not intended to be the final and complete embodiment of any terms or conditions of this Agreement, and are to be updated from time to time during the Term, as appropriate and in accordance with the provisions of this Agreement.
20.18 Counterparts. This Agreement may be executed and delivered (including by facsimile transmission or PDF or any other electronically transmitted signatures) in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
20.19 No Third Party Beneficiaries. This Agreement is intended for the benefit of the Parties, their respective permitted successors and assigns, and is not for the benefit of, nor many any provision hereof be enforced by, any other Person.
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[Signature page follows]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the Execution Date by their respective duly authorized representatives as set forth below.
| GLAXO WELLCOME UK LIMITED | ||
| By: | /s/ John Sadler | |
| Its: | Authorized Signatory | |
| For and on behalf of Edinburgh Pharmaceutical Industries Limited | ||
| BEECHAM S.A. | ||
| By: | /s/ Regis Simard | |
| Its: | Director | |
| and | ||
| By: | /s/ Beurier Daniel | |
| Its: | Director | |
| VIR BIOTECHNOLOGY, INC. | ||
| By: | /s/ George Scangos | |
| Its: | President and Chief Executive Officer | |
[SIGNATURE PAGE TO DEFINITIVE COLLABORATION AGREEMENT]
SCHEDULE 1.1
309 ANTIBODY AND SELECT VARIANTS
Vir mAb-S309 [***]
[***]
[***]
[***]
SCHEDULE 1.100
FINANCIAL SCHEDULE
General Principles
Pre-tax profit or loss for the Territory (“Pre-Tax Profit or Loss”) and Development Costs shall be calculated in accordance with this Schedule 1.100. Unless otherwise agreed by the Financial Working Group, Pre-Tax Profit or Loss shall [***], and any other cost not specifically included in Allowable Expenses and Development Costs shall exclude any cost not specifically included in the definition of “Development Costs”, including, [***].
Principles for Calculation of Development Costs, Pre-Tax Profit or Loss
| 1. | Pre-Tax Profit or Loss shall be calculated for each [***] by determining [***] incurred during such [***]. Notwithstanding the foregoing, on a [***] basis, the terms of Section 9.4.2 shall apply. |
| 2. | No cost item shall be allocated to more than one cost category, i.e., [***]. |
| 3. | Costs incurred by a Party in connection with Commercialization or Commercial Manufacture shall be allocated to the appropriate category of Allowable Expenses in accordance with [***]. |
| 4. | Where a Party incurs costs under this Agreement that apply to (a) more than one Collaboration Product, (b) more than one Collaboration Program, or (c) one or more Collaboration Programs as well as products or programs that are not included under this Agreement then such Party shall [***]. |
| 5. | All undefined terms shall be construed in accordance with such Accounting Standards, but only to the extent consistent with their usage and the other definitions in this Schedule 1.100 and the Agreement. To the extent [***] requested by the Non-Lead Party, the Lead Party shall provide the Non-Lead Party the appropriate back-up detail for Development Costs and Pre-Tax Profit or Loss to enable the Non-Lead Party to state its share of such Development Costs and Pre-Tax Profit or Loss in its applicable Accounting Standard. In addition, following the Effective Date, each Party shall consider in good faith reasonable procedures proposed by the other Party for sharing financial information in order to permit each Party to close its books periodically in a timely manner. |
| 6. | The Parties shall comply with any reporting requirements under securities law. For the avoidance of doubt, income and withholding Taxes imposed on either of the Parties shall not be included in the calculation of Pre-Tax Profit or Loss. |
Financial Definitions
The following definitions shall apply for the purposes of calculating Pre-Tax Profit or Loss, and other financial terms in the Agreement, including Development Cost sharing. If a financial term is not defined in this Schedule 1.100, then such term shall, on a Collaboration Product-by-Collaboration Product basis, be defined by the Financial Working Group. For purposes for the following definitions, the terms “costs” and “expenses” shall mean all direct Third Party invoiced costs and FTE Costs, unless otherwise expressly provided herein.
“Allowable Expenses” means the sum of the following costs and expenses incurred during the Term by the Parties or their Affiliates, in the conduct of Commercial Manufacture and Commercialization of the Collaboration Products in the Territory, in accordance with this Agreement during the applicable [***]:
[***]
Allowable Expenses shall, subject the annual Commercialization Budget and the terms of Section 9.4.2, include all Third Party invoiced expenses as well as FTE Costs reasonably necessary and identifiable to the Collaboration Products, either direct expenses or expenses that shall be allocated based on [***]. Upon request by either Party, the Financial Working Group shall review the methodology used to allocate expenses in connection with the calculation of Allowable Expenses. If the Financial Working Group does not approve such methodology, the Financial Working Group shall agree upon a revised methodology. Notwithstanding any other clauses in this Schedule 1.100, [***].
“Bad Debt” means [***].
“Blocking Third Party IP Costs” means [***] attributable or allocable to, Development, Manufacture, and Commercialization of the applicable Collaboration Product and paid to a Third Party to license or acquire Intellectual Property Rights for the Development, Manufacture or Commercialization of the applicable Collaboration Product in accordance with Section 9.6 or as otherwise set forth in this Agreement.
“Development Costs” means the following costs incurred by the Parties following the Effective Date in conducting Development under the applicable Collaboration Programs, in each case to the extent incurred in accordance with this Agreement and the applicable Development Plan and Development Budget (as may be amended and approved by the JSC in accordance with Section 5.1.3) and [***]:
[***]
“[***]” means [***].
“[***]” means [***].
“Existing Third Party IP Agreement” means any license, acquisition or other agreement existing as of the Effective Date pursuant to which a Party has obtained any Intellectual Property Rights included within Licensed Technology, including the agreements listed on Schedule 10.9.
“FTE Costs” means, as applicable with respect to any period, [***].
“[***]” means, [***].
“[***]” means, [***].
“Manufacturing Cost” means, with respect to a Collaboration Product, a Party’s reasonable and necessary FTE Costs and Third Party invoiced cost, determined in accordance with GAAP for Vir and IFRS for GSK, as applicable and consistently applied, and the terms and conditions of this Agreement (including approval by the JSC), incurred in Manufacturing or acquisition or securing Manufacturing capacity for such Collaboration Product. Manufacturing Costs are comprised of [***], where:
[***].
Manufacturing Cost shall [***]. For clarity, to the extent approved by the JSC, all costs associated with the binding commitments set forth in the Samsung DS Letter Agreement [***], to the extent applicable to Commercial Manufacture, shall be included in Manufacturing Costs that are Allowable Expenses. Further for clarity, Blocking Third Party IP Costs shall not be included in Manufacturing Cost. Notwithstanding the foregoing or anything to the contrary herein, [***].
“[***]” means [***]:
[***].
“[***]” means [***].
“Net Sales” means the actual gross amount invoiced by the LCP or the Non Opt-Out Party (with respect to a Sole Development Product), or its respective Affiliates, licensee or permitted Sublicensee, for sales or other commercial disposition of a Collaboration Product or Sole Development Product, as the case may be, [***] to a Third Party purchaser, excluding sales between or among the LCP or Non Opt-Out Party and its respective Affiliates, or its licensees or Sublicensees, less the following deductions [***].
[***].
[***].
[***].
[***].
[***].
“[***]” means [***].
“[***]” means [***].
“[***]” means [***].
“[***]” means [***].
“[***]” means [***].
“[***]” means:
[***].
“[***]” means [***].
“[***]” means [***].
“[***]” means [***].
SCHEDULE 1.122
GSK SPECIFIED INTERNAL POLICIES
[***]
SCHEDULE 1.250
VIR FUNCTIONAL GENOMICS TARGETS
[***]
SCHEDULE 2.3.1
EXISTING VIR THIRD PARTY AGREEMENTS
[***]
SCHEDULE 4.2.2
[***]
SCHEDULE 5.6.5
ANIMAL WELFARE
[***]
2
SCHEDULE 8.1
KEY TERMS FOR PHARMACOVIGILANCE TECHNICAL AGREEMENT
[***]
SCHEDULE 9.5.2
ROYALTIES FOLLOWING OPT-OUT
[***]
SCHEDULE 9.5.3
[***]
SCHEDULE 10.9
EXISTING THIRD PARTY IP AGREEMENTS
[***]
SCHEDULE 13.1.1
FORM OF MATERIAL TRANSFER RECORD
Material Transfer Record
[***]
SCHEDULE 20.1
ARBITRATION
[***]
Exhibit 10.55
Execution Version
STOCK PURCHASE AGREEMENT
THIS STOCK PURCHASE AGREEMENT (“Agreement”) is entered into as of April 5, 2020 (the “Execution Date”), by and between Glaxo Group Limited, a private limited liability company incorporated under the laws of England and Wales having an office at 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom (“GSK”), and Vir Biotechnology, Inc. a Delaware corporation having an office at 499 Illinois Street, Suite 500, San Francisco, CA 94158 (“Vir”). The capitalized terms used herein and not otherwise defined have the meanings given to them in Appendix 1.
RECITALS
Vir has agreed to sell, and GSK has agreed to purchase, shares of Common Stock subject to and in accordance with the terms and provisions of this Agreement.
Contemporaneously with the execution of this Agreement, GlaxoSmithKline Intellectual Property Development Limited and GlaxoSmithKline Biologicals SA, Affiliates of GSK, and Vir are entering into that certain preliminary agreement set forth in Appendix 2 containing the terms agreed by such parties to govern their strategic collaboration to develop, manufacture and commercialize antibody products, vaccine products and functional genomic products in the Field (as defined below) (the “Preliminary Collaboration Agreement”) until such time as the Preliminary Collaboration Agreement is expanded into a longer form definitive collaboration agreement mutually agreed, and entered into, by the parties to the Preliminary Collaboration Agreement (the “Definitive Collaboration Agreement”).
AGREEMENT
For good and valuable consideration, GSK and Vir agree as follows:
| Section | 1. SALE AND PURCHASE OF STOCK |
1.1 Purchase of Stock. Subject to the terms and conditions of this Agreement, at the Closing, Vir will issue and sell to GSK, and GSK will purchase from Vir, 6,626,027 shares of Common Stock (the “Shares”) at a price per share equal to $37.73 for an aggregate purchase price of $249,999,998.71 (the “Purchase Price”).
1.2 Payment. At the Closing, GSK will pay the Purchase Price by wire transfer of immediately available funds in accordance with wire instructions, which instructions will have been provided by Vir to GSK at least three (3) Business Days prior to the Closing, and Vir will deliver the Shares in restricted book-entry form to GSK.
1.3 Closing.
(a) Closing. The closing of the transaction contemplated by Section 1.1 (the “Closing”) will be held at the offices of Vir or through the electronic exchange of documents and signatures, as promptly as practicable, and in no event more than five (5) Business Days after the conditions to the Closing set forth in Section 7 are satisfied or waived for the Closing (other than those conditions that by their nature are to be satisfied or waived at the Closing) or at such other place, if any, time and/or date as may be jointly designated by GSK and Vir for the Closing.
(b) Closing Deliverables.
(i) At the Closing, Vir will deliver to GSK:
A. a duly executed cross-receipt in form and substance reasonably satisfactory to each party (the “Cross-Receipt”);
B. a certificate in form and substance reasonably satisfactory to GSK and duly executed on behalf of Vir by an authorized officer of Vir, certifying that the conditions to the Closing set forth in Section 7.2(a), (b), (c) and (d) of this Agreement have been fulfilled; and
C. a certificate of the secretary of Vir dated as of the Closing Date certifying that attached thereto is a true and complete copy of all resolutions adopted by the Board authorizing the execution, delivery and performance of this Agreement and the transactions contemplated herein and that all such resolutions are in full force and effect and are all the resolutions adopted in connection with the transactions contemplated hereby as of the Closing Date.
(ii) At the Closing, GSK will deliver to Vir:
A. a duly-executed Cross-Receipt; and
B. a certificate in form and substance reasonably satisfactory to Vir and duly executed on behalf of GSK by an authorized officer of GSK, certifying that the conditions to the Closing set forth in Section 7.1(b) and (c) of this Agreement have been fulfilled.
| Section | 2. REPRESENTATIONS AND WARRANTIES OF VIR |
Except as otherwise specifically contemplated by this Agreement, Vir hereby represents and warrants to GSK that:
2.1 Private Placement. Neither Vir nor any Person acting on its behalf, has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under any circumstances that would require registration of the Shares under the Securities Act. Subject to the accuracy of the representations made by GSK in Section 3, the Shares will be issued and sold to GSK in compliance with applicable exemptions from the registration and prospectus delivery requirements of the Securities Act and the registration and qualification requirements of all applicable securities Laws of the states of the United States. Vir has not engaged any brokers, finders or agents, or incurred, or will incur, directly or indirectly, any liability for brokerage or finder’s fees or agents’ commissions or any similar charges in connection with this Agreement and the transactions contemplated hereby.
2.2 Organization and Qualification. Vir is duly incorporated, validly existing and in good standing under the laws of the State of Delaware, with full corporate power and authority to
2
conduct its business as currently conducted. Vir is duly qualified to do business and is in good standing in every jurisdiction in which the nature of the business conducted by it or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, would not reasonably be expected to have a Material Adverse Effect on Vir.
2.3 Authorization; Enforcement. Vir has all requisite corporate power and authority to enter into and to perform its obligations under this Agreement, to consummate the transactions contemplated hereby and to issue the Shares in accordance with the terms hereof. The execution, delivery and performance of this Agreement by Vir and the consummation by it of the transactions contemplated hereby (including the issuance of the Shares at the Closing in accordance with the terms hereof) have been duly authorized by the Board and no further consent or authorization of Vir, the Board, or its stockholders is required. This Agreement has been duly executed by Vir and constitutes a legal, valid and binding obligation of Vir enforceable against Vir in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, or moratorium or similar Laws affecting creditors’ and contracting parties’ rights generally.
2.4 Issuance of Shares. The Shares are duly authorized and, upon issuance in accordance with the terms of this Agreement, will be validly issued, fully paid and non-assessable and will not be subject to preemptive rights or other similar rights of stockholders of Vir.
2.5 SEC Documents, Financial Statements.
(a) The Common Stock is registered pursuant to Section 12(b) or 12(g) of the Exchange Act. Vir has delivered or made available (by filing on the SEC’s electronic data gathering and retrieval system (EDGAR)) to GSK complete copies of its most recent Annual Report on Form 10-K, and any report on Form 8-K, in each case filed with the SEC after October 10, 2019 and prior to the Execution Date (the “SEC Documents”). As of its date, each SEC Document complied in all material respects with the requirements of the Exchange Act, and other Laws applicable to it, and, as of its date, such SEC Document did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. No inquiries or any other investigation conducted by or on behalf of GSK or its representatives or counsel will modify, amend or affect GSK’s right to rely on the truth, accuracy and completeness of the SEC Documents and Vir’s representations and warranties contained in this Agreement.
(b) The financial statements, together with the related notes and schedules, of Vir included in the SEC Documents comply as to form in all material respects with all applicable accounting requirements and the published rules and regulations of the SEC and all other applicable rules and regulations with respect thereto. Such financial statements, together with the related notes and schedules, have been prepared in accordance with GAAP applied on a consistent basis during the periods involved (except (i) as may be otherwise indicated in such financial statements or the notes thereto or (ii) in the case of unaudited interim statements, to the extent they may not include footnotes or may be condensed or summary statements), and fairly present in all material respects the financial condition of Vir and its consolidated subsidiaries as of the dates thereof and the results of operations and cash flows for the periods then ended (subject, in the case of unaudited statements, to normal year-end audit adjustments).
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(c) The Common Stock is listed on Nasdaq, and Vir has taken no action designed to, or that to its knowledge is likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act or delisting the Common Stock from Nasdaq. As of the date of this Agreement, Vir has not received any notification that, and has no knowledge that, the SEC or Nasdaq is contemplating terminating such registration or listing.
2.6 Internal Controls; Disclosure Controls and Procedures. Vir maintains internal control over financial reporting as defined in Rule 13a-15(f) under the Exchange Act. Vir has implemented the “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) required in order for the principal executive officer and principal financial officer of Vir to engage in the review and evaluation process mandated by the Exchange Act, and is in compliance with such disclosure controls and procedures in all material respects. Each of the principal executive officer and the principal financial officer of Vir has made all certifications required by Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 with respect to all reports, schedules, forms, statements and other documents required to be filed by Vir with the SEC.
2.7 Capitalization and Voting Rights.
(a) The authorized capital of Vir as of the date hereof consists of: (i) 300,000,000 shares of Common Stock of which, as of April 5, 2020, (A) 109,821,390 shares were issued and outstanding, (B) 11,925,151 shares were reserved for issuance pursuant to Vir’s equity incentive plans (including its stock purchase plan) described in the SEC Documents, (C) 244,444 shares were reserved for issuance pursuant to outstanding warrants, and (D) 7,894,104 shares were issuable upon the exercise of stock options outstanding, and (ii) 10,000,000 shares of Preferred Stock, of which no shares are issued and outstanding as of the date of this Agreement. All of the issued and outstanding shares of Common Stock (1) have been duly authorized and validly issued, (2) are fully paid and non-assessable and (3) were issued in compliance with all applicable federal and state securities Laws and not in violation of any preemptive rights.
(b) All of the authorized shares of Common Stock are entitled to one (1) vote per share.
(c) Except as described or referred to in the SEC Documents, as of April 4, 2020, there were not: (i) any outstanding equity securities, options, warrants, rights (including conversion or preemptive rights) or other agreements pursuant to which Vir is or may become obligated to issue, sell or repurchase any shares of its capital stock or any other securities of Vir other than equity securities that may have been granted pursuant to its equity incentive plans, which plans are described in the SEC Documents; or (ii) any restrictions on the transfer of capital stock of Vir other than pursuant to federal or state securities Laws or as set forth in this Agreement.
(d) Vir is not a party to or subject to any agreement or understanding relating to the voting of shares of capital stock of Vir or the giving of written consents by a stockholder or director of Vir.
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2.8 No Conflicts; Government Consents and Permits.
(a) The execution, delivery and performance of this Agreement by Vir and the consummation by Vir of the transactions contemplated hereby (including the issuance of the Shares) will not (i) conflict with or result in a violation of any provision of Vir’s Amended and Restated Certificate of Incorporation or Amended and Restated Bylaws, each as in effect on the date hereof, (ii) violate or conflict with, or result in a breach of any provision of, or constitute a default under, any agreement, indenture, or instrument to which Vir is a party, or (iii) result in a violation of any Law (including United States federal, state and U.K. securities Laws and regulations and regulations of any self-regulatory organizations) applicable to Vir, except in the case of clauses (ii) and (iii) only, for such conflicts, breaches, defaults, and violations as would not reasonably be expected to have, a Material Adverse Effect on Vir or result in a liability for GSK.
(b) Vir is not required to obtain any consent, authorization or order of, or make any filing or registration with, any court or governmental agency or any regulatory agency or self-regulatory organization in order for it to execute, deliver or perform any of its obligations under this Agreement in accordance with the terms hereof, or to issue and sell the Shares in accordance with the terms hereof other than such as have been made or obtained, and except for (i) any post-closing filings required to be made under federal or state securities Laws, (ii) any required filings or notifications regarding the issuance or listing of additional shares with Nasdaq, and (iii) the applicable premerger notification and waiting period requirements of the HSR Act, and such other Antitrust Law as may be applicable to the Agreement.
2.9 Litigation. Other than as set forth in the SEC Documents filed prior to the date of this Agreement, there is no action, suit, proceeding or investigation pending (of which Vir has received notice or otherwise has knowledge) or, to Vir’s knowledge, threatened, against Vir or that Vir intends to initiate, except where such action, suit, proceeding or investigation, as the case may be, and would not reasonably be expected to have a Material Adverse Effect.
2.10 Licenses and Other Rights; Compliance with Laws. Vir has all franchises, permits, licenses and other rights and privileges (“Permits”) necessary to permit it to own its properties and to conduct its business as presently conducted and is in compliance thereunder, except where the failure to be in compliance would not reasonably be expected to have, a Material Adverse Effect. Vir has not taken any action that would interfere with its ability to renew all such Permit(s), except where the failure to renew such Permit(s) would not reasonably be expected to have, a Material Adverse Effect. Vir is and has been in compliance with all Laws applicable to its business, properties and assets, and to the products and services sold by it, except where the failure to be in compliance has not had and would not reasonably be expected to have a Material Adverse Effect.
2.11 Intellectual Property.
(a) The Intellectual Property that is owned by Vir or its subsidiaries is owned free from any Liens or restrictions. All of Vir’s material Intellectual Property Licenses are in full force and effect in accordance with their terms, are free of any Liens or restrictions, and, to Vir’s knowledge, neither Vir, nor any other party thereto, is in material breach of any such material Intellectual Property License. To Vir’s knowledge, no event has occurred that with notice or lapse
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of time or both (i) would constitute a breach or default of any such material Intellectual Property License, (ii) would result in the termination thereof, or (iii) would cause or permit the acceleration or other change of any right or obligation or the loss of any benefit thereunder by Vir or its subsidiaries except in the case of each of clauses (i) through (iii) as would not reasonably be expected to have a Material Adverse Effect.
(b) Except as set forth in the SEC Documents, there is no legal claim or demand of any Person or any proceeding that is pending or threatened in writing, (i) challenging the right of Vir in respect of any Intellectual Property of Vir, or (ii) claiming that any default exists under any Intellectual Property License, except, in the case of clauses (i) and (ii) above, where any such claim, demand or proceeding has not had, and would not reasonably be expected to have, a Material Adverse Effect.
(c) Except as set forth in the SEC Documents: (i) Vir or one of its subsidiaries owns, free and clear of any Lien or encumbrance, or, to Vir’s knowledge, has a valid license, or an enforceable right to use, as it is used or held for use, all U.S. and non-U.S. patents, trade secrets, know-how, trademarks, service marks, copyrights, and other proprietary and Intellectual Property rights, and all grants and applications with respect to the foregoing (collectively, the “Proprietary Rights”) necessary for the conduct of Vir’s business, except where the failure to own or have any of the foregoing would not reasonably be expected to have, a Material Adverse Effect (such Proprietary Rights owned by or licensed to Vir collectively, the “Vir Rights”); and (ii) Vir and its subsidiaries have taken reasonable measures to protect the Vir Rights, consistent with prudent commercial practices in the biotechnology industry, except where failure to take such measures has not had, and would not reasonably be expected to have, a Material Adverse Effect.
2.12 Health Care Matters. Vir: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the Health Care Laws (as defined below) of the Food and Drug Administration (“FDA”), the Department of Health and Human Services and any comparable state, foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, sale, promotion, distribution, storage, import, export or disposal of any of Vir’s product candidates or any product manufactured or distributed by Vir; (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or the Applicable Regulatory Authorities alleging or asserting non-compliance with any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and Vir is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or the Applicable Regulatory Authorities or any other third party alleging that any product operation or activity is in material violation of any Health Care Laws and has no knowledge that the Applicable Regulatory Authorities or any other third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received notice that any of the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory
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Authorizations and has no knowledge that any of the Applicable Regulatory Authorities is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vii) is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Applicable Regulatory Authority; and (viii) along with its employees, officers and directors, has not been excluded, disqualified, suspended or debarred from participation in any government health care program or human clinical research or, to Vir’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, disqualification or exclusion.
2.13 Clinical Trials. None of Vir’s product candidates has received marketing approval from any Applicable Regulatory Authority. All clinical and pre-clinical studies and trials conducted by or on behalf of or sponsored by Vir, or in which Vir has participated, with respect to Vir’s product candidates, including any such studies and trials that are described in the SEC Documents, or the results of which are referred to in the SEC Documents, as applicable (collectively, “Company Trials”), were, and if still pending are, to Vir’s knowledge, being conducted in all material respects in accordance with all applicable Health Care Laws of the Applicable Regulatory Authorities, including the FDA’s current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted. The descriptions in the SEC Documents of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom. Vir has no knowledge of any other studies or trials not described in the SEC Documents, the results of which are inconsistent with or call into question the results described or referred to in the SEC Documents. Vir has not received any written notices, correspondence or other communications from the Applicable Regulatory Authorities or any other governmental entity or any institutional review board (“IRB”) or independent ethics committee (“IEC”) requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, and, to Vir’s knowledge, there are no reasonable grounds for the same. No investigational new drug application or comparable submission filed by or on behalf of Vir with the FDA has been terminated or suspended by the FDA or any other Applicable Regulatory Authority. Vir has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial, and Vir has obtained (or caused to be obtained) applicable IRB or IEC approvals for each Company Trial. To Vir’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct.
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2.14 Absence of Certain Changes.
(a) Except as disclosed in the SEC Documents filed prior to the Execution Date, since December 31, 2019, no change or event has occurred, except where such change or event has not had, and would not reasonably be expected to have, a Material Adverse Effect on Vir.
(b) Except as set forth in the SEC Documents filed prior to the Execution Date or as contemplated by this Agreement or the Preliminary Collaboration Agreement, since December 31, 2019, Vir has not (i) declared or paid any dividends, or authorized or made any distribution upon or with respect to any class or series of its capital stock, or (ii) sold, exchanged or otherwise disposed of any of its material assets or rights.
(c) Since December 31, 2019, Vir has not admitted in writing its inability to pay its debts generally as they become due, filed or consented to the filing against it of a petition in bankruptcy or a petition to take advantage of any insolvency act, made an assignment for the benefit of creditors, consented to the appointment of a receiver for itself or for the whole or any substantial part of its property, or had a petition in bankruptcy filed against it, been adjudicated a bankrupt, or filed a petition or answer seeking reorganization or arrangement under the federal bankruptcy Laws or any other Laws of the United States or any other jurisdiction.
2.15 Not an Investment Company. Vir is not, and after receipt of the Purchase Price, will not be, an “investment company” as defined in the Investment Company Act of 1940, as amended.
2.16 Critical Technology. Vir does not produce, design, test, manufacture, fabricate, or develop one or more “critical technologies” within the meaning of the Defense Production Act of 1950, as amended, including all implementing regulations thereof.
2.17 No Integration. Vir has not, directly or through any agent, sold, offered for sale, solicited offers to buy or otherwise negotiated in respect of, any security (as defined in the Securities Act) that is or will be integrated with the Shares sold pursuant to this Agreement in a manner that would require the registration of the Shares under the Securities Act.
| Section | 3. REPRESENTATIONS AND WARRANTIES OF GSK |
Except as otherwise specifically contemplated by this Agreement, GSK hereby represents and warrants to Vir that:
3.1 Authorization; Enforcement. GSK has the requisite corporate or other similar power and authority to enter into this Agreement and to consummate the transactions contemplated hereby. GSK has taken all necessary corporate or other similar action to authorize the execution, delivery and performance of this Agreement. Upon the execution and delivery of this Agreement, this Agreement will constitute a valid and binding obligation of GSK enforceable against GSK in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar Laws affecting creditors’ and contracting parties’ rights generally.
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3.2 No Conflicts; Government Consents and Permits.
(a) The execution, delivery and performance of this Agreement by GSK and the consummation by GSK of the transactions contemplated hereby (including the purchase of the Shares) will not (i) conflict with or result in a violation of any provision of GSK’s memorandum and articles of association or equivalent organizational documents, (ii) violate or conflict with, or result in a breach of any provision of, or constitute a default under, any agreement, indenture, or instrument to which GSK is a party, or (iii) result in a violation of any Law (including U.S. federal and state and U.K. securities Laws and regulations and regulations of any self-regulatory organizations) applicable to GSK, except in the case of clauses (ii) and (iii) only, for such conflicts, breaches, defaults, and violations as have not had, and would not reasonably be expected to have, a Material Adverse Effect on GSK or result in a liability for Vir.
(b) GSK is not required to obtain any consent, authorization or order of, or make any filing or registration with, any court or governmental agency or any regulatory agency or self-regulatory organization in order for it to execute, deliver or perform any of its obligations under this Agreement in accordance with the terms hereof, or to purchase the Shares in accordance with the terms hereof other than such as have been made or obtained except for the applicable premerger notification and waiting period requirements of the HSR Act, and such other Antitrust Law as may be applicable to the Agreement.
3.3 Investment Purpose. GSK is purchasing the Shares for its own account and not with a present view toward the public distribution thereof and has no arrangement or understanding with any other Persons regarding the distribution of such Shares except as would not result in a violation of the Securities Act. GSK will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire or take a pledge of) any of the Shares except in accordance with the Securities Act and to the extent permitted by Section 6.1 and Section 6.2.
3.4 Reliance on Exemptions. GSK understands that Vir intends for the Shares to be offered and sold to it in reliance upon specific exemptions from the registration requirements of United States federal and state securities Laws and that Vir is relying upon the truth and accuracy of, and GSK’s compliance with, the representations, warranties, agreements, acknowledgments and understandings of GSK set forth herein in order to determine the availability of such exemptions and the eligibility of GSK to acquire the Shares.
3.5 Accredited Investor; Access to Information. GSK is an “accredited investor” as defined in Regulation D under the Securities Act and is knowledgeable, sophisticated and experienced in making, and is qualified to make decisions with respect to investments in shares presenting an investment decision like that involved in the purchase of the Shares. GSK has been furnished with materials relating to the offer and sale of the Shares that have been requested by GSK, including the SEC Documents, and GSK has had the opportunity to review the SEC Documents. GSK has been afforded the opportunity to ask questions of Vir. Neither such inquiries nor any other investigation conducted by or on behalf of GSK or its representatives or counsel will modify, amend or affect GSK’s right to rely on the truth, accuracy and completeness of the SEC Documents and Vir’s representations and warranties contained in this Agreement.
3.6 Restricted Securities. GSK understands that the Shares will be characterized as “restricted securities” under the U.S. federal securities Laws inasmuch as they are being acquired
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from Vir in a private placement under Section 4(a)(2) of the Securities Act and that under such Laws and applicable regulations such Shares may be resold without registration under the Securities Act only in certain limited circumstances.
3.7 Foreign Purchaser. GSK is not a United States person (as defined by Section 7701(a)(30) of the U.S. Internal Revenue Code of 1986, as amended), and hereby represents that it has satisfied itself as to the full observance of the Laws of its jurisdiction in connection with its purchase of the Shares including (a) the legal requirements within its jurisdiction for the purchase of the Shares, (b) any foreign exchange restrictions applicable to such purchase, (c) any governmental or other consents that may need to be obtained, and (d) the income Tax and other Tax consequences, if any, that may be relevant to the purchase, holding, redemption, sale, or transfer of the Shares.
3.8 Governmental Review. GSK understands that no U.S. federal or state agency or any other Governmental Authority has passed upon or made any recommendation or endorsement of the Shares or an investment therein.
| Section | 4. CERTAIN COVENANTS |
4.1 Definitive Collaboration Agreement. Immediately following the Execution Date, Vir and GSK shall commence negotiations with the intent to enter into the Definitive Collaboration Agreement. Vir and GSK shall use their respective best efforts to negotiate diligently and agree upon final terms for the Definitive Collaboration Agreement as promptly as practicable following the Execution Date and in no event later than the later of (x) the Antitrust Clearance Date and (y) forty-five (45) days following the Execution Date (or such longer period as Vir and GSK may mutually agree in writing) (the “Negotiation Period”). For the avoidance of doubt, entry into the Definitive Collaboration Agreement is not a condition to the effectiveness of this Agreement or the Preliminary Collaboration Agreement. If all conditions set forth in Section 7.1 and Section 7.2 of this Agreement have been satisfied or waived, but the Definitive Collaboration Agreement has not been finalized and executed, the Closing shall occur in accordance with the terms hereof and the Preliminary Collaboration Agreement, which is binding and governs the parties’ collaboration relationship, shall continue in full force and effect and Vir and GSK shall continue to negotiate or otherwise finalize the Definitive Collaboration Agreement in accordance with Appendix E of the Preliminary Collaboration Agreement.
4.2 Execution of Definitive Collaboration Agreement. Each of Vir and GSK shall duly execute and deliver the Definitive Collaboration Agreement, on final terms as are (a) mutually agreed by Vir and GSK within the Negotiation Period, or (b) in the absence of such mutual agreement, determined in accordance with Appendix E of the Preliminary Collaboration Agreement.
4.3 Preliminary Collaboration Agreement. Upon execution by the parties thereto, the Preliminary Collaboration Agreement shall be a fully integrated and binding agreement and in full force and effect, subject only to the satisfaction of the conditions set forth therein. Neither party, nor any of their respective Affiliates shall seek to assert that the Preliminary Collaboration Agreement or any term thereof is unenforceable for vagueness, or for not having sufficiently clear or defined terms, for failure of consideration or because it lacks any essential term for enforcement
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and each of Vir and GSK, on behalf of themselves and their Affiliates, hereby waive any right to make such an assertion. To the extent that any material term has not been included in the Preliminary Collaboration Agreement, Vir and GSK agree that such term (or terms) will be provided through the process set forth in Appendix E of the Preliminary Collaboration Agreement and will be binding and enforceable as if it had been included in the Preliminary Collaboration Agreement.
| Section | 5. STANDSTILL AGREEMENT |
5.1 Prior to the one-year anniversary of the Effective Date (the “Standstill Period”), GSK and its Affiliates will not, directly or indirectly, except as expressly approved or invited by Vir or otherwise expressly permitted pursuant to this Section 5.
(a) effect or seek, offer or propose (whether publicly or otherwise) to effect, or cause or participate, directly or indirectly (including through any other Person), in, (i) any acquisition of any securities (or beneficial ownership thereof) or material assets of Vir, (ii) any tender or exchange offer, merger, or other business combination involving Vir, (iii) any recapitalization, restructuring, liquidation, dissolution or other extraordinary transaction with respect to Vir, or (iv) any “solicitation” of “proxies” (as such terms are used in the proxy rules of the SEC) or consents to vote any voting securities of Vir;
(b) form, join or in any way participate in a “group” (as defined under the Exchange Act) with respect to any securities of Vir;
(c) otherwise act, alone or in concert with others, to seek to control or influence the management, Board or policies of Vir (other than such policies as may be within the scope of the Preliminary Collaboration Agreement or the Definitive Collaboration Agreement);
(d) take any action that would reasonably be expected to require Vir to make a public announcement regarding any of the types of matters set forth in clause (a) above; or
(e) enter into any discussions or arrangements with any Person with respect to any of the foregoing.
5.2 GSK also agrees during the Standstill Period not to request Vir (or its representatives), directly or indirectly, amend or waive any provision of this Section 5 other than by means of a confidential communication to the Vir Chairman of the Board or Chief Executive Officer.
5.3 GSK represents and warrants that, as of the Execution Date, neither GSK nor any of its Affiliates owns, of record or beneficially, any voting securities of Vir, or any securities convertible into or exercisable for any voting securities of Vir.
5.4 Notwithstanding the provisions set forth in Sections 5.1 and 5.2 (the “Standstill Provisions”), GSK shall immediately, and without any other action by Vir, be released from its obligations under the Standstill Provisions if: (a) Vir executes, or publicly announces its intention to execute, a definitive agreement with a third party providing for an acquisition (by way of merger, tender offer or otherwise), of more than 50% of Vir’s
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outstanding Common Stock or all or substantially all of Vir’s assets, (b) any person or “group” (as defined under the Exchange Act) commences a tender offer or makes an offer or proposal which is made public seeking to acquire beneficial ownership of more than 50% of Vir’s outstanding Common Stock (with any acquisition described in clauses (a) and (b) referred to as a “Change of Control Transaction”), (c) Vir waives any standstill or similar provision in any other agreement between Vir and a third party for the explicit purpose of allowing the third party to pursue or engage in any Change of Control Transaction, or (d) Vir publicly announces the commencement of a formal process to solicit proposals for a potential business combination transaction. None of (i) the ownership or purchase by an employee benefit plan of GSK or GSK’s Affiliates in any diversified index, mutual or pension fund managed by an independent advisor, which fund in-turn holds, directly or indirectly, securities of Vir, (ii) the acquisition of the equity securities of an entity that owns such securities prior to such acquisition so long as such acquisition is not consummated for the purpose of circumventing this Section 5 or (iii) transfers or resales of the Shares by GSK to any other person in compliance with Section 6, will be deemed to be a breach of GSK’s standstill obligations under this Section 5.
| Section | 6. TRANSFER, RESALE, LEGENDS, REGISTRATION RIGHTS |
6.1 Transfer or Resale. GSK understands that:
(a) the Shares have not been and are not being registered under the Securities Act or any applicable state securities Laws and, consequently, GSK may have to bear the risk of owning the Shares for an indefinite period of time because the Shares may not be transferred unless (i) the resale of the Shares is registered pursuant to an effective registration statement under the Securities Act; (ii) GSK has delivered to Vir an opinion of counsel (in form, substance and scope customary for opinions of counsel in comparable transactions) to the effect that the Shares to be sold or transferred may be sold or transferred pursuant to an exemption from such registration; or (iii) the Shares are sold or transferred pursuant to Rule 144 under the Securities Act (“Rule 144”); and
(b) any sale of the Shares made in reliance on Rule 144 may be made only in accordance with the terms of Rule 144 and, if Rule 144 is not applicable, any resale of the Shares under circumstances in which the seller (or the Person through whom the sale is made) may be deemed to be an underwriter (as that term is defined in the Securities Act) may require compliance with some other exemption under the Securities Act or the rules and regulations of the SEC thereunder.
6.2 Lock-Up. GSK agrees that it will hold and will not sell any of the Shares (or otherwise make any short sale of, grant any option for the purchase of, or enter into any hedging or similar transaction with the same economic effect as a sale of the Shares) until the one-year anniversary of the Effective Date. Notwithstanding the foregoing, this Section 6.2 will not preclude (i) distributions of Shares to general or limited partners, members, shareholders, Affiliates or wholly owned subsidiaries of GSK or any investment fund or other entity controlled or managed by GSK; provided, in each case, that following any such transfer such Shares will remain subject to the provisions of this Section 6.2; or (ii) transfers pursuant to a bona fide third party tender offer for all outstanding shares of Common Stock, merger, consolidation or other similar transaction made to all holders of Vir’s securities involving a change of control of Vir (including the entering
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into any lock-up, voting or similar agreement pursuant to which GSK may agree to transfer, sell, tender or otherwise dispose of Shares or other such securities in connection with such transaction, or vote any Shares or other such securities in favor of any such transaction); provided that in the event that such tender offer, merger, consolidation or other such transaction is not completed, the Shares shall remain subject to the provisions of this Section 6.2.
6.3 Legends. GSK understands the Shares will bear restrictive legends in substantially the following form (and a stop-transfer order may be placed against transfer of the Shares):
THE SHARES HAVE NOT BEEN REGISTERED UNDER THE U.S. SECURITIES ACT OF 1933, AS AMENDED, OR ANY APPLICABLE STATE SECURITIES LAWS. THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED OR HYPOTHECATED IN THE ABSENCE OF A REGISTRATION STATEMENT IN EFFECT WITH RESPECT TO THE SECURITIES UNDER SUCH ACT OR APPLICABLE STATE SECURITIES LAWS OR A CERTIFICATE AND/OR AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED.
THE SALE, PLEDGE, HYPOTHECATION OR TRANSFER OF THESE SECURITIES IS SUBJECT TO THE TERMS AND CONDITIONS OF A STOCK PURCHASE AGREEMENT DATED APRIL 5, 2020 BETWEEN VIR BIOTECHNOLOGY, INC. AND GLAXO GROUP LIMITED.
If such Shares may be transferred pursuant to Section 6.2 (excluding transfers pursuant to Section 6.2(i)), GSK may request that Vir remove, and Vir agrees to authorize and instruct (including by causing any required legal opinion to be provided) the removal of any legend from the Shares, if permitted by applicable securities Law, within two (2) Business Days of any such request; provided, however, that each party will be responsible for any fees it incurs in connection with such request and removal.
6.4 Registration Rights. If, following the one year anniversary of the Effective Date, GSK proposes to publicly resell the Shares pursuant to Rule 144 and GSK in good faith believes it will be unable to sell all of the Shares proposed to be sold by it pursuant to Rule 144 without volume or manner-of-sale restrictions, GSK shall notify Vir and Vir shall file as promptly as practicable a secondary only registration statement on Form S-3 (or any successor form to Form S-3) promulgated under the Securities Act (which, if Vir is then a “well-known seasoned issuer” (as defined in Rule 405 under the Securities Act), shall be filed pursuant to General Instruction I.D of Form S-3 (an “Automatic Shelf Registration Statement”)), registering the resale of such Shares (the “Registrable Securities”) (or, in the event that Form S-3 is not available for the registration of the resale of the Registrable Securities, another appropriate form reasonably acceptable to GSK) by GSK (the “Registration Statement”). Vir shall use commercially reasonable efforts (a) if the Registration Statement is not an Automatic Shelf Registration Statement, to cause the Registration Statement to become effective as promptly as practicable; (b) to cause the Registration Statement to remain effective until the earlier of (i) the date on which GSK has disposed of all of the Registrable Securities and (ii) Rule 144 is available for the disposition of all Registrable Securities without volume or manner-of-sale restrictions; (c) to undertake any additional actions reasonably necessary to maintain the availability of, and to facilitate the disposition by GSK of the Registrable Securities pursuant to, the Registration Statement; and (d) to obtain any required consent under
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Vir’s Amended and Restated Investors’ Rights Agreement, dated as of November 19, 2017, by and among Vir and the investors party thereto or any other agreement to which Vir is a party related to the filing of the Registration Statement. GSK agrees to cooperate with Vir as reasonably requested by Vir in connection with the preparation and filing of the Registration Statement, including furnishing to Vir such information regarding itself, the shares of Common Stock held by it and the intended method of disposition of the Registrable Securities as shall be reasonably required to effect the registration of such Registrable Securities. Vir shall bear all expenses incurred in connection with the performance of its obligations under this Section 6.4; provided, however, that Vir shall have no obligation to pay for any commissions or transfer taxes of GSK. Vir’s obligations under this Section 6.4 shall also apply to any shares in the capital of Vir issued or issuable with respect to the Registrable Securities as a result of any share split, share dividend, recapitalization, exchange or similar event.
| Section | 7. CONDITIONS TO CLOSING |
7.1 Conditions to Obligations of Vir. Vir’s obligation to complete the purchase and sale of the Shares and deliver the Shares to GSK is subject to the fulfillment or waiver of the following conditions at or prior to the Closing:
(a) Receipt of Funds. Vir will have received immediately available funds in the full amount of the Purchase Price for the Shares being purchased hereunder.
(b) Representations and Warranties. The representations and warranties made by GSK in Section 3 will be true and correct in all material respects as of the Closing Date, except to the extent such representations and warranties are made as of another date, in which case such representations and warranties will be true and correct in all material respects as of such other date.
(c) Covenants. All covenants and agreements contained in this Agreement to be performed or complied with by GSK on or prior to the Closing Date shall have been performed or complied with in all material respects.
(d) Absence of Litigation. No proceeding challenging this Agreement or the transactions contemplated hereby, or seeking to prohibit, alter, prevent or materially delay the Closing, will have been instituted or be pending before any Governmental Authority.
(e) No Governmental Prohibition; HSR Clearance. The sale of the Shares by Vir and the purchase of the Shares by GSK will not be prohibited by any applicable Law at the time of the Closing. Each of the HSR Conditions shall have been satisfied.
(f) Preliminary Collaboration Agreement. GSK and Vir shall have duly executed and delivered the Preliminary Collaboration Agreement and such agreement (or as it may be succeeded by the Definitive Collaboration Agreement) shall be in full force and effect.
(g) Closing Deliverables. All closing deliverables as required under Section 1.3(b)(ii) shall have been delivered by GSK to Vir.
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7.2 Conditions to GSK’s Obligations at the Closing. GSK’s obligation to complete the purchase and sale of the Shares is subject to the fulfillment or waiver of the following conditions at or prior to the Closing:
(a) Representations and Warranties. The representations and warranties made by Vir in Section 2 will be true and correct in all material respects as of the Closing Date, except to the extent such representations and warranties are made as of another date, in which case such representations and warranties will be true and correct in all material respects as of such other date.
(b) Covenants. All covenants and agreements contained in this Agreement to be performed or complied with by Vir on or prior to the Closing Date shall have been performed or complied with in all material respects.
(c) Transfer Agent Instructions. Vir will have delivered to its transfer agent irrevocable written instructions to issue the Shares to GSK in a form and substance acceptable to such transfer agent.
(d) Nasdaq Qualification. Nasdaq shall have raised no objection to the consummation of the transactions contemplated by this Agreement in the absence of stockholder approval of such transactions.
(e) Absence of Litigation. No proceeding challenging this Agreement or the transactions contemplated hereby, or seeking to prohibit, alter, prevent or materially delay the Closing, will have been instituted or be pending before any Governmental Authority.
(f) Preliminary Collaboration Agreement. GSK and Vir shall have duly executed and delivered the Preliminary Collaboration Agreement and such agreement (or as it may be succeeded by the Definitive Collaboration Agreement) shall be in full force and effect.
(g) No Governmental Prohibition; HSR Clearance. The sale of the Shares by Vir, and the purchase of the Shares by GSK will not be prohibited by any applicable Law at the time of the Closing. Each of the HSR Conditions shall have been satisfied.
(h) Closing Deliverables. All closing deliverables as required under Section 1.3(b)(i) shall have been delivered by Vir to GSK.
| Section | 8. INDEMNIFICATION |
8.1 Indemnification by Vir. Vir shall indemnify and hold harmless GSK and its Affiliates, and the directors, officers, employees and other agents and representatives of GSK and its Affiliates, from and against any and all liabilities, judgments, claims, settlements, losses, damages, fees, Liens, Taxes, penalties, obligations and expenses (including reasonable attorney’s fees and expenses and costs and expenses of investigation) (collectively, “Losses”) incurred or suffered, directly or indirectly, by any such Person arising from, by reason of or in connection with: (i) any breach or inaccuracy of any representation or warranty of Vir contained in this Agreement or any certificate delivered hereunder; and (ii) the non-fulfillment or breach by Vir of any agreements or obligations under this Agreement.
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8.2 Indemnification by GSK. GSK shall indemnify and hold harmless Vir and its Affiliates, and the directors, officers, employees and other agents and representatives of Vir and its Affiliates, from and against any and all Losses incurred or suffered, directly or indirectly, by any such Person arising from, by reason of or in connection with: (i) any breach or inaccuracy of any representation or warranty of GSK contained in this Agreement or any certificate delivered hereunder; and (ii) the non-fulfillment or breach by GSK of any agreements or obligations under this Agreement.
8.3 Calculation of Losses. Any indemnity payment hereunder shall be treated as an adjustment to the Purchase Price to the extent permitted by applicable Law. Where the receipt of any such payment is treated for Tax purposes in a manner other than as an adjustment to the Purchase Price, the amount of the payment shall be adjusted to take account of any net Tax cost actually incurred, or benefit actually enjoyed, by the Indemnified Party in respect thereof.
8.4 Certain Procedures for Indemnification.
(a) If any Person entitled to indemnification under this Agreement (an “Indemnified Party”) asserts a claim for indemnification, or receives notice of the assertion of any claim or of the commencement of any action by any Person not a party to this Agreement against such Indemnified Party, for which a party to this Agreement is required to provide indemnification under this Section 8 (an “Indemnifying Party”), the Indemnified Party shall promptly notify the Indemnifying Party in writing of the claim or the commencement of that action; provided, however, that the failure to so notify the Indemnifying Party shall not relieve the Indemnifying Party from any liability which it may have to the Indemnified Party, except to the extent that such failure materially prejudices the Indemnifying Party’s ability to defend such action.
(b) With respect to third party claims for which indemnification is claimed hereunder, (i) the Indemnifying Party shall be entitled to participate in the defense of any such claim, and (ii) if, in the reasonable judgment of the Indemnified Party, such claim can properly be resolved by money damages alone and the Indemnifying Party has the financial resources to pay such damages, and the Indemnifying Party admits that this indemnity fully covers the claim or litigation, then the Indemnifying Party shall be entitled (y) to direct the defense of any claim at its sole cost and expense, but such defense shall be conducted by legal counsel reasonably satisfactory to the Indemnified Party, and (z) to settle and compromise any such claim or action for money damages alone; provided, however, that if the Indemnified Party has elected to be represented by separate counsel pursuant to the proviso below, or if such settlement or compromise does not include an unconditional release of the Indemnified Party for any liability arising out of such claim or action, such settlement or compromise shall be effected only with the written consent of the Indemnified Party. After notice from the Indemnifying Party to the Indemnified Party of its election to assume the defense of such claim or action, the Indemnifying Party shall not be liable to the Indemnified Party under this Section 8.4 for any legal or other expenses subsequently incurred by the Indemnified Party in connection with the defense thereof other than reasonable costs of investigation or of assistance as contemplated by this Section 8.4; provided, however, that if, in the opinion of the Indemnified Party, it is advisable for the Indemnified Party to be represented by separate counsel due to actual or potential conflicts of interest, the Indemnified Party shall have the right to employ counsel to represent it and in that event the fees and expenses of such separate counsel shall be paid by the Indemnifying Party; provided further, that in no event
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shall the Indemnifying Party be responsible for the fees of more than one counsel to the Indemnified Party. The Indemnified Party and the Indemnifying Party shall each render to each other such assistance as may reasonably be requested in order to ensure the proper and adequate defense of any such claim or proceeding.
8.5 Survival; Expiration.
(a) Notwithstanding any investigation made by or on behalf of Vir or GSK prior to, on or after the Closing Date, the representations and warranties contained in this Agreement (including the exhibits and schedules hereto) and any certificate delivered hereunder shall survive the Closing and shall terminate on the second anniversary of the Closing Date.
(b) The covenants of the parties hereto shall survive until fully performed and discharged, unless otherwise expressly provided herein.
(c) Any right of indemnification or reimbursement pursuant to this Section 8 with respect to a claimed breach, inaccuracy or non-fulfillment of any representation, warranty, agreement or obligation shall expire on the applicable date of termination of the representation, warranty or covenant claimed to be breached (the “Expiration Date”), unless on or prior to the applicable Expiration Date, the Indemnifying Party has received written notice from the Indemnified Party of such breach, inaccuracy or non-fulfillment from the Indemnified Party or is based on fraud or intentional or willful breach of the Indemnifying Party, in which case the Indemnified Party may continue to pursue its right of indemnification or reimbursement hereunder beyond the Expiration Date of the applicable representation, warranty, agreement or obligation. For the avoidance of doubt no claims based on fraud or intentional or willful breach will be subject to any of the limitations set forth in this Section 8.5.
| Section | 9. DISPUTE RESOLUTION |
9.1 Any dispute arising out of or relating to the Agreement, or the breach, termination or validity thereof (a “Dispute”), shall be finally resolved pursuant to the following provision:
(a) In the event a Dispute arises, the parties agree that they shall attempt in good faith to resolve the Dispute by negotiation between GSK’s Senior Vice President, Global Corporate Development and Vir’s Chief Executive Officer (or their respective designee with power and authority to resolve such dispute) (such individuals, the “Senior Executives”). Either party may refer a Dispute to the Senior Executives by serving notice that a Dispute has arisen and demand that negotiations commence. If the parties are unable for any reason to resolve a Dispute within thirty (30) days of service of the notice, either party shall have the right to refer the Dispute for mediation as set forth in Section 9.1(b).
(b) The parties agree that they shall try in good faith to resolve the Dispute by referring it for confidential mediation under the CPR Mediation Procedure in effect at the start of mediation, before resorting to arbitration. If the parties cannot agree on a mediator within twenty-one (21) days after the Dispute was referred to mediation, the mediator shall, upon request by either party, be appointed by CPR pursuant to CPR Mediation Procedure. The cost of mediator shall be borne equally by the parties. Any Dispute not resolved within forty-five (45) days (or within such other time period as may be agreed to by parties in writing) after appointment of the mediator shall be finally resolved by arbitration pursuant to this Section 9.
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(c) The arbitration shall be administered by the International Centre for Dispute Resolution (“ICDR”) in accordance with its International Arbitration Rules, except as those rules may be modified herein or by mutual agreement of the parties. Any disputes concerning the propriety of the commencement of the arbitration or the scope or applicability of this agreement to arbitrate shall be finally settled by the arbitrators. In any such arbitration, the number of arbitrators shall be three. Each party shall appoint one arbitrator within fourteen (14) days after submission of the Answer to the Notice of Arbitration, and the two party-appointed arbitrators shall appoint a third arbitrator, who shall serve as chair of the tribunal, within twenty-one (21) days of the appointment of the later-appointed arbitrator. If any of the arbitrators are not appointed within the time prescribed above, then the ICDR shall appoint the arbitrator(s) in accordance with its International Arbitration Rules.
(d) The seat of the arbitration shall be New York City, New York, and the language of the arbitration shall be English. The parties submit to the non-exclusive jurisdiction of the state and federal courts located in New York County in the state of New York for the limited purpose of enforcing this Agreement to arbitrate and any action for preliminary relief. The arbitration award shall be final and binding and the parties undertake to carry out any award without delay. Judgment upon the award may be entered by any court having jurisdiction thereof or having jurisdiction over the relevant party and its assets.
(e) GSK and Vir agree that the existence of the arbitration, any non-public information provided in the arbitration, all submissions made in the arbitration, any rulings and the award shall be kept confidential except as may be necessary to prepare for or conduct the arbitration hearing on the merits, or except as may be necessary in connection with a court application for a preliminary remedy, a judicial challenge to the award or its enforcement, or unless otherwise required by Law or judicial decision.
(f) For the avoidance of doubt, any disputes with respect to the terms of the Preliminary Collaboration Agreement or the Definitive Collaboration Agreement shall be resolved in accordance with the dispute resolution provisions therein, including the provisions of Section 17 and Appendices E and F of the Preliminary Collaboration Agreement, and not the provisions of this Section 9. For clarity, any dispute with respect to the terms of Sections 4.1, 4.2 or 4.3 hereof, including a breach thereof, shall not be considered a dispute with respect to the terms of the Preliminary Collaboration Agreement or the Definitive Collaboration Agreement and shall be subject to the related provisions of this Agreement, including the terms of this Section 9.1 and Section 8, Section 11.1 and Section 11.13 hereof.
| Section | 10. TERMINATION |
10.1 Ability to Terminate. This Agreement may be terminated prior to the Closing:
(a) at any time by mutual written consent of Vir and GSK;
(b) by Vir, upon thirty (30) days’ written notice to GSK, so long as Vir is not then in breach of its representations, warranties, covenants or agreements under this Agreement
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such that any of the conditions set forth in Section 7.1, as applicable, could not be satisfied by the Termination Date, (i) upon a breach of any covenant or agreement on the part of GSK set forth in this Agreement that has not been cured within such 30-day notice period, or (ii) if any representation or warranty of GSK shall have been or become untrue, in each case such that any of the conditions set forth in Section 7.1 could not be satisfied by the Termination Date;
(c) by GSK, upon thirty (30) days’ written notice to Vir, so long as GSK is not then in breach of its representations, warranties, covenants or agreements under this Agreement such that any of the conditions set forth in Section 7.2 of this Agreement, as applicable, could not be satisfied by the Termination Date, (i) upon a breach of any covenant or agreement on the part of Vir set forth in this Agreement that has not been cured within such 30-day notice period, or (ii) if any representation or warranty of Vir shall have been or become untrue, in each case such that any of the conditions set forth in Section 7.2 of this Agreement could not be satisfied by the Termination Date;
(d) by either Vir or GSK, upon written notice to the other, if the Antitrust Clearance Date has not occurred on or before July 10, 2020 (the “Termination Date”). In such event, neither party shall have any further obligations under this Agreement.
10.2 Effect of Termination. In the event of the termination of this Agreement pursuant to Section 10, (a) this Agreement (except for this Section 10.2, and Section 8, Section 9, Section 11.1 and Sections 11.3 through 11.14 and any definitions set forth in this Agreement and used in such Sections) shall forthwith become void and have no effect, without any liability on the part of any party hereto or its Affiliates, and (b) all filings, applications and other submissions made pursuant to this Agreement, to the extent practicable, shall be withdrawn from the agency or other Person to which they were made or appropriately amended to reflect the termination of the transactions contemplated hereby; provided, however, that nothing contained in this Section 10.2 shall relieve any party from liability for fraud or any intentional or willful breach of this Agreement.
| Section | 11. GOVERNING LAW; MISCELLANEOUS |
11.1 Governing Law. This Agreement will be governed by and interpreted in accordance with the laws of the State of Delaware without regard to the principles of conflict of laws that would require the application of the substantive Laws of another jurisdiction.
11.2 HSR Clearance; Market Listing.
(a) Subject to the terms and conditions of this Agreement, each of GSK and Vir will use its reasonable best efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary, proper or advisable under applicable Law to consummate the acquisition of the Shares, the transactions contemplated by the Preliminary Collaboration Agreement and the negotiation and entry into the Definitive Collaboration Agreement, as soon as practicable after the date hereof, including taking all steps as may be necessary, subject to the limitations in this Section 11.2, to obtain all applicable waiting period expirations or terminations, consents, clearances, waivers, licenses, registrations, permits, authorizations, orders and approvals. In furtherance and not in limitation of the foregoing, each of GSK and Vir agrees to (i)
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file or cause to be filed with the FTC and the DOJ any notifications required to be filed under the HSR Act no later than April 10, 2020, or if the DOJ and FTC are not accepting filings on such day, on the first day thereafter that filings are accepted (unless otherwise mutually agreed to by the parties), and (ii) use commercially reasonable efforts to obtain as promptly as practicable the termination or expiration of any waiting period under the HSR Act, including by filing as soon as practicable and advisable any supplemental or additional information which may reasonably be requested by the FTC or the DOJ or any other Governmental Authority in connection with applicable Antitrust Law; provided that the obligations in clause (ii) shall not require Vir or GSK or any of its Affiliates to (x) sell, divest (including through a license or a reversion of licensed or assigned rights), hold separate, transfer or dispose of any assets, operations, rights, product lines, businesses or interest therein of Vir or GSK or any of their Affiliates (or consent to any of the foregoing actions); or (y) litigate or otherwise formally oppose any determination (whether judicial or administrative in nature) by a Governmental Authority seeking to impose any of the restrictions referenced in clause (x). GSK shall be responsible for the payment of all filing fees payable under the HSR Act and any other applicable Antitrust Law.
(b) Each of GSK and Vir shall use commercially reasonable efforts to provide or cause to be provided promptly all assistance and cooperation to allow GSK and Vir to prepare and submit any filings or submissions under the HSR Act, including providing to GSK and Vir, as applicable, any information that it may require for the purpose of any filing, notification, application or request for further information made in respect of any such filing.
(c) Each of GSK and Vir shall, in connection with the transactions contemplated hereby, and the obtaining of all waiting period expirations or terminations, consents, clearances, waivers, licenses, orders, registrations, approvals, permits and authorizations under the HSR Act or any other Antitrust Law, with respect to actions taken on or after the date of this Agreement, without limitation: (i) promptly notify the other of, and if in writing, furnish the other with copies of (or, in the case of oral communications, advise the other of) any material communications from or with any Governmental Authority, including the FTC and the DOJ, with respect to the agreement, (ii) cooperate in all respects and consult with each other in connection with any filing or submission and in connection with any investigation or other inquiry, (iii) permit the other to review and discuss in advance, and consider in good faith the view of the other in connection with, any proposed written or oral communication with any Governmental Authority, (iv) not participate in any substantive meeting or have any substantive communication with any Governmental Authority unless it has given the other party a reasonable opportunity to consult with it in advance and, to the extent permitted by such Governmental Authority, gives the other the opportunity to attend and participate therein, (v) furnish the other party’s outside legal counsel with copies of all supplemental filings and substantive communications between it and any such Governmental Authority with respect to the Agreement; provided that neither party will be required to provide the other party with its board of directors or internal committee materials; and any materials subject to this Section 11.2(c) may be restricted to outside counsel and may be redacted or withheld as necessary (A) to comply with contractual arrangements, (B) to address good faith legal privilege or confidentiality concerns and (C) to comply with applicable Law, (vi) furnish the other party’s outside legal counsel with such necessary information and reasonable assistance as the other party’s outside legal counsel may reasonably request in connection with its preparation of necessary submissions of information to any such Governmental Authority, and (vii) use commercially reasonable efforts to respond as soon as practicable to reasonable requests
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for information by any Governmental Authority. Neither GSK nor Vir shall commit to or agree with any Governmental Authority to stay, toll, or extend any applicable waiting period under the HSR Act or other applicable Antitrust Law, or pull and refile under the HSR Act, without the prior written consent of the other.
(d) From the Execution Date through the Closing, Vir shall use commercially reasonable efforts to (a) maintain the listing and trading of the Common Stock on Nasdaq and (b) effect the listing of the Shares on Nasdaq.
11.3 Counterparts; Electronic Signatures. This Agreement may be executed and delivered (including by facsimile transmission or PDF or any other electronically transmitted signatures) in two counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
11.4 Headings. The headings of this Agreement are for convenience of reference only, are not part of this Agreement and do not affect its interpretation.
11.5 Rules of Construction.
(a) For purposes of this Agreement, whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include the masculine and feminine genders.
(b) As used in this Agreement, (i) the words “include” and “including,” and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words “without limitation”, (ii) the words “hereby,” “herein,” “hereunder” and “hereto” shall be deemed to refer to this Agreement in its entirety and not to any specific section of this Agreement and (iii) “or” has the inclusive meaning represented by the phrase “and/or”.
(c) Except as otherwise indicated, all references in this Agreement to “Sections” and “Appendices” are intended to refer to Sections of this Agreement, as appropriate, and Appendices to this Agreement.
(d) As used in this Agreement, the term “days” means calendar days unless otherwise specified. When calculating the period of time before which, within which or following which any act is to be done or step taken pursuant to this Agreement, the date that is the reference date in calculating such period shall be excluded. If the last day of such period is a non-Business Day, the period in question shall end on the next succeeding Business Day.
(e) Unless otherwise indicated, all monetary amounts herein are in United States dollars.
11.6 Severability. If any provision of this Agreement should be held invalid, illegal or unenforceable in any jurisdiction, the parties will negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the parties and all other provisions hereof will remain in full force and effect in such jurisdiction and will be liberally construed in order to carry out the intentions of the parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability will not affect the validity, legality or enforceability of such provision in any other jurisdiction.
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11.7 Entire Agreement; Amendments. This Agreement, the Preliminary Collaboration Agreement and, once entered into, the Definitive Collaboration Agreement (including any schedules, appendices and exhibits hereto or thereto and any certificates delivered hereunder) constitute the entire agreement between the parties hereto with respect to the subject matter hereof and thereof. There are no restrictions, promises, warranties or undertakings, other than those set forth or referred to herein or therein. This Agreement supersedes all prior agreements and understandings between the parties hereto with respect to the subject matter hereof. No provision of this Agreement may be waived or amended other than by an instrument in writing signed by the party to be charged with enforcement. Any amendment or waiver effected in accordance with this Section 11.7 shall be binding upon GSK and Vir.
11.8 Notices. All notices required or permitted hereunder will be in writing and will be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) when sent by confirmed email if sent during normal business hours of the recipient, if not, then on the next Business Day, or (c) one Business Day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. The addresses for such communications are:
| If to Vir, addressed to: | Vir Biotechnology, Inc. | |
| 499 Illinois Street, Suite 500 | ||
| San Francisco, CA 94158 | ||
| Attention: | ||
| E-mail: | ||
| and | Vir Biotechnology, Inc. | |
| 499 Illinois Street, Suite 500 | ||
| San Francisco, CA 94158 | ||
| Attention: | ||
| E-mail: | ||
| with a copy to: | Cooley LLP | |
| 3175 Hanover Street | ||
| Palo Alto, CA 94304-1130 | ||
| Attention: | ||
| E-mail: | ||
| If to GSK, addressed to: | Glaxo Group Limited | |
| with a copy to: | Covington & Burling LLP | |
| The New York Times Building | ||
| 320 Eighth Avenue | ||
| New York, New York 10018 | ||
| Attention: | ||
| E-mail: | ||
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11.9 Successors and Assigns. This Agreement is binding upon and inures to the benefit of the parties and their successors and assigns. Vir will not assign this Agreement or any rights or obligations hereunder without the prior written consent of GSK, and GSK will not assign this Agreement or any rights or obligations hereunder without the prior written consent of Vir; provided, however, that GSK may assign this Agreement together with all of the Shares it then owns (subject to Section 6) to any wholly-owned subsidiary and any such assignee may assign the Agreement together with all of the Shares it then owns (subject to Section 6) to GSK or any other subsidiary wholly-owned by GSK, in any such case, without such consent; provided that the assignee agrees to assume GSK’s obligations under Section 6 of this Agreement.
11.10 Third Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto, their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other Person.
11.11 Further Assurances. Each party will do and perform, or cause to be done and performed, all such further acts and things, and will execute and deliver all other agreements, certificates, instruments and documents, as the other party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.
11.12 No Strict Construction. The language used in this Agreement is deemed to be the language chosen by the parties to express their mutual intent, and no rules of strict construction will be applied against a party.
11.13 Equitable Relief. Vir recognizes that, if it fails to perform or discharge any of its obligations under this Agreement, any remedy at Law may prove to be inadequate relief to GSK. Vir therefore agrees that GSK is entitled to seek temporary and permanent injunctive relief or specific performance in any such case. GSK also recognizes that, if it fails to perform or discharge any of its obligations under this Agreement, any remedy at Law may prove to be inadequate relief to Vir. GSK therefore agrees that Vir is entitled to seek temporary and permanent injunctive relief or specific performance in any such case.
11.14 Expenses. Vir and GSK are each liable for, and will pay, their own expenses incurred in connection with the negotiation, preparation, execution and delivery of this Agreement, including attorneys’ and consultants’ fees and expenses.
11.15 Public Disclosure. On or within one Business Day of the Execution Date, Vir and GSK shall issue a joint press release in a form mutually agreed to by Vir and GSK. In addition, Vir shall file a Current Report on Form 8-K with the SEC within the time period required by such form and including such disclosures as required by such form with respect to this Agreement and the transactions contemplated herein, such Current Report on Form 8-K to be in a form mutually agreed to by Vir and GSK. No other written release, public announcement, disclosure or filing concerning the purchase of the Shares, this Agreement, the Preliminary Collaboration Agreement, the Definitive Collaboration Agreement or the transactions contemplated hereby or thereby shall
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be issued, filed or furnished, as the case may be, by any party without the prior written consent of the other party (which consent shall not be unreasonably withheld, conditioned or delayed) and, except as set forth in this Section 11.15, the parties agree to keep the terms of this Agreement, the Preliminary Collaboration Agreement and the Definitive Collaboration Agreement confidential. Notwithstanding the foregoing, the parties acknowledge and agree that applicable Law or the requirements of a national securities exchange or another similar regulatory body may require either party to file or otherwise disclose a copy of this Agreement, the Preliminary Collaboration Agreement or the Definitive Collaboration Agreement. The party required to make such filing or otherwise disclose shall notify the other party and shall provide the other party with at least three (3) days to request redactions thereof prior to making such filing or disclosure. The disclosing party shall use commercially reasonable efforts to procure confidential treatment of such proposed redactions pursuant to the Securities Act and the Exchange Act, in each case as amended, and the rules, regulations and guidelines promulgated thereunder, or any other applicable Law or the rules, regulations or guidelines promulgated hereunder; provided that the foregoing shall not prevent the party from making such public disclosures as it must make to comply with applicable Law.
[Remainder of page intentionally left blank.]
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IN WITNESS WHEREOF, GSK and Vir have caused this Agreement to be duly executed as of the date first above written.
| GLAXO GROUP LIMITED | ||
| By: | /s/ Victoria Whyte | |
| Name: | Victoria Whyte | |
| Its: | Company Secretary | |
| VIR BIOTECHNOLOGY, INC. | ||
| By: | /s/ George Scangos | |
| Name: | George Scangos | |
| Its: | President and Chief Executive Officer | |
[Signature page to Stock Purchase Agreement]
APPENDIX 1
DEFINED TERMS
“Affiliate” of an entity means any corporation, firm, partnership or other entity that directly or indirectly through one or more intermediaries controls, is controlled by or is under common control with it. An entity will be deemed to control another entity if it (i) owns, directly or indirectly, at least 50% of the outstanding voting securities or capital stock (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of such other entity, or has other comparable ownership interest with respect to any entity other than a corporation; or (ii) has the power, whether pursuant to contract, ownership of securities or otherwise, to direct the management and policies of the entity.
“Agreement” has the meaning set forth in the preamble.
“Antitrust Clearance Date” has the meaning set forth in the definition of “Effective Date.”
“Antitrust Law” means the HSR Act, the Sherman Antitrust Act, as amended, the Clayton Act, as amended, the Federal Trade Commission Act, as amended, and any other applicable Law designed to prohibit, restrict or regulate actions or transactions having the purpose or effect of monopolization, restraint of trade or harm to competition.
“Applicable Regulatory Authorities” has the meaning set forth in Section 2.12.
“Automatic Shelf Registration Statement” has the meaning set forth in Section 6.4.
“Board” means the board of directors of Vir.
“Business Day” means a day Monday through Friday on which banks are generally open for business in the State of California, the State of New York and London, England.
“Change of Control Transaction” has the meaning set forth in Section 5.4.
“Closing” has the meaning set forth in Section 1.3(a).
“Closing Date” means the date on which the Closing actually occurs.
“Common Stock” means shares of Vir’s common stock, par value $0.0001 per share.
“Company Trials” has the meaning set forth in Section 2.13.
“CPR” means the International Institute for Conflict Prevention & Resolution (www.cpradr.org).
“Cross-Receipt” has the meaning set forth in Section 1.3(b)(i)(A).
“Definitive Collaboration Agreement” has the meaning set forth in the Recitals.
“Dispute” has the meaning set forth in Section 9.1.
“DOJ” means the U.S. Department of Justice.
“Effective Date” means the date that is the date on which: (a) the waiting period under the HSR Act shall have expired or earlier been terminated; (b) no judicial or administrative proceeding opposing consummation of all or any part of this Agreement shall be pending; and (c) no Law, order or injunction (whether temporary, preliminary or permanent) prohibiting consummation of the transactions contemplated by this Agreement or any material portion hereof shall be in effect (each of clauses (a) through (c), collectively, the “HSR Conditions,” and such date on which all of the HSR Conditions have been met, the “Antitrust Clearance Date”), unless either party exercises its termination right under Section 10.1(d) at any time prior to the Antitrust Clearance Date.
“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations of the SEC thereunder.
“Execution Date” has the meaning set forth in the preamble.
“Expiration Date” has the meaning set forth in Section 8.5(c).
“FDA” has the meaning set forth in Section 2.12.
“Field” means the prevention, treatment and prophylaxis of diseases caused by coronaviruses (including SARS-COV-2 and any variants thereof) in humans, including the disease known as CoVID-19.
“FTC” means the U.S. Federal Trade Commission.
“GAAP” means generally accepted accounting principles in the United States of America.
“Good Clinical Practices” means the legal, scientific and ethical standards for the performance of clinical research on medicinal products involving humans, including as reflected in the regulations of the FDA at 21 C.F.R. parts 50, 54, 56, and 312.
“Good Laboratory Practices” means the legal, scientific and ethical standards for the performance of nonclinical laboratory studies, including as set out in the regulations of the FDA at 21 C.F.R. part 58.
“Governmental Authority” means any Federal, state, provincial, local, municipal, foreign or other governmental or quasi-governmental authority, including any arbitrator and applicable securities exchanges, or any department, minister, agency, commission, commissioner, board, subdivision, bureau, agency, instrumentality, court or other tribunal of any of the foregoing.
“GSK” has the meaning set forth in the preamble.
“Health Care Laws” means Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (the Medicaid statute); the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); any other criminal
laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287 and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the Exclusion Laws, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations, each and all as may be amended from time to time.
“HIPAA” has the meaning set forth in the definition of “Health Care Laws.”
“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
“HSR Conditions” has the meaning set forth in the definition of “Effective Date.”
“ICDR” has the meaning set forth in Section 9.1(c).
“IEC” has the meaning set forth in Section 2.13.
“Indemnified Party” has the meaning set forth in Section 8.4(a).
“Indemnifying Party” has the meaning set forth in Section 8.4(a).
“Intellectual Property” shall mean trademarks, trade names, trade dress, service marks, copyrights, and similar rights (including registrations and applications to register or renew the registration of any of the foregoing), patents and patent applications, trade secrets, and any other similar intellectual property rights.
“Intellectual Property License” shall mean any license, permit, authorization, approval, contract or consent granted, issued by or with any Person relating to the use of Intellectual Property.
“IRB” has the meaning set forth in Section 2.13.
“Law” means any federal, state, local or foreign constitution, treaty, law, statute, ordinance, rule, regulation, interpretation, directive, policy, order, writ, decree, injunction, judgment, stay or restraining order of any Governmental Authority, the terms of any permit, and any other ruling or decision of, agreement with or by, or any other requirement of, any Governmental Authority.
“Lien” means any lien (statutory or otherwise), claim, charge, option, security interest, pledge, mortgage, restriction, financing statement or similar encumbrance of any kind or nature whatsoever (including any conditional sale or other title retention agreement and any lease having substantially the same effect as any of the foregoing and any assignment or deposit arrangement in the nature of a security device).
“Losses” has the meaning set forth in Section 8.1.
“Material Adverse Effect” means any change, effect or circumstance, individually or in the aggregate, (a) that is reasonably likely to be materially adverse to the business, operations, assets or financial condition of Vir or GSK, as the case may be, taken as a whole, or (b) that materially impairs the ability of Vir or GSK to perform its obligations pursuant to the transactions contemplated by this Agreement or the Preliminary Collaboration Agreement; provided however, that, none of the following (alone or when aggregated with any other effects), shall be deemed to be a Material Adverse Effect, and none of the following (alone or when aggregated with any other effects), shall be taken into account for purposes of clause (a) above: (A) (1) general market, economic or political conditions or (2) conditions (or any changes therein) in the industries in which Vir or GSK conducts business, in each case, including any acts of terrorism or war, weather conditions, global virus pandemics, epidemics or other force majeure events, in the case of each of clauses (1) and (2), solely to the extent that such effects do not have and are not reasonably likely to have a material disproportionate impact on Vir or GSK, as the case may be; (B) this Agreement, the Preliminary Collaboration Agreement and the transactions contemplated hereby and thereby; or (C) changes in the trading price or volume of the Common Stock or GlaxoSmithKline plc’s ordinary shares, in and of themselves.
“Nasdaq” means The Nasdaq Global Select Market.
“Negotiation Period” has the meaning set forth in Section 4.1.
“Permits” has the meaning set forth in Section 2.10.
“Person” means a human being, labor organization, partnership, firm, enterprise, association, joint venture, corporation, limited liability company, cooperative, legal representative, foundation, society, political party, estate, trust, trustee, trustee in bankruptcy, receiver or any other organization or entity whatsoever, including any Governmental Authority.
“Preferred Stock” means shares of Vir’s preferred stock, par value $0.0001 per share.
“Preliminary Collaboration Agreement” has the meaning set forth in the Recitals.
“Proprietary Rights” has the meaning set forth in Section 2.11(c).
“Purchase Price” has the meaning set forth in Section 1.1.
“Registrable Securities” has the meaning set forth in Section 6.4.
“Registration Statement” has the meaning set forth in Section 6.4.
“Regulatory Authorizations” has the meaning set forth in Section 2.12.
“Rule 144” has the meaning set forth in Section 6.1(a).
“SEC” means the United States Securities and Exchange Commission or any successor entity.
“SEC Documents” has the meaning set forth in Section 2.5(a).
“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations of the SEC thereunder.
“Senior Executives” has the meaning set forth in Section 9.1(a).
“Shares” has the meaning set forth in Section 1.1.
“Standstill Period” has the meaning set forth in Section 5.1.
“Standstill Provisions” has the meaning set forth in Section 5.4.
“Tax” means any federal, state, local, or foreign income, gross receipts, license, payroll, employment, excise, severance, stamp, occupation, premium, windfall profits, environmental (including taxes under Section 59A of the Internal Revenue Code of 1986, as amended), customs duties, capital stock, franchise, profits, withholding, social security (or similar), unemployment, disability, real property, personal property, sales, use, transfer, registration, value added, alternative or add-on minimum, estimated, or other tax of any kind whatsoever, including any interest, penalty, or addition thereto, whether disputed or not.
“Termination Date” has the meaning set forth in Section 10.1(d).
“Vir” has the meaning set forth in the preamble.
“Vir Rights” has the meaning set forth in Section 2.11(c).
Appendix 2
See attached.
Exhibit 10.56
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
| CONFIDENTIAL | EXECUTION VERSION |
CLINICAL DEVELOPMENT
AND MANUFACTURING AGREEMENT
BETWEEN
BIOGEN INC.
AND
VIR BIOTECHNOLOGY, INC.
DATED May 22, 2020
TABLE OF CONTENTS
| Page | ||||||
| ARTICLE 1 | DEFINITIONS |
1 | ||||
| ARTICLE 2 | SCOPE |
7 | ||||
| ARTICLE 3 | PAYMENTS |
13 | ||||
| ARTICLE 4 | MANUFACTURING AND FILL FINISH |
16 | ||||
| ARTICLE 5 | REGULATORY |
19 | ||||
| ARTICLE 6 | CONFIDENTIALITY AND NON-USE |
21 | ||||
| ARTICLE 7 | INTELLECTUAL PROPERTY |
23 | ||||
| ARTICLE 8 | REPRESENTATIONS AND WARRANTIES |
25 | ||||
| ARTICLE 9 | INDEMNIFICATION |
27 | ||||
| ARTICLE 10 | LIMITATIONS OF LIABILITY |
28 | ||||
| ARTICLE 11 | INSURANCE |
28 | ||||
| ARTICLE 12 | TERM AND TERMINATION |
28 | ||||
| ARTICLE 13 | NOTICE |
30 | ||||
| ARTICLE 14 | MISCELLANEOUS |
30 | ||||
| ATTACHMENT A-1, A-2, etc. | STATEMENTS OF WORK | |
| ATTACHMENT B | FORM OF CONFIDENTIAL DISCLOSURE AND LIMITED USE AGREEMENT | |
| ATTACHMENT C | ACCESS FEES | |
| ATTACHMENT D | MANUFACTURING REQUEST | |
i
CLINICAL DEVELOPMENT AND MANUFACTURING AGREEMENT
This Clinical Development and Manufacturing Agreement (“Agreement”) is made as of this 22nd day of May, 2020 (“Effective Date”), by and between Vir Biotechnology, Inc., a Delaware corporation, having a place of business at 499 Illinois Street, Suite 500, San Francisco, CA 94158 (“Vir”) and Biogen Inc., a Delaware corporation, having a place of business at 225 Binney Street, Cambridge, MA 02142 (“Biogen”).
RECITALS
A. Biogen develops, manufactures and commercializes its own and Third Party proprietary biopharmaceutical products and has facilities for and expertise in developing and manufacturing biologics, including proprietary cell line engineering and expression technologies;
B. Vir develops, markets and sells drug products directed to the treatment of infectious diseases, including diseases caused by the coronavirus known as SARS-CoV-2;
C. Vir wishes to obtain, and Biogen wishes to provide, certain services relating to the development of certain biologic drug products;
D. Vir may wish to obtain, and Biogen shall have the option, as further detailed in this Agreement, to provide certain manufacturing activities for clinical supply of certain biologic drug products; and
E. Vir wishes to obtain, and Biogen wishes to provide, as further detailed in this Agreement, certain technology transfer and manufacturing activities to enable Vir to obtain timely access to and production of commercial supply of certain biologic products for prevention and/or treatment of COVID-19 patients;
Vir and Biogen desire to enter into this Agreement to provide the terms and conditions upon which Vir may engage Biogen to provide services as further detailed in individual SOWs (as defined below).
THEREFORE, in consideration of the premises set forth above and the mutual covenants, terms and conditions set forth below, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
The following terms have the following meanings in this Agreement:
1.1 “Access Fees” has the meaning set forth in Section 3.1.3.
1.2 “Advisory Forecast” has the meaning set forth in Section 4.1.3.
1.3 “Affiliate(s)” means any person, firm, trust, partnership, corporation, company or other entity or combination thereof which directly or indirectly: (i) controls a Party; (ii) is controlled by a Party; or (iii) is under common control with a Party. As used in this definition, the terms “control” and “controlled” will mean ownership of fifty percent (50%) or more (including ownership by trusts with substantially the same beneficial interests) of the voting and equity rights of such person, firm, trust, partnership, corporation, company or other entity or combination thereof or the power to direct the management of such person, firm, trust, corporation or other entity or combination thereof.
1.4 “Agreement” has the meaning set forth in the introductory paragraph, and includes all its Attachments and other appendices (all of which are incorporated herein by reference) and any amendments to any of the foregoing made as provided herein or therein.
1.5 “Annual Cap” has the meaning set forth in Section 4.1.4.
1.6 “Applicable Laws” means, with respect to Vir, all laws, ordinances, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of each jurisdiction in which Drug Substance or Drug Product is produced, marketed, distributed, used or sold; and with respect to Biogen, all laws, ordinances, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of the jurisdiction in which Biogen performs Services; provided that cGMP shall not constitute Applicable Laws except to the extent expressly stated in the applicable SOW.
1.7 “Attempted Batch(es)” has the meaning set forth in Section 1.8.
1.8 “Batch” means a specific quantity of Drug Substance or Drug Product produced in accordance with a defined set of release criteria. “Batches” includes (i) batches subject to the Binding Forecast set forth in Section 4.1.3; (ii) batches for which Manufacturing has actually commenced (“Attempted Batches”), and (iii) batches produced in accordance with and meeting their applicable Specifications, including successful in-process testing and completing of applicable documentation (“Successful Batches”).
1.9 “Baseline Yield” has the meaning set forth in Attachment C.
1.10 “Batch Record” means a Manufacturing record for a Batch generated by Biogen concurrently with the production of a specific Batch such that successive steps in such processes are documented.
1.11 “Binding Forecast” has the meaning set forth in Section 4.1.3.
1.12 “Biogen” has the meaning set forth in the introductory paragraph, or any successor or permitted assign.
1.13 “Biogen Defective Processing” has the meaning set forth in Section 4.3.
1.14 “[***]” has the meaning as set forth [***].
1.15 “Biogen Indemnitees” has the meaning set forth in Section 9.2.
1.16 “Biogen IP” has the meaning set forth in Section 7.1.
1.17 “Biogen Process Invention” has the meaning set forth in Section 7.1.
1.18 “[***]” means, [***].
1.19 “Biogen Proprietary Know-How” means [***].
1.20 “Campaign” means a Batch or series of Batches of the same Product that are produced in sequence using the same Manufacturing equipment (including the same bioreactor); provided that a change of equipment initiated by Biogen for reasons of equipment malfunction or maintenance, capacity constraint, or other reasons other than a requirement or request of Vir will, for purposes of this definition, be considered to be a part of the same Campaign.
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1.21 “Capital Costs” means (i) with respect to any item of capital equipment required for Manufacturing the Product, the cost of acquiring such item of capital equipment itself, any engineering, installation, and/or validation costs relating to such capital equipment, and the costs of decommissioning or removing such capital equipment, and (ii) with respect to Facility modifications, Biogen’s documented costs for making such modifications, and, as applicable, restoring the Facility to its prior state once such modifications are no longer needed, including internal staff time, labor and materials costs and any testing, inspections and certifications required with respect to such modifications as set forth in Section 2.6.1.
1.22 “[***]” has the meaning set forth in [***].
1.23 “Certificate of Analysis” means a document in Biogen’s standard format that sets forth the analytical test results for a specified lot of Product or Batch to be released to Vir hereunder.
1.24 “Certificate of Conformance” means a document in Biogen’s standard format that (i) is in conformance with Applicable Law and (ii) states whether such Product is manufactured in accordance with cGMPs and the defined Process; and (iii) confirms in writing that the applicable lot or Batch of Products meets the applicable Specifications and acceptance criteria.
1.25 “cGMP” means current good manufacturing practices as set forth in the regulations promulgated by the FDA under the U.S. Food, Drug and Cosmetic Act, 21 C.F.R. Part 210 et seq., as amended from time to time, applicable guidance documents issued by the FDA, EC Directive 2003/94/EC and EC Delegated Regulation 2017/1569 and European Medicines Agency guidance documents, and applicable documents developed by the International Conference on Harmonization (ICH), in each case to the extent that they are applicable to Drug Substance or Drug Product and the Parties hereunder.
1.26 “Change Order” means an amendment to an SOW agreed to by the Parties in writing in accordance with the terms set forth in Section 2.2.
1.27 “Commercial Supply Agreement” has the meaning set forth in Section 2.1.3.
1.28 “Confidential Information” has the meaning set forth in Section 6.1.
1.29 “Defective Product” has the meaning set forth in Section 4.3.
1.30 “Deliverables” has the meaning set forth in Section 2.10.1.
1.31 “Designated Drug Substance” has the meaning set forth in Section 2.10.2.
1.32 “Development” or “Develop” means the activities to be performed hereunder by Biogen solely or in collaboration with Vir directed towards creating or refining the Process for Manufacturing Drug Substance and Drug Product, as set forth in one or more SOWs.
1.33 “Deviation” means a departure from any of Biogen’s process, system, procedure, or other conformance standard.
1.34 “Discloser” has the meaning set forth in Section 6.1.
1.35 “Document Retention Period” has the meaning set forth in Section 5.1.
1.36 “Drug Product” means drug product containing Drug Substance, as identified in an SOW, and which is the subject of the Services to be provided pursuant to such SOW.
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1.37 “Drug Substance” means a peptide, polypeptide or protein expressed by a cell line, including any posttranslational modification thereof, as identified in the applicable SOW, and which is the subject of the Services to be provided pursuant to an SOW. For clarity, the SOWs under this Agreement shall be for antibodies directed to SARS-CoV-2.
1.38 “Effective Date” has the meaning set forth in the introductory paragraph.
1.39 “Exception Notice” has the meaning set forth in Section 4.3.
1.40 “Facility” means the Biogen facility located at [***], and/or the Biogen facility located at [***], and/or such other facility(ies) as may be mutually agreed by the Parties and specified in an applicable SOW from time to time[***].
1.41 “FDA” means the U.S. Food and Drug Administration or any successor entity thereof having or performing substantially the same function.
1.42 “Fill Finish” means the compounding, filling, producing and primary packaging of Drug Product in accordance with the applicable Specifications.
1.43 “[***]” means [***].
1.44 “High-Value Materials” means all (i) bulk chromatography resins, (ii) Drug Substance in API form when used in the Manufacturing of Drug Product, and (iii) other materials or components identified in an SOW as High-Value Materials, that in each case, are used in the Manufacture of Products and which are not Vir-supplied Materials.
1.45 “[***]” has the meaning set forth in [***].
1.46 “Improvements” means [***].
1.47 “Inspection Period” has the meaning set forth in Section 4.3.
1.48 “Intellectual Property” has the meaning set forth in Section 7.1.
1.49 “Invention” has the meaning set forth in Section 7.1.
1.50 “JSC” has the meaning set forth in Section 2.12.
1.51 “Latent Defect” has the meaning set forth in Section 4.4.
1.52 “Letter of Intent” means the confidential letter of intent by and between Biogen and Vir dated March 3, 2020.
1.53 “Losses” has the meaning set forth in Section 9.1.
1.54 “Manufacturing” or “Manufacture” means the steps, processes and activities to produce cGMP Drug Substance or Drug Product hereunder (as applicable), including, manufacturing, processing, packaging, labeling, testing, stability testing, process qualification, cell culture, purification, formulation and the release, shipping, storage or supply of Drug Substance or Drug Product.
1.55 “Manufacturer” has the meaning set forth in Attachment C.
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1.56 “Manufacturing Release” has the meaning set forth in Section 2.9.
1.57 “Manufacturing Request” has the meaning set forth in Section 2.1.2.
1.58 “Materials” means any antibody sequences, cDNA, mammalian cell line or other similar biologic material provided by or on behalf of Vir to Biogen or by or on behalf of Biogen to Vir under this Agreement.
1.59 “non-cGMP” means, with respect to any Product or Services, that such Product or Service is not intended to comply to cGMP, and, with respect to Products in particular, is not intended for use in humans.
1.60 “OOS” has the meaning set forth in Section 3.1.6.
1.61 “Party” means either Biogen or Vir, and “Parties” means both Biogen and Vir.
1.62 “PPQ Batch(es)” means those process performance qualification Batches used to: (a) demonstrate and document the consistency and reproducibility of a Manufacturing Process at a Facility; (b) establish the comparability of the applicable Product Manufactured at such Facility to Product manufactured by Biogen or another Third Party as required by the Regulatory Authorities; and (c) support Regulatory Approval of both such Facility and such Manufacturing Process at such Facility. Each PPQ Batch is intended to produce Product that is or expected to be (following Regulatory Approval) commercially saleable.
1.63 “Process” means the production process Developed hereunder and analytical methods for the Manufacture of the Drug Substance or Drug Product, including any improvements or modifications thereto, comprising all technical information relating to the process of manufacture and testing reasonably required to produce such Drug Substance or Drug Product, including any associated documentation, as set forth or referenced in the applicable Specification for such Product.
1.64 “Procured Equipment” has the meaning set forth in Section 2.6.1.
1.65 “Product” means Drug Substance or Drug Product, as the context requires.
1.66 “Project Documentation” means any interim or final analyses, written reports and records identified as deliverables in an SOW. For the avoidance of doubt, documents that may be generated in the course of performing Services, but that are generally applicable to Biogen’s business, such as facility and equipment standard operating procedures (SOPs), will not constitute Project Documentation.
1.67 “Project Manager” has the meaning set forth in Section 2.4.
1.68 “Purchase Order” has the meaning set forth in Section 4.2.
1.69 “QC Hold Waiver” has the meaning set forth in Section 5.6.
1.70 “Quality Agreement” has the meaning set forth in Section 5.5.
1.71 “Recipient” has the meaning set forth in Section 6.1.
1.72 “Regulatory Approval” means, with respect to a country, all approvals, licenses, registrations or authorization by an applicable Regulatory Authority, necessary to import Drug Substance or Drug Product, and to commercialize and market Drug Product.
5
1.73 “Regulatory Authority” means the international, federal, state or local governmental or regulatory bodies, agencies, departments, bureaus, courts or other entities responsible for (i) the regulation (including pricing) of any aspect of pharmaceutical or medicinal products intended for human use or (ii) health, safety or environmental matters generally.
1.74 “Representatives” of an entity means such entity’s duly-authorized officers, directors, employees, agents, accountants, attorneys or other professional advisors.
1.75 “Services” means all work performed by Biogen for Vir pursuant to an SOW. “Development Services” shall mean Services consisting of Development activities, “Technology Transfer Services” shall mean Services consisting of Technology Transfer activities, “Manufacturing Services” shall mean Services consisting of pre-commercial/clinical Manufacturing activities as the context requires, and “Unplanned Services” shall have the meaning as set forth in Section 3.1.6.
1.76 “SOW” means a separate statement of work agreed to and executed by the Parties that defines the scope of work to be performed by Biogen and the responsibilities of the Parties with respect to such work, which statements of work shall be appended hereto at Attachment A as successive addenda upon execution thereof by duly authorized representatives of each of the Parties.
1.77 “Specifications” means the written specifications for Drug Substance or Drug Product, as applicable, agreed to by the Parties in an SOW, in each case as may be modified or amended by the mutual written agreement of the Parties from time to time.
1.78 “Successful Batch(es)” has the meaning set forth in Section 1.8.
1.79 “Technology Transfer” means the transfer, scale-up, testing, qualification, and licensure of a Facility necessary to Manufacture a Product, including: (a) transfer of the Manufacturing Process to the Facility, including the Process description, technical information, Manufacturing documentation, analytical methods, reference standards, materials, including, if stated in an applicable SOW, a portion of the master cell bank and/or working cell bank; (b) implementation of the Manufacturing Process at such Facility, including technical assistance and cooperation by appropriate employees of Biogen [***]; (c) all Manufacturing Process fit activities to the extent mutually agreed in the applicable SOW, including required process development and validation work and process engineering required to modify/equip and qualify such Facility for commercial Manufacturing; and (d) regulatory support for all required Regulatory Approvals of the Facility for commercial Manufacturing, each as relevant for the Facility in question and as further described in the applicable SOW(s).
1.80 “Term” has the meaning set forth in Section 12.1.
1.81 “Third Party” means any person, entity, or organization, including any government or sovereign, other than Biogen, Vir and their respective Affiliates.
1.82 “Unplanned Services” has the meaning set forth in Section 3.1.6.
1.83 “Vir” has the meaning set forth in the introductory paragraph, or any successor or permitted assign.
1.84 “Vir Indemnitees” has the meaning set forth in Section 9.1.
1.85 “Vir Invention” has the meaning set forth in Section 7.1.
1.86 “Vir IP” has the meaning set forth in Section 7.1.
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1.87 “Vir-Specific Items” has the meaning set forth in Section 3.1.5.
1.88 “Vir-supplied Materials” means any Material provided to Biogen for use in the Services by Vir, or by a Vir Affiliate or Third Party on behalf of Vir.
1.89 “[***]” means [***].
1.90 “[***]” means [***].
ARTICLE 2
SCOPE
2.1 Services. This Agreement is intended to cover Development Services related to Drug Substance and Drug Product, and, pursuant to the terms of this Section 2.1, Technology Transfer Services and Manufacturing Services for the pre-commercial/clinical supply of Product. The JSC shall discuss any potential Manufacturing needs of Vir related to Product as applicable. The Parties acknowledge and agree that (a) prior to the Effective Date, certain activities have been conducted under the Letter of Intent, including with respect to cell line development (the “Prior Development Activities”), which are applicable to the Services to be conducted hereunder, and (b) the Prior Development Activities shall be deemed to be Services conducted under this Agreement, and subject to the terms set forth herein, and (c) this Agreement shall be retroactively effective with respect to all Prior Development Activities and all Confidential Information disclosed by either Party in connection with such Prior Development Activities, from and after March 3, 2020.
2.1.1 Statements of Work; Conflict. Biogen shall use commercially reasonable efforts to perform the Services in accordance with the specific terms set forth in each SOW, provided that Biogen shall use commercially reasonable efforts to perform any activities related to Technology Transfer pursuant to this Section 2.1 and/or Section 2.5, in each case that are allocated to Biogen under an applicable SOW, in each case in accordance with the timelines set forth therein. Each SOW shall clearly define (as applicable) the Services, Vir-supplied Materials, other Materials, Drug Substance and/or Drug Product to be manufactured thereunder, Specifications, and the responsibilities of the Parties with respect to the SOW. No single SOW shall require more than [***]. Each SOW will include, as appropriate, the scope of work, pricing and payment schedule. Each SOW shall be subject to, and shall incorporate by reference, all of the terms and conditions of this Agreement. To the extent any terms or conditions of an SOW conflict with the terms and conditions of this Agreement, the terms and conditions of this Agreement shall control, except to the extent that the applicable SOW expressly and specifically states that it supersedes this Agreement on a specific matter. This Agreement shall supersede the terms of any purchase order, acknowledgement or delivery document. This Agreement shall not modify in any way the terms of any other development, license, manufacturing, packaging or other agreement between Vir and Biogen or their respective Affiliates. Vir agrees that [***], and any termination of such SOW by Vir shall be subject to Section 12.4.
2.1.2 Pre-Commercial/Clinical Manufacturing and Supply. As soon as reasonably practicable following the Effective Date, the Parties will discuss and agree upon the pre-commercial/clinical Manufacturing capacity for pre-commercial/clinical Manufacturing of Product at Biogen’s Facilities subject to this Section 2.1.2 and [***], in order to guide Vir’s forecasting for Product pursuant to Section 4.1. If Biogen, [***], is able to commit to providing sufficient Manufacturing capacity to Vir for pre-commercial/clinical supply of Product during the Term, and, if Vir wishes Biogen to perform Manufacturing Services under this Agreement, Vir shall submit such request for Manufacturing Services formally to Biogen in accordance with the notice procedures set forth in Article 13 (a “Manufacturing Request”). Promptly following Biogen’s receipt of a Manufacturing Request, the JSC shall discuss such Manufacturing Request, provided that Biogen may, in its sole and absolute discretion, for any or no reason
7
whatsoever, accept or reject such Manufacturing Request within [***]. If Biogen does not affirmatively accept such Manufacturing Request within [***] Biogen will be deemed to have rejected such Manufacturing Request. Biogen’s obligation to perform Manufacturing Services shall be further subject to the execution by the Parties of mutually agreeable SOWs for Manufacturing Services, as further set forth in Section 2.2. Without limiting the foregoing, the Parties agree that as of the Effective Date, (a) Vir has submitted, and Biogen has accepted, a Manufacturing Request for the Manufacture of certain Batches of Drug Substance and a to-be-agreed-upon amount of Drug Product, which Manufacturing Request is attached to this Agreement as Attachment D, (b) the Parties have agreed upon the terms of SOW A-1 governing the process development of Drug Substance specified in such Manufacturing Request (the “Process Development SOW”), (c) the Parties have agreed upon the terms of SOW A-2 governing the Manufacture of the Drug Substance specified in such Manufacturing Request (the “Initial DS SOW”) and (d) the Parties have agreed upon the terms of SOW A-3 governing Manufacture of the Drug Product specified in such Manufacturing Request (the “Initial DP SOW”). The Process Development SOW, Initial DS SOW and Initial DP SOW are attached to this Agreement as Attachment A-1, Attachment A-2 and Attachment A-3 respectively. The quantities, dosages and timing of Drug Product Manufacturing Services will be as defined in a mutually agreeable SOW(s).
2.1.3 Commercial Manufacturing and Supply. As of the Effective Date, the Parties do not intend that commercial-scale Manufacturing be conducted under this Agreement. Notwithstanding the foregoing, in anticipation of the potential negotiation of a commercial-scale manufacturing agreement (a “Commercial Supply Agreement”), the Parties may discuss the possibility of [***] including the possibility of Biogen (i) [***], (ii) [***] and (iii) [***]. Further, neither Party is obliged to negotiate or enter into a Commercial Supply Agreement [***].
2.2 Amendments to Scope/Change Orders. Any material change in the details of an SOW or the assumptions upon which the SOW is based, including, but not limited to (i) [***], (ii) [***], or (iii) [***], may require changes in the pricing and time lines, [***], and in all events shall require a written amendment to the SOW (a “Change Order”). Each Change Order shall detail the requested changes to the applicable task, responsibility, duty, pricing, timeline or other matter. The Change Order will become effective upon the execution of the Change Order by both Parties, and Biogen will be given a reasonable period of time within which to implement the changes. Both Parties shall act in good faith and promptly when considering a Change Order requested by the other Party. Without limiting the foregoing, Vir shall not [***]. Biogen shall not be obligated to perform any modified or additional Services until a Change Order has been executed by the Parties with respect to such Services.
2.3 Vir Responsibilities. Unless otherwise agreed by the Parties in writing or in the SOW, Vir agrees that it shall (i) provide current and accurate scientific data in Vir’s possession and control regarding each project described in an SOW and its requirements for such project, including test methods and data and methods concerning Development, formulation, fill and finish of the Product if applicable, in each case to the extent necessary for Biogen to perform its responsibilities under a SOW (ii) provide Biogen with information necessary to develop each SOW, including information reasonably required to prepare the scope of work and provide estimated or fixed costs, (iii) use commercially reasonable efforts to perform the activities identified as its responsibility in each SOW in accordance with the timelines set forth therein; (iv) review and approve all Specifications for work or Product, (v) if applicable, review and approve all in-process and finished Product test results to ensure conformity of such results with the agreed Product Specifications, regardless of which Party is responsible for finished Product release, and (vi) if applicable, prepare all submissions to Regulatory Authorities in connection with the Product.
2.4 Project Managers. Each Party shall designate one project manager for each SOW (each a “Project Manager”), who shall be responsible for making technical and operational decisions relating to such SOW, as well as communicating to each other technical and operational issues regarding the Services.
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2.5 Technology Transfer. The Parties intend that all Manufacturing Processes Developed by Biogen under any applicable Development SOW(s) shall be portable by Vir from one Facility to another Facility, or to a facility of any Third Party that Vir designates in writing to Biogen from time to time for the conduct of pre-commercial/clinical and commercial Manufacturing, provided, however, Biogen does not guarantee the successful implementation of any Manufacturing Processes at Third Party facilities. Upon the expiration of this Agreement or its termination by Vir pursuant to Sections 12.2 or 12.3, or at Vir’s written request at any other time during the Term, Biogen shall use commercially reasonable efforts to perform a Technology Transfer of the Manufacturing Process to a Biogen Facility, to Vir or its Affiliates, or to a Third Party contractor designated by Vir. Vir acknowledges that such documentation and materials will [***]. Certain [***] required to Manufacture the Process will be made available to Vir through arrangements with Biogen’s suppliers pursuant to Section 7.5.4. Subject to Section 3.1.2, Vir shall reimburse Biogen on a reasonable hourly-rate basis for such technical assistance as further defined in the applicable SOW(s) governing Technology Transfer activities. In no event shall Biogen be obliged to perform any activities under this Section 2.5 after [***] of the date of expiration or termination of this Agreement.
2.6 Capital Modifications, Expenditures and Maintenance.
2.6.1 Equipment and Capital Costs. Biogen will provide to Vir for review and prior written approval a budget of the Capital Costs to be incurred by Biogen for any capital equipment or Facility modifications required to Manufacture the Product in a Facility. [***]. Unless the Parties agree to a different reimbursement arrangement within an applicable SOW, Vir shall reimburse Biogen for the Capital Costs for the capital equipment or the making of Facility modifications in each case [***] (all of the foregoing, the “Procured Equipment”). Ownership of the Procured Equipment shall vest in Biogen and, unless otherwise mutually agreed in writing by the Parties, shall (a) be marked “Vir Use Only”, and (b) be used solely by Biogen for Manufacture of the Product under the applicable SOW(s).
2.6.2 Maintenance. Biogen shall be responsible for routine maintenance of Procured Equipment. Vir shall be responsible for the cost of any non-routine repair or replacement, of Procured Equipment used in the Process which is required during the Term (other than in connection with any damage or destruction to the extent resulting from the negligence or willful misconduct of Biogen). Upon Vir’s prior written consent, Biogen shall repair or replace such equipment and Biogen shall invoice Vir for such for repair expenses or capital for the replacement on the basis of the relevant cost therefor, and Vir shall pay all such invoices in accordance with Article 3.
2.6.3 Facilities. Biogen shall not be required to make a modification to a Facility, or to implement a Process, that is not fundamentally compatible with the Facility, including equipment used in and Manufacturing processes performed in such Facility, as established by Biogen. [***].
2.7 Vir-supplied Material; High-Value Materials.
2.7.1 Provision. Except as expressly set forth in an SOW, Vir will provide all samples, reference materials, and other Materials, as applicable, required for each SOW. [***] and Vir shall be responsible for forecasting and ordering from Biogen, in accordance with this Agreement, sufficient quantities of Drug Substance, including a mutually agreed allowance for loss, to enable Biogen to Manufacture Drug Product in accordance with the applicable forecasts, SOW(s) and Purchase Orders. Vir shall be responsible at its expense for securing any necessary export or import, or similar clearances, permits or certifications, including U.S. Drug Enforcement Administration (DEA) licenses, required in respect of such supply. Biogen shall use such items solely for use in the Services. Prior to delivery of any such items, Vir shall provide to Biogen a copy of all associated material safety data sheets, safe handling instructions and health and environmental information, and any regulatory certifications or authorizations that may be required under Applicable Laws relating to Vir-supplied Materials, and shall promptly provide any updates thereto.
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2.7.2 Responsibilities for Vir-supplied Materials. Following receipt of Vir-supplied Materials, Biogen shall visually check such items to verify their identity and assess for any visible non-conformance with the specifications relating thereto. Unless otherwise expressly required by the Specifications, or the applicable SOW, Biogen shall have no obligation to test such items to confirm that they meet the associated specifications or certificate of analysis or otherwise; but if Biogen detects a nonconformity with applicable specifications, Biogen shall give Vir prompt written notice of such nonconformity. Biogen shall not be liable for any defects in Vir-supplied Materials, or in Services, Drug Product as a result of defective Vir-supplied Materials, unless Biogen failed to properly perform the foregoing obligations. Biogen shall follow Vir’s reasonable written instructions in respect of return or disposal of defective Vir-supplied Materials, at Vir’s cost. Vir shall retain title to Vir-supplied Materials at all times and shall bear the risk of loss thereof, except for any loss resulting from Biogen’s gross negligence or willful misconduct.
2.7.3 Delays. Biogen reserves the right to cancel or postpone, [***], all or any part of an SOW upon written notice to Vir if Vir fails to timely supply conforming Vir-supplied Materials. In the event of such cancellation, Biogen shall comply with Article 12, and except as set forth therein, shall have no further obligations or liability with respect to the affected SOW. In the event of such postponement, Biogen shall reschedule the work at the next available slot following receipt of conforming Vir-supplied Materials. [***].
2.7.4 High-Value Materials. Notwithstanding any provision herein to the contrary, except as otherwise set forth in an SOW, [***]. For clarity, in the case of Manufacturing by a Biogen subcontractor at a Third Party Facility, Vir’s obligation to pay replacement costs under this Section 2.7.4 shall not apply to the extent Biogen is not obligated to pay equivalent replacement costs for loss of High-Value Materials at a Third Party Facility under the terms of Biogen’s agreement with such Third Party
2.8 Error. Except with respect to pre-commercial/clinical Manufacturing Services (which, for clarity, are subject to Section 4.3), in the event of a material error by Biogen (including as a result of gross negligence) in performing any Services which renders the results unacceptable to a regulatory agency or Regulatory Authority to which Vir intends to submit such results, Biogen’s sole obligation to Vir shall be for Biogen to repeat the relevant Services at Biogen’s own cost. In such event, Vir shall supply, at its cost, Biogen with sufficient quantities of Vir-supplied Materials in order for Biogen to complete such re-performance and Biogen shall schedule and complete such re-performance at the earliest possible date.
2.9 Release. This Section 2.9 applies solely to Manufacturing Services and does not apply to Development Services. Drug Substance and Drug Product shall be released by Biogen only when [***] (collectively, “Manufacturing Release”). Biogen shall keep Vir reasonably updated as to the proposed schedule and time for Manufacturing Release of each Batch of Drug Substance and Drug Product. Biogen shall notify Vir without undue delay if Biogen becomes aware that it will or has reason to believe that it may be unable to meet the previously estimated date for Manufacturing Release of the applicable Drug Substance or Drug Product. In the event of such a delay for a particular Batch, Biogen shall notify Vir of the reason for the delay. For clarity, unless otherwise set forth in an SOW, Vir shall be responsible for the final release of Drug Product.
2.10 Delivery; Title and Risk of Loss.
2.10.1 Delivery Terms. Biogen shall deliver all master cell banks and working cell banks, Drug Substance, Drug Product, samples, and other tangible items specified as deliverables in an SOW or this Agreement (collectively, the “Deliverables”) [***].
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2.10.2 Drug Substance and Drug Product. Biogen shall retain title to and risk in Drug Substance that is designated for conversion to Drug Product by Biogen (“Designated Drug Substance”) for a period of [***]. To the extent not already held by Vir, and except for Designated Drug Substance held by Biogen, title to the Deliverables shall transfer to Vir upon [***]; provided, however, that Biogen shall [***]. Except for Designated Drug Substance, risk of loss in the Deliverables shall transfer to Vir upon [***]. Vir shall arrange for collection of Drug Substance and Drug Product within [***], except for Designated Drug Substance. Designated Drug Substance will become part of Biogen’s work-in-process at the time when it is first used in the Process for Drug Product. Notwithstanding anything herein, if Vir’s Purchase Orders for Drug Product are for quantities of Drug Product that are insufficient to absorb all of the Designated Drug Substance (on a first-released, first-used basis) within [***] of the Designated Drug Substance, risk in and title to the excess Designated Drug Substance shall be deemed to transfer to Vir upon [***]. For clarity, this Section 2.10.2 only applies to the extent Biogen has accepted a Manufacturing Request in accordance with Section 2.1.2.
2.10.3 Storage of Cell Banks. Biogen will store all master cell bank(s)and/or working cell bank(s) developed by Biogen or received by Biogen as Vir-supplied Material (including [***]) in accordance with the applicable SOW(s) for Services and the Specification. Biogen shall not permit the transfer of the master cell bank(s)and/or working cell bank(s) to any facility that is not specifically authorized in advance and in writing by Vir. Vir will only send Biogen the quantity of [***] requested by Biogen under the terms of the applicable SOW. For clarity, Section 6.7 shall apply to [***].
2.10.4 Project Documentation. Biogen shall deliver Project Documentation in accordance with any documentation delivery dates set forth in an SOW, subject to reasonable extensions of time for any Project Documentation that is affected by any Change Order or delay as set forth elsewhere herein. Biogen may deliver Project Documentation in a customary and mutually acceptable electronic format as further described in an SOW. Biogen shall have the right to (i) retain copies of any Project Documentation that it is required to retain by Applicable Laws, including retaining original records if so required by Applicable Laws, and (ii) use such Project Documentation solely for purposes of compliance with cGMP requirements or Applicable Laws, or for any other use expressly stated in an SOW. Furthermore, [***]. For clarity, this Section 2.10.4 only applies to the extent Biogen has accepted a Manufacturing Request in accordance with Section 2.1.2.
2.10.5 Samples and Excess Materials. Following completion of each relevant phase of an SOW, samples will be stored in quarantine at the Facility in accordance with Applicable Laws. After [***], Biogen will dispose of samples, at Vir’s cost, unless prior written instructions have been provided by Vir for returning samples to Vir at Vir’s cost. Biogen will also dispose of unused Vir-supplied Materials within [***] of the termination of the relevant SOW, at Vir’s cost, unless prior written instructions have been provided by Vir for returning such materials to Vir at Vir’s cost.
2.11 Subcontractors. Subject to the other terms and conditions of this Agreement, Biogen reserves the right to employ subcontractors to undertake certain Services upon prior written notice to Vir, which notice shall identify the subcontractor and describe the activities to be performed by such subcontractor. [***]. Any subcontractors engaged by Biogen to provide any part of the Services will be subject to written obligations consistent with those applicable to Biogen under this Agreement, including with respect to any confidentiality obligations and ownership of the Deliverables and Inventions.
2.12 Joint Steering Committee. Promptly following the Effective Date, the Parties shall establish a joint steering committee (the “JSC”). The JSC shall oversee and review Development, Technology Transfer, and Manufacturing activities for clinical supply in connection with Drug Product and Drug Substance, [***]. The JSC shall be responsible for monitoring the need for Drug Substance and Drug Product in the context of the global incidence and prevalence of SARS-CoV-2/COVID-19. To that end, Vir shall share with the JSC periodic non-binding forecasts for its clinical and commercial requirements for Drug Substance and Drug Product to facilitate planning and the discussion of potential Manufacturing Requests
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pursuant to Section 2.1.2 as well as the potential negotiation of a Commercial Supply Agreement pursuant to Section 2.1.3. Any forecasts provided under Section 4.1 shall supersede any informational forecasts provided under this Section 2.12. The JSC shall be comprised of at least one (1) representative (or such other number of representatives as the Parties may mutually agree) from each of Biogen and Vir. Each Party’s Project Manager shall be a non-voting member of the JSC. Upon its formation, the JSC shall meet in person or by teleconference at least [***] following the Effective Date, and thereafter at least [***], or more or less frequently as the Parties mutually deem appropriate, provided that the JSC shall meet at least [***]. All decisions of the JSC shall be made by consensus, with each Party having one (1) vote; provided that Biogen shall have final decision-making authority with regard to Biogen’s capacity to Manufacture Drug Substance and/or Drug Product. If the JSC cannot agree on a matter within [***] after it has attempted to reach such decision in good faith, then, with the exception of capacity questions, which shall be decided solely by Biogen, the matter shall be escalated for resolution to a senior executive nominated by each Party. If such senior executives cannot resolve the matter within [***] following referral, the status quo shall prevail with respect to such matter.
ARTICLE 3
PAYMENTS
3.1 Fees.
3.1.1 Fees—Development Services. Vir shall pay for the Development Services as provided in this Agreement and each applicable SOW for Development Services.
3.1.2 Fees – Technology Transfer Services. Vir shall pay for any services relating to Biogen’s performance of Technology Transfer services as provided in this Agreement and each applicable SOW for such Technology Transfer services, including any Third Party testing services that may be requested by Vir (or recommended by Biogen and accepted by Vir) as part of the Technology Transfer services. Such Third Party testing services shall be paid by Vir on a pass-through basis.
3.1.3 Fees – Manufacturing Services. Vir shall pay for the Manufacturing Services as provided in this Agreement and each applicable SOW for Manufacturing Services. For avoidance of doubt, Vir shall be responsible for all costs payable to Third Parties for Manufacturing at the Third Party’s Facility, including any Third Party testing services that may be required as part of such Manufacturing Services, unless otherwise agreed with Biogen pursuant to Section 2.1. Any Third Party testing services that may be required as part of the Manufacturing Services shall be specified in SOPs developed for the Process and shall be paid by Vir on a pass-through basis. In addition to the fees for the performance of the Manufacturing Services set forth in this Agreement and each SOW for Manufacturing Services, Vir agrees to pay the access fees specified in the Attachment C (“Access Fees”) for all Manufacturing of Products using any Improvements whether such Manufacturing is performed directly by Vir, its Affiliates or its or their licensees or collaborators or by Third Parties contracted by any of the foregoing.
3.1.4 Price Changes. With the exception of [***], Biogen may reasonably revise the fees provided in an SOW if (i) any information relating to an SOW which is provided by Vir is materially inaccurate or incomplete, and such inaccurate or incomplete information directly and adversely impacts the costs of Biogen providing the Services, or (ii) pursuant to a Change Order, there is a material revision to the scope of Services under the applicable SOW or Biogen’s responsibilities thereunder. In addition, the fees provided in an SOW [***] shall be subject to annual review by the Parties to address changes in inflation, increased overhead charges, and other commercially reasonable factors.
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3.1.5 Vir-Specific Purchases. Vir shall be responsible for the costs of all Materials, reference standards, specialty chemicals, and other Vir-specific purchases required to perform the Services, including any High-Value Materials not supplied by Vir (collectively, “Vir-Specific Items”), [***] unless provided by Vir to Biogen at no cost as Vir-supplied Materials pursuant to Section 2.7. Vir shall be responsible for the costs of replacing any Vir-Specific Items that become obsolete prior to their scheduled use in Manufacturing Drug Substance or Drug Product, provided that Biogen shall manage inventory of Vir-Specific Items in order to minimize the chances of obsolescence.
3.1.6 Unplanned Services. Biogen will notify Vir of the cost of performing any unplanned investigational studies, out of specification (“OOS”) investigations or additional Vir-requested retesting Services not otherwise specified in an SOW (collectively, “Unplanned Services”), and subject to Vir’s approval, not to be unreasonably withheld, of the applicable Change Order for said Unplanned Services in accordance with Section 2.2, Biogen will invoice Vir for the cost of performing these Unplanned Services provided that any Unplanned Services directly due to a Biogen error will be subject to Section 2.8.
3.1.7 Cancellations and Postponements.
(a) SOWs for Batch Manufacture or Fill Finish pursuant to Section 2.1 shall be non-cancellable with respect to any part within the Binding Forecast.
(b) With respect to Services other than Batch Manufacture or Fill Finish (which, for clarity, are subject to Section 3.1.7(a)), if Vir [***], then Vir shall pay Biogen any applicable cancellation fees set forth in the applicable SOW.
(c) Notwithstanding Sections 3.1.7(a) and 3.1.7(b), Biogen shall [***] to reallocate any Service resources and materials or manufacturing slots vacated by any such cancellation or postponement to Biogen, other customers of Biogen, or, if agreed by Vir, other Vir projects conducted by Biogen under separate a separate SOW in order to mitigate any losses arising from such postponement or cancellation, and Vir shall only be liable for the remainder of any Binding Forecast or for cancellation fees, as applicable, in connection with Service resources and materials or manufacturing slots left vacant and unable to be filled by Biogen, other customers of Biogen, or other Vir projects.
3.2 Invoicing. Unless otherwise provided in the applicable SOW, Biogen shall invoice Vir as follows:
3.2.1 for Batch Manufacture and/or Fill Finish pursuant to Biogen’s acceptance of a Manufacturing Request pursuant to Section 2.1.2 upon the earliest to occur of the following: (i) [***]; (ii) [***]; or (iii) if a Third Party is to perform finished product testing, then [***] following shipment of Drug Substance or Drug Product samples to a Third Party testing agency, but only if such testing agency has not yet delivered its test results for such Drug Substance or Drug Product and Biogen has performed all of its responsibilities except for those responsibilities which incorporate test results from the Third Party testing agency;
3.2.2 for any SOW that can be completed within [***] (other than Batch Manufacture and/or Fill Finish), Biogen shall invoice Vir upon [***];
3.2.3 for any SOW that cannot be completed within [***] (other than Batch Manufacture and/or Fill Finish), Biogen shall invoice Vir [***], or as set forth on the applicable SOW;
3.2.4 for any Vir-Specific Items other than High-Value Materials, Biogen shall invoice Vir for such Vir-Specific Items with the invoice for the Batch for which such Vir-Specific Items were ordered. The costs of High-Value Materials, shall be invoiced when purchased by Biogen, provided that the [***] fee set forth in Section 3.1.5 shall be pro-rated across the Batches for which such High-Value Materials are used, with the balance (if any) of such fee to be invoiced if and when such High-Value Materials become obsolete or if the applicable SOW or this Agreement is terminated; or
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3.2.5 for any milestone payment, Biogen shall invoice Vir when the milestone trigger event occurs.
3.3 Payment Terms. Payment of all Biogen invoices shall be due [***] after the date of receipt of invoice, subject to Section 3.4 with respect to any disputed amounts. Vir shall make payment in U.S. dollars, and otherwise as directed in the applicable invoice. If any payment is not received by Biogen by its due date, then [***].
3.4 Method of Payment. Unless otherwise specified in an SOW, all undisputed amounts payable to Biogen under this Agreement will be paid in U.S. Dollars, without deduction, and by authenticated and value dated Swift telegraphic transfer for any such payments made from outside the U.S., quoting invoice numbers of payment to the bank account identified in the applicable invoice or by such other means as Biogen will notify Vir in writing from time to time. If Vir disputes the amount of any invoice, it shall notify Biogen within [***] following receipt of the invoice, and the Parties shall meet within [***] following such notice to seek to resolve such dispute.
3.5 Taxes. All taxes, duties and other amounts assessed (excluding tax based on net income and franchise taxes) on Services, Procured Equipment, components, Drug Substance or Drug Product prior to or upon provision or sale to Biogen or Vir, as the case may be, and on any other Vir-supplied Materials, are the responsibility of Vir, and Vir shall reimburse Biogen for all such taxes, duties or other expenses paid by Biogen or such sums will be added to invoices directed to Vir, where applicable. If any deduction or withholding in respect of tax or otherwise is required by law to be made from any of the sums payable hereunder, Vir shall be obliged to pay to Biogen such greater sum as will leave Biogen, after deduction or withholding as is required to be made, with the same amount as it would have been entitled to receive in the absence of any such requirement to make a deduction or withholding. For clarity, all prices and amounts due set forth herein are stated exclusive of any value added tax, goods and services tax or other forms of sales tax.
ARTICLE 4
MANUFACTURING AND FILL FINISH
To the extent Biogen has accepted a Manufacturing Request in accordance with Section 2.1.2, subsequent to which the Services include pre-commercial/clinical Manufacturing and/or Fill Finish, the following shall apply except to the extent that the Parties otherwise agree in writing. The Parties acknowledge that [***].
4.1 Forecasts.
4.1.1 Initial Forecast. At the first meeting of the JSC following the acceptance of a Manufacturing Request by Biogen, or at such other time as may be agreed in writing by the Parties, Vir shall provide Biogen with an initial forecast consistent with the provisions of this Agreement and Biogen agrees to confirm, reject or otherwise respond to Vir within [***] thereafter to such initial forecast.
4.1.2 Forecast Length. The initial forecast shall cover the next [***] (or the period covered by the Parties’ [***]), setting forth the timing and number of Campaigns to be conducted and Batches of Drug Substance and Drug Product (as applicable) that Vir expects to order from Biogen during this period and which is consistent with the Manufacturing capacity agreed by Biogen pursuant to Section 2.1.2. Within [***] prior to the beginning of each calendar quarter, Vir shall submit to Biogen a rolling written forecast of its requirements of pre-commercial/clinical Product to be supplied by Biogen during the remainder of the agreed forecast period.
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4.1.3 Binding and Non-binding Portions. [***]. Each forecast made under Section 4.1 shall include a forecast of the total quantity of each Product (in Batches, kilograms or other relevant unit) that will be required for the [***] (each, a “Binding Forecast”). The forecast for the subsequent [***] (the “Advisory Forecast”) shall include the total quantity of each Product reasonably anticipated to be made during such [***]. The Parties acknowledge that each Binding Forecast shall be binding as set forth above in [***], and will represent a binding commitment for Vir or its Affiliate(s) to pay for the number of Batches needed to produce such forecasted Product in such [***]. The Project Managers shall be responsible for scheduling the Manufacturing to meet Vir’s Binding Forecast, subject to the terms of this Section 4.1.3. [***].
4.1.4 [***].
4.2 Orders. Vir shall deliver to Biogen, together with each Binding Forecast, a written binding purchase order (each, a “Purchase Order”) for the amount of Product that Vir wishes to order during the first calendar quarter covered by such Binding Forecast. For further clarity, the Parties acknowledge and agree that Batches must be forecasted and ordered in full Batch increments; forecasts and orders for partial Batches will not be accepted unless otherwise set forth in a SOW. Biogen shall provide Vir with written notice (but in any event within [***]) of its acceptance of each such Purchase Order. If Biogen fails to provide notice to Vir of acceptance within such [***] period, such Purchase Order shall be deemed accepted. Biogen shall [***] provide Vir with Product in quantities sufficient to fulfill Vir’s Purchase Order, in accordance with the delivery dates set forth in the applicable Purchase Order. [***]. Notwithstanding the foregoing, Biogen shall have the right to reject any quantities of Product within any Purchase Order that exceed [***] of the quantity of the applicable Product forecasted by Vir for the relevant period in the most recent Binding Forecast, provided that Biogen shall [***] any, Purchase Order for quantities up to [***] of the most recent Binding Forecast. If Biogen in its discretion determines to accept any Purchase Order greater than [***] of the most recent Binding Forecast, Biogen shall [***] to supply Vir with such excess Manufacturing capacity and/or quantities, as applicable. Each Purchase Order shall specify: (i) the quantity of Product to be made under each Campaign, (ii) the requested location for delivery of each Successful Batch; (iii) the requested time of delivery of each Successful Batch; (iv) the carrier and/or manner of shipment that Biogen should use in delivering each Successful Batch; and (v) the Materials to be ordered by Biogen for supply of Product to Vir or Vir-supplied Materials to be provided directly by Vir to Biogen for use in the Manufacture of Product. [***].
4.3 Nonconforming Drug Substance or Drug Product. Subject to Sections 4.4 and 4.5, unless within [***] after tender of delivery of Drug Substance or Drug Product, as applicable (the “Inspection Period”), Vir or its designee notifies Biogen in writing (an “Exception Notice”) that such Drug Substance or Drug Product does not meet the warranty set forth in Section 8.1.4 (“Defective Product”), and provides a sample of the alleged Defective Product, the Drug Substance or Drug Product shall be deemed accepted by Vir, and Vir shall have no right to reject such Drug Substance or Drug Product. Upon timely receipt of an Exception Notice from Vir, Biogen shall conduct an appropriate investigation to determine whether or not it agrees with Vir that Drug Substance or Drug Product is Defective Product and to determine the cause of any nonconformity. If Biogen agrees that Drug Substance or Drug Product is Defective Product and determines that the cause of the nonconformity is attributable to [***], then Vir shall not be responsible to pay for such Defective Product, and Biogen shall, [***].
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4.4 Latent Defects. For the purposes of this Agreement, a “Latent Defect” means a defect or other condition that causes Drug Substance or Drug Product to be Defective Product that [***]. In the case of discovery of any Latent Defect, Vir will have [***] after discovery of such Latent Defect to notify Biogen of such Latent Defect. Where Vir provides Biogen with an Exception Notice in connection with the existence of a Latent Defect, the Parties shall [***], and if Biogen agrees that Drug Substance or Drug Product is Defective Product as a result of Biogen Defective Processing, then Biogen shall, [***].
4.5 Discrepant Results. If the Parties disagree as to whether Drug Substance or Drug Product is Defective Product (whether under Section 4.3 or Section 4.4) and/or whether the cause of the nonconformity is Biogen Defective Processing, and the disagreement is not resolved within [***] (or such other period as may be agreed in writing by the Parties) of the Exception Notice date, the Parties shall cause a mutually acceptable independent Third Party to review records, test data and to perform comparative tests and/or analyses on samples of the alleged Defective Product and its components, including Vir-supplied Materials. [***]. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall [***].
4.6 [***]. Subject to the provisions of this Section 4.6, and to [***], Vir agrees that [***].
ARTICLE 5
REGULATORY
The requirements set forth in this Article 5 shall apply to the Services to the extent required by Applicable Laws. Vir acknowledges and agrees that the Development Services shall be performed on a non-cGMP basis and that the laws, regulations and guidelines governing cGMP Manufacturing shall not be deemed to apply to the Development Services unless otherwise requested by Vir and specified in the applicable SOW. For clarity, this Article 5 applies to Technology Transfer services agreed by the Parties but only applies to Manufacturing Services to the extent Biogen has accepted a Manufacturing Request in accordance with Section 2.1.2.
5.1 Recordkeeping. Unless the Parties otherwise agree in writing, Biogen shall maintain [***] complete and accurate Batch Records, laboratory data, reports and other technical records relating to Drug Substance or Drug Product in accordance with Biogen standard operating procedures and Applicable Laws. Such records shall be maintained for [***] (the “Document Retention Period”). Following the expiry of the Document Retention Period, and prior to disposing of or destroying such documentation, Biogen shall first offer to deliver such documentation to Vir. If Vir refuses in writing the delivery of such documentation or fails to respond to such offer within [***], Biogen may destroy such documentation.
5.2 Regulatory Compliance. Biogen shall obtain and maintain all permits and licenses with respect to general Facility operations required by any Regulatory Authority in the jurisdiction in which Biogen performs Services. Vir shall obtain and maintain all other Regulatory Approvals, authorizations and certificates, including those with respect to Drug Substance or Drug Product. Vir shall [***]. Vir shall not identify Biogen in any regulatory filing or submission without Biogen’s prior written consent. Such consent shall not be unreasonably withheld or delayed and shall be memorialized in a writing signed by authorized representatives of both Parties. Upon written request, Vir shall [***]. During the Term, Biogen will provide information to Vir as reasonably needed for regulatory filings and inquiries by Regulatory Authorities relating to Drug Substance or Drug Product, at Vir’s request and expense; provided, however, that Biogen may [***]. Vir shall provide to Biogen all information concerning Drug Substance and Drug Product and related Regulatory Approvals, authorizations and certificates in Vir’s possession as reasonably required to allow Biogen to satisfy its obligations under Applicable Laws relating to performance of this Agreement.
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5.3 Governmental Inspections and Requests. Each Party shall promptly advise the other Party of any inspection or inquiry by any Regulatory Authority concerning any SOW, Drug Substance or Drug Product. Biogen shall, subject to any Third Party facility or subcontractor restrictions if applicable, permit up to [***] of Vir to be present at any inspection relating specifically to Services under this Agreement, provided that Vir may be excluded from any part of the Facility or inspection that does not [***] to the Services or Product, and Vir shall not have the right to direct Biogen’s conduct of any such inspection. Upon request, Biogen shall, subject to any Third Party facility or subcontractor restrictions if applicable, provide Vir with a copy of any report issued by such Regulatory Authority received by Biogen following a visit to the Facility concerning the Drug Substance or Drug Product, redacted as appropriate to protect any confidential information of Biogen and Biogen’s other customers; and Vir shall provide Biogen with any [***] correspondence with such Regulatory Authority, including FDA refusal to file, rejection or warning letters. Vir acknowledges that it may not direct the manner in which Biogen fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Vir shall [***].
5.4 Facility Audits and Observation. This Section 5.4 only applies to Technology Transfer Services and Manufacturing Services and does not apply to Development Services.
5.4.1 Quality Audits. During the Term, Vir’s Representatives shall be granted access upon at least [***] prior notice, at reasonable times during regular business hours, and subject to any Third Party facility or subcontractor restrictions if applicable, to (i) the portion of the Facility where Biogen performs Services, (ii) relevant personnel involved in Services and (iii) Services records described in Section 5.1, in each case [***] for the purpose of verifying that Biogen is performing Services in accordance with cGMPs, Applicable Laws, the Specifications and the master Batch records, as applicable. Vir may not conduct an audit under this Section 5.4.1 more than [***] during any [***] period; provided that additional inspections may be conducted in the event there is a [***] quality or compliance issue concerning Drug Substance, Drug Product or the Services. Vir’s Quality Assurance Manager will arrange Vir audits with Biogen Quality Management. Audits shall be designed to minimize disruption of operations at the Facility.
5.4.2 Additional Observation Rights. Upon at least [***] prior notice, from time to time, but no more frequently than [***] every [***] (or such other period as is stated in an SOW), Vir may, subject to subcontractor contractual restrictions if applicable to any Third Party Facility, send up to [***] to the Facility [***] to observe the Services for a period not to exceed [***] (or such other period as is stated in an SOW).
5.4.3 Visitation Terms. Vir’s Representatives shall be required to sign Biogen’s standard visitor confidentiality agreement prior to being allowed access to the Facility. Such Representatives shall comply with the Facility’s rules and regulations for visitors. Vir shall [***].
5.5 Quality Agreement. Prior to the Manufacture or Fill Finish by Biogen of any Drug Substance or Drug Product required to be Manufactured or Fill Finished in accordance with cGMP, including materials to be used in human clinical trials, the Parties shall negotiate in good faith and enter into a quality agreement starting from Biogen’s standard template or as otherwise agreed by the Parties (“Quality Agreement”). If determined necessary by Biogen or Vir, the Parties shall enter into separate Quality Agreements for different Facilities. In the event of a conflict between any of the provisions of this Agreement or an SOW and the Quality Agreement with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Agreement shall govern. In the event of a conflict between any of the provisions of this Agreement or an SOW and the Quality Agreement with respect to any commercial matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement or the SOW (per the order of precedence set forth in Section 2.1.1) shall govern. For clarity, this Section 5.5 only applies to Technology Transfer Services and Manufacturing Services.
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5.6 Waiver of In Process Quality Control Holds. Project scheduling may include certain FDA “Points to Consider” (PTC) assays and other in-process assays, as set forth in an SOW. PTC and in-process assays may prevent an SOW from progressing to subsequent scheduled events until the results of these PTC and in-process assays are completed, documented and audited by the appropriate QC group. In the event that Vir wishes to expedite an SOW by proceeding to subsequent project events without waiting for PTC and/or assay results, Vir shall provide Biogen with a written waiver referencing this Section 5.6 (“QC Hold Waiver”). If Biogen reasonably disagrees with proceeding with Manufacturing under a QC Hold Waiver, Biogen may decline to proceed and will not be deemed to be in breach of its obligations hereunder while results are pending from the PTC or other in-process assays and upon Vir written request Biogen shall describe the rationale for such disagreement in writing to Vir. If Biogen agrees to continue Manufacturing under a QC Hold Waiver, Biogen shall remain responsible for activities and Services up to the QC Hold Waiver to the extent provided in this Agreement and such Manufacturing thereafter shall be at Vir’s risk. Vir shall [***]. Biogen shall remain responsible for activities up to the QC Hold Waiver to the extent provided in this Agreement. For clarity, this Section 5.6 only applies to Manufacturing Services.
5.7 Countries Subject to Restrictions. Biogen shall not be obliged to perform any Services which would involve any countries that are targeted by the comprehensive sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom, or the United States of America.
ARTICLE 6
CONFIDENTIALITY AND NON-USE
6.1 Definition. As used in this Agreement, the term “Confidential Information” includes all information furnished by or on behalf of Biogen or Vir (the “Discloser”), its Affiliates or any of its or their respective Representatives, to the other Party (the “Recipient”), its Affiliates or any of its or their respective Representatives, whether furnished before, on or after the Effective Date and furnished in any form, including written, verbal, visual, electronic or in any other media or manner and information acquired by observation or otherwise during any site visit at the other Party’s facility. Confidential Information includes all proprietary technologies, know-how, trade secrets, discoveries, inventions and any other intellectual property (whether or not patented), analyses, compilations, business or technical information and other materials prepared by either Party, their respective Affiliates, or any of its or their respective Representatives. For the avoidance of doubt, (a) all confidential information disclosed under the Letter of Intent will be deemed Confidential Information of the applicable Discloser disclosed under this Agreement, and (b) the Biogen Proprietary Know-How is Biogen’s Confidential Information. The existence and terms of this Agreement shall be deemed to be the Confidential Information of both Parties. The existence and terms of any future negotiations between the Parties (to the extent occurring during the Term) with respect to a Commercial Supply Agreement or other potential contracts, including proposed pricing and other proposed contractual terms, shall be deemed to be the Confidential Information of both Parties.
6.2 Exclusions. Notwithstanding Section 6.1, Confidential Information does not include information that (i) is or becomes generally available to the public or within the industry to which such information relates other than as a result of a breach of this Agreement, (ii) is already known by the Recipient at the time of disclosure as demonstrated by the Recipient’s written records, (iii) becomes available to the Recipient on a non-confidential basis from a source that is entitled to disclose it on a non-confidential basis, or (iv) was or is independently developed by or for the Recipient without reference to the Confidential Information of the Discloser as evidenced by the Recipient’s written records.
6.3 Mutual Obligation. The Recipient agrees that it will not use the Discloser’s Confidential Information except in connection with the performance of its obligations hereunder and, with respect to Project Documentation and Manufacturing data, as set forth in Section 2.10.4, and will not disclose, without the prior written consent of the Discloser, Confidential Information of the Discloser to any Third Party, except that the Recipient may disclose the Discloser’s Confidential Information:
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6.3.1 to any of its Affiliates and its or their respective Representatives, and to its or their contractors, that (i) need to know such Confidential Information for the purpose of performing under this Agreement, or in the case of Biogen’s potential contractors, for the purpose of evaluating whether or not to enter into a subcontract for Services under this Agreement, (ii) are advised of the contents of this Article 6 and (iii) are bound to the Recipient by obligations of confidentiality at least as restrictive as the terms of this Article 6. Each Party shall be responsible for any breach of this Article 6 by its Affiliates or any of its or their respective Representatives;
6.3.2 to its actual and potential investors, acquirors, licensees and collaboration partners, in each case, to the extent such parties are advised of the contents of this Article 6 and are bound to the Recipient by obligations of confidentiality at least as restrictive as the terms of this Article 6. Each Party shall be responsible for any breach of this Article 6 by any Third Party to whom it discloses under this Section 6.3.2; and
6.3.3 to the extent required by Applicable Laws; provided that prior to making any such legally required disclosure, the Recipient shall give the Discloser reasonable prior notice of the requirement for and contents of such disclosure under the circumstances. Any such disclosure, however, shall not relieve the Recipient of its obligations contained herein with respect to future disclosures of such Confidential Information. For clarity, any legally required disclosure of the terms of this Agreement or other subject matter that is expressly described in Section 6.4 shall be subject to Section 6.4 instead of this Section 6.3.3.
6.4 Publicity. Neither Party will disclose any terms of this Agreement or make a press release, announcement or engage in any other form of publicity relating to the transactions which are the subject of this Agreement, or any ancillary matter, without first obtaining the prior written consent of the other Party. The Party wishing to make such disclosure, release, announcement or publicity will provide a copy of the proposed text thereof to the other Party for its review and approval at least [***] prior to the proposed release. The reviewing Party may provide specific, reasonable comments on such release, announcement or publicity reasonably in advance of the date of the proposed release, but will not unreasonably withhold or delay its approval to such release, announcement or publicity. Notwithstanding the foregoing, either Party may make such a disclosure to the extent required by Applicable Laws or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which such Party has its securities listed or traded, provided that the disclosing Party make reasonable efforts to provide the other Party with reasonable notice beforehand and to coordinate with the other Party with respect to the wording and timing of any such disclosure, including any redacted form of this Agreement required to be filed in connection therewith. In addition, Vir shall not use Biogen’s name in a manner that could be construed as an endorsement of Vir’s Drug Substance, or Drug Product, including any scientific conclusion as to safety or efficacy.
6.5 No Implied License. Except as expressly set forth in Article 7, the Recipient will obtain no right of any kind or license under any Confidential Information of the Discloser, including any patent application or patent, by reason of this Agreement. All Confidential Information will remain the sole property of the Discloser, subject to Article 7.
6.6 Return of Confidential Information. Upon expiration or termination of this Agreement, or, solely with respect to Project Documentation that comprises the Discloser’s Confidential Information, upon the expiration of any retention period required by Applicable Law, the Recipient will (and will cause its Affiliates and its and their respective Representatives to) cease its use and, upon written request, within [***] either return or destroy (and certify as to such destruction) all Confidential Information of the Discloser, including any copies thereof, except for a single copy which may be retained for the sole purpose of ensuring compliance with its obligations under this Agreement.
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6.7 Return of Materials. Upon the earlier of expiration or termination of this Agreement or completion of an SOW, Biogen shall upon Vir’s written request, return to Vir or destroy all Materials relating to such SOW, at Vir’s cost. If Vir has not provided authority regarding the disposition of Materials within [***] after such termination, expiration or completion date, Biogen shall destroy the Materials.
6.8 Publication. Biogen shall not publish or otherwise disclose to any Third Party the results of any use of the Materials without the prior express written consent of Vir, except that Biogen may use and disclose data associated with the Services (including gene expression levels achieved) if such data is presented without any information directly or indirectly identifying Vir or its Intellectual Property. Vir shall not publish or otherwise disclose to any third person the results of any use of the Materials in combination with any Biogen Confidential Information without the prior express written consent of Biogen.
6.9 Survival. The obligations of this Article will terminate [***] from the expiration or termination of this Agreement, except with respect to trade secrets, for which the obligations of this Article will continue for so long as such information remains a trade secret under Applicable Law.
6.10 Prior Confidentiality Agreement. This Agreement supersedes the Mutual Confidentiality Agreements between Vir and Biogen, dated on or about [***], and any confidential information exchanged under such Confidentiality Agreement will be deemed Confidential Information hereunder, and will be subject to the terms of this Agreement.
ARTICLE 7
INTELLECTUAL PROPERTY
7.1 Definitions. For purposes hereof, “Intellectual Property” means all intellectual property (whether or not patented), including patents, patent applications, know-how, trade secrets, copyrights, trademarks, designs, concepts, technical information, manuals, standard operating procedures, instructions, specifications, inventions, processes, data, improvements and developments. “Vir IP” means all Intellectual Property and embodiments thereof owned by or licensed to Vir as of the date hereof or developed by Vir other than in connection with this Agreement; “Biogen IP” means all Intellectual Property and embodiments thereof owned by or licensed to Biogen as of the date hereof or developed by Biogen other than in connection with this Agreement, including the Biogen Proprietary Know-How, that are [***] for the Manufacture of the Drug Substance and/or Drug Product; “Invention” means any Intellectual Property developed by either Party or jointly by the Parties in connection with this Agreement (including all SOWs and Change Orders under this Agreement); “Vir Invention” means any Invention other than an Improvement or a Biogen Process Invention that relates to the Vir IP or to Vir’s Materials; and “Biogen Process Invention” means [***].
7.2 Ownership of Intellectual Property. All Vir IP and Vir Inventions shall be owned solely by Vir and no right therein is granted to Biogen under this Agreement, except as set forth in Section 7.5. All Improvements, Biogen IP and Biogen Process Inventions shall be owned solely by Biogen and no right therein is granted to Vir under this Agreement except as set forth in Section 7.5.
7.3 Assignment of Rights. If either Party develops an Invention that is the property of the other Party pursuant to Section 7.2, the inventing Party shall notify the other Party. Each of Vir and Biogen shall, and does hereby, assign, and shall cause its Affiliates, employees, consultants and agents to so assign with full title guarantee, to the other Party, without additional compensation, such right, title and interest in and to any Intellectual Property (including Inventions) as is necessary to fully effect the ownership provisions set out in Section 7.2, and any accrued rights of action in respect thereof. Each of Vir and Biogen shall, if so requested by the other Party, execute all such documents and do all such other acts and things as may be reasonably required to comply with this Section 7.3 to vest in the appropriate Party all rights in the relevant Intellectual Property and shall procure execution by any named inventor of all such documents as may reasonably be required by the other Party in connection with any related patent application.
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7.4 Patentable Inventions. In case any Inventions are patentable:
7.4.1 the Party owning such Invention pursuant to Section 7.2 shall have the right, in its sole discretion, to determine the patent strategy for such Invention, which may include not obtaining patent protection in a particular country or any country;
7.4.2 the Party owning such Invention shall notify the other Party in writing at least [***] prior to filing any patent application covering such Invention with respect to which a Representative of the non-owning Party is an inventor;
7.4.3 without prejudice to the generality of Section 7.3, the Party not owning an Invention shall cooperate with the other Party and/or its attorneys upon reasonable request, at the expense of the other Party, in (i) properly filing and prosecuting patent applications, (ii) vesting title herein provided and (iii) providing non-financial assistance in enforcing any patents resulting from such patent applications; and
7.4.4 the cost of patenting Inventions will be borne by the owner of the Invention.
7.5 Licenses.
7.5.1 License from Vir to Biogen. Vir hereby grants Biogen a non-exclusive, royalty-free, non-transferable worldwide license to all Vir IP and Vir Inventions that are necessary to perform Biogen’s obligations under this Agreement during the Term, and to perform any obligations of Biogen that survive the expiration or termination of this Agreement. The foregoing license shall be sublicensable only to Biogen’s Affiliates and subcontractors for purposes of performing Biogen’s obligations under this Agreement.
7.5.2 License from Biogen to Vir. Biogen hereby grants to Vir a non-exclusive, perpetual, irrevocable, royalty-free, worldwide license under the Biogen IP and Biogen Process Inventions to use the Deliverables and any items transferred pursuant to Section 2.5 [***]. Vir agrees that it shall not itself, and shall not permit its Affiliates or any Third Party to, reverse engineer or analyze any Biogen Proprietary Know-How or embodiments thereof with the objective of determining its composition of matter or other characteristics. For clarity, this license shall survive termination or expiration of this Agreement.
7.5.3 License to Improvements. Biogen hereby grants to Vir a non-exclusive, worldwide license under the Biogen IP and Biogen Process Inventions to use the Improvements [***] subject to Vir’s compliance with [***].
7.5.4 [***].
7.5.5 Sublicensing. The licenses set forth in Section 7.5.2 and 7.5.3 shall be sublicensable to Vir’s Affiliates and to Vir’s or its Affiliates’ licensees of rights to Manufacture Drug Substance or Drug Products ([***]), and its and their respective contract manufacturers, provided that Vir notifies Biogen in writing in advance of granting such sublicense and that the sublicensee, including each such contract manufacturer, enters into a confidentiality and limited use agreement (“CDA and Limited Use Agreement”) with Biogen in a form reasonably acceptable to Biogen to protect the Biogen IP, Biogen Process Inventions, and any Biogen Confidential Information and other Biogen Intellectual Property rights in the Deliverables or other technology transfer items that are provided to such sublicensee in connection with the sublicense. Biogen’s form of CDA and Limited Use Agreement as of the Effective Date is attached
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hereto as Attachment B. Vir acknowledges and agrees that it shall not conduct a technology transfer to, or Manufacture at, any Third Party facility using items that embody or incorporate any Biogen IP or Biogen Process Inventions, or otherwise give any Third Party access to any Biogen IP or Biogen Process Inventions prior to the execution by such Third Party of a CDA and Limited Use Agreement in accordance with this Section 7.5.5. [***].
ARTICLE 8
REPRESENTATIONS AND WARRANTIES
8.1 Biogen. Biogen represents, warrants and undertakes to Vir that, unless otherwise agreed to by the Parties in the SOW:
8.1.1 Biogen has the full power and right to enter into this Agreement and there are no outstanding agreements, assignments, licenses, encumbrances or rights of any kind held by any Third Party, private or public, that are inconsistent with the provisions of this Agreement;
8.1.2 Biogen shall perform all Services in accordance with all Applicable Laws;
8.1.3 Biogen will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b);
8.1.4 at the time of delivery by Biogen as provided in Section 2.10, Drug Substance or Drug Product [***];
8.1.5 with respect to each SOW, [***];
8.1.6 with respect to each SOW, [***]; and
8.1.7 no transactions or dealings under this Agreement shall be conducted with or on behalf of an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of America.
8.2 Vir. Vir represents, warrants and undertakes to Biogen that:
8.2.1 Vir has the full power and right to enter into this Agreement and except to the extent set forth in Section 4.6 under Vir’s agreement with [***], there are no outstanding agreements, assignments, licenses, encumbrances or rights of any kind held by any Third Party, private or public, that are inconsistent with the provisions of this Agreement;
8.2.2 all Vir-supplied Materials shall have been produced, to Vir’s knowledge, in accordance with Applicable Laws, shall comply with all applicable specifications, and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws;
8.2.3 all Deliverables provided to Vir by Biogen shall be held, used and disposed of by or on behalf of Vir in accordance with all Applicable Laws (including, in connection with any such items that are not labeled, 21 CFR § 201.150); specifically, Vir shall not permit the human consumption of any such items, except to the extent such consumption occurs in the course of clinical trials that expressly permit such use and that have been approved by appropriate governmental authorities; and Vir will otherwise comply with all Applicable Laws applicable to Vir’s performance under this Agreement;
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8.2.4 as of the Effective Date, Vir has all necessary authority to use and to permit Biogen to use pursuant to this Agreement all Intellectual Property related to the Drug Substance, or Drug Product or Vir-supplied Materials (including artwork), and the performance of Services in connection with the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; there are no patents owned by others related to the Vir IP utilized with the Drug Substance, or Drug Product that would be infringed by Vir’s performance of its obligations under this Agreement; and, to its knowledge, there are no trade secrets or other proprietary rights of others related to the Vir IP utilized with the Drug Substance, or Drug Product that would be infringed or misused by Vir’s performance of this Agreement;
8.2.5 as of the Effective Date, Vir [***];
8.2.6 as of the Effective Date, Vir [***].
8.2.7 no transactions or dealings under this Agreement shall be conducted with or on behalf of an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of America.
8.3 Limitations. THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 8 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER PARTY AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE 9
INDEMNIFICATION
9.1 Indemnification by Biogen. Biogen shall indemnify and hold harmless Vir, its Affiliates, and their respective directors, officers and employees (“Vir Indemnitees”) from and against any and all suits, claims, losses, demands, liabilities, damages, costs and expenses (including reasonable attorneys’ fees and reasonable investigative and production costs) in connection with any suit, demand or action by any Third Party (“Losses”) arising out of or resulting from (i) any breach of its representations, warranties or obligations set forth in this Agreement, including in connection with any Manufacture of Product or (ii) any negligence or willful misconduct by Biogen; in each case except to the extent that any of the foregoing arises out of or results from any Vir Indemnitee’s negligence, willful misconduct or breach of this Agreement or the Quality Agreement, or Vir is obliged to indemnify a Biogen Indemnitee pursuant to Section 9.2.
9.2 Indemnification by Vir. Vir shall indemnify and hold harmless Biogen, its Affiliates, and their respective directors, officers and employees (“Biogen Indemnitees”) from and against any and all Losses arising out of or resulting from (i) any breach of its representations, warranties or obligations set forth in this Agreement, (ii) any manufacture, packaging, sale, promotion, distribution, use of or exposure to Drug Substance, Drug Product or Vir-supplied Materials, including Losses on the basis of product liability or strict liability, (iii) the conduct of any clinical trials utilizing any material or Drug Substance, or Drug Product which is the subject of this Agreement or any SOW, including any recalls relating to such clinical trials, (iv) any actual or alleged infringement or violation of any Third Party patent, trade secret, copyright, trademark or other proprietary rights by Biogen’s use in accordance of this Agreement of Intellectual Property or other information or materials provided by Vir, including Vir-supplied Materials, or (v) any negligence or willful misconduct by Vir; in each case except to the extent that any of the foregoing arises out of or results from any Biogen Indemnitee’s negligence, willful misconduct or breach of this Agreement or the Quality Agreement, or Biogen is obliged to indemnify a Vir Indemnitee pursuant to Section 9.1.
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9.3 Indemnification Procedures. All indemnification obligations in this Agreement are conditioned upon the Party seeking indemnification (i) promptly notifying the indemnifying Party of any claim or liability of which the Party seeking indemnification becomes aware (including a copy of any related complaint, summons, notice or other instrument); provided, that failure to provide such notice within a reasonable period of time shall not relieve the indemnifying Party of any of its obligations hereunder except to the extent the indemnifying Party is prejudiced by such failure, (ii) allowing the indemnifying Party, if the indemnifying Party so requests, to conduct and control the defense of any such claim or liability and any related settlement negotiations (at the indemnifying Party’s expense), (iii) cooperating with the indemnifying Party in the defense of any such claim or liability and any related settlement negotiations (at the indemnifying Party’s expense) and (iv) not compromising or settling any claim or liability without prior written consent of the indemnifying Party.
ARTICLE 10
LIMITATIONS OF LIABILITY
10.1 TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, BIOGEN SHALL HAVE NO LIABILITY UNDER THIS AGREEMENT FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED VIR-SUPPLIED MATERIALS, WHETHER OR NOT SUCH VIR-SUPPLIED MATERIALS ARE USED IN THE SERVICES OR INCORPORATED INTO DRUG SUBSTANCE OR DRUG PRODUCT.
10.2 TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, BIOGEN’S TOTAL LIABILITY UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED [***].
10.3 TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR LOSS OF REVENUES, PROFITS OR DATA ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, WHETHER IN CONTRACT OR IN TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
ARTICLE 11
INSURANCE
Each Party shall, at its own cost and expense, obtain and maintain in full force and effect during the Term the following: (i) Commercial General Liability Insurance with a per-occurrence limit of not less than [***]; (ii) Products and Completed Operations Liability Insurance with a per-occurrence limit of not less than [***]; (iii) Workers’ Compensation Insurance with statutory limits and Employers Liability Insurance with limits of not less than [***] per accident; and (iv) [***]. Each Party may self-insure all or any portion of the required insurance as long as, together with its Affiliates, its U.S. GAAP net worth is greater than [***] or its annual EBITDA (earnings before interest, taxes, depreciation and amortization) is greater than [***]. Each required insurance policy, other than self-insurance, shall be obtained from an insurance carrier with [***]. If any of the required policies of insurance are written on a claims made basis, such policies shall be maintained throughout the Term and for a period of at least [***] thereafter. Upon the other Party’s written request from time to time, each Party shall promptly furnish to the other Party a certificate of insurance or other evidence of the required insurance.
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ARTICLE 12
TERM AND TERMINATION
12.1 Term. This Agreement shall commence on the Effective Date and shall continue for three (3) years or, if later, until the expiration or termination of all the SOWs, unless earlier terminated in accordance with Section 12.2 or Section 12.3 (as may be extended in accordance with this Section, the “Term”). The Term shall automatically be extended for successive one (1) year periods unless and until one Party gives the other Party at least [***] prior written notice of its desire to terminate as of the end of the then-current Term; provided that as long as any SOW is in effect, unless the terminating Party gives notice of its intent to terminate any SOW, the terms of this Agreement shall remain in effect in respect of such SOW.
12.2 Termination by Vir Without Cause. Vir may terminate this Agreement or any SOW without cause at any time during the Term on one hundred eighty (180) days’ prior written notice to Biogen. Upon receipt by Biogen of any such termination notice, Biogen will promptly cease or wind down, as appropriate, work under the terminated SOW(s) unless otherwise requested by Vir in such notice.
12.3 Mutual Termination Rights. Either Party may terminate this Agreement immediately without further action if (i) the other Party files a petition in bankruptcy, or enters into an agreement with its creditors, or applies for or consents to the appointment of a receiver, administrative receiver, trustee or administrator, or makes an assignment for the benefit of creditors, or suffers or permits the entry of any order adjudicating it to be bankrupt or insolvent and such order is not discharged within [***], or takes any equivalent or similar action in consequence of debt in any jurisdiction; or (ii) the other Party materially breaches any of the provisions of this Agreement, and such breach is not cured within [***] after the giving of written notice requiring the breach to be remedied; provided, that in the case of a failure of Vir to make payments in accordance with the terms of this Agreement, Biogen may terminate this Agreement if such payment breach is not cured within [***] of receipt of notice of non-payment from Biogen.
12.4 Effect of Termination. Expiration or termination of this Agreement shall be without prejudice to any rights or obligations that accrued to the benefit of either Party prior to such expiration or termination. In the event that this Agreement or any SOW is terminated, Vir shall, in connection with the terminated SOW(s), pay Biogen for (i) the remainder of the Binding Forecast (except in the case of a termination by Vir under Section 12.3), (ii) for Manufacturing Services performed, and (iii) for all Development and any other non-Manufacturing Services performed up to the date of termination plus any applicable cancellation fees for incomplete Development and any other non-Manufacturing Services pursuant to Section 3.1.7(b), and shall reimburse Biogen for all reasonable costs and expenses incurred, and all non-cancelable commitments made, in the performance of Services in accordance with any ongoing SOW, including (i) reasonable out-of-pocket costs incurred to wind down and cease any ongoing Services and (ii) all costs for Vir-specific purchases made by Biogen pursuant to Section 3.1.5. Following the expiration or termination of this Agreement, Biogen shall transfer to Vir free of charge title in any readily portable Procured Equipment and make such readily portable Procured Equipment available for removal by Vir at Vir’s expense. If Vir fails to make arrangements to remove such readily portable Procured Equipment within [***] after the date of expiration or termination of this Agreement, Biogen shall be entitled to arrange for such removal for off-site storage or disposal, at Biogen’s discretion, and invoice Vir for reasonable removal costs and any subsequent storage or disposal costs. To the extent Vir has not made payment for such Procured Equipment, the amounts due will be invoiced by Biogen on return and Vir will pay such invoice within [***] of receipt. For clarity, title to any fixed, non-portable Procured Equipment located in the Facility shall remain with Biogen upon the expiration or termination of this Agreement at no cost to Biogen. Biogen shall have the right to dispose of such Procured Equipment in its discretion.
12.5 Survival. All accrued rights of a Party, including Biogen’s accrued right to payments shall survive the termination or expiration of this Agreement. The rights and obligations of the Parties under the following Sections and Articles shall survive the expiration or termination of this Agreement, in each case in accordance with their respective terms (as applicable), 2.5 (Technology Transfer), 2.10.5 (Samples and Excess Materials), 3.1.7 (Cancellations and Postponements), 3.3 (Payment Terms), 3.4 (Method of Payment), 3.5 (Taxes), 5.1 (Recordkeeping), 6 (Confidentiality and Non-Use), 7 (Intellectual Property), 8.3 (Limitations), 9 (Indemnification), 10 (Limitations of Liability), 11 (Insurance), 12.4 (Effect of Termination), 12.5 (Survival), 13 (Notice), 14 (Miscellaneous), and the definitions of all defined terms used in any of the foregoing.
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ARTICLE 13
NOTICE
All notices to be given as required in the Agreement will be in writing and may be delivered personally or mailed either by a reputable express carrier with required receipt signature or certified mail, postage prepaid to the Parties at the addresses set forth below or at such other address as either Party may provide by written notice to the other Party in accordance with the provisions of this Article 13. Such notice will be effective: (i) on the date sent, if delivered personally; (ii) the date after delivery if sent by express carrier; or (iii) on the date received if sent by certified mail. Notwithstanding the foregoing notices of breach, termination or extension sent by email are not valid unless also sent by one of the other methods stated herein.
If to Biogen:
Biogen MA Inc.
Attn: [***]
225 Binney Street
Cambridge, MA 02142
With a copy (which shall not constitute notice) to:
Biogen MA Inc.
Attn: [***]
225 Binney Street
Cambridge, MA 02142
If to Vir:
Vir Biotechnology, Inc.
Attn: [***]
499 Illinois Street, Suite 500
San Francisco, CA 94158
Email: [***]
ARTICLE 14
MISCELLANEOUS
14.1 Entire Agreement; Amendments. This Agreement, including the SOWs and any other attachments, any Quality Agreements executed hereunder, and any Change Orders or other amendments to any of the foregoing, and the Letter of Intent (solely with respect to the Prior Development Activities and Confidential Information disclosed in connection therewith) constitutes the entire understanding between the Parties, and supersedes any contracts, agreements or understandings (oral or written) of the Parties, with respect to the subject matter hereof. For the avoidance of doubt, this Agreement does not supersede any existing generally applicable confidentiality agreement between the Parties as it relates to time periods prior to the date hereof or to business dealings not covered by this Agreement. No term of this Agreement may be amended in whole or in part by any Party or any Third Party, including by operation of law or order, except upon written agreement of both Parties, unless otherwise expressly provided in this Agreement.
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14.2 Captions; Interpretive Matters. The captions in this Agreement are for convenience only and are not to be interpreted or construed as a substantive part of this Agreement. Unless otherwise expressly provided herein or the context of this Agreement otherwise requires, (i) words of any gender include each other gender, (ii) words such as “herein,” “hereof” and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear, (iii) words using the singular shall include the plural, and vice versa, (iv) the words “include(s)” and “including” shall be deemed to be followed by the phrase “but not limited to,” “without limitation” or words of similar import, (v) the word “or” shall be deemed to include the word “and” (e.g. “and/or”) and (vi) references to “Article,” “Section,” “subsection,” “clause” or other subdivision, or to an Attachment or other appendix, without reference to a document are to the specified provision or Attachment or other appendix of this Agreement. References to any laws, rules or regulations are to such laws, rules and regulations as they may be amended from time to time. This Agreement shall be construed as if it were drafted jointly by the Parties.
14.3 Further Assurances. The Parties agree to execute, acknowledge and deliver such further instruments and to take all such other incidental acts as may be reasonably necessary or appropriate to carry out the purpose and intent of this Agreement.
14.4 No Waiver. Failure by either Party to insist upon strict compliance with any term of this Agreement in any one or more instances will not be deemed to be a waiver of its rights to insist upon such strict compliance with respect to any subsequent failure.
14.5 Severability. If any term of this Agreement is declared invalid or unenforceable by a court or other body of competent jurisdiction, the remaining terms of this Agreement will continue in full force and effect.
14.6 Independent Contractors. The relationship of the Parties is that of independent contractors, and neither Party will incur any debts or make any commitments for the other Party except to the extent expressly provided in this Agreement. Nothing in this Agreement is intended to create or will be construed as creating between the Parties the relationship of joint ventures, co-partners, employer/employee or principal and agent. Neither Party shall have any responsibility for the compensation of the other Party’s employees or contractors or for any employee benefits of any such employee or contractor.
14.7 Successors and Assigns. This Agreement will be binding upon and inure to the benefit of the Parties, their successors and permitted assigns. Neither party shall have any right to grant, assign or transfer to any Third Party by assignment, sale, grant, transfer, operation of law or otherwise, any rights or interest greater than the rights or interests granted to such party under this Agreement. Neither Party may assign this Agreement, in whole or in part, including by operation of law or order, without the prior written consent of the other Party, except that [***]. Any permitted assignee shall assume all obligations of its assignor under this Agreement and no assignment shall relieve any Party of responsibility for the performance of any obligation under this Agreement to the extent such obligation accrued prior to the data of assignment. Any attempted assignment in violation of this Section 14.7 shall be null and void.
14.8 Performance Through Affiliates; Sublicensee Guaranty; No Third Party Beneficiaries. Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates; provided, for clarity, that the license rights set forth in Section 7.5.1 can only be executed by Vir’s Affiliates under a sublicense granted by Vir to such Affiliate pursuant to Section 7.5.5. Any Affiliate of Vir or Affiliate of Biogen may execute an SOW under this Agreement, in which case, any reference to “Vir” in this Agreement shall mean such Affiliate of Vir and any reference to “Biogen” in this Agreement shall mean such Affiliate of Biogen for purposes of such SOW, and such Affiliates shall be bound by the terms of this Agreement for purposes of such SOW. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s
27
obligations under this Agreement or any SOW (whether executed by a Party or its Affiliates) shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate. With respect to each sublicensee of Vir that executes a CDA and Limited Use Agreement pursuant to the terms hereof, as between Vir and Biogen, Vir shall use commercially reasonable efforts to cause such sublicensee to comply with the provisions of CDA and Limited Use Agreement in connection with such performance and Vir shall promptly report any breaches of such CDA and Limited Use Agreement to Biogen. This Agreement shall not confer any rights or remedies upon any person or entity other than the Parties named herein and their respective Affiliates, successors and permitted assigns.
14.9 Governing Law. This Agreement, and all matters arising directly or indirectly hereunder, shall be governed by and construed under the laws of the state of Delaware, USA, excluding its conflicts of law provisions. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.
14.10 Jurisdiction, Equitable Relief.
14.10.1 Subject to Section 14.10.2, Biogen and Vir irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the state of Delaware and the United States District Court for the state of Delaware for any action, suit or proceeding (other than appeals therefrom), and agree not to commence any action, suit or proceeding (other than appeals therefrom) except in such courts, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum. [***].
14.10.2 Biogen and Vir agree that irreparable damage may occur in the event of a breach of Article 6. It is accordingly agreed that each Party shall be entitled to seek an injunction or injunctions to prevent breaches of Article 6 and to enforce specifically the terms and provisions of such articles or sections of this Agreement in any court of the U.S. or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity. Each Party hereby waives any requirement that any other Party post a bond or other security as a condition for obtaining any such relief.
14.11 Right to Dispose and Set Off. If Biogen requests in writing from Vir direction with respect to disposal of any inventories of Drug Substance, Drug Product, Vir-supplied Materials, other Materials, equipment, samples or other items belonging to Vir and is unable to obtain a response from Vir within [***], Biogen shall be entitled in its sole discretion to (i) dispose of all such items and (ii) set-off any and all amounts due to Biogen or any of its Affiliates from Vir against any credits Vir may hold with Biogen or any of its Affiliates.
14.12 Force Majeure. Except as to payments required under this Agreement, neither Party shall be liable in damages for, nor shall this Agreement be terminable or cancelable by reason of, any delay or default in such Party’s performance hereunder if such default or delay is caused by events beyond such Party’s reasonable control, including acts of God, law or regulation or other action or failure to act of any government or agency thereof, war or insurrection, terrorism, civil commotion, destruction of production facilities or materials by earthquake, fire, flood or weather, labor disturbances, epidemic, pandemic or failure of suppliers, vendors, public utilities or common carriers; provided that the Party seeking relief under this Section shall promptly notify the other Party of such cause(s) beyond such Party’s reasonable control. A Party that invokes this Section 14.12 shall use commercially reasonable efforts to perform its ongoing obligations to the other Party as soon as practicable. If the cause(s) shall continue unabated for [***], then both Parties shall meet to discuss and negotiate in good faith what modifications to this Agreement should result from such cause(s).
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14.13 Compliance with Anti-Corruption Laws. Each Party is aware of and understands that there are anti-bribery and anti-corruption statutes (including but not limited to the U.S. Foreign Corrupt Practices Act) to which each Party is subject that prohibit, inter alia, the payment or offering, giving, promising to give, or authorizing the giving of, directly or indirectly, anything of value to a government official, or any relative, business associate or employee thereof, for the purpose of obtaining or retaining any business under this Agreement or inducing or influencing any governmental act or decision affecting either Party, and each Party shall ensure that, in connection with its obligations under this Agreement, it shall conduct their activities in a manner that is consistent with such statutes.
14.14 Counterparts. This Agreement may be executed in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. Any photocopy, facsimile or electronic reproduction of the executed Agreement shall constitute an original.
[Remainder of page intentionally blank; signature page follows]
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IN WITNESS WHEREOF, the Parties have caused their respective duly authorized representatives to execute this Agreement effective as of the Effective Date.
| VIR BIOTECHNOLOGY, INC. | ||
| By: | /s/ George Scangos | |
| Name: | George Scangos | |
| Title: | President and CEO | |
| BIOGEN INC. | ||
| By: | /s/ Alphonse Galdes | |
| Name: | Alphonse Galdes | |
| Title: | EVP, PO&T | |
[Signature Page to Development and Clinical Supply Agreement]
ATTACHMENT A
STATEMENTS OF WORK
To be executed from time to time by the Parties and attached hereto as successively numbered Attachments (e.g., Attachment A-1, A-2, A-3, etc.
ATTACHMENT A-1
Process Development SOW
[Attached]
STATEMENT OF WORK
| Title of Work Package | ||
| Statement of Work #1 for Development and Process & Analytical Establishment of VIR SARS COV-2 mAb | ||
| Agreement | ||
| This “Statement of Work #1” (“SOW”) effective from the date of last signature (“Effective Date”) is made between VIR Biotechnology having offices at 499 Illinois Suite 500, San Francisco, CA 94158 (“VIR Biotechnology”). and Biogen, Inc., a Delaware corporation, with a place of business at 225 Binney Street, Cambridge, Massachusetts 02142, USA (“Biogen”). | ||
| Agreement References | ||
| Clinical Development and Manufacturing Agreement (“CDMA”)
|
This Statement of Work is subject to the terms of Clinical Development and Manufacturing Agreement between Biogen Inc. and VIR Biotechnology with an Effective Date of May 22, 2020, as amended | |
| Quality Assurance Agreement
|
[***] | |
| Purchase Order(s) | [***] | |
COMPANY INFORMATION:
| Site Addresses and Activities | ||
| VIR Biotechnology SARS COV-2 mAb Drug Substance Development and Process/Analytical Establishment | Biogen Inc., 5000 Davis Drive, Durham, North Carolina, USA 27709; and 225 Binney St, Cambridge, MA 02142 | |
VIR Biotechnology CONTACTS:
| Contact | Role | |
| [***] | [***] | |
| [***] | [***] |
Page 1 of 18
Attachment A-1
|
NOTE: Any changes in the scope of the project or financial terms of this project must be reviewed and approved by both the Primary VIR Biotechnology Representative and VIR Biotechnology Technical Project Leader and the applicable Biogen representative. Except as expressly provided for in this Statement of Work #1, no additional payments to this Statement of Work #1 will be made without this prior approval; otherwise VIR Biotechnology will not be liable for any costs incurred by Biogen. |
Effective from date of final signature
Agreement
| Vir Biotechnology |
Biogen, Inc., | |||
| /s/ George Scangos |
/s/ Alphonse Galdes | |||
| Name: George Scangos | Name: Alphonse Galdes | |||
| Position: CEO | Title: EVP PO&T | |||
| Date: 22-May-2020 | Date: 26-May-2020 | |||
| History of Change | Reason for Issue | |
| Version 0 | First Issue | |
Page 2 of 18
Attachment A-1
Statement of Work #1 for Drug Substance
Development and Process & Analytical
Establishment of VIR Biotechnology SARS-CoV-2
mAB S309 Monoclonal Antibody
For
VIR Biotechnology
Page 3 of 18
TABLE OF CONTENTS
| Page | ||||||
| 1. |
Statement of Work |
5 | ||||
| 1.1 |
Background | 5 | ||||
| 1.2 |
Key Assumptions | 5 | ||||
| 1.3 |
Project Timing: | 5 | ||||
| 1.4 |
Unanticipated results: | 5 | ||||
| 2. |
Services |
6 | ||||
| 2.1 |
Project Management | 6 | ||||
| 2.2 |
[***] | 6 | ||||
| 2.3 |
[***] | 6 | ||||
| 2.4 |
[***] | 6 | ||||
| 2.5 |
[***] | 6 | ||||
| 2.6 |
[***] | 6 | ||||
| 2.7 |
[***] | 6 | ||||
| 2.8 |
[***] | 6 | ||||
| 2.9 |
[***] | 6 | ||||
| 3. |
Miscellaneous |
6 | ||||
| 3.1 |
Responsible persons | 6 | ||||
| 4. |
Annexes |
8 | ||||
| Annex 1: Example Drug Substance Development Targets |
8 | |||||
| Annex 2: Pricing Schedule—Estimate |
9 | |||||
Page 4 of 18
Attachment A-1
1. Statement of Work
1.1 Background
This SOW (including the appendices, which are incorporated into and form part of this SOW) are subject to the provisions of the Clinical Development and Manufacturing Agreement made between VIR Biotechnology and Biogen having an Effective Date of May 22, 2020 (the “Agreement”).
The Product referred to in this SOW is VIR Biotechnology VIR SARS-COV-2 MAB S309.
1.2 Key Assumptions
[***].
1.3 Project Timing:
[***].
1.4 Unanticipated results:
[***].
Page 5 of 18
2. Services
[***].
2.1 Project Management
Biogen will provide a Technical Project Manager who will serve as the primary point of contact for VIR Biotechnology. This Project Managers will be responsible for the following, which will continue over the length of the program:
[***].
2.2 [***]
2.3 [***]
2.4 [***]
2.5 [***]
2.6 [***]
2.7 [***]
2.8 [***]
2.9 [***]
3. Miscellaneous
3.1 Responsible persons
[***]
Page 6 of 18
Attachment A-1
| 4. | Annexes |
Annex 1: Example Drug Substance Development Targets
[***].
Page 7 of 18
Attachment A-1
Annex 2: Pricing Schedule—Estimate
[***].
Page 8 of 18
Attachment A-1
[***].
Page 9 of 18
ATTACHMENT A-2
Initial DS SOW
[Attached]
STATEMENT OF WORK
| Title of Work Package | ||
| Statement of Work #2 for Clinical Manufacturing of VIR SARS COV-2 mAb | ||
| Agreement | ||
| This “Statement of Work #2” (“SOW #2”) effective from the date of last signature (“Effective Date”) is made between VIR Biotechnology having offices at 499 Illinois Suite 500, San Francisco, CA 94158 (“VIR Biotechnology”). and Biogen, Inc., a Delaware corporation, with a place of business at 225 Binney Street, Cambridge, Massachusetts 02142, USA (“Biogen”). | ||
| Agreement References | ||
| Clinical Development and Manufacturing Agreement (“CDMA”) | This Statement of Work #2 is subject to the terms of Clinical Development and Manufacturing Agreement between Biogen Inc. and VIR Biotechnology with an Effective Date of May 22, 2020, as amended | |
| Quality Assurance Agreement | To be developed | |
| Purchase Order(s) | [***] | |
COMPANY INFORMATION:
| Site Addresses and Activities | ||
| VIR Biotechnology SARS COV-2 mAb Clinical Manufacturing | Biogen Inc., 5000 Davis Drive, Durham, North Carolina, USA 27709; and 225 Binney St, Cambridge, MA 02142 | |
VIR Biotechnology CONTACTS:
| Contact |
Role | |
| [***] | [***] | |
| [***] | [***] | |
| NOTE: Any changes in the scope of the project or financial terms of this project must be reviewed and approved by both the Primary VIR Biotechnology Representative and VIR Biotechnology Technical Project Leader and the applicable Biogen representative. Except as expressly provided for in this Statement of Work #1, no additional payments to this Statement of Work #2 will be made without this prior approval; otherwise VIR Biotechnology will not be liable for any costs incurred by Biogen.
| ||
Page 1 of 6
Attachment A-2
| 1. | Statement of Work |
| 1.1. | Background |
This SOW #2 is subject to the provisions of the Clinical Development and Manufacturing Agreement made between VIR Biotechnology and Biogen having an Effective Date of May 22, 2020 (the “CDMA”). This Statement of Work #2 is deemed an SOW and is appended to the CDMA as Attachment A-2 pursuant to and governed by the terms of the CDMA and is entered into by and between Biogen and VIR Biotechnology and is attached to the CDMA, incorporated therein and made fully a part thereof and sets forth details of the Services to be provided pursuant hereto. Capitalized terms not otherwise defined by this SOW are deemed to have the meanings as defined in the CDMA. This SOW may not be altered, changed or amended except by a writing signed by each of the parties hereto as further set forth in the CDMA.
This SOW #2 will be accompanied by a Manufacturing Request for Manufacturing Services by Vir pursuant to and governed by the terms of the CDMA and is entered into by and between Biogen and VIR Biotechnology and is attached to the CDMA, incorporated therein and made fully a part thereof and sets forth details of the Services to be provided pursuant hereto.
The Product referred to in this SOW #2 is VIR Biotechnology VIR SARS-COV-2 MAB S309.
| 1.2. | Services |
[***]
| 1.3. | Summary Fees and Costs |
[***]
Page 2 of 6
| 1.4. | Estimated Resin Cost |
[***]
| 1.5. | Estimated Consumables & Raw Materials Cost |
[***]
Notwithstanding anything herein that may be interpreted to the contrary, the Parties agree that upon execution of this SOW #2 and Manufacturing Request that this SOW #2 shall be subject to Section 12.4 of the CDMA.
Page 3 of 6
Attachment A-2
| Biogen MA, Inc., | Vir Biotechnology | |||||||
| By: | /s/ Alphonse Galdes |
By: | /s/ George Scangos | |||||
| Name: Alphonse Galdes, duly authorized | Name: George Scangos | |||||||
| Title: EVP Pharmaceutical Operations & Technology | Position: CEO | |||||||
| Date: 26-May-2020 | Date: 22-May-2020 | |||||||
Page 4 of 6
Attachment A-2
Schedule A
Process Implementation Schedule (DRAFT)
[***].
Page 5 of 6
ATTACHMENT A-3
Intial DP SOW
[Attached]
Attachment A-3
STATEMENT OF WORK
| Title of Work Package | ||
| Statement of Work #3 for Clinical Drug Product Manufacturing of VIR SARS COV-2 mAb | ||
| Agreement | ||
| This “Statement of Work #3” (“SOW #3”) effective from the date of last signature (“Effective Date”) is made between VIR Biotechnology having offices at 499 Illinois Suite 500, San Francisco, CA 94158 (“VIR Biotechnology”). and Biogen, Inc., a Delaware corporation, with a place of business at 225 Binney Street, Cambridge, Massachusetts 02142, USA (“Biogen”). | ||
| Agreement References | ||
| Clinical Development and Manufacturing Agreement (“CDMA”) | This Statement of Work #3 is subject to the terms of Clinical Development and Manufacturing Agreement between Biogen Inc. and VIR Biotechnology with an Effective Date of May 22, 2020, as amended | |
| Quality Assurance Agreement | To be developed | |
| Purchase Order(s) | [***] | |
COMPANY INFORMATION:
| Site Addresses and Activities | ||
| VIR Biotechnology SARS COV-2 mAb Clinical Manufacturing |
Biogen Inc., 5000 Davis Drive, Durham, North Carolina, USA 27709; and 225 Binney St, Cambridge, MA 02142 | |
VIR Biotechnology CONTACTS:
| Contact |
Role | |
| [***] | [***] | |
| [***] | [***] | |
NOTE: Any changes in the scope of the project or financial terms of this project must be reviewed and approved by both the Primary VIR Biotechnology Representative and VIR Biotechnology Technical Project Leader and the applicable Biogen representative. Except as expressly provided for in this Statement of Work #1, no additional payments to this Statement of Work #2 will be made without this prior approval; otherwise VIR Biotechnology will not be liable for any costs incurred by Biogen. | ||
49
1. Statement of Work
1.1. Background
This SOW #3 is subject to the provisions of the Clinical Development and Manufacturing Agreement made between VIR Biotechnology and Biogen having an Effective Date of May 22, 2020 (the “CDMA”). This Statement of Work #3 is deemed an SOW and is appended to the CDMA as Attachment A-3 pursuant to and governed by the terms of the CDMA and is entered into by and between Biogen and VIR Biotechnology and is attached to the CDMA, incorporated therein and made fully a part thereof and sets forth details of the Services to be provided pursuant hereto. Capitalized terms not otherwise defined by this SOW are deemed to have the meanings as defined in the CDMA. This SOW may not be altered, changed or amended except by a writing signed by each of the parties hereto as further set forth in the CDMA.
This SOW #3 will be accompanied by a Manufacturing Request for Manufacturing Services by Vir pursuant to and governed by the terms of the CDMA and is entered into by and between Biogen and VIR Biotechnology and is attached to the CDMA, incorporated therein and made fully a part thereof and sets forth details of the Services to be provided pursuant hereto.
The Product referred to in this SOW #3 is VIR Biotechnology VIR SARS-COV-2 MAB S309.
1.2. Services
[***]
1.3. Summary Fees and Costs
[***]
| Biogen MA, Inc., | Vir Biotechnology | |
| By: /s/ Alphonse Galdes |
By: /s/ George Scangos | |
| Name: Alphonse Galdes, duly authorized | Name: George Scangos | |
| Title: EVP Pharmaceutical Operations & Technology | Position: CEO | |
| Date: 26-May-2020 | Date: 22-May-2020 | |
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ATTACHMENT B
FORM OF CONFIDENTIAL DISCLOSURE AND LIMITED USE AGREEMENT
[***].
51
Exhibit A
Selected Biogen Proprietary Know-How
[***].
52
ATTACHMENT C
ACCESS FEES
Pursuant to Section 3.1.3, Vir shall pay Biogen Access Fees for all successful Manufacturing of Drug Substance using any Improvements, regardless of whether such Manufacturing is performed directly by Vir, its Affiliates or its or their licensees or collaborators or by Third Parties contracted by any of the foregoing. The entity performing such Manufacturing is referred to below as the “Manufacturer”. Access Fees are payable without regard to the amounts paid by the purchaser of the Product to the Manufacturer. Access Fees apply to both pre-commercial/clinical and commercial-scale Manufacturing and will only be payable by Vir to Biogen on Successful Batches of purified bulk Drug Substance.
The “Access Fee” is equal to [***]. [***].
53
ATTACHMENT D
INITIAL MANUFACTURING REQUEST
54
Exhibit 10.57
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
| CONFIDENTIAL | EXECUTION VERSION |
300, Songdo bio-daero
Yeonsu-gu, Incheon 21987
Republic of Korea
Vir Biotechnology, Inc.
499 Illinois Street
Suite 500
San Francisco, CA 94158
Binding Letter Agreement
This Binding Letter Agreement (“Letter Agreement”) confirms the recent discussions between Vir Biotechnology , Inc. (“Vir”) and Samsung BioLogics Co., Ltd. (“Samsung”) whereby Vir reserves some of Samsung’s capacity in its [***] facility referred to as Plant #3 (the “Capacity Reservation”) and retains Samsung to perform certain development and/or manufacturing services (the “Services”) regarding Vir’s SARS-Cov-2 mAb (the “Product”). Samsung and Vir are each a “Party” and collectively the “Parties”. This Letter Agreement is a binding contractual obligation of the Parties as of the date this Letter Agreement is signed by both Parties (the “Letter Agreement Execution Date”). Any capitalized terms used herein but not defined shall be as defined in Exhibit B to this Letter Agreement.
Section 1. Definitive Agreement. Additional terms and conditions related to the Services and the rights and obligations of each Party related thereto will be specified in a definitive agreement (the “Definitive Agreement”). As of the Letter Agreement Execution Date, the Parties shall exercise best efforts to execute the Definitive Agreement before July 31, 2020. The terms agreed upon in this Letter Agreement shall be incorporated into the Definitive Agreement.
Section 2. Services. As of the Letter Agreement Execution Date, Samsung will begin to perform the Services under the pricing set forth in Exhibit A, which may be modified as necessary and agreed through amendment of this Letter Agreement or Definitive Agreement. The Parties agree that regardless of whether the Definitive Agreement is executed, Vir shall be responsible to compensate Samsung for Samsung’s fees and out-of-pocket costs, including but not limited to raw material or equipment procurement, related to any portion of the Services begun after the Letter Agreement Execution Date. Both Parties further agree that the terms and conditions contained in Exhibit B shall apply to the Services. Exhibits A and B are hereby incorporated into this Letter Agreement and shall be incorporated into the Definitive Agreement.
Section 3. Capacity Reservation. As of the Letter Agreement Execution Date, Vir purchases a firm and binding Capacity Reservation at Samsung’s Plant #3 consisting of the following manufacturing slots: [***] in 2021, [***] in 2021, and [***] in 2022. In reliance on such purchase, Samsung shall reserve the Capacity Reservation for Vir which shall be final, non-cancellable, and non-adjustable, and shall not offer such Capacity Reservation to third parties. Vir is fully liable for the batch price cost of such slot(s), as described in Exhibit A, on a take-or-pay basis regardless of whether or not such manufacturing slots are utilized. Samsung shall have the right to invoice Vir the portion of the Capacity Reservation that is not or will not be utilized by Vir [***] (the “Capacity Reservation Shortfall”) as if such portion had been utilized by Vir, as compensation for such reserved but unused capacity. [***].
Section 4. Confidentiality. All confidential or proprietary information disclosed by one Party to the other (or by or to any of their respective affiliates, officers, directors, employees, representatives and agents) in connection with this Letter Agreement, Definitive Agreement, and/or Services, the fact that the Parties are contemplating shall be deemed to be Confidential Information as defined in, and shall be subject to the terms of, the Mutual Confidentiality Agreement dated as of [***] by and between Samsung and Vir (the “CDA”). In addition, a Recipient may disclose Discloser’s Confidential Information to its actual and potential investors, acquirors, licensees and collaboration partners, in each case, who have a need to know such Confidential Information and who are bound by written obligations of confidentiality and non-use at least as restrictive as those contained in the CDA. Recipient will be responsible for any breach or threatened breach of the CDA by any such actual and potential investors, acquirors, licensees and collaboration partners. The CDA is attached hereto as Exhibit C.
Section 5. Termination. This Letter Agreement shall terminate as follows: (1) upon completion and signing of the Definitive Agreement; or (2) upon mutual written agreement by the Parties. Vir’s obligations pursuant to Sections 2 and 3 of this Letter Agreement shall survive termination of this Letter Agreement. In the event this Letter Agreement is terminated without signing of the Definitive Agreement, the Capacity Reservation Shortfall shall immediately become due.
Section 6. Limitation of Liability. NEITHER PARTY SHALL BE LIABLE FOR ANY INDIRECT, PUNITIVE, EXEMPLARY, MULTIPLIED, SPECIAL, INCIDENTAL, LOST PROFITS OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH THIS Letter Agreement AND EACH PARTY IRREVOCABLY WAIVES ANY RIGHT TO SEEK SUCH DAMAGES. Vir and Samsung (each, an “Indemnifying Party”) shall indemnify and hold harmless the other Party (the “Indemnified Party”) and its officers, directors, employees or agents from and against any losses, costs, or other damages (“Damages”) arising or resulting from any third party claims to the extent such Damages are relating to, arising out of, in connection with, or resulting from claims, demands or actions based upon (i) gross negligence or willful misconduct of the Indemnifying Party or its officers, directors, employees or agents, or (ii) any claim alleging infringement of a third party’s intellectual property rights. [***].
Section 7. Assignment. No Party shall be entitled to assign, transfer or convey this Letter Agreement or any of its rights or obligations hereunder, in whole or in part, by operation of law or otherwise, without the prior written consent of the other Party, and any attempt to do so without such consent shall be void. Notwithstanding the foregoing, Vir may assign this Agreement to its collaboration partner with respect to the Product, and each party will have the right to assign this Agreement to any successor in interest to all or substantially all of such party’s business or assets to which this Agreement relates whether through asset or stock acquisition, merger, consolidation, or otherwise, in one or a series of transactions. Nothing shall relieve the assigning Party of any of its responsibilities or obligations hereunder and, as a condition of such assignment, the assignee shall agree in writing to be bound by all obligations of the assigning Party hereunder. This Agreement shall be binding upon the successors and permitted assigns of the Parties.
Section 8. General. To the extent not conflicting with or superseded by the terms of this Letter Agreement, the applicable terms of the CDA shall apply to this Letter Agreement, mutatis mutandis.
[Signature Page follows]
AGREED TO AND ACCEPTED BY THE PARTIES:
| VIR BIOTECHNOLOGY, INC. 499 Illinois Street, Suite 500 San Francisco, CA 94158 |
SAMSUNG BIOLOGICS, CO., LTD. 300, Songdo bio-daero, Yeonsu-gu, Incheon, Republic of Korea 21987 | |||||||
| AUTHORIZED SIGNATURE: | AUTHORIZED SIGNATURE: | |||||||
| By: | /s/ George Scangos | By: | /s/ Tae Han Kim | |||||
| PRINTED SIGNATORY’S NAME: | PRINTED SIGNATORY’S NAME: | |||||||
| George Scangos | Tae Han Kim |
|||||||
| PRINTED SIGNATORY’S TITLE: | PRINTED SIGNATORY’S TITLE: | |||||||
| CEO | CEO | |||||||
| DATE SIGNED: | DATE SIGNED: | |||||||
| April 8, 2020 | April 9, 2020 | |||||||
Attached:
Exhibit A: Pricing
Exhibit B: Terms and Conditions
Exhibit C: Mutual Confidentiality Agreement
EXHIBIT A –PRICING
| Service |
Price (USD) |
Comments | ||||
| Stage 1 |
Project Management |
[***] |
[***] | |||
| Stage 2 |
Technology Transfer of USP/DSP |
[***] |
[***] | |||
| Stage 3 |
Engineering Batch |
[***] |
[***] | |||
| Stage 4 |
Clinical / Compassionate Use / Commercial Batch |
[***] |
[***] | |||
PRICING AND PAYMENT ASSUMPTIONS
| • | Batch pricing is based on a single Campaign per annum. |
| • | More definitive scope of work to be defined in the Definitive Agreement. More services may be added including but not limited to process validation, cleaning validation, regulatory filing support, PAI inspection etc. |
| • | The proposed prices are valid for year 2020 and will be adjusted annually based on the Korean Consumer Price Index. |
| • | Batch Prices are exclusive of all raw materials and consumables including but not limited to resin, media, filter , containers, bags, etc. [***] will incur a [***] handling charge. And Other Raw Materials will incur a [***] handling surcharge. |
| • | All costs associated with activities outsourced to 3rd party contractors and/or external laboratories will be passed through to Vir with a [***] handling surcharge. |
| • | All prices exclude freight charges, insurance, duties, taxes, travel expenses, etc. |
| • | Pricing is based on these assumptions and if the assumptions change there may be an associated change in the pricing. |
EXHIBIT B – SERVICE TERMS AND CONDITIONS
| Topic
|
Terms
| |
| Definitions |
• “Manufacturing Process” means the process to manufacture the Product drug substance using a single bioreactor [***] as a result of sequential inoculation, cell culture, harvest, purification, and bulk fill.
• “Batch” means Product produced through one run of the Manufacturing Process.
• “Engineering Batch” means a Batch manufactured to demonstrate successful transfer and/or implementation of the Manufacturing Process to Samsung’s facility.
• “Campaign” shall mean a series of Batches of the Product that are produced in sequence.
• “Cadence” means the time period between sequential Batches, as measured by the difference in time between the beginning of bulk fill for such Batches. | |
| Technology Transfer | Vir will provide all process-related information including manufacturing reports, analytical methods, Product-specific equipment, facility, and materials and will provide additional information as requested by Samsung Biologics.
| |
|
Vir will provide all available documentation demonstrating that all biological materials transferred to Samsung Biologics are tested for [***]. These documents are reviewed and approved by Samsung QA [***] of any biological materials into the cGMP facility. If the technology transfer and analytical method transfer are not completed on time due to incomplete development of the process, then Vir shall [***].
| ||
|
Vir will provide a fully characterized Working Cell Bank (WCB) for manufacturing Vir’s Product at Samsung’s facility.
All WCB vials shipped to Samsung Biologics must be shipped under liquid nitrogen , and a sufficient number of vials shall be provided to carry out the project.
Upon receipt, Samsung will store WCB vials in on-site, secured, and monitored storages. WCB vials will be tracked and handled according to Samsung’s internal procedures.
| ||
|
Samsung will collaborate with Vir for technical gap assessment and FMEA or other appropriate assessment according to Samsung’s internal procedure or Vir’s strategy if necessary, during technology transfer.
| ||
| Equipment | Due to the Product still being under development and with limited time before the start of technology transfer, a full assessment on required special equipment purchase cannot be made and implemented in time. Vir and Samsung will work together in advance to exchange necessary information as early as possible and Vir will use best efforts to develop the process to best fit Samsung’s existing equipment and facility to achieve [***]. If there is an inefficiency due to misalignment of Vir’s Manufacturing Process and Samsung’s facility, Samsung will [***].
If necessary and agreed, Samsung will procure certain equipment and perform the installation/commissioning/qualification/validation of the equipment. Vir shall bear the financial responsibility of the agreed equipment and the costs related to such installation/commissioning/qualification/validation. | |
| Raw Material |
Vir will provide a list of qualified suppliers for raw materials, consumables, components, disposables. Otherwise, Samsung will purchase the required raw materials and components from its own qualified vendors. The cost of purchased raw materials and safety stock will be passed through to Vir with the respective handling surcharge as outlined in the pricing assumptions.
| |
|
Samsung will procure raw materials and safety stocks according to the Capacity Reservation and Vir may also choose to deliver the raw materials to Samsung to maintain sufficient inventory levels. In case when the raw material is insufficient, Samsung will manufacture Batches only up to the number which can be covered by prepared raw materials.
| ||
| Analytical Testing |
Vir will transfer validated analytical methods and specifications to Samsung. Samsung may perform certain site specific qualification and validation for the methods agreed between Samsung and Vir. Analytical method development is not included in the scope of work.
| |
|
Samsung will conduct [***]. Samsung Biologics uses [***].
| ||
| Manufacturing |
Samsung will provide [***].
| |
|
Notwithstanding anything to the contrary, Samsung makes no warranty that Engineering Batches will meet agreed specifications or be successful, and thus under no circumstances shall Samsung be obligated to re-manufacture an Engineering Batch for its failure to meet the agreed specifications.
| ||
|
All costs associated with activities outsourced to external laboratories or 3rd party contractors will be passed through to Vir with [***].
| ||
|
Both Vir and Samsung will work together to meet a [***] between each Batch. If there is a bottleneck that prevents Samsung from achieving [***], only [***]. For example, [***].
| ||
|
In the event a Batch does not have success criteria defined such as release criteria or critical parameters, but Samsung manufactures the Batch in accordance with the Manufacturing Process that Vir has developed, Samsung will be paid [***].
| ||
|
Both Vir and Samsung will work diligently to close all deviations to release the Batches in a timely manner and not unreasonably withhold the closure of any deviation.
| ||
| Delivery |
Samsung will deliver the Product FCA (as defined by Incoterms 20 10) at Samsung’s Facility in accordance with agreed timeline in proposal.
| |
| Invoice and Payment |
Each Batch will be invoiced upon Samsung’s [***]. Invoicing for Service Fees other than Batch manufacture will be 100% upon initiation of activities. Invoices for any Capacity Reservation Shortfall shall be issued December 31 of the year in which such shortfall occurs. All invoices shall be paid by Vir within [***] of receipt. |
|
Batch Failure and Remedies |
Samsung shall be responsible in the event of Batch failure if due [***] to Samsung’s gross negligence and/or willful misconduct. Vir shall be responsible in the event of Batch failure due to [***].
| |
| Regulatory Approvals |
Vir will obtain and maintain the Regulatory Approvals and Samsung Biologics shall cooperate and provided reasonable assistance including but not limited to Facility and information related to performed Services. |
EXHIBIT C: MUTUAL CONFIDENTIALITY AGREEMENT
Exhibit 10.58
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
| CONFIDENTIAL | EXECUTION VERSION |
DEVELOPMENT AND MANUFACTURING COLLABORATION AGREEMENT
by and between
VIR BIOTECHNOLOGY, INC.
and
WUXI BIOLOGICS (HONG KONG) LIMITED
25 February 2020
TABLE OF CONTENTS
Page
| 1. |
DEFINITIONS |
1 | ||||||
| 2. |
GOVERNANCE |
12 | ||||||
| 2.1 |
Alliance Managers |
12 | ||||||
| 2.2 |
Joint Steering Committee |
12 | ||||||
| 2.3 |
JSC Responsibilities |
13 | ||||||
| 2.4 |
Subcommittees |
13 | ||||||
| 2.5 |
Progress Reports |
14 | ||||||
| 2.6 |
Decision Making |
14 | ||||||
| 2.7 |
Resolution of Disputes |
14 | ||||||
| 3. |
DEVELOPMENT PROGRAM |
15 | ||||||
| 3.1 |
Development Program |
15 | ||||||
| 3.2 |
Development Activities |
16 | ||||||
| 3.3 |
Subcontractors |
16 | ||||||
| 3.4 |
Standards of Performance |
17 | ||||||
| 3.5 |
Development Data |
17 | ||||||
| 3.6 |
Pharmacovigilance |
18 | ||||||
| 3.7 |
Development Program Costs |
18 | ||||||
| 3.8 |
Materials |
18 | ||||||
| 4. |
DEVELOPMENT; REGULATORY; COMMERCIALIZATION |
19 | ||||||
| 4.1 |
Development |
19 | ||||||
| 4.2 |
Regulatory Matters |
19 | ||||||
| 4.3 |
Commercialization |
19 | ||||||
| 4.4 |
No Harmful Actions |
20 | ||||||
| 4.5 |
Notification of Threatened Action |
20 | ||||||
| 4.6 |
Remedial Actions |
20 | ||||||
| 4.7 |
Cross-Territorial Restrictions |
21 | ||||||
| 5. |
MANUFACTURE AND SUPPLY |
21 | ||||||
| 5.1 |
Preclinical and Clinical Supply and Quality Agreement |
21 | ||||||
| 5.2 |
Commercial Supply |
21 | ||||||
| 5.3 |
Manufacturing Transfer |
21 | ||||||
| 5.4 |
Technology Transfer |
22 | ||||||
| 5.5 |
Vir Designee |
22 | ||||||
-i-
TABLE OF CONTENTS
(continued)
| Page | ||||||||
| 6. |
LICENSE GRANTS; INTELLECTUAL PROPERTY OWNERSHIP | 23 | ||||||
| 6.1 |
Development Plan Licenses |
23 | ||||||
| 6.2 |
Development and Commercialization Licenses |
23 | ||||||
| 6.3 |
Affiliate Rights |
24 | ||||||
| 6.4 |
Sublicenses |
24 | ||||||
| 6.5 |
Cell Line License Agreement |
25 | ||||||
| 7. |
FINANCIAL TERMS |
25 | ||||||
| 7.1 |
Royalties |
25 | ||||||
| 7.2 |
Royalty Term |
25 | ||||||
| 7.3 |
Sublicense Revenue |
26 | ||||||
| 7.4 |
No Other Compensation |
26 | ||||||
| 7.5 |
Method of Payment |
26 | ||||||
| 7.6 |
Currency Conversion |
27 | ||||||
| 7.7 |
Late Payments |
27 | ||||||
| 7.8 |
Records and Audits |
27 | ||||||
| 7.9 |
Taxes |
28 | ||||||
| 8. |
IP OWNERSHIP; PATENT MATTERS |
28 | ||||||
| 8.1 |
Ownership. |
28 | ||||||
| 8.2 |
Disclosure of Inventions |
29 | ||||||
| 8.3 |
Joint Collaboration Patent Rights |
29 | ||||||
| 8.4 |
Enforcement of Joint Collaboration Patent Rights |
31 | ||||||
| 9. |
TREATMENT OF CONFIDENTIAL INFORMATION |
31 | ||||||
| 9.1 |
Nondisclosure and Non-Use |
31 | ||||||
| 9.2 |
Exceptions |
31 | ||||||
| 9.3 |
Authorized Disclosure |
32 | ||||||
| 9.4 |
Required Disclosure |
33 | ||||||
| 9.5 |
Publicity; Publications |
33 | ||||||
| 10. |
REPRESENTATIONS AND WARRANTIES |
34 | ||||||
| 10.1 |
Mutual Representations |
34 | ||||||
| 10.2 |
No Other Warranties |
35 | ||||||
| 10.3 |
Disclaimer |
35 | ||||||
-ii-
TABLE OF CONTENTS
(continued)
| Page | ||||||||
| 11. |
CERTAIN GENERAL COVENANTS |
35 | ||||||
| 11.1 | WuXi and Vir General Covenants | 35 | ||||||
| 11.2 |
Vir and WuXi Covenants |
36 | ||||||
| 12. |
INDEMNIFICATION |
37 | ||||||
| 12.1 |
Indemnification by WuXi |
37 | ||||||
| 12.2 |
Indemnification by Vir |
37 | ||||||
| 12.3 |
Indemnification Procedures |
37 | ||||||
| 12.4 |
LIMITATION OF LIABILITY |
38 | ||||||
| 13. |
TERM AND TERMINATION |
38 | ||||||
| 13.1 |
Term; Termination |
38 | ||||||
| 13.2 |
Effects of Expiration or Termination |
38 | ||||||
| 13.3 |
Remedies |
39 | ||||||
| 13.4 |
Surviving Provisions |
39 | ||||||
| 14. |
DISPUTES |
40 | ||||||
| 14.1 |
Disputes |
40 | ||||||
| 14.2 |
Executive Officer Escalation |
40 | ||||||
| 14.3 |
Arbitration. |
40 | ||||||
| 15. |
MISCELLANEOUS |
41 | ||||||
| 15.1 |
Management of Human Genetic Resources in China |
41 | ||||||
| 15.2 |
Notices |
41 | ||||||
| 15.3 |
Governing Law |
42 | ||||||
| 15.4 |
Entire Agreement; Amendment |
42 | ||||||
| 15.5 |
Waiver |
42 | ||||||
| 15.6 |
Headings |
42 | ||||||
| 15.7 |
Assignment |
42 | ||||||
| 15.8 |
Performance by Affiliates |
42 | ||||||
| 15.9 |
Construction |
43 | ||||||
| 15.10 |
Interpretation |
43 | ||||||
| 15.11 |
Severability |
43 | ||||||
| 15.12 |
Status |
43 | ||||||
| 15.13 |
Section 365(n) |
43 | ||||||
| 15.14 |
Further Assurances |
44 | ||||||
| 15.15 |
Counterparts |
44 | ||||||
-iii-
TABLE OF CONTENTS
(continued)
| Page | ||||
| Schedule 1.13 | – | Amendment to Cell Line License Agreement | ||
| Schedule 1.99 | – | Vir Background Technology | ||
| Schedule 3.1.1 | – | Draft Development Plan and Allocation of Development Activities | ||
| Schedule 3.1.2 | – | Initial Development Work Order | ||
-iv-
DEVELOPMENT AND MANUFACTURING COLLABORATION AGREEMENT
This Development and Manufacturing Collaboration Agreement (this “Agreement”) is made effective as of February 25, 2020 (the “Effective Date”) by and between Vir Biotechnology, Inc., a Delaware corporation having an address at 499 Illinois Street, San Francisco, CA 94158 USA (“Vir”), and WuXi Biologics (Hong Kong) Limited., a Hong Kong corporation with a place of business at Building 1, 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China 200131 (“WuXi”). Vir and WuXi are each hereafter referred to individually as a “Party” and together as the “Parties.”
WHEREAS, Vir is a biotechnology company focused on discovering, developing, promoting and marketing biopharmaceutical products in the field of infectious diseases throughout the world;
WHEREAS, WuXi and its Affiliates are contract development and manufacturing organizations with significant experience providing biologics development and manufacturing services to biotechnology and pharmaceutical companies;
WHEREAS, the Parties desire to conduct optimization and further development of Vir’s proprietary Antibodies, and to collaborate in connection with the clinical development, manufacturing and commercialization of such Antibodies in the WuXi Territory (in the case of WuXi) and in the Vir Territory (in the case of Vir), as further set forth herein.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Vir and WuXi hereby agree as follows:
| 1. | DEFINITIONS |
Capitalized terms used in this Agreement will have the meanings specified below or elsewhere herein.
| 1.1 | “Affiliate” means, with respect to a Party, any corporation or other business entity controlling, controlled by or under common control with such Party. The term “controlling” (with correlative meanings for the terms “controlled by” and “under common control with”) as used in this definition means either (a) possession of the direct or indirect ownership of more than fifty percent (50%) of the voting or income interest of the applicable corporation or other business entity, or (b) the ability, by contract or otherwise, to control the management of the applicable corporation or other business entity. |
| 1.2 | “Agreement” has the meaning set forth in the Preamble. |
| 1.3 | “Alliance Manager” shall have the meaning set forth in Section 2.1. |
| 1.4 | “Antibody” means a human monoclonal antibody (a) that binds specifically to the Virus (either alone or in addition to binding to any other viral antigen), and (b) that has anti-viral activity in preclinical studies based on well-established methods. |
1
| 1.5 | “Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act 1977, the UK Bribery Act 2010, the People’s Republic of China (the “PRC”) Criminal Law and the PRC Anti-unfair Competition Law (the “AUCL”), and any other applicable Laws for the prevention of fraud, corruption, racketeering, money laundering or terrorism. |
| 1.6 | “Applicable Law” means any law, statute, rule or regulation issued by a Governmental Authority or Regulatory Authority and any judicial, governmental, or administrative order, judgment, decree, or ruling, in each case as applicable to the subject matter of this Agreement and the Parties and having a binding effect on it and them. |
| 1.7 | “Approved CMO” has the meaning set forth in Section 5.3. |
| 1.8 | “Background Technology” means any Intellectual Property Rights that (a) are Controlled by a Party prior to the Effective Date, (b) are developed independently by or on behalf of a Party in the performance of activities outside the scope of this Agreement and without using or referencing any Confidential Information of the other Party or its Affiliates, or (c) are acquired, licensed, or sublicensed from a Third Party by a Party after the Effective Date (or otherwise come into the Control of a Party). |
| 1.9 | “Biosimilar” means, with respect to a given Product in a given country of the Territory, any biological product on the market in such country that is approved (a) by the applicable Regulatory Authority in such country under the biosimilarity standard set forth in the United States under 42 U.S.C. §§ 262(i)(2) and (k), or any similar standard under its foreign equivalent Applicable Law, on a country-by-country basis where such Product is marketed, provided that such Applicable Law exists; and (b) in reliance in whole or in part, on a prior Regulatory Approval (or on any safety or efficacy data submitted in support of such prior Regulatory Approval) of such Product. For countries or jurisdictions where no explicit biosimilar regulations exist, “Biosimilar” includes products which have been deemed to be a Biosimilar or otherwise deemed interchangeable by a Regulatory Authority in such country or jurisdiction. Any product or component thereof licensed, marketed, sold, manufactured, or produced by or on behalf of a Party, its Affiliates or Sublicensees, or by a Third Party that purchased such product or component in a chain of distribution that included a Party, its Affiliates or Sublicensees, will not constitute a Biosimilar. |
| 1.10 | “Bispecific Antibody” means a human bispecific antibody that (a) binds specifically to the Virus, (b) is generated by using two Antibodies, that each bind to a different antigen target, or different epitopes on the same target, and (c) has anti-viral activity in preclinical studies based on well-established methods. |
| 1.11 | “Business Day” means any day other than a Saturday or Sunday on which banking institutions in San Francisco, California and Hong Kong are open for business. |
| 1.12 | “Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30, and December 31. |
| 1.13 | “Cell Line License Agreement” means the license agreement between [***]. |
2
| 1.14 | “cGLP” means current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory standards in other jurisdictions in the WuXi Territory or the Vir Territory), as may be amended from time to time. |
| 1.15 | “cGMP” means the current standards for systems to assure the proper design, monitoring, and control of processes and facilities to be used for the manufacture, processing, packing, or holding of a drug as specified by applicable laws of the relevant countries at the time of manufacturing conducted in accordance with this Agreement, defined under (a) U.S. 21 C.F.R. Parts 210 and 211 and (b) the equivalent law or regulation in any other applicable jurisdiction in the Vir Territory or the WuXi Territory, each as may be amended from time to time. |
| 1.16 | “Change of Control” means, with respect to a Party, (a) a merger, consolidation, recapitalization, or reorganization of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent at least 50% of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger, consolidation, recapitalization, or reorganization, (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of 50% or more of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s and its controlled Affiliates’ assets relating to the subject matter of this Agreement. Notwithstanding the foregoing, any transaction or series of transactions effected for the purpose of financing the operations of the applicable Party or changing the form or jurisdiction of organization of such Party (such as an initial public offering or other offering of equity securities to non-strategic investors or corporate reorganization) will not be deemed a “Change of Control” for purposes of this Agreement. |
| 1.17 | “Clinical Supply” has the meaning set forth in Section 5.1. |
| 1.18 | “Clinical Supply Agreement” has the meaning set forth in Section 5.1. |
| 1.19 | “Clinical Trial” means any human clinical trial of a Product. |
| 1.20 | “Collaboration Technology” means Collaboration Know-How and Collaboration Patents. |
| 1.21 | “Collaboration Know-How” means any and all Know-How that is both (i) Controlled by a Party (or by the Parties, jointly) and (ii) generated in the performance of the activities contemplated under this Agreement. |
| 1.22 | “Collaboration Patents” means Patent Rights Controlled by a Party (or by the Parties jointly) that claim or Cover an invention within Collaboration Know-How. |
| 1.23 | “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective under this Agreement, those efforts and resources commensurate with those efforts commonly used in the biopharmaceutical industry by a company of comparable size in connection with the development or commercialization of biopharmaceutical products that are of similar status, including, with respect to commercial potential of the product, the proprietary |
3
| position of the product, the regulatory status and approval process of the product, the probable profitability of the applicable product, and other relevant factors such as technical, legal, scientific or medical factors. In determining the level of efforts constituting “Commercially Reasonable Efforts,” the following shall not be taken into account: (a) any other pharmaceutical or biologic product a Party is then researching, developing or commercializing, alone or with one or more collaborators or (b) any payment required to be made to the other Party hereunder. |
| 1.24 | “Commercialization” or “Commercialize(d)” means any and all activities directed to marketing, promoting, distributing, importing, exporting, using, offering to sell or selling Antibodies or Products, and activities directed to obtaining or maintaining Pricing Approvals, as applicable. |
| 1.25 | “Commercial Supply” has the meaning set forth in Section 5.2. |
| 1.26 | “Confidential Information” means (a) any information relating to this Agreement, including the terms and existence of this Agreement, and (b) all trade secrets, processes, formulae, data, know-how, improvements, inventions, chemical or biological materials, techniques, marketing plans, strategies, financial information, customer lists, organizational charts or other information or materials that have been conceived, created, discovered, developed or reduced to practice by a Party or its Affiliate, and (c) any other information and materials that are confidential or proprietary to a Party (including all such information and materials of any Third Party), in each case, that are disclosed by such Party or its Affiliate (the “Disclosing Party”) to the other Party or its Affiliate (the “Receiving Party”), regardless of whether any of the foregoing are marked “confidential” or “proprietary”, in each case, whether communicated to the Receiving Party by the Disclosing Party in oral, written, graphic, or electronic form. Each Party will be considered a Receiving Party with respect to the terms and existence of this Agreement. |
| 1.27 | “Control” or “Controlled” means, with respect to any Patent Rights or other Intellectual Property Rights, that the applicable Party owns or has a license to such Patent Rights or other Intellectual Property Rights and has the ability to grant to the other Party access to and a license (or sublicense, as applicable) under same without violating the terms of any agreement with a Third Party. |
| 1.28 | “Cover” means, as to a particular subject matter at issue and a claim of a relevant Patent Right, that the making, using, selling, offering for sale, or importation of such subject matter would be within the scope of one or more claims of such Patent Right. |
| 1.29 | “Develop,” “Developing,” or “Development” means all activities related to preclinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, Manufacturing scale-up, qualification and validation, quality assurance/quality control, clinical studies, manufacturing (including Manufacturing) in support thereof, statistical analysis and report writing, the preparation and submission of drug approval applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition of or in support of obtaining or maintaining a Regulatory Approval for a Product. When used as a verb, “Develop” means to engage in Development. |
4
| 1.30 | “Development Activities” has the meaning set forth in Section 3.2. |
| 1.31 | “Development Budget” has the meaning set forth in Section 3.1.4. |
| 1.32 | “Development Data” has the meaning set forth in Section 3.5. |
| 1.33 | “Development Plan” has the meaning set forth in Section 3.1.1. |
| 1.34 | “Development Program” has the meaning set forth in Section 3.1.1. |
| 1.35 | “Development Work Order” means a work order entered into by the Parties under the MSA prior to the Effective Date or at any time during the Term for the conduct of Initial Development Activities. |
| 1.36 | “Disclosing Party” has the meaning set forth in Section 1.26. |
| 1.37 | “Dispute” has the meaning set forth in Section 14.1. |
| 1.38 | “Effective Date” has the meaning set forth in the Preamble. |
| 1.39 | “Executive Officers” has the meaning in Section 2.6.2. |
| 1.40 | “Exploit” means to research, develop, make, have made, use, offer for sale, sell, have sold, import, export or otherwise exploit, or transfer possession of or title in, a product. Cognates of the word “Exploit” shall have correlative meanings. |
| 1.41 | “FDA” means the United States Food and Drug Administration and any successor agency or authority thereto. |
| 1.42 | “Field” means all prophylactic, therapeutic, preventive and diagnostic uses in humans. |
| 1.43 | “First Commercial Sale” means, with respect to any Product in a country in the WuXi Territory, the first sale for end use or consumption of such Product in such country after Regulatory Approval of such Product has been granted in such country. |
| 1.44 | “Governmental Authority” means any federal, state, local, or foreign government, any governmental, regulatory or administrative authority, agency, bureau or commission or any court, tribunal or judicial or arbitral body. |
| 1.45 | “Improvement” means, with respect to any Know-How, Patent Rights or other Intellectual Property Rights, any advancement, modification, development or improvement thereto arising as a result of activities under this Agreement. |
| 1.46 | “IND” means an Investigational New Drug application required pursuant to 21 C.F.R. Part 312 or any comparable filings outside of the United States required to commence human clinical trials in such country or region, including any Clinical Trial Application (“CTA”) or Chinese IND or equivalent filing with the NMPA, and all supplements or amendments that may be filed with respect to the foregoing. |
5
| 1.47 | “Indemnifying Party” has the meaning set forth in Section 12.3. |
| 1.48 | “Indemnitee” means a Vir Indemnitee or a WuXi Indemnitee, as applicable. |
| 1.49 | “Initial Development Activities” has the meaning set forth in Section 3.1.2. |
| 1.50 | “Initial Vir Antibodies” means the Antibodies Controlled by Vir and transferred to WuXi (either before or following the Effective Date) under the terms of the MSA (including any Antibodies transferred under any Development Work Order). |
| 1.51 | “Intellectual Property Rights” means all proprietary rights throughout the world, however denominated (whether registered or unregistered), including (a) Patent Rights, (b) copyrights and design rights, (c) Trademarks and all goodwill associated with any and all of the foregoing, (d) Know-How, (e) database rights, (f) domain names, and (g) all other intellectual property rights and all registrations, applications, and rights to apply for any of them. |
| 1.52 | “Invention” means any process, method, technique, method of manufacture, composition of matter, discovery, development, know-how, or other invention that is first conceived, developed, generated or reduced to practice, constructively or actually, by or on behalf of either Party or their respective Affiliates or jointly by the Parties (or their respective Affiliates) in the course of performance of activities under this Agreement. |
| 1.53 | “Joint Collaboration Patent Rights” means any Patent Rights included in the Joint Collaboration Technology. |
| 1.54 | “Joint Collaboration Technology” has the meaning set forth in Section 8.1.3. |
| 1.55 | “JSC” has the meaning set forth in Section 2.2. |
| 1.56 | “JSC Meetings” has the meaning set forth in Section 2.2. |
| 1.57 | “Know-How” means any proprietary or confidential information or materials, including records, discoveries, inventions, improvements, modifications, processes, techniques, methods, assays, chemical or biological materials, designs, protocols, formulas, data (including physical data, chemical data, toxicology data, animal data, raw data, clinical data, and analytical and quality control data), dosage regimens, control assays, product specifications, marketing, algorithms, technology, forecasts, profiles, strategies, plans, results in any form whatsoever, know-how, trade secrets, technology, compositions, reagents, constructs, compounds, discoveries, results of experimentation or testing, skill and experience, papers, invention disclosures, blueprints, drawings, flowcharts, diagrams, chemical compositions, formulae, diaries, notebooks, compilations of information, customer and supplier lists, pricing and cost information, and business and marketing plans and proposals, and all rights related to any of the foregoing (in each case, patentable, copyrightable, or otherwise). |
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| 1.58 | “Law” means applicable federal, state, local, municipal, foreign or other law, statute, legislation, constitution, principle of common law, resolution, ordinance, code, edict, decree, proclamation, treaty, convention, rule, or regulation that is issued, enacted, adopted, passed, approved, promulgated, made, implemented, or otherwise put into effect by or under the authority of any Governmental Authority. |
| 1.59 | “Licensed Cell Line” has the meaning set forth in the Cell Line License Agreement. |
| 1.60 | “Licensee Recombinant Protein” has the meaning set forth in the Cell Line License Agreement. |
| 1.61 | “Losses” has the meaning set forth in Section 12.1. |
| 1.62 | “Manufacture” and “Manufacturing” means performing all steps of the Manufacturing Process, including: (a) acquisition, testing and release of materials and raw materials; (b) upstream and downstream processing of drug substance; (c) formulation and filling of drug product; (d) in-process quality control testing; (e) labeling and packaging; (f) final quality release; and (g) storage prior to shipping of any Product and the related controls. “Manufactured” will be the act of completing Manufacture. |
| 1.63 | “Manufacturing Major Market” means [***]. |
| 1.64 | “Manufacturing Process” means with respect to a Product, the manufacturing production process for the manufacture of a Product, include any analytical methods used therein, including any improvements or modifications thereto arising pursuant to this Agreement or the MSA. |
| 1.65 | “MSA” means [***]. |
| 1.66 | “MSA Invention” has the meaning set forth in Section 8.1.2. |
| 1.67 | “Necessary Development Data” has the meaning set forth in Section 3.5. |
| 1.68 | “NMPA” means the National Medical Products Administration and any successor agency or authority thereto. |
| 1.69 | “Party” and “Parties” have the meaning set forth in the Preamble. |
| 1.70 | “Patent Rights” means (a) any and all United States and foreign patents or patent applications; (b) any and all foreign patent applications, foreign patents or related foreign patent documents that claim priority to the patents or patent applications in (a); (c) any and all patents issuing from the foregoing; (d) any and all claims of continuation-in-part applications that claim priority to such United States patent applications, and such claims in any patents issuing from such continuation-in-part applications, but only where such claims are directed to inventions disclosed in the manner provided in the first paragraph of 35 USC §112; and (e) any and all divisionals, continuations, reissues, re-examinations, renewals, substitutions and extensions of the foregoing, and all foreign equivalents thereof. |
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| 1.71 | “Person” means any individual, corporation, limited or general partnership, limited liability company, joint venture, trust, unincorporated association, governmental body, authority, bureau or agency, or any other entity or body (as defined in Section 13(d) of the Securities Exchange Act of 1934, as amended). |
| 1.72 | [***] |
| 1.73 | “Phase I Clinical Trial” means any human clinical trial of a Product conducted mainly to evaluate the safety of chemical or biologic agents or other types of interventions (e.g., a new radiation therapy technique) that would satisfy the requirements of 21 C.F.R. § 312.21(a) or its non-United States equivalents. For clarity, for the purposes of this Agreement, a Phase I Clinical Trial may include a Phase IB or Phase I/II clinical trial, so long as such Phase IB or Phase I/II clinical trial is the first clinical trial conducted for a Vir Antibody in the Vir Territory. |
| 1.74 | “Products” means all products containing or comprising a Vir Antibody. Products shall exclude any Bispecific Antibody but shall include any product that contains a combination of a Vir Antibody with any Combination Component, as further set forth in the definition of WuXi Net Sales. |
| 1.75 | “Prosecuting Party” has the meaning set forth in Section 8.3.1. |
| 1.76 | “Qualified Affiliate” has the meaning set forth in Section 1.86. |
| 1.77 | “Quality Agreement” means [***]. |
| 1.78 | “Receiving Party” has the meaning set forth in Section 1.26. |
| 1.79 | “Regulatory Approval” means, with respect to a country or other jurisdiction, any and all necessary approvals, licenses, registrations, or authorizations of any Regulatory Authority, in each case, that are necessary to market and sell a product in such country or other jurisdiction. |
| 1.80 | “Regulatory Authority” means, with respect to a particular country, extra-national territory, province, state, or other regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval or, to the extent required for such country, extra-national territory, province, state, or other or regulatory jurisdiction, pricing or reimbursement approval, in each case, of a biopharmaceutical product in such country, state, province, or some or all of such extra-national territory or regulatory jurisdiction, including the FDA, and NMPA, and in each case, including any successor thereto. |
| 1.81 | “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any applicable Regulatory Authority, other than an issued and unexpired Patent Right, including any regulatory data protection exclusivity (including, where applicable, pediatric exclusivity and/or orphan drug exclusivity) and/or any other exclusivity afforded by restrictions which prevent the granting by a Regulatory Authority of Regulatory Approval to market a Biosimilar. |
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| 1.82 | “Regulatory Filing” means any filing with any Governmental Authority in the Vir Territory (in the case of Vir), or the WuXi Territory (in the case of WuXi), each as applicable, with respect to the research, Development, Manufacture or Commercialization of a Product. |
| 1.83 | “Regulatory Support” has the meaning set forth in Section 3.2. |
| 1.84 | “Royalty Term” has the meaning set forth in Section 7.2. |
| 1.85 | “Selected Antibody” has the meaning set forth in Section 3.1.2. |
| 1.86 | “Subcontractor” has the meaning set forth in Section 3.3. |
| 1.87 | “Sublicensee” shall mean any Person to whom Vir or Wuxi, or their respective Affiliates, has granted a sublicense under this Agreement, other than (a) an Affiliate of Vir to which Vir has granted a sublicense under this Agreement, and (b) a Qualified Affiliate of WuXi to which WuXi has granted a sublicense under Section 6.3 of this Agreement. |
| 1.88 | “Sublicense Revenue” means any and all consideration (including equity), upfront payments, option fees, license fees, and milestone payments, in cash payments or any other form of consideration (as determined using the fair market value of such other form of consideration), received by WuXi or its Affiliates for the grant by WuXi or its Affiliates of a sublicense (and including the grant of an option to take such a sublicense) under this Agreement to a Third Party, including any right granted to a Third Party to make, have made, use, sell, offer for sale, have sold, market, distribute or import a Product ([***]). Notwithstanding the foregoing, Sublicense Revenue specifically excludes: [***]. Notwithstanding the foregoing, the Parties intend that WuXi should have the flexibility to sublicense its rights hereunder to any wholly owned subsidiary of WuXi or other Affiliate of WuXi with similar or substantially similar resources and expertise as WuXi with respect to the performance of the activities hereunder, as part of its overall corporate structuring and to better operationalize the Development and/or Commercialization of Products in specific markets or territories in the WuXi Territory. Therefore, Sublicense Revenue shall not be calculated on amounts received under sublicenses granted to such an Affiliate where such Affiliate is conducting research, Development, Manufacture or Commercialization of the Product solely for or on behalf of, or instead of, WuXi (or its shareholders) (such an Affiliate, a “Qualified Affiliate”), provided that any further sublicenses granted by such Affiliate to any Third Party (the “Triggering Sublicensee”) shall be subject to the requirement that such Affiliate pay Sublicense Revenue under Section 7.3 to WuXi, which such payment WuXi shall remit to Vir as though WuXi had entered directly into such sublicense with such Triggering Sublicensee. |
| 1.89 | “Term” has the meaning set forth in Section 13.1. |
| 1.90 | “Termination Event” has the meaning set forth in Section 13.1. |
| 1.91 | “Third Party” means any Person other than WuXi, Vir, and their respective Affiliates. |
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| 1.92 | “Trademarks” means all registered and unregistered trademarks, service marks, trade dress, trade names, logos, insignias, symbols, designs, and all other indicia of ownership or origin, and combinations thereof. |
| 1.93 | “Transitioned Manufacturing” has the meaning set forth in Section 5.3. |
| 1.94 | “Valid Claim” means a claim of any issued and unexpired patent or patent application within the Vir Background Patent Rights, Vir Collaboration Patent Rights or Joint Collaboration Patent Rights, as applicable, that has not been held invalid or unenforceable by a final decision of a court or governmental agency of competent jurisdiction, which decision can no longer be appealed or was not appealed within the time allowed; provided, however, that if a claim of a pending patent application within the Vir Background Patent Rights, Vir Collaboration Patent Rights or Joint Collaboration Patent Rights shall not have issued within [***] after the earliest filing date from which such claim takes priority, such claim shall not constitute a Valid Claim for the purposes of this Agreement unless and until a Patent Right issues with such claim (from and after which time the same would be deemed a Valid Claim). |
| 1.95 | “VAT” has the meaning set forth in Section 7.9.2. |
| 1.96 | “Vir” has the meaning set forth in the Preamble. |
| 1.97 | “Vir Antibodies” means [***]. |
| 1.98 | “Vir Background Patent Right” means any Patent Right included in the Vir Background Technology. |
| 1.99 | “Vir Background Technology” means all Background Technology Controlled by Vir or any of its Affiliates, including [***] that is [***] and is [***] Vir Background Technology includes Know-How or Patent Rights set forth on Schedule 1.97, as updated from time to time. |
| 1.100 | “Vir Collaboration Patent Rights” means the Collaboration Patents [***]. |
| 1.101 | “Vir Development Activities” means those Development Activities allocated to be performed by or on behalf of Vir under the applicable Development Plan. |
| 1.102 | “Vir Indemnitees” means Vir, its Affiliates and the respective directors, officers, employees, and agents of Vir and its Affiliates. |
| 1.103 | “Vir’s Knowledge” means, together with words and phrases of similar import, the actual knowledge of [***]. |
| 1.104 | “Vir Materials” has the meaning set forth in the MSA. |
| 1.105 | “Vir Technology” means the Vir Background Technology and Vir’s interest in the Joint Collaboration Technology. |
| 1.106 | “Vir Territory” means all countries worldwide except for the WuXi Territory. |
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| 1.107 | “Virus” means the novel coronavirus, denoted 2019-nCov by the WHO and also known as Wuhan coronavirus and SARS-Cov-2, which is a positive-sense, single-stranded RNA coronavirus. |
| 1.108 | “WuXi” has the meaning set forth in the Preamble. |
| 1.109 | “WuXi Background Patent Right” means any Patent Right included in the WuXi Background Technology. |
| 1.110 | “WuXi Background Technology” means all Background Technology Controlled by WuXi or any of its Affiliates at any time during the Term related to the Product or Antibody, including all Know-How Controlled by WuXi or any of its Affiliates that is necessary or reasonably useful to Exploit any Antibody or Product. |
| 1.111 | “WuXi Bispecific Platform Technology” means Patent Rights and Know-How Controlled by WuXi as of the Effective Date or during the Term that (a) [***]. For clarity, WuXi Background Technology does not include WuXi Bispecific Platform Technology. |
| 1.112 | “WuXi Indemnitees” means WuXi, its Affiliates, and the respective directors, officers, employees, and agents of WuXi and its Affiliates. |
| 1.113 | “WuXi’s Knowledge” means [***]. |
| 1.114 | “WuXi Net Sales” means, on a Product-by-Product basis, the gross invoice price charged by WuXi, its Affiliates or Sublicensees to Third Parties for sales of Products in the WuXi Territory, less the following deductions actually incurred, allowed or otherwise specifically allocated to the sale of such Product and calculated with respect to such sale in accordance with WuXi’s standard accounting practices (to the extent not inconsistent with GAAP): |
[***]
WuXi Net Sales will be determined from books and records maintained in accordance with GAAP, consistently applied throughout the organization and across all products of the entity whose sales of Products are giving rise to WuXi Net Sales.
WuXi Net Sales shall also include, with respect to any Product sold or otherwise disposed of for any consideration other than an exclusively monetary consideration on bona fide arm’s length terms in the WuXi Territory, an amount equal to the average sales price for such Product having the same dosage form and strength during the applicable reporting period in the country in the WuXi Territory where such sale or other disposal occurred when such Product is sold alone and not with other products, or if such Product is not sold alone in such country in the WuXi Territory during the applicable reporting period, then an amount equal to the average sales price during the applicable reporting period generally achieved for such Product having the same dosage form and strength in the other countries in the WuXi Territory.
[***].
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[***].
| 1.115 | “WuXi Development Activities” means those Development Activities allocated to be performed by or on behalf of WuXi under the applicable Development Plan. |
| 1.116 | “WuXi Technology” means the WuXi Background Technology and WuXi’s interest in the Joint Collaboration Technology. |
| 1.117 | “WuXi Territory” means People’s Republic of China, Hong Kong and Macau and Taiwan |
| 2. | GOVERNANCE |
| 2.1 | Alliance Managers. Each of Vir and WuXi shall appoint one representative who possesses a general understanding of and necessary expertise in development, regulatory, manufacturing and commercialization of Antibodies to act as its respective alliance manager(s) for this relationship (an “Alliance Manager”). Each Party may replace its respective Alliance Manager at any time upon written notice to the other in accordance with this Agreement. Any Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager. Each Alliance Manager shall be charged with creating and maintaining a collaborative work environment within the Joint Steering Committee. Consistent with the Development Plan, each Alliance Manager will also be responsible for: |
| 2.1.1 | providing a primary single point of communication responsible for the flow of communication and for seeking consensus both within the respective Party’s organization and together with the other Party regarding key strategy and plan issues; |
| 2.1.2 | ensuring awareness of the governance procedures and rules set forth herein and monitoring compliance therewith; |
| 2.1.3 | identifying and raising disputes to the JSC for discussion in a timely manner; and |
| 2.1.4 | planning and coordinating internal and external communications in accordance with the terms of this Agreement. |
The Alliance Managers shall have the right to attend all JSC and subcommittee meetings, as a non-voting member. Each Alliance Manager may bring any matter to the attention of the JSC where such Alliance Manager reasonably believes that such matter requires attention of the JSC. Within [***] after the Effective Date, each Party shall appoint and notify the other Party of the identity of their representative to act as its Alliance Manager under this Agreement.
| 2.2 | Joint Steering Committee. Prior to or within [***] after the Effective Date, the Parties will form a joint steering committee (“JSC”) to oversee the collaboration and exchange of services, technology, and other information between the Parties. The JSC will have [***] participants from each Party (or such other number of representatives as the Parties may agree in writing), and each Party will nominate its representatives on the JSC within [***] following the Effective Date. The participants from each Party will be members of such Party’s senior management or senior |
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| scientific teams, as appropriate, with the necessary expertise in the manufacturing and clinical development of antibody products to make decisions arising within the scope of the JSC’s responsibilities, and each Party may change one or more of its representatives to the JSC upon written notice to the other Party. Within [***] after the Effective Date, each of WuXi and Vir will nominate a representative to serve as the co-chairpersons of the JSC and, in such capacity, will be responsible for agreeing on and setting the agenda of meetings of the JSC, with input from the other participants, and for conducting the meetings of the JSC and circulating minutes thereafter. The JSC will meet [***] after the Effective Date, and thereafter, [***] (“JSC Meetings”). At least one JSC Meeting conducted during each Calendar year will be conducted in person at a location determined by the JSC in advance of such JSC Meetings. The Parties agree that their respective Alliance Managers may attend the JSC meetings on a non-voting basis. If agreed by the JSC on a case-by-case basis, the JSC may invite other non-members (including working team members) to participate in the discussions and meetings of the JSC on a non-voting basis, provided that any such non-member participants that are not employees of a Party are bound by written obligations of confidentiality, non-disclosure, and non-use provisions at least as restrictive as those set forth in this Agreement. In addition to JSC Meetings, one or more non-JSC members from each Party, including scientists, engineers and other persons that are actively engaged in, or otherwise directly responsible and with direct visibility into, the conduct of Development Activities, as appropriate and agreed, will meet more frequently to plan scientific and Manufacturing Process development experiments, exchange data, and discuss results, in each case, related to the Development Activities. Any issues arising in connection with the non-JSC meetings referenced in the immediately preceding sentence shall be escalated to the Parties’ respective Alliance Managers for resolution. |
| 2.3 | JSC Responsibilities. The JSC will retain oversight and information sharing responsibilities with respect to activities conducted under this Agreement, and in particular will have the following responsibilities: |
| [***] |
| 2.4 | Subcommittees. The JSC may establish and disband such subcommittees as deemed necessary by the JSC. Each such subcommittee shall consist of the same number of representatives designated by each Party, which number shall be mutually agreed by the Parties. Each Party shall be free to change its representatives on written notice to the other Party or to send a substitute representative to any subcommittee meeting. Each Party’s representatives and any substitute for a representative shall be bound by the obligations of confidentiality set forth in in this Agreement. Except as expressly provided in this Agreement, no subcommittee shall have the authority to bind the Parties hereunder and each subcommittee shall report to the JSC. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings. If a dispute arises which cannot be resolved by a subcommittee, the co-chair of either Party may cause such dispute to be referred to the Joint Steering Committee for resolution. |
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| 2.5 | Progress Reports. Prior to each JSC Meeting, each Party will provide to the other Party’s representatives on the JSC: [***]. Each Party will provide to the JSC its advice and recommendations concerning such reports (and the information and data therein) where necessary or useful for the JSC to make recommendations concerning the Development Program, and shall endeavor to answer any questions or provide any additional data required for the JSC to make an informed decision regarding the applicable Development Plan or the Development Program. |
| 2.6 | Decision Making. |
| 2.6.1 | Authority to Make Decisions. A quorum for a meeting of the JSC will require the presence of at least [***] from each of WuXi and Vir or suitable delegates of either Party’s representatives if agreed by the Parties in advance. Any decisions by the JSC will require the unanimous vote of the JSC, with each Party having one vote. |
| 2.6.2 | Decisions of the JSC. The JSC will use good faith efforts to promptly resolve any such matter for which it has authority. Subject to the terms of this Agreement, including Section 2.7.2, if the JSC cannot or does not, after reasonable efforts, reach agreement on any matter that is within the scope of the JSC’s authority pursuant to Section 2.3 within a period of [***] following initial discussion thereof by the JSC, then the co-chair of either Party may cause such dispute to be referred to [***] (collectively, the “Executive Officers”) in accordance with Section 2.7.1. |
| 2.7 | Resolution of Disputes. |
| 2.7.1 | Referral to Executive Officers. If a Party makes an election under Section 2.6.2 to refer a matter on which the JSC cannot reach a consensus decision for resolution by the Executive Officers, then each Party’s co-chair to the JSC will communicate the respective positions of such Party to their respective Executive Officers. The Executive Officers will use good faith efforts to resolve any such matter so referred to them as soon as practicable and any final decision that the Executive Officers agree to in writing will be conclusive and binding on the Parties. |
| 2.7.2 | Final Decision-Making Authority. In the event that consensus cannot be reached with respect to a decision after a meeting of the Executive Officers, then, (a) [***]. |
| 2.7.3 | Limits on JSC Decision Making Authority. Notwithstanding any provision to the contrary set forth in this Agreement, without each Party’s prior written consent, no decision of the JSC may (a) take or decline to take any action that would be reasonably likely to result in a violation of any Applicable Law, the requirements of any Governmental Authority, or any agreement between a Party and any Third Party or that would be reasonably likely to result in the infringement, misappropriation, or other violation of any Intellectual Property Rights of any Third Party; provided that such Party provides a copy of any such agreement to the other Party, (b) conflict with this Agreement, (c) excuse a Party from any obligation specifically enumerated under this Agreement, (d) negate any consent right or other right specifically allocated to a Party under this Agreement, (e) resolve any dispute involving the breach or alleged breach of this Agreement or amend or modify this Agreement or any of the Parties’ respective rights and obligations hereunder, (f) resolve a matter if the provisions of this Agreement specify that agreement of the Parties, including consent of each Party, is required for such matter, or (g) require a Party to perform any act that would cause such Party to breach any of its obligations hereunder. |
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| 3. | DEVELOPMENT PROGRAM |
| 3.1 | Development Program. |
| 3.1.1 | Development Plan. Once the JSC has been formed, the JSC will promptly review, discuss, and determine the Development and Manufacturing activities to be performed by the Parties under the collaboration related to the Vir Antibodies and Products, apart from the Initial Development Activities (which, for clarity, will continue to be governed by the terms of the MSA, as further described in Section 3.1.2) (such activities, the “Development Activities”), with the goal of selecting one or more Vir Antibodies suitable for filing an IND and advancing into clinical Development and possible Commercialization (the program for the conduct of the Development Activities, , the “Development Program”). For clarity, Development Activities will include the conduct of all Clinical Trials for the Product. All Development Activities will be conducted by the Parties pursuant to a written global development plan that outlines the Development (including pre-clinical, clinical and commercial Manufacturing , the details of which shall be subject to separate agreements as further described in Sections 5.1 and 5.2) activities that will be performed with respect to the Vir Antibodies in each of the Vir Territory and the WuXi Territory (as such plan may be updated pursuant to Section 3.1.5, the “Development Plan”). [***]. For the Development Plan in WuXi Territory, WuXi has the right to develop a separate plan specific for the WuXi Territory following the local regulatory authority guideline and discuss it with Vir at JSC. WuXi has the sole discretion to finalize the Development Plan to the extent specifically relating to the WuXi Territory. |
| 3.1.2 | Initial Development Activities. WuXi will perform an initial set of Development and Manufacturing activities directed to the Vir Antibodies, [***]. The Initial Development Activities will be conducted by WuXi under one or more existing or additional Development Work Order(s) entered into pursuant to the terms of the MSA, at Vir’s sole cost and expense. The Development Work Order for a portion of the Initial Development Activities has been agreed by the Parties and is attached to this Agreement as Schedule 3.1.2. |
| 3.1.3 | Selected Antibody. Notwithstanding the conduct of Initial Development Activities under the MSA, all data, results and materials generated under any Development Work Order shall be evaluated by the Parties through the JSC. [***]. If WuXi notifies Vir in writing that it does not wish to proceed with Development Activities for a given Selected Antibody (a “Rejected Antibody”), then (a) [***]. Following the JSC’s determination that the Manufacturing Process development activities pursuant to the relevant Development Work Order(s) have been satisfactorily completed, the Initial Development Activities shall be deemed completed, and the Parties shall thereafter collaborate to conduct all subsequent Development Activities and Manufacturing activities in accordance with the terms of this Agreement, as specified under the Development Plan for the Selected Antibod(ies), and as such Development Plan may be updated from time to time pursuant to Section 3.1.5. |
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| 3.1.4 | Development Budgets. Each Party or its authorized Third Party designees will perform the Development Activities as set forth in the applicable Development Plan in accordance with a budget that sets forth the number of FTEs anticipated to be dedicated to, and the costs to be incurred in, the performance of such Development Activities (each such budget for a Development Plan, as may be amended pursuant to Section 3.1.5, a “Development Budget”). [***]. The JSC will review, discuss, and determine whether to approve each Development Budget. |
| 3.1.5 | Development Plan Updates. From time to time during the Term, but no less frequently than [***], the JSC will review and, if needed or reasonable to do so, will update the Development Plan (including each Development Budget set forth therein), including to contemplate the performance of additional clinical trials or additional Development or Manufacturing activities under the Development Plan for the Selected Antibodies. Each such update to a Development Plan will take into account, as applicable, emerging data, regulatory input, and other issues that may arise during the course of performance of activities under such Development Plan. The JSC will review, discuss, and determine whether to approve each such update, and upon the JSC’s approval thereof, each update to a Development Plan or Development Budget will be documented in writing and signed by each Party’s representatives to the JSC. Thereafter, such updated Development Plan and Development Budget will be deemed to supersede the prior version. |
| 3.2 | Development Activities. Each Party will perform all Development Activities assigned to it under the Development Plan in accordance with such plan. In general, except as set forth in this Agreement or on Schedule 3.1.1, each Party will be responsible for the internal personnel and out-of-pocket costs incurred in performing Development Activities. [***] The Parties will appropriately resource and prioritize the performance of all Development Activities according to the applicable personnel resource estimates, timelines, and deliverables set forth in the applicable Development Plan. From time to time during the Term, through the JSC, Vir may reasonably request, or WuXi may recommend, that WuXi provide consultation or advisory support to Vir in connection with regulatory matters and strategy in connection with the global Development and Commercialization of Products, including in connection with the CMC portion of any Regulatory Filings (such services, “Regulatory Support”). WuXi shall not unreasonably withhold consent to provide such Regulatory Support, provided that Vir shall reimburse WuXi’s reasonable out of pocket costs incurred in providing such Regulatory Support. [***] Vir shall pay any undisputed invoice within [***] following receipt of the invoice from WuXi. |
| 3.3 | Subcontractors. Either Party may engage its Affiliates, or Third Party subcontractors (including contract research organizations (but excluding contract manufacturing organizations)) (each such Third Party, a “Subcontractor”) to perform certain of its obligations under this Agreement. Any Subcontractor to be engaged by such Party to perform its obligations set forth in this Agreement will meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activity. The activities of any such Subcontractors will |
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| be considered activities of such Party under this Agreement. The subcontracting Party will be responsible for ensuring compliance by any such Subcontractors with the terms of this Agreement, as if such Third Party(ies) are such Party hereunder. Each Party will, and will contractually require that its Affiliates and Subcontractors, if any, conduct the relevant Development Activities in accordance with such Party’s commitments with respect to the Development Program, including compliance with Applicable Laws and the terms of any quality agreement between WuXi and Vir. All personnel conducting activities under any Development Plan on behalf of a Party will be bound by a written agreement containing terms substantially similar to the terms set forth in Section 11.2.1. |
| 3.4 | Standards of Performance. |
| 3.4.1 | Compliance with Law. Each Party will, and will ensure that in its written agreement(s) with its Subcontractors, including a quality agreement as applicable, that such Subcontractors are obligated to, conduct its respective activities under the Development Program in accordance with (a) all applicable Laws, including all current governmental regulatory requirements concerning cGLP and cGMP; and (b) generally prevailing industry standards and practices for the performance of similar services. |
| 3.4.2 | No Debarred Persons. Each Party will ensure that neither it nor its Affiliates employs or will employ in any capacity, and will ensure that its Subcontractors, in performing any services hereunder, do not employ in any capacity, the services of any Person debarred under 21 U.S.C. 335a. Each Party will promptly notify the other Party in writing immediately if any such debarment occurs or comes to its attention, and will, with respect to any Person so debarred, promptly remove such Person from performing any function or capacity related to the Development Program. |
| 3.4.3 | Facilities. Each Party will have functioning throughout the Term, whether at its own facilities or at a Third Party site, all duly-certified facilities and technology to perform all activities allocated to such Party under each Development Plan, and expertise to conduct program management, design and oversight of the foregoing activities. |
| 3.4.4 | Animal Compliance. Each Party will, and will ensure that its Subcontractors, comply with all Applicable Laws relating to the care and use of laboratory animals. |
| 3.5 | Development Data. Each Party shall provide to the other Party all data, results, records, or reports that are generated by or on behalf of such Party in the course of performing any Development Activities, but excluding any Inventions (collectively, the “Development Data”) that is necessary or reasonably useful for such other Party to (a) perform its activities under the Development Plan, or (b) conduct Development (including obtaining all necessary Regulatory Approvals), Manufacture and Commercialization of Products for its respective territory (“Necessary Development Data”). Necessary Development Data shall be exchanged through the JSC and will be treated as Confidential Information of both Parties for purposes of and subject to the provisions of Article 7, with both Parties being deemed the Receiving Party with respect thereto (subject to the licenses granted in Section 8.1.3). At each JSC Meeting, each Party will share with the JSC all Necessary Development Data generated by or on behalf of such Party since the prior JSC Meeting. |
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| 3.6 | Pharmacovigilance. No later than [***] following the Effective Date, the Parties shall negotiate and enter into a separate pharmacovigilance agreement including customary terms specifying the procedure for the information exchange of safety data and adverse events that may occur during the clinical Development of a Product (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall be in a mutually agreed format and shall enable each Party to meet reporting requirements with any applicable Regulatory Authority and shall include the set-up and maintenance of a global safety database for Products (which database shall be held in Vir’s name). |
| 3.7 | Development Program Costs. Unless otherwise agreed by the Parties in connection with a given Development Plan and associated Development Budget, each Party will be responsible for its own internal and Out of Pocket Costs incurred in conducting the Development Activities allocated to such Party under the Development Plan. Notwithstanding the foregoing, the costs associated with activities performed under any Development Work Order, including the Initial Development Activities, shall be governed by the terms of the applicable Development Work Order and the MSA. |
| 3.8 | Materials. As of the Effective Date, Vir has transferred certain materials to WuXi, including the Vir Antibodies, under the terms of a Development Work Order, which transfer is subject to the terms of the MSA. In order to facilitate activities under a given Development Plan, during the Term, either Party may provide additional materials to the other Party under the terms of this Agreement, the transfer of which materials will be documented in writing setting forth (a) the type and name of the materials transferred, (b) the amount of the materials transferred, (c) the date of the transfer of such materials and the purpose of such material transfer by the recipient Party, and (d) any specific restrictions or compliance actions required regarding the use or subsequent transfer of such materials under this (i.e., any consent or notice). Except as otherwise expressly set forth under this Agreement or the terms of the MSA, any Clinical Supply Agreement or any commercial supply agreement (i) all materials provided by WuXi to Vir will, as between the Parties, remain the sole property of WuXi and all materials provided by Vir to WuXi will remain the sole property of Vir, (ii) each Party will use the materials provided by the other Party only in the performance of the Development Activities conducted in accordance with the applicable Development Plan, and in accordance with any instructions of the providing Party and applicable Law, and (iii) except as provided in the applicable Development Plan, neither Party will use or deliver to or for the benefit of any Third Party any materials belonging to the other Party without the prior written consent of such other Party. Each Party will use the materials supplied under this Agreement with prudence and appropriate caution as not all of their characteristics may be known. Each Party will provide the other with the most current material safety data sheet for the materials upon their transfer. Except as expressly set forth in this Agreement, THE MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY. |
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| 4. | DEVELOPMENT; REGULATORY; COMMERCIALIZATION |
| 4.1 | Development. Subject to the performance of each Party’s obligations under the Development Plan, (a) WuXi and its Affiliates shall have the sole right to Develop and Manufacture, including seeking Regulatory Approvals for, Products in the Field in the WuXi Territory, in each case at WuXi’s sole expense, and (b) Vir hall have the sole right to Develop and Manufacture, including seeking Regulatory Approvals for, Products in the Field in the Vir Territory, in each case at Vir’s sole expense. WuXi shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for at least one Product in the Field in the WuXi Territory. WuXi shall have the right to satisfy its diligence obligations under this Section 4.1 through its Affiliates or Sublicensees. For each Product, until the grant of Regulatory Approval for a Product in the WuXi Territory, WuXi will provide to the JSC reports at each meeting of the JSC, and after the first anniversary of the Effective Date, [***] (or such other frequency as the JSC may determine) summarizing the key Development (including regulatory) activities undertaken and summarizing the results achieved with respect to the applicable Products during the prior Calendar Quarter. Following the delivery of each report, WuXi will make appropriate personnel available to Vir during business hours and on reasonable advanced notice to answer reasonable questions regarding the information contained in such report, in order for Vir to obtain a reasonable understanding regarding the Development status of the applicable Products. |
| 4.2 | Regulatory Matters. |
| 4.2.1 | Vir will be solely responsible for the preparation, submission and maintenance of all Regulatory Filings and obtaining all Regulatory Approvals with respect to Products in the Vir Territory, including all communications and interactions with Regulatory Authorities in the Vir Territory, and shall hold all such Regulatory Approvals in Vir’s name. WuXi will be solely responsible for the preparation, submission and maintenance of all Regulatory Filings and obtaining all Regulatory Approvals with respect to Products in the WuXi Territory, including all communications and interactions with Regulatory Authorities in the WuXi Territory, and unless prohibited under Applicable Law, shall hold such Regulatory Approvals in WuXi’s name. |
| 4.2.2 | WuXi will grant Vir direct access to or the right to reference any and all WuXi Regulatory Filings and Regulatory Approvals for the Product in the WuXi Territory, to the extent necessary for the Development and Commercialization of the Products in the Vir Territory. Vir will grant WuXi direct access to or the right to reference any and all Vir Regulatory Filings and Regulatory Approvals for the Product in the Vir Territory, to the extent necessary for the Development, and Commercialization of the Products in the WuXi Territory. |
| 4.3 | Commercialization. |
| 4.3.1 | WuXi and its Affiliates shall be solely responsible for, and shall bear all costs associated with, the Commercialization of Products in the WuXi Territory, including distribution, marketing and sales activities. Subject to the express written terms of this Agreement, all decisions concerning the distribution, marketing and sales of Products in the WuXi Territory including the design, sale, price and promotion of Products in the WuXi Territory shall be within the sole discretion of WuXi. |
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| 4.3.2 | Vir shall be solely responsible for, and shall bear all costs associated with, the Commercialization of Products in the Vir Territory, including distribution, marketing and sales activities. Subject to the express written terms of this Agreement, all decisions concerning the distribution, marketing and sales of Products in the Vir Territory including the design, sale, price and promotion of Products in the Vir Territory shall be within the sole discretion of Vir. |
| 4.3.3 | Following the receipt of Regulatory Approval for any Product in the WuXi Territory, WuXi shall (directly and/or through one or more Affiliates and/or Sublicensees) use Commercially Reasonable Efforts to Commercialize such Product in the WuXi Territory. For clarity, sale of Products at or below cost or at a low profit margin for public health purposes shall be deemed to be consistent with the use of Commercially Reasonable Efforts to Commercialize Products. |
| 4.4 | No Harmful Actions. If a Party believes that the other Party is taking or intends to take any action with respect to any Product that could reasonably be expected to have a material adverse impact upon the Development, Manufacture, Commercialization or regulatory status of any Product in the other Party’s Territory, the impacted Party may bring the matter to the attention of the JSC and the Parties shall discuss in good faith to promptly resolve such concern. |
| 4.5 | Notification of Threatened Action. Each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the Development, Manufacture, Commercialization or regulatory status of any Product. Upon receipt of such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action. |
| 4.6 | Remedial Actions. Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product may be subject to any recall, corrective action or other regulatory action taken by virtue of Applicable Laws (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Each Party shall have sole discretion with respect to any matters relating to any Remedial Action in its respective territory, including the decision to commence such Remedial Action and the control over such Remedial Action, at its cost and expense; provided, however, that if Vir determines that any Remedial Action with respect to any Product in the WuXi Territory should be commenced or is required by Applicable Laws or Regulatory Authority, Vir shall discuss such Remedial Action with WuXi and WuXi shall carry out such Remedial Action upon Vir’s request and [***]. Each Party shall provide the other Party, [***], with such assistance in connection with a Remedial Action as may be reasonably requested by such other Party. Notwithstanding the foregoing, any Remedial Action that relates to the Manufacture of Products hereunder shall be governed by the terms and conditions of the commercial supply agreement entered into pursuant to Section 5.2. |
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| 4.7 | Cross-Territorial Restrictions. Each Party hereby covenants and agrees that it shall not, and shall ensure that its Affiliates and Sublicensees will not, intentionally or knowingly, either directly or indirectly, promote, market, distribute, import, sell or have sold the Products into countries outside its respective territory. If a Party receives any order for any Product from a prospective purchaser reasonably believed to be located in a country outside of its respective territory, such Party shall immediately refer that order to the other Party and such Party shall not accept any such orders. |
| 5. | MANUFACTURE AND SUPPLY |
| 5.1 | Preclinical and Clinical Supply and Quality Agreement. Except for the Rejected Antibody under Section 3.1.3, WuXi shall be responsible, at WuXi’s expense, for the Development Activities set forth in Section 3.1.1(a) through (d), and for manufacturing and supplying, (a) [***], and (b) [***]. WuXi shall be responsible for manufacturing and supplying, at Vir’s expense, Vir’s requirements for Vir Antibodies and Products for use in clinical Development activities (other than the supply provided under subclause (b) at WuXi’s expense) (“Clinical Supply”) and such other Products Covered by the Vir Technology, as may be requested in writing by Vir from time to time, and (b) WuXi’s requirements for pre-clinical testing and Clinical Supply. WuXi shall provide Product for Clinical Supply to Vir [***]. |
| 5.2 | Commercial Supply. WuXi shall be responsible (at Vir’s request, as described below) for manufacturing and supplying (a) Vir’s requirements for Products for Commercialization in the Vir Territory (“Commercial Supply”), and (b) WuXi’s requirements for Commercial Supply in the WuXi Territory. Vir may request in writing at any time during the Term that WuXi provide Commercial Supply to Vir for Vir’s Commercialization of Products in the Vir Territory. Promptly following any such request, the Parties will negotiate the terms of a commercial supply agreement and quality agreement, to be negotiated in good faith on reasonable and customary terms, and entered into by the Parties within [***] after the date of such request by Vir (or such longer period as the Parties may mutually agree). The terms of such commercial supply agreement shall be consistent with this Article 5. Any such Commercial Supply to Vir would be on a non-exclusive basis, and Vir would have the right to obtain Commercial Supply of Products from any Third Party, subject to a transition of Manufacturing in accordance with Sections 5.3 and 5.4. Notwithstanding the foregoing, [***]. |
| 5.3 | Manufacturing Transfer. Vir shall have the right at any time during the Term and on [***] written notice to WuXi, to request that WuXi transition the Manufacture of Vir Antibodies and Products to Vir (or a mutually agreed upon designee of Vir, including a CMO reasonably acceptable to WuXi) so as to obtain Clinical Supply and/or Commercial Supply of Vir Antibodies and Products from a Third Party, including where (i) [***]. If Vir makes such a request to transition the Manufacturing Process and Manufacturing of Vir Antibodies or Products for Vir (the “Transitioned Manufacturing”) to an alternate source of preclinical or Clinical Supply or Commercial Supply, the Parties shall cooperate to transition the Transitioned Manufacturing to Vir (or to Vir’s selected contract manufacturing organization the “Approved CMO”). If WuXi or any |
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| Affiliate has an existing relationship with such Approved CMO, WuXi shall facilitate discussions between Vir and such Approved CMO with respect to Vir’s negotiation and entry into a contract for the continued supply of Vir Antibodies or Product for Vir’s further supply needs for Products. In any event, WuXi shall cooperate to provide to Vir (or to such Approved CMO under obligations of confidentiality) all existing manufacturing data, information or other Know-How (including the then-current Manufacturing Process) then in WuXi’s or its Affiliates’ possession and Control and reasonably required for Vir (or such Approved CMO) to perform such Transitioned Manufacturing of Vir Antibodies or Products (the “WuXi Manufacturing Know-How”) at Vir’s reasonable cost and expense. WuXi shall also, in connection therewith, grant and hereby grants to Vir or to such Approved CMO a non-exclusive, royalty-free (except for any royalties payable under the Cell Line License Agreement) license under any WuXi Manufacturing Know-How, to use such manufacturing technology solely for the purposes of Manufacturing or having Manufactured Vir Antibodies or Products for Vir for the Vir Territory under a manufacturing transfer and licensing agreement. Subject to Article 13, Vir shall be responsible for all reasonable costs associated with the transition to Vir (or to such Approved CMO) (including payment at a commercially reasonable full time equivalent personnel rate for hours of consulting support provided by WuXi). Vir shall be responsible for all costs associated with the Manufacture, technology transfer and supply of Products by any such Approved CMO. The Parties shall use their Commercially Reasonable Efforts to complete the transition of the Transitioned Manufacturing as soon as practicable, as applicable, and in any event within four (4) months following the date of Vir’s initial request. Where WuXi transfers a Licensed Cell Line to a Third Party CMO, Vir shall be responsible for the payment of a royalty to WuXi on Net Sales in the Vir Territory for Product manufactured by CMOs other than WuXi, in accordance with the terms of the Cell Line License Agreement. Where WuXi performs Transitioned Manufacturing, it shall provide Vir with an estimate of reasonable, documented costs associated with such transition to Vir (or to such Approved CMO) within [***] following the end of the applicable Calendar Quarter, and provide an invoice therefor within [***] following the end of such Calendar Quarter. Vir shall pay any undisputed invoice within [***] following receipt of the invoice from WuXi. |
| 5.4 | Technology Transfer. The transfer of Transitioned Manufacturing and continued supply of Products, if any, pursuant to Section 5.3 shall be conducted in accordance with a transition plan (“Manufacturing Transition Plan”) which shall be mutually approved by the Parties and which will set forth responsibilities and schedules for transferring the Transitioned Manufacturing as expeditiously as reasonably practicable. The Manufacturing Transition Plan shall set forth the number of hours of consulting support that WuXi will provide as reasonably requested and necessary to facilitate the transition of the Transitioned Manufacturing for Products. |
| 5.5 | Vir Designee. Vir shall have the right to collaborate with, or have performed all or a portion of the Development of the Products in the Vir Territory by a Third Party designated by Vir in its sole discretion (a “Vir Designee”) (including for clarity, having such Vir Designee serve as the sponsor for any Clinical Trial intended to be conducted by or for Vir in the Vir Territory), and Vir shall have the right (but not the obligation) to exercise any or all of its Development rights or fulfill any or all of its related obligations under this Agreement through such Vir Designee. WuXi shall cooperate fully with any Vir Designee(s) in connection with any Development Activities performed by a Vir Designee to the same extent that WuXi has the obligation under this Agreement to |
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| cooperate with Vir. Without limiting the generality of the foregoing, Vir shall have the right to designate any Vir Designee as the recipient of Clinical Supply of the Product, and WuXi shall supply directly to such Vir Designee, pursuant to the Clinical Supply Agreement or a separate clinical supply agreement entered into between WuXi and such Vir Designee (which shall contain terms that are substantially similar to those set forth in the Clinical Supply Agreement between WuXi and Vir pursuant to Section 5.1. In addition, at the request of Vir or the Vir Designee, WuXi shall enter into an appropriate quality agreement with such Vir Designee upon terms mutually agreed upon between WuXi and such Vir Designee. |
| 6. | LICENSE GRANTS; INTELLECTUAL PROPERTY OWNERSHIP |
| 6.1 | Development Plan Licenses. |
| 6.1.1 | Grant to WuXi. Vir hereby grants to WuXi a royalty-free, non-exclusive, worldwide license, with the right to grant sublicenses solely to Subcontractors engaged in accordance with Section 3.3, under the Vir Technology and Vir’s interest in any Collaboration Technology solely to perform the Development Activities allocated to WuXi as set forth under and in accordance with the applicable Development Plan, including any Initial Development Activities under the MSA. |
| 6.1.2 | Grant to Vir. WuXi hereby grants to Vir a royalty-free, non-exclusive, worldwide license, with the right to grant sublicenses solely to Subcontractors engaged in accordance with Section 3.3, under the WuXi Technology and WuXi’s interest in any Collaboration Technology solely to perform the Development Activities allocated to Vir as set forth under and in accordance with the applicable Development Plan, including any Initial Development Activities under the MSA. |
| 6.2 | Development and Commercialization Licenses. |
| 6.2.1 | Vir Grant. Subject to the terms and conditions of this Agreement, Vir hereby grants to WuXi (a) an exclusive (even as to Vir and its Affiliates), royalty bearing, sublicenseable (but only in accordance with Section 6.3), license under the Patents included in the Vir Technology and Vir Collaboration Patent Rights, and (b) a non-exclusive, royalty bearing, sublicenseable (but only in accordance with Section 6.3) license under the Know-How included in the Vir Technology and Vir’s interest in Collaboration Know-How, in each case ((a) and (b)), to Develop, Manufacture and Commercialize Vir Antibodies and Product(s) in the Field in the WuXi Territory during the Term. Notwithstanding the foregoing, the Vir Background Know-How and Vir’s solely owned Collaboration Know-How shall be sublicenseable only in connection with the rights of WuXi with respect to Vir Antibodies and Products and not with respect to any other products or services. For clarity, no license is hereby extended to WuXi to Develop, Manufacture or Commercialize any product, compound or active ingredient Controlled by Vir that is not a Vir Antibody (including in any Combination Product) or Product, under any Vir Technology, or under Vir’s interest in the Collaboration Technology. |
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| 6.2.2 | WuXi Grant. Subject to the terms and conditions of this Agreement, WuXi hereby grants to Vir (a) an exclusive (even as to WuXi and its Affiliates), royalty-free (subject to Section 6.5 with respect [***] sublicenseable (but only in accordance with Section 6.3), license under the Patent Rights [***] and (b) a non-exclusive, royalty bearing, sublicenseable (but only in accordance with Section 6.3) license under the Know-How included in the WuXi Technology and WuXi’s interest in Collaboration Know-How, excluding any Know-How included in the WuXi Bispecific Platform Technology, in each case ((a) and (b)), to Develop, Manufacture and Commercialize Vir Antibodies and Product(s) in the Field in the Vir Territory during the Term. Notwithstanding the foregoing, the WuXi Background Know-How and WuXi’s solely owned Collaboration Know-How shall be sublicenseable only in connection with the rights of Vir with respect to Vir Antibodies and Products and not with respect to any other products or services. For clarity, (a) no license is hereby extended to Vir to Develop, Manufacture or Commercialize any product, compound or active ingredient Controlled by WuXi that is not a Vir Antibody (including in any Combination Product), under any WuXi Technology, or under WuXi’s interest in the Collaboration IP, and (b) no license is granted to Vir under the WuXi Bispecific Platform Technology. |
| 6.3 | Affiliate Rights. The rights licensed to WuXi under this Article 6 shall be extended to those Affiliates of WuXi, provided that, each Affiliate agrees to be bound by the terms and conditions of this Agreement as if it were WuXi hereunder, and any act or omission by an Affiliate of WuXi will be deemed as an act or omission by WuXi hereunder, and WuXi shall be responsible for each of its Affiliates complying with all obligations of WuXi under this Agreement. |
| 6.4 | Sublicenses. |
| 6.4.1 | Sublicenses by Vir. Vir and its Affiliates shall be entitled, [***] to grant one or more sublicenses under the licenses granted to Vir under Section 6.2, in full or in part, by means of written agreement to any Affiliate or to one or more Third Parties (with the right to sublicense through multiple tiers), provided, however, that as a condition precedent to and requirement of any such sublicense: (a) any such permitted sublicense shall be consistent with and subject to the terms and conditions of this Agreement; and (b) Vir will continue to be responsible for full performance of Vir’s obligations under the Agreement and will be responsible for all actions of such Sublicensee as if such Sublicensee were Vir hereunder. |
| 6.4.2 | Sublicenses by WuXi. WuXi and its Affiliates shall be entitled, [***] to grant one or more sublicenses under the licenses granted to WuXi under Section 6.2, in full or in part, by means of written agreement to any Affiliate or to one or more Third Parties (with the right to sublicense through multiple tiers), provided, however, that as a condition precedent to and requirement of any such sublicense: (a) any such permitted sublicense shall be consistent with and subject to the terms and conditions of this Agreement; (b) WuXi will continue to be responsible for full performance of WuXi’s obligations under the Agreement and will be responsible for all actions of such Sublicensee as if such Sublicensee were WuXi hereunder, and (c) WuXi shall be liable to make payments of Sublicense Revenue to Vir in connection with such sublicenses in accordance with Section 7.3. |
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| 6.5 | Cell Line License Agreement. The Parties acknowledge and agree that pursuant to Article 4 of the Cell Line License Agreement, Vir may be required to pay a royalty to WuXi on Net Sales (as defined in the Cell Line License Agreement) of Products that incorporate a Licensee Recombinant Protein expressed by the Licensed Cell Line. The Parties further agree that simultaneous with, or within [***] following the Effective Date, they will enter into an amendment to the Cell Line License Agreement, amending the definition of Work Orders under the Cell Line License Agreement to include (a) all work orders entered into under the MSA following the effective date of the Cell Line License Agreement, and (b) all Development Work Orders, in each case under which WuXi provides (or has provided) to Vir any Licensee Recombinant Protein. Accordingly, the Parties agree that if (i) WuXi develops and provides to Vir any Licensee Recombinant Protein under a Development Work Order that is incorporated into any Products, (ii) Vir requests Transitioned Manufacturing and technology transfer to a Third Party under Sections 5.3 and 5.4, and (c) WuXI is responsible for Manufacturing less than [***] of Vir’s requirements for Products for Commercialization, then Vir shall be required to pay to WuXi (A) a License Fee pursuant to Section 3.1 of the Cell Line License Agreement, and (B) a royalty on Net Sales of Products at a rate of up to [***] in accordance with the terms of the Cell Line License Agreement (as amended by the Cell Line License Agreement Amendment set forth in Schedule 1.13). For clarity, the Cell Line License Agreement shall remain in force and shall continue to apply to Vir with respect to any Products that incorporate a Licensee Recombinant Protein, including the payment terms set forth in Article 5 thereof. |
| 7. | FINANCIAL TERMS |
| 7.1 | Royalties. WuXi shall pay to Vir royalties on annual Net Sales of all Products sold by WuXi, its Affiliates or Sublicensees in the WuXi Territory during the Royalty Term for each such Product. Such annual Net Sales for Products shall be aggregated for all Products in order to determine the royalty rate applicable to the corresponding incremental portion of such aggregate annual Net Sales, as set forth in the table below. |
| Aggregate Annual Net Sales in WuXi Territory (in USD) |
Royalty Rate | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] |
| 7.2 | Royalty Term. Royalties will be payable on a quarterly basis; any such payments shall be made within [***] after the end of the Calendar Quarter during which the applicable Net Sales occurred. |
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| WuXi’s obligation to pay royalties with respect to a particular Product in a particular country shall commence upon the First Commercial Sale of such Product in such country (or any sale permitted in the WuXi Territory prior to the grant of Regulatory Approval of the Products, if earlier) and shall expire on the later of (a) the date on which the Exploitation of such Product is no longer Covered by a Valid Claim of (i) a Patent included in the Vir Background Patent Rights or a Joint Collaboration Patent in such country, (b) the loss of Regulatory Exclusivity for the Product in such country, or (c) the [***] of the First Commercial Sale of the first Product in such Program in such country (the “Royalty Term”). WuXi shall provide Vir with an estimate of the royalties payable on Net Sales in the WuXi Territory by WuXi, its Affiliates or Sublicensees within [***] following the end of the applicable Calendar Quarter, and shall provide an updated report with payment in accordance with Section 7.5. |
| 7.3 | Sublicense Revenue. WuXi shall pay Vir a percentage of all Sublicense Revenue paid to WuXi or its Affiliates by a Sublicensee in consideration for any sublicense granted to Sublicensee pursuant to Section 6.3, based on the timing of the grant of such sublicense, as follows: |
| 7.3.1 | For sublicenses granted [***] in the WuXi Territory – [***] of all Sublicense Revenue; and |
| 7.3.2 | For sublicenses granted [***] in the WuXi Territory – [***] of all Sublicense Revenue. |
WuXi will make Sublicense Revenue payments to Vir within [***] after the receipt by WuXi of any Sublicense Revenue from any Sublicensee, provided that in the case of any Sublicense Revenue received by WuXi in the form of non-cash consideration, such Sublicense Revenue shall be payable to Vir within [***] following the conversion at fair market value of such non-cash Sublicense Revenue to its cash equivalent.
| 7.4 | No Other Compensation. Other than as explicitly set forth in this Agreement or in connection with the supply of Products by WuXi to Vir pursuant to the MSA or any applicable supply agreements, neither Party will be obligated to pay any additional fees, milestone payments, royalties or other payments of any kind to the other hereunder. |
| 7.5 | Method of Payment. Unless otherwise agreed by the Parties, all payments due from WuXi to Vir under this Agreement shall be paid in U.S. Dollars by wire transfer or electronic funds transfer of immediately available funds to the following account: |
| [***] |
Vir may change the account listed above with [***] written notice to WuXi. On a Product-by-Product basis following the First Commercial Sale of the first Product until expiration of the last applicable Royalty Term, WuXi shall prepare and deliver to Vir royalty reports of the sale of Products by WuXi, its Affiliates and Sublicensees for each Calendar Quarter within [***] of the end of each such Calendar Quarter specifying in the aggregate and on a Product-by-Product and country-by-country basis: (a) total gross amounts for Products sold or otherwise disposed of by WuXi, its Affiliates and Sublicensees; (b) amounts deducted by category in accordance with Section 1.66 from gross amounts to calculate Net Sales; (c) Net Sales; and (d) royalties payable.
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| 7.6 | Currency Conversion. In the case of sales outside the United States, amounts received by WuXi will be expressed in the U.S. Dollar equivalent calculated on a quarterly basis in the currency of the country of sale and converted to their U.S. Dollar equivalent using the a rate of exchange which corresponds to the rate of exchange for such currency reported in The Wall Street Journal, Internet U.S. Edition at www.wsj.com, as of the last day of the applicable reporting period (or, if unavailable on such date, the first date thereafter on which such rate is available). |
| 7.7 | Late Payments. If any payment due hereunder is not made when due, the payment shall accrue interest beginning on the day following the due date thereof, calculated at two percentage points above the annual rate of the prime interest rate quoted by The Wall Street Journal, Internet U.S. Edition at www.wsj.com on the date said payment is due, the interest being compounded on the last day of each Calendar Quarter; provided that in no event shall said annual interest rate exceed the maximum rate permitted by Applicable Law. Each such payment when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not negate or waive the right of any Party to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment including, but not limited to termination of this Agreement as set forth in Article 13. |
| 7.8 | Records and Audits. Each party will keep complete and accurate records of the underlying revenue and expense data relating to the calculations of (a) WuXi Net Sales (in the case of WuXi), or (b) Net Sales (in the case of Vir, solely where Vir is required to pay a royalty to WuXi under the terms of the Cell Line License Agreement) generated in the then current calendar year and payments required under this Agreement, and during the preceding [***]. Each party will have the right, once annually, and solely during any period when royalties are payable by the other party under this Agreement (in the case of WuXi) or the Cell Line License Agreement (in the case of Vir) at its own expense, to have an internationally recognized, independent, certified public accounting firm, selected by it and subject to the other party’s prior written consent (which shall not be unreasonably withheld), review any such records of the other party and its Affiliates and Sublicensees in the location(s) where such records are maintained by the other party upon reasonable written notice (which shall be [***] prior written notice) and during regular business hours and under obligations of strict confidence, for the sole purpose of verifying the basis and accuracy of payments made (i) by WuXi under Sections 7.1 and 7.3, or (ii) by Vir, under the Cell Line License Agreement, and within the [***] preceding the date of the request for review. No calendar year will be subject to audit under this Section 7.8 more than once. Should such inspection lead to the discovery of a discrepancy to one party’s detriment, the other party will, within [***] after receipt of such report from the accounting firm, pay any undisputed amount of the discrepancy together with interest at the rate set forth in Section 7.7. The auditing party will pay the full cost of the review unless the underpayment of amounts due to the auditing party is greater than [***] of the amount due for the entire period being examined, in which case the other party will pay the cost charged by such accounting firm for such review. Should the audit lead to the discovery of a discrepancy to the other party ‘s detriment, such other party may credit the amount of the discrepancy, without interest, against future payments payable to the auditing party under this Agreement or the Cell Line License Agreement, as applicable, and if there are no such payments payable, then the auditing party shall pay to the other party the amount of the discrepancy, without interest, within [***] of the auditing party’s receipt of the report. |
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| 7.9 | Taxes. |
| 7.9.1 | Withholding. In the event that any Applicable Law requires WuXi to withhold taxes with respect to any payment to be made by WuXi pursuant to this Agreement, WuXi will notify the Vir of such withholding requirement prior to making the payment to Vir and provide such assistance to Vir, including the provision of such standard documentation as may be required by a tax authority, as may be reasonably necessary in Vir’s efforts to claim an exemption from or reduction of such taxes. WuXi will, in accordance with such Applicable Law withhold taxes from the amount due, remit such taxes to the appropriate tax authority, and furnish Vir with proof of payment of such taxes within [***] following the payment. If taxes are paid to a tax authority, WuXi shall provide reasonable assistance to Vir to obtain a refund of taxes withheld, or obtain a credit with respect to taxes paid. |
| 7.9.2 | VAT. All payments due to Vir from WuXi pursuant to this Agreement shall be paid exclusive of any value-added tax (“VAT”) (which, if applicable, shall be payable by WuXi upon receipt of a valid VAT invoice). If Vir determines that it is required to report any such tax, WuXi shall promptly provide Vir with applicable receipts and other documentation necessary or appropriate for such report. For clarity, this Section 7.9.2 is not intended to limit WuXi’s right to deduct value-added taxes in determining Net Sales. |
| 8. | IP OWNERSHIP; PATENT MATTERS |
| 8.1 | Ownership. |
| 8.1.1 | Background Technology. Each Party will own all right, title and interest in its Background Technology. Vir may update Schedule 1.99 with additional Vir Background Technology to be used under one or more Development Plans from time to time, and WuXi may update Schedule 1.110 with additional WuXi Background Technology to be used under one or more Development Plans from time to time. |
| 8.1.2 | Collaboration Technology. Ownership of Collaboration Technology shall follow inventorship. Inventorship will be determined according to United States Patent Law (without reference to any conflict of law principles). For clarity, the terms of the MSA shall determine ownership of inventions or improvements arising under any Development Work Order or the MSA, including in connection with any Initial Development Activities (a “MSA Invention”), and any such MSA Invention shall be included in each Party’s Background Technology and within the licenses granted under this Agreement. WuXi, on behalf of itself and its Affiliates, hereby grants and agrees to grant to Vir a fully paid up, perpetual, worldwide, non-exclusive license, with a right to grant sublicenses, under Collaboration Technology solely owned by WuXi, solely to the extent such Collaboration Technology claims an Improvement to Vir Background Technology, to Exploit such |
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| Improvement to Vir Background Technology for all purposes. Vir, on behalf of itself and its Affiliates, hereby grants and agrees to grant to WuXi a fully paid up, perpetual, worldwide, non-exclusive license, with a right to grant sublicenses, under Collaboration Technology solely owned by Vir, solely to the extent such Collaboration Technology claims an Improvement to WuXi Background Technology, to Exploit such Improvement to WuXi Background Technology for all purposes. |
| 8.1.3 | Practice Under and Other Use of Joint Collaboration Technology. Subject to the rights and licenses granted to, and the obligations of, each Party pursuant to this Agreement and, if applicable, the License Agreements, the Parties will jointly own all jointly invented Collaboration Technology (the “Joint Collaboration Technology”), and each Party shall be entitled to the free use and enjoyment of all such Joint Collaboration Technology. Subject to the rights granted under and the restrictions set forth in this Agreement, including in each Party’s respective territory, neither Party will have any obligation to account to the other Party for profits, or to obtain any approval of the other Party to license, assign, or otherwise exploit any Joint Collaboration Technology by reason of joint ownership thereof, and each Party hereby waives any right it may have under the applicable Law of any jurisdiction to require any such approval or accounting. To the extent any further consent is required to enable a Party to so license or exploit its interest in the Joint Collaboration Technology, the other Party may not unreasonably withhold consent to such request, and shall deliver such consent, if applicable, promptly upon such Party’s reasonable request. |
| 8.2 | Disclosure of Inventions. Each Party will promptly disclose to the other Party all Inventions made in the course of performing any Development and Manufacturing Activities that such Party makes, conceives, discovers, or otherwise generates, whether solely or jointly with others, within [***] of becoming aware of such Invention, including all invention disclosures or other similar documents submitted to such Party by its or its Affiliates’ employees, agents, or independent contractors relating thereto. Each Party will also promptly respond to reasonable requests from the other Party for additional information relating thereto. |
| 8.3 | Joint Collaboration Patent Rights. |
| 8.3.1 | Filing, Prosecution, and Maintenance. Except as otherwise agreed by the Parties, each Party will own a joint undivided interest in each Joint Collaboration Patent Right. Subject to the terms of this Agreement, (a) WuXi will have the first right, but not the obligation, to prepare, file, prosecute, and maintain any Joint Collaboration Patent Rights that claim inventions that specifically relate to any Manufacturing Process, or the Manufacture of Products or Antibodies, and (b) Vir shall have the first right, but not the obligation to prepare, file, prosecute, and maintain any Joint Collaboration Patent Rights that claim inventions that specifically relate to the composition or method of use of Antibodies or Products, in each case of (a) or (b), throughout the world using patent counsel selected by the prosecuting Party in the name of both Parties. The prosecuting Party (the “Prosecuting Party”) shall periodically inform the other Party of all material steps with respect to the preparation, filing, prosecution and maintenance of the Joint Collaboration Patent Rights, |
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| including by providing such other Party with a copy of all material submissions to any patent office (including the text of each patent application) and all substantive correspondence received from any patent office with respect to the Joint Collaboration Patent Rights, as applicable, sufficiently in advance of submitting such filings or responses so as to allow for a reasonable opportunity for the other Party to review and comment thereon (including providing comments with respect to any decision to file or not to file in a given jurisdiction). The Prosecuting Party shall (a) consider in good faith the requests and suggestions of the other Party with respect to such drafts and with respect to strategies for filing and prosecuting the Joint Collaboration Patent Rights (including the jurisdictions in which to prosecute and not prosecute) and (b) shall incorporate all such reasonable comments timely provided by the other Party, provided that the Prosecuting Party shall have the final authority over such prosecution decisions. The non-prosecuting Party will (i) upon the Prosecuting Party’s request, reasonably assist the Prosecuting Party in connection therewith, and (ii) reimburse the Prosecuting Party for [***] of the reasonable costs and expenses incurred by the Prosecuting Party in preparing, filing, prosecuting, and maintaining such Joint Collaboration Patent Rights, which reimbursement will be made pursuant to invoices submitted no more often than once per Calendar Quarter, and within [***] following the end of the Calendar Quarter. |
| 8.3.2 | Background Patents. Each Party will be responsible for the preparation, filing, prosecution, maintenance, defense and extension of Patent Rights claiming Improvements to such Party’s Background Technology and any other Inventions made solely by or on behalf of a Party that are not otherwise included in the Joint Collaboration Technology. |
| 8.3.3 | Abandonment. If the Prosecuting Party at any time wishes to abandon or decline to prosecute any Joint Collaboration Patent Rights or otherwise declines to share in its 50% of the costs thereof, then on a country by country basis, the Prosecuting Party will provide the other Party with written notice of such election at least [***] prior to the deadline for filing any such prosecution action for such Patent Right or the date on which the abandonment of any such Patent Right would become effective, in which event, (a) the Prosecuting Party will have no responsibility for any expenses incurred in connection with such Joint Collaboration Patent Right after delivery of such written notice, (b) the other Party will have the right to continue and control prosecution and maintenance of the Joint Collaboration Patent Rights, and (c) if such other Party elects to continue prosecution or maintenance, then the Prosecuting Party, upon the other Party’s request, will execute such documents and perform such acts, at such other Party’s expense, as may be reasonably necessary to (i) assign to the other Party all of the Prosecuting Party’s rights, title, and interests in and to such Joint Collaboration Patent Right and (ii) permit the other Party to file, prosecute, and maintain such Joint Collaboration Patent Right. For clarity, if the Prosecuting Party abandons any Joint Collaboration Patent Right, and also declines to share in its 50% of the costs thereof following such abandonment and assignment to the other Party, then such Joint Collaboration Patent Right will thereafter no longer be considered a Joint Collaboration Patent Rights, and such Patent Right be solely owned by such other Party and included within such Party’s Background Technology. |
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| 8.4 | Enforcement of Joint Collaboration Patent Rights. |
| 8.4.1 | Notice. If either Party becomes aware of any potential infringement of any Joint Collaboration Patent Right anywhere in the world, then such Party will promptly notify the other Party in writing. The Parties will discuss in good faith through the JSC which Party should take the lead take action to obtain a discontinuance of the infringement or bring suit against the Third Party infringer of any Joint Collaboration Patent Right, provided that in the event of a dispute, the Prosecuting Party with respect to a given Joint Collaboration Patent Right shall have the first right, but not the obligation to enforce such Joint Collaboration Patent Right, and provided that WuXi will have the first right to enforce any Joint Collaboration Patent Right in the WuXi Territory. The enforcing Party will have the right to cause the other Party to join as a party plaintiff to any such suit, at the enforcing Party’s expense, where such joinder is necessary for the enforcement of any such Joint Collaboration Patent Right. If, after [***] after the date of notice of such infringement, the Party chosen by the JSC to enforce any Joint Collaboration Patent Right has not obtained a discontinuance of infringement of any such Joint Collaboration Patent Right, or filed suit against such Third Party infringer or provided the Party not chosen by the JSC with information and arguments demonstrating to the Party not chosen by the JSC’s reasonable satisfaction that there is insufficient basis for the allegation of such infringement, then the Party not chosen by the JSC will have the right, but not the obligation, to bring suit against such Third Party infringer of such Joint Collaboration Patent Right with the Party chosen by the JSC’s prior written consent, which consent will not be unreasonably withheld, conditioned, or delayed. |
| 8.4.2 | Recoveries. Each Party will bear its own expenses in connection with any enforcement action taken by such Party in connection with Joint Collaboration Patent Rights. Any recovery obtained by either Party as a result of any proceeding against a Third Party infringer will be allocated as follows: (a) each Party will be reimbursed pro rata for all out-of-pocket litigation costs incurred by that Party; and (b) after such reimbursement, the Parties will share equally the remaining portion of any such recovery. |
| 9. | TREATMENT OF CONFIDENTIAL INFORMATION |
| 9.1 | Nondisclosure and Non-Use. Each Party agrees that, during the Term and for a period of [***] thereafter, the Receiving Party receiving Confidential Information of the Disclosing Party (or that has received any such Confidential Information from the other Party prior to the Effective Date) will (a) maintain in confidence such Confidential Information using the efforts such Receiving Party uses to maintain in confidence its own proprietary industrial information of similar kind and value; (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted below; and (c) not use such Confidential Information for any purpose except those expressly permitted by this Agreement. |
| 9.2 | Exceptions. The obligations under Section 9.1 will not apply with respect to any portion of the other Party’s Confidential Information that the Receiving Party can demonstrate: |
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| 9.2.1 | was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or restrict its use, prior to disclosure by the Disclosing Party; |
| 9.2.2 | is subsequently lawfully disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation on the Receiving Party to keep it confidential or restrict its use; |
| 9.2.3 | is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party, through no wrongful act, fault or negligence on the part of such Receiving Party; or |
| 9.2.4 | is independently developed by employees, contractors, consultants, or agents of the Receiving Party or any of its Affiliates through activities outside of the Development Program (including any Initial Manufacturing Activities) without the aid, application, or use of Confidential Information of the Disclosing Party. |
| 9.3 | Authorized Disclosure. To the extent (and only to the extent) that it is reasonably necessary to fulfill its obligations or exercise its rights under this Agreement, the Receiving Party may disclose Confidential Information belonging to the Disclosing Party in the following instances: |
| 9.3.1 | to an Approved CMO in connection with Transitioned Manufacturing (and subsequent Manufacture of Products) under Article 5; |
| 9.3.2 | filing or prosecuting patent applications and enforcing and defending Patent Rights, in each case, in accordance with this Agreement; |
| 9.3.3 | pursuing regulatory filings provided that the Disclosing Party shall take all reasonable steps to limit disclosure of the Confidential Information so disclosed outside the applicable governmental authority and to otherwise maintain the confidentiality of such Confidential Information; |
| 9.3.4 | prosecuting or defending litigation under this Agreement; |
| 9.3.5 | subject to Section 9.4, complying with applicable Law and with judicial process, if, in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance; |
| 9.3.6 | disclosing, in connection with the performance of this Agreement and solely on a need-to-know basis, to Subcontractors, actual or potential Sublicensees or academic or collaboration partners, including any Subcontractor, or to its Affiliates or its or its Affiliates’ respective employees, contractors (including clinical investigators), consultants or agents; provided that each of the foregoing, prior to any disclosure, is bound by written obligations of confidentiality and non-use no less restrictive than the obligations set forth in this Article 9. |
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| 9.3.7 | disclosing to the members of its board of directors and its attorneys, independent accountants, financial advisors, actual or potential lenders, acquirers, licensors, financing sources, or investors; provided that each of the foregoing, prior to any disclosure, is bound by written obligations of confidentiality and non-use no less restrictive than the obligations set forth in this Article 9, provided further that such disclosure is only made on a reasonable need-to-know basis. |
The Receiving Party will remain responsible for any failure by any Third Party who receives Confidential Information pursuant to this Section 9.3 to treat such Confidential Information as protected under this Article 9.
If and whenever any Confidential Information is disclosed in accordance with this Section 9.3, such disclosure will not cause any such information to cease to be Confidential Information except to the extent that such permitted disclosure results in a public disclosure of such information (other than by breach of this Agreement). Where reasonably possible and subject to Section 9.4, the Receiving Party will notify the Disclosing Party of the Receiving Party’s intent to make such disclosure pursuant to Section 9.3.1 through Section 9.3.5 sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information.
| 9.4 | Required Disclosure. A Receiving Party may disclose the Disclosing Party’s Confidential Information pursuant to interrogatories, requests for information or documents, subpoena, civil investigative demand issued by a court or governmental agency or as otherwise required by Law; provided that, if permitted, the Receiving Party will notify the Disclosing Party promptly upon receipt thereof, giving (where practicable) the Disclosing Party sufficient advance notice to permit it to oppose, limit, or seek confidential treatment for such disclosure, and to file for patent protection if relevant. In any event, the Receiving Party will furnish only that portion of the Confidential Information that it is advised by counsel is legally required, whether or not a protective order or other similar order is obtained by the Disclosing Party. |
| 9.5 | Publicity; Publications. Neither Party will use the name, insignia, symbol, trademark, trade name, or logotype of the other Party or its Affiliates in any publication, press release, promotional material, external presentation or other form of publicity without the prior written consent of the other Party, and neither Party will identify the other Party as an actual or potential investor, strategic or collaboration partner, licensee, or acquirer of such Party without the prior written consent of the other Party, except for those disclosures authorized under Section 9.2 or Section 9.4 or made pursuant to this Section 9.5. Each Party agrees not to issue any other press release or other public statement disclosing other information relating to this Agreement or the transactions contemplated hereby, including the Discovery Data, without the prior written consent of the other Party, which consent will not be unreasonably withheld, conditioned, or delayed. Notwithstanding any provision to the contrary set forth in this Agreement, any disclosure that is required by Law or the rules of a securities exchange, as reasonably advised by the disclosing Party’s counsel, may be made subject to the following terms of this Section 9.5. The Parties agree that any such announcement will not contain business or technical information that is the Confidential Information of the Party not subject to such disclosure obligation and, if disclosure of such business or technical information is |
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| required by Law, then the Parties will use reasonable efforts to minimize such disclosure and obtain confidential treatment for any such information that is disclosed to a Governmental Authority. Each Party agrees to provide to the other Party a copy of any public announcement or disclosure required by Law regarding this Agreement or the subject matter thereof as soon as reasonably practicable under the circumstances prior to its scheduled release or disclosure. Each Party will use Commercially Reasonable Efforts to provide the other Party with an advance copy of any such announcement or disclosure required by Law at least [***] prior to its scheduled release or disclosure. Each Party will have the right to expeditiously review and recommend changes to any such announcement or disclosure and, except as otherwise required by Law or on the advice of the Party’s counsel whose announcement or disclosure has been reviewed, such Party will remove any information the reviewing Party reasonably deems to be inappropriate for disclosure. The contents of any announcement, similar publicity, or disclosure that has been reviewed and approved by the reviewing Party can be re-released by either Party without a requirement for re-approval so long as such information remains accurate and reasonably up to date so as not to be misleading. |
| 10. | REPRESENTATIONS AND WARRANTIES |
| 10.1 | Mutual Representations. Each Party hereby represents and warrants as of the Effective Date that: |
| 10.1.1 | it is a corporation duly organized, validly existing, and in good standing under the Laws of the country of its incorporation; |
| 10.1.2 | the execution and delivery of this Agreement and the performance of the transactions and other matters contemplated by this Agreement have been duly authorized by all appropriate corporate actions of such Party; |
| 10.1.3 | this Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms, and the execution, delivery, and performance of this Agreement by the Parties does not conflict with any agreement or understanding, whether written or oral, to which such Party is a party or by which it is bound; |
| 10.1.4 | none of the execution, delivery, or the performance by such Party of this Agreement, nor the consummation by such Party of the transactions and other matters contemplated hereby will: (a) require the consent of any Person, violate or conflict with, or result in a breach of, any provision of, or constitute a default under (or, with notice or lapse of time or both, would constitute a default under) any agreement, whether written or oral, that would result in a material adverse effect; or (b) violate or conflict with any Applicable Law or court order applicable to such Party or to which the assets of such Party are subject or bound that would result in a material adverse effect; |
| 10.1.5 | Each Party has the full right and legal capacity to grant the rights granted to the other Party hereunder without violating the rights of any Third Party; |
| 10.1.6 | there are no consents, approvals, permits, authorizations, waivers, or other actions by, or filings with or notifications to, any Governmental Authority that are required to be obtained or made by such Party in connection with the execution, delivery, or performance by such Party of this Agreement or the performance of such Party’s obligations hereunder; |
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| 10.1.7 | such Party is not currently subject to any agreement (whether written or oral) between such Party and any other Person, or to any outstanding order, judgment or decree of any court or administrative agency, that restricts such Party in any way from granting the rights to the other Party hereunder; |
| 10.1.8 | to such Party’s Knowledge, no Person is infringing or threatening to infringe or misappropriate any Intellectual Property Rights Controlled by such Party that are licensed to the other Party hereunder; |
| 10.1.9 | to such Party’s Knowledge, no Patent Rights Controlled by such Party that are licensed to the other Party hereunder are subject to any threatened or ongoing dispute regarding the inventorship or ownership of any rights contained therein; and |
| 10.1.10 | such Party has enforceable written agreements with all of its employees who (a) may perform services under the Development Program assigning to such Party ownership of (and waive any moral rights to) all intellectual property rights created in the course of their employment, or otherwise sufficient for such Party to comply with its obligations hereunder; or (b) may receive the other Party’s Confidential Information otherwise sufficient for such Party to comply with its obligations under Article 9. |
| 10.2 | No Other Warranties. Nothing in this Agreement is or will be construed as: |
| 10.2.1 | a warranty or representation by either Party as to the validity or scope of any patent application or patent licensed hereunder; and |
| 10.2.2 | a warranty or representation that the Development Program will be successful in developing products that will be successfully developed and commercialized. |
| 10.3 | Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR AS TO THE SUCCESS OR LIKELIHOOD OF SUCCESS OF THE RESEARCH UNDER THIS AGREEMENT, OR ANY OTHER EXPRESS OR IMPLIED WARRANTIES. |
| 11. | CERTAIN GENERAL COVENANTS |
| 11.1 | WuXi and Vir General Covenants. Each Party covenants to the other Party that, from the Effective Date and during the Term, such Party will perform and observe the following covenants and provisions: |
| 11.1.1 | Corporate Existence. It will maintain its corporate existence in good standing in the jurisdiction of its incorporation and the qualification in each other foreign jurisdiction in which it does business, except where the failure to maintain such foreign qualification would not have a material adverse effect on the business, operations, or financial condition of such Party. |
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| 11.1.2 | Compliance with Laws. Each Party will comply with all applicable Laws, including Anti-Corruption Laws, the noncompliance with which could adversely affect its business, operations, or condition (financial or otherwise) or adversely affect the ability of each Party to consummate the transactions and other matters contemplated by this Agreement. None of such Party’s employees, agents, or contractors will, directly or indirectly, engage in any activities that violate any Anti-Corruption Law (a) in order to influence official action of any government official, or (b) with the intention of or as a condition to inducing any person to carry out a duty or function improperly or to reach a favorable decision on an improper basis, in each case, in connection with the activities contemplated under this Agreement. |
| 11.1.3 | Maintenance of Insurance. Each Party will maintain insurance with insurance companies or associations that such Party reasonably believes to be financially sound and reputable, in such amounts and covering such risks, as determined by such Party’s board of directors in good faith, as is usually carried by companies engaged in similar businesses and owning similar properties in the same general areas in which such Party operates. |
| 11.2 | Vir and WuXi Covenants. Each Party covenants and agrees that, from the Effective Date and during the Term, such Party will perform and observe the following covenants and provisions: |
| 11.2.1 | Confidentiality and Invention Assignment Agreements; Controls. Each Party will obtain and maintain enforceable written agreements with all of its employees, and will use reasonable efforts to obtain and maintain enforceable written contracts with its Subcontractors, consultants, and agents who may perform activities in furtherance of the Development Program or receive the other Party’s Confidential Information (a) assigning to such Party’s ownership of (and waiving any moral rights to), all intellectual property rights created in the course of their employment or service, or otherwise sufficient for such Party to comply with its obligations; and (b) agreeing to keep Confidential Information of Vir and WuXi confidential (and otherwise sufficient for such Party to comply with its obligations under Article 7 regarding the other Party’s Confidential Information). In addition, such Party will adopt and publish internal policies and take all other necessary and reasonable steps to protect and preserve the confidentiality of its trade secrets and other proprietary and confidential information, and all disclosure of such information to, and use by, any Third Party (other than (i) competent regulators, accountants and counsel, in each instance acting in their professional capacities, or (ii) pursuant to an applicable governmental order) has been pursuant to the terms of a written confidentiality agreement between such Third Party and such Party. |
| 11.2.2 | Notice of Infringement. If such Party learns of any actual, alleged, or threatened infringement by a Third Party of the Joint Collaboration Patent Rights, then such Party will promptly notify the other Party, and such Party and will provide the other Party with available evidence of such infringement. |
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| 11.2.3 | Qualified Personnel. Such Party will ensure that (a) neither such Party nor any employee, agent or Subcontractor of such Party that will be involved in the conduct of the Development Program has been debarred under Subsection (a) or (b) of Section 306 of the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. §335a); (b) no Person who has been debarred under Subsection (a) or (b) of Section 306 of such Act will be employed by such Party or any Sublicensee or Subcontractor of such Party in the conduct of the Development Program; and (c) no Person on any of the FDA clinical investigator enforcement lists will participate in the conduct of the Development Program. Such Party will promptly notify the other Party in writing if, at any time, such Party becomes aware of any facts or circumstances that would make the preceding statements untrue or inaccurate in any respect, specifying such facts or circumstances in reasonable detail. |
| 12. | INDEMNIFICATION |
| 12.1 | Indemnification by WuXi. Subject to Section 12.3, WuXi will indemnify, defend, and hold harmless the Vir Indemnitees from and against any and all losses, damages, fees, expenses, settlement amounts, and costs (including reasonable attorneys’ fees and witness fees) (collectively, “Losses”) arising from any Third Party claim, arising out of (a) any breach by WuXi of its representations, warranties, or covenants made under this Agreement; or (b) gross negligence or willful misconduct of WuXi or its Affiliates or its or their Sublicensees, or any of their employees, contractors, or agents, in connection with this Agreement or the performance WuXi’s obligations or exercise of WuXi’s rights under this Agreement; provided that the foregoing indemnity will not apply to the extent that any such Losses (i) are attributable to the gross negligence or willful misconduct of any Vir Indemnitees, or (ii) are otherwise subject to an obligation by Vir to indemnify the WuXi Indemnitees under Section 12.2. |
| 12.2 | Indemnification by Vir. Subject to Section 12.3, Vir will indemnify, defend, and hold harmless the WuXi Indemnitees from and against any and all Losses arising from a Third Party claim, arising out of (a) any breach by Vir of its representations, warranties, or covenants made under this Agreement; or (b) gross negligence or willful misconduct of Vir or its Affiliates or its or their Sublicensees, or any of their employees, contractors, or agents, in connection with this Agreement or the performance Vir’s obligations or exercise of Vir’s rights under this Agreement; provided, however, that the foregoing indemnity will not apply to the extent that any such Losses (i) are attributable to the gross negligence or willful misconduct of any WuXi Indemnitees; or (ii) are otherwise subject to an obligation by WuXi to indemnify the Vir Indemnitees under Section 12.1 (Indemnification by WuXi). |
| 12.3 | Indemnification Procedures. If any Indemnitee is seeking indemnification under Section 12.1 or Section 12.2 from a Party (the “Indemnifying Party”), then such seeking Party will notify the Indemnifying Party of such claim with respect to such Indemnitee as soon as reasonably practicable after the Indemnitee receives notice of the claim, and the Party (on behalf of itself and such Indemnitee) will permit the Indemnifying Party to assume direction and control of the defense of |
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| the claim (including the right to settle the claim solely for monetary consideration) and will cooperate as reasonably requested (at the expense of the Indemnifying Party) in the defense of the claim. The indemnification obligations under this Article 12 will not apply to any harm suffered as a direct result of any delay in notice to the Indemnifying Party hereunder or to amounts paid in settlement of any claim, demand, action, or other proceeding if such settlement is effected without the written consent of the Indemnifying Party. The Indemnifying Party will not unreasonably withhold, condition, or delay its consent to a settlement solely for monetary consideration that is proposed by the Indemnitee. The Indemnitee, its employees and agents, will reasonably cooperate with the Indemnifying Party and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by Section 12.1 or Section 12.2. |
| 12.4 | LIMITATION OF LIABILITY. EXCEPT FOR A BREACH OF ARTICLE 9, FOR CLAIMS OF A THIRD PARTY THAT ARE SUBJECT TO INDEMNIFICATION UNDER THIS ARTICLE 12, OR FOR ANY LIABILITY ARISING FROM A PARTY’S FRAUD OR WILLFUL MISCONDUCT, NEITHER PARTY, NOR ANY OF THEIR RESPECTIVE AFFILIATES OR SUBLICENSEES, WILL BE LIABLE TO THE OTHER PARTY TO THIS AGREEMENT, ITS AFFILIATES OR ANY OF THEIR SUBLICENSEES FOR ANY DIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES, OR LOST PROFITS OR REVENUES ARISING OUT OF OR RESULTING FROM THIS AGREEMENT, REGARDLESS OF WHETHER IT HAS BEEN INFORMED OF THE POSSIBILITY OR LIKELIHOOD OF SUCH DAMAGES OR THE TYPE OF CLAIM, CONTRACT OR TORT (INCLUDING NEGLIGENCE). |
| 13. | TERM AND TERMINATION |
| 13.1 | Term; Termination. The term of this Agreement (the “Term”) will commence on the Effective Date and will continue until the expiration of all of WuXi’s payment obligations to Vir hereunder, unless earlier terminated in accordance with this Section 13.1, provided that Vir’s payment obligation shall expire in accordance with the Term of the Cell Line License Agreement. This Agreement may be terminated as follows (each of the following, a “Termination Event”): |
| 13.1.1 | in its entirety, by written agreement of each Party; |
| 13.1.2 | from and after the first anniversary of the Effective Date, by WuXi with respect to the entire Agreement, or on a Product-by-Product basis, in either case, effective upon ninety (90) days’ prior written notice to Vir; |
| 13.1.3 | by either Party, with respect to the entire Agreement, if the other Party materially breaches this Agreement and fails to cure such breach within sixty (60) days after receiving written notice thereof. |
| 13.2 | Effects of Expiration or Termination. Upon the occurrence of a Termination Event pursuant to Section 13.1 then, except as otherwise stated in Section 13.4, the following will apply as of the effective date of termination: |
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| 13.2.1 | Except in the case of termination by WuXi for Vir’s material breach under Section 13.1.3, all rights and licenses granted by Vir to WuXi in this Agreement will immediately terminate. In the event that this Agreement is terminated by WuXi under Section 13.1.3, however, all rights and licenses granted by Vir to WuXi shall remain effect and shall automatically become perpetual and irrevocable, subject to WuXi continuing to meet all payment obligations to Vir under Sections 7.1 and 7.3 as if this Agreement remained in force, provided that the percentages applicable to royalties and sublicense revenue shall be reduced by [***]; |
| 13.2.2 | In the event of termination by WuXi for convenience under Section 13.1.2, or by Vir for WuXi’s material breach under Section 13.1.3, all rights and licenses granted by WuXi to Vir set forth herein with respect to WuXi Technology in connection with the Development, Manufacture and Commercialization of Products will remain in force, provided that on a country-by-country basis, and if Vir Develops and Commercializes, following such termination, any product that would have been a Product if Developed and Commercialized under this Agreement, and the manufacture or sale of such Product in such country is Covered by [***]), then Vir shall pay to WuXi a royalty on net sales of such Reversion Products (applied mutatis mutandis as if such sales were Net Sales under this Agreement) equal to (a) [***] on net sales of Reversion Products in the Vir Territory, and (b) [***] on net sales of Reversion Products in the countries of the WuXi Territory, provided that where the termination is for WuXi’s material breach, the foregoing royalty rates will each be reduced by [***]; |
| 13.2.3 | Except in the case of termination by WuXi for Vir’s material breach under Section 13.1.3, WuXi will transfer to Vir, at Vir’s reasonable expense, within [***] following the effective date of such termination, all Regulatory Filings and Regulatory Approvals Controlled by WuXi in relation to Products; |
| 13.2.4 | If WuXi has not conducted a transition and technology transfer of Manufacturing under Sections 5.3 and 5.4 prior to the effective date of termination, WuXi shall cooperate with Vir to effect such Transitioned Manufacturing in accordance with the terms of Sections 5.3 and 5.4 as soon as reasonably practicable (and in any case within [***] following termination), at Vir’s reasonable expense; and |
| 13.2.5 | Each Party will cooperate in good faith to wind down any then-ongoing activities under the Development Plan. |
| 13.3 | Remedies. Except as otherwise expressly set forth in this Agreement, the termination provisions of this Article 13 are in addition to any other relief and remedies available to either Party at law. |
| 13.4 | Surviving Provisions. Notwithstanding any provision to the contrary set forth in this Agreement, the rights and obligations of the Parties set forth in Articles 1, 9, 12, 14 and 15, and Sections 3.8 (with respect to Materials transferred by either Party prior to the effective date of termination), 7.5 through 7.7 (with respect to payments due prior to the effective date of termination), 7.8, 7.9, 8.1, 10.3 and 13.2, as well as any rights or obligations otherwise accrued hereunder, will survive the expiration or termination of this Agreement for any reason. |
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| 14. | DISPUTES |
| 14.1 | Disputes. Except as otherwise set forth in this Agreement, disputes of any nature arising under, relating to, or in connection with this Agreement (“Disputes”) will be resolved pursuant to this Article 14. |
| 14.2 | Executive Officer Escalation. In the event of any Dispute between the Parties is not resolved on an informal basis within [***] from receipt of a written notice of a Dispute, either Party may, by written notice to the other, have such Dispute referred to the Executive Officers (or their designee, which designee is required to have decision-making authority on behalf of such Party), who will attempt to resolve such Dispute by negotiation and consultation for a [***] period following receipt of such notice. The Executive Officers (or their designees, as applicable) will use good faith efforts to resolve any such Dispute so referred to them as soon as practicable, and any final decision that the Executive Officers agree to in writing will be conclusive and binding on the Parties. |
| 14.3 | Arbitration. |
| 14.3.1 | If the Parties are unable to resolve any dispute or claim between them through good faith negotiation or by escalation under Section 14.2, all disputes arising out of or relating to this Agreement and any activities conducted by the Parties hereunder, including any question regarding its formation, existence, validity, interpretation, performance, breach or termination, or any dispute regarding non-contractual obligations arising out of or relating to it shall be referred to and finally resolved by arbitration administered by the Hong Kong International Arbitration Centre (HKIAC) under the HKIAC Administered Arbitration Rules in force when the Notice of Arbitration is submitted. The law of this arbitration clause shall be Hong Kong law. The seat, or legal place, of arbitration shall be Hong Kong. The number of arbitrators shall be three. Each party shall nominate one arbitrator and the two party-nominated arbitrators shall nominate the third arbitrator, who shall serve as the presiding arbitrator, within [***] after the second arbitrator’s appointment. The language of the arbitration shall be English and each arbitrator must have experience in the biotechnology, pharmaceutical, diagnostic or medical device industry, and each arbitrator must be fluent in English. |
| 14.3.2 | The existence and content of the arbitral proceedings and any ruling or awards shall be kept confidential by the Parties and members of the arbitral tribunal except (a) to the extent that disclosure may be required of a Party to fulfill a legal duty, protect or pursue a legal right, or enforce or challenge an award in bona fide legal proceedings before a state court or other judicial authority, (b) with the consent of all Parties, (c) where needed for the preparation or presentation of a claim or defense in the arbitration, (d) where such information is already in the public domain other than a result of a breach of this clause, or (e) by order of the arbitral tribunal upon application of a Party. |
40
| 14.3.3 | The arbitration award shall be final and binding on the Parties, and the Parties undertake to carry out any award without delay. Judgment on the award may be entered in any court of competent jurisdiction. |
| 15. | MISCELLANEOUS |
| 15.1 | Management of Human Genetic Resources in China. If any Development Activities (or any activities performed under a Development Work Order) involve the management of China’s human genetic resources, then the Regulation of the People’s Republic of China on the Administration of Human Genetic Resources (the “Regulation”) shall apply, and the relevant service or activity shall be implemented only after the approval of the applicable Regulatory Authority in the WuXi Territory is obtained, or all necessary filings are completed in accordance with the requirements of the Regulation. The Parties shall cooperate with each other in good faith and in a timely fashion to complete all required filing requirements and obtain any approval required under the Regulation. |
| 15.2 | Notices. All notices that are required or permitted hereunder will be in writing and sufficient if delivered by internationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, and in each case, addressed as follows (with a courtesy copy sent by email, which will not constitute notice): |
If to Vir:
Vir Biotechnology, Inc.
499 Illinois Street
San Francisco, CA 94158, USA
[***]
With a copy to (which will not constitute notice hereunder):
Cooley LLP
3175 Hanover Street
Palo Alto, CA 94304
[***]
If to WuXi:
WuXi Biologics (Hong Kong) Limited
Building 1, 288 Fute Zhong Road
Waigaoqiao Free Trade Zone
Shanghai, China 200131
[***]
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice will be deemed to have been given: (a) on the Business Day after dispatch if sent by internationally-recognized overnight courier; or (b) on the fifth Business Day after dispatch if sent by registered or certified mail, postage prepaid, return receipt requested.
41
| 15.3 | Governing Law. This Agreement will be construed, interpreted, and applied in accordance with the laws of the state of New York (excluding its body of law controlling conflicts of law). |
| 15.4 | Entire Agreement; Amendment. This Agreement and the other agreements referred to herein, including the MSA (and associated quality agreement) and the Cell Line License Agreement, in each case as amended from time to time, constitute the entire Agreement between the Parties with respect to the subject matter hereof and supersedes all prior representations, understandings and agreements between the Parties with respect to the subject matter hereof. For the avoidance of doubt, all intellectual property, materials, and data made, conceived, discovered, or otherwise generated by a Party, or exchanged by and between the Parties, under the MSA will be deemed to have been made, conceived, discovered, or otherwise generated by a Party, or exchanged by the Parties under the MSA, and will be subject to the terms thereof. No modification of this Agreement will be effective unless in writing with specific reference to this Agreement and signed by the Parties. |
| 15.5 | Waiver. The terms or conditions of this Agreement may be waived only by a written instrument executed by the Party waiving compliance. The failure of either Party at any time or times to require performance of any provision hereof will in no manner affect its rights at a later time to enforce the same. No waiver by either Party of any condition or term will be deemed as a continuing waiver of such condition or term or of another condition or term. |
| 15.6 | Headings. Section and subsection headings are inserted for convenience of reference only and do not form part of this Agreement. |
| 15.7 | Assignment. Neither this Agreement nor any right or obligation hereunder may be assigned, delegated, or otherwise transferred, in whole or part, by either Party without the prior express written consent of the other, except that either Party may assign this Agreement and it rights and obligations hereunder in whole or in part to an Affiliate of such Party or in whole to its successor-in-interest in connection with a Change of Control of such Party. Any purported assignment in violation of this Section 15.7 (Assignment) will be null, void, and of no legal effect. The terms and conditions of this Agreement will be binding upon and inure to the benefit of the permitted successors and assigns of the Parties. |
| 15.8 | Performance by Affiliates. Each Party may discharge any obligations and exercise any right hereunder (including any obligations specified hereunder to be performed under any Development Work Order or the MSA) through any of its Affiliates. Notwithstanding anything to the contrary in the MSA, each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement (or the MSA, as applicable), and shall cause its Affiliates to comply with the provisions of this Agreement (or the MSA, as applicable) in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement (or the MSA, as applicable) shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate. |
42
| 15.9 | Construction. The Parties acknowledge and agree that: (a) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (b) the rule of construction to the effect that any ambiguities are resolved against the drafting Party will not be employed in the interpretation of this Agreement; and (c) the terms and provisions of this Agreement will be construed fairly as to all Parties hereto and not in favor of or against any Party, regardless of which Party was generally responsible for the preparation of this Agreement. |
| 15.10 | Interpretation. Except where the context expressly requires otherwise, (a) the use of any gender herein will be deemed to encompass references to either or both genders, and the use of the singular will be deemed to include the plural (and vice versa), (b) the words “include,” “includes,” and “including” will be deemed to be followed by the phrase “without limitation,” (c) the word “will” will be construed to have the same meaning and effect as the word “shall,” (d) any definition of or reference to any agreement, instrument, or other document herein will be construed as referring to such agreement, instrument, or other document as from time to time amended, supplemented, or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any person will be construed to include the person’s successors and assigns, (f) the words “herein,” “hereof,” and “hereunder” and words of similar import, will each be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Articles, Sections, Schedules, or Exhibits will be construed to refer to Articles, Sections, Schedules, or Exhibits of this Agreement, and references to this Agreement include all Schedules hereto, (h) the word “notice” means notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder “agree,” “consent,” “approve,” or the like will require that such agreement, consent, or approval be specific and in writing, whether by written agreement, letter, approved minutes, or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or section or other division thereof, will be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or.” |
| 15.11 | Severability. If any provision of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then-current applicable Law from time to time in effect during the Term, it is the intention of the Parties that such provision be deemed to be severed from this Agreement and the remainder of this Agreement will not be affected thereby. The Parties agree to renegotiate any such severed provision in good faith in order to provide a reasonably acceptable, valid alternative to the severed provision, it being the intent of the Parties that the basic purposes of this Agreement are to be effectuated. |
| 15.12 | Status. Nothing in this Agreement is intended or will be deemed to constitute a partner, agency, employer-employee, or joint venture relationship between the Parties. |
| 15.13 | Section 365(n). All licenses granted under this Agreement are deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined in Section 101 of such Code. The Parties agree that each Party, as licensee, may fully exercise all |
43
of its rights and elections under the U.S. Bankruptcy Code and any foreign equivalent thereto in any country having jurisdiction over a Party or its assets. The Parties further agree that, in the event that a Party elects to retain its rights as a licensee under such Code, such Party will be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology. Such embodiments of the technology will be delivered to the licensee Party not later than:
| (a) | the commencement of bankruptcy proceedings against the licensor, upon written request, unless the licensor elects to perform its obligations under the Agreement; or |
| (b) | if not delivered under Section 15.13(a) (Section 365(n)) above, upon the rejection of this Agreement by or on behalf of the licensor, upon written request. |
Any agreements supplemental hereto will be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of the Bankruptcy Code.
| 15.14 | Further Assurances. Each Party agrees to execute, acknowledge and deliver such further instructions, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. |
| 15.15 | Counterparts. This Agreement may be executed simultaneously in one or more counterparts, by digital or telephonic facsimile transmission, each of which will be deemed an original, but all of which together will constitute one and the same instrument. |
[Remainder of page intentionally left blank]
44
IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their respective duly authorized representatives as of the Effective Date.
| WUXI BIOLOGICS (HONG KONG) LIMITED. | VIR BIOTECHNOLOGY, INC. | |||||
| By: | /s/ Chris Chen |
By: | /s/ George Scangos | |||
| Name: Zhisheng (Chris) Chen, Ph.D. Title: Chief Executive Officer |
Name: George Scangos, Ph.D. Title: President and Chief Executive Officer | |||||
Signature Page to Development and Manufacturing Collaboration Agreement
Schedule 1.13
Amendment to Cell Line License Agreement
[See attached]
[***]
Schedule 1.99
Vir Background Technology
[***]
Schedule 3.1.1
Draft Development Plan and Allocation of Development Activities
| 1) | CMC Development and Manufacturing - Generation 1 Process |
WuXi Bio shall be responsible for conducting all of the activities in Table 1 [***].
Table 1: Generation 1 (“Gen1”) Development and Manufacturing activities
| Activity 1 – Feasibility Assessment | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| Activity 2 – Platform Method/Process/Formulation Evaluation | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| Activity 3 – Non-GMP Manufacturing (50L) | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| Activity 4 – cGMP Manufacturing (200L) | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| Activity 5 – Stability Studies | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| 2) | CMC Development and Manufacturing—Generation 2 Process |
WuXi Bio shall be responsible for conducting all of the activities in Table 2 [***] in accordance with Section 5.1.
Table 2: Generation 2 (“Gen2”) Development and Manufacturing activities
| Activity 1 – Cell Line Construction and Development | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| Activity 2 – Cell Banking and Testing | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| Activity 3 – Assay Transfer and Qualification | Duration | |
| [***] | [***] | |
| Activity 4 – Abbreviated Process and Formulation Development | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| Activity 5 – cGMP Manufacturing (200/500L) | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| Activity 6 – Stability Studies | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| 3) | Preclinical and Regulatory Development Activities |
WuXi Bio shall be responsible for conducting all of the activities in Table 3 [***] with Section 5.1 unless indicated otherwise in Table 3. Details and timing for each of the Activities in Table 3 will be discussed and agreed by the JSC.
Table 3: Preclinical and Regulatory Development activities
| Activity 1 – Bioanalysis TK/ADA/Cytokine | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| Activity 2 – General Toxicology/PK | Duration | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| [***] | [***] | |
| Activity 3 – Regulatory Activities | ||
| [***] | [***] | |
| [***] | [***] | |
| 4) | Clinical Development Activities |
[***]
Schedule 3.1.2
Development Work Order for Initial Development Activities
WORK ORDER 005
(Project ID: VIR-20200131)
This Work Order is dated February 4, 2020, and is between Vir Biotechnology, Inc. (“Vir”) and WuXi Biologics (Hong Kong) Limited (“Company”).
Except as expressly provided in this Work Order, he terms of the Master Service Agreement (“MSA”) between Vir Biotechnology, Inc. and WuXi Biologics (Hong Kong) Limited, [***] are hereby incorporated by reference into this work order. References to the MSA will be deemed to be references to this Work Order with the necessary modifications. Each capitalized term used but not defined in this Work Order has the meaning given in the MSA.
| 1. | [***] |
| 2. | FEES; PAYMENT SCHEDULE |
| 2.1 | General Terms. Expenses, milestones, payment and default and other general terms are provided in the Terms and Conditions. |
| 2.2 | Service Fee and Payment. Refer to Appendix 1. |
| 2.3 | Payment Instructions. Unless an invoice provides otherwise, Client shall pay the invoice in USD by wire transfer to the account listed below: |
| Name | WuXi Biologics (Hong Kong) Limited | |||
| Address | [***] | |||
| Currency | [***] | |||
| Intermediate Bank: | [***] | |||
| Beneficiary Bank | [***] | |||
| Beneficiary | [***] | |||
| Beneficiary Account | [***] |
| 3. | COMMUNICATIONS |
| 3.1 | Technical Communications. All technical communications required under this work order are to be sent via reputable international courier or email and addressed as follows: |
| If to Client: | If to Provider: | |
| Vir Biotechnology, Inc 499 Illinois St., Suite 500 San Francisco, CA |
WuXi Biologics (Hong Kong) Limited 288 FuTe Middle Rd Shanghai 200231 | |
| Confidential | 1 |
WORK ORDER 005 Project ID VIR-20200131
| [***] | [***] |
| Confidential | 2 |
WORK ORDER 005 Project ID VIR-20200131
| 4. | DISPUTE RESOLUTION |
| 4.1 | If the Parties are unable to resolve any dispute or claim between them through good faith negotiation under Section 15.1 of the MSA, all disputes arising out of or relating to this Work Order and any Services provided hereunder, including any question regarding its formation, existence, validity, interpretation, performance, breach or termination, or any dispute regarding non-contractual obligations arising out of or relating to it shall be referred to and finally resolved by arbitration administered by the Hong Kong International Arbitration Centre (HKIAC) under the HKIAC Administered Arbitration Rules in force when the Notice of Arbitration is submitted. The law of this arbitration clause shall be Hong Kong law. The seat, or legal place, of arbitration shall be Hong Kong. The number of arbitrators shall be three. Each Party shall nominate one arbitrator and the two Party-nominated arbitrators shall nominate the third arbitrator, who shall serve as the presiding arbitrator, within [***] after the second arbitrator’s appointment. The language of the arbitration shall be English. |
| 4.2 | The existence and content of the arbitral proceedings and any ruling or awards shall be kept confidential by the Parties and members of the arbitral tribunal except (a) to the extent that disclosure may be required of a Party to fulfill a legal duty, protect or pursue a legal right, or enforce or challenge an award in bona fide legal proceedings before a state court or other judicial authority, (b) with the consent of all Parties, (c) where needed for the preparation or presentation of a claim or defense in the arbitration, (d) where such information is already in the public domain other than a result of a breach of this clause, or (e) by order of the arbitral tribunal upon application of a Party. |
| 4.3 | The arbitration award shall be final and binding on the Parties, and the Parties undertake to carry out any award without delay. Judgment on the award may be entered in any court of competent jurisdiction. |
| 4.4 | The dispute resolution provisions set forth in this Section 4 are expressly intended to replace and supersede Section 15.2 of the MSA. |
Thus, this Work Order was executed on the date stated in the introductory clause.
| Vir Biotechnology Inc.
[***] |
WuXi Biologics (Hong Kong) Limited
[***] |
| Confidential | 3 |
WORK ORDER 005 Project ID VIR-20200131
APPENDIX 1
DNA Synthesis and Cloning of 2019-nCoV Variants
Contract Services Proposal for Vir
Project ID VIR-20200131
| Attention to: |
[***] | |
| From: |
WUXI BIOLOGICS (HONG KONG) LIMITED | |
| Technical Contact: | [***] | |
| Business Contact: | [***] | |
| Customer Service: | [***] | |
| Date Issued: | [***] | |
| Valid to: | [***] | |
| Version: | [***] | |
The information in this quote and the other information that we provide to you in connection with this quotation process is confidential information of WuXi Biologics and is being provided to you on the condition that you will maintain its confidentiality. You may not disclose it to other parties or use it for other purposes. Similarly, we will maintain the confidentiality of the confidential information that you disclose to us in connection with this quotation process.
| Confidential | 4 |
WORK ORDER 005 Project ID VIR-20200131
Price Outline & Assumptions
WuXI Biologics Is providing a quote of [***] for Vir Biotechnology (“Client”).
The total duration of the project starting from DNA sequence analysis and cloning is expected to be approximately [***].
The total cost of this project to Client is [***]. These prices are subject to the assumptions and conditions stated in the Price Assumptions & Conditions section following the quotation tables below.
| 1) | Work Order Scope |
The scope of Services for this Work Order is as follows:
| Activity 1 – Cell Line Construction and Development |
Price for Services |
Duration | ||
| [***] | [***] | [***] | ||
| [***] | [***] |
| 2) | Optional Services |
The table below lists all the optional services and prices which WuXi Biologics offers. They are not included in the total quote above. They will be performed at extra cost only when requested by Vir.
| Optional |
Activities Price |
Duration | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] |
| Confidential | 5 |
WORK ORDER 005 Project ID VIR-20200131
| 3) | Price Assumptions and Conditions |
| 1. | Invoicing will be as follows: [***]. Invoices are “billed and payable” in U.S. dollars only. |
| 2. | This quote assumes [***]. |
| 3. | [***]. |
| 4. | [***]. |
| 5. | All report deliverables as defined will be issued using [***]. |
| 6. | The prices provided in this quote are good through [***]. |
Service Description
| 1. | Service: Cell Line Construction and Development |
| [***] |
| 2. | Deliverables: Cell Line Construction and Development |
[***]
| 3. | Facilities |
[***]
| Confidential | 6 |
Exhibit 10.59
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
| CONFIDENTIAL | EXECUTION VERSION |
LETTER OF INTENT
BETWEEN Vir Biotechnology, Inc.
AND WUXI BIOLOGICS (HONG KONG) LIMITED
This Letter of Intent (“LOI”) confirms the recent discussions between Vir Biotechnology, Inc. (“Vir”) and WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”) whereby Vir reserves some capacity in WuXi Biologics’s bulk drug substance facility referred to as Manufacturing #2 (the “Capacity Reservation”) and retains WuXi Biologics to perform certain development and/or manufacturing services (the “Services”) regarding Vir’s VIR-7831 SARS-Cov-2 mAb (also referred to as WBP2275 within WuXi Biologics) (the “Initial Product”) or any backup SARS CoV-2 mAb product that Vir may specify from time to time (collectively, the Initial Product and any backup product specified by Vir, the “Product”).
WuXi Biologics and Vir may each be referred to in this LOI as a “Party” and collectively as the “Parties”. This LOI is a binding contractual obligation of the Parties as of the last signature date below by both Parties (the “LOI Effective Date”). Any capitalized terms used herein but not defined shall be as defined in the Development and Manufacturing Collaboration Agreement between the Parties effective as of February 25, 2020. The Parties do hereby agree as follows:
| 1. | Definitive Agreement. Additional terms and conditions related to the Services and the rights and obligations of each Party related thereto will be specified in a commercial manufacturing and supply agreement (the “Commercial MSA”) and commercial quality agreement (the “Commercial QAG”). This LOI does not obligate either Party to enter into the Commercial MSA, the terms of which remain subject to discussion and approval by each Party. Notwithstanding the foregoing, the Parties shall use their respective commercially reasonable efforts to negotiate and enter into the Commercial MSA before July 30, 2020. The terms agreed upon in this LOI shall be incorporated into the Commercial MSA. |
| 2. | Section 2. Capacity Reservation. As of the LOI Execution Date, (a) Vir will purchase a firm and binding capacity reservation at WuXi Biologics’s Manufacturing #2 bulk drug substance facility (the “Facility”) to Manufacture [***] in accordance with the Manufacturing schedule and parameters in Appendix 1, and (b) WuXi Biologics will schedule such capacity reservation. |
| 2.1. | Campaign. WuXi Biologics will Manufacture [***] (the “Campaign”) in accordance with the Manufacturing schedule and parameters in Appendix 1. |
| 2.1.1. | [***]. At Vir’s sole discretion, at any time prior to [***], Vir may request that WuXi Biologics [***]. If Vir elects to [***], the Parties will mutually agree on the timing and scheduling of [***]. |
| 2.1.2. | PPQ Batches. Vir will designate [***] batches from the Campaign that will be used to Manufacture process performance qualification batches (“PPQ Batches”) intended (a) [***] and (b) [***] . Vir will notify WuXi Biologics by [***] if Vir elects to Manufacture all PPQ Batches in 2020 and shall designate which Campaign batches shall be PPQ Batches. [***]. |
| 2.1.3. | PPQ Batches in 2020. If Vir elects to Manufacture all PPQ Batches in 2020 pursuant to Section 2.1.2, WuXi Biologics will Manufacture (a) [***] and (b) [***] . The Parties will agree upon the schedule for such manufacture promptly following Vir’s request. |
| 2.1.4. | PPQ Batches in 2021. If Vir elects to Manufacture all PPQ Batches in 2021, [***] WuXi Biologics will Manufacture (a) [***] and (b) [***] . |
| 2.1.5. | Optional Batches. Vir will have the option, on written notice to WuXi Biologics, to [***] provided that Vir provides written notice of its option exercise no later than [***]. If Vir provides such notice, the Parties will agree upon the scheduling of the Manufacture of such batches, provided that unless otherwise agreed in writing, the vial thaw for the first of the [***] optional batches will begin by [***]. The exercise date will be adjusted accordingly if the vial thaw for the first optional batch occurs later than [***] . |
| 3. | Section 3. Fees & Payment. Fees and payment for the batches scheduled in Section 2 shall be as follows: |
| 3.1. | Batch Price. For each batch of Product [***] (“Successful Batch”) Vir shall pay WuXi Biologics [***] (“Production Service Fee”). The Production Service Fee [***]. For avoidance of doubt, the Production Service Fee includes [***]. |
Table 1: Batch Pricing
[***]
| 3.2. | PPQ Batch Fees |
| 3.2.1. | PPQ Batch Fees. VIR will pay additional charges of up to but not exceeding [***] for a total for all PPQ Batches [***]. The PPQ Batch Fee will be based [***] . Such definitive scope of work and associated PPQ Batch Fee(s) will be defined in the Commercial MSA. |
| 3.2.2. | Process Validation and Stability Studies. As of the LOI Execution Date, or at any time during the term of the Commercial MSA, Vir shall have an option but not obligation to request WuXi Biologics to perform [***] as further defined in the Commercial MSA. |
| Confidential Information | Page 2 of 7 |
| 3.3. | Raw Material Fees. |
| 3.3.1. | Raw Material Fees. WuXi Biologics will purchase the [***] (“Raw Materials”) from qualified vendors in accordance with the Commercial QAG. The actual cost of purchased Raw Materials [***] in the Commercial MSA. The Raw Material pass-through costs [***]. |
Table 2: [***]
[***]
| 3.3.2. | Advance Purchase. Upon execution of this LOI, WuXi Biologics is authorized to [***], provided further that: |
| 3.3.2.1. | WuXi Biologics will [***] requested by Vir pursuant to Section 2.1.5 on or after [***]. If the [***] of Raw Material [***], WuXi Biologics will include an additional [***] in the Raw Material order for the [***]. |
| 3.3.2.2. | If the Parties terminate the LOI pursuant to Section 5.5(b), or fail to execute a Commercial MSA after WuXi Biologics has placed Raw Materials orders for the [***], including Raw Material [***], WuXi Biologics will use best efforts (a) for orders that are cancellable, cancel such Raw Material orders and (b) for orders that are not cancellable, reuse such Raw Materials for other Vir projects or WuXi Biologics other clients. Vir [***]. |
| 3.3.2.3. | As of the LOI Execution Date Vir has authorized WuXi Biologics to purchase [***]. |
| 3.4. | Take or Pay. Vir is liable for the Production Service Fee for all 2020 and 2021 [***] Batches, including [***], on a take-or-pay basis provided that: |
| 3.4.1. | 2020 Batches. [***]. |
| 3.4.2. | 2021 Batches. [***]. |
| 3.5. | Production Service Fee Invoicing: WuXi Biologics will invoice Vir for one hundred percent (100%) of the applicable Batch Price for each Successful Batch, including for each PPQ Batch, the applicable PPQ Batch Fees in accordance with Section 3.2.1, upon shipment of such batch to the location designated by Vir. |
| 3.6. | Raw Material Invoicing: WuXi Biologics will invoice Vir for the cost of the Raw Materials [***] upon issuing binding orders to each of the Raw Material vendors. |
| 4. | Section 5. Terms and Conditions. |
| 4.1. | Vir may assign this LOI to any Affiliate of Vir or any third party collaboration partner, licensee, or licensor, and each Party will have the right to assign this LOI to any successor in interest to all or substantially all of such Party’s business or assets to which this agreement relates whether through asset or stock acquisition, merger, consolidation, or otherwise, in one or a series of transactions and Vir shall provide a written notice to WuXi Biologics within thirty (30) once such assignment has been implemented. |
| Confidential Information | Page 3 of 7 |
| 4.2. | The terms of this LOI can be amended by mutual agreement in writing by the Parties. |
| 4.3. | Nothing in this LOI shall be construed as a bar to any future collaboration or other agreements that may be negotiated between WuXi Biologics and Vir. |
| 4.4. | This LOI is intended to be legally binding on the Parties solely with respect to the obligations expressly set forth herein and effective immediately upon execution. |
| 4.5. | This LOI shall terminate as follows: (a) upon completion and signing of the Commercial MSA; or (b) upon mutual written agreement by the Parties. |
| 4.6. | This LOI will be governed by the laws of the state of New York, United States, notwithstanding any choice of law provision or principle to the contrary. |
VIR PO Number PO33103
[signature page follows]
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| AGREED TO AND ACCEPTED BY THE PARTIES: | ||||
| WuXi Biologics (Hong Kong) Limited | Vir Biotechnology, Inc. | |||
| /s/ Chris Chen |
/s/ George Scangos | |||
| Name: Chris Chen | Name: George Scangos | |||
| Title: CEO | Title: President & CEO | |||
| Date: June 15, 2020 | Date: June 15, 2020 | |||
| Confidential Information | Page 5 of 7 |
Appendix I
[***]
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the reference to our firm under the caption “Experts” in the Registration Statement (Form S-1) and related Prospectus of Vir Biotechnology, Inc. for the registration of shares of its common stock and to the incorporation by reference therein of our report dated March 26, 2020, with respect to the consolidated financial statements of Vir Biotechnology, Inc. included in its Annual Report (Form 10-K) for the year ended December 31, 2019, filed with the Securities and Exchange Commission.
| /s/ Ernst & Young LLP |
| Redwood City, California |
| July 6, 2020 |
Exhibit 99.1
CONSENT TO BE NAMED AS A DIRECTOR NOMINEE
Vir Biotechnology, Inc., a Delaware corporation (the “Company”), is filing a Registration Statement on Form S-1 (the “Registration Statement”) with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), in connection with a public offering (the “Public Offering”) of its common stock. In connection with the Public Offering, I hereby consent, pursuant to Rule 438 of the Securities Act, to being named as a nominee to the board of directors of the Company in the Registration Statement, and any amendments and supplements thereto. I also consent to the filing of this consent as an exhibit to the Registration Statement and any amendments and supplements thereto.
| /s/ Elliott Sigal |
| Name: Elliott Sigal |
| Date: July 6, 2020 |