UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date
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Securities registered under Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| The Stock Market LLC | ||||
| The Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging
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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 13(a) of the Exchange Act.
Item 1.01 Entry into a Material Definitive Agreement
On May 9, 2023, BriaCell Therapeutics Corp. (the “Company”) entered into a Master Service and Technology Agreement (the “MST Agreement”) with Prevail InfoWorks, Inc. (“InfoWorks”) pursuant to which InfoWorks will provide clinical services and technologies for the Company’s upcoming pivotal study in advanced metastatic breast cancer. The Company has agreed to pay InfoWorks $5,379,945 upon signing of the MST Agreement and pay InfoWorks additional fees upon the achievement of certain milestones.
On May 12, 2023, the Company entered into a stock purchase agreement (the “Purchase Agreement”) with Prevail Partners, LLC, an investment fund and affiliate of InfoWorks, pursuant to which the Company agreed to issue 463,408 common shares (the “Shares”) for an aggregate purchase price of $4,000,000. The Shares are expected to be issued on or around May 19, 2023, subject to approval from the Toronto Stock Exchange. The funds received will be used to pay amounts owed to InfoWorks under the MST Agreement. The Shares were offered in reliance on the exemption from registration afforded by Rule 506 of Regulation D and Section 4(a)(2) of the Securities Act of 1933, as amended.
The foregoing descriptions of the MST Agreement and Purchase Agreement are not complete and are qualified in their entireties by reference to the full text of the form of MST Agreement and Purchase Agreement, copies of which are filed as Exhibit 10.1 and Exhibit 10.2 respectively, to this Report and are incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits
EXHIBIT INDEX
| Exhibit | Description | |
| 10.1 | Master Service and Technology Agreement dated May 9, 2023 | |
| 10.2 | Stock Purchase Agreement dated May 12, 2023 | |
| 99.1 | Press release dated May 15, 2023 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BRIACELL THERAPEUTICS CORP. | |
| /s/ William V. Williams | |
| May 15, 2023 | William V. Williams President and Chief Executive Officer |
Exhibit 10.1
Master Service and Technology Agreement
THIS AGREEMENT is effective as of May 9, 2023 (this “Agreement”).
Parties
| (1) | Prevail InfoWorks, Inc. is a corporation having its principal place of business at 211 North 13th Street, Suite 600, Philadelphia, PA 19107-1610, USA (“Prevail”); and |
| (2) | BriaCell Therapeutics Corp. is a corporation having its principal place of business at 2929 Arch Street, 3rd Floor, Philadelphia, PA 19104 (“Company”). |
| (3) | Prevail and Company may be individually referred to as a “Party” or collectively as the “Parties.” |
Background
| (1) | Prevail provides clinical research services to life science companies and has developed certain software applications and platforms, which it makes available as a service to customers via the Internet for a fee for the purpose of managing the customers’ clinical trials and analyzing the data from them. |
| (2) | Company wishes to use Prevail’s services and software in its business operations. |
| (3) | Prevail has agreed to provide and Company has agreed to use and pay for Prevail’s services and technologies subject to the terms and conditions of this Agreement. |
Agreed terms
| 1. | Definitions |
The definitions in this clause apply in this Agreement.
Applicable Laws: all supranational, national, state, and local laws and regulations including, without limitation, the regulations and guidelines of the United States Federal Food, Drug and Cosmetic Act (21 U.S.C. 301, et. seq.) (the “FDA Act”), the Canadian Food and Drugs Act, RSC 1985, C F-27 and its associated regulations (the “CA FDA Act”) and, as applicable, accepted standards of practice that may be applicable to a Study or the Services including but not limited to:
(a) the FDA Act, the CA FDA Act and associated legislation and Health Canada regulations, policies, and guidelines in effect from time-to-time governing investigational drugs;
(b) all International Conference on Harmonization (ICH) guidance documents as appropriate including ICH E6: Guidelines on Good Clinical Practice (ICH/GCP);
(c) United States Federal anti-kickback statutes and related safe harbor regulations and associated Canadian legislation;
(d) all relevant anti-corruption and anti-bribery laws (including, without limitation, the Federal Corrupt Practices Act)
Company Data: the data generated in the clinical trial or trials referenced in an executed SOW if applicable, as well as data imported or inputted by Company, Authorized Users, or Prevail or others on Company’s behalf in connection the Services or facilitating Company’s use of the Services.
Authorized Users: those officers, directors, employees, agents, and independent contractors of Company who are authorized by Company to use the Services and the Documentation, as further described in clause 3.
Business Day: any day which is not a Saturday, Sunday or public holiday in the USA.
| Confidential | 1 |
Confidential Information: is defined in clause 10.
Debarment Act: the Generic Drug Enforcement Act of 1992, as amended, 21 U.S.C. §§ 306.
Documentation: the documents made available to Company by Prevail from time to time which sets out a description of the Services and the user instructions for the Services, including any executed SOWs.
Effective Date: the effective date of this Agreement as specified above.
Initial Term: the initial term of this Agreement is 28 months.
Normal Business Hours: 8:00 a.m. to 5:00 p.m. Eastern Time, USA, each Business Day.
Renewal Period: the period described in clause 14.1.
Services: the services provided by Prevail to Company under this Agreement as set forth in a Statement of Work attached hereto and any other executed Statements of Work.
Software: the online software applications provided by Prevail as part of the Services.
Study Invention: any (a) trade secrets, discovery, invention, technology, copyright, moral rights, trademarks, trade names, logos, know how, method, result, data, material, information, concept, ideas, concepts, processes, works, formulas, source and object codes, programs, other works of authorship, improvements, developments, designs, techniques and any other intellectual or proprietary assets whether or not patentable or protectable by any other intellectual property law, that Company or Prevail or their respective employees, agents, and/or subcontractors, either alone or jointly with others, makes conceives, creates, develops, or reduces to practice or causes to be conceived, developed or reduced to practice as a result of, (a) the use of the Company’s investigational product in a Study, (b) conducting a Study, (c) performing any obligations or activities assigned to such Party or Parties in connection with this Agreement or any Study, or (d) using Company’s investigational product or Confidential Information. “Study Invention” shall not include any inventions, processes, patents, know-how, trade secrets, improvements, other intellectual property and assets, including but not limited to analytical methods, procedures and techniques, procedure manuals, data, computer technical expertise, hardware and/or software, which (i) have been independently developed by Prevail, (ii) relate to Prevail’s business or operations, and (iii) are used, improved, modified or developed by Prevail during the term of this Agreement, without the use of any of Company’s resources or equipment, or any reference to Company’s investigational product or Confidential Information.
Subscription Fees: the subscription fees payable by Company to Prevail for the Software and Services, as set forth in Schedule 1 attached hereto and any other executed SOWs.
Term: period of time between the commencement of this Agreement and its expiration or termination, whichever is earlier.
User Subscriptions: the user subscriptions purchased by Company pursuant to clause 5 which entitle Authorized Users to access and use the Services and the Documentation in accordance with this Agreement.
| 2. | Scope of Services |
During the Initial Term and any Renewal Period, and from time to time, Company may purchase Services from Prevail that will be set forth in a Statement of Work (“SOW”) agreed by and duly executed by both Parties, beginning with SOW 1 attached hereto. Each executed SOW shall be governed by this Agreement and include: (i) description of Services to be provided, (ii) fee and payment schedule for the Services and a reasonably detailed budget, (iii) description of deliverables to be delivered by Prevail and their intended use, and (iv) a project timeline. Any changes or modifications to the SOW shall be mutually agreed upon in writing by the Parties as provided for in this Agreement. Once executed by both Parties, each SOW shall be deemed incorporated into this Agreement by reference. There will be no limit to the number of SOWs that may be added to this Agreement. In the event that the terms of an executed SOW conflict with the terms of this Agreement, the terms of this Agreement shall govern unless the SOW specifically references Section 2 of this Agreement and indicates such specific terms of the SOW shall govern.
| Confidential | 2 |
| 3. | Changes to Scope of Services |
In the event that Company would like Prevail to alter the Services under a given SOW or the assumptions underlying the budget, the Parties shall agree upon a signed written amendment to the SOW prior to the provision of said Services. Prevail has no obligation to perform and Company has no obligation to pay for any additional or modified Services absent written amendment to the SOW by the Parties with respect thereto.
| 4. | Investigators |
If the Services described in a particular SOW require Prevail to pay Sites and/or Investigators to perform a Study on Company’s behalf, Company acknowledges and agrees Prevail will only pay Investigators from advances or pre-payments received from Company for Investigators’ services, and that Prevail will not make payments to Investigators prior to receipt of sufficient funds from Company. Company further acknowledges and agrees that payments for Investigators’ services are expenses payable to third parties, are their sole responsibility and are separate from payments for Prevail Services.
| 5. | Technology User subscriptions |
Subject to terms and conditions set forth in this Agreement and SOWs duly signed by both Parties (including the attached SOW 1), Prevail hereby grants to Company a non-exclusive, non-transferable right to permit Authorized Users to use the Services and the Documentation during the Term solely for Company’s product research, development and commercialization and business operations (which, for the avoidance of doubt, shall include use by Company’s Authorized Users in connection with Company’s clinical studies). Company may, from time to time during any Subscription Term, purchase additional User Subscriptions in excess of the number set out in a SOW and Prevail shall grant access to the Services and the Documentation to such additional Authorized Users in accordance with the provisions of this Agreement.
| 6. | Company data |
| 6.1 | As between Company and Prevail, Company shall solely own all rights, title, and interest in and to all of Company Data and shall have sole responsibility for the legality, reliability, integrity (as collected, but not as stored in the Software), accuracy and quality of Company Data. |
| 6.2 | Company Data will be hosted, under Prevail’s responsibility, in a secure data center certified as ISO/IEC 27001:2013 and SOC 2 compliant, for computing infrastructures and security. Prevail shall follow its archiving procedures for Company Data as set out in its standard operating procedures (SOPs) and back-up policy which include hosting Company Data at another location in a second secure data center, as such documents may be amended by Prevail in its sole discretion from time to time provided that such amendments do not result in a lower standard for secured hosting of Company Data or adding exceptions to Prevail’s responsibility to store Company Data in two secured data centers in different locations. Prevail shall store Company Data in Canada or in the USA. Upon Company’s written request, Prevail shall allow Company to review such SOPs and back-up policies relating to hosting of Company’s Data. Except in case of breach of its obligations under this Agreement or under applicable law, gross negligence or willful misconduct, in the event of any loss or damage to Company Data, Company’s sole and exclusive remedy shall be for Prevail to use reasonable commercial endeavors to restore the lost or damaged Company Data from the latest back-up of such Company Data maintained by Prevail in accordance with the archiving procedure described in its SOPs and back-up policy, a summary of which is set forth in Schedule 1. |
| 6.3 | Prevail will ensure that no Company Data is used for any purposes whatsoever other than to provide the Services hereunder. |
| Confidential | 3 |
| 7. | Prevail’s obligations |
| 7.1 | Prevail shall, during the Term, provide the Services and make available the Documentation to Company subject to the terms of this Agreement, Applicable Laws, and Prevail’s applicable Standard Operating Procedures unless other SOPs are identified within a SOW. |
| 7.2 | Prevail undertakes that the Services will be performed substantially in accordance with the Documentation and with reasonable skill and care. |
| 7.3 | Prevail represents and warrants that it has not been debarred and has not been convicted of a crime which could lead to debarment, under the Debarment Act. In the event that Prevail or any of its officers, directors, or employees becomes debarred or receives notice of action or threat of action with respect to its debarment, Prevail shall notify Company immediately in writing. |
| 7.4 | Prevail shall make the Software available in accordance with the Availability service level described below in Section 7.6. |
| 7.5 | Prevail will, as part of the Services and at no additional cost to Company, provide Company with Prevail’s standard customer support services in accordance with Prevail’s support services policy in effect at the time that the Services are provided. Prevail may amend the support services policy in its sole and absolute discretion from time to time, provided that Prevail will provide Company notice if the change is material and will not reduce an agreed upon support level during the effective period of a SOW for Services. Unless stated otherwise in an applicable SOW, Prevail’s standard support includes phone support for Authorized Users in the geographies where the clinical study(ies) identified in the SOW is being conducted. The support is provided by trained Tier 1 support staff on a 24/7/365 basis, who can escalate to Tier 2 support when needed during Normal Business Hours, and all support is governed by Prevail’s internal Quality Assurance SOPs. Company may elect to purchase enhanced support services separately at Prevail’s then current rates. |
| 7.6 | Prevail will provide the following technical service levels (“Service Levels”): |
(a) Availability:
The Software Availability for any given month shall be at least 99.9% (“Availability”) uptime, and is measured by subtracting from the total minutes in a given month, the total minutes of Service Interruption in such month, divided by the total minutes in such month and then multiplied by 100.
For purposes of the foregoing “Service Interruption” means, except for Scheduled Maintenance, the period of time that the Software is either: (i) not available for Company log-in; or (ii) substantially not functioning. By way of example: If in a given 30 day month there are 60 minutes of Service Interruption, then the Service Availability for such month would be calculated as follows:
= (43,200 being the total minutes in a 30 day month) – (60 minutes of Service Interruption) / 43,200
= 43,140 / 43,200
= 0.999
Service Availability for the month would be 99.9%
For purposes of the foregoing “Scheduled Maintenance” means routine, planned maintenance for the Software as made known to Company in advance.
| Confidential | 4 |
If Prevail does not meet the Availability for a given month, then Prevail will provide a credit (each, a “Service Credit”) to Company equal to the percentages as set forth in the table below of the prior one (1) month’s Subscription Fees paid to Prevail for the impacted Software: Such Service Credits, if applicable, will be applied to any monies owed by Company in the following month or if no such monies are owed, then Prevail shall refund the amount of the Service Credit to Company.
| Availability | Service Credit | |
| < 99.9% - >= 98.0% | 5% | |
| < 97.9% - >= 95.0% | 10% | |
| < 94.9% | 25% |
(b) Priority Level Definitions:
(i) Critical: defined as any problem that completely prevents the operation of the Software or Services and for which there is no work-around.
(ii) Priority: defined as any problem that substantially restricts the operations of the Software or Services for which there is no alternative solution or work- around.
(iii) General: defined as any problem that does not substantially restrict the operations of the Software or Services or any other error for which there is an alternative solution or work-around.
| Priority Level | Description | Initial Response Time from Notification | Status Updates | Targeted Resolution | ||||
| Critical | See Definition | 15 minutes | Every Hour | As soon as possible not to exceed 4 hours | ||||
| Priority | See Definition | 30 minutes | 4 Hours | 8 Business hours | ||||
| General | See Definition | 60 minutes | 24 Hours | 48 hours unless otherwise agreed upon by both parties |
The Initial Response Times in the above chart commence from the time Company first notifies Prevail of the problem or failure, while the other times commence from the earlier of first notification by Company of the problem or failure or Prevail otherwise becoming aware of the problem or failure.
In the event that (a) Prevail fails to meet the same Service Level in each of three consecutive months, or (b) Prevail fails to meet any Service Levels in any of four months within a six month rolling period, then Company may terminate this Agreement for material breach, and Prevail shall not have any right to cure such breach.
| Confidential | 5 |
| 7.7 | Prevail represents and warrants that it has implemented, uses, and will maintain: |
| (a) | such level of security measures, consistent with up-to-date industry standards, to (i) defend against viruses, worms, Trojan horses or other harmful computer code, files, scripts, agents or software that may hinder Company access to and/or damage, interfere with or disrupt the integrity of the Company Data; (ii) help to avoid risk of any third party’s unauthorized access to Company Data (including anti-malware controls); and (iii) protect against loss of Company Data due to power supply failure or line interference; | |
| (b) | appropriate technical and organizational measures, internal controls, and information security routines intended to protect Company Data against accidental loss, destruction, or alteration; unauthorized disclosure or access; or unlawful destruction; | |
| (c) | data recovery procedures, including regular and multiple copies of Company Data (in different places) from which Company Data may be recovered; such redundant storage and Prevail procedures for recovering data are designed to attempt to reconstruct Company Data in its original or last-replicated state from before the time it was lost or destroyed; | |
| (d) | reviews of data recovery procedures at least every twelve months; and | |
| (e) | measures aimed at protecting Company Data against accidental or unlawful destruction or accidental loss, alteration, unauthorized disclosure, or access, and against all unlawful forms of processing; in addition, Prevail agrees that only Prevail’s or its subcontractors’ technical support personnel are permitted to have access to Company Data when required to perform their job functions. |
If Prevail becomes aware of any unlawful access to any Company Data stored by and/or on behalf of Prevail, or unauthorized access to such equipment or facilities resulting in loss, disclosure, or alteration of Company Data (“Security Incident”), Prevail will promptly (1) notify Company of the Security Incident; (2) investigate the Security Incident and provide Company with detailed information about the Security Incident; and (3) promptly take reasonable steps to mitigate the effects and to minimize any damage resulting from the Security Incident. Prevail shall cooperate fully with Company, with its authorized agent and with any regulatory agency and/or any law enforcement agency in the investigation and remediation of such Security Incident. All notices and communications to Company relating to a suspected, alleged, or actual Security Incident shall be the Confidential Information of Company.
| 7.8 | Prevail represents and warrants that, to the extent applicable, it shall comply with the U.S. Health Insurance Portability and Accountability Act, as amended (“HIPAA”), with respect to protected health information as defined under HIPAA, and any other applicable data privacy and protection laws relevant to the Services. Prevail shall limit its use, onward transfer, and further disclosure of any protected personal information to only those activities specified in this Agreement, an executed SOW, or otherwise expressly authorized by Company. |
| 7.9 | If the Services will involve the collection or processing of personal data (as defined by applicable data protection legislation) within the European Union, then Sponsor (or its designee) shall serve as the Data Controller and Prevail shall serve as the Data Processor of such personal data, as defined by the General Data Protection Regulation (Regulation (EU) 2016/679 Regulation of the European Parliament and the Council on the Protection of individuals with regard to the processing of personal data and on the free movement of such data) (“GDPR”), and Prevail shall act only under the instructions of the Sponsor in regard to such personal data. Within their respective roles, the Parties agree to comply with the requirements of the GDPR. |
| Confidential | 6 |
| 8. | Company’s obligations |
Company shall:
| (a) | comply with all Applicable Laws; | |
| (b) | remain responsible for any regulatory obligations not specifically and expressly transferred to Prevail under the applicable SOW or “transfer of obligations” form, which Prevail may provide under Applicable Law; | |
| (c) | provide Prevail with reasonably necessary co-operation in relation to this Agreement, including access to such information as may be reasonably necessary for Prevail to render the Services; and | |
| (d) | be solely responsible for procuring and maintaining its network connections and telecommunications links from its systems to Prevail’s data centers, and all problems, conditions, delays, delivery failures and all other loss or damage arising from or relating to Company’s network connections or telecommunications links or caused by the Internet. |
| 9. | Fees and payment |
Company shall pay the Fees to Prevail for the Services and Software in accordance with the executed SOW(s).
| 10. | Intellectual Property |
| 10.1 | Company owns all right, title, and interest in and to any Study Inventions, regardless of the Party that makes, discovers, creates, or invents such Study Invention. Prevail hereby irrevocably and unconditionally hereby assigns, and agrees to assign, to Company all of its right, title, and interest in and to all such Study Inventions including those that are made, conceived, created, developed, or reduced to practice by Prevail, any of its employees or permitted subcontractors and any other intellectual property rights therein so as to vest in Company such right, title, and interest in and to such Study Inventions and any related patent claims and other intellectual property rights therein. For clarity, this assignment includes a present conveyance to the Company of all right, title and interest in and to all Study Inventions not yet in existence. If any intellectual property rights or other rights, including moral rights, in the Study Inventions cannot (as a matter of law) be assigned by Prevail to Company, then (i) Prevail unconditionally and irrevocably waives the enforcement of such rights and all claims and causes of action of any kind against Company with respect to such rights, and (ii) to the extent Prevail cannot (as a matter of law) make such waiver, Prevail unconditionally grants to Company an exclusive, perpetual, irrevocable, worldwide, fully-paid license, with the right to sublicense through multiple levels of sublicensees, under any and all such rights (1) to reproduce, create derivative works of, distribute, publicly perform, publicly display, digitally transmit, and otherwise use the Study Inventions in any medium or format, whether now known or hereafter discovered, (2) to use, make, have made, sell, offer to sell, import, and otherwise exploit any product or service based on, embodying, incorporating, or derived from the Study Inventions, and (3) to exercise any and all other present or future rights in the Study Inventions. |
| 10.2 | Company acknowledges and agrees that Prevail and/or its licensors own all intellectual property rights in the Services and the Documentation. Except as expressly stated herein, this Agreement does not grant Company any rights to, or in, patents, copyrights, database rights, trade secrets, trade names, trademarks (whether registered or unregistered), or any other rights or licenses in respect to the Services or the Documentation. |
| 10.3 | Prevail represents and warrants that it has all the rights in relation to the Software, Services and the Documentation that are necessary to grant all the rights it purports to grant under, and in accordance with, the terms of this Agreement, and that the Software, Services, and Documentation, and Company’s access to and use of the Software, Services, and Documentation as contemplated by this Agreement, shall not infringe or misappropriate the intellectual property of any third party. |
| Confidential | 7 |
| 11. | Confidentiality |
For the purposes herein, “Confidential Information” shall mean any non-public information relating to the business, operations and, more generally, any activities of a Party, whether or not marked or identified as confidential or proprietary, which the receiving Party should reasonably understand to be confidential information under the circumstances, including know-how, trade secret and, in the case of Company, Company Data and Study Inventions.
Each Party shall (i) maintain the confidentiality of the other Party’s Confidential Information, using, at a minimum, the same safeguards afforded its own confidential, proprietary trade secrets, but in no event no less than reasonable care; (ii) use the other Party’s Confidential Information only to the extent required for the performance of this Agreement; (iii) restrict disclosure and access to the other Party’s Confidential Information only to its employees, suppliers, permitted subcontractors, advisors and consultants who have a need to know for the performance of this Agreement, provided that they are bound by confidentiality and restricted use obligations no less restrictive than those contained herein; and (iv) not disclose, provide, transfer, rent, sublicense, or otherwise make available any portion of the other Party’s Confidential Information to any third party except as permitted under (iii) above. The non-disclosure and restricted use obligations shall not apply to information which receiving Party can prove through competent proof (i) is now or hereafter known to the public through no fault of the receiving Party, (ii) was in the possession of the receiving Party prior to disclosure by the disclosing Party, (iii) has been properly obtained without restriction from a third party who is not bound by an obligation of confidentiality, (iv) is independently developed by receiving Party without reference to, use of or reliance upon the disclosing Party’s Confidential Information or (v) information disclosed by court order or as otherwise required by law or regulation, provided that the Party required to disclose the information provides prompt advance notice to enable the other Party to seek a protective order or otherwise to prevent such disclosure. The obligations in this article 11 shall continue indefinitely after the expiration or termination of this Agreement.
| 12. | Indemnification and Limitation of liability |
| 12.1 | Prevail shall indemnify, defend, and hold harmless Company and its affiliates, and their respective employees, officers, directors (or their equivalent), agents, assigns and successors-in-interest (each an “Indemnified Party”) from and against any and all losses, damages, liabilities, costs (including reasonable legal fees) (“Losses”) incurred by an Indemnified Party resulting from any third-party claim, suit, action, demand, or proceeding for damages or losses (“Third-Party Claim”) caused by (i) the Software, the Services, any deliverables to the extent provided by Prevail, or any use thereof in accordance with this Agreement, infringing or misappropriating such third party’s intellectual property rights (an “IP Infringement Claim”), and (ii) the use of the Company Data in a manner not authorized by this Agreement. |
| 12.2 | NEITHER PARTY SHALL BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES, OR ANY LOSS OF REVENUE OR PROFITS (EXCLUDING FEES UNDER THE AGREEMENT), DATA, OR DATA USE. PREVAIL’S MAXIMUM LIABILITY FOR ANY DAMAGES ARISING OUT OF OR RELATED TO THIS AGREEMENT, THE SOFTWARE OR SERVICES, WHETHER IN CONTRACT OR TORT, OR OTHERWISE, SHALL IN NO EVENT EXCEED, IN THE AGGREGATE, THE TOTAL AMOUNTS ACTUALLY PAID TO PREVAIL FOR THE SOFTWARE AND SERVICES UNDER THIS AGREEMENT THAT IS THE SUBJECT OF THE CLAIM IN THE TWELVE (12) MONTH PERIOD IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO SUCH CLAIM. |
| Confidential | 8 |
| 12.3 | THE EXCLUSIONS AND LIMITS ON LIABILITY SET FORTH IN SECTIONS 12.1 AND 12.2 ABOVE WILL NOT APPLY TO EXCLUDE OR LIMIT: (i) PREVAIL’S INDEMNIFICATION OBLIGATIONS; (ii) A PARTY’S LIABILITY ARISING IN CONNECTION WITH ITS BREACH OF CONFIDENTIALITY; (iii) A PARTY’S LIABILITY ARISING FROM SUCH PARTY’S FRAUD OR WILLFUL MISCONDUCT; (iv) A BREACH BY A PARTY OF THE OTHER PARTY’S INTELLECTUAL PROPERTY RIGHTS ; OR (v) A PARTY’S LIABILITY ARISING IN CONNECTION WITH ITS BREACH OF PRIVACY OR INFORMATION SECURITY OBLIGATIONS, PROVIDED THAT, PREVAIL’S MAXIMUM LIABILITY FOR ANY DAMAGES ARISING OUT OF OR RELATED TO SUCH A BREACH SHALL IN NO EVENT EXCEED, IN THE AGGREGATE, THE TOTAL AMOUNTS ACTUALLY PAID TO PREVAIL FOR THE SOFTWARE AND SERVICES UNDER THIS AGREEMENT THAT IS THE SUBJECT OF THE CLAIM IN THE THIRTY-SIX MONTH PERIOD IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO SUCH CLAIM. |
| 13. | Insurance |
Each Party shall maintain in effect during the Term of this Agreement adequate forms and levels of insurance as may reasonably be expected by a going concern in the jurisdictions in which it conducts business.
| 14. | Term and termination |
| 14.1 | This Agreement shall commence on the Effective Date and shall continue for the Initial Term and, thereafter, this Agreement shall be automatically renewed for successive periods of 12 months (each a Renewal Period), unless: |
| (a) | either Party notifies the other Party of termination, in writing, at least 60 days before the end of the Initial Term or any Renewal Period, in which case this Agreement shall terminate upon the expiry of the applicable Initial Term or Renewal Period; or | |
| (b) | otherwise terminated in accordance with the provisions of this Agreement; |
and the Initial Term together with any subsequent Renewal Periods shall constitute the Term.
| 14.2 | Without prejudice to any other rights or remedies to which the parties may be entitled, either Party may terminate this Agreement without liability to the other if the other Party commits a material breach of any of the terms of this Agreement and (if such a breach is remediable) fails to remedy that breach within 30 days of that Party being notified in writing of the breach. |
| 14.3 | Company may terminate this Agreement, or any SOW (or a portion thereof) at any time prior to completion by giving 30 days prior written notice to Prevail. Prevail shall promptly comply with the terms of such notice(s) to terminate work on the SOW (as applicable) and use its best efforts to limit any further cost to Company. |
| 14.4 | On termination of this agreement for any reason: |
| (a) | Company shall pay Prevail all direct expenses and fees for Services completed (or its prorated amount if partially completed) and of its costs incurred or irrevocably obligated as of the date of termination, in each case pursuant to this Agreement, and such other reasonable costs incurred to close out its work in the Study. If there are additional costs associated with any winding down period, those costs will be agreed to in writing by the Parties; | |
| (b) | all licenses granted under this Agreement shall immediately terminate; | |
| (c) | each Party shall return and make no further use of any equipment, property, Documentation, and other items (and all copies of them) belonging to the other Party; | |
| (d) | Company shall provide Prevail written instructions within 30 days, with which Prevail shall comply, to either return Company Data and Study Inventions or dispose of Company Data and Study Inventions at Company’s reasonable expense. If Company Data is being returned to Company, Prevail shall use reasonable commercial endeavors to deliver the then most recent back-up of Company Data to Company within 60 days of its receipt of such a written request, provided that Company has, at that time, paid all fees and charges outstanding at and resulting from termination (whether or not due at the date of termination); and | |
| (e) | the accrued rights of the parties as of the time of termination, and the continuation after termination of any provision expressly stated to survive or implicitly surviving termination, shall not be affected or prejudiced. |
| Confidential | 9 |
| 15. | Entire agreement and Counterparts |
This agreement, and any documents referred to in it, constitute the whole agreement between the parties and supersede any previous arrangement, understanding or agreement between them relating to the subject matter they cover.
This Agreement (including its SOWs) may be executed in any number of counterparts, all of which together shall constitute a single document. This Agreement and its SOWs may be executed by facsimile or digital file showing a Party’s signature (e.g., a .pdf). Such facsimile or digital file shall be deemed an original and fully enforceable and admissible in any legal proceeding.
| 16. | Modification and Assignment |
No supplement or modification of this Agreement shall be binding unless executed in writing by both parties.
Neither Party shall, without the prior written consent of the other Party, assign, transfer, charge, or sub-contract all or any of its rights or obligations under this Agreement; provided that either Party may assign its rights and delegate its duties under this Agreement, in whole or in part, to an affiliate or to a successor to such Party’s business by merger, acquisition, purchase of the business related to this Agreement or other similar corporate transaction.
| 17. | Governing Law |
This Agreement shall be governed by the laws of the Commonwealth of Pennsylvania, U.S.A. without regard to the conflicts of law provisions thereof.
| 18. | Notices |
Any notice required to be given under this Agreement shall be in writing and shall be delivered by hand or overnight delivery to the other Party at its address set out in this Agreement, or such other address as may have been notified by that Party for such purposes.
This Agreement has been entered into on the date stated at the beginning of it.
| BriaCell Therapeutics Corp. | Prevail InfoWorks, Inc. | |||
| By: | /s/ William V. Williams | By: | /s/ Jack Houriet | |
| Name: | William V. Williams | Name: | Jack Houriet | |
| Title: | President and CEO | Title: | CEO | |
| Date: | 2023 May 9 | Date: | May 9, 2023 | |
| Confidential | 10 |
Exhibit 10.2
STOCK PURCHASE AGREEMENT
This Stock Purchase Agreement (“Agreement”) is made and entered into as of May 12, 2023 (“Effective Date”), between BriaCell Therapeutics Corp. (“Company” or the “Company”) and Prevail Partners, LLC (“Prevail Partners”), Tax ID# 27-0256095. Company and Prevail Partners are collectively referred to herein as the “Parties.”
WITNESSETH
WHEREAS, Company identifies and develops proprietary pharmaceutical products and transitions them from basic research (discovery) through clinical trials;
WHEREAS, Company and Prevail InfoWorks, Inc. (“InfoWorks”), an affiliate of Prevail Partners, have contemporaneously executed a Master Service and Technology Agreement (“MSTA”), pursuant to which agreement the Company has engaged InfoWorks to provide technologies and services in a Phase 3, Randomized, Open-label Study Comparing the Bria-IMT regimen in combination with PD-1 Inhibition vs Physician’s Choice of Treatment in Metastatic Breast Cancer Patients (the “Clinical Trial”); and
WHEREAS, Prevail Partners desires to purchase equity securities of the Company and the Company desires to issue and sell such securities to Prevail Partners in the form of Common Shares, on the terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the mutual agreements, promises, and undertakings hereinafter set forth, the Company and Prevail Partners agree as follows:
1. Stock Purchase. Prevail Partners agrees to purchase US$4,000,000 worth of shares of Company’s Common Stock (collectively, the “Shares”) at a price per share that shall be equal to a premium of 20.0% above the volume-weighted average price (“VWAP”) of the common shares of the Company on the Nasdaq Stock Exchange (“Nasdaq”) for the thirty (30) trading days immediately preceding the Effective Date, calculated by dividing the total dollar value of the shares of the Company traded on the Nasdaq through the period by the total number of shares traded on the Nasdaq through the relevant period, to five decimal places (the “Share Price”). Notwithstanding the foregoing in no event shall the Shares be sold at a price per Share that is lower than the “Minimum Share Price.”1 In consideration for a cash payment of US$4,000,000 by Prevail Partners (the “Purchase Payment”), the Company shall issue to Prevail Partners such number of shares of its Common Stock that equals the Purchase Payment divided by the higher of the Share Price or Minimum Share Price. Prevail Partners will make the Purchase Payment to Company within five (5) business days after the signing of the MSTA for the Clinical Trial and Company’s payment of the Upfront Payment for Direct Expenses to InfoWorks pursuant to the payment schedule in Statement of Work No. 1, which is incorporated by reference into the MSTA.
1 “Minimum Share Price” means the lower of (i) the closing price (as reflected on Nasdaq.com) prior to the date of entry into this agreement or (ii) the average closing price of the Company’s Common Stock (as reflected on Nasdaq.com) for the five trading days immediately preceding the signing of this agreement.
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Prevail Partners may, if separately agreed to in writing by the Parties, make the Purchase Payment directly to InfoWorks in satisfaction of invoices or any portions thereof for the aforementioned Upfront Payment issued to the Company by InfoWorks pursuant to the MSTA.
The Company shall issue the Shares to Prevail Partners contemporaneously with the Purchase Payment, with such Purchase Payment being made by cash consideration or in exchange for debt (i.e., services already rendered to the Company). No later than thirty (30) business days after the Purchase Payment, Company shall deliver to Prevail Partners a certificate representing the purchased Shares, which may be in electronic format. As holder of the Shares, Prevail Partners shall be entitled to all of the same rights and privileges, including, without limitation, dividends and voting rights, as other holders of Company stock of the same class.
Prevail Partners acknowledges and understands that the Shares will be subject to resale restrictions under applicable U.S. and Securities laws and that as the purchaser of the Shares, Prevail Partners, and not the Company, is responsible for compliance with applicable resale restrictions or hold periods and will comply with all relevant securities laws in connection with any resale of the Shares.
Prevail Partners acknowledges and agrees that they are purchasing the Shares pursuant to an exemption from any prospectus, registration or similar requirements under applicable U.S. and Canadian securities laws, and that the offer, sale and delivery of the Shares to Prevail Partners is conditional upon such offer, sale and deliver being exempt from the requirements under applicable securities laws requiring the filing of a prospectus in connection with the distribution of the Shares or upon the issuance of such rulings, orders, consents or approvals as may be required to permit such sale without the requirement of filing a prospectus.
2. Notices. Notifications in connection with this Agreement shall be given or made in accordance with the requirements below. Any notice required or permitted to be given hereunder by either party hereunder shall be in writing and may be delivered personally or by a reputable overnight delivery service, or sent by registered or certified mail, return receipt requested, postage prepaid to the following addresses:
If to Prevail Partners: Prevail Partners, LLC, 211 North 13th Street, Suite 600, Philadelphia, PA 19107 USA. Attention: Patrick Keenan, Managing Director.
If to Company: BriaCell Therapeutics Corp., 2929 Arch Street, 3rd Floor, Philadelphia, PA 19104 USA. Attention: William V. Williams, MD, FACP, President & CEO.
Notices shall be effective upon receipt.
3. Representations and Warranties of the Company. The Company hereby represents and warrants to Prevail Partners that:
| (a) | Except as previously disclosed in the Company’s public securities filings, there is not pending or, to the best knowledge of the Company, threatened any suit, action or proceeding against or affecting the Company that would reasonably be expected to materially and adversely affect the business, operations, properties, assets, or condition, financial or otherwise, of the Company; |
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| (b) | The Company has all requisite power and authority to enter into and perform this Agreement and to deliver the Shares hereunder. All corporate action on the part of Company necessary for the execution of this Agreement, for the performance of Company’s obligations hereunder and for the sale of the Shares has been taken, and no further consents, licenses, permissions, authorizations, registrations, or qualifications from or with any party or any governmental entity, other than customary Toronto Stock Exchange (“TSX”) and Nasdaq approvals and certain post-close filings to be made by the Company with securities regulators, are necessary for the Company to execute this Agreement, perform its obligations hereunder and deliver the Shares to Prevail Partners. This Agreement is duly executed and delivered by the Company and constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms; | |
| (c) | The issuance and sale of the Shares to Prevail Partners is subject to applicable customary TSX and Nasdaq approvals, which the Company will use commercially reasonable efforts to obtain; and | |
| (d) | The Shares as delivered to Prevail Partners shall be duly and validly issued, fully paid and non-assessable, and free of all liens and encumbrances. |
4. Representations and Warranties of Prevail Partners. Prevail Partners hereby represents and warrants to the Company that:
| (a) | It is an accredited investor, within the meaning of applicable U.S. and Canadian securities laws, and has all requisite power and authority to enter into and perform this Agreement. All corporate action on the part of Prevail Partners necessary for the execution of this Agreement, for the performance of Prevail Partners’ obligations hereunder and for the purchase of the Shares has been taken, and no further consents, licenses, permissions, authorizations, registrations, or qualifications from or with any party or any governmental entity are necessary for Prevail Partners to execute this Agreement and perform its obligations hereunder; | |
| (b) | It is aware that the Shares are “restricted securities,” as such term is defined in Rule 144 (“Rule 144”) promulgated under the Securities Act of 1933, as amended (the “Securities Act”), and they may not be sold pursuant to Rule 144 unless all of the conditions of Rule 144 are met. Prevail Partners understands that the Company has no obligation to register or qualify any of its securities or to take any action or provide any information necessary to the availability of any such exemption; | |
| (c) | It is aware that Prevail Partners’ ability to transfer the Shares is limited by, among other things, applicable Canadian securities laws, and that, in particular, as the holder of the Shares, Prevail Partners must not trade such securities before the date which is four months and one day after the date of issuance; | |
| (d) | It understands that the Shares are not, and will not be, registered under applicable securities laws, and the sale of the Shares by the Company does not give rise to any obligation of the Company to prepare and file a prospectus or similar document or to register the Shares for sale under such applicable securities laws; | |
| (e) | It understands that an investment in the Shares is a speculative investment which involves a high degree of risk and the potential loss of its entire investment, and it represents that by reason of its management, business, or financial experience, it has the capacity to protect its own interests in connection with the transactions contemplated in this Agreement; |
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| (f) | It has had an opportunity to discuss the Company’s business, management, and financial affairs with the Company’s management. It acknowledges that it has received all information it has requested from the Company and it considers necessary or appropriate for deciding whether to acquire the Shares and represents that it has had an opportunity to ask questions and receive answers from the Company regarding the terms and conditions of the offering of the Shares and to obtain any additional information necessary to verify the accuracy of the information given to it and no valid request to the Company by Prevail Partners for information of any kind about the Company or the Shares purchase have been refused or denied by the Company or remains unfulfilled as of the date hereof. and | |
| (g) | This Agreement is duly executed and delivered by Prevail Partners and constitutes a legal, valid, and binding obligation of Prevail Partners, enforceable against Prevail Partners in accordance with its terms. |
5. Survival. The representations and warranties set forth in Section 3 and 4
hereof shall survive for two years and one day after the Effective Date.
6. No-Trade Agreement. Prevail Partners hereby agrees not to sell, transfer, 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 with respect to the Shares or any common stock or other securities of the Company prior to the conclusion of the Clinical Trial and subsequent public release of information by the Company pertaining to the outcome of the Clinical Trial. Without limiting the foregoing, Prevail Partners agrees to abide by the rules of applicable securities regulations with respect to restrictions on trading.
7. Confidentiality. Prevail Partners hereby understands and agrees that any information received by Prevail Partners from the Company is confidential, and Prevail Partners may not share any such information with outside parties. Prevail Partners acknowledges that applicable securities laws restrict (i) the purchase or sale of such securities by any person who has received material non-public or “price sensitive” information from the issuer of such securities, and (ii) the communication of material non-public or “price sensitive” information to any person who could reasonably be expected to purchase or sell such securities in reliance upon such information (commonly referred to as “insider trading” or “insider dealing”). Accordingly, Prevail Partners represents and warrants to, and agrees that all non-public information disseminated to Prevail Partners is subject to this Section 7 of this Agreement, and that Prevail Partners will not use, communicate or disclose such information in violation of applicable laws.
8. Indemnification. The Company on one hand and Prevail Partners on the other hand each indemnify and hold harmless the other and its officers, directors, employees and agents, if any (with respect to each indemnified party, the “Indemnitee(s)”) from and against all costs, losses, liabilities, damages, claims, expenses of any nature (including reasonable attorneys’ fees and disbursements), judgments, fines, settlements, and any other amounts arising from any and all claims, demands, or proceedings incurred or accrued by an Indemnitee as a result of a breach by the indemnifying party of its representations, warranties, or obligations under this Agreement. The indemnification provided by this Section 7 shall be in addition to any other rights to which the Indemnitee(s) may be entitled under any agreement, as a matter of law or equity or otherwise, and shall inure to the benefit of the heirs, successors, assigns and administrators of the Indemnitee(s). Subject to the foregoing sentence, the provisions of this Section 7 are for the benefit of the Indemnitee(s) and shall not be deemed to create any rights for the benefit of any other persons.
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9. General Provisions. This Agreement is intended to set forth the full and complete understanding of the parties with respect to its subject matter, and it fully supersedes and nullifies the Stock Purchase Agreement entered into by the Parties on May 9, 2023. This Agreement shall be governed by and interpreted in accordance with the laws of the State of Delaware.
10. Public Disclosure. Each of the Parties hereby acknowledges that neither Party is permitted to publicly share information concerning the transactions contemplated by this Agreement. Notwithstanding the foregoing, Prevail Partners hereby acknowledges that the Company is permitted to share such information publicly for the purposes of obtaining approvals from the TSX and/or Nasdaq, in which case the Company will provide Prevail Partners with a reasonable opportunity to review and provide comment on such public disclosure.
11. Further Assurances. Each of the Parties shall from time to time execute and deliver such further documents and instruments and do all acts and things as the other Party may reasonably require to effectively carry out or better evidence or perfect the full intent and meaning of this Agreement.
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the Effective Date.
| PREVAIL PARTNERS, LLC | ||
| By: | /s/ Mary Schaheen | |
| Name: | Mary Schaheen | |
| Title: | President | |
| BRIACELL THERAPEUTICS CORP. | ||
| By: | /s/ William V. Williams | |
| Name: | William V. Williams | |
| Title: | President and CEO | |
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Exhibit 99.1
BriaCell Announces $4 Million Strategic Investment and Clinical Alliance with Prevail Partners, LLC and Prevail InfoWorks, Inc.
| ● | Prevail Partners, LLC to purchase 463,408 BriaCell common shares at a price of $8.63 for gross proceeds of $4 million, representing a 20% premium to the trailing thirty (30) trading day VWAP. |
| ● | Prevail InfoWorks, Inc. to act as Contract Research Organization (CRO) for BriaCell’s upcoming pivotal study, expected to commence in 2023. |
PHILADELPHIA and VANCOUVER, British Columbia, May 15, 2023— BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, announces that the Company has signed a Master Service and Technology Agreement (“MSTA”) agreement with Prevail InfoWorks, Inc. (“InfoWorks”), a Philadelphia, PA based Contract Research Organization (CRO), to provide clinical services and technologies for BriaCell’s upcoming pivotal study in advanced metastatic breast cancer. Services include clinical site coordination, project management, clinical monitoring and pharmacovigilance (safety management) services, and the use of InfoWork’s integrated real-time data analytics platform, The Single Interface®, for clinical support and real-time data analysis.
Prevail Partners, LLC (“Prevail Partners”), an investment fund and affiliate of InfoWorks, has agreed to purchase 463,408 BriaCell common shares at a price of $8.63 for gross proceeds of $4 million, representing a 20% premium to the trailing thirty (30) trading day volume-weighted average price of the common shares of the Company on the Nasdaq Stock Exchange. Subject to exchange approvals and other customary closing conditions, the subscription is expected to close on or about May 19, 2023.
“We have high confidence in Prevail InfoWorks’ ability to coordinate our pivotal clinical trial in advanced breast cancer. They have extensive experience and expertise which should assure rapid accrual and smooth execution of the study. Additionally, fast, reliable data access is essential to successful and timely completion of our upcoming pivotal trial, lowers our clinical risk, and may speed up the FDA approval timeline,” stated Dr. William V. Williams, BriaCell’s President & CEO. “Prevail Partners’ strategic investment in BriaCell’s registration study further highlights the confidence Prevail has in our ability to execute on enrolment targets and subsequent survival data.”
Prevail Partners acknowledges and agrees that they are purchasing the Shares pursuant to an exemption from any prospectus, registration or similar requirements under applicable U.S. and Canadian securities laws, and that the offer, sale and delivery of the Shares to Prevail Partners is conditional upon such offer, sale and deliver being exempt from the requirements under applicable securities laws requiring the filing of a prospectus in connection with the distribution of the Shares or upon the issuance of such rulings, orders, consents or approvals as may be required to permit such sale without the requirement of filing a prospectus. The common shares purchased by Prevail Partners are subject to applicable US and Canadian resale restrictions.
About BriaCell Therapeutics Corp.
BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. More information is available at https://briacell.com/.
About Prevail Partners, LLC
Prevail Partners, LLC is a corporate strategic investment fund investing in clinical stage therapeutics companies. More information is available at https://prevailpartners.com/.
About Prevail InfoWorks, Inc.
Prevail InfoWorks, Inc. is a global full-service CRO/FSP and one-stop-shop for clinical trial services and systems. More information is available at https://prevailinfoworks.com/.
Safe Harbor
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including in relation to the implementation of the Prevail Partners and InfoWorks arrangements and completion of the corresponding CRO-supported clinical trials, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
Investor Relations Contact:
CORE IR
Prevail Partners, LLC Contact:
Mary Schaheen
President
267-797-2011
Prevail InfoWorks, Inc. Contact:
Jack Houriet
CEO
267-797-2001