OBIO 8-K
Orchestra BioMed Holdings, Inc. (OBIO)
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
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| Item 1.01. | Entry into Material Definitive Agreement. |
Termination and Right of First Refusal Agreement
On October 24, 2025 (the “Effective Date”), Orchestra BioMed, Inc. (“Orchestra”), a wholly owned subsidiary of Orchestra BioMed Holdings, Inc. (the “Company”), entered into a termination and right of first refusal agreement (the “Termination and ROFR Agreement”) with Terumo Medical Corporation (“TMC”) and Terumo Corporation (“TC” and, together with TMC “Terumo”), pursuant to which that certain Distribution Agreement by and between Orchestra and Terumo, dated June 13, 2019 (as subsequently amended, the “Distribution Agreement”), was terminated, and Orchestra agreed to grant Terumo a right of first refusal (the “ROFR”) with respect to certain transactions involving the Company’s product candidate known as Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) for the treatment of coronary artery disease globally in exchange for a fee of $10 million (the “ROFR Fee”), which is to be paid no later than 10 business days after the Effective Date. The ROFR does not apply to other vascular indications, such as below-the-knee peripheral artery disease, which were covered by the Distribution Agreement prior to its termination. Accordingly, all rights to these indications are fully retained by the Company.
Pursuant to the Distribution Agreement, Orchestra previously received a $30 million non-refundable payment from Terumo, which is not affected by the Termination and ROFR Agreement. Pursuant to the terms of the Termination and ROFR Agreement, Orchestra has no further performance obligations under the Distribution Agreement.
The ROFR has a term that began on the Effective Date and will end on the date that is 90 days after Orchestra discloses primary endpoint data from its U.S. clinical trial for Virtue SAB pursuant to its investigational device exemption (“IDE”) for coronary in-stent restenosis (“ISR”) to Terumo or the public, whichever occurs first (the “ROFR Period”); provided, however, that the ROFR Period will immediately expire if Terumo completes the acquisition from a third party of the exclusive right to make, use, sell, offer to sell or distribute a Competing Product (as defined in the Termination and ROFR Agreement) in the United States.
Notice of Third-Party Proposal
The ROFR provides that, in the event that during the ROFR Period, Orchestra receives a written proposal (a “Third-Party Proposal”) reflecting the material terms of an agreement pursuant to which Orchestra would grant a to a third party either (i) an outright or staged acquisition rights to Virtue SAB or its components or (ii) a license of or the right to distribute Virtue SAB, in each case, in the treatment of coronary artery diseases (a “Virtue Transaction”), Orchestra will promptly deliver notice of each such Third-Party Proposal together with a copy of the applicable Third-Party Proposal to Terumo (a “Third Party Proposal Notice”).
Exercise of ROFR
Pursuant to the Termination and ROFR Agreement, Terumo will have 30 days after delivery of the Third-Party Proposal Notice (the “ROFR Determination Period”) to exercise the ROFR by providing written notice to Orchestra (the “ROFR Notice”). In the event that Terumo exercises the ROFR during the ROFR Determination Period, the Company and Terumo will negotiate in good faith and on an exclusive basis during the period beginning on the date of delivery of the ROFR Notice and ending 90 says thereafter (the “Terumo ROFR Negotiation Period”) to enter into a Virtue Transaction on substantially the same terms set forth in the applicable Third-Party Proposal.
If Terumo fails to deliver a ROFR Notice to Orchestra prior to the expiration of the ROFR Determination Period, Terumo shall be deemed to have waived the ROFR with respect to the applicable Third-Party Proposal. If Terumo is deemed to have waived a Terumo ROFR pursuant to the preceding sentence, or if Terumo delivers a ROFR Notice within the applicable ROFR Determination Period, but the parties fail to enter into a definitive agreement regarding a Virtue Transaction prior to expiration of the Terumo ROFR Negotiation Period, then, in either case, effective upon such expiration, (i) the ROFR shall terminate, and be of no further force or effect, with respect to the applicable Third-Party Proposal Notice and (ii) Orchestra shall be free to terminate negotiations with Terumo and to enter into a Virtue Transaction with the applicable third party; provided that Orchestra shall not enter into a definitive agreement with the applicable third party on terms and conditions that are materially different than the applicable Third Party Proposal without first providing Terumo with a renewed Third Party Proposal Notice and ROFR Determination Period; provided, further, that, if Orchestra does not consummate a transaction with respect to such Third Party Proposal within 90 days after termination of the ROFR, Terumo will retain its ROFR during the remaining portion of the ROFR Period.
Orchestra’s obligation to provide Terumo with the ROFR is subject to Terumo paying the ROFR Fee and consummation of the Private Placement (as defined below).
Sale Transaction
Subject to Terumo paying the ROFR Fee and consummation of the Private Placement, in the event that the Company receives a written proposal reflecting the material terms of an agreement for a Sale Transaction (as defined in the Termination and ROFR Agreement) of Orchestra (such transaction an “Orchestra Sale”), or if Orchestra’s board of directors approves a formal transaction process for an Orchestra Sale (a “Sale Process”), Orchestra will promptly give Terumo written notice (an “Orchestra Sale Notice”). During the period of 30 days that begins with the delivery of the Orchestra Sale Notice (the “Orchestra Sale Notice Period”), Orchestra will not enter into a binding agreement or other arrangement for an Orchestra Sale with any third party. During the Orchestra Sale Notice Period, Terumo shall be given the opportunity to make an offer with respect to a Virtue Transaction, and Orchestra will consider in good faith any such offer made. In addition, Orchestra shall give Terumo the opportunity to participate in any Sale Process and shall consider any offer by Terumo in connection therewith in good faith.
Term. The Termination and ROFR Agreement will remain in effect for (a) the ROFR Period or (b) the end of any Terumo ROFR Negotiation Period and expiration of the parties rights and obligations under Section 3.2 of the Termination and ROFR Agreement with respect to the exercise of the ROFR, whichever comes later; provided that the Termination and ROFR Agreement will automatically terminate in the event that Orchestra has not disclosed primary endpoint data from a U.S. clinical trial pursuant to its IDE for coronary ISR to Terumo or the public prior to the tenth anniversary of the Effective Date.
The foregoing description of the Termination and ROFR Agreement is a summary only, does not purport to be complete, and is qualified in its entirety by the full terms and conditions of the Termination and ROFR Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated herein by reference.
Stock Purchase Agreement
On October 24, 2025, concurrent with the execution of the Termination and ROFR Agreement, the Company and TMC entered into a stock purchase agreement, (the “Stock Purchase Agreement”), pursuant to which TMC agreed to purchase 200,000 shares (the “Shares”) of the Company’s Series A Convertible Preferred Stock, par value $0.0001 per share (“Series A Preferred Stock”) at a purchase price equal to $100.00 per Share (the “Purchase Price”) for gross proceeds to the Company of $20.0 million. The closing of the sale of the Shares pursuant to the Stock Purchase Agreement (“Closing”) is expected to occur no later than November 7, 2025, subject to the satisfaction of customary closing conditions. The Stock Purchase Agreement contains customary representations and warranties of the Company and TMC, and customary covenants on the part of the Company.
Pursuant to the terms of the Distribution Agreement, Terumo previously made a $5 million common stock investment in Orchestra. As a result of this $5 million investment, Terumo now owns 493,037 shares of the Company’s common stock (“Common Stock”), which shares are subject to a one-year lockup pursuant to the Lockup Agreement described below.
Series A Preferred Stock
The Company will file a Certificate of Designation of Series A Convertible Preferred Stock (the “Certificate of Designation”) with the Secretary of State of the State of Delaware prior to Closing. The Certificate of Designation will set forth the rights, preferences, powers, restrictions, and limitations of the Series A Preferred Stock and will be effective prior to Closing. Below is a summary of certain of the provisions of the Certificate of Designation.
Rank; Liquidation
With respect to distribution of assets upon liquidation, dissolution or winding up of the Company, whether voluntary or involuntary, a holder of Series A Preferred Stock (a “Holder” or, collectively, “Holders”) will be entitled to be paid out of the assets of the Company available for distribution to its stockholders before any payment is made to the holders of Common Stock (or any other class of securities junior to the Series A Preferred Stock) an amount equal to the liquidation value of the Shares held by such Holder. The liquidation value of the Series A Preferred Stock will equal the Purchase Price of $100.00 per Share (the “Liquidation Value”) and will be subject to adjustment for stock splits and the like in accordance with the terms of the Certificate of Designation.
Conversion
Under the terms of the Certificate of Designation, a Holder may convert its Shares into Common Stock on or after the earlier of (i) the date that both (a) the Company has publicly disclosed primary endpoint data from its U.S. IDE study for ISR and (b) the trading price of the Common Stock has been above $15.00 per share on any trading day subsequent to such public disclosure or (ii) the consummation of a Change of Control (as defined in the Certificate of Designation). A Holder may convert all or any portion of the outstanding whole Shares held by such Holder into an aggregate number of shares of Common Stock as is determined by (i) multiplying the number of Shares to be converted by the Liquidation Value thereof, and then (ii) dividing the result by the Conversion Price (as defined below) in effect immediately prior to such conversion, with cash being paid in lieu of fractional shares The “Conversion Price” for the Series A Preferred Stock will be the greater of (i) $12.00 per share and (ii) a 20% discount to the closing price of the Common Stock on the Nasdaq Global Market on the date of conversion. Assuming no adjustments to the Conversion Price or the Liquidation Value as a result of stock splits or similar transactions, the 200,000 Shares to be issued would convert into a maximum of 1,666,666 shares of Common Stock.
Redemption at the Option of Holders upon a Change of Control
Upon the occurrence of a Change of Control, subject to limited exceptions, each Holder of Shares shall have the right to require the Company to redeem all or any part of such Holder’s Shares at a redemption price in cash equal to the aggregate Liquidation Value of such Shares.
No Voting Rights
Except as otherwise required by the Delaware General Corporation Law, the Holders shall have no voting rights.
Participating Dividends
If the Company declares or pays a dividend or distribution on all shares of the Common Stock, whether such dividend or distribution is payable in cash, securities, or other property but excluding any dividend or distribution payable on the Common Stock in shares of Common Stock, the Company shall simultaneously declare and pay a dividend on the Series A Preferred Stock on a pro rata basis with the Common Stock determined on an as-converted basis assuming all Shares had been converted as of immediately prior to the record date of the applicable dividend (or if no record date is fixed, the date as of which the record holders of Common Stock entitled to such dividends are to be determined).
Lockup Agreement
On October 24, 2025, concurrent with the execution of the Termination and ROFR Agreement, the Company and Terumo entered into a Lockup Agreement (the “Lockup Agreement”), pursuant to which Terumo agreed, subject to limited exceptions, that it and its affiliates will not Transfer (as such term is defined in the Lockup Agreement) or enter into any swap, hedging or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of any shares of Common Stock held by Terumo until October 24, 2026; provided that the Lockup Agreement only applies to Common Stock held by Terumo and its affiliates as of the date of the Lockup Agreement.
The foregoing descriptions of the Stock Purchase Agreement, the Series A Preferred Stock and the Lockup Agreement are only summaries, do not purport to be complete, and are qualified in their entirety by the full terms and conditions of the Stock Purchase Agreement, the form of Certificate of Designation attached thereto as Exhibit A and the Lockup Agreement . The Stock Purchase Agreement and the Lockup Agreement are filed as Exhibits 10.2 and 10.3, respectively, to this Current Report and are incorporated herein by reference.
| Item 1.02. | Termination of a Material Definitive Agreement. |
The information required by this item with respect to the Termination and ROFR Agreement and the termination of the Distribution Agreement is included in Item 1.01 hereto and is incorporated herein by reference.
| Item 3.02. | Unregistered Sales of Equity Securities. |
The information required by this item with respect to the Series A Preferred Stock is included in Item 1.01 hereto and is incorporated herein by reference.
The Series A Preferred Stock was sold in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). TMC provided written representations to the Company regarding its suitability to invest in the Series A Preferred Stock. The Company did not engage in general solicitation in connection with the sale of the Series A Preferred Stock.
| Item 7.01. | Regulation FD Disclosure. |
On October 28, 2025, the Company issued a press release announcing, among other things, the Termination and ROFR Agreement and the Stock Purchase Agreement. A copy of the press release is attached to this Current Report as Exhibit 99.1 and is incorporated herein solely for purposes of this Item 7.01 disclosure.
The information in Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act or the Exchange Act, regardless of any incorporation by reference language in any such filing.
| Item 8.01. | Other Events. |
On October 27, 2025, the Company announced the first patient enrollments in the Virtue SAB in the Treatment of Coronary ISR Trial (“Virtue Trial”), the Company’s U.S. IDE pivotal trial comparing its highly differentiated Virtue® Sirolimus AngioInfusionTM Balloon (“Virtue SAB”) to the AGENT paclitaxel-coated balloon, currently the only drug-coated balloon (“DCB”) FDA-approved for a coronary indication. The initial cases were successfully completed by the teams at The Christ Hospital Heart & Vascular Institute in Cincinnati, OH, and St. Francis Hospital & Heart Center in Roslyn, NY, marking the initiation of the Virtue Trial. Designed to support regulatory approval of Virtue SAB, the Virtue Trial is expected to enroll 740 patients at up to 75 centers in the United States with enrollment completion currently planned for mid-2027.
Virtue SAB: Redefining Delivery of Sirolimus
Virtue SAB is designed to deliver a large liquid dose of a proprietary extended-release formulation of sirolimus, SirolimusEFR™, through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit and helps overcome certain limitations of DCBs. SirolimusEFR™ is designed to enable enhanced tissue uptake and extended release of therapeutic levels of sirolimus through the critical healing period, exceeding previously published target tissue concentrations of proven drug-eluting stents. In the multi-center SABRE pilot study, Virtue SAB demonstrated promising clinical results for the treatment of single-layer coronary ISR:
| · | 12-month target lesion failure of 2.8% |
| · | Zero target lesion revascularizations from 12-month follow-up through 36-month follow-up; and |
| · | 6-month late lumen loss of 0.12mm. |
Virtue SAB has FDA Breakthrough Device Designation for the treatment of coronary in-stent restenosis (“ISR”), as well as for coronary small vessel disease and below-the-knee peripheral artery disease. The Company estimates the total global market opportunity for drug-eluting balloons to be over $10 billion annually.
A Head-to-Head Randomized Evaluation of a Sirolimus-Eluting Balloon vs. a Paclitaxel-Coated Balloon
The Virtue Trial is a prospective, multi-center, randomized trial comparing clinical outcomes of Virtue SAB to AGENT Paclitaxel DCB in the treatment of coronary ISR. Data from the Virtue Trial is expected to be used to support regulatory approval in the U.S. The primary endpoint is a non-inferiority comparison of Target Lesion Failure (TLF) defined as a composite of cardiac death, nonfatal target vessel myocardial infarction and ischemia-driven target lesion revascularization at 12 months.
Forward-Looking Statements
Certain statements included in this Current Report on Form 8-K (this “Current Report”) that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, timing, implementation and design of the Virtue Trial, the ability of data from the Virtue Trial to support regulatory approval in the U.S., and the potential efficacy and safety of the Company’s commercial product candidates. These statements are based on various assumptions, whether or not identified in this Current Report, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; failure to realize the anticipated benefits of the business combination; risks related to regulatory approval of the Company’s product candidates; the timing of, and the Company’s ability to achieve, expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025, as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q.
The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this Current Report. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
Description | |
| 10.1 | Termination and ROFR Agreement, by and between the Orchestra BioMed, Inc., Terumo Corporation and Terumo Medical Corporation, dated October 24, 2025 | |
| 10.2 | Stock Purchase Agreement, by and between the Company and Terumo Medical Corporation, dated October 24, 2025 | |
| 10.3 | Lockup Agreement, by and among the Company, Terumo Corporation and Terumo Medical Corporation, dated October 24, 2025 | |
| 99.1 | Press Release, dated October 28, 2025 | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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.
ORCHESTRA BIOMED HOLDINGS, INC. | |||
| By: | /s/ Andrew Taylor | ||
| Name: | Andrew Taylor | ||
| Title: | Chief Financial Officer | ||
Date: October 28, 2025
Exhibit 99.1
Orchestra BioMed and Terumo Enter into New $30 Million Virtue SAB Strategic Agreements
| · | New agreement grants Terumo Virtue SAB coronary indication right of first refusal and supersedes prior distribution agreement |
| · | Terumo to pay a total of $30 million to Orchestra BioMed |
| · | Orchestra BioMed retains all development and distribution rights to Virtue SAB in all indications |
| · | Orchestra BioMed recently initiated patient enrollment for the Virtue Trial, its U.S. pivotal IDE trial of Virtue SAB in the treatment of coronary in-stent restenosis (“ISR”) |
New Hope, PA – October 28, 2025 – Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced that it has entered into a termination and right of first refusal agreement (the “ROFR Agreement”) with Terumo Corporation (TYO: 4543) and Terumo Medical Corporation (collectively, “Terumo”) with respect to Virtue® Sirolimus AngioInfusionTM Balloon (“SAB”) for the treatment of coronary artery disease worldwide. The ROFR Agreement, which supersedes and terminates the prior Virtue SAB distribution agreement between Orchestra BioMed and Terumo (the “Prior Agreement”), grants Terumo a right of first refusal (“ROFR”) to acquire the rights, or enter a distribution arrangement, with respect to Virtue SAB for the treatment of coronary artery disease, in exchange for an upfront payment of $10 million. Terumo and Orchestra BioMed have also entered into a securities purchase agreement, pursuant to which Terumo has agreed to invest an additional $20 million in Orchestra BioMed through a new series of non-voting preferred stock, which is convertible into common stock in the future, subject to certain conditions, at a minimum of $12 per share (the “Securities Purchase Agreement”). Terumo previously made a $30 million non-refundable payment and $5 million common stock investment in Orchestra BioMed upon execution of the Prior Agreement.
David Hochman, Chairman and Chief Executive Officer of Orchestra Biomed stated: “Our new agreements with Terumo reflect the differentiated value of Virtue SAB for the treatment of atherosclerotic disease in the coronary arteries and provide strategic optionality for both companies. This new arrangement highlights the strong clinical and commercial potential of Virtue SAB to become a best-in-class therapy in the global coronary market. The $30 million in proceeds from Terumo provides meaningful additional capital resources to advance both of our pivotal stage programs to key clinical and regulatory milestones. We are glad to be aligned with our colleagues at Terumo and are thrilled to have initiated the Virtue Trial evaluating our fundamentally different approach to treating coronary in-stent restenosis.”
Ghada Farah, President of Terumo Interventional Systems commented: “We are very pleased to enter into a new strategic agreement with Orchestra BioMed that reflects the significant potential for Virtue SAB in the treatment of coronary artery disease. We believe it aligns the objectives of both companies, and we wish Orchestra BioMed great success as they enroll patients in the Virtue Trial.”
The ROFR Agreement
Under the ROFR Agreement, Orchestra BioMed will have the opportunity to seek development and commercialization partnerships for Virtue SAB in any therapeutic indication, including coronary artery disease treatment. Terumo will have the first right to review and respond to any potential third party offers presented to Orchestra BioMed related to the global coronary market. The ROFR period expires ninety (90) days after Orchestra BioMed discloses primary endpoint data from the Virtue Trial to Terumo or the public, whichever is earlier (the “ROFR period”).
The transactions contemplated by the ROFR Agreement and the Securities Purchase Agreement are subject to customary closing conditions and are expected to close no later than November 7, 2025.
About Orchestra BioMed
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market- leading global medical device companies. The Company’s two flagship product candidates - Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusionTM Balloon (Virtue SAB) - are currently undergoing pivotal clinical trials for their lead indications which both represent multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT) for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. The Company has a right of first refusal agreement with Terumo Corporation and Terumo Medical Corporation, a leading global medical device company, for a potential transaction related to Virtue SAB for the treatment of coronary artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.
About Virtue SAB
Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™. It uses a non-coated microporous AngioInfusion™ Balloon to protect the drug in transit and consistently deliver a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee.
About Coronary In-Stent Restenosis (ISR)
Coronary ISR is a serious complication of coronary stenting, which can increase the risk of life-threatening heart problems. It is characterized by a re-narrowing of a coronary artery segment that was previously treated with a stent. According to the National Cardiovascular Data Registry, coronary ISR occurs in up to 10% of stented patients during the first year and continues at a rate of up to 3% per year thereafter, resulting in an estimated over 325,000 coronary ISR lesions annually worldwide that may require treatment. The only device treatments currently approved by the FDA for use in coronary ISR lesions are balloon angioplasty and intravascular radiation therapy known as brachytherapy. Traditional balloon angioplasty has high retreatment rates and brachytherapy is considered a last resort treatment due to radiation burden, expense, limited availability, and long-term requirement for dual antiplatelet therapy. If left untreated, coronary ISR may lead to stable angina, unstable angina, acute coronary syndrome, acute myocardial infarction, or death.
References to Websites and Social Media Platforms
References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference
of the information contained at or available through such websites or social media platforms, and you should not consider such information
to be part of this press release.
Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the closing of the transactions contemplated by the ROFR Agreement and the Securities Purchase Agreement, the timing of the initiation of the Virtue Trial, and the potential safety and efficacy of the Company’s product candidates. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s product candidates; the timing of, and the Company’s ability to achieve, expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 31, 2025, as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q.
The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
Investor Contact
Silas Newcomb
Orchestra BioMed
Media Contact
Kelsey Kirk-Ellis
Orchestra BioMed
Exhibit 10.1
Execution Version
TERMINATION AND RIGHT OF FIRST REFUSAL AGREEMENT
This TERMINATION AND RIGHT OF FIRST REFUSAL AGREEMENT (“Agreement”) is entered into as of October 24, 2025 (the “Effective Date”) by and between ORCHESTRA BIOMED, INC., a corporation having its principal office at 150 Union Square Drive, New Hope, PA 18938, United States (“OBIO”) and TERUMO CORPORATION, having its registered place of business at 2-44-1 Hatagaya, Shibuya-ku Tokyo, 151-0072 Japan (“TC”) and TERUMO MEDICAL CORPORATION, a corporation having its principal office at 265 Davidson Avenue, Somerset, NJ 08873 (“TMC” and together with TC, “Terumo”). OBIO and Terumo may be referred to individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, the Parties previously entered into that certain Distribution Agreement dated June 13, 2019 (as amended) and that certain Letter Agreement dated June 20, 2022 (collectively, the “Distribution Agreement”);
WHEREAS, the Parties wish to terminate the Distribution Agreement;
WHEREAS, OBIO wishes to grant, and Terumo wishes to receive, a right of first refusal with respect to OBIO’s product known as Virtue SAB, as further described in this Agreement;
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, OBIO and Terumo hereby agree as follows:
Article 1
DEFINITIONS
1.1 “Affiliate” of a Party means any entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Party, as the case may be, but for only so long as such control exists. As used in this Section 1.1, “control” means (a) to possess, directly or indirectly, the power to direct the management or policies of an entity, whether through ownership of voting securities, or by contract relating to voting rights or corporate governance; or (b) direct or indirect beneficial ownership of more than fifty percent (50%) (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the voting share capital or other equity interest in such entity.
1.2 “Applicable Laws” means the applicable provisions of any and all national, supranational, regional, state and local laws, treaties, statutes, rules, regulations, administrative codes, industry codes, guidance, ordinances, judgments, decrees, directives, injunctions, orders or permits (including regulatory approvals) of or from any court, arbitrator, regulatory authority, any other governmental agency or authority having jurisdiction over or related to the subject item or stock exchange, and other laws and regulations pertaining to domestic or international corruption, commercial bribery, fraud, kickback, embezzlement or money laundering.
1.3 “Business Day” means a day other than a Saturday or Sunday or any public holiday in the United States or Japan.
1.4 “Competing Product” means a sirolimus-coated balloon or sirolimus-eluting balloon that has received an IDE or IND from the FDA, excluding any sirolimus-coated balloon or sirolimus-eluting balloon that Terumo sells or is developing internally, in each case, as of the Effective Date.
1.5 “Confidential Information” has the meaning set forth in Section 5.1.
1.6 “Delivery Device” means the laser drilled balloon catheter, syringe (prefilled sterile water), dose unit, 3-way stopcock and recon unit designed and manufactured to be a component of the Product.
1.7 “Drug” means polymer-encapsulated, lyophilized, controlled-release Sirolimus designed and manufactured to be a component of the Product.
1.8 “FDA” means the Food and Drug Administration, or any successor agency thereto having the administrative authority to regulate the marketing of human pharmaceutical, therapeutic and medical device products in the United States.
1.9 “Field” means the treatment of coronary artery diseases.
1.10 “FSA” means Financial Services Agency in Japan or any successor agency.
1.11 “IDE” means an investigational device exemption by the FDA.
1.12 “IND” means an investigational new drug application approval by the FDA.
1.13 “ISR” means in-stent restenosis.
1.14 “Person” means any individual, corporation, partnership, limited liability company, trust or other entity.
1.15 “PMA” means a premarket approval by the FDA.
1.16 “Product” means OBIO’s product known as Virtue SAB, consisting of the Drug and the Delivery Device.
1.17 “Sale Transaction” means, with respect to any Person, (a) a merger or consolidation or other business combination to which such Person is a party, except any such merger, consolidation or other business combination in which the holders of equity securities of such Person outstanding immediately prior to such merger or consolidation continue to represent, immediately following such merger or consolidation, at least a majority, by voting power, of the holders of equity securities of the surviving or resulting entity (or its ultimate parent entity), (b) a transaction or series of related transactions in which a Person, or a group of related Persons, acquires directly or indirectly equity interests from the equityholders of such Person representing more than fifty percent (50%) of the outstanding voting power of such Person, or (c) any exclusive license, sale, assignment, transfer or other disposition by such Person of all or substantially all of its assets.
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1.18 “SEC” means the U.S. Securities and Exchange Commission or any successor agency.
1.19 “Securities Laws” means the Securities Exchange Act of 1934, as amended, the Securities Act of 1933, as amended, the Japanese Securities Exchange Act, the rules of Tokyo Stock Exchange, and any other applicable securities laws or rules of any applicable securities exchanges, along with any amendments thereto.
1.20 “Territory” means the United States of America.
1.21 “Terumo ROFR Period” means the period beginning on the Effective Date and ending on the date that is ninety (90) days after OBIO discloses primary endpoint data from its United States clinical trial for the Product pursuant to its IDE for coronary ISR to Terumo or the public, whichever is earlier.
1.22 “Third Party” means any Person other than OBIO, Terumo and their respective Affiliates.
1.23 “Virtue Transaction” means the grant to a third party of either (a) an outright or staged acquisition of rights to the Drug, Delivery Device or the Product, or (b) a license of or of the right to distribute the Product, in the case of each of (a) and (b) in the Field. For the avoidance of doubt a Virtue Transaction shall not include a Sale Transaction with respect to OBIO Holdings or OBIO Corporation.
Article 2
TERMINATION OF DISTRIBUTION AGREEMENT; INVESTMENT
2.1 Termination of Distribution Agreement.
(a) The Parties hereby terminate in its entirety the Distribution Agreement, without giving effect to Sections 15.3, 15.4, 15.5, and 15.6 thereof. The Parties acknowledge that all amounts paid under the Distribution Agreement as of the Effective Date are non-refundable and that such payments were: (a) in respect of work previously performed and completed by OBIO to secure IDE approval from the FDA for the conduct of a coronary ISR study in the United States, and (b) Service Charges in accordance with Section 5.1(b)(vii) of the Distribution Agreement.
(b) Upon written request of the other Party, each Party shall as soon as reasonably practicable either (i) deliver to the other Party any Confidential Information (as defined in the Distribution Agreement) of such other Party disclosed pursuant to the Distribution Agreement that is then in its possession or (ii) destroy all original copies thereof and confirm said destruction in writing, provided that nothing in this section shall require a Party to return or destroy any material a Party is required to retain to comply with provisions of this Agreement or Applicable Laws, nor shall anything in this section require a Party to return or destroy copies of any material created pursuant to a Party’s archiving and back-up procedures or retained in a Party’s e-mail or document management system.
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2.2 Mutual General Waiver and Release. Each Party, on behalf of itself and its affiliates, and their respective direct and indirect directors, officers, members, managers, shareholders, general partners, limited partners, agents, employees, subsidiaries, parents, heirs, executors, administrators, accountants, attorneys and other representatives, predecessors, successors and assigns, past, present or future, expressly releases, fully and finally, the other Party and their respective affiliates, and their respective directors, officers, members, managers, shareholders, general partners, limited partners, agents, employees, subsidiaries, parents, heirs, executors, administrators, accountants, attorneys and other representatives, predecessors, successors and assigns, past, present or future from and against all manner of claims, causes of action, suits, demands, debts, sums of money, accounts, covenants, contracts, controversies, agreements, and promises on its part of any kind whatsoever, known or unknown, suspected or unsuspected, direct, indirect or contingent, in law or in equity that each Party has, had or could have had from the beginning of time through the Effective Date, including, but not limited to, any claims arising under or related to the Distribution Agreement. For the avoidance of doubt, the releases described in this Section shall not extend to any breach of this Agreement.
2.3 Acquisition of Preferred Stock. Subject to the terms of the Preferred Stock Purchase Agreement dated the date hereof and attached hereto as Exhibit A, Terumo has agreed to acquire, and Orchestra Biomed Holdings, Inc. has agreed to sell, 200,000 shares of Orchestra Biomed Holdings, Inc. preferred stock for a non-refundable cash payment of Twenty Million U.S. Dollars ($20,000,000) (the “Stock Sale”).
Article 3
RIGHT OF FIRST REFUSAL
3.1 Notice of Third-Party Proposal. Subject to the payment of the ROFR Fee and consummation of the Stock Sale, in the event that during the Terumo ROFR Period, OBIO receives a written proposal, offer, indication of interest, letter of intent, term sheet or other document reflecting the material terms of an agreement for a Virtue Transaction (each such proposal, a “Third-Party Proposal”), OBIO will promptly deliver notice of each such Third-Party Proposal together with a copy of the applicable Third-Party Proposal to Terumo (a “Third-Party Proposal Notice”). During the period of thirty (30) days that begins with the delivery of the Third-Party Proposal Notice (the “ROFR Determination Period”), OBIO shall not enter into a binding agreement or other arrangement for such noticed Third-Party Proposal or any other Virtue Transaction, or enter into a binding agreement or other arrangement that provides for exclusive negotiations with respect to such noticed Third-Party Proposal or any other Virtue Transaction, with any Third Party. For clarity, the foregoing shall not prevent OBIO from freely engaging in discussions with any Third Party about a potential Virtue Transaction or furnishing information with respect to the Product to such Third Party under confidentiality and non-use obligations no less restrictive than those set forth here, nor, subject to Section 3.2, require OBIO, as a result of engaging in such discussions or providing such information, to deliver a Third-Party Proposal Notice.
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3.2 Exercise of Terumo ROFR. Subject to the payment of the ROFR Fee and consummation of the Stock Sale, Terumo shall have the right, at any time during the ROFR Determination Period, to exercise a right of first refusal with respect to each Third-Party Proposal Notice (the “Terumo ROFR”) by providing written notice to OBIO (a “ROFR Notice”) during the corresponding ROFR Determination Period. Upon Terumo’s timely exercise of the Terumo ROFR, OBIO and Terumo shall negotiate in good faith and on an exclusive basis during the period beginning on the date of delivery of the corresponding ROFR Notice and ending ninety (90) days thereafter (the “Terumo ROFR Negotiation Period”), to enter into a Virtue Transaction on substantially the same terms set forth in the applicable Third-Party Proposal Notice. If Terumo fails to deliver a ROFR Notice to OBIO prior to expiration of the ROFR Determination Period, then, effective upon such expiration, Terumo shall be deemed to have waived the Terumo ROFR with respect to the applicable Third-Party Proposal. If Terumo is deemed to have waived a Terumo ROFR pursuant to the preceding sentence, or if Terumo delivers a ROFR Notice within the applicable ROFR Determination Period, but the Parties fail to enter into a definitive agreement regarding a Virtue Transaction prior to expiration of the Terumo ROFR Negotiation Period, then, in either case, effective upon such expiration, (i) the Terumo ROFR shall terminate, and be of no further force or effect, with respect to the applicable Third-Party Proposal Notice and (ii) OBIO shall be free to terminate negotiations with Terumo and to enter into a Virtue Transaction with the applicable Third Party; provided that OBIO shall not enter into a definitive agreement with the applicable Third Party on terms and conditions that are materially different than the applicable Third-Party Proposal without first providing Terumo with a renewed Third-Party Proposal Notice and ROFR Determination Period pursuant to Section 3.1; and also provided that, if OBIO fails to enter into a definitive agreement with respect to the noticed Virtue Transaction during the ninety (90) day-period following the expiration of the Terumo ROFR, then the Terumo ROFR shall renew and remain in effect pursuant to the terms of this Section 3.2 for any other Third-Party Proposals during the Terumo ROFR Period. For clarity, neither OBIO nor Terumo shall have any obligation to enter into a definitive agreement for such proposed Virtue Transaction.
3.3 Sale Transaction. Subject to the payment of the ROFR Fee and consummation of the Stock Sale, in the event that OBIO receives a written proposal, offer, indication of interest, letter of intent, term sheet or other document reflecting the material terms of an agreement for a Sale Transaction of OBIO (such transaction an “OBIO Sale”), or if the OBIO Board of Directors approves a formal transaction process for an OBIO Sale (a “Sale Process”), OBIO will promptly give Terumo written notice of the foregoing (an “OBIO Sale Notice”). During the period of thirty (30) days that begins with the delivery of the OBIO Sale Notice (the “OBIO Sale Notice Period”), OBIO will not enter into a binding agreement or other arrangement for an OBIO Sale with any Third Party. During the OBIO Sale Notice Period, Terumo will be given the opportunity to make an offer with respect to a Virtue Transaction and OBIO will consider in good faith any such offer made. In addition, OBIO shall give Terumo the opportunity to participate in any Sale Process, and shall consider any offer by Terumo in connection therewith in good faith.
3.4 Terumo Offer. Subject to the payment of the ROFR Fee and consummation of the Stock Sale, in the event that during the Terumo ROFR Period, Terumo delivers to OBIO a bona fide proposal for a Virtue Transaction, OBIO will consider and discuss with Terumo such proposal in good faith. For clarity, neither OBIO nor Terumo shall have any obligation to enter into a definitive agreement for such proposed Virtue Transaction.
3.5 Information Sharing. Subject to the payment of the ROFR Fee and consummation of the Stock Sale, OBIO and Terumo shall meet semi-annually, in person or virtually as mutually agreed by the Parties, during the Terumo ROFR Period to discuss clinical, commercial and operational aspects of the Product. Each Party shall designate an individual to coordinate the semi-annual meeting between the Parties (“Coordinator(s)”). For Terumo the individual is Tim Hoeman and for OBIO the individual is Mark Pomeranz (Executive Vice President, Interventional Therapies). Each Party may change its Coordinator at any time by written notice to the other Party. Without limiting the foregoing, during any Terumo ROFR Negotiation Period or OBIO Sale Notice Period, OBIO shall, and shall cause its Affiliates to, cooperate with Terumo, its Affiliates and their respective representatives, including by providing Terumo, its Affiliates and its and their relevant representations with access to information and data reasonably requested by such Persons to conduct due diligence with respect to the Product or OBIO Sale, as applicable.
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Article 4
PAYMENTS
4.1 Cash Payment. In consideration for the rights granted hereunder, Terumo shall, no later than ten (10) Business Days after the Effective Date, make a non-refundable cash payment to OBIO in the amount of Ten Million U.S. Dollars ($10,000,000) (the “ROFR Fee”).
4.2 Payment Method. All amounts specified to be payable under this Agreement are in U.S. dollars and shall be paid in U.S. dollars. All payments under this Agreement shall be made by bank wire transfer in immediately available funds to the account designated on Exhibit B or by such other means as directed by such Party in writing. Payments hereunder will be considered to be made as of the day on which they are received by the payee Party’s designated bank.
Article 5
CONFIDENTIALITY
5.1 Confidential Information. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, the Parties agree that during the Term and for ten (10) years thereafter, the receiving Party (the “Receiving Party”) shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as set forth in this Agreement any information or materials furnished to it or its Affiliates by or on behalf of the other Party (the “Disclosing Party”) or its Affiliates pursuant to this Agreement (including, but not limited to, Section 3.4), the Distribution Agreement or any other written agreement between the Parties or their Affiliates, in any form (written, oral, photographic, electronic, magnetic, or otherwise), including all information concerning the Product and any other technical or business information of whatever nature (collectively, “Confidential Information” of the Disclosing Party). Each Party may use the Confidential Information of the other Party only to the extent required to accomplish the purposes of this Agreement (including to exercise its rights or fulfill its obligations under this Agreement). Each Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own (but in no event less than reasonable care) to ensure that its employees, agents, consultants and other representatives do not disclose or make any unauthorized use of the Confidential Information of the other Party. Each Party will promptly notify the other upon discovery of any unauthorized use or disclosure of the Confidential Information of the other Party.
5.2 Exceptions. Notwithstanding Section 5.1, the obligations of confidentiality and non-use shall not apply to information that the Receiving Party can prove by competent written evidence: (a) is now, or hereafter becomes, through no act or failure to act on the part of the Receiving Party or any of its Affiliates, generally known or available; (b) is known by the Receiving Party or any of its Affiliates, other than under an obligation of confidentiality to the Disclosing Party, at the time of receiving such information; (c) is hereafter lawfully furnished to the Receiving Party or any of its Affiliates by a Third Party, which Third Party did not receive such information directly or indirectly from the Disclosing Party under an obligation of confidence; (d) is independently discovered or developed by the Receiving Party or any of its Affiliates without the use of Confidential Information belonging to the Disclosing Party; or (e) is the subject of a written permission to disclose provided by the Disclosing Party.
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5.3 Permitted Disclosures. Notwithstanding the provisions of Section 5.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement or if and to the extent such disclosure is reasonably necessary in the following instances:
(a) making any filings or disclosures pursuant to any of the Securities Laws;
(b) prosecuting or defending litigation as permitted by this Agreement; and
(c) complying with applicable court orders, governmental regulations or, applicable subpoenas or reasonable requests issued by governmental authorities in relation to compliance with Applicable Laws.
Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to this Section 5.3 it will, except where impracticable, give reasonable advance notice to the other Party of such disclosure and use efforts to secure confidential treatment of such information at least as diligent as such Party would use to protect its own confidential information, but in no event less than reasonable efforts. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential Information hereunder.
5.4 Public Announcements.
(a) Except as required by Applicable Laws (including, without limitation, the Securities Laws and disclosure requirements of the FSA, SEC, Tokyo Stock Exchange or any other stock exchange on which securities issued by a Party or its Affiliates are traded), neither Party shall make any public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other; provided that each Party may make any public statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, or issue press releases (including, but not limited to, as set forth in Section 5.4(c) below), so long as any such public statement or press release is not inconsistent with prior public disclosures or public statements approved by the other Party pursuant to this Section 5.4(a) and does not reveal non-public information about the other Party. In the event of a public announcement required by Applicable Laws, to the extent practicable under the circumstances, the Party making such announcement shall provide the other Party with a copy of the proposed text of such announcement sufficiently in advance of the scheduled release to afford such other Party a reasonable opportunity to review and comment upon the proposed text.
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(b) The Parties will coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement in accordance with the rules of the SEC) with the FSA, SEC, Tokyo Stock Exchange, Nasdaq or any other stock exchange on which securities issued by a Party or its Affiliate are traded, and each Party will use reasonable efforts to seek confidential treatment for the terms proposed to be redacted; provided that each Party will ultimately retain control over what information to disclose, and provided, further, that the Parties will use reasonable efforts to file redacted versions with any governing bodies which are consistent with redacted versions previously filed with any other governing bodies. Other than such obligation, neither Party (nor its Affiliates) will be obligated to consult with or obtain approval from the other Party with respect to any filings to the FSA, SEC, Tokyo Stock Exchange, Nasdaq or any other body governing a stock exchange.
(c) The Parties agree to issue an initial press release promptly, but in no event more than four (4) Business Days (as determined in the State of New York) following the Effective Date, in a form to be mutually agreed upon by the Parties.
(d) Except as expressly permitted in this Agreement or as required by Applicable Laws, neither Party may use the other Party’s trademarks, service marks or trade names, or otherwise refer to or identify that other Party in marketing or promotional materials, press releases, statements to news media or other public announcements, without the other Party’s prior written consent, which the other Party may grant or withhold in its sole discretion.
5.5 Equitable Relief. Given the nature and value of the Confidential Information and the competitive damage and irreparable harm that would result to a Party upon unauthorized disclosure, use or transfer of its Confidential Information to any Third Party, the Parties agree that monetary damages may not be a sufficient remedy for any breach of this Article 5. If the Receiving Party becomes aware of any breach or threatened breach of this Article 5 by the Receiving Party or a Third Party to whom the Receiving Party disclosed the Disclosing Party’s Confidential Information, the Receiving Party promptly shall notify the Disclosing Party and cooperate with the Disclosing Party to regain possession of its Confidential Information and prevent any further breach. In addition to all other remedies, a Party shall be entitled to seek specific performance and injunctive and other equitable relief as a remedy for any breach or threatened breach of this Article 5 without furnishing proof of actual damages.
Article 6
REPRESENTATIONS, WARRANTIES AND COVENANTS; LIMITATION OF LIABILITY
6.1 Mutual Representations, Warranties and Covenants. Each Party hereby represents and warrants to the other Party, as of the Effective Date, as follows:
(a) such Party is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, is qualified to do business and is in good standing as a foreign corporation in each jurisdiction in which the conduct of its business or the ownership of its properties requires such qualification and failure to have such would prevent such Party from performing its obligations under this Agreement;
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(b) the execution, delivery and performance of this Agreement by such Party have been duly authorized by all necessary corporate action, and this Agreement is a legal and valid obligation binding on such Party and enforceable in accordance with its terms and does not: (i) to such Party’s knowledge and belief, violate any law, rule, regulation, order, writ, judgment, decree, determination or award of any court, governmental body or administrative or other agency having jurisdiction over such Party; nor (ii) conflict with, or constitute a default under, any agreement, instrument or understanding, oral or written, to which such Party is a party or by which it is bound;
(c) such Party has obtained, or is not required to obtain, the consent, approval, order or authorization of any Third Party, or has completed, or is not required to complete, any registration, qualification, designation, declaration or filing with any regulatory authority or governmental authority in connection with the execution and delivery of this Agreement and the performance by such Party of its obligations under this Agreement;
(d) such Party has the right to grant the rights contemplated under this Agreement and has not, and will not during the term, grant any right to any Third Party that would conflict with the rights granted to the other Party hereunder; and
(e) in the performance of its obligations hereunder, such Party shall comply and shall cause its and its Affiliates’ employees to comply with all Applicable Laws.
6.2 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED.
6.3 Limitation of Liability. NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT.
Article 7
TERM AND TERMINATION
7.1 Term. This Agreement shall commence on the Effective Date and shall remain in effect for (a) the Terumo ROFR Period or (b) the end of any Terumo ROFR Negotiation Period and expiration of the Parties’ rights and obligations under Section 3.2, whichever (the foregoing (a) or (b)) comes later (the “Term”); provided that this Agreement shall automatically terminate in the event that OBIO has not disclosed primary endpoint data from a United States clinical trial pursuant to its IDE for coronary ISR to Terumo or the public prior to the tenth (10th) anniversary of the Effective Date.
7.2 Early Termination.
(a) Mutual Agreement. The Parties may terminate this Agreement by mutual written agreement.
(b) Material Breach. A Party shall have the right to terminate this Agreement upon written notice to the other Party (“Breaching Party”) if such Breaching Party is in breach of a material provision of this Agreement and has not cured such breach within thirty (30) days after delivery of notice from the terminating Party (“Date of Notice”); provided, however, that, if such alleged material breach is not reasonably susceptible of cure within such thirty (30) day period and the Breaching Party uses and demonstrates in writing reasonable, diligent, and persistent reasonable efforts within that period to cure such alleged material breach, such thirty (30) day period shall be extended as long as is reasonably necessary (but no more than ninety (90) days from the Date of Notice) and no such termination shall occur for so long as such reasonable efforts continue or if such breach is cured (but in each case for no longer than ninety (90) days from the Date of Notice).
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(c) Terumo Acquisition of Competing Product. This Agreement shall automatically terminate if Terumo completes the acquisition from a Third Party (whether by acquisition, merger, exclusive license or otherwise) of the exclusive right to make, use, sell, offer to sell or distribute a Competing Product in the Territory. Terumo will provide OBIO with prompt notice of any of the foregoing.
7.3 Effect of Termination. Upon written request of the other Party, each Party shall as soon as reasonably practicable either (i) deliver to the other Party any Confidential Information of such other Party that is then in its possession or (ii) destroy all original copies thereof and confirm said destruction in writing, provided that nothing in this section shall require a Party to return or destroy any material a Party is required to retain to comply with provisions of this Agreement or Applicable Laws, nor shall anything in this section require a Party to return or destroy copies of any material created pursuant to a Party’s archiving and back-up procedures or retained in a Party’s e-mail or document management system.
7.4 Survival. The following Articles and Sections will survive any expiration or termination of this Agreement: Section 6.2, Section 6.3, Section 7.3, this Section 7.4, Article 2, and Article 8.
Article 8
GENERAL PROVISIONS
8.1 Governing Law. This Agreement and all questions regarding its existence, validity, interpretation, breach or performance and any dispute or claim arising out of or in connection with it (whether contractual or non-contractual in nature such as claims in tort, from breach of statute or regulation or otherwise) shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, United States, without regard to any laws or rules that would result in the application of the laws of any other jurisdiction. The United Nations Conventions on Contracts for the International Sale of Goods shall not be applicable to this Agreement.
8.2 Dispute Resolution. Any controversy or claim arising out of or relating to this Agreement shall first be submitted for mediation under the auspices of the International Centre for Dispute Resolution (“ICDR”). The Parties agree that they will utilize the services of the same mediator selected by the parties to mediate their dispute in 2025, if she is available and willing to accept the assignment. If she is not available or willing to accept the assignment, the Parties will cooperate with the ICDR and with one another in selecting a mediator. Any dispute that is not resolved pursuant to such mediation shall be resolved by binding arbitration administered by the ICDR in accordance with its International Arbitration Rules (“ICDR Rules”). The arbitral tribunal shall be conducted by an arbitral tribunal composed of three arbitrators (collectively, “Tribunal”). Within thirty (30) days of the commencement of arbitration, each Party shall appoint one arbitrator in accordance with the ICDR Rules. Within thirty (30) days of the appointment of the first two arbitrators, the Parties shall jointly appoint the presiding arbitrator. If the Parties cannot agree on appointment of the presiding arbitrator within that time, the presiding arbitrator shall be appointed by the ICDR in accordance with the ICDR Rules. The seat of the arbitration shall be New York City, New York. The language of the arbitration shall be English. The award issued by the Tribunal shall be final and binding on the Parties. A judgment recognizing or enforcing such award may be rendered by any court of competent jurisdiction. Nothing in this Agreement shall prevent the Parties from seeking injunctive relief in aid of arbitration, which the Parties may seek from any court of competent jurisdiction and/or the Tribunal (or, if the Tribunal has not been constituted, pursuant to the emergency relief provisions of the ICDR Rules). For the purpose of injunctive relief or recognizing or enforcing the award, the Parties irrevocably consent and submit to the jurisdiction of the state and federal courts of the Southern District of New York and waive any claim or defense that such court lacks jurisdiction or that such forum is not convenient or proper.
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8.3 Assignment. Neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld. This Agreement shall be binding upon successors and permitted assigns of the Parties. Any assignment not in accordance with this Section 8.3 will be null and void. Without limiting any other obligations of the Parties hereunder, in the event that OBIO undergoes a Sale Transaction, OBIO shall ensure that, promptly following completion of such Sale Transaction, the surviving Person following completion of such Sale Transaction expressly assumes in writing all of OBIO’s obligations under this Agreement and provides Terumo with a copy of such writing.
8.4 Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
8.5 Notices. All notices required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile or email (and promptly confirmed by personal delivery, registered or certified mail or overnight courier or confirmatory email by recipient), sent by internationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
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If to OBIO, addressed to:
Orchestra BioMed Holdings, Inc.
150 Union Square Drive
New Hope, PA 18938
Attention: David P. Hochman
Email: [Omitted Pursuant to Item 601(a)(6)]
With copy to:
Paul Hastings LLP
200 Park Avenue
New York, NY 10166
Attention: Samuel A. Waxman
Email: [Omitted Pursuant to Item 601(a)(6)]
If to Terumo, addressed to:
Terumo Corporation
Toranomon Hills Station Tower 28F
2-6-1 Toranomon, Minato-ku
Tokyo, 105-5528, Japan
Attention: Fumihisa Hirose
Email: [Omitted Pursuant to Item 601(a)(6)]
With copy to:
Terumo Corporation
Toranomon Hills Station Tower 28F
2-6-1 Toranomon, Minato-ku
Tokyo, 105-5528, Japan
Attention: Ghada Farah
Email: [Omitted Pursuant to Item 601(a)(6)]
With copy to:
Terumo Medical Corporation
265 Davidson Avenue
Somerset, NJ 08873
Attention: James Rushworth
Email: [Omitted Pursuant to Item 601(a)(6)]
With further copy to:
Terumo Medical Corporation
265 Davidson Avenue
Somerset, NJ 08873
Attention: General Counsel
Email: [Omitted Pursuant to Item 601(a)(6)]
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With further copy to:
Skadden, Arps, Slate, Meagher & Flom LLP
500 Boylston Street
Boston, MA 02116
Attention: Christopher G. Clark
Email: [Omitted Pursuant to Item 601(a)(6)]
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 shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a Business Day; (b) on the Business Day after dispatch if sent by internationally recognized overnight courier; and (c) on the third Business Day following the date of mailing if sent by mail.
8.6 Entire Agreement; Amendments. This Agreement, together with the exhibits hereto, contains the entire understanding of the Parties with respect to the subject matter hereof and thereof and supersedes and cancels all previous express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, in respect to the subject matter hereof and thereof, including the Distribution Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of all of the Parties, but “written instrument” does not include the text of e-mails or similar electronic transmissions.
8.7 Headings. The captions to the several Articles and Sections hereof are not a part of this Agreement but are merely for convenience to assist in locating and reading the several Sections hereof.
8.8 Independent Contractors. It is expressly agreed that OBIO and Terumo shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither OBIO nor Terumo shall have the authority to make any statements, representations or commitments of any kind or to take any action that shall be binding on the other Party, without the prior written consent of the other Party.
8.9 Waiver. The waiver by either Party of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.
8.10 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.
8.11 Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.
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8.12 Interpretation. All references in this Agreement to an Article or Section shall refer to an Article or Section in or to this Agreement, unless otherwise stated. Any reference to any federal, national, state, local, or foreign statute or law shall be deemed also to refer to all rules and regulations promulgated thereunder, unless the context requires otherwise. The word “including” and similar words means including without limitation. The words “herein,” “hereof” and “hereunder” and other words of similar import refer to this Agreement as a whole and not to any particular Section or other subdivision. All references to days, months, quarters or years are references to calendar days, calendar months, calendar quarters, or calendar years, unless stated otherwise. References to the singular include the plural.
8.13 No Third Party Beneficiaries. This Agreement is neither expressly nor impliedly made for the benefit of any Party other than OBIO and Terumo, except as otherwise set forth in this Agreement with respect to the Third Parties referenced in Section 2.2; provided that this Agreement may be terminated, varied or amended in accordance with its terms or with the agreement of Terumo and OBIO without the consent of such Persons.
8.14 English Language. This Agreement is in the English language, and the English language shall control its interpretation. In addition, all notices required or permitted to be given under this Agreement, and all written, electronic, oral or other communications between the Parties regarding this Agreement, shall be in the English language.
8.15 Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all such counterparts shall together constitute but one and the same instrument. Electronic signatures complying with the New York Electronic Signatures and Records Act (N.Y. State Tech. §§ 301-309), as amended from time to time, or other applicable law will be deemed original signatures for purposes of this Agreement. Transmission by telecopy, electronic mail or other transmission method of an executed counterpart of this Agreement will constitute due and sufficient delivery of such counterpart.
[Signature Pages Follow]
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IN WITNESS WHEREOF, the Parties have executed this Termination and Right of First Refusal Agreement as of the Effective Date.
| ORCHESTRA BIOMED, INC. | ||
| By: | /s/ David Hochman | |
| Name: | David Hochman | |
| Title: | Chief Executive Officer | |
| TERUMO CORPORATION | ||
| By: | /s/ Fumihisa Hirose | |
| Name: | Fumihisa Hirose | |
| Title: | President, Cardiac & Vascular Company | |
| TERUMO MEDICAL CORPORATION | ||
| By: | /s/ James Rushworth | |
| Name: | James Rushworth | |
| Title: | President & COO | |
EXHIBIT A
PREFERRED STOCK PURCHASE AGREEMENT
EXHIBIT B
OBIO WIRE INFORMATION
Exhibit 10.2
Execution Version
STOCK PURCHASE AGREEMENT
This STOCK PURCHASE AGREEMENT (this “Agreement”) is dated as of October 24, 2025, by and between Orchestra BioMed Holdings, Inc., a Delaware corporation (the “Issuer”), and Terumo Medical Corporation, a Delaware corporation (the “Investor”).
W I T N E S S E T H:
WHEREAS, the Investor, wishes to purchase, and the Issuer wishes to issue and sell, upon the terms and conditions stated in this Agreement, 200,000 shares (the “Shares”) of the Issuer’s Series A Convertible Preferred Stock, par value $0.0001 per share (“Preferred Stock”), which shall be convertible into shares (the “Conversion Shares”) of the Issuer’s common stock, par value $0.0001 per share (“Common Stock”) pursuant to the terms and subject to the conditions contained in the Certificate of Designation of Series A Convertible Preferred Stock (the “Certificate of Designation”), substantially in the form as attached hereto as Exhibit A, at a purchase price equal to $100.00 per Share (the “Purchase Price”) for gross proceeds of $20,000,000;
WHEREAS, the Issuer intends to issue the Shares to the Investor pursuant to this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the U.S. Securities Act of 1933, as amended (the “Securities Act”);
NOW THEREFORE, in consideration of the foregoing and the mutual agreements, covenants, provisions and warranties herein contained and for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
Article 1
PURCHASE AND SALE
1.1 Purchase and Sale of Shares. Subject to the terms and conditions set forth in this Agreement, at the Closing, the Issuer agrees to issue and sell to the Investor the Shares and the Investor agrees to purchase the Shares at a price per share equal to the Purchase Price.
1.2 Closing. Subject to satisfaction or waiver of the conditions set forth in Article 5 of this Agreement, the closing of the purchase and sale of the Shares (the “Closing”) shall take place on a date mutually agreed to between the Issuer and the Investor, and, if no date is mutually agreed to, the Closing shall occur at 8:00 a.m. New York City time on the tenth (10th) business day following the date of this Agreement, at the offices of counsel to the Issuer, Paul Hastings LLP located at 200 Park Avenue, New York, New York 10166, or at such other place as the applicable parties to the Closing shall agree in writing.
1.3 Deliveries at Closing.
(a) At the Closing, the Investor shall deliver to the Issuer the aggregate Purchase Price for the Shares by wire transfer of immediately available funds to the account designated by the Issuer in writing.
(b) At the Closing, the Issuer shall deliver to the Investor the following:
(i) the instruments, consents, certificates and other documents required of the Issuer pursuant to Section 5.2; and
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(ii) the Shares via book-entry position on the books of the transfer agent of the Issuer, free and clear of any liens or other restrictions whatsoever (other than those arising under applicable securities laws), registered in the name of the Investor (or its nominee in accordance with its delivery instructions).
Article 2
REPRESENTATIONS AND WARRANTIES OF THE ISSUER
The Issuer represents and warrants to the Investor that the statements contained in this Article 2 are true and correct as of the date of this Agreement and as of the Closing (except for representations and warranties that speak as of a specific date, which shall be made as of such date):
2.1 Organization and Good Standing. The Issuer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, has the requisite power and authority to own, lease and operate its properties and to carry on its business as now conducted and described in the SEC Reports (as defined below) and is qualified to do business in each jurisdiction in which the character of its properties or the nature of its business requires such qualification.
2.2 Capitalization. The Issuer’s disclosure of its authorized, issued and outstanding capital stock in the SEC Reports containing such disclosure was accurate in all material respects as of the date indicated in such SEC Reports and there have been no material changes to the authorized, issued and outstanding capital stock of the Issuer since the date of the most recent SEC Report containing such disclosure. All of the issued and outstanding shares of Common Stock have been duly authorized and validly issued and are fully paid and non-assessable. None of the outstanding shares of capital stock of the Issuer were issued in violation of any preemptive or other similar rights of any securityholder of the Issuer which have not been waived, and such shares were issued in compliance in all material respects with applicable state and federal securities law and any rights of third parties. Except as disclosed in the SEC Reports, there are no outstanding rights (including, without limitation, pre-emptive rights), warrants or options to acquire, or instruments convertible into or exchangeable for, any shares of capital stock or other equity interest in the Issuer or any of its subsidiaries, or any contract, commitment, agreement, understanding or arrangement of any kind relating to the issuance of any capital stock of the Issuer or any such subsidiary, any such convertible or exchangeable securities or any such rights, warrants or options; the capital stock of the Issuer conforms in all material respects to the description thereof contained in the SEC Reports; and all the outstanding shares of capital stock or other equity interests of each subsidiary owned, directly or indirectly, by the Issuer have been duly and validly authorized and issued, are fully paid and non-assessable (except, in the case of any foreign subsidiary, for directors’ qualifying shares) and are owned directly or indirectly by the Issuer, free and clear of any lien, charge, encumbrance, security interest, restriction on voting or transfer or any other claim of any third party.
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2.3 Authorization and Validity of this Agreement. The Issuer has all requisite power and authority to execute and deliver this Agreement, to perform its obligations under the terms of this Agreement, including the issuance and sale of the Shares, and to consummate the transactions contemplated hereby. The execution and delivery of this Agreement, the performance by the Issuer of its obligations under the terms of this Agreement and the consummation of the transactions contemplated hereby, including the issuance and sale of the Shares, have been duly and validly authorized by all requisite corporate action of the Issuer, its officers, directors and stockholders (none of which actions have been modified or rescinded, and all of which actions are in full force and effect). This Agreement has been duly executed and delivered by the Issuer and, assuming the due authorization, execution and delivery by the Investor of this Agreement and that this Agreement constitutes the legal, valid and binding agreement of the Investor, constitutes a legal, valid and binding obligation of the Issuer, enforceable against the Issuer in accordance with its terms, except as such enforceability may be limited or otherwise affected by bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and/or similar laws relating to or affecting the rights of creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law).
2.4 Title to Shares; Conversion Shares. The Shares have been duly authorized and upon payment by the Investor of the Purchase Price and delivery by the Issuer of the Shares pursuant to the terms hereof, the Shares will be validly issued, fully paid and non-assessable, and the Investor will acquire good and marketable title thereto, free and clear of all mortgages, liens, pledges, charges, claims, security interests and other encumbrances (other than any restrictions created by the Investor or any restrictions created by federal or state securities laws). The issuance and delivery of the Shares does not (a) obligate the Issuer to offer to issue, or issue, shares of Preferred Stock or other securities to any person pursuant to any preemptive rights, rights of first refusal, rights of participation or similar rights, or (b) result in any adjustment (automatic, at the election of any person or otherwise) of the exercise, conversion, exchange or reset price under, or any other anti-dilution adjustment pursuant to, any outstanding securities of the Issuer. The Conversion Shares have been duly authorized and reserved for issuance pursuant to the terms of the Preferred Stock, and when issued by the Issuer upon valid conversion of the Preferred Stock and payment of the conversion price, will be validly issued, fully paid and non-assessable, and the Investor will acquire good and marketable title thereto, free and clear of all mortgages, liens, pledges, charges, claims, security interests and other encumbrances (other than any restrictions created by the Investor or any restrictions created by federal or state securities laws). Upon valid conversion of the Preferred Stock, the Conversion Shares will not (a) obligate the Issuer to offer to issue, or issue, shares of Common Stock or other securities to any person pursuant to any preemptive rights, rights of first refusal, rights of participation or similar rights, or (b) result in any adjustment (automatic, at the election of any person or otherwise) of the exercise, conversion, exchange or reset price under, or any other anti-dilution adjustment pursuant to, any outstanding securities of the Issuer.
2.5 Non-Contravention. The execution and delivery of this Agreement by the Issuer, the performance by the Issuer of its obligations hereunder, and the consummation by the Issuer of the transactions contemplated hereby do not, and will not as of the Closing, conflict with, contravene, result in a violation or breach of or default under (with or without the giving of notice or the lapse of time, or both), permit any party to terminate, amend or accelerate the provisions of, or result in the imposition of any claim, lien, pledge, deed of trust, option, charge, security interest, hypothecation, encumbrance, right of first offer, voting trust, proxy, right of third parties or other restriction or limitation of any nature whatsoever (each, a “Lien”), or any obligation to create any Lien, upon any of the properties or assets of the Issuer under (i) any contract, agreement, indenture, letter of credit, mortgage, security agreement, pledge agreement, deed of trust, bond, note, guarantee, surety obligation, warranty, license, franchise, permit, power of attorney, lease, instrument or other agreement (each, a “Contract”) to which the Issuer is a party or by which any of its property or assets may be bound, except as would not, individually or in the aggregate, be reasonably expected to have a material adverse effect on the assets, business, results of operation or financial operations of the Issuer and its subsidiaries, taken as a whole, or prevents, impairs, delays or impedes the legal authority of the Issuer to enter into and timely perform in any material respect its obligations under this Agreement (a “Material Adverse Effect”) or (ii) any provision of the organizational documents of the Issuer.
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2.6 Consents. Assuming the accuracy of the representations and warranties of the Investor set forth in Article 3 hereof, no consent, approval, authorization, filing with or order of or registration with, any court or governmental agency or body is required in connection with the authorization, execution or delivery by the Issuer of this Agreement, the issuance and sale of the Shares and the performance by the Issuer of its other obligations under this Agreement, except (a) as have been or will be obtained or made under the Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”), (b) customary post-closing filings with the Securities and Exchange Commission (“SEC”) or pursuant to state securities laws in connection with the offer and sale of the Shares by the Issuer in the manner contemplated herein, which will be filed on a timely basis, (c) notices that may be required by the rules of the Nasdaq Global Market (“Nasdaq”) or (d) such that the failure of which to obtain would not have a Material Adverse Effect. All notices, consents, authorizations, orders, filings and registrations which the Issuer is required to deliver or obtain prior to the Closing pursuant to the preceding sentence have been obtained or made or will be delivered or obtained or effected, and shall remain in full force and effect, on or prior to the Closing.
2.7 Exemption from Registration; No Integration; No General Solicitation.
(a) Subject to the accuracy of the representations and warranties of the Investor, it is not necessary in connection with the offer, sale and delivery of the Shares to the Investor in the manner contemplated by this Agreement to register the Shares under the Securities Act.
(b) Neither the Issuer nor any affiliate (as defined in Rule 501(b) of Regulation D under the Securities Act) (“Affiliate”) of the Issuer has directly, or through any agent, (i) sold, offered for sale, solicited offers to buy or otherwise negotiated in respect of, any security (as defined in the Securities Act) which is or will be integrated with the sale of the Shares in a manner that would require the registration under the Securities Act of the Shares or (ii) offered, solicited offers to buy or sold the Shares by any form of general solicitation or general advertising (as those terms are used in Regulation D under the Securities Act) or in any manner involving a public offering within the meaning of Section 4(a)(2) of the Securities Act.
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2.8 SEC Filings. The Issuer has filed all forms, statements, certifications, reports and documents required to be filed by it with the SEC under Section 13, 14(a) and 15(d) of the Exchange Act for the one year preceding the date of this Agreement and is in compliance with General Instruction I.A.3 of Form S-3. As of the time it was filed with the SEC (or, if amended or superseded by a filing prior to the date of this Agreement, then on the date of such filing), each of the filed SEC Reports complied in all material respects with the applicable requirements of the Exchange Act, and, as of the time they were filed, none of the filed SEC Reports contained any untrue statement of a material fact or omitted 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. There are no outstanding or unresolved comments from the SEC staff with respect to the SEC Reports. To the Issuer’s knowledge, none of the SEC Reports are the subject of an ongoing SEC review. The interactive data in eXtensible Business Reporting Language included in the SEC Reports fairly presents the information called for in all material respects and has been prepared in accordance with the SEC’s rules and guidelines applicable thereto. As used in this Agreement, “SEC Reports” means (a) the Issuer’s most recently filed Annual Report on Form 10-K and (b) all Quarterly Reports on Form 10-Q or Current Reports on Form 8-K filed or furnished (as applicable) by the Issuer following the end of the most recent fiscal year for which an Annual Report on Form 10-K has been filed and prior to the execution of this Agreement, together in each case with any documents incorporated by reference therein or exhibits thereto.
2.9 Compliance with Nasdaq Continued Listing Requirements. The Issuer is in compliance with applicable Nasdaq continued listing requirements. There are no proceedings pending or threatened against the Issuer relating to the continued listing of the Issuer’s Common Stock on Nasdaq and the Issuer has not received any notice of, nor is there any reasonable basis for, the delisting of the Issuer’s Common Stock from Nasdaq.
2.10 Investment Company. The Issuer is not required to be registered as, and immediately following the Closing will not be required to register as, an “investment company” within the meaning of the Investment Company Act of 1940, as amended.
2.11 Brokers’ Fees. There is no investment banker, broker, finder, financial advisor or other intermediary who has been retained by or is authorized to act on behalf of the Issuer who is entitled to any fee or commission from the Investor in connection with the Investor’s purchase of the Shares as contemplated by this Agreement.
Article 3
REPRESENTATIONS AND WARRANTIES OF THE INVESTOR
The Investor represents and warrants to the Issuer that the statements contained in this Article 3 are true and correct as of the date of this Agreement and as of the Closing:
3.1 Organization and Good Standing. The Investor is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization.
3.2 Authorization and Validity of this Agreement. The Investor has all requisite power and authority to execute and deliver this Agreement, to perform its obligations hereunder and to consummate the transactions contemplated hereby. The execution and delivery of this Agreement, the performance by the Investor of its obligations hereunder and the consummation of the transactions contemplated hereby have been duly and validly authorized by all requisite corporate action of the Investor. Assuming this Agreement constitutes the legal and binding agreement of the Issuer, this Agreement constitutes a legal, valid and binding obligation of the Investor, enforceable against the Investor in accordance with its terms, except as such enforceability may be limited or otherwise affected by bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and/or similar laws relating to or affecting the rights of creditors generally or by general equity principles (regardless of whether such enforceability is considered in a proceeding in equity or at law).
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3.3 Non-Contravention. The execution and delivery of this Agreement by the Investor, the performance by the Investor of its obligations hereunder, and the consummation by the Investor of the transactions contemplated hereby do not, and will not as of the Closing, conflict with, contravene, result in a violation or breach of or default under (with or without the giving of notice or the lapse of time, or both), permit any party to terminate, amend or accelerate the provisions of, or result in the imposition of any Lien (or any obligation to create any Lien) upon any of the property or assets of the Investor under (i) any Contract to which the Investor is a party or by which any of its property or assets may be bound, except as would not, individually or in the aggregate, be reasonably expected to materially delay or hinder the ability of the Investor to perform its obligations under this Agreement or (ii) any provision of the organizational documents of the Investor.
3.4 Investment Purpose. The Shares to be acquired by the Investor pursuant to this Agreement are being acquired for investment for its own account and with no intention of distributing or reselling the Shares or any part thereof in any transaction that would be in violation of the securities laws of the United States or any state of the United States or any foreign jurisdiction. The Investor further agrees that it has not entered and prior to the Closing will not enter into any Contract with respect to the distribution, sale, transfer or delivery of the Shares.
3.5 Investment Experience; Access to Information. The Investor is sufficiently experienced in financial and business matters to be capable of evaluating the merits and risks involved in purchasing the Shares and to make an informed decision relating thereto and can bear the economic risk of its investment in the Shares. The Investor has carefully reviewed any disclosure documents (including this Agreement and the SEC Reports) used in connection with the sale of Shares pursuant to this Agreement. The Investor has had adequate opportunity to ask questions of, and receive answers from, the officers, employees, agents, accountants, and representatives of the Issuer concerning the business, operations, financial condition, assets, liabilities of the Issuer and all other matters relevant to its investment in the Shares. The Investor has not been organized solely for the purpose of acquiring the Shares.
3.6 Independent Investment Decision. The Investor understands that nothing in this Agreement or any other materials presented by or on behalf of the Issuer to the Investor in connection with the purchase of the Shares constitutes legal, tax or investment advice. The Investor has consulted such legal, tax and investment advisors as it, in such Investor’s sole discretion, has deemed necessary or appropriate in connection with its purchase of the Shares.
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3.7 Restricted Shares.
(a) The Investor understands and hereby acknowledges that the Shares are, and upon conversion of the Preferred Stock the Conversion Shares will be, “restricted securities” within the meaning of Rule 144 promulgated under the Securities Act and have not been registered under the Securities Act or any state securities law and may not be offered or sold except pursuant to registration or pursuant to an exemption from the registration requirements of the Securities Act and any applicable states securities laws. The Investor is familiar with Rule 144 promulgated under the Securities Act, as presently in effect, and understands the resale limitations imposed thereby and by the Securities Act.
(b) The Investor acknowledges and agrees that it has been advised to consult legal counsel prior to making any offer, resale, transfer, pledge or disposition of any of the Shares.
(c) The Investor acknowledges that no federal or state agency has passed upon or endorsed the merits of the offering of the Shares or made any findings or determination as to the fairness of this investment.
(d) The Investor understands and hereby acknowledges that the Shares, and any securities issued in respect of or in exchange for the Shares, including the Conversion Shares, will bear a legend in substantially the following form:
THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, (“THE SECURITIES ACT”) OR APPLICABLE STATE LAWS, AND MAY NOT BE OFFERED, SOLD, ASSIGNED, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT.
3.8 Qualified Institutional Buyer; Accredited Investor. The Investor is a “qualified institutional buyer” (as defined in Rule 144A under the Securities Act) or an institutional “accredited investor” as that term is defined in Rule 501(a) under Regulation D promulgated pursuant to the Securities Act. The Investor further represents and warrants that (x) it is capable of evaluating the merits and risk of such investment and (y) that it has not been organized for the purpose of acquiring the Shares and is an “institutional account” as defined by FINRA Rule 4512(c). The Investor is aware that the Issuer is relying upon the representations, warranties and agreements contained in this Agreement for the purpose of determining whether this transaction meets the requirements of the exemption from the registration requirements of the Securities Act and any applicable state laws.
3.9 Non-Solicitation. The Investor acknowledges and agrees that the Investor is purchasing the Shares directly from the Issuer. Investor became aware of this offering of the Shares directly from the Issuer as a result of a pre-existing, substantive relationship with the Issuer, and/or its advisors (including without limitation attorneys, accountants, bankers, consultants and financial advisors), agents, control persons, representatives, Affiliates, directors, officers, managers, members, and/or employees, and/or the representatives of such persons. The Shares were offered to the Investor solely by direct contact between the Investor and the Issuer and/or its representatives. The Investor did not become aware of this offering of the Shares, nor were the Shares offered to the Investor, by any other means, and neither the Issuer and/or its representatives acted as investment advisor, broker or dealer to the Investor. The Investor is not purchasing the Shares as a result of any general or public solicitation or general advertising, or publicly disseminated advertisement, article, notice or other communication regarding the Shares published in any newspaper, magazine or similar media or broadcast over television, radio or the internet or presented at any seminar or any other general solicitation or general advertisement, including any of the methods described in Section 502(c) of Regulation D under the Securities Act.
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3.10 Certain Trading Activities. Other than consummating the transaction contemplated hereby, the Investor has not, nor has any Person acting on behalf of or pursuant to any understanding with the Investor, directly or indirectly executed any purchases or sales, including a “short sale,” as such term is defined Rule 200 of Regulation SHO under the Exchange Act, of the securities of the Issuer during the period commencing as of the time that the Investor was first contacted by the Issuer or any other Person regarding the transaction contemplated hereby and ending immediately prior to the date of this Agreement. The Investor has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction), other than disclosures made to its advisors and agents who have a need to know such information.
Article 4
COVENANTS
4.1 Listing. The Issuer shall use commercially reasonable efforts to maintain the listing and trading of its Common Stock on Nasdaq and, in accordance therewith, will use reasonable best efforts to comply in all material respects with the Issuer’s reporting, filing and other obligations under the rules and regulations of Nasdaq.
4.2 Integration; Aggregation. The Issuer shall not, and shall use its commercially reasonable efforts to ensure that no Affiliate of the Issuer shall, sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that will be integrated with the offer or sale of the Shares in a manner that would require the registration under the Securities Act of the sale of the Shares to the Investor, or that will be aggregated with the offer or sale of the Shares for purposes of the rules and regulations of Nasdaq such that it would require stockholder approval prior to the closing of such other transaction unless stockholder approval is obtained before the closing of such subsequent transaction.
4.3 Removal of Legends.
(a) In connection with any sale, assignment, transfer or other disposition of the Shares or the Conversion Shares by the Investor pursuant to Rule 144 or pursuant to any other exemption under the Securities Act such that the purchaser acquires freely tradable shares and upon compliance by the Investor with the requirements of this Agreement, if requested by the Investor by notice to the Issuer, the Issuer shall (i) with respect to the Preferred Stock, issue new shares without restrictive legends for such shares sold or (ii) with respect to Conversion Shares, request the transfer agent for the Common Stock to remove any restrictive legends related to the book entry shares of Common Stock sold or disposed of, in each case, as soon as reasonably practicable following any such request therefor from the Investor; provided that the Issuer has timely received from the Investor customary representations and other documentation reasonably acceptable to the Issuer in connection therewith. The Issuer shall be responsible for the fees of its transfer agent and its legal counsel associated with such legend removal.
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(b) Anytime following the one-year anniversary of the issuance of the Shares and provided that the Investor is not an Affiliate of the Issuer at such time, the Issuer shall as soon as reasonably practicable following receipt of a duly completed and executed Legend Removal Certificate from the Investor substantially in the form attached hereto as Exhibit B, (A) deliver to the transfer agent instructions that the transfer agent shall make a new, unlegended entry for such book entry shares, and (B) cause its counsel to deliver to the transfer agent one or more opinions to the effect that the removal of such legends in such circumstances may be effected under the Securities Act if required by the transfer agent to effect the removal of the legend in accordance with the provisions of this Agreement.
4.4 Indemnification.
(a) The Issuer agrees to indemnify and hold harmless the Investor and its directors, officers, trustees, members, managers, employees and agents (collectively, the “Indemnified Persons”), from and against any and all losses, claims, damages, liabilities and expenses (including without limitation reasonable and documented attorney fees and disbursements and other documented out-of-pocket expenses reasonably incurred in connection with investigating, preparing or defending any action, claim or proceeding, pending or threatened and the costs of enforcement thereof) to which such Person may become subject as a result of any breach of representation, warranty, covenant or agreement made by or to be performed on the part of the Issuer under this Agreement, and will reimburse any such Person for all such amounts as they are incurred by such Person solely to the extent such amounts have been finally judicially determined not to have resulted from such Person’s fraud or willful misconduct.
(b) Any person entitled to indemnification hereunder shall (i) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party; provided that any person entitled to indemnification hereunder shall have the right to employ separate counsel and to participate in the defense of such claim, but the fees and expenses of such counsel shall be at the expense of such person unless (a) the indemnifying party has agreed in writing to pay such fees or expenses, (b) the indemnifying party shall have failed to assume the defense of such claim and employ counsel reasonably satisfactory to such person or (c) in the reasonable judgment of any such person, based upon written advice of its counsel, a conflict of interest exists between such person and the indemnifying party with respect to such claims (in which case, if the person notifies the indemnifying party in writing that such person elects to employ separate counsel at the expense of the indemnifying party, the indemnifying party shall not have the right to assume the defense of such claim on behalf of such person); and provided, further, that the failure of any indemnified party to give written notice as provided herein shall not relieve the indemnifying party of its obligations hereunder, except to the extent that such failure to give notice shall materially adversely affect the indemnifying party in the defense of any such claim or litigation. It is understood that the indemnifying party shall not, in connection with any proceeding in the same jurisdiction, be liable for fees or expenses of more than one separate firm of attorneys at any time for all such indemnified parties. No indemnifying party will, except with the consent of the indemnified party, which consent shall not be unreasonably withheld, conditioned or delayed, consent to entry of any judgment or enter into any settlement unless such judgment or settlement (i) imposes no liability or obligation on, (ii) includes as an unconditional term thereof the giving of a complete, explicit and unconditional release from the party bringing such indemnified claims of all liability of the indemnified party in respect of such claim or litigation in favor of, and (iii) does not include any admission of fault, culpability, wrongdoing, or wrongdoing or malfeasance by or on behalf of, the indemnified party. No indemnified party will, except with the consent of the indemnifying party, which consent shall not be unreasonably withheld, conditioned or delayed, consent to entry of any judgment or enter into any settlement.
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(c) As used herein, “Person” means an individual, partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or any other entity or organization.
4.5 Conversion Shares. The Issuer shall reserve and keep available at all times, a sufficient number of shares of Common Stock for the purpose of enabling the Issuer to issue the Conversion Shares.
4.6 Further Assurances. Each party hereto shall execute and deliver such instruments and take such other actions prior to or after the Closing as any other party may reasonably request in order to carry out the intent of this Agreement, including without limitation obtaining any required consents or approvals from third parties. The Investor acknowledges that the Issuer will rely on the acknowledgments, understandings, agreements, representations and warranties contained in this Agreement. Prior to the Closing, the Investor agrees to promptly notify the Issuer if any of the acknowledgments, understandings, agreements, representations and warranties set forth in Article 3 of this Agreement are no longer accurate.
Article 5
CONDITIONS PRECEDENT TO THE OBLIGATIONS
5.1 Mutual Conditions. The obligations of the Issuer and the Investor to consummate the purchase and sale of the Shares contemplated hereby are subject to the following conditions: (i) the absence of any order, decree, judgment or injunction of a court of competent jurisdiction or other governmental or regulatory authority precluding the consummation of the purchase and sale of the Shares contemplated hereby and (ii) there shall not have been any action taken or any statute, rule or regulation enacted, promulgated or deemed applicable to, the purchase and sale of the Shares contemplated hereby by any court, governmental agency or regulatory or administrative authority that makes consummation of such transactions illegal.
5.2 Conditions to the Obligations of the Investor. The obligations of the Investor under this Agreement to consummate the purchase and sale of the Shares contemplated hereby are subject to the fulfillment (or waiver by the Investor) of the following conditions precedent:
(a) Representation and Warranties. The representations and warranties of the Issuer contained herein shall be true and correct in all material respects, except for those representation and warranties qualified by materiality or Material Adverse Effect, which shall be true and correct in all respects, as of the date of this Agreement and as of the Closing, as though made on and as of such date.
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(b) Performance. The Issuer shall have performed in all material respects the obligations and conditions herein required to be performed or observed by the Issuer on or prior to the Closing.
(c) Consents. The Issuer shall have obtained any and all consents, permits, approvals, registrations and waivers necessary for the consummation of the purchase and sale of the Shares, all of which shall be in full force and effect.
(d) Opinion of Issuer Counsel. The Issuer shall have delivered to the Investor the opinion of Paul Hastings LLP, dated as of the Closing, in customary form and substance to be reasonably agreed upon with the Investor and addressing such legal matters as the Investor and the Issuer reasonably agree.
(e) Compliance Certificate. An authorized officer of the Issuer shall have delivered to the Investor at the Closing a certificate certifying that the conditions specified in Sections 5.2(a), (b), (c) and (g) of this Agreement have been fulfilled.
(f) Secretary’s Certificate. The Secretary of the Issuer shall have delivered to the Investor at the Closing a certificate certifying (i) the Issuer’s certificate of incorporation; (ii) the Issuer’s bylaws; and (iii) resolutions of the Issuer’s Board of Directors (or an authorized committee thereof) approving this Agreement, the transactions contemplated by this Agreement and the issuance of the Shares.
(g) Listing Requirements. No stop order or suspension of trading shall have been imposed by Nasdaq, the SEC or any other governmental or regulatory body with respect to public trading in the Common Stock. The Common Stock shall be listed on Nasdaq and shall not have been suspended, as of the Closing, by the SEC or Nasdaq from trading thereon nor shall suspension by the SEC or Nasdaq have been threatened, as of the Closing, in writing by the SEC or Nasdaq; and the Issuer shall have filed with Nasdaq a Notification Form: Listing of Additional Shares for the listing of the Shares and Nasdaq shall have raised no objection to such notice and the transactions contemplated hereby.
(h) Certificate of Designation. Prior to the Closing, the Issuer shall have filed with the Secretary of State of Delaware the Certificate of Designation, substantially in the form as attached hereto as Exhibit A.
5.3 Conditions to the Obligations of the Issuer. The obligations of the Issuer under this Agreement to consummate the purchase and sale of the Shares contemplated hereby are subject to the fulfillment (or waiver in writing by the Issuer) of the conditions that (i) all representations and warranties of the Investor shall be deemed to have been made again at and as of the Closing and shall then be true and accurate and (ii) the Investor shall have performed and complied in all material respects with all agreements required by this Agreement to be performed or complied with by it prior to or at the Closing.
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Article 6
MISCELLANEOUS
6.1 Termination. This Agreement may be terminated by mutual written consent of the Issuer and the Investor. In the event of any termination of this Agreement, this Agreement shall become void and have no effect, without any liability to any person in respect hereof on the part of any party hereto, except for any liability resulting from such party’s breach of this Agreement prior to such termination.
6.2 Survival. Each of the representations and warranties contained in this Agreement shall survive indefinitely. Each of the covenants contained in this Agreement shall survive the Closing until performed in accordance with their terms.
6.3 Assignment; Successors and Assigns. This Agreement and the rights granted hereunder may not be assigned by either party without the prior written consent of the other party. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their successors and permitted assigns as provided in this Agreement.
6.4 Third Party Beneficiaries. Nothing in this Agreement, express or implied, is intended to confer upon any person, other than the parties hereto or their respective successors and permitted assigns, any rights, remedies, obligations or liabilities under or by any reason of this Agreement, except as expressly provided in this Agreement.
6.5 Amendments. The provisions of this Agreement may not be amended or modified except by a writing signed by each of the parties.
6.6 Governing Law. THIS AGREEMENT AND THE RIGHTS AND OBLIGATIONS OF THE PARTIES UNDER THIS AGREEMENT SHALL BE GOVERNED BY, AND CONSTRUED AND INTERPRETED IN ACCORDANCE WITH, THE LAW OF THE STATE OF NEW YORK, WITHOUT REGARD TO PRINCIPLES OF CONFLICTS OF LAW. EACH OF THE PARTIES HERETO IRREVOCABLY AND UNCONDITIONALLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK OR, IF SUCH COURT WILL NOT ACCEPT JURISDICTION, THE SUPREME COURT OF THE STATE OF NEW YORK OR ANY COURT OF COMPETENT CIVIL JURISDICTION SITTING IN NEW YORK COUNTY, NEW YORK FOR THE PURPOSE OF ANY ACTION OR JUDGMENT RELATING TO OR ARISING OUT OF THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY AND TO THE LAYING OF VENUE IN SUCH COURT. EACH OF THE PARTIES HEREBY WAIVES THE DEFENSE OF AN INCONVENIENT FORUM TO THE MAINTENANCE OF ANY SUCH ACTION OR PROCEEDING IN SAID COURTS.
6.7 Waiver of Trial By Jury. TO THE EXTENT PERMITTED BY APPLICABLE LAW, EACH PARTY HERETO IRREVOCABLY WAIVES ALL RIGHT OF TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ANY MATTER ARISING HEREUNDER.
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6.8 Waivers; Remedies. No failure or delay on the part of any party in exercising any right, privilege, power or remedy under this Agreement, and no course of dealing shall (a) impair such right, power or remedy or (b) operate as a waiver thereof. No waiver shall be asserted against any party unless signed in writing by such party. The single or partial exercise of any right, power or remedy provided by law or under this Agreement shall not preclude any other or further exercise of any other right, power or remedy. The rights, powers and remedies provided in this Agreement are cumulative and not exclusive of any rights, powers and remedies provided by law.
6.9 Notices.
(a) All notices, requests, demands, waivers and other communications to be given by either party hereunder shall be in writing and shall sent to the following address:
If to the Issuer:
Orchestra BioMed Holdings, Inc.
150 Union Square Drive
New Hope, Pennsylvania 18938
Attention: Chief Financial Officer
Email: [Omitted Pursuant to Item 601(a)(6)]
with a copy (which shall not constitute notice) to:
Paul Hastings LLP
200 Park Avenue
New York, New York 10166
Attention: Yariv Katz
Email: [Omitted Pursuant to Item 601(a)(6)]
If to the Investor:
Terumo Medical Corporation
265 Davidson Avenue
Somerset, NJ 08873
Attention: James Rushworth
Email: [Omitted Pursuant to Item 601(a)(6)]
with a copy (which shall not constitute notice) to:
Terumo Medical Corporation
265 Davidson Avenue
Somerset, NJ 08873
Attention: General Counsel
Email: [Omitted Pursuant to Item 601(a)(6)]
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with a further copy (which shall not constitute notice) to:
Skadden, Arps, Slate, Meagher & Flom LLP
500 Boylston Street
Boston, MA 02116
Attention: Christopher G. Clark
Email: [Omitted Pursuant to Item 601(a)(6)]
or such other address as may be specified in writing to the other party hereto.
(b) All such notices, requests, demands, waivers, and other communications hereunder shall be in writing and shall be deemed to have been given: (a) when delivered by hand (with written confirmation of receipt); (b) when received by the addressee if sent by a nationally recognized overnight courier (receipt requested); (c) on the date sent by facsimile or e-mail of a PDF document (with confirmation of transmission) if sent during normal business hours of the recipient, and on the next business day if sent after normal business hours of the recipient; or (d) on the fifth day after the date mailed, by certified or registered mail, return receipt requested, postage prepaid. .
6.10 Execution in Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all such counterparts shall together constitute but one and the same instrument. Electronic signatures complying with the New York Electronic Signatures and Records Act (N.Y. State Tech. §§ 301-309), as amended from time to time, or other applicable law will be deemed original signatures for purposes of this Agreement. Transmission by telecopy, electronic mail or other transmission method of an executed counterpart of this Agreement will constitute due and sufficient delivery of such counterpart.
6.11 Headings. The Article and Section headings contained herein are for the convenience of the parties only and shall not affect the construction or interpretation of this Agreement.
6.12 Severability. Each provision of this Agreement shall be considered severable and if for any reason any provision or provisions herein are determined to be invalid, unenforceable or illegal under any existing or future law, such invalidity, unenforceability or illegality shall not impair the operation of or affect those portions of this Agreement which are valid, enforceable and legal.
6.13 Entire Agreement. This Agreement, including the exhibits hereto, contains the entire understanding of the parties with respect to the subject matter hereof, and supersedes all prior agreements and understandings, both written and oral, among the parties with respect to the subject matter hereof.
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IN WITNESS WHEREOF, the parties have executed and delivered this Agreement as of the date first written above.
| ISSUER: | ||
| Orchestra BioMed Holdings, Inc. | ||
| By: | /s/ David Hochman | |
| Name: David Hochman | ||
| Title: Chief Executive Officer | ||
| INVESTOR: | ||
| Terumo Medical Corporation | ||
| By: | /s/ James Rushworth | |
| Name: James Rushworth | ||
| Title: President & COO | ||
Exhibit A
CERTIFICATE OF DESIGNATION
CERTIFICATE OF DESIGNATION OF SERIES A CONVERTIBLE PREFERRED STOCK OF
ORCHESTRA BIOMED HOLDINGS, INC.
Pursuant to Section 151 of the General Corporation Law of the State of Delaware (the “DGCL”), Orchestra BioMed Holdings, Inc., a corporation organized and existing under the General Corporation Law of the State of Delaware (the “Corporation”), in accordance with the provisions of Section 103 thereof, does hereby submit the following:
WHEREAS, the Certificate of Incorporation of the Corporation (the “Certificate of Incorporation”) authorizes the issuance of up to 10,000,000 shares of preferred stock, par value $0.0001 per share, of the Corporation (“Preferred Stock”) in one or more series, and expressly authorizes the Board of Directors of the Corporation (the “Board”), subject to limitations prescribed by law, to provide, out of the unissued shares of Preferred Stock, for series of Preferred Stock, and, with respect to each such series, to establish and fix the number of shares to be included in such series and state the designations, powers, preferences, privileges and relative participating, optional, or other rights and such qualifications, limitations, or restrictions of the shares of such series; and
WHEREAS, it is the desire of the Board to establish and fix the number of shares to be included in a new series of Preferred Stock and the designations, powers, preferences, privileges and relative participating, optional, or other rights and the qualifications, limitations, or restrictions of the shares of such new series.
NOW, THEREFORE, BE IT RESOLVED, that the Board does hereby provide for the issue of a series of Preferred Stock and does hereby in this Certificate of Designation (the “Certificate of Designation”) establish and fix and herein state and express the designations, powers, preferences, privileges and relative participating, optional, or other rights and qualifications, limitations, or restrictions of such series of Preferred Stock as follows:
1. Designation. There shall be a series of Preferred Stock that shall be designated as “Series A Convertible Preferred Stock” (the “Series A Preferred Stock”) and the number of Shares constituting such series shall be 200,000. The rights, preferences, powers, restrictions, and limitations of the Series A Preferred Stock shall be as set forth herein.
2. Defined Terms. For purposes hereof, the following terms shall have the following meanings:
“Business Day” means any day other than Saturday, Sunday or other day on which commercial banks in The City of New York are authorized or required by law to remain closed; provided, however, for clarification, commercial banks shall not be deemed to be authorized or required by law to remain closed due to “stay at home,” “shelter-in-place,” “non-essential employee” or any other similar orders or restrictions or the closure of any physical branch locations at the direction of any governmental authority so long as the electronic funds transfer systems (including for wire transfers) of commercial banks in The City of New York are generally open for use by customers on such day.
“Board” has the meaning set forth in the Recitals.
“Certificate of Designation” has the meaning set forth in the Recitals.
“Certificate of Incorporation” has the meaning set forth in the Recitals.
“Change of Control” means (a) any sale, lease, or transfer or series of related sales, leases, or transfers of (i) all or substantially all of the consolidated assets of the Corporation and its Subsidiaries or (ii) Virtue SAB (as such term is defined in the Corporation’s Form 10-Q for the quarter ended June 30, 2025); (b) any sale, transfer, or issuance (or series of related sales, transfers, or issuances) of capital stock by the Corporation or the holders of Common Stock (or other voting stock of the Corporation) that results in a “person” or “group” within the meaning of Section 13(d) of the Exchange Act becoming the direct or indirect “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act (except that such person will be deemed to have beneficial ownership of all securities that such person has the right to acquire, whether such right is currently exercisable or is exercisable only upon the occurrence of a subsequent condition), of the capital stock of the Corporation representing more than 50% of the total voting power of the outstanding capital stock of the Corporation; or (c) any merger, consolidation, recapitalization, or reorganization of the Corporation with or into another Person (whether or not the Corporation is the surviving corporation) that results in the inability of the holders of Common Stock (or other voting stock of the Corporation) immediately prior to such merger, consolidation, recapitalization, or reorganization to designate or elect a majority of the board of directors (or its equivalent) of the resulting entity or its parent company.
“Common Stock” means the common stock, par value $0.0001 per share, of the Corporation.
“Convertible Securities” means any securities (directly or indirectly) convertible into or exchangeable for Common Stock, but excluding Options.
“Corporation” has the meaning set forth in the Preamble.
“Conversion Price” means, for each Share of Series A Preferred Stock, a dollar amount equal to the greater of (i) $12.00 or (ii) a twenty percent (20%) discount to the Market Price of the Common Stock on the Series A Conversion Date.
“Conversion Shares” means the shares of Common Stock or other capital stock of the Corporation then issuable upon conversion of the Series A Preferred Stock in accordance with the terms of Section 8.
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“Date of Issuance” means, for any Share of Series A Preferred Stock, October [●], 2025.
“DGCL” has the meaning set forth in the Preamble.
“Exchange Act” means Securities Exchange Act of 1934, as amended.
“Holder” means a holder of Series A Preferred Stock, and “Holders” means multiple holders of Series A Preferred Stock.
“Junior Securities” means, collectively, the Common Stock and any other class of securities that is specifically designated as junior to the Series A Preferred Stock.
“Liquidation” has the meaning set forth in Section 6.1.
“Liquidation Value” means, with respect to any Share on any given date, $100.00 (as adjusted for any stock splits, stock dividends, recapitalizations, or similar transaction with respect to the Series A Preferred Stock).
“Market Price” means, as of any given date, the VWAP of the Common Stock as of the Trading Day ended immediately prior to such given date.
“Notice of Conversion” has the meaning set forth in Section 8.1(a).
“Options” means any warrants or other rights or options to subscribe for or purchase Common Stock or Convertible Securities.
“Permitted Conversion Date” means the earlier of the date: (i) that both (a) the Corporation has Publicly Disclosed primary endpoint data from its U.S. investigational device exemption study for in-stent restenosis (the “Primary End Point Data Publication”) and (b) the VWAP of the Common Stock has been above the Threshold Stock Price per share on any Trading Day subsequent to the Primary End Point Data Publication; and (ii) of the consummation of a Change of Control.
“Person” means an individual, corporation, partnership, joint venture, limited liability company, governmental authority, unincorporated organization, trust, association, or other entity.
“Preferred Stock” has the meaning set forth in the Recitals.
“Primary End Point Data Publication” has the meaning set forth in the definition of Permitted Conversion Date.
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“Principal Market” means the Nasdaq Global Market.
“Publicly Disclosed” means any disclosure to the public, including through (i) a press release or (ii) a current or periodic report made by the Corporation with the U.S. Securities and Exchange Commission on EDGAR pursuant to Section 13 or 15(d) of the Exchange Act (i.e., a Form 8-K, a Form 10-Q or a Form 10-K).
“Securities Act” means the Securities Act of 1933, as amended, or any successor federal statute, and the rules and regulations thereunder, which shall be in effect at the time.
“Series A Conversion Date” has the meaning set forth in Section 8.1(a)
“Series A Preferred Stock” has the meaning set forth in Section 1.
“Share” means a share of Series A Preferred Stock, and “Shares” means multiple shares of Series A Preferred Stock.
“Subsidiary” means, with respect to any Person, any other Person of which a majority of the outstanding shares or other equity interests having the power to vote for directors or comparable managers are owned, directly or indirectly, by the first Person.
“Trading Day” means, as applicable, (a) with respect to all price or trading volume determinations relating to the Common Stock, any day on which the Common Stock is traded on the Principal Market, or, if the Principal Market is not the principal trading market for the Common Stock, then on the principal securities exchange or securities market on which the Common Stock is then traded; provided that “Trading Day” shall not include any day on which the Common Stock is scheduled to trade on such exchange or market for less than 4.5 hours or any day that the Common Stock is suspended from trading during the final hour of trading on such exchange or market (or if such exchange or market does not designate in advance the closing time of trading on such exchange or market, then during the hour ending at 4:00:00 p.m., New York time) or (b) with respect to all determinations other than price or trading volume determinations relating to the Common Stock, any day on which the Nasdaq Global Market (or any successor thereto) is open for trading of securities.
“Threshold Stock Price” means $15.00 per share of Common Stock, subject to adjustment in the same manner, and at the same time, as the Conversion Price under Section 8.4.
“VWAP” means, for any security as of any date, the volume-weighted average price for such security on the Principal Market (or, if the Principal Market is not the principal trading market for such security, then on the principal securities exchange or securities market on which such security is then traded), during the period beginning at 9:30 a.m., New York time, and ending at 4:00 p.m., New York time, as reported by Bloomberg through its “VAP” function (set to 09:30 start time and 16:00 end time) or, if the foregoing does not apply, the volume-weighted average price of such security in the over-the-counter market for such security during the period beginning at 9:30 a.m., New York time, and ending at 4:00 p.m., New York time, as reported by Bloomberg, or, if no volume-weighted average price is reported for such security by Bloomberg for such hours, the average of the highest closing bid price and the lowest closing ask price of any of the market makers for such security as reported by OTC Markets Group (or a similar organization or agency succeeding to its functions of reporting prices). If the VWAP cannot be calculated for such security on such date on any of the foregoing bases, the VWAP of such security on such date shall be the fair market value as determined by the Board in good faith and in a commercially reasonable manner. All such determinations shall be appropriately adjusted for any stock dividend, stock split, stock combination, recapitalization or other similar transaction during such period.
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3. Rank. With respect to distribution of assets upon liquidation, dissolution, or winding up of the Corporation, whether voluntary or involuntary, all Shares of the Series A Preferred Stock shall rank senior to all Junior Securities.
4. Participating Dividends. If the Corporation declares or pays a dividend or distribution on all shares of the Common Stock, whether such dividend or distribution is payable in cash, securities, or other property but excluding any dividend or distribution payable on the Common Stock in shares of Common Stock, the Corporation shall simultaneously declare and pay a dividend on the Series A Preferred Stock on a pro rata basis with the Common Stock determined on an as-converted basis assuming all Shares had been converted pursuant to Section 8 as of immediately prior to the record date of the applicable dividend (or if no record date is fixed, the date as of which the record holders of Common Stock entitled to such dividends are to be determined).
5. Redemption at the Option of Holders upon a Change of Control.
5.1 Upon the occurrence of a Change of Control, each Holder of Shares shall have the right to require the Corporation to redeem all or any part of such Holder’s Shares at a redemption price in cash (the “Change of Control Payment”) equal to the aggregate Liquidation Value of such Shares, except to the extent that the Holder has previously or concurrently elected to exercise its right to convert such Shares into Common Stock pursuant to Section 8. Notwithstanding the foregoing, the Corporation will not be required to make a Change of Control Offer upon a Change of Control if a third party makes the Change of Control Offer in the manner, at the times and otherwise in compliance with the requirements set forth in this Certificate of Designation applicable to a Change of Control Offer made by the Corporation and redeem all Shares validly tendered and not withdrawn under such Change of Control Offer.
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5.2 Within thirty (30) days following any Change of Control, the Corporation shall deliver a notice (a “Change of Control Offer”) to each Holder describing: (a) that a Change of Control has occurred and that such Holder has the right to require the Corporation to redeem such Holder’s then outstanding Shares as described in Section 5.1, (b) the transaction or transactions that constitute such Change of Control, (c) the redemption date (which shall be no earlier than thirty (30) days nor later than sixty (60) days from the date such notice is delivered) (the “Change of Control Payment Date”), (d) that any Shares not properly tendered will remain outstanding, (e) that unless the Corporation defaults in the payment of the Change of Control Payment, all Shares accepted for payment pursuant to the Change of Control Offer will be canceled on the Change of Control Payment Date; (f) that Holders electing to have any Shares redeemed pursuant to a Change of Control Offer will be required to surrender such Shares to the Corporation (or its agent) prior to the close of business on the third Business Day preceding the Change of Control Payment Date, (g) that Holders will be entitled to withdraw their tendered Shares and their election to require the Corporation to redeem such Shares by written notice to the Corporation not later than the expiration time of the Change of Control Offer that such Holder is withdrawing its tendered Shares and its election to have such Shares redeemed, (h) if such notice is delivered prior to the occurrence of a Change of Control, stating that the Change of Control Offer is conditional on the occurrence of such Change of Control; and (i) any other instructions determined by the Corporation, consistent with this Section 5.2, that a Holder must follow in order to have its Shares redeemed.
5.3 Holders electing to have Shares redeemed shall be required to surrender such Shares to the Corporation at the address specified in the notice at least three Business Days prior to the Change of Control Payment Date. Holders shall be entitled to withdraw their election if the Corporation receives not later than the expiration of the Change of Control Offer by written notice to the Corporation not later than the expiration time of the Change of Control Offer that such Holder is withdrawing its tendered Shares and its election to have such Shares redeemed.
5.4 The Corporation will comply, to the extent applicable, with the requirements of Rule 14e-1 of the Exchange Act and any other securities laws or regulations in connection with the redemption of Shares pursuant to this Section 5. To the extent that the provisions of any securities laws or regulations conflict with provisions of this Section 5, the Corporation will comply with the applicable securities laws and regulations and will not be deemed to have breached its obligations under this Section 5 by virtue of such compliance.
5.5 On the Change of Control Payment Date, the Corporation will, to the extent permitted by law, accept for payment all Shares properly tendered pursuant to the Change of Control Offer), deliver to the Holders the Change of Control Payment in respect of all Shares tendered and cause the cancellation of the Shares tendered and redeemed by the Corporation.
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6. Liquidation.
6.1 Liquidation. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Corporation (a “Liquidation”), the Holders of Shares then outstanding shall be entitled to be paid out of the assets of the Corporation available for distribution to its stockholders, before any payment shall be made to the holders of Junior Securities by reason of their ownership thereof, an amount equal to the aggregate Liquidation Value of all Shares held by such Holder. If any portion of the Liquidation Value is paid in a form of consideration other than cash, then such consideration shall be valued at fair market value as determined by the Board in good faith.
6.2 Insufficient Assets. If upon any Liquidation the remaining assets of the Corporation available for distribution to its stockholders shall be insufficient to pay the Holders the full preferential amount to which they are entitled under Section 6.1, (a) the Holders shall share ratably in any distribution of the remaining assets and funds of the Corporation in proportion to the respective full preferential amounts which would otherwise be payable in respect of the Series A Preferred Stock in the aggregate upon such Liquidation if all amounts payable on or with respect to such Shares were paid in full, and (b) the Corporation shall not make or agree to make any payments to the holders of Junior Securities by reason of their ownership thereof.
6.3 Notice Requirement. In the event of any Liquidation, the Corporation shall, within ten (10) days after the date the Board approves such action, or no later than twenty (20) days after any stockholders’ meeting called to approve such action, or within twenty (20) days after the commencement of any involuntary proceeding, whichever is earlier, give each Holder written notice of the proposed action. Such written notice shall describe the material terms and conditions of such proposed action, including a description of the stock, cash, and property to be received by the Holders upon consummation of the proposed action and the date of delivery thereof. If any material change in the facts set forth in the initial notice shall occur, the Corporation shall promptly give written notice to each Holder of such material change.
7. No Voting Rights. Except as otherwise required by the DGCL,the Holders shall have no voting rights.
8. Right to Convert. Subject to the provisions of this Section 8, at any time and from time to time on or after the Permitted Conversion Date, any Holder shall have the right to convert all or any portion of the outstanding whole Shares held by such Holder into an aggregate number of shares of Common Stock as is determined by (i) multiplying the number of Shares (including any fraction of a Share) to be converted by the Liquidation Value thereof, and then (ii) dividing the result by the Conversion Price in effect immediately prior to such conversion, with cash being paid in lieu of fractional shares of Common Stock in accordance with Section 8.1(c).
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8.1 Procedures for Conversion; Effect of Conversion.
(a) Procedures for Holder Conversion. In order to effectuate a conversion of Shares pursuant to Section 8, a Holder shall (a) provide the Corporation with the form of conversion notice attached hereto as Annex A (a “Notice of Conversion”) and (b) surrender the Shares being converted, along with Notice of Conversion, to the Corporation. Each Notice of Conversion shall specify the number of Shares owned prior to the conversion at issue, the number of Shares to be converted, the Liquidation Value of the Shares to be converted, the applicable Conversion Price, the number of Shares owned subsequent to the conversion at issue and the address or DWAC instructions for delivery. The conversion of such Shares hereunder shall be deemed effective as of the date that the Holder has both provided a duly completed Notice of Conversion to the Corporation and surrendered the Shares to be converted (the “Series A Conversion Date”). Upon the receipt by the Corporation of the Notice of Conversion and the surrender of such Shares, the Corporation shall as promptly as practicable (but in any event within two (2) Trading Days thereafter) deliver to the relevant Holder the number of whole shares of Common Stock through the facilities of the DTC (or, if unavailable in the opinion of counsel to the Company, in book-entry format) to which such Holder shall be entitled upon conversion of the applicable Shares as calculated pursuant to Section 8 with cash being paid in lieu of any fractional shares of Common Stock as provided in Section 8.1(c). All shares of capital stock issued hereunder by the Corporation shall be duly and validly issued, fully paid, and nonassessable, free and clear of all taxes, liens, charges, and encumbrances with respect to the issuance thereof.
(b) Effect of Conversion. All Shares converted as provided in this Section 8.1 shall no longer be deemed outstanding as of the Series A Conversion Date and all rights with respect to such Shares shall immediately cease and terminate as of the Series A Conversion Date, other than the right of the Holder to receive shares of Common Stock and payment in lieu of any fraction of a share of Common Stock in exchange therefor.
(c) Fractional Shares. The Corporation shall not be required to issue a fractional share of Common Stock upon conversion of Shares. As to any fraction of a share of Common stock that the Holder would otherwise be entitled to receive upon conversion of Shares, the Corporation shall promptly after the Series A Conversion Date pay to such Holder an amount in cash (by delivery of a certified or official bank check or by wire transfer of immediately available funds) equal to the product of (i) such fraction multiplied by (ii) the Market Price of one share of Common Stock on the Series A Conversion Date.
8.2 Reservation of Stock. The Corporation shall at all times when any Share is outstanding reserve and keep available out of its authorized but unissued shares of capital stock, solely for the purpose of issuance upon the conversion of the Series A Preferred Stock, such number of shares of Common Stock issuable upon the conversion of all outstanding Series A Preferred Stock pursuant to this Section 8, taking into account any adjustment to such number of shares so issuable in accordance with Section 8.4 hereof. The Corporation shall take all such actions as may be necessary to assure that all such shares of Common Stock may be so issued without violation of any applicable law or governmental regulation or any requirements of any domestic securities exchange upon which shares of Common Stock may be listed (except for official notice of issuance which shall be immediately delivered by the Corporation upon each such issuance). The Corporation shall not close its books against the transfer of any of its capital stock in any manner which would prevent the timely conversion of the Shares.
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8.3 No Charge or Payment. The issuance of shares of Common Stock upon conversion of Shares pursuant to this Section 8 shall be made without payment of additional consideration by, or other charge, cost, or tax to, the Holder in respect thereof.
8.4 Adjustment to Conversion Price and Number of Conversion Shares. In order to prevent dilution of the conversion rights granted under this Section 8, the Conversion Price and the number of Conversion Shares issuable on conversion of the Shares shall be subject to adjustment from time to time as provided in this Section 8.4.
(a) Adjustment to Conversion Price and Conversion Shares upon Dividend, Subdivision, or Combination of Common Stock. If the Corporation shall, at any time or from time to time after the Date of Issuance, (i) pay a dividend or make any other distribution upon the Common Stock or any other capital stock of the Corporation payable in shares of Common Stock or in Options or Convertible Securities, or (ii) subdivide (by any stock split, recapitalization, or otherwise) its outstanding shares of Common Stock into a greater number of shares, the Conversion Price in effect immediately prior to any such dividend, distribution, or subdivision shall be proportionately reduced and the number of Conversion Shares issuable upon conversion of the Series A Preferred Stock shall be proportionately increased. If the Corporation at any time combines (by combination, reverse stock split, or otherwise) its outstanding shares of Common Stock into a smaller number of shares, the Conversion Price in effect immediately prior to such combination shall be proportionately increased and the number of Conversion Shares issuable upon conversion of the Series A Preferred Stock shall be proportionately decreased. Any adjustment under this Section 8.4(a) shall become effective at the close of business on the date the dividend, subdivision, or combination becomes effective.
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(b) Adjustment to Conversion Price and Conversion Shares upon Reorganization, Reclassification, Consolidation, or Merger. In the event of any (i) capital reorganization of the Corporation, (ii) reclassification of the stock of the Corporation (other than a change in par value or from par value to no par value or from no par value to par value or as a result of a stock dividend or subdivision, split-up or combination of shares), (iii) consolidation or merger of the Corporation with or into another Person, (iv) sale of all or substantially all of the Corporation’s assets to another Person or (v) other similar transaction (other than any such transaction covered by Section 8.4(a)), in each case which entitles the holders of Common Stock to receive (either directly or upon subsequent liquidation) stock, securities, or assets with respect to or in exchange for Common Stock, each Share of Series A Preferred Stock shall, immediately after such reorganization, reclassification, consolidation, merger, sale, or similar transaction, remain outstanding and shall thereafter, in lieu of or in addition to (as the case may be) the number of Conversion Shares then convertible for such Share, be exercisable for the kind and number of shares of stock or other securities or assets of the Corporation or of the successor Person resulting from such transaction to which such Share would have been entitled upon such reorganization, reclassification, consolidation, merger, sale, or similar transaction if the Share had been converted in full immediately prior to the time of such reorganization, reclassification, consolidation, merger, sale, or similar transaction and acquired the applicable number of Conversion Shares then issuable hereunder as a result of such conversion (without taking into account any limitations or restrictions on the convertibility of such Share, if any); and, in such case, appropriate adjustment shall be made with respect to such Holder’s rights under this Certificate of Designation to insure that the provisions of this Section 8 shall thereafter be applicable, as nearly as possible, to the Series A Preferred Stock in relation to any shares of stock, securities, or assets thereafter acquirable upon conversion of Series A Preferred Stock. The provisions of this Section 8.4(b) shall similarly apply to successive reorganizations, reclassifications, consolidations, mergers, sales, or similar transactions. The Corporation shall not effect any such reorganization, reclassification, consolidation, merger, sale, or similar transaction unless, prior to the consummation thereof, the successor Person (if other than the Corporation) resulting from such reorganization, reclassification, consolidation, merger, sale, or similar transaction, shall assume, by written instrument substantially similar in form and substance to this Certificate of Designation, the obligation to deliver to the Holders such shares of stock, securities, or assets which, in accordance with the foregoing provisions, such Holders shall be entitled to receive upon conversion of the Series A Preferred Stock. Notwithstanding anything to the contrary contained herein, with respect to any corporate event or other transaction contemplated by the provisions of this Section 8.4(b), each Holder shall have the right to elect prior to the consummation of such event or transaction, to give effect to the provisions of Section 8 hereunder, instead of giving effect to the provisions contained in this Section 8.4(b) with respect to such Holder’s Series A Preferred Stock.
(c) Certificate as to Adjustment.
(i) As promptly as reasonably practicable following any adjustment of the Conversion Price, but in any event not later than ten (10) Trading Days thereafter, the Corporation shall furnish to each Holder of record of Series A Preferred Stock at the address specified for such Holder in the books and records of the Corporation (or at such other address as may be provided to the Corporation in writing by such Holder) a certificate of an executive officer setting forth in reasonable detail such adjustment and the facts upon which it is based and certifying the calculation thereof.
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(ii) As promptly as reasonably practicable following the receipt by the Corporation of a written request by any Holder, but in any event not later than five (5) Trading Days thereafter, the Corporation shall furnish to such Holder a certificate of an executive officer certifying the Conversion Price then in effect and the number of Conversion Shares or the amount, if any, of other shares of stock, securities, or assets then issuable to such Holder upon conversion of the Shares.
(d) Notices. In the event:
(i) that the Corporation shall take a record of the holders of its Common Stock (or other capital stock or securities at the time issuable upon conversion of the Series A Preferred Stock) for the purpose of entitling or enabling them to receive any dividend or other distribution, to receive any right to subscribe for or purchase any shares of capital stock of any class or any other securities, or to receive any other security; or
(ii) of any capital reorganization of the Corporation, any reclassification of the Common Stock of the Corporation, any consolidation or merger of the Corporation with or into another Person, or sale of all or substantially all of the Corporation’s assets to another Person; or
(iii) of the voluntary or involuntary dissolution, liquidation, or winding-up of the Corporation;
then, and in each such case, the Corporation shall, unless a Holder is also a holder of Common Stock, send or cause to be sent to each Holder of record of Series A Preferred Stock at the address specified for such Holder in the books and records of the Corporation (or at such other address as may be provided to the Corporation in writing by such Holder) at least five (5) Trading Days prior to the applicable record date or the applicable expected effective date, as the case may be, for the event, a written notice specifying, as the case may be, (A) the record date for such dividend, distribution, or other right or action, and a description of such dividend, distribution, or other right or action, or (B) the effective date on which such reorganization, reclassification, consolidation, merger, sale, dissolution, liquidation, or winding-up is proposed to take place, and the date, if any is to be fixed, as of which the books of the Corporation shall close or a record shall be taken with respect to which the holders of record of Common Stock (or such other capital stock or securities at the time issuable upon conversion of the Series A Preferred Stock) shall be entitled to exchange their shares of Common Stock (or such other capital stock or securities) for securities or other property deliverable upon such reorganization, reclassification, consolidation, merger, sale, dissolution, liquidation, or winding-up, and the amount per share and character of such exchange applicable to the Series A Preferred Stock and the Conversion Shares.
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9. Reissuance of Series A Preferred Stock. Any Shares redeemed, converted, or otherwise acquired by the Corporation or any Subsidiary shall be canceled and retired as authorized and issued shares of capital stock of the Corporation and no such Shares shall thereafter be reissued, sold, or transferred.
10. Notices. Except as otherwise provided herein, all notices, requests, consents, claims, demands, waivers, and other communications hereunder shall be in writing and shall be deemed to have been given: (a) when delivered by hand (with written confirmation of receipt); (b) when received by the addressee if sent by a nationally recognized overnight courier (receipt requested); (c) on the date sent by facsimile or e-mail of a PDF document (with confirmation of transmission) if sent during normal business hours of the recipient, and on the next Business Day if sent after normal business hours of the recipient; or (d) on the fifth day after the date mailed, by certified or registered mail, return receipt requested, postage prepaid. Such communications must be sent (a) if to the Corporation, its principal executive offices and (b) if to a Holder, such Holder’s address at it appears in the stock records of the Corporation (or at such other address for a Holder as shall be specified in a notice given in accordance with this Section 10).
11. Amendment and Waiver. No provision of this Certificate of Designation may be amended, modified, or waived except by an instrument in writing executed by the Corporation and the Holders of not less than two-thirds of the then total outstanding Shares, and any such written amendment, modification, or waiver will be binding upon the Corporation and each Holder.
[signature page follows]
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IN WITNESS WHEREOF, this Certificate of Designation is executed on behalf of the Corporation by its Chief Executive Officer this [●] day of October 2025.
| Orchestra BioMed Holdings, Inc. | ||
| By: | ||
| David P. Hochman | ||
| Chief Executive Officer | ||
ANNEX A
NOTICE OF CONVERSION
(TO BE EXECUTED BY THE REGISTERED HOLDER IN ORDER TO CONVERT SHARES OF SERIES A PREFERRED STOCK)
Exhibit B
LEGEND REMOVAL CERTIFICATE
Exhibit 10.3
EXECUTION COPY
October 24, 2025
Terumo Corporation
2-44-1 Hatagaya
Shibuya-ku Tokyo
151-0072 Japan
Terumo Medical Corporation
265 Davidson Avenue
Somerset, NJ 08873
Re: Lockup Agreement
Ladies and Gentlemen,
Reference is made to that certain Termination and Right of First Refusal Agreement dated as of even date herewith by and between ORCHESTRA BIOMED, INC., (“Orchestra”), and TERUMO CORPORATION (“TC”) and TERUMO MEDICAL CORPORATION, (“TMC” and together with TC, “Terumo”) (the “Termination Agreement”). Reference is also made to that certain Stock Purchase Agreement between TMC and ORCHESTRA BIOMED HOLDINGS, INC. (“Orchestra Holdings” or the “Company”) dated of even date herewith. Orchestra and Terumo may be referred to individually as a “Party” and collectively as the “Parties.” Capitalized terms used but not defined in this Lockup Agreement (this “Lockup Agreement”) have the meanings ascribed to them in the Termination Agreement.
150 Union Square Drive – New Hope, PA 18938 | T. 917.254.4900 | www.orchestrabiomed.com
| 1. | Lockup Agreement. Terumo hereby understands and agrees that it and its Affiliates shall not sell, offer, pledge, contract to sell, grant any option or contract to purchase, purchase any option or contract to sell, grant any right or warrant to purchase, lend or otherwise transfer or encumber, directly or indirectly, any shares of common stock of the Company (each, a “Transfer”), nor shall Terumo or its Affiliates enter into any swap, hedging or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of any shares of common stock of the Company (or any shares of a third party for which such Company shares were exchanged in connection with a business combination between Company and such third party) held by Terumo until the twelve (12) month anniversary of the date hereof (the “Release Date”); provided that the foregoing shall only apply to common stock of the Company held by Terumo or its Affiliates as of the date hereof. Terumo hereby covenants and agrees that (i) it and its Affiliates shall abide by the restrictions set forth above and (ii) the Company shall be entitled to place “stop transfer” instructions with the Company’s transfer agent in compliance with the above restrictions. The foregoing provisions of this Section 1(a) shall not apply to the sale of any shares to an underwriter pursuant to an underwriting agreement, or the Transfer of any shares of capital stock to Permitted Assignees (as defined below); provided that any such Permitted Assignee agrees to be bound in writing by the restrictions set forth herein, and provided, further, that any such Transfer shall not involve a disposition for value. The underwriters in connection with such registration are intended third-party beneficiaries of this Section 1(a) and shall have the right, power and authority to enforce the provisions hereof as though they were a party hereto. Terumo further agrees to execute, or cause its Affiliates to execute, such agreements as may be reasonably requested by the underwriters in connection with such registration that are consistent with this Section 1(a) or that are necessary to give further effect thereto. Any discretionary waiver or termination of the restrictions of any or all of such agreements by the Company or the underwriters shall apply pro rata to all holders subject to such agreements, based on the number of shares subject to such agreements. For the purposes of this Lockup Agreement, (a) “Permitted Assignees” means (1) with respect to a person, Affiliates (as defined below) of such person, (2) with respect to a partnership, its general and limited partners, (3) with respect to a limited liability company, its members and (4) with respect to an individual party, any Immediate Family Member (as defined below) of such party or any trust for the direct or indirect benefit of the individual or any Immediate Family Member, (b) “Immediate Family Member” means a child, stepchild, grandchild, parent, stepparent, grandparent, spouse, sibling, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law, including, adoptive relationships, of a natural person referred to herein and (c) “Affiliate” means with respect to any specified person, any other person who, directly or indirectly, controls, is controlled by, or is under common control with such person, including, without limitation, any general partner, managing member, officer or director of such person or any venture capital fund now or hereafter existing that is controlled by one or more general partners or managing members of, or shares the same management company with, such person. This Section 1(a) shall supersede any prior agreements between Terumo and the Company with respect to the subject matter hereof. |
| 2. | Miscellaneous. Each Party hereto agrees to execute and deliver such additional documents and instruments and to perform such additional acts as any party may reasonably request or as may be reasonably necessary or appropriate to effectuate, consummate or perform any of the terms, provisions or conditions of this Lockup Agreement. The section headings used in this Lockup Agreement are for convenient reference only and shall not be considered or referred to in resolving any interpretation of this Lockup Agreement. Unless otherwise indicated, references herein to sections shall be deemed and construed to refer to the corresponding sections of this Lockup Agreement. This Lockup Agreement shall be construed as though all parties drafted it. This Lockup Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall constitute but one and the same instrument. Counterparts and signatures transmitted by facsimile or other electronic means shall be valid as originals. The provisions of this Lockup Agreement shall inure to the benefit of, and be binding upon, the transferees, successors, assigns, heirs, executors, conservators, guardians, custodians, trustees and administrators of the parties hereto. This Lockup Agreement shall be governed by the internal laws of the State of New York, without regard to conflict of law principles that would result in the application of any law other than the law of the State of New York. |
[Signature page(s) follow]
IN WITNESS WHEREOF, the Parties have executed this Lockup Agreement as of the date first referenced above.
| Orchestra BioMed Holdings, Inc. | ||
| By: | /s/ David Hochman | |
| Name: David Hochman | ||
| Title: Chairman and CEO | ||
| Terumo Corporation | ||
| By: | /s/ Fumihisa Hirose | |
| Name: Fumihisa Hirose | ||
| Title: President, Cardiac & Vascular Company | ||
| Terumo Medical Corporation | ||
| By: | /s/ James Rushworth | |
| Name: James Rushworth | ||
| Title: President & COO | ||