API Commercial Supply Agreement between Cara Therapeutics, Inc. and Polypeptide Laboratories S.A
CERTAIN PORTIONS OF THIS EXHIBIT (INDICATED BY ***) HAVE BEEN EXCLUDED PURSUANT TO ITEM 601(B)(10) OF REGULATION S-K BECAUSE THEY ARE BOTH NOT MATERIAL AND ARE THE TYPE THAT THE COMPANY TREATS AS PRIVATE AND CONFIDENTIAL.
API COMMERCIAL SUPPLY AGREEMENT
THIS API COMMERCIAL SUPPLY AGREEMENT (this “Agreement”) is entered into and effective as of July, 5th, 2021 (the “Effective Date”) by and between POLYPEPTIDE LABORATORIES S.A., a limited liability corporation organized under the laws of France and having its principal office at 7, rue de Boulogne, 67100 Strasbourg, France (“PolyPeptide”), and CARA THERAPEUTICS, a limited liability company having its principal offices at 4 Stamford Plaza, 107 Elm Street, 9th Floor, Stamford, CT, 06902 USA (“CARA”).
PolyPeptide and CARA are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
WHEREAS, CARA is engaged in the research, development and commercialization of proprietary pharmaceutical products.
WHEREAS, PolyPeptide is a company that has developed substantial expertise in manufacturing peptides, including the API (as defined herein), for use in pharmaceutical products; and
WHEREAS, the Parties desire to enter into a supply agreement pursuant to which PolyPeptide will manufacture and supply the API to CARA.
NOW, THEREFORE, in consideration of the foregoing recitals, mutual covenants, agreements, representations and warranties contained herein, the Parties hereby agree as follows:
If PolyPeptide fails to meet the Purchase Order or any portion thereof on or before the applicable Shipment Date, in addition to other remedies that may be available to CARA under the Legal Requirements for breach of contract or otherwise, CARA may purchase the shortage of such API from Third Parties (a “Secondary Supplier”).
If, for any particular Calendar Quarter during the Term, CARA does not submit Purchase Order(s) during such Calendar Quarter ordering an aggregate amount of API from PolyPeptide in the amount specified in the binding portion of the Forecast for such Calendar Quarter, then as PolyPeptide’s sole and exclusive remedy for CARA not submitting such Purchase Order amounts, CARA shall pay to Polypeptide, within 30 days of receipt of Polypeptide’s corresponding invoice, an amount equal to then current [***] for such Calendar Quarter less the actual amount of API ordered by CARA under Purchase Orders submitted during such Calendar Quarter.
|(a)||General. All API shall be sold [***] (as defined in INCOTERMS® 2020 of the I.C.C.) following shipment instructions provided by CARA. Freight charges will be supported by CARA and will be communicated in written form by PolyPeptide to CARA once the shipment instructions are confirmed by CARA. PolyPeptide shall package the API for shipment (including in containers, packaging, container closure systems and labeling) in accordance with the API Specifications and its customary practices as reasonably acceptable to CARA. Any additional costs or expenses for PolyPeptide resulting from CARA’s required changes in the packaging and/or labeling of the API shall be paid by CARA to PolyPeptide. Delivery of a Batch of API ordered under a Purchase Order shall take place by PolyPeptide at the point in time when PolyPeptide has notified CARA that the Batch is ready for collection by CARA, which shall be on the Shipment Date specified in such Purchase Order (subject to the applicable terms of Section 2.05). At the time PolyPeptide delivers particular API under a Purchase Order pursuant to this Section 3.05(a), PolyPeptide shall deliver to CARA a Certificate of Analysis with respect to such API, attested to and signed by a corporate officer of PolyPeptide. CARA shall notify PolyPeptide if it is unable to collect the delivered Batch within that timeframe. [***] of a delivered Batch that is not collected with ten business Days of delivery.|
|(b)||Title/Risk of Loss. Risk of loss for any API shall pass from PolyPeptide to CARA when such API is delivered to CARA’s designated carrier as provided in Section 3.05(a); provided, however, that nothing in this Article III shall in any manner limit CARA’s rights under Article VI. Title to any API shall pass from PolyPeptide to CARA when such API is fully paid by CARA to Polypeptide as provided in Section 3.02. If API is rejected by CARA after delivery under this Agreement, and such API is to be returned to PolyPeptide, then title to and risk of loss for such rejected API shall pass from CARA to PolyPeptide when such API is made available to the carrier selected by CARA. All returned API shall be shipped [***] (as defined in INCOTERMS® 2010) from the place where the API is stored when CARA makes the decision to return it.|
|(a)||CARA Requested Changes. During the Term, except as set forth in Section 4.02(c), [***] in a manner that would materially negatively impact PolyPeptide’s performance of its API manufacturing obligations hereunder unless it receives the written consent of PolyPeptide to the particular change, which consent shall not be unreasonably withheld or delayed. If CARA requests, and PolyPeptide consents, a discretionary change to the API Specifications, PolyPeptide shall make all revisions to the API Specifications requested by CARA and approved by PolyPeptide. CARA retains at all times the right and responsibility for final approval of the API Specifications. CARA shall pay PolyPeptide all documented reasonable amounts incurred in implementing a change to the API Specifications requested by CARA under this Section 4.02(a). For all changes to the API Specifications requested by CARA pursuant to this Section 4.02, CARA shall, in its discretion, following consultation with PolyPeptide, if reasonably practicable, either (i) perform, or arrange for the performance of, all development work in connection therewith or have PolyPeptide perform such development work at the Facility at CARA’s expense. For the avoidance of doubt, Section 4.02(a) (i) does not give CARA any right to use or disclose (A) any PolyPeptide Intellectual Property (except as may be permitted by the PolyPeptide License), or (B) any PolyPeptide Confidential Information (except as may be permitted under Article XII hereof). PolyPeptide agrees to use commercially reasonable efforts to minimize its costs associated with any API Specification change. At the request of CARA, PolyPeptide shall evaluate and disclose to CARA the|
|estimated costs and timing of any such development work that would be needed by any potential revisions to the API Specifications.|
|(b)||PolyPeptide Changes. PolyPeptide shall not make any revisions or changes to the API Specifications, the manufacturing process or Material Third Party Suppliers, without prior written Consent of CARA, which Consent shall not be unreasonably withheld or delayed (such changes as initiated by either PPL or Cara are subject to review and approval of regulatory authorities. The parties acknowledge that timing of such regulatory approval is unpredictable). If the Parties implement a change in the API Specifications or the manufacturing process under this Section 4.02, they shall negotiate any changes in any affected Purchase Order to provide reasonable accommodation for changed circumstances. The costs of revisions requested by PolyPeptide under this Section 4.02(b) and approved by CARA shall be borne by PolyPeptide without any increase in the API Price.|
|(c)||Changes Mandated by Legal Requirements. Notwithstanding anything in subsections (a) and (b) of this Section 4.02 to the contrary, (i) PolyPeptide shall implement all changes to the API Specifications intended to maintain compliance with Legal Requirements, to bring the API Specifications into compliance with Legal Requirements or to accommodate the demands or requests of any Governmental Body; (ii) unless such changes are generally applicable to the Facility or PolyPeptide’s manufacture of other products, CARA shall bear the expense of any of such changes implemented under this Section 4.03(c); and (iii) if the changes are generally applicable to the Facility or PolyPeptide’s manufacture of other products, PolyPeptide shall bear the expense of any of such changes. Notwithstanding the foregoing, if changes to Legal Requirements generally affecting manufacturers of drugs containing the API significantly increase the cost for PolyPeptide to supply API hereunder, then the Parties agree to negotiate in good faith any appropriate adjustments to the API Price under this Agreement.|
|(a)||Process Validation for Improved Manufacturing Processes. The Parties acknowledge that CARA or PolyPeptide may from time to time desire to pursue strategies and efficiencies for improving the manufacturing processes for the API. Each Party agrees to reasonably evaluate and discuss any such suggestions for improvements that the other Party reasonably believes in good faith may result in significant cost or time savings in the API manufacturing process.|
|(b)||General. Without limiting the foregoing, at CARA’s request, PolyPeptide shall perform for CARA on an on-going basis all Validations and stability studies required by the API Specifications, (c)GMPs or Legal Requirements in connection with the regular course of manufacturing the API for commercial supply to CARA hereunder. Such activities will be subject to price proposal(s) and purchase order(s) from CARA.|
|(c)||Duties. In performing its duties under this Section 4.04, PolyPeptide shall implement and operate an ICH complaint stability program for commercial Batches supply.|
|(d)||Manufacturing Process Review. At either Party’s reasonable request, the Parties shall promptly meet, in person or telephonically, to review such matters related to manufacturing of the API as may be specified by a Party, including discussing strategies for improving the API manufacturing processes.|
In the event of expiration or termination of this Agreement for any reason:
CARA has the right, within 60 (sixty) days from the date of expiration or termination , to place a last time buy order with PolyPeptide for API in quantities not exceeding the Binding Forecast ("Last Time Buy Order") with the same terms and conditions of this Agreement; however subject to the Parties’ mutual agreement on the supply price applicable to such Last Time Buy Order, such price to be commercially reasonable. The applicable terms and conditions of this Agreement shall be deemed to survive any such termination or expiration solely with respect to such supply of the ordered API, and shall expire automatically upon completion of delivery of conforming API and payment therefor. For clarity, the supply exclusivity provision shall not survive any such expiration or termination. If this Agreement is terminated by either Party in accordance with Article XIV, a price increase (revising the reference prices by yearly French inflation rate as soon as published by Institut National de la Statistique at des Etudes Economiques (INSEE)) shall apply to such Last Time Buy Order.
The Parties agree that all deliveries of API ordered pursuant to this Section 4.05 are to be as follows and subject to delivery within a 18 (eighteen) months period following PolyPeptide receiving the last Forecast.
Should CARA’ actual requirements be higher than the Last Time Buy Order, PolyPeptide will use all best efforts to meet CARA’s excess requirements and provided further that demands.
Testing and Quality Assurance are covered by the Quality Agreement in force between CARA and PolyPeptide. Reference to the Quality Agreement in force is given is Appendix 5. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement, the provisions of the Quality Agreement shall govern.
|(a)||PolyPeptide Ownership. As between the Parties, PolyPeptide owns all rights in and to the PolyPeptide Intellectual Property. Except as expressly provided in Section 7.03(b) below, nothing in this Agreement shall be deemed to transfer or convey to CARA, expressly or by|
|implication, any license or any other right, title or interest in or to the PolyPeptide Intellectual Property.|
|(b)||CARA Ownership. As between the Parties, CARA owns all rights in and to the CARA Intellectual Property, including all Intellectual Property rights in and to the API, the documentation, specifications and processes associated with the API, the Product, the Drug Applications, and the documentation, specifications and processes associated with the API and the Product, but excluding any of the foregoing to the extent it is PolyPeptide Intellectual Property. Except as expressly provided in Section 7.03(a) below, PolyPeptide does not have, and nothing in this Agreement shall be deemed to transfer or convey to PolyPeptide, by virtue of this Agreement or otherwise, a license or any other right, title or interest in or to the CARA Intellectual Property.|
|(a)||API Product Developments. All Intellectual Property relating to the API or the development or manufacture or use of the API, that is conceived, reduced to practice, authored or otherwise invented, discovered, generated or developed in whole or in part by PolyPeptide in the course of its activities under this Agreement, whether patentable or not, and any authorship of works relating to the API that are created by PolyPeptide, including any trademarks, trade dress, trade secrets or copyrights, shall be “API Product Developments.”|
|(b)||Ownership of API Product Developments. Subject to the rights and licenses granted in Section 7.03 below, CARA shall own all right, title and interest in and to all API Product Developments and all rights to Intellectual Property appurtenant thereto or arising therefrom, such API Product Developments being works made for hire pursuant to this Agreement.|
|(c)||Patents. Notwithstanding any obligation of confidentiality between PolyPeptide and CARA under this Agreement or any other agreement, but subject however to Section 12.03 of this Agreement, CARA, at its own expense and discretion, shall have the sole and exclusive rights to file and prosecute appropriate patent applications and maintain patents issuing therefrom covering inventions in such API Product Developments. Upon CARA’s reasonable request and at CARA’ expense, PolyPeptide shall take such reasonable actions as CARA deems necessary or appropriate to assist CARA in obtaining patent or other proprietary protection in CARA’s name with respect to any such API Product Developments.|
|(a)||Grant of License to CARA Intellectual Property. Subject to the terms and conditions of this Agreement, CARA hereby grants PolyPeptide a worldwide, non-exclusive, royalty-free, non-transferable (except in connection with a permitted assignment under Section 15.04), limited license to use the applicable CARA Intellectual Property for the sole purpose of manufacturing the API for CARA pursuant to this Agreement. This license shall terminate upon the expiration or termination of this Agreement (except for limited survival solely as needed for the limited purpose of fulfilling any Last Time Buy Order). The license granted in this Section 7.03(a) shall be referred to as the “CARA License.”|
|(b)||Grant of License to PolyPeptide Intellectual Property. Subject to the terms and conditions of this Agreement, PolyPeptide hereby grants CARA a worldwide, non-exclusive, royalty-free, non-transferable (except in connection with a permitted assignment under Section 15.04), license to use the applicable PolyPeptide Intellectual Property for the manufacture and sale of Product using API supplied by PolyPeptide pursuant to this Agreement. CARA may grant sublicense(s) under the foregoing PolyPeptide License to its designated Product manufacturing contractors. This license shall terminate upon the later of (i) expiration or termination of this Agreement and (ii) such time as CARA is no longer in possession of API supplied by PolyPeptide, including API that has been incorporated into Product that has not reached expiry. The license granted in this Section 7.03(b) shall be referred to as the “PolyPeptide License.” For the avoidance of doubt, regardless of the termination or expiration of this Agreement, CARA shall retain the PolyPeptide License to use the PolyPeptide|
|Intellectual Property for the manufacture and sale of the Product for so long as necessary to sell all inventory that incorporates API provided by PolyPeptide under this Agreement.|
Each Party shall promptly notify the other Party of any suspected or threatened infringement, misappropriation or other unauthorized use of the other Party’s Intellectual Property that comes to such Party’s attention. The notice shall set forth the facts of such suspected or threatened infringement in reasonable detail (but subject to any confidentiality obligations and to preservation of applicable legal privileges). The Party [***], but not the obligation, to institute, prosecute and control, at its expense, any action or proceeding against the Third-Party infringer of its Intellectual Property and to retain any and all amounts recovered or awarded in any such action (or settlement thereof). If a Party institutes an action against such infringer, the other Party shall give such Party, at its request, reasonable assistance regarding its filing and prosecution of the action as reasonably needed, such assistance at the expense of the Party who institutes the action.
|(a)||Data. PolyPeptide shall provide to CARA copies (in electronic or hard-copy form, as requested by CARA) of or access to data generated under this Agreement as may be reasonably requested from time to time by CARA on a bona fide need-to-know basis, except as may be restricted for the preservation trade secrets owned by PolyPeptide. PolyPeptide shall provide final reports for Batch failures, including recommendation for API disposition for all investigations involving (i) foreign matter or particulate contamination; or (ii) any test results indicating non-compliance with the applicable (c)GMPs or the API Specifications.|
Annual Report. PolyPeptide shall prepare and provide to CARA a written annual report documenting (i) the prior Calendar Year’s Batch records; (ii) packaging changes; (iii) process changes; (iv) changes in API testing methods performed pursuant to Article VI hereof; (v) Batches of API rejected or aborted; (vi) any other discrepancies that require reporting pursuant to (c)GMP or Legal Requirements; (vii) “trends” in the manufacture of API during the prior Calendar Year; and (viii) ICH stability data summary.
|(a)||Compliance. The manufacture, generation, processing, transport, treatment, storage, disposal and other handling API by PolyPeptide hereunder (including handling and use of applicable Third Party Materials in connection therewith) shall be in accordance with and conform to the API Specifications, (c)GMPs, ICH guidelines, all Legal Requirements, this Agreement and the Quality Agreement.|
|(b)||API Warranty. Upon receipt by CARA (or its designee) of a lot of API delivered hereunder, the API shall comply with the applicable (c)GMPs, the API Specifications, the applicable ICH guidelines and all Legal Requirements; shall be free from defects in materials and workmanship; and shall not be adulterated or misbranded within the meaning of applicable Legal Requirements.|
|(c)||Status; Enforceability. PolyPeptide is a validly existing corporation in good standing under the laws of the jurisdiction of its incorporation; the execution, delivery and performance of this Agreement by PolyPeptide has been duly authorized by all requisite corporate action; this Agreement constitutes a legal, valid and binding obligation of PolyPeptide, enforceable against PolyPeptide in accordance with the terms hereof; and the execution, delivery and performance of this Agreement by PolyPeptide will not violate or conflict with any other agreement or instrument to which PolyPeptide is a party.|
|(d)||Certain Persons. PolyPeptide has not used, and will not use, in any capacity associated with or related to the manufacture of the API, the services of any Persons who have been, or are in the process of being, (i) debarred under 21 U.S.C. § 335a(a) or (b) or any comparable Legal Requirements or (ii) excluded from participation in the Medicare program, any state Medicaid program or any other health care program. Furthermore, neither PolyPeptide nor any of its officers, employees or consultants has been convicted of an offense under either a federal or state law that is cited in 21 U.S.C. § 335(a) as a ground for debarment, denial of approval or suspension, any other law cited in any comparable Legal Requirements as a ground for debarment, denial of approval or suspension. PolyPeptide shall notify CARA immediately upon learning of any circumstance that would cause this representation to become false or inaccurate.|
|(e)||Regulatory Consents. PolyPeptide has or will have all Consents necessary to timely perform its obligations hereunder and to manufacture the API used in Product for commercial sale.|
|(f)||Maintenance of Facility. During the Term of this Agreement, PolyPeptide shall maintain the Facility, required local licenses, the equipment used to manufacture the API, PolyPeptide Intellectual Property and any applicable contracts necessary to manufacture the API in accordance with the API Specifications, Legal Requirements, (c)GMPs, the Quality Agreement and PolyPeptide’s standard operating procedures.|
|(g)||Negative Pledge. The transfer of the API by PolyPeptide to CARA is and shall be rightful and free and clear of any liens or encumbrances.|
|(h)||Security Measures. PolyPeptide shall maintain reasonable security policies at the Facility and shall use commercially reasonable efforts to have security measures in place to protect the integrity of the API, Third Party Materials, data and works-in- process at the Facility.|
|(i)||Non-Infringement. [***] PolyPeptide’s performance of its obligations under this Agreement will not [***] of any Third Party.|
|(a)||Status; Enforceability. CARA is a validly existing limited liability company in good standing under the laws of the jurisdiction of its incorporation; the execution, delivery and performance of this Agreement by CARA has been duly authorized by all requisite corporate action; this|
|Agreement constitutes the legal, valid and binding obligation of CARA, enforceable against CARA in accordance with the terms hereof (except as such enforcement may be limited by principles of equity or by debtor protection laws); and the execution, delivery and performance of this Agreement by CARA will not violate or conflict with any other agreement or instrument to which CARA is a party.|
|(b)||Certain Persons. CARA has not used, and will not use, in any capacity associated with or related to the Product, the services of any Persons who have been, or are in the process of being, (i) debarred under 21 U.S.C. § 335a(a) or (b) or any comparable Legal Requirements, or (ii) excluded from participation in the Medicare program, any state Medicaid program or any other health care program. Furthermore, neither CARA nor any of its officers, employees or consultants has been convicted of an offense under either a federal or state law that is cited in 21 U.S.C. § 335(a) as a ground for debarment, denial of approval or suspension or any other law cited in any comparable Legal Requirements as a ground for debarment, denial of approval or suspension. CARA shall notify PolyPeptide immediately upon learning of any circumstance that would cause this certification under this Section 9.02(b) to become false or inaccurate.|
|(c)||Regulatory Consents. [***] hereunder and will, prior to commercial sale of Product, have all [***] of the Product once the Product is approved by health authorities.|
|(d)||Non-infringement. [***], (i) the manufacture and delivery of the API under this Agreement, (ii) the use by PolyPeptide of CARA’ Intellectual Property to manufacture the API, and (iii) CARA’s commercial sale of Product, will not [***] of any Third Party, provided that excluded from the foregoing warranty is any use of any PolyPeptide Intellectual Property. [***] by a Third Party that [***] by PolyPeptide’s production of API under this Agreement using the manufacturing processes intended to be utilized hereunder, or (ii) [***] Polypeptide’s performance of API manufacturing hereunder.|
Section 12.01Definition of Confidential Information. “Confidential Information” means, with respect to a Party, any and all data, results and other Know-How, which may include scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial results, data and other information, that is or was provided or disclosed by such Party (or its Affiliate) to the other Party (or its Affiliate), whether communicated in writing or orally or by any other method, in connection with this Agreement including all such information that was disclosed under the Prior Agreement. Notwithstanding the foregoing, the term “Confidential Information” excludes particular information that, in each case as demonstrated by competent written documentation: (a)is publicly disclosed and made generally available to the public, either before or after it becomes known to the receiving Party, and other than through any act or omission of the receiving Party or its Affiliates in breach of this Agreement; (b) was known to the receiving Party or its Affiliate, without obligation to a Third Party to keep it confidential, prior to the date of first disclosure by the disclosing Party to the receiving Party; (c) is subsequently disclosed to the receiving Party or its Affiliate by a Third Party lawfully in
possession thereof without obligation to keep it confidential and without a breach of such Third Party’s obligations of confidentiality; or (d) has been independently developed by the receiving Party or its Affiliate without the aid, application or use of the disclosing Party’s Confidential Information (the competent written proof of which must be contemporaneous with such independent development).
Section 12.02Nondisclosure and Limited Use Obligations. Each of the Parties agree that during the Term, and for a period of ten (10) years thereafter, each Party and its Affiliates shall (a) maintain in confidence the Confidential Information of the other Party, using efforts to protect such information that are at least as strong as those that such Party uses to maintains its own confidential information (but in no event less than reasonable efforts), (b) not disclose such Confidential Information to any Third Party without the prior written consent of the other Party, or as otherwise expressly permitted in this Agreement, and (c) not use such Confidential Information for any purpose except those permitted by this Agreement.
Section 12.03Authorized Disclosure. Notwithstanding anything to the contrary in this Article 8, a Party may disclose particular Confidential Information of the other Party to the extent such disclosure is reasonably necessary in the following instances:
Prosecuting, enforcing or defending applicable Patent Rights that are the subject of this Agreement in accordance with Article VII of this Agreement.
making filings covering a Product with Governmental Bodies;
complying with Legal Requirements (including securities laws and the requirements of the securities exchange on which a Party’s stock is traded) or submitting information to tax or other Governmental Bodies; provided that if a Party is required by Law to make any public disclosure of Confidential Information of the other Party, to the extent it may legally do so, it will give reasonable advance notice to the other Party of such disclosure and will use its reasonable efforts to secure confidential treatment of such Confidential Information prior to its disclosure (whether through protective orders or otherwise);
to its Affiliates, and to employees, accountants, and lawyers, on a need to know basis, each of whom prior to disclosure must be subject to appropriate obligations of confidentiality and non-use equivalent in scope to those set forth in this ARTICLE VIII and that are of reasonable duration in view of the circumstances of the disclosure; or
to the extent mutually agreed to in writing by the Parties.
|(a)||Failure to Achieve Acceptance of Pre-Approval Inspection. PolyPeptide receives at any time correspondence from FDA indicating that the Facility is not approved for the manufacture of API.|
|(b)||Failure to Supply Unrelated to Force Majeure. In the event of a Supply Failure by PolyPeptide (relating to failure to deliver conforming API ordered by CARA), CARA shall have the right to terminate this Agreement upon [***] to PolyPeptide. “Supply Failure” for purposes of this Section is deemed to have occurred in the event that PolyPeptide does not deliver [***] conforming API ordered by CARA under a Purchase Order by the Shipment Date specified in such Purchase Order, and PolyPeptide does not deliver to CARA all the missing quantity of conforming API by the date [***] days after such Shipment Date.|
|(c)||Supply of Nonconforming API. PolyPeptide delivers Nonconforming API pursuant to [***] Purchase Orders in any [***] period.|
|(d)||Late Shipment. PolyPeptide delivers API pursuant to two or more Purchase Orders more than [***] after the applicable Shipment Date during any [***] period.|
|(e)||Failure to Obtain or Maintain Consents. PolyPeptide fails to obtain, maintain and comply with all Consents required for the performance of its obligations under this Agreement.|
|(a)||Failure to Obtain Approval of the Drug Application. CARA’s failure to obtain approval of the Drug Application for the Product from the FDA [***] the Effective Date.|
|(b)||Failure to Accept API Unrelated to a Force Majeure Event. CARA’s [***] API delivered by PolyPeptide unrelated to a Force Majeure Event [***] for purposes of determining [***] API shall be [***] Batch of the API delivered over a [***] period.|
|(c)||Failure to Pay. CARA’s failure to pay PolyPeptide invoiced amounts for conforming API (that is, supplied API that is not subject to an active investigation of issues relating to whether it is Nonconforming API, or the API or invoiced amount is otherwise disputed in good faith by CARA) within [***] from the applicable due dates [***] Purchase Orders.|
If to CARA:
CARA THERAPEUTICS, Inc.
4 Stamford Plaza
107 Elm Street, 9th Floor
Stamford, CT 06902
Attn: Frederique Menzaghi, Chief Scientific Officer
With a mandatory copy to:
Office of the General Counsel
Cara Therapeutics, Inc.
4 Stamford Plaza
107 Elm Street, 9th Floor
Stamford, CT 06902
If to PolyPeptide:
7, rue de Boulogne
F-67100 Strasbourg, France
Attention:Mr. Vincent Mancuso, General Manager
E-mail address ***@***
For CARA: Derek Chalmers, President & CEO
For PolyPeptide: Mr. Vincent Mancuso, General Manager
If such Dispute is not resolved by the end of the [***] period, then either Party shall be entitled to refer the matter to be finally settled by arbitration to be held in accordance with the then-current Rules of Arbitration and Conciliation of the International Chamber of Commerce by three arbitrators to be appointed in accordance with the said Rules, with each such arbitrator being completely independent of each Party and its Affiliates and experienced in the drafting and interpretation of pharmaceutical supply agreements. The Parties agree that any such unresolved Dispute, and any claim or dispute related to the validity of this arbitration clause, may be resolved solely by binding arbitration under this Section 15.05. The arbitration shall take place in [***]. The proceedings shall be conducted, and all documentation shall be presented in the English language. The award of the arbitrators shall be final, binding and without appeal. Any competent court shall be able to order enforcement of the award. Each Party will bear its own attorneys’ fees and other costs and expenses incurred pursuant to this Section 15.05. For avoidance of doubt, the foregoing shall not prohibit or delay a Party from seeking appropriate injunctive or other equitable relief.
|(a)||Headings. The headings of the Sections of this Agreement are for reference purposes only, are not part of this Agreement and shall not in any way affect the meaning or interpretation of this Agreement.|
|(b)||Appendices. All Appendices delivered pursuant to this Agreement shall be deemed part of this Agreement and incorporated herein by reference as if fully set forth herein. If any Appendices conflicts with any of the terms or provisions of this Agreement, the terms and provisions of this Agreement shall prevail. The Appendices attached to this Agreement are:|
|-||Appendix 1:Chemical structure of the API|
|-||Appendix 2:Specification of the API|
|-||Appendix 3:API Forecasts|
|-||Appendix 4:API prices; Lead-times for the different scales|
|-||Appendix 5:Quality Agreement|
|(c)||Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original but all of which together shall constitute one and the same instrument. Facsimile signatures shall be treated as original signatures.|
Signature Page Follows
IN WITNESS WHEREOF, each of the Parties hereto has caused this Agreement to be duly executed as of the date first written above.
CARA THERAPEUTICSPOLYPEPTIDE LABORATORIES S.A
By: /s/ Derek Chalmers By: /s/ Jean Ruppert
Name: Derek ChalmersName:Mr. Jean Ruppert
Title:Chief Executive OfficerTitle:Sales Director
Date:July 16th, 2021Date:July 5th, 2021
H-DPhe-DPhe-DLeu-DLys-γ-(4-N-piperidinyl)amino carboxylic acid
Reference is made to the Specification in force referenced Spec-SP070543-14
Between PolyPeptide Laboratories France SAS and Cara Therapeutics
signed by PolyPeptide Laboratories France SAS representatives on May 22nd, 23rd, 27th, 2019
and signed by Cara Therapeutics representatives on May 31st, 2019
API-Forecast - Shipment readiness
Exemplary the template for the forecast is shown below.
The forecasts as indicated below are CARA forecasts as of July 05th 2021 and are subject to an update by CARA on December 15, March 15, June 15, and September 15 of each year during the term of the contract.
Forecast for 2021 - API ready for Shipment (Shipment date to be mentioned on purchase order)
12/2021:1 batch of 2 kg
Forecast for 2022 - API ready for Shipment (Shipment date to be mentioned on purchase order)
Forecast for 2023 - API ready for Shipment (Shipment date to be mentioned on purchase order)
API prices; Lead-times for the different scales; Invoicing Specification
|-||For a commercial batch [***] scale (gross weight):|
[***] Euros per gram
|-||For a commercial batch [***] scale (gross weight):|
[***] Euros per gram
|-||For a commercial batch at [***] scale (gross weight):|
[***] Euros per gram
Lead-time per API-batch in the different scales:
Product Number (PolyPeptide)
Product (CARA Name)
[***] gross weight
[***] months from purchase order reception at PolyPeptide
[***] – gross weight
[***] months from purchase order reception at PolyPeptide
[***] – gross weight
[***] months from purchase order reception at PolyPeptide
Lead-time means the time elapsed from Polypeptide accepts a purchase order until such order is ready for shipment to the Drug product manufacturer.
Prices for other batch sizes upon request and subject to confirmation with an amendment to the present Agreement and in any case after a risk assessment performed by PolyPeptide.
The unit price for production of API will remain valid until 31.12.2021 and will then be revised on a yearly basis with retroactive effect on January, 1st of each year by revising the above-specified reference prices by yearly French inflation rate as soon as published by Institut National de la Statistique et des Etudes Economiques (INSEE).
POLYPEPTIDE shall submit invoices for payment of the Product only after the Product has been delivered.
All invoices shall be sent by email using ***@*** .
Invoices sent by email must attach the invoice in pdf file format. CARA may update email addresses from time to time and shall inform POLYPEPTIDE of any changes.
Reference is made to the Quality Agreement in force between
Cara Therapeutics and PolyPeptide Laboratories France SAS and PolyPeptide S.A
with effective date on June 29th, 2020