Master Services Agreement
Exhibit 10.1
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and the registrant customarily and actually treats as private and confidential.
This Master Services Agreement (this “Agreement”) dated September 20, 2017 (the “Effective Date”), between Chondrial Therapeutics, Inc. having a place of business at 000 Xxxxxxxx Xxxx, Xxxxx 000, Xxxx Xxxxxx, XX 00000 (“Client”) and KBI Biopharma, Inc., having a place of business at 0000 Xxxxxx Xxxx, Xxxxxx, Xxxxx Xxxxxxxx 00000 (“KBI Biopharma”) (Client and KBI Biopharma, each a “Party”, and collectively, the “Parties”).
Whereas, Client is engaged in the discovery and development of new biological therapeutics;
Whereas, KBI Biopharma is in the business of providing biological development and clinical manufacturing services; and
Whereas, Client desires KBI Biopharma to perform certain services in accordance with the terms of this Agreement and KBI Biopharma desires to perform such services.
Now, therefore, in consideration of the above statements, which form part of this Agreement, and other good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, the Parties hereto agree as follows:
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1. |
Services to be Performed |
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1.1 |
Scope. KBI Biopharma shall use reasonable commercial efforts to perform the services (the “Services”) detailed in the proposal, which has been executed by the Parties and attached hereto as Attachment One and incorporated herein by reference (the “Proposal”). Any deliverables to be provided to Client as a result of the performance by KBI Biopharma of the Services shall be set forth in the Proposal (the “Deliverables”). In the event that Client requests KBI Biopharma to perform services beyond the scope of services specifically stated in the Proposal, KBI Biopharma shall have no obligation to perform such supplemental services unless and until a Change Order is executed in accordance with Article 5 below, or unless the Parties agree in writing on a proposal for additional services to be performed under this Agreement. |
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1.2 |
Additional Services. The Parties may agree upon additional services to be performed under the terms of this Agreement, as may be described in purchase orders or proposals to be mutually agreed upon by the Parties in writing. Such additional proposals or purchase orders, when signed by both Parties, shall be included in the term “Proposal” as used in this Agreement and the additional services described therein shall be included in the term “Services” as used in this Agreement. |
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1.3 |
Compliance with Laws. As applicable to the Services, KBI Biopharma shall perform the Services in |
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regulatory requirements of KBI or commitments made by KBI Biopharma to regulatory authorities, of which matters KBI Biopharma shall promptly notify Client in writing. Should the U.S. government regulatory requirements change, KBI Biopharma will use reasonable efforts to satisfy the new requirements. Notwithstanding the foregoing, in the event that compliance with such new U.S. regulatory requirements necessitates a change in the scope or nature of the Services to be completed, KBI Biopharma will submit to Client a Change Order in accordance with Article 5.
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2. |
Client Obligations |
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2.1 |
General. Unless otherwise agreed to by the Parties in writing, in each case in accordance with the Proposal, Client is solely responsible for, and performance hereunder by KBI Biopharma is contingent upon: (a) provision of complete and accurate scientific data regarding the product which is the subject of the Proposal (the “Product”) and such other data that is to be supplied by Client pursuant to the Proposal; (b) provision of all information necessary to effect the reliable transfer of methods to KBI Biopharma; (c) provision of specific reagents, reference standards or other materials necessary for execution of Services, as may be described in the Proposal; (d) if applicable, review and approval of in-process and finished product test results to ensure conformity of such results with required Product specifications, regardless of which Party is responsible for finished Product release; (e) preparation of all submissions to regulatory authorities for the Product; and (f) performance of all other obligations of Client set forth in the Proposal. Client shall perform its obligations as set forth in this Agreement, cooperate with KBI Biopharma in the execution of the Services and shall not engage in any act or omission, which may reasonably be expected to prevent or delay the successful execution of the Services. Such cooperation shall include, but not be limited to, informing KBI Biopharma of global regulatory strategy for development and approval of the Product to the extent relevant to the Proposal, prompt review and approval of documents requiring Client’s signature, timely delivery of methods and materials and prompt response to other similar issues. |
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2.2 |
Provision of Regulatory Submissions. Prior to making any submission for regulatory approval of the Product, upon the request of KBI Biopharma, Client shall provide copies of all relevant parts of regulatory submissions relating to KBI Biopharma’s manufacturing procedures (if applicable to the Services) to KBI Biopharma for review and reasonable opportunity to comment, provided that KBI Biopharma agrees to provide any comments within five (5) days of receipt of such information from Client. |
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2.3 |
Information Regarding Hazardous Materials. Client shall provide to KBI Biopharma, on an on-going basis throughout the Term (as defined below), any applicable safe handling instructions for any substance or material provided by or on behalf of Client to KBI Biopharma in sufficient time for review and training by KBI Biopharma prior to delivery of any such substance or material to KBI Biopharma. Where appropriate or required by law, Client shall provide a Material Safety Data Sheet and instructions for proper storage for all Client-provided materials, finished product and reference standards. |
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2.4 |
Other Company Materials. As soon as practicable following the execution of this Agreement, Client shall provide to KBI Biopharma all materials, know-how, information and technical assistance under Client’s control which is associated with the Product or otherwise required for the performance of the Services in accordance with the Proposal. Client agrees that such materials, know-how, information and technical assistance shall be complete and accurate to the extent required for KBI Biopharma to perform the Services. Client hereby grants to KBI Biopharma during the Term of this Agreement the right to use any and all patent rights, trade secrets, intellectual property and other materials under Client’s control to the extent useful for KBI Biopharma to perform the Services. |
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3. |
Performance |
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3.1 |
Schedule. Due to the unpredictable nature of biological processes, the timelines and schedules for the performance of the Services (including without limitation the dates for production and delivery of Product) and the yield or quantity of Product as set out in the Proposal are estimates only. KBI Biopharma shall keep Client regularly informed in writing of any such changes that are necessary to the Proposal, and agrees that such changes will be made to the minimum extent reasonably necessary. Client shall not be entitled to cancel any unfulfilled part of the Services or refuse acceptance of Product related to the Proposal on grounds of late performance of the Services or late delivery of the Product subject to the provisions of this Section 3.1. In such event, KBI Biopharma shall not be liable for any loss, damage, costs or expenses of any nature, whether direct, indirect, incidental or consequential, arising out of any delay in performance or delivery howsoever caused or arising out of any failure to produce the estimated quantities of Product for delivery on the estimated schedule. KBI Biopharma shall not delay or reschedule a Client manufacturing run for any reasons other than those expressly set forth in this Agreement, such as Client’s breach, non-payment, or technical difficulties. |
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3.2 |
Technical Difficulties. If it becomes apparent to either KBI Biopharma or Client at any stage in the provision of any Services that, as a result of scientific or technical reasons out of the reasonable control of either Party, it will not be possible to complete the Services in the manner described in this Agreement or the Proposal or any Change Order thereto, the Parties will (a) identify the problem, (b) submit the problem in writing to senior management of each Party, and (c) negotiate in good faith for a thirty (30) day period from the date senior management of the Parties first convene regarding how to resolve such problem in a commercially reasonable manner. If the Parties do not agree on a commercially reasonable resolution to the problems within such thirty (30) day period, KBI Biopharma and Client shall each have the right to terminate this Agreement by written notice to the other Party, subject to Section 24.2. |
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3.3 |
Quality Agreement. In the event that the Proposal specifically enumerates Services that include the performance of activities that are subject to cGMP, contemporaneously with the execution of this Agreement, or as soon as practicable after the execution hereof, the Parties shall develop and agree upon a quality agreement describing the regulatory and compliance roles and responsibilities of each Party, including without limitation, procedures for handling Product recalls and non-conforming Product, the format and content of which shall be agreed upon by the Parties (the “Quality Agreement”). Upon execution by both Parties, the Quality Agreement shall be incorporated herein and attached hereto as Attachment Two. |
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3.4 |
Non-Conforming Services. Within [***] of delivery of the Product or Services, Client shall inform KBI Biopharma of any material non-conformity with required specifications set forth in the Proposal, as may be further provided in the Quality Agreement. Additionally, KBI Biopharma may identify a material non-conformity during production of the Product or execution of the Services. In the event that such non-conformity is attributable to a breach of KBI Biopharma’s obligations under this Agreement or to gross negligence or willful misconduct in KBI Biopharma’s execution of the services, then, as Client’s sole and exclusive remedy, KBI Biopharma shall, subject to Client providing the replacement Client-supplied source materials and/or the cost thereof, as applicable, re-perform such non-conforming Services as soon as possible with no additional fees to Client. |
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4. |
Work Output |
All reports specified in the Proposal and other applicable cGMP documentation (“Work Output”) will be prepared using KBI Biopharma’s standard format(s) unless otherwise specified in the Proposal or this Agreement. Client will be supplied with copies of Work Output generated as a result of the Services as set forth in the Proposal or Quality Agreement. All Work Output and any required Product samples will be archived by KBI Biopharma for a period of five (5) years following completion of the Services unless otherwise provided in the Proposal or required by applicable U.S. laws or regulations. At such time after, Work Output and Product samples will be sent to Client and a reasonable return fee will be charged. If Client chooses to have KBI Biopharma dispose of Work Output and Product samples, a reasonable disposal fee will be charged.
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5. |
Change Orders |
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5.1 |
Change Orders. The budget for the Services specified in the Proposal and the estimated timelines specified therein are subject to the assumptions stated in the Proposal. The assumptions related to the design and objectives of the Proposal, manpower requirements, timing, capital expenditure requirements, if any, and other matters relating to the completion of the Services shall be set forth in the Proposal (“Proposal Assumptions”). KBI Biopharma also assumes that Client will cooperate and fully perform its obligations under this Agreement and the Proposal in a timely manner, that no event outside of KBI Biopharma’s control will occur (including without limitation a Force Majeure Event), and that there are no adverse changes to any applicable laws, rules or regulations relating to the performance of the Services (the foregoing assumptions together with the Proposal Assumptions, collectively, the “Assumptions”). In the event of a failure of any of the Assumptions, the objectives of the Proposal cannot be achieved based on the Assumptions, or Client requests a change to the Proposal, then the scope of services to be performed shall be amended as provided in this Article 5 (a “Modification”). Modifications shall also arise in the event (i) Client revises KBI Biopharma’s responsibilities, the specifications, the Proposal instructions, procedures, Assumptions, processes, test protocols, test methods, or analytical requirements; or (ii) Client’s requirements or any Client provided information is inaccurate or incomplete. |
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5.2 |
Change Order Process. In the event a Modification is requested by Client or by KBI Biopharma, within ten (10) business days KBI Biopharma shall provide Client with a change order containing a complete description of the required Modifications to the budget, activities and/or duration specified in the Proposal (“Change Order”). Client and KBI Biopharma shall negotiate in good faith for a period of ten (10) business days following receipt of such Change Order by Client (the “Change Order Negotiation Period”) to agree on a Change Order that is mutually acceptable. If practicable, and agreed to by Client, KBI Biopharma shall continue work on the Services during any such negotiations, but shall have no obligation to commence work with respect to any Change Order unless authorized in writing by Client. In the event the Parties are unable to agree upon such Change Order within the Change Order Negotiation Period, either Party may elect to terminate this Agreement, or if reasonably possible, to agree that KBI Biopharma will continue to perform the Services without regard to the unresolved Change Order; provided, however, that the estimated timelines shall be adjusted to reflect any delay during the Change Order Negotiation Period. In the event that this Agreement is so terminated, the provisions with respect to the effect of termination set forth in Section 24.5 shall apply. Any disputes arising from this Section 5.2 shall be resolved in accordance with the dispute resolution procedures set forth in Article 22. |
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5.3 |
Regulatory Changes. Notwithstanding the foregoing, with respect to any changes or modifications to the Proposal, Services or Product specifications dictated by the FDA or other applicable law or authority, Client shall be responsible for the costs of making such changes (including without limitation capital costs), validating the manufacturing process after any such change is made, and any increases in the cost of manufacturing the Product or provision of Services as a result of such change. With respect to any such changes dictated by the FDA or other applicable law or authority, the Parties will promptly meet to discuss the actions necessary to comply with such changes and the costs associated therewith. If, after reasonable efforts, the Parties are unable to agree on such changes (including the costs payable by Client pursuant to this Section 5.3), or if KBI Biopharma is unable to comply with such changes or modifications through the exercise of commercially reasonable efforts, KBI Biopharma or Client may, in its sole discretion, terminate this Agreement upon written notice to the other Party. |
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5.4 |
Non-Material Changes. Notwithstanding the foregoing, Client acknowledges, however, that KBI Biopharma is given flexibility to conduct the Services, although not expressly stated in the Proposal, |
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and requirements if such specifications and requirements are fixed in writing by the Parties. As used herein, “Material Change” is defined as any variation, alteration or modification of activities, materials, or methods provided in the Proposal that (i) impacts the regulatory commitments or filings for the Product, (ii) affects the quality, purity, identity or strength of the Product, or (iii) materially increases the cost of or timelines for manufacturing the Product.
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6. |
Compensation |
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6.1 |
Fees and Invoices. In consideration for KBI Biopharma performing the Services, Client shall pay to KBI Biopharma such amounts as described in the Price and Payment Terms section of the Proposal and as otherwise described in this Agreement. Following payment of an initial fee as provided in Section 6.2, the remainder of the service fees may be invoiced by KBI Biopharma monthly based on a billing schedule derived from the Proposal. Payments are due thirty (30) days from date of invoice issuance, except as specifically provided in this Agreement. Charges for materials may be invoiced to Client and are payable at the time that KBI Biopharma orders such materials for Client’s project. Client agrees to pay to KBI Biopharma the cost of materials, consumables, and third party services (if described in the Proposal or otherwise approved in advance by Client as provided in Section 23.2) plus [***] to compensate KBI Biopharma for the cost of purchasing, material handling, inventory and administration and management of third party services necessary for KBI Biopharma to perform the Services. Late payments are subject to an interest charge of [***] per month or, if less, the maximum legal interest rate per month. Failure to xxxx for interest due shall not be a waiver of KBI Biopharma’s right to charge interest. All payments are non-refundable. If paid by wire transfer, any applicable wire transfer fees must be included in the payment issued to KBI Biopharma. Client shall be responsible for, and shall promptly pay to KBI Biopharma upon demand, all costs and expenses (including without limitation reasonable attorneys’ fees and court costs) incurred by KBI Biopharma in connection with the collection of payments due under this Agreement. Unless within thirty (30) days of the date of invoice, Client has advised KBI Biopharma in good faith and in writing the specific basis for disputing an invoice, Client’s failure to promptly pay an invoice may, at KBI Biopharma’s election, constitute a material breach of this Agreement, and in addition to other remedies available to KBI Biopharma under Section 24.3, KBI Biopharma shall be entitled to suspend performance of Services until Client has paid any past due invoices. |
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6.2 |
Start-up Payment. KBI Biopharma requires payment of an initial fee as specified in the Proposal, prior to commencement of Services, and before KBI Biopharma will begin facilities preparation and resource allocation commitments with respect to Client’s project(s). Initial fees are due upon execution of this Agreement or the applicable Proposal, whichever occurs later. The initial fee shall be applied to the final project invoice. Upon termination of a Proposal or this Agreement, any remaining portion of the initial fee shall be applied to all outstanding amounts due from Client under the applicable Proposal. Unless otherwise provided in this Agreement or the applicable Proposal, initial fees are non-creditable and nonrefundable to any Services other than under the applicable Proposal. Client shall be entitled to apply the balance of initial fees paid for a terminated Proposal toward the initial fee payment for a subsequent Proposal for Services initiated within twelve months of the conclusion of Services under the terminated Proposal. |
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6.3 |
Client Delays. KBI Biopharma has allocated resources to the Services that may be difficult or |
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manufacturing run (based on the manufacturing slots reserved for Client in the most recent schedule provided to Client) for any reason other than a material breach of this Agreement by KBI Biopharma, or in the event that a manufacturing run is cancelled or postponed for scientific or technical issues related to Client’s Product which are outside of KBI Biopharma’s control, Client shall pay KBI Biopharma, upon receipt of an invoice, the following amounts, less all amounts already paid to KBI Biopharma for the applicable manufacturing Services:
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(i) |
[***] of the price of the Services for the applicable manufacturing run if such cancellation or postponement occurs [***] prior to the scheduled vial thaw date (as communicated by KBI Biopharma to Client in writing) or at any time following the scheduled vial thaw date; |
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(ii) |
[***] of the price of the Services for the applicable manufacturing run if such cancellation or postponement occurs from [***] prior to the scheduled vial thaw date; or |
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(iii) |
[***] of the price of the Services for the applicable manufacturing run if such cancellation or postponement occurs from [***] prior to the scheduled vial thaw date. |
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(iv) |
[***] of the price of the Services for the applicable manufacturing run if such cancellation or postponement occurs from [***] prior to the scheduled vial thaw date. |
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6.4 |
Taxes. Any federal, state, county or municipal sales or use tax, excise tax, customs charges, duties or similar charge, or any other tax assessment (other than that assessed against KBI Biopharma’s income), license, fee or other charge lawfully assessed or charged on the manufacture, sale or transportation of Product sold or Services performed pursuant to this Agreement, and all government license filing fees and, if applicable, Prescription API User (PDUFA) annual establishment fees assessed to Client by FDA with respect to all Products and Services shall be paid by Client. |
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7. |
Confidentiality |
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7.1 |
Confidential Information. During the Term and for a period of five (5) years thereafter, each Party |
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Biopharma hereunder, regardless of whether such information is marked “confidential” or subsequently summarized in writing.
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7.2 |
Exceptions. Notwithstanding the foregoing, Confidential Information shall not include that portion of information or materials that the Recipient can demonstrate by contemporaneous written records was: |
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(i) |
known to the public at the time of its disclosure to the Recipient, or thereafter became generally known to the public, other than as a result of actions or omissions of the Recipient in violation of this Agreement; |
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(ii) |
disclosed to the Recipient on an unrestricted basis from a source unrelated to the Disclosing Party and not known by the Recipient to be under a duty of confidentiality to the Disclosing Party, as evidenced by competent written proof; or |
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(iii) |
independently developed by the Recipient, or known by the Recipient prior the date of disclosure by the Recipient, without the use of Confidential Information of the Disclosing Party, as evidenced by competent written proof. |
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7.3 |
Additional Protections. Each Party shall take all reasonable steps to maintain the confidentiality of the Confidential Information of the other Party, which steps shall be no less protective than those that such Party takes to protect its own information and materials of a similar nature, but in no event less than a reasonable degree of care. Neither Party shall use or permit the use of any Confidential Information of the other Party except for the purposes of carrying out its obligations or exercising its rights under this Agreement. All Confidential Information of a Party, including all copies and derivations thereof, is and shall remain the sole and exclusive property of the Disclosing Party and subject to the restrictions provided for herein. Neither Party shall disclose any Confidential Information of the other Party other than to those of its directors, officers, employees, independent contractors, and external advisors directly concerned with the carrying out of this Agreement, on a strictly applied “need to know” basis, provided that any such disclosure is made subject to obligations of confidentiality no less stringent than the obligations provided herein. |
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7.4 |
Permitted Disclosures. The obligations set forth in this Article 7 shall not apply to the extent that Recipient is required to disclose information by law, judicial order by a court of competent jurisdiction, or the rules of a securities exchange or requirement of a governmental agency for purposes of obtaining approval to test or market Product, or disclosures of information to a patent office for the purposes of filing a patent application as permitted in this Agreement; provided, however, that the Recipient shall provide prior written notice thereof to the Disclosing Party and sufficient opportunity for the Disclosing Party to review and comment on such required disclosure and request confidential treatment thereof or a protective order therefore. Any disclosure permitted pursuant to this Section 7.4 shall not be considered an exception under Section 7.2. |
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7.5 |
Injunctive Relief. The Parties acknowledge that either Party’s breach of this Article 7 may cause the other Party irreparable injury for which it may not have an adequate remedy at law. In the event of a breach, the non-breaching Party shall be entitled to seek injunctive relief in addition to any other remedies it may have at law or in equity, in accordance with Article 21. |
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8. |
Inventions |
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8.1 |
Inventions. KBI Biopharma agrees to promptly disclose to Client any and all data, results, ideas, |
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assignments or other instruments and give testimony which shall be necessary to apply for and obtain letters of patent of the US or of any foreign country with respect to the Product Invention and Client shall compensate KBI Biopharma for the time devoted to such activities and reimburse it for expenses incurred. For Product Inventions assigned pursuant to this section, Client shall provide KBI Biopharma a royalty-free license to use such Product Inventions to the extent necessary to perform the Services.
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8.2 |
Process Technology and Process Inventions. Notwithstanding the foregoing, Client acknowledges that KBI Biopharma possesses and shall retain full ownership of information and technology relating to general manufacturing and analytical methods and processes, (“Process Technology”) and KBI Biopharma shall retain all rights to any data, ideas, know-how, information, developments, and inventions related to the Process Technology that are developed, conceived or reduced to practice in connection with the Services which can be generally applied to the production of biologics other than the Product and which do not use, reference, rely on or incorporate Client Materials (collectively, “Process Inventions”). |
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8.3 |
Process Technology and Process Inventions License. For Process Technology and Process Inventions, KBI Biopharma hereby grants to Client a perpetual, world-wide, royalty-free, non-exclusive license for Client to use such Process Technology and/or Process Inventions to manufacture or have manufactured the Product. If KBI Biopharma requests, and at KBI Biopharma’s expense, Client will execute any and all applications, assignments or other instruments and give testimony which shall be necessary to apply for and obtain letters of patent of the US or of any foreign country with respect to the Process Inventions and KBI Biopharma shall compensate Client for the time devoted to such activities and reimburse it for expenses incurred. |
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8.4 |
Client Materials. All Client Materials that KBI Biopharma may have access to in order to perform the Services shall be owned exclusively by the Client. Nothing in this Agreement shall be deemed to grant any rights to KBI Biopharma in any Client Materials, other than the right for KBI Biopharma to use such Client Materials to perform the Services. For the purposes hereof, “Client Materials” means all Client proprietary materials and information, intellectual property and developments, including without limitation, all patents, patent applications, know-how, inventions, designs, concepts, technical information, manuals, or instructions which, as of the Effective Date, are owned, licensed or controlled by Client relating to the development, formulation, manufacture, processing, packaging, analysis or testing of the Product. In the event that Client loses or forfeits its rights in such proprietary Client Materials during the Term of this Agreement for any reason, Client shall provide notice of same to KBI Biopharma immediately and this Agreement shall be subject to immediate termination by KBI Biopharma at that time, subject to Section 24.2. |
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9. |
Use of Intellectual Property Rights |
Except as expressly stated in this Agreement, no intellectual property rights of any kind or nature are conveyed by this Agreement and neither Party shall have any right, title or interest in or to the other Party’s intellectual property rights for any purpose whatsoever without such other Party’s prior written consent.
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10. |
Facility Visits and Audits |
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10.1 |
Scope of Visit. Client shall have the right, upon no less than thirty (30) days’ prior written notice to KBI Biopharma, to visit KBI Biopharma and during regular business hours to observe the progress of the Services (i.e., person in the plant) and to inspect related records and data for the purpose of making quality control inspections so as to assure compliance with this Agreement. Client shall also have the right to perform “for cause” audits to address cGMP quality issues upon no less than ten (10) days’ notice to KBI Biopharma. The form, participants, duration and procedures of all visits shall be subject to KBI Biopharma’s reasonable approval. |
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10.2 |
Client Obligations. It shall be the duty of Client to follow KBI Biopharma’s reasonable safety rules |
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employees, representatives, and guests of any of them shall: (a) be subject to the nondisclosure obligation described in Article 7, (b) follow such security and facility access procedures as are designated by KBI Biopharma, (c) be accompanied by a KBI Biopharma representative, (d) not enter areas of any KBI Biopharma facility at times when any third party’s products are being manufactured to assure protection of KBI Biopharma’s or third party’s confidential information, (e) stay within the areas of KBI Biopharma’s facilities designated for the visit and shall not visit areas of the facility other than those areas necessary for the performance of the facility visit provided for herein without KBI Biopharma’s prior written permission, and (f) use good faith efforts to avoid disrupting KBI Biopharma’s operations. All information learned, observed or obtained by Client during any visit to KBI Biopharma’s facilities shall be deemed “Confidential Information” of KBI Biopharma under Article 7, regardless of whether such information is marked “Confidential” or subsequently summarized in writing. Client warrants that it, and its subcontractors, employees, agents, representatives, and any personnel acting on behalf of Client hereunder who visit the KBI Biopharma facility: (i) are not debarred, under subsections 306(a) or (b) of the Generic Drug Enforcement Act of 1992, as each may be amended from time to time, and (ii) will at all times comply with all safety and security regulations in effect from time to time and communicated by KBI Biopharma, and (iii) will at all times comply with Article 7 with respect to the confidentiality and use of KBI Biopharma Confidential Information.
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10.3 |
Costs. With the exception of “for cause” audits which may be conducted as needed, Client may conduct one (1) such quality assurance facility visit per calendar year using no more than two (2) auditors for a maximum of two (2) days at no cost to Client. Additional audits will be invoiced separately on a time and materials basis at the then current rate for such services. |
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11. |
Regulatory Inspections |
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11.1 |
General. KBI Biopharma will promptly notify Client of any regulatory inspections directly relating to the Services (including related to the facilities utilized for the Services), in accordance with the terms of the Quality Agreement (if applicable). KBI Biopharma agrees to reasonably cooperate with all regulatory authorities and submit to reasonable inspections by such authorities. |
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11.2 |
Costs. Client shall be responsible for, and shall promptly pay, all documented costs charged by a regulatory authority for inspections directly related to the Services to be provided in the Proposal. KBI Biopharma’s costs in connection with regulatory inspections will be invoiced separately on a time and materials basis at the then current rate for such services. |
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12. |
Warranties |
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12.1 |
Warranties of KBI Biopharma. |
12.1.1.As of the Effective Date, KBI Biopharma represents and warrants to Client that it has all requisite corporate power and authority to enter into and perform all of its obligations under this Agreement. The execution and delivery of this Agreement and the consummation of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action in respect thereof on the part of KBI Biopharma. Neither the execution and delivery of this Agreement nor the performance of the transactions contemplated hereby, nor compliance by KBI Biopharma with the provisions hereof, shall conflict with any obligations or agreements of KBI Biopharma to any person, contractual or otherwise.
12.1.2.KBI Biopharma warrants to Client that it will render the Services with due care, consistent with industry standards for work of a similar nature, and that to KBI Biopharma’s knowledge, KBI Biopharma’s Process Technology and Process Inventions will not violate or infringe on the patent or intellectual property rights of any third party.
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12.1.3.KBI Biopharma represents to Client that it is not debarred, and warrants to Client that it will not knowingly use in any capacity the services of any person debarred, under subsections 306(a) or (b) of the Generic Drug Enforcement Act of 1992, as each may be amended from time to time.
12.1.4.EXCEPT AS EXPRESSLY WARRANTED IN THIS SECTION 12.1, KBI BIOPHARMA MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE SERVICES OR PRODUCT, EXPRESS OR IMPLIED, IN ANY MANNER AND EITHER IN FACT OR BY OPERATION OF LAW, AND SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF TRADE OR NONINFRINGEMENT. KBI BIOPHARMA MAKES NO WARRANTIES THAT THE EXECUTION OF THE SERVICES WILL RESULT IN ANY SPECIFIC QUANTITY OR AMOUNT OF PRODUCT.
12.1.5.KBI Biopharma has warranted, in Section 12.1.2, that the Services will be rendered with due care; however, no predetermined results are assured. Client understands and agrees that the Services are experimental in nature, that biopharmaceutical process development is subject to certain inherent risks, and as such, nothing in this Agreement shall be construed as a guarantee or warranty by KBI Biopharma that the Services, the Products, the Deliverables, or the materials, data, information of other results produced in connection therewith, will meet or otherwise satisfy any of the objectives, goals or targets stated in the Proposal. Client hereby acknowledges and agrees that there is absolutely no guarantee:
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(i) |
that the results of the Services will be successful in any way or will be commercially exploitable, profitable or approved by any regulatory authority; |
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(ii) |
that the Product, or any product, resulting from the Services will fulfill certain specifications or certain yields; or |
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(iii) |
the Products, the Services and/or the results of the Services will satisfy the requirements of any regulatory agencies at the time of submission of such results to such agencies. |
12.1.6.Client’s sole and exclusive remedy and KBI Biopharma’s sole and exclusive obligation under the warranties provided in this Agreement shall be the remedy provided in Section 3.4.
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12.2 |
Warranties of Client. |
12.2.1.As of the Effective Date, Client represents and warrants to KBI Biopharma that it has all requisite corporate power and authority to enter into and perform all of its obligations under this Agreement. The execution and delivery of this Agreement and the consummation of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action in respect thereof on the part of Client. Neither the execution and delivery of this Agreement nor the performance of the transactions contemplated hereby, nor compliance by Client with the provisions hereof, shall conflict with any obligations or agreements of Client to any person, contractual or otherwise.
12.2.2.Client represents and warrants to KBI Biopharma that it holds legal title to, or is fully entitled to provide, the materials, methods, plans, processes and other intellectual property necessary to conduct the Services.
12.2.3.Client represents and warrants to KBI Biopharma that all materials provided by Client for use in the performance of the Services shall be free of defects and contaminants and shall be fit for use in the performance of the Services.
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12.2.4.Client represents and warrants to KBI Biopharma that it will hold, use and/or dispose of Product and all materials provided by KBI Biopharma in accordance with all applicable laws, rules and regulations.
12.2.5.Client represents and warrants to KBI Biopharma that no specific safe handling instructions are applicable to any substance or material provided by Client to KBI Biopharma, except as disclosed to KBI Biopharma in writing in sufficient time for review and training by KBI Biopharma prior to delivery of any such substance or material to KBI Biopharma.
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13. |
Indemnification |
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13.1 |
Indemnification by KBI Biopharma. Subject to Section 13.2 below, KBI Biopharma will indemnify, defend and hold harmless Client and its shareholders, directors, officers, employees and agents (each, a “Client Indemnitee”) from and against all costs, losses, expenses (including reasonable attorneys’ fees) and direct damages (collectively, “Losses”) resulting from all lawsuits, claims, demands, actions and other proceedings by or on behalf of any third party (collectively “Claims”) to the extent arising out of or resulting from: (i) KBI Biopharma’s material breach of any covenant, warranty, or a failure of any material representation made hereunder by KBI Biopharma; (ii) KBI Biopharma’s gross negligence or intentional misconduct, or (iii) the infringement or alleged infringement as a result of or arising from the Process Technology or Process Inventions, as used in the Services; except in each case to the extent such Claims or Losses arise from negligence or intentional misconduct on the part of a Client Indemnitee or a breach of this Agreement by Client. |
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13.2 |
Indemnification by Client. Client will indemnify, defend and hold harmless KBI Biopharma and its shareholders, directors, officers, employees and agents (each, a “KBI Biopharma Indemnitee”) from and against all Losses resulting from all Claims to the extent arising out of or resulting from: (i) Client’s material breach of any covenant, warranty, or a failure of any material representation made hereunder by Client; (ii) Client’s development (including the conduct of clinical trials in humans), handling, manufacturing, testing, storage, transportation, disposal, marketing, commercialization (including any recalls, field corrections or market withdrawals), distribution, promotion, sale or use of the Product or Deliverables (including without limitation as a result of any illness, injury or death to persons, including employees, agents or contractors of Client or damage to property); (iii) Client’s gross negligence or intentional misconduct; (iv) the infringement or alleged infringement as a result of, or arising from, the Services as requested by Client the Client Materials or the Product on the intellectual property rights of a third party, except in each case to the extent such Claims or Losses arise from negligence or intentional misconduct on the part of a KBI Biopharma Indemnitee or a breach of this Agreement by KBI Biopharma. |
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13.3 |
Indemnification Procedure. If any Claim covered by Article 13 is brought: |
13.3.1.the indemnified Party shall promptly notify the indemnifying Party in writing of such Claim, provided, however, the failure to provide such notice within a reasonable period of time shall not relieve the indemnifying Party of any of its obligations hereunder except to the extent the indemnifying Party is prejudiced by such failure or delay;
13.3.2.the indemnifying Party shall assume, at its cost and expense, the sole defense of such Claim through counsel selected by the indemnifying Party and reasonably acceptable to the other Party, except that those indemnified may at their option and expense select and be represented by separate counsel;
13.3.3.the indemnifying Party shall maintain control of such defense and/or the settlement of such
Claim;
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13.3.4.the indemnified Party may, at its option and expense, participate in such defense, and if it so participates, the indemnifying Party and the indemnified Party shall cooperate with one another in such defense;
13.3.5.the indemnifying Party will have authority to consent to the entry of any settlement or otherwise to dispose of such Claim (provided and only to the extent that an indemnified Party does not have to admit liability and such judgment does not involve equitable relief), and an indemnified Party may not consent to the entry of any judgment, enter into any settlement or otherwise to dispose of such Claim without the prior written consent of the indemnifying Party (not to be unreasonably withheld or delayed); and
13.3.6.the indemnifying Party shall pay the full amount of any judgment, award or settlement with respect to such Claim and all other costs, fees and expenses related to the resolution thereof; provided, however, that such other costs, fees and expenses have been incurred or agreed, as the case may be, by the indemnifying Party in its defense or settlement of the Claim.
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14. |
Limitations of Liability |
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14.1 |
Notwithstanding anything herein to the contrary, KBI Biopharma’s total liability for any loss, including without limitation Losses indemnifiable pursuant to Article 13, suffered by Client resulting from this Agreement, work conducted pursuant to any Proposal or any other liability of any nature, shall be limited to the payment of damages which shall not exceed [***]. |
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14.2 |
EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL, INDIRECT, PUNITIVE, CONSEQUENTIAL (INCLUDING WITHOUT LIMITATION, LOST PROFITS), EXEMPLARY OR SPECIAL DAMAGES OF ANY TYPE, ARISING IN CONNECTION WITH THIS AGREEMENT, ANY PROPOSAL, QUALITY AGREEMENT OR ATTACHMENTS OR DOCUMENTS RELATED THERETO, WHETHER OR NOT FORESEEABLE AND WHETHER SUCH DAMAGES ARISE IN TORT, CONTRACT, EQUITY, STRICT LIABILITY, OR OTHERWISE, EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. |
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15. |
Force Majeure |
Except for each Party’s payment, confidentiality and indemnity obligations, the obligations of either Party under this Agreement shall be excused during each period of delay caused by matters such as acts of God, strikes, supplier delays, shortages of raw materials, power failure, government orders, sufferance of or voluntary compliance with acts of government or governmental regulation (not in existence on the Effective Date, and including without limitation, acts of the FDA or an applicable foreign equivalent), or acts of war or terrorism, which are reasonably beyond the control of the Party obligated to perform (each, a “Force Majeure Event”). A Force Majeure Event shall not include a lack of funds, bankruptcy or other financial cause or disadvantage. Nothing contained in this Agreement shall affect either Party’s ability or discretion regarding any strike or other employee dispute or disturbance and all such strikes, disputes or disturbances shall be deemed to be beyond the control of such Party. A Force Majeure Event shall be deemed to continue only so long as the affected Party shall be using its commercially reasonable effort to overcome such condition. If either Party shall be affected by a Force Majeure Event, such Party shall give the other Party prompt notice thereof, which notice shall contain the affected Party’s estimate of the duration of such condition and a description of the steps being taken or proposed to be taken to overcome such Force Majeure Event. Any delay, or invalidity in the results delivered, in the performance of the Services occasioned by any such cause shall not constitute a default under this Agreement, and the obligations of the Parties shall be suspended during the period of delay so occasioned. During any period of any Force Majeure Event, the Party that is not directly affected by such Force Majeure Event may take any reasonable action necessary to mitigate the effects of such Force Majeure Event. If any part of the Services is invalid as a result of such disability, KBI Biopharma will, upon written request from Client, but at Client’s sole cost and expense, repeat that part of the Services affected by the Force Majeure Event.
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16. |
Insurance |
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16.1 |
KBI Biopharma Insurance. KBI Biopharma shall secure and maintain in full force and effect throughout the Term policies of insurance for (a) workers’ compensation in accordance with applicable statutory requirements, employer’s liability in an amount not less than $1,000,000, and automobile liability in an amount not less than $1,000,000, (b) commercial general liability in an amount not less than $2,000,000 per occurrence and $2,000,000 in the aggregate, and (c) products liability in an amount not less than $2,000,000 per occurrence and $2,000,000 in the aggregate. |
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16.2 |
Client Insurance. Client shall secure and maintain in full force and effect throughout the Term, and for a period of three (3) years after completion of any clinical trials in which any Product provided under this Agreement is used, policies of insurance for (a) workers’ compensation in accordance with applicable statutory requirements, employer’s liability in an amount not less than [***], and automobile liability in an amount not less than [***], (b) primary and noncontributory commercial general liability in an amount not less than [***] per occurrence and [***] in the aggregate, (c) primary and noncontributory products/completed operations liability in an amount not less than [***] per occurrence and [***] in the aggregate, and (d) primary and noncontributory umbrella liability in an amount not less than [***] per occurrence and [***] in the aggregate provided that Chondrial shall not be required to procure the coverage described in clauses (b), (c) and (d) above until commencement of the first clinical trial using the Product in humans. |
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17. |
Independent Contractor; Non-Solicitation |
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17.1 |
Independent Contractor. KBI Biopharma shall perform the Services as an independent contractor of the Client. The relationship between the Parties shall not constitute a partnership, joint venture or agency nor constitute either Party as the agent, employee or legal representative of the other. The Parties agree that neither shall have power or right to bind or obligate the other, nor shall either hold itself out as having such authority. |
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17.2 |
Non-Solicitation. During the Term of this Agreement and for [***] thereafter, each Party agrees not to directly or indirectly solicit to hire or hire (in any capacity) any person who is an employee, contractor, consultant or representative of the other Party; provided that newspaper, internet or other advertisements to fill job openings shall not be deemed to be “solicitation” hereunder. Any exceptions to this provision must be in writing and signed by each Party and, for each person that is hired in such manner, the hiring Party shall compensate the other Party at the rate of [***] of such person’s annualized base salary. |
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18. |
Publicity |
Either Party may only issue press releases or public disclosures describing the Services provided hereunder with the prior written consent of the other Party. The use of the name, trademark, logo, or other identifying materials of either Party or its employees in any publicity, advertising or promotional material shall require the other Party’s express prior written consent.
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19. |
Shipment |
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19.1 |
General. Unless otherwise agreed in writing by the Parties, all Deliverables, products, raw |
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such product, raw materials, samples, components or other materials at Client’s expense (including insurance) and in accordance with Client’s reasonable written instructions.
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19.2 |
Shipping Charges. Client shall pay to KBI Biopharma, in addition to actual shipping costs, a handling fee of [***] for each standard shipment of any Deliverables, products, raw materials, samples, components or other materials provided hereunder. |
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20. |
Notices |
Any notice required to be given pursuant to the terms and provisions hereof shall be in writing and shall be sent by certified or registered mail, postage prepaid with return receipt requested, or by nationally recognized overnight courier, postage prepaid with return receipt requested, or by confirmed facsimile (with printed confirmation of receipt), to the other Party at the following address:
If to Client:
Chondrial Therapeutics, Inc.
000 Xxxxxxxx Xxxx Xxxxx 000
Xxxx Xxxxxx, XX 00000
Attention: Vice President Regulatory Affairs and Counsel
With a copy to the Chief Executive Officer, at the same address.
If to KBI Biopharma:
KBI Biopharma, Inc.
0000 Xxxxxx Xxxx
Xxxxxx, Xxxxx Xxxxxxxx 00000
Attention: Vice President Finance
with a copy to the Vice President and General Counsel, at the same address.
Each notice shall be deemed sufficiently given, served, sent, or received for all purposes at such time as it is delivered to the addressee or at such time as delivery is refused by the addressee upon presentation.
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21. |
Choice of Law |
This Agreement shall be construed and enforced in accordance with the laws of and in the venue of the State of Delaware, without regard to its, or any other jurisdiction’s, rules regarding conflicts or choice of laws. The Parties waive application of the provisions of the 1980 U.N. Convention on Contracts for the International Sale of Goods, as amended.
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22. |
Dispute Resolution |
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22.1 |
Initial Attempts to Resolve Disputes. If a dispute arises between the Parties in connection with this Agreement, the respective presidents or senior executives of KBI Biopharma and Client shall first meet as promptly as practicable and attempt to resolve in good faith such dispute. If such parties cannot resolve the dispute within thirty (30) days after written notice given by one Party to the other specifically invoking this stage in the dispute resolution procedure, either Party may by written notice to the other commence the arbitration process set forth in Section 22.2 below. |
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22.2 |
Arbitration. If a dispute has not been resolved by negotiation as provided in Section 22.1 above, |
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designated by the two so designated. The arbitration, it shall be conducted in English and held in Delaware. The arbitrators will render their award in writing and, unless all Parties agree otherwise, will include an explanation in reasonable detail of the reasons for their award. Judgment upon the award rendered by the arbitrators may be entered in any court having jurisdiction thereof. The Parties expressly waive any putative right they may otherwise have to seek an award arising out of any dispute hereunder of punitive damages or any other damages limited or excluded by this Agreement. The arbitrator will have the authority to grant injunctive relief and other specific performance. The arbitrator will, in rendering its decision, apply the substantive law of the State of Delaware, without regard to its conflict of laws’ provisions. The decision and/or award rendered by the arbitrator will be final and non-appealable (except for an alleged act of corruption or fraud on the part of the arbitrator).
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22.3 |
Expenses. All expenses and fees of the arbitrators and expenses for hearing facilities and other expenses of the arbitration will be borne equally by the Parties unless the Parties agree otherwise or unless the arbitrators in the award assess such expenses against one of the Parties or allocate such expenses other than equally between the Parties. Each of the Parties will bear its own counsel fees and the expenses of its witnesses except (i) to the extent otherwise provided in this Agreement or by applicable law or (ii) to the extent the arbitrators in their discretion determine for any reason to allocate such fees and expenses among the Parties in a different manner. Any attorney or retired judge who serves as an arbitrator will be compensated at a rate equal to his or her current regular hourly billing rate unless otherwise mutually agreed upon by the Parties and the arbitrator. |
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22.4 |
Interlocutory Relief. Compliance with this Article 22 is a condition precedent to seeking relief in any court or tribunal in respect of a dispute, but nothing in this Article 22 will prevent a Party from seeking interlocutory relief in the courts of appropriate jurisdiction provided in Article 21, pending the arbitrator’s determination of the merits of the controversy, if applicable to protect the Confidential Information, property or other rights of that Party. For such disputes, the Parties agree to and submit to the sole and exclusive jurisdiction of the Delaware courts, both state and federal. |
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23. |
Assignment and Delegation |
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23.1 |
Assignment. This Agreement between the Parties shall not be assigned in whole or in part by either Party without the prior written consent of the other, which consent shall not be unreasonably withheld or delayed; provided, however, either Party may assign this Agreement in its entirety without the other Party’s consent, upon written notice to the other Party, as part of: (a) the sale of all or substantially all of the assets or the entire business to which this Agreement relates, (b) the license by Client to a third party of rights to any Product, or (c) a merger, consolidation, reorganization or other combination with or into another person or entity, in each case, pursuant to which the surviving entity or assignee assumes in writing the assigning or merging Party’s obligations hereunder. Any attempt to assign, or purported assignment of, this Agreement in contravention to this Section 23.1 shall be void ab initio and of no effect. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. |
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23.2 |
Delegation. Neither Party may delegate any performance under this Agreement; however, performance of the Services hereunder may be delegated or subcontracted by KBI Biopharma with the written consent of Client, which consent shall not be unreasonably withheld. |
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24. |
Term and Termination |
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24.1 |
Term. The term of this Agreement (the “Term”) shall be from the Effective Date until the fifth |
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written agreement of the Parties. KBI Biopharma and Client each agree that, if Client’s efforts to develop a Product are successful, they will use commercially reasonable and good faith efforts to negotiate an extension of the Term to include commercial scale Product manufacturing in the Services to be provided by KBI Biopharma.
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24.2 |
Termination without Breach. Client may terminate this Agreement or a Proposal prior to completion of the Proposal by providing thirty (30) days written notice to KBI Biopharma, subject to the conditions of this Section 24.2. Upon receipt of such notice of termination, KBI Biopharma will promptly scale down the affected portion of the Proposal and use reasonable commercial efforts to avoid (or minimize, where non-cancellable) additional expenses. It is understood between the Parties that KBI Biopharma will incur substantial costs for reservations of resources and planning in order to undertake the provision of Services. Therefore, in the event that this Agreement or a Proposal is terminated for any reason other than (i) by Client for KBI Biopharma’s material breach in accordance with Section 24.3 or (ii) by Client in accordance with Section 24.4, Client shall pay KBI Biopharma upon receipt of invoice all of its costs for Services performed and expenses incurred or irrevocably obligated related to the Proposal and any amounts due per section 6.3. |
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24.3 |
Termination for Breach. In the event of a material breach of this Agreement by a Party that is not cured within thirty (30) days of written notice of such breach by the non-breaching Party, the non-breaching Party may terminate this Agreement or a Proposal immediately upon written notice. Upon such termination, KBI Biopharma will promptly scale down the affected portion of the Proposal and use its reasonable commercial efforts to avoid (or minimize, where non-cancellable) additional expenses. It is understood between the Parties that KBI Biopharma will incur substantial costs for reservations of resources and planning in order to undertake the provision of Services. Therefore, in the event of termination under this Section 24.3 by KBI Biopharma, Client shall pay KBI Biopharma upon receipt of invoice all of its costs incurred or irrevocably obligated related to the Proposal and any amounts due per section 6.3. In the event of termination under this Section 24.3 by Client (i) Excluding the first initial fee payable under each proposal, KBI Biopharma shall, notwithstanding any provisions of this Agreement concerning payments being non-refundable, refund to Client any portion of amounts paid by Client to KBI Biopharma that have not been and cannot be applied to the price of Services properly performed, (ii) if requested by Client, KBI Biopharma shall continue to provide Services under the terms of this Agreement and any related Proposal and Quality Agreement (all of which shall continue in force while such Services are being performed by KBI Biopharma) until such time as the Client has an agreement in place with a replacement provider of Services and such provider is ready to provide Services, and (iii) KBI Biopharma agrees to provide knowledge transfer services and otherwise provide support for the transition of Services to such replacement provider, such transition services to be provided at KBI Biopharma’s sole cost and expense. |
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24.4 |
Bankruptcy. This Agreement may be terminated upon written notice by a Party in the event: (i) the other Party voluntarily enters into bankruptcy proceedings; (ii) the other Party makes an assignment for the benefit of creditors; (iii) a petition is filed against the other Party under a bankruptcy law, a corporate reorganization law, or any other law for relief of debtors or similar law analogous in purpose or effect, which petition is not stayed or dismissed within sixty (60) days of filing thereof; or (iv) the other Party enters into liquidation or dissolution proceedings or a receiver is appointed with respect to any assets of the other Party, which appointment is not vacated within one hundred and twenty (120) days. |
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24.5 |
Effects of Termination. Upon termination of this Agreement for any reason, each Party shall, as |
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property rights or Confidential Information of the other Party, except as may be specifically provided in this Agreement.
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25. |
Survival |
Articles 4, 7, 8, 9, 13, 14, 18, 20, 21, 22, 25, 26, and Sections 6.4, 12.2.4, 16.2, 24.2, 24.3 and 24.5 hereof shall survive termination or expiration of this Agreement. Expiration or termination shall not extinguish the rights and remedies of either Party with respect to any antecedent breach of any of the provisions of this Agreement or payments due or earned under this Agreement.
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26. |
Severability |
In the event that any one or more of the provisions of this Agreement should be held for any reason by any court or authority having final jurisdiction over this Agreement, or over any of the Parties to this Agreement, to be invalid, illegal, or unenforceable, such provision or provisions shall be reformed to approximate as nearly as possible the intent of the Parties, and if not reformable, shall be divisible and deleted in such jurisdictions; elsewhere, this Agreement shall not be affected.
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27. |
Waiver and Remedies |
The delay or waiver (or single or partial exercise) by either Party hereto of any right, power, or privilege hereunder, or of any failure of the other Party to perform, or of any breach by the other Party, shall not be deemed a waiver of any other right, power, or privilege hereunder or of any other breach by or failure of such other Party, whether of a similar nature or otherwise. Any such waiver must be made in writing. Except as may otherwise be specifically set forth in this Agreement, 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 or equity. No Party shall have any right of set off with respect to amounts it has an obligation to pay hereunder. No provision of this Agreement shall in any way inure to the benefit of any third person so as to constitute to any such person a third-party beneficiary of this Agreement or otherwise give rise to any cause of action in any person not a Party hereto.
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28. |
Entire Agreement, Amendment, Construction, Precedence |
This Agreement, the Proposal(s), and any applicable Quality Agreement constitute the entire agreement between the Parties and supersede all prior and contemporaneous negotiations, representations, commitments, agreements and understandings between the Parties (whether written or oral) relating to the subject matter hereof. This Agreement may not be amended or modified without the mutual written consent of both Parties. In the event of any conflict among the components of this Agreement, the following order of precedence shall apply: (i) the terms and conditions of the Agreement, (ii) the Quality Agreement (if existing), and (iii) the Proposal. If Client chooses to issue a purchase order for the delivery of the Services or any component thereof, such purchase order should reference this Agreement and shall be issued solely for the convenience of Client and to provide subject matter description; however, any legal terms and conditions contained or referenced therein shall be of no effect.
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29. |
Counterparts |
This Agreement, the Quality Agreement(s), the Proposal(s) and any other attachment may be executed in counterparts, each of which will be deemed an original but all of which together will constitute a single instrument. A facsimile or electronic transmission of the above referenced documents, or a counterpart, shall be legal and binding on the Parties.
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[Signature Page Follows.]
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The Parties by their authorized representatives execute this Agreement as of the Effective Date.
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KBI BIOPHARMA, INC. |
CLIENT |
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By:/s/ Xxx Xxxxx |
By:/s/ Xxxxxx X. Xxx-Xxxxxx |
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Name: Xxx Xxxxx |
Name: Xxxxxx X. Xxx-Xxxxxx |
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Title: President & CEO |
Title: President, CEO |
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Date: 20Sep2017 |
Date:9/26/17 |
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Chondrial Legal Approved /s/ Xxxxxxxx X. Xxxxxxxxx |
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Attachment One: Proposal
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Attachment Two: Quality Agreement
