Terms of Sale for GMP, INDe, and iPSC RNA Products

1.1. These are the terms and conditions (“Terms”) which govern the sale of GMP, INDe, and iPSC RNA products (collectively, the “Products”), and/or services to produce Products, including without limitation drug product analytical or GMP manufacturing services (collectively, the “Services”) by Synthego Holdings LLC (“Synthego”) to the person or entity purchasing such Products or Services from Synthego pursuant to an order accepted by Synthego (“Customer”, and together with Synthego, the “Parties” and each, a “Party”). Customer will be deemed to have accepted these Terms by placing an order for Products and/or Services with Synthego.

1.2. These Terms (including all documents incorporated herein by reference), the Proposal or Quotation (as defined below) issued to Customer from Synthego, any Product Specifications (as defined below) included in or attached to such Proposal or Quotation, and those specific terms of a purchase order or other document that are expressly agreed upon by Synthego in writing, constitute the entire contract between the Parties relating to the subject matter hereof (the “Contract”), and supersede all prior agreements and understandings between the Parties, whether written or oral. Any additional or different terms and conditions, including without limitation any terms and conditions in Customer’s purchase order or any other document not agreed upon by Synthego in writing, are hereby expressly rejected by Synthego and will not apply. In the event of a conflict, any Quotation issued to Customer from Synthego takes precedence over these terms, and a separate written agreement covering the same subject matter signed by both Parties takes precedence over both. If one or more of these Terms is held invalid, illegal, or unenforceable by a court of competent jurisdiction, the remaining Terms will be unimpaired.

2.1. For all Products or Services requested by Customer and that Synthego wishes to offer to manufacture or perform for Customer, Synthego will provide a proposal (“Proposal”) or quotation (“Quotation”) describing the specific Products or Services to be ordered, Product quantities, optional testing, cost, and other deliverables, such as quality documentation. The Quotation will also set forth certain specifications that the Products will be required to meet (“Product Specifications”). All Quotations will be made in U.S. Dollars. Synthego’s Quotations do not include any taxes (including VAT), duties, levies or other government fees (“Taxes”) that may apply to an order. If such Taxes apply, it will be Customer’s responsibility to pay them. If Synthego pays them, Synthego will add them to Customer’s invoice.

2.2. Customer will provide acceptance of a Quotation by issuing a purchase order (a “Purchase Order”) to Synthego, referencing the Quotation number and version. Purchase Orders must be accepted by Synthego in writing to be binding on the Parties and will be binding upon such acceptance. Any terms or conditions contained in a Purchase Order are expressly rejected by Synthego and will not be binding on the Parties.

2.3. Upon acceptance of a Purchase Order, Synthego will reserve a manufacturing slot for Customer and will invoice Customer for 50% of the total cost of Customer’s order (the “Reservation Fee”). Customer’s Reservation Fee is non-refundable, subject to Section 12.2. In order to retain the manufacturing slot, Customer must pay Synthego the Reservation Fee within ten (10) days of the invoice date. If Synthego receives the Reservation Fee later than this date, it shall have the right to move Customer’s order to a later manufacturing slot. Upon receipt of the Reservation Fee, Synthego will confirm Customer’s manufacturing start date (“Start Date”) and will provide its estimated delivery timeline. Prior to receipt of the Reservation Fee, Synthego reserves the right to cancel Customer’s order.

2.4. Shipment of Product. Synthego’s Quotations include shipping and handling costs, except where Synthego agrees to use Customer’s account, in which case Customer shall engage and pay the commercial transportation carrier (“Carrier”) directly, subject to coordination with Synthego’s shipping department and Synthego’s approval of the Carrier and shipping method. Synthego reserves the right to select the packaging and shipping method to ensure the integrity of the Products. Synthego will not be held liable for delays in shipping or customs clearance. Separate line items may include charges for insulated boxes, special hazardous fees and/or handling fees which will be charged when required for shipment. All Products are sold FCA Synthego’s facility (Incoterms® 2020). The Products are delivered when Synthego loads them onto the Carrier at Synthego’s facility. At this point, Customer becomes responsible for risk of loss and damage. If any Products are lost or damaged during transportation, Synthego will try to help Customer address the problem with the Carrier. Title to Products will pass to Customer when Customer or the Carrier takes delivery of the Products at Synthego’s facility. Synthego reserves the right to make delivery in installments, which will be separately invoiced. Upon Customer request, Synthego will store a batch of Product for one (1) week following batch release without additional charge. For requests to store a batch of Product for any additional time, Synthego will charge a monthly storage fee at its standard rates.

2.5. Delivery of Product-Related Documentation. When a batch of Product is ready for release to Customer, Synthego will (a) send by e-mail to Customer batch-related documentation and (b) ship the batch of Product to Customer in accordance with Section 2.4. Customer must confirm the shipping address for the relevant batch of Product within seven (7) business days of Customer’s receipt of such email. In the event that Customer fails to confirm such shipping address within seven (7) business days, ownership of such batch of Product will transfer to Customer and Customer will be responsible for storage costs at Synthego’s then-current monthly rate. Risk of loss for the stored batch of Product is the responsibility of Customer and Synthego’s sole liability for such batch shall be for losses due to Synthego’s gross negligence. In the event Customer requests early shipment of a batch of Product prior to completion batch-related documentation, Synthego will invoice Customer for the full amount upon shipment.

3.1. At any time prior to the date sixty (60) days before Customer’s Start Date, Customer may, by providing written notice to Synthego, elect to move Customer’s manufacturing slot to another available slot (provided such new manufacturing slot is no more than twelve (12) months later than the originally scheduled Start Date) for an additional change fee equal to ten percent (10%) of the total cost of the portion of Customer’s order that is affected by such change, excluding any prior change fee incurred. Such change will be effective upon Synthego’s receipt of Customer’s change fee, and Synthego will confirm Customer’s new Start Date for the order or such portion of the order, as applicable.

3.2. Any changes that Customer may propose to the Product Specifications, Product quantities, Carrier and method of shipment, the Start Date, or place of delivery of Products must be provided to Synthego in writing and must be accepted by Synthego in writing, at Synthego’s sole discretion. Synthego reserves the right to decline requests to change Product Specifications, and Product quantities that are submitted within sixty (60) days of the current, confirmed Start Date. Furthermore, if Customer fails to notify Synthego of its desire to move Customer’s manufacturing slot to another available slot at least sixty (60) days prior to the scheduled Start Date, Synthego reserves the right to treat such failure to notify Synthego as a cancellation of such order. Additionally, if Customer notifies Synthego that it wants to move its manufacturing slot to another available slot that is more than twelve (12) months after the originally scheduled Start Date, Customer will be deemed to have canceled the applicable order.

Invoices for all amounts due, other than the Reservation Fee, shall be paid within thirty (30) days from the date the invoice is received unless provided otherwise in an applicable Quotation. Synthego will invoice Customer for the Reservation Fee upfront as set forth in Section 2.3 and for the remaining fees as set forth in the Proposal or Quotation. All payments shall be made in U.S. Dollars. If Synthego does not receive Customer’s payment within thirty (30) days from the invoice date, without affecting Synthego’s other rights, Synthego has the right to suspend delivery or reject Customer’s future orders, and charge Customer a late-payment charge, from the due date until paid, at the rate of 1% per month (12% per year) or, if less, the maximum amount allowed by law.

5.1. Immediately upon Customer’s receipt of any Products shipped hereunder, Customer should review the Certificate of Analysis and inspect the Products for damage and for compliance with the Product Specifications. Upon approval from Technical Support, Customer can return Products that are damaged or that fail to meet the Product Specifications, or request that Synthego correct any Product shortages by contacting Technical Support within ten (10) business days from the day Customer receives the Products. When Customer contacts Customer Service within this timeframe, Synthego will give Customer instructions on returning the Products, a returned material authorization number (RMA #), and provide an estimated timeline to deliver replacement Products; however, Customer must return any such Products not later than twenty (20) business days after Customer first received them. If Customer does not contact Synthego within the initial ten (10) business-day period, the Products will be deemed accepted and conforming to the Product Specifications.

5.2. For any properly returned Products that fail to meet the Product Specifications, Synthego will, at Synthego’s discretion, either replace the Products free of charge, issue a Product credit, or issue a refund for the Product value and shipping charges. No Product credit will be available for use if a past due balance is outstanding on the account. Any Product credit not used within six (6) months of the date of issue will expire. For any verified Product shortage, Synthego will, at Synthego’s discretion, either use commercially reasonable efforts to manufacture and deliver such amount of Product necessary to correct the shortage, or issue a Product credit or refund corresponding to the amount of the shortage.

6.1. Performance of Services. Synthego warrants to the Customer that the Services will be performed in a good and workmanlike manner in accordance with its standard operating procedures and according to this Contract.

6.2. Specifications. Synthego warrants to Customer that the Products shall, upon delivery to the Carrier, meet the requirements for such Products set forth in the Product Specifications for a period of one (1) year from the date of Customer’s receipt of such Products. In the case of GMP Products, Synthego warrants to Customer that such Products have been manufactured in compliance with current Good Manufacturing Practices, to the extent set forth in the International Conference on Harmonisation (ICH) Quality Guidelines for Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (Q7), Quality Risk Management (Q9), and Pharmaceutical Quality System (Q10), and in 21 CFR Part 11 (Electronic Records; Electronic Signatures). This warranty does not apply to any Product that is subsequently altered by Customer or the Carrier. Additionally, Synthego’s warranty will not be effective if Synthego determines that the Products have not been properly used or stored by Customer.

6.3. THE WARRANTIES SET FORTH IN SECTIONS 6.1 AND 6.2 ARE EXCLUSIVE, AND SYNTHEGO MAKES NO OTHER REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OF NON-INFRINGEMENT OF THIRD-PARTY INTELLECTUAL PROPERTY RIGHTS, OR REGARDING RESULTS OBTAINED THROUGH THE USE OF THE PRODUCT(S), WHETHER ARISING FROM A STATUTE OR OTHERWISE IN LAW OR FROM A COURSE OF PERFORMANCE, DEALING OR USAGE OF TRADE, ALL OF WHICH ARE EXPRESSLY DISCLAIMED.

6.4. CUSTOMER ACKNOWLEDGES AND AGREES THAT SYNTHEGO’S MANUFACTURING PROCESS AND FACILITIES HAVE NOT BEEN EVALUATED, REVIEWED, OR AUDITED BY ANY REGULATORY AUTHORITY FOR COMPLIANCE WITH CURRENT GOOD MANUFACTURING PRACTICES. IN THE CASE OF INDe PRODUCTS AND iPSC PRODUCTS, CUSTOMER ACKNOWLEDGES AND AGREES THAT THE MANUFACTURING OF SUCH PRODUCTS DOES NOT COMPLY WITH CURRENT GOOD MANUFACTURING PRACTICES. CUSTOMER IS SOLELY RESPONSIBLE FOR ENSURING THAT THE QUALITY STANDARD OF THE PRODUCTS IS SUFFICIENT FOR CUSTOMER’S INTENDED USE. ADDITIONALLY, CUSTOMER ACKNOWLEDGES AND AGREES THAT THE PRODUCTS ARE FOR CUSTOMER’S RESEARCH AND DEVELOPMENT PURPOSES ONLY AND NOT FOR THERAPEUTIC OR DIAGNOSTIC USE.

6.5. Synthego’s warranty in Section 6.2 will not be effective if Synthego determines that Customer, the Carrier, or any party handling the Products on Customer’s behalf have altered or misused the Products, have failed to store them in accordance with Synthego’s instructions, or if the defects to the Products result from negligence or intentional misuse by Customer, the Carrier, or any party handling the Products on Customer’s behalf. Synthego’s sole and exclusive liability, and Customer’s exclusive remedy with respect to Products that fail to meet the warranties set forth in Section 6.2, as proved to Synthego’s satisfaction (applying analytical methods reasonably selected by Synthego) to be defective or nonconforming, will be the replacement of the Products free of charge upon Customer’s return of the Products in accordance with Synthego’s instructions, although at Synthego’s discretion Synthego may provide a Product credit or refund in accordance with Article 5 (Inspection and Returns) above.

6.6. Customer Assistance. All (i) customer service assistance in correcting Product shortages, with respect to Products that do not meet Product Specifications, or in processing Product returns; (ii) technical assistance up to five (5) hours of FTE time; and (iii) information generated through Customer’s use of any tools, features or functionality Synthego makes available to Customer through Synthego’s websites, will be provided without additional charge. Synthego reserves the right to refuse to offer or to charge an hourly rate for any additional technical assistance that Customer requires. Synthego makes no warranties of any kind, express or implied, with respect to technical assistance or information provided by Synthego or on Synthego’s behalf, and Customer assumes sole responsibility and liability for results obtained in reliance thereon. Any suggestions by Synthego regarding use, selection, application or suitability of the Products shall not be deemed to be, or construed as, an implied or express warranty.

7.1. Confidential Information. Pursuant to the Contract, either Party (“Disclosing Party”) may disclose its Confidential Information to the other Party (“Receiving Party”). “Confidential Information” means: (i) any information disclosed (directly or indirectly) by Disclosing Party to Receiving Party pursuant to the Contract (including, without limitation, research, product plans, products, prices, services, customers, markets, software, inventions, processes, designs, drawings, formulations, specifications, product configuration information, marketing and finance documents, prototypes, samples, data sets, and equipment) that is (i) disclosed in written, graphic, machine readable or other tangible form and is marked “Confidential,” “Proprietary” or in some other manner to indicate its confidential nature; (ii) disclosed orally and is designated as confidential at the time of its initial disclosure and reduced to a written summary by Disclosing Party that is marked in a manner to indicate its confidential nature and delivered to Receiving Party within thirty (30) days after its initial disclosure; or (iii) information (whether disclosed orally or in writing) that should otherwise reasonably understood by the Receiving Party to be confidential to the Disclosing Party under the circumstances of disclosure under the Contract or by the nature of the information itself. Confidential Information may include information of a third party that is in the possession of Disclosing Party and is disclosed to Receiving Party under the Contract. Without limiting the foregoing, Synthego will treat Customer’s interest in a given Product as Customer Confidential Information and will not disclose the same to third parties, subject only to the exceptions set forth in Section 7.2. Notwithstanding the foregoing, Synthego reserves the right to make and sell the same or similar products to other customers.

7.2. Use and Disclosure. During the term of the Contract and for five (5) years after the termination or expiration of the Contract, the Receiving Party will (a) not use Confidentiality Information of the Disclosing Party except in performing Receiving Party’s obligations or exercising its rights under the Contract, and will limit disclosure of any Confidential Information of the Disclosing Party to its employees, subcontractors or agents (its “Representatives”) who have a need to know such Confidential Information in connection with the business relationship between the Parties to which the Contract relates, and only for that purpose and who are subject to binding confidentiality obligations substantially as protective of the Confidential Information as the terms and conditions hereof; (b) protect the Confidential Information of the Disclosing Party from unauthorized use, access, or disclosure in the same manner as the Receiving Party protects its own confidential information, and with no less than reasonable care using reasonable precautions to prevent its disclosure to and/or use by any unauthorized third party; and (c) not disclose any Confidential Information of the Disclosing Party to any third parties (except as otherwise provided for herein). Notwithstanding the foregoing, a Receiving Party (i) may disclose the existence of the Contract or the fact that there have been discussions between the parties hereto of a possible business relationship to a potential financing source or acquirer of such Receiving Party who is legally bound to confidentiality restrictions with respect to such information no less stringent than those set forth in the Contract in connection with confidential discussions with and due diligence review by such financing source or acquirer and (ii) may disclose Confidential Information to its Representatives who are attorneys, accountants, auditors or other professional advisors, for use by such Representatives in providing professional advice to the Receiving Party with respect to the Confidential Information. The Receiving Party shall be responsible for any breach of the Contract by any of their respective Representatives.

7.3. Exclusions. Confidential Information shall not, however, include any information Receiving Party can show with competent evidence: (i) was publicly known or made generally available prior to the time of disclosure by Disclosing Party to Receiving Party; (ii) becomes publicly known or made generally available after disclosure by Disclosing Party to Receiving Party through no wrongful action or inaction of Receiving Party; (iii) is in the rightful possession of Receiving Party on a non-confidential basis at the time of disclosure by Disclosing Party to Receiving Party; (iv) is obtained by Receiving Party from a third party on a non-confidential basis and without a breach of such third party’s obligations of confidentiality; or (v) is independently developed by Receiving Party without use of or reference to Disclosing Party’s Confidential Information. For the avoidance of doubt, while the fact that Customer provided Synthego with a specific sequence will be Customer Confidential Information, nothing will prevent Synthego from performing services for or supplying the same or similar products to other customers that request the same or similar sequences or edits of Products.

7.4. Disclosure Required by Law. A Receiving Party will be permitted to disclose Confidential Information to the extent that such disclosure is required by law, regulation, act or order of any governmental authority or agency, provided that where permissible the Receiving Party gives the Disclosing Party prompt written notice of such required disclosure and cooperates with the Disclosing Party, at the Disclosing Party’s reasonable request and expense, in any lawful action to contest or limit the scope of such required disclosure, including filing motions and otherwise making appearances before a court. The Receiving Party will restrict any required disclosure to only that portion of the Confidential Information that is legally required to be disclosed, and the Confidential Information so disclosed shall maintain its confidentiality protection for all purposes other than such legally required disclosure.

7.5. Return. All Confidential Information (including all summaries and whole or partial copies or embodiments thereof) is and will at all times remain the property of the Disclosing Party and, at the Disclosing Party’s request, will be promptly returned at the Disclosing Party’s expense or destroyed at the sole discretion of the Disclosing Party; provided, however, that Receiving Party may retain one copy of the Confidential Information in its confidential files solely for purposes of monitoring compliance with the Contract and may retain Confidential Information to the extent required under applicable law or regulation. Notwithstanding the foregoing, neither Party shall have any obligation to destroy any electronic information stored in any electronic back-up systems in the ordinary course of business. Any retained Confidential Information shall remain subject to the terms of the Contract.

7.6. Privacy. Customer acknowledges and agrees that the terms of Synthego’s privacy policy, available at https://www.synthego.com/legal/privacy-policy, are incorporated by reference into the Contract, and that Synthego may collect and use personal information in accordance with its privacy policy. Synthego does not require any individually identifiable health information to perform its obligations under the Contract, including without limitation any individually identifiable health information that is subject to the Health Insurance Portability and Accountability Act of 1996 or Health Information Technology for Economic and Clinical Health Act or any regulations promulgated thereunder (collectively “PHI”). Customer agrees not to transfer any PHI to Synthego under the Contract and will immediately notify Synthego if it becomes aware of any PHI being inadvertently transferred to Synthego, in which case Synthego will promptly return such PHI to Customer.

8.1. The Products and results of Services are for Customer’s research and development purposes only, including clinical research and development. Customer represents that Customer will use the Products and results of Services solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use or sale of drugs or veterinary biological products. Synthego does not submit its Products for regulatory review by any government body or other organization. Customer is solely responsible for making sure that the way Customer uses the Products complies with applicable laws, regulations, and governmental policies and for obtaining all necessary approvals, intellectual property rights, licenses and permissions that Customer may need related to Customer’s use of the Products. Customer agrees to properly test and use any Products purchased from Synthego, as well as any final products made through the use of the Products, in strict compliance with all applicable governmental food, drug, device, and cosmetic requirements and other applicable governmental requirements, now and hereinafter enacted. Because Synthego’s Products are intended for research and development purposes, they may not be on the Toxic Substances Control Act (TSCA) inventory. Customer assumes responsibility to assure that the Products Customer purchases from Synthego are approved for use under TSCA, if applicable.

8.2. It is solely Customer’s responsibility to make sure the Products are suitable for Customer’s particular use and to conduct any research necessary to learn the hazards involved for any of Customer’s uses of Products purchased from Synthego. Customer also has the duty to warn Customer’s employees, independent contractors, and others who may use or be exposed to the Products of any risks associated with the Products. Customer agrees to comply with instructions for use of the Products furnished by Synthego, if any, and not to misuse or adulterate the Products. If the Products purchased from Synthego are to be repackaged, relabeled or used as starting materials or components of other products, Customer will verify Synthego’s quality assessment of the Products (as contained in the quality documentation provided to Customer), qualify the Products provided by Synthego for such applications, and comply with all applicable laws and regulations related to such repackaging, relabeling, or use.

8.3. Customer may perform compositional, structural, functional or such other analysis of Synthego’s Products in order to confirm that the Products meet the Product Specifications or satisfy applicable regulatory requirements with respect to the Products. Customer may not undertake deconvolution or reverse engineering with respect to Synthego’s Products or otherwise attempt to determine Synthego’s methods of manufacturing the Products, except as provided in the preceding sentence. Without limiting the foregoing restriction or any other use restrictions hereunder with respect to the Products and Customer’s use of the Products, Customer may not conduct a competitive analysis of the Products or use the Products in any manner in connection with the development or commercialization of a competitive service or product offering.

9.1. Customer acknowledges that it is paying for Synthego to supply certain Products and/or perform certain Services hereunder. The purchase of such Products by Customer conveys to Customer the right to use such Products subject to Article 8, but not the right to make or have made such Product. Synthego hereby grants to Customer a limited non-exclusive, non-transferrable license to use any intellectual property rights owned by Synthego contained in any Products provided to Customer hereunder only to the extent such license is required for Customer to use of such Products purchased hereunder for Customer’s internal research and development purposes and in compliance with this Contract. No other intellectual property rights are conveyed hereunder by Synthego and Customer acknowledges that Synthego, as a platform provider and supplier of products, will not be restricted in any manner from supplying the same or similar products to other customers. Notwithstanding the foregoing, Synthego will maintain Customer’s interest in a given Product as Customer's Confidential Information.

9.2. Customer acknowledges and agrees that all intellectual property rights in the products and in any Synthego technology, intellectual property and know-how (a) used to perform Services, (b) used to make the Products or (c) useful for the manufacture or use of the Products will at all times remain vested in Synthego and its licensors. For the avoidance of doubt, Synthego retains all right, title and interest in and to any of its know-how or other intellectual property, including without limitation any know-how or other intellectual property conceived, reduced to practice or made by or on behalf of Synthego, that is an improvement to, or modification, enhancement or derivative work of any Synthego know-how or other intellectual property or that relates to the processes, procedures, or methods used by Synthego to provide the Products.

9.3. Except as expressly stated herein, no right or license under Synthego’s intellectual property, express or implied, is granted hereunder. No license or immunity under any third party (non-Synthego) intellectual property is either granted or implied by the sale of any of Synthego’s Products. In particular, no licenses to third party intellectual property relating to CRISPR systems, methods, and compositions are provided. It is solely Customer’s responsibility to determine whether Customer may be required to obtain any additional or third party intellectual property rights depending upon the particular application in which Customer uses the Product, and to obtain such additional or third party intellectual property rights if required.

10.1. Indemnification of Synthego. Customer hereby indemnifies, defends and holds harmless Synthego, its officers, agents, employees, distributors and affiliates (“Synthego Indemnitees”) against any cost, loss, damage, expense or other liability (including reasonable attorneys’ fees and costs) (“Losses”) which may be incurred by or imposed upon any Synthego Indemnitees in connection with any third party claims, suits, investigations, actions, demands or judgments (“Claims”) arising out of (a) Customer’s breach of the Contract, including without limitation breaches of Article 8, (b) Customer’s gross negligence, recklessness or willful misconduct, (c) Synthego’s manufacture, storage, delivery, sale, or transfer of the Products to the extent consistent with the Product Specifications or other direction of Customer, (d) Customer’s failure (including the failure of any party acting on Customer’s behalf) to comply with the Contract, including these Terms, or (e) Synthego’s use of materials Customer provides to Synthego for the purpose of the Contract, except to the extent any such Losses are covered by Synthego’s indemnification obligations under Section 10.2.

10.2. Indemnification of Customer. Synthego hereby indemnifies, defends and holds harmless Customer, its officers, agents, employees, and affiliates (the “Customer Indemnitees”) against any Losses which may be incurred by or imposed upon any Customer Indemnitee in connection with any Claims arising out of (a) infringement or misappropriation of any third party’s intellectual property rights by Synthego’s manufacture of the Products using any manufacturing or design methods of general applicability or equipment used in performing the Services under the Contract (but expressly excluding any Claim to the extent arising from (i) Customer’s materials or Customer’s Confidential Information provided to Synthego or their use by Synthego as permitted under the Contract, (ii) compliance by Synthego with the written instructions, specifications or other written directions of Customer or (iii) use of the Products) or (b) Synthego’s gross negligence, recklessness or willful misconduct in performing any activity contemplated by the Contract, except to the extent any such Losses are covered by Customer’s indemnification obligations under Section 10.1.

10.3. Indemnification Procedure. An “Indemnitor” means the indemnifying Party. An “Indemnitee” means the indemnified Party, its affiliates, and their respective directors, officers, employees and agents. An Indemnitee which intends to claim indemnification under Sections 10.1 or 10.2 hereof shall promptly notify the Indemnitor in writing of any Claim in respect of which the Indemnitee, its affiliates, or any of their respective directors, officers, employees and agents intend to claim such indemnification. The Indemnitee shall permit, and shall cause its affiliates and their respective directors, officers, employees and agents to permit, the Indemnitor, at its discretion, to settle any such Claim to the complete control of such defense or settlement by the Indemnitor; provided, however, that in order for the Indemnitor to exercise such rights, such settlement shall not adversely affect the Indemnitee’s rights under the Contract or impose any obligations on the Indemnitee in addition to those set forth herein. No such Claim shall be settled without the prior written consent of the Indemnitor and the Indemnitor shall not be responsible for any legal fees or other costs incurred other than as provided herein. The Indemnitee, its affiliates and their respective directors, officers, employees and agents shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any Claim covered by this indemnification, all at the reasonable expense of the Indemnitor. The Indemnitee shall have the right, but not the obligation, to be represented by counsel of its own selection and expense.

11.1. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, OTHER THAN WITH RESPECT TO CLAIMS ARISING FROM BREACH OF ARTICLE 7 (CONFIDENTIALITY AND PRIVACY) OR ARTICLE 8 (PRODUCT USES AND RESTRICTIONS; LIMITED RIGHTS) HEREUNDER OR A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTIONS 10.1 OR 10.2, NEITHER PARTY WILL BE LIABLE FOR ANY LOSS OF PROFITS, LOSS OF USE, OR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, INDIRECT, PUNITIVE, OR EXEMPLARY DAMAGES THIS CONTRACT OF ANY KIND, WHETHER OR NOT SUCH PARTY WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND NOTWITHSTANDING THE FAILURE OR ESSENTIAL PURPOSE OF ANY REMEDY.

11.2. SYNTHEGO’S MAXIMUM AGGREGATE LIABILITY ARISING OUT OF OR IN CONNECTION WITH THE CONTRACT, OR ANY ORDER, IS LIMITED TO THE AMOUNT CUSTOMER PAID TO SYNTHEGO UNDER THE APPLICABLE ORDER.

11.3. DELIVERY DATES AND TIMES ARE ESTIMATES ONLY AND SYNTHEGO WILL NOT BE LIABLE (IN CONTRACT, TORT OR OTHERWISE) FOR ANY LOSSES, EXPENSES, CLAIMS OR DAMAGES CAUSED BY A LATE DELIVERY.

11.4. The exclusions and limitations in this Article 11 (Limitations of Liability) will not exclude or limit either Party’s liability to the extent that such liability cannot be limited or excluded pursuant to applicable law.

12.1. Termination for Default. Either Party may immediately terminate the Contract if one of the following events occurs with respect to the other party (a “Default Event”) (a) the other Party is in material breach of the Contract which is incapable of cure or which the other Party fails to cure within thirty (30) days after written notice thereof or (b) the other Party becomes insolvent, files, commences or has commenced against it (which if involuntary is not dismissed within ninety (90) days) any proceeding concerning bankruptcy, insolvency, dissolution, liquidation, cessation of operations, reorganization of indebtedness, assignment for the benefit of a creditor or the like, cease to continue all or substantially all of its business affairs or becomes unable to meet its financial obligations in the normal course of business.

12.2. Termination for Feasibility. Synthego may cancel or terminate the Quotation if, despite commercially reasonable efforts, it is technically unfeasible to produce the Products. Synthego will use commercially reasonable efforts to notify Customer promptly if it determines that the Products cannot be made. Either party may terminate the Quotation associated with such Projects and Synthego will cease any additional work under such Quotation. In this case, Synthego will return the Reservation Fee but reserves the right to retain a portion of the Reservation Fee in compensation for work performed and expenses incurred to that point in performance of the Quotation.

12.3. Compensation. Customer may cancel or terminate the Contract at will prior to the Start Date, provided that Synthego will retain the Reservation Fee as a charge for such cancellation. If Customer cancels or terminates the Contract within thirty (30) days of the Start Date, or any time after the Start Date, in addition to Synthego’s right to retain the Reservation Fee as set forth above, Customer will be responsible for paying the balance of the amounts set forth in the Quotation, and Synthego will invoice Customer for these amounts. Payments shall be made in accordance with Article 4 (Payment).

12.4. Effects of Termination. Article 4 (Payment); Article 6 (Limited Warranty), Article 7 (Confidentiality and Privacy); Article 8 (Product Uses and Restrictions); Article 9 (Intellectual Property); Article 10 (Indemnification); Section 12.4 (Effects of Termination); Article 14 (Export Control), and Article 16 (General Provisions), as well as any rights or obligations that expressly or by their nature survive termination or expiration and any rights or obligations accrued prior to expiration or termination, will survive any termination or expiration of the Contract. For the avoidance of doubt, termination or expiration of the Contract will not affect either Party’s liability for any breach of the Contract such Party may have committed before such expiration or termination.

13.1. Audit. Customer (or Customer’s nominee) shall have the right to audit Synthego’s facilities used in the performance of the Services under this Contract or its processes used or relevant to the performance of the Services under this Contract in accordance with the applicable quality agreement. Customer may conduct any additional for-cause audits as necessary.

13.2. Regulatory Inspections. Synthego will make its facilities available for inspection by representatives of regulatory authorities in compliance with applicable laws. Synthego will be responsible for inspections of its facility by any regulatory authorities, and will, to the extent permitted by applicable law, promptly (and in any event no later than two (2) business days of receipt of notice from a regulatory authority, notify Customer if any such inspection is directly related to the Services or the Product. With respect to any inspection directly related to the Services or the Product, Synthego will upon the request of Customer and at Customer's cost (a) provide Customer with copies of all documents, reports or communications received from or given to any regulatory authority associated therewith, (b) permit Customer's representatives to be present on site and participate, as appropriate, in such inspection or related meetings, and (c) permit Customer the opportunity to review and provide comments to any communications with regulatory authorities related thereto. All information, records, or business information concerning Synthego that is disclosed or made available by Synthego to Customer’s employees and representatives, and representatives of regulatory authorities, or otherwise obtained by such employees and representatives, in connection with any audit will be deemed to be Confidential Information of Synthego.

13.3. Regulatory Authority Communications. Customer agrees to promptly notify Synthego in writing to qa-notification@synthego.com of any filing, or notice, made to or received from any regulatory authority pertaining or related to any Products Manufactured by Synthego (“Regulatory Communication”). Such notice must include relevant details about the Regulatory Communication and any subsequent actions taken by the regulatory authority.

Customer acknowledges that Products received from Synthego are subject to U.S. export control laws and regulations. Customer represents and warrants to Synthego that Customer will not, directly or indirectly, (a) sell, export, re-export, transfer, divert, or otherwise dispose of any products, software, or technology (including products derived from or based on such technology) received from Synthego to any destination, entity, or person prohibited by the laws or regulations of the U.S., or (b) use the Products for any use prohibited by the laws or regulations of the U.S. and/or Customer’s local jurisdiction, without obtaining prior authorization from the competent government authorities as required by those laws and regulations.

Each Party shall be excused from the performance of its obligations under the Contract to the extent that such performance is prevented by force majeure (defined below) and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of these Terms, “force majeure” shall include conditions beyond the control of the Parties, including an act of God; acts of terrorism; voluntary or involuntary compliance with any regulation, law or order of any government; war, rioting or other civil commotion; labor strike, lock-out, or labor shortage; epidemic; failure or default of public utilities or common carriers (including but not limited to loss of electricity, gas, water, telephone or internet service); destruction of production facilities or materials by fire, earthquake, storm, or flood; or any like catastrophe. The payment of invoices due and owing hereunder shall in no event be delayed by the payer because of a force majeure affecting the payer.

Synthego’s exercise of any option or failure to exercise any rights hereunder will not constitute a waiver of its rights to damages for breach of contract and will not constitute a waiver of any subsequent failure, delay, or breach by Customer. Customer acknowledges and agrees that (a) a breach or threatened breach by Customer of its obligations under Articles 7 (Confidentiality and Privacy) and 9 (Intellectual Property) would give rise to irreparable harm to Synthego for which monetary damages would not be an adequate remedy (b) in the event of a breach or a threatened breach by Customer of any such obligations, Synthego shall, in addition to any and all other rights and remedies that may be available to Synthego at law, at equity or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Customer agrees that Customer will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this Article 16. If any provision or part of the Contract is found by any court of competent jurisdiction to be invalid or unenforceable, such invalidity or unenforceability will not affect the other provisions of the Contract. Headings are for convenience only and will not be used in the interpretation of these Terms. The Contract will be governed by and construed in accordance with the laws of California, USA without regard to conflicts of law provisions. Any disputes under the Contract shall be brought in the state courts and the Federal courts located in the Northern District of California, and the Parties hereby consent to the personal jurisdiction and exclusive venue of these courts. TO THE EXTENT PERMITTED BY APPLICABLE LAW, EACH OF THE PARTIES HERETO IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THE CONTRACT. This Contract and a Party’s rights and obligations under this Contract may not be assigned, delegated, or otherwise transferred in whole or in part, by operation of law or otherwise, by a Party without the other Party’s express prior written consent, provided that either Party may assign this Contract without such consent to an affiliate or in connection with the merger, consolidation, sale or transfer of all or substantially all of the Party’s business to which this Contract relates. Any attempted assignment, delegation, or transfer in violation of the foregoing will be null and void.

Note: For GMP Accubase™ purchases, please view our addendum to the GMP Terms of Sale here.