Common use of Third Party Manufacturers Clause in Contracts

Third Party Manufacturers. The Parties acknowledge that Intellia may use one or more Third Party contract manufacturers to manufacture such Regeneron Products pursuant to Section 8.2(a); provided that the selection of such Third Party contract manufacturer shall be subject to Regeneron’s prior written approval, not to be unreasonably withheld, conditioned or delayed. Intellia will give Regeneron [***] days’ written notice (the “Rejection Period”) prior to engaging any Third Party contract manufacturer for manufacture of pre-clinical Regeneron Products hereunder, and permit Regeneron to review such proposed Third Party contract manufacturer within such Rejection Period. If Intellia provides written notice to Regeneron of its intended engagement of a Third Party contract manufacturer to manufacture pre-clinical Regeneron Product pursuant to Section 8.2(a) and Regeneron either (i) consents to such Third Party manufacturer or (ii) Regeneron does not provide written notice of its reasonable rejection of such Third Party contract manufacturer within the Rejection Period, then Regeneron shall have accepted or be deemed to have accepted, respectively, such Third Party contract manufacturer as a permitted Third Party manufacturer hereunder. If Regeneron provides its written rejection of such Third Party contract manufacturer within such Rejection Period, then (x) Intellia shall not utilize such Third Party contract manufacturer to manufacture Regeneron Product to be supplied to Regeneron pursuant to Section 8.2(a), and (y) the Parties shall discuss and mutually agree upon an alternative Third Party contract manufacturer acceptable to both Parties and Intellia shall exercise reasonable, good faith efforts to enter into a contract with such Third Party contract manufacturer for supply of such Regeneron Products thereunder, or (z) Regeneron shall have the right to enter into a contract with a Third Party contract manufacturer for supply of such Regeneron Products to Regeneron, provided, further, that in each such case (y) and (z), Intellia shall ensure that copies of all Know-How Controlled by Intellia (or any of its Affiliates) necessary or useful for the manufacture of such Regeneron Product in accordance herewith shall be provided to such Third Party contract manufacturer, in accordance with this Agreement, which manufacturing shall be performed in accordance with CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Applicable Laws and all other requirements as set forth in the Product R&D Plan. With respect to any such Third Party contract manufacturer for Regeneron Products, Regeneron shall have the right (and Intellia shall ensure that Regeneron has the right) to audit the facilities utilized in the manufacture of Regeneron Products or records related thereto of any such Third Party contract manufacturer. Regeneron shall have the right to review and comment on the draft agreement or amendment with each such Third Party contract manufacturer to the extent applicable to the manufacture and supply of one or more Regeneron Products hereunder, and Intellia shall consider in good faith the comments of Regeneron thereon (provided that Regeneron shall timely provide such review and comment). If any such materials are manufactured by such Third Party contract manufacturer, Intellia shall pass through to Regeneron such Regeneron Product specific warranties as Intellia receives from such Third Party contract manufacturer with respect thereto solely to the extent permitted under Intellia’s agreement with such Third Party contract manufacturer or, if not permitted, Intellia shall provide substantially similar warranties with respect to any supply hereunder as are provided by any such Third Party contract manufacturer to Intellia.

Third Party Manufacturers. The Parties acknowledge that Intellia may use one or more Celltech shall not enter into any Supply Agreement with a Third Party contract manufacturers for Antibody Raw Material as specified in this Article 6 without first obtaining the consent of Amgen to such agreement (such consent not to be unreasonably withheld or delayed). Celltech shall use Commercially Reasonable Efforts to ensure that, in addition to the terms set forth in Articles 6.2 and 6.3 (as appropriate), such Supply Agreement shall contain terms that, in the event that either Celltech or Amgen assumes exclusive responsibility for manufacture and supply of Antibody Raw Material pursuant to Article 6.7, will grant Celltech the right to (a) terminate such agreement on reasonable notice with respect to Antibody Raw Materials, (b) have transferred to Amgen or Celltech (as appropriate) and to receive assistance reasonably required by Amgen or Celltech (as appropriate) to effect transfer of the Third Party’s Information relating to the manufacture and analysis of Antibody Raw Material in sufficient detail for Amgen or Celltech (as appropriate) to implement the [*] of such [*], including Information contained in the [*] of any applicable Regulatory Filings and the results of any stability studies performed on Antibody Raw Material, (c) have provided Amgen or Celltech (as appropriate) such Information pertaining to the manufacture and analysis of Antibody Raw Material as Amgen or Celltech (as appropriate) shall reasonably request; (d) if requested by Amgen or Celltech (as appropriate), obtain reasonable assistance in the manufacture of trial batches of Antibody Raw Material to enable Amgen or Celltech (as appropriate) to determine its ability to manufacture Antibody Raw Material; (e) audit in accordance with Article 6.6; (f) obtain copies of any direct communications by or to the Manufacturing Lead from Regulatory Authorities having jurisdiction in the Territory regarding and concerning the manufacture of any Antibody Product and (g) name Amgen as a permitted assignee or sublicensee. Once Amgen has given such Regeneron Products pursuant consent, Amgen shall be deemed to Section 8.2(a); provided that have accepted the selection terms of such Third Party contract manufacturer Supply Agreement. Both Parties shall comply and operate in accordance with the terms of any such Supply Agreement accepted by Amgen and entered into by Celltech. To the extent the same relates to Antibody Product, all (i) out-of–pocket costs, expenses and liabilities (calculated on an arm’s-length basis in accordance with GAAP), (ii) FTE Cost and (iii) cost of Materials used, which are incurred by Celltech in discharging its obligations pursuant to this Article 6 shall be subject to Regeneron’s prior written approvalResearch and Development Costs if incurred for Development and a Commercialisation Expense if incurred for Commercialisation, not to be unreasonably withheld, conditioned or delayed. Intellia will give Regeneron [***] days’ written notice (the “Rejection Period”) prior to engaging and all amounts recovered from any Third Party contract manufacturer for manufacture supplier shall be credited to Product Contribution revenues, provided however, that if the costs, liabilities and/or amounts recovered are also applicable to products other than Antibody Products, then only an equitable portion of pre-clinical Regeneron Products hereundersuch costs, and permit Regeneron to review such proposed liabilities and/or amounts recovered shall be so allocated. The sharing of liabilities under any Third Party contract manufacturer within such Rejection PeriodSupply Agreement is without prejudice to Article 18. If Intellia provides written notice to Regeneron In the event that Amgen obtains supply of its intended engagement of Antibody Product in Finished Form from a Third Party contract manufacturer Party, costs, liabilities and/or amounts recovered shall also be allocated to manufacture pre-clinical Regeneron Product pursuant to Section 8.2(a) Research and Regeneron either (i) consents to such Third Party manufacturer Development Costs or (ii) Regeneron does not provide written notice of its reasonable rejection of such Third Party contract manufacturer within the Rejection Period, then Regeneron shall have accepted or be deemed to have accepted, respectively, such Third Party contract manufacturer as a permitted Third Party manufacturer hereunder. If Regeneron provides its written rejection of such Third Party contract manufacturer within such Rejection Period, then (x) Intellia shall not utilize such Third Party contract manufacturer to manufacture Regeneron Product to be supplied to Regeneron pursuant to Section 8.2(a), and (y) the Parties shall discuss and mutually agree upon an alternative Third Party contract manufacturer acceptable to both Parties and Intellia shall exercise reasonable, good faith efforts to enter into a contract with such Third Party contract manufacturer for supply of such Regeneron Products thereunder, or (z) Regeneron shall have the right to enter into a contract with a Third Party contract manufacturer for supply of such Regeneron Products to Regeneron, provided, further, that in each such case (y) and (z), Intellia shall ensure that copies of all Know-How Controlled by Intellia (or any of its Affiliates) necessary or useful for the manufacture of such Regeneron Product in accordance herewith shall be provided to such Third Party contract manufacturer, in accordance with this Agreement, which manufacturing shall be performed in accordance with CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Applicable Laws and all other requirements as set forth in the Product R&D Plan. With respect to any such Third Party contract manufacturer for Regeneron Products, Regeneron shall have the right (and Intellia shall ensure that Regeneron has the right) to audit the facilities utilized in the manufacture of Regeneron Products or records related thereto of any such Third Party contract manufacturer. Regeneron shall have the right to review and comment on the draft agreement or amendment with each such Third Party contract manufacturer to the extent applicable to the manufacture and supply of one or more Regeneron Products hereunder, and Intellia shall consider in good faith the comments of Regeneron thereon (provided that Regeneron shall timely provide such review and comment). If any such materials are manufactured by such Third Party contract manufacturer, Intellia shall pass through to Regeneron such Regeneron Product specific warranties as Intellia receives from such Third Party contract manufacturer with respect thereto solely to the extent permitted under Intellia’s agreement with such Third Party contract manufacturer or, if not permitted, Intellia shall provide substantially similar warranties with respect to any supply hereunder as are provided by any such Third Party contract manufacturer to IntelliaCommercialisation Expenses mutatis mutandis.

Third Party Manufacturers. The Parties acknowledge that Intellia may use one or more Third Party contract manufacturers to manufacture such Regeneron Products pursuant Without limiting CyDex’s responsibility under this Agreement, CyDex shall have the right, subject to Section 8.2(a3.10 and upon written notice to Company, to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged by CyDex to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol (each, a “Third-Party Manufacturer”); provided . CyDex shall guarantee the performance of all Third-Party Manufacturers and shall promptly notify Company of the name and other relevant information of any Third-Party Manufacturer intended to be used by CyDex to satisfy its supply obligations of Captisol to any Permitted Purchasers hereunder. CyDex shall warrant that such Captisol shall, at a minimum, meet the Specifications as set forth in Exhibit B and the Minimum Remaining Shelf Life and have been manufactured in accordance with all applicable laws and regulations, including under conditions of GMP and under the same DMF and manufacturing processes referenced in Company’s IND or NDA. The parties hereby agree that The Hovione Group is a Third-Party Manufacturer as of the Effective Date of this Agreement. Unless otherwise instructed by CyDex, Company shall reference The Hovione Group’s manufacturing processes, and no others, in Company’s INDs and NDAs in each country that the selection of such Third Party contract manufacturer shall be subject to Regeneron’s prior written approvalSupply Agreement has not been terminated, not to be unreasonably withheld, conditioned or delayed. Intellia will give Regeneron except (i) [***] days’ written notice or (ii) in the “Rejection Period”) prior to engaging any event CyDex notifies Company that it is using a different Third Party contract manufacturer for manufacture of pre-clinical Regeneron Products hereunder, and permit Regeneron Manufacturer. If CyDex decides to review such proposed change or add a Third Party contract manufacturer within such Rejection Period. If Intellia provides written notice to Regeneron of its intended engagement Manufacturer, or if the facilities of a Third Party contract manufacturer Manufacturer used to manufacture pre-clinical Regeneron Product pursuant to Section 8.2(a) and Regeneron either (i) consents to such Third Party manufacturer or (ii) Regeneron does not provide written notice of its supply Captisol are changed, CyDex shall use commercially reasonable rejection of such Third Party contract manufacturer within the Rejection Period, then Regeneron shall have accepted or be deemed to have accepted, respectively, such Third Party contract manufacturer as a permitted Third Party manufacturer hereunder. If Regeneron provides its written rejection of such Third Party contract manufacturer within such Rejection Period, then (x) Intellia shall not utilize such Third Party contract manufacturer to manufacture Regeneron Product to be supplied to Regeneron pursuant to Section 8.2(a), and (y) the Parties shall discuss and mutually agree upon an alternative Third Party contract manufacturer acceptable to both Parties and Intellia shall exercise reasonable, good faith efforts to enter into a contract with such Third Party contract manufacturer continue to supply Company from the original manufacturing site listed in the Company’s regulatory filings until Company has obtained any required amendment or other modification of the regulatory approvals for supply of such Regeneron Products thereunder, or (z) Regeneron shall have the right to enter into a contract with a Third Party contract manufacturer for supply of such Regeneron Products to Regeneron, provided, further, that in each such case (y) and (z), Intellia shall ensure that copies of all Know-How Controlled by Intellia (or any of its Affiliates) necessary or useful for the manufacture of such Regeneron Product in accordance herewith shall be provided to such Third Party contract manufacturer, in accordance with this Agreement, which manufacturing shall be performed in accordance with CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[Licensed Products. ***]”* Certain information on this page has been omitted and filed separately with the Commission. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Applicable Laws and all other requirements as set forth in the Product R&D Plan. With respect to any such Third Party contract manufacturer for Regeneron Products, Regeneron shall have the right (and Intellia shall ensure that Regeneron Confidential treatment has the right) to audit the facilities utilized in the manufacture of Regeneron Products or records related thereto of any such Third Party contract manufacturer. Regeneron shall have the right to review and comment on the draft agreement or amendment with each such Third Party contract manufacturer to the extent applicable to the manufacture and supply of one or more Regeneron Products hereunder, and Intellia shall consider in good faith the comments of Regeneron thereon (provided that Regeneron shall timely provide such review and comment). If any such materials are manufactured by such Third Party contract manufacturer, Intellia shall pass through to Regeneron such Regeneron Product specific warranties as Intellia receives from such Third Party contract manufacturer with respect thereto solely to the extent permitted under Intellia’s agreement with such Third Party contract manufacturer or, if not permitted, Intellia shall provide substantially similar warranties been requested with respect to any supply hereunder as are provided by any such Third Party contract manufacturer to Intelliathe omitted portions.

Third Party Manufacturers. The Parties acknowledge that Intellia may use one or more Celltech shall not enter into any Supply Agreement with a Third Party contract manufacturers for Antibody Raw Material as specified in this Article 6 without first obtaining the consent of Amgen to such agreement (such consent not to be unreasonably withheld or delayed). Celltech shall use Commercially Reasonable Efforts to ensure that, in addition to the terms set forth in Articles 6.2 and 6.3 (as appropriate), such Supply Agreement shall contain terms that, in the event that either Celltech or Amgen assumes exclusive responsibility for manufacture and supply of Antibody Raw Material pursuant to Article 6.7, will grant Celltech the right to (a) terminate such agreement on reasonable notice with respect to Antibody Raw Materials, (b) have transferred to Amgen or Celltech (as appropriate) and to receive assistance reasonably required by Amgen or Celltech (as appropriate) to effect transfer of the Third Party's Information relating to the manufacture and analysis of Antibody Raw Material in sufficient detail for Amgen or Celltech (as appropriate) to implement the [*] of such[*], including Information contained in the [*] of any applicable Regulatory Filings and the results of any stability studies performed on Antibody Raw Material, (c) have provided Amgen or Celltech (as appropriate) such Information pertaining to the manufacture and analysis of Antibody Raw Material as Amgen or Celltech (as appropriate) shall reasonably request; (d) if requested by Amgen or Celltech (as appropriate), obtain reasonable assistance in the manufacture of trial batches of Antibody Raw Material to enable Amgen or Celltech (as appropriate) to determine its ability to manufacture Antibody Raw Material; (e) audit in accordance with Article 6.6; (f) obtain copies of any direct communications by or to the Manufacturing Lead from Regulatory Authorities having jurisdiction in the Territory regarding and concerning the manufacture of any Antibody Product and (g) name Amgen as a permitted assignee or sublicensee. Once Amgen has given such Regeneron Products pursuant consent, Amgen shall be deemed to Section 8.2(a); provided that have accepted the selection terms of such Third Party contract manufacturer Supply Agreement. Both Parties shall comply and operate in accordance with the terms of any such Supply Agreement accepted by Amgen and entered into by Celltech. To the extent the same relates to Antibody Product, all (i) out-of-pocket costs, expenses and liabilities (calculated on an arm's-length basis in accordance with GAAP), (ii) FTE Cost and (iii) cost of Materials used, which are incurred by Celltech in discharging its obligations pursuant to this Article 6 shall be subject to Regeneron’s prior written approvalResearch and Development Costs if incurred for Development and a Commercialisation Expense if incurred for Commercialisation, not to be unreasonably withheld, conditioned or delayed. Intellia will give Regeneron [***] days’ written notice (the “Rejection Period”) prior to engaging and all amounts recovered from any Third Party contract manufacturer for manufacture supplier shall be credited to Product Contribution revenues, provided however, that if the costs, liabilities and/or amounts recovered are also applicable to products other than Antibody Products, then only an equitable portion of pre-clinical Regeneron Products hereundersuch costs, and permit Regeneron to review such proposed liabilities and/or amounts recovered shall be so allocated. The sharing of liabilities under any Third Party contract manufacturer within such Rejection PeriodSupply Agreement is without prejudice to Article 18. If Intellia provides written notice to Regeneron In the event that Amgen obtains supply of its intended engagement of Antibody Product in Finished Form from a Third Party contract manufacturer Party, costs, liabilities and/or amounts recovered shall also be allocated to manufacture pre-clinical Regeneron Product pursuant to Section 8.2(a) Research and Regeneron either (i) consents to such Third Party manufacturer Development Costs or (ii) Regeneron does not provide written notice of its reasonable rejection of such Third Party contract manufacturer within the Rejection Period, then Regeneron shall have accepted or be deemed to have accepted, respectively, such Third Party contract manufacturer as a permitted Third Party manufacturer hereunder. If Regeneron provides its written rejection of such Third Party contract manufacturer within such Rejection Period, then (x) Intellia shall not utilize such Third Party contract manufacturer to manufacture Regeneron Product to be supplied to Regeneron pursuant to Section 8.2(a), and (y) the Parties shall discuss and mutually agree upon an alternative Third Party contract manufacturer acceptable to both Parties and Intellia shall exercise reasonable, good faith efforts to enter into a contract with such Third Party contract manufacturer for supply of such Regeneron Products thereunder, or (z) Regeneron shall have the right to enter into a contract with a Third Party contract manufacturer for supply of such Regeneron Products to Regeneron, provided, further, that in each such case (y) and (z), Intellia shall ensure that copies of all Know-How Controlled by Intellia (or any of its Affiliates) necessary or useful for the manufacture of such Regeneron Product in accordance herewith shall be provided to such Third Party contract manufacturer, in accordance with this Agreement, which manufacturing shall be performed in accordance with CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Applicable Laws and all other requirements as set forth in the Product R&D Plan. With respect to any such Third Party contract manufacturer for Regeneron Products, Regeneron shall have the right (and Intellia shall ensure that Regeneron has the right) to audit the facilities utilized in the manufacture of Regeneron Products or records related thereto of any such Third Party contract manufacturer. Regeneron shall have the right to review and comment on the draft agreement or amendment with each such Third Party contract manufacturer to the extent applicable to the manufacture and supply of one or more Regeneron Products hereunder, and Intellia shall consider in good faith the comments of Regeneron thereon (provided that Regeneron shall timely provide such review and comment). If any such materials are manufactured by such Third Party contract manufacturer, Intellia shall pass through to Regeneron such Regeneron Product specific warranties as Intellia receives from such Third Party contract manufacturer with respect thereto solely to the extent permitted under Intellia’s agreement with such Third Party contract manufacturer or, if not permitted, Intellia shall provide substantially similar warranties with respect to any supply hereunder as are provided by any such Third Party contract manufacturer to IntelliaCommercialisation Expenses mutatis mutandis.

Third Party Manufacturers. The Parties acknowledge that Intellia may use one or more Third Party contract manufacturers to manufacture such Regeneron Products pursuant to Section 8.2(a); provided that the selection of such Third Party contract manufacturer shall be subject to Regeneron’s prior written approval, not to be unreasonably withheld, conditioned or delayed. Intellia will give Regeneron [***] days’ written notice (the “Rejection Period”) prior to engaging any Third Party contract manufacturer for manufacture of pre-clinical Regeneron Products hereunder, and permit Regeneron to review such proposed Third Party contract manufacturer within such Rejection Period. If Intellia provides written notice to Regeneron of its intended engagement of a Third Party contract manufacturer to manufacture pre-clinical Regeneron Product pursuant to Section 8.2(a) and Regeneron either (i) consents to such Third Party manufacturer or (ii) Regeneron does not provide written notice of its reasonable rejection of such Third Party contract manufacturer within the Rejection Period, then Regeneron shall have accepted or be deemed to have accepted, respectively, such Third Party contract manufacturer as a permitted Third Party manufacturer hereunder. If Regeneron provides its written rejection of such Third Party contract manufacturer within such Rejection Period, then (x) Intellia shall not utilize such Third Party contract manufacturer to manufacture Regeneron Product to be supplied to Regeneron pursuant to Section 8.2(a), and (y) the Parties shall discuss and mutually agree upon an alternative Third Party contract manufacturer acceptable to both Parties and Intellia shall exercise reasonable, good faith efforts to enter into a contract with such Third Party contract manufacturer for supply of such Regeneron Products thereunder, or (z) Regeneron shall have the right to enter into a contract with a Third Party contract manufacturer for supply of such Regeneron Products to Regeneron, provided, further, that in each such case (y) and (z), Intellia shall ensure that copies of all Know-How Controlled by Intellia (or any of its Affiliates) necessary or useful for the manufacture of such Regeneron Product in accordance herewith shall be provided to such Third Party contract manufacturer, in accordance with this Agreement, which manufacturing shall be performed in accordance with CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Applicable Laws and all other requirements as set forth in the Product R&D Plan. With respect to any such Third Party contract manufacturer for Regeneron Products, Regeneron shall have the right (and Intellia shall ensure that Regeneron has the right) to audit the facilities utilized in the manufacture of Regeneron Products or records related thereto of any such Third Party contract manufacturer. Regeneron shall have the right to review and comment on the draft agreement or amendment with each such Third Party contract manufacturer to the extent applicable to the manufacture and supply of one or more Regeneron Products hereunder, and Intellia shall consider in good faith the comments of Regeneron thereon (provided that Regeneron shall timely provide such review and comment). If any such materials are manufactured by such Third Party contract manufacturer, Intellia shall pass through to Regeneron such Regeneron Product specific warranties as Intellia receives from such Third Party contract manufacturer with respect thereto solely to the extent permitted under Intellia’s agreement with such Third Party contract manufacturer or, if not permitted, Intellia shall provide substantially similar warranties with respect to any supply hereunder as are provided by any such Third Party contract manufacturer to Intellia.

Third Party Manufacturers. The Parties acknowledge that Intellia may use Without limiting Sintetica’s responsibility under this Agreement, Sintetica shall have the right, upon written notice to Harrow (except for the case already acknowledged and agreed to in the last sentence of this paragraph), to satisfy its supply obligations to Harrow hereunder either in whole or in part through arrangements with one or more Third Parties engaged by Sintetica to perform services or supply facilities or goods in connection with the Manufacture or testing of Product (each, a “Third-Party contract manufacturers to manufacture such Regeneron Products pursuant to Section 8.2(aManufacturer” or “TPM”); provided that the selection . Sintetica shall be responsible for any acts or omissions of such Third Third-Party contract manufacturer Manufacturers in breach of Sintetica’s representations, warranties and obligations under this Agreement to the same extent as if Sintetica had committed the breach itself. The Parties acknowledge and agree that as of the Effective Date, Sintetica will obtain Product Manufactured by the TPM, Unither Pharmaceuticals at its manufacturing site in Coutances, France. ● Sintetica shall endeavor to have the contractual arrangements with each TPM be subject to Regeneron’s prior written approval, not to be unreasonably withheld, conditioned or delayed. Intellia will give Regeneron [***] days’ written notice (consistent with the “Rejection Period”) prior to engaging any Third Party contract manufacturer for manufacture relevant Manufacturing provisions of pre-clinical Regeneron Products hereunderthis Agreement, and permit Regeneron use Commercially Reasonable Efforts to review monitor and enforce the TPM’s performance under such proposed Third Party contract manufacturer within arrangements to ensure that such Rejection Periodprovisions of the are met. If Intellia provides written notice to Regeneron of its intended engagement of a Third Party contract manufacturer to manufacture pre-clinical Regeneron Product pursuant to Section 8.2(a) and Regeneron either (i) consents to such Third Party manufacturer or (ii) Regeneron does not provide written notice of its reasonable rejection of such Third Party contract manufacturer within the Rejection Period, then Regeneron shall have accepted or be deemed to have accepted, respectively, such Third Party contract manufacturer as a permitted Third Party manufacturer hereunder. If Regeneron provides its written rejection of such Third Party contract manufacturer within such Rejection Period, then (x) Intellia shall not utilize such Third Party contract manufacturer to manufacture Regeneron Product to be supplied to Regeneron pursuant to Section 8.2(a● The performance by Sintetica described in Sections 6.3(d), and (y) the Parties shall discuss and mutually agree upon an alternative Third Party contract manufacturer acceptable to both Parties and Intellia shall exercise reasonable, good faith efforts to enter into a contract with such Third Party contract manufacturer for supply in other provisions of such Regeneron Products thereunder, or (z) Regeneron shall have the right to enter into a contract with a Third Party contract manufacturer for supply of such Regeneron Products to Regeneron, provided, further, that in each such case (y) and (z), Intellia shall ensure that copies of all Know-How Controlled by Intellia (or any of its Affiliates) necessary or useful for the manufacture of such Regeneron Product in accordance herewith shall be provided to such Third Party contract manufacturer, in accordance with this Agreement, which manufacturing shall be performed have been written in accordance with CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Applicable Laws and all other requirements as set forth in the Product R&D Plan. With respect regard to any Manufacturing activities that may be carried out directly by Sintetica, where applicable. For purposes of this Agreement, however, and even where not so indicated expressly, such Third Party contract manufacturer provisions should be interpreted mutatis mutandis so as to regard also performance of (the same) Manufacturing activities by TPMs for Regeneron ProductsSintetica, Regeneron shall have and to regard also Sintetica’s responsibilities and obligations under the right (and Intellia shall ensure that Regeneron has the right) to audit the facilities utilized present Section for such TPM performance. As an example for clarification, in the manufacture of Regeneron Products or records related thereto of any such Third Party contract manufacturer. Regeneron shall have the right to review and comment on the draft agreement or amendment with each such Third Party contract manufacturer Section 6.3(d), to the extent applicable to Manufacturing activities carried out by a TPM for Sintetica, such Section should (also) be read as follows: “Sintetica shall, during the manufacture and supply of one or more Regeneron Products hereunderTerm, ensure that each TPM maintain its relevant Manufacturing sites, and Intellia shall consider all property, equipment, machinery and systems therein, used in good faith performing Sintetica obligations under this Agreement, in the comments ordinary course of Regeneron thereon business and in compliance with GMP and Applicable Law (provided that Regeneron shall timely provide including Drug Security and Supply Chain Act) and free of material defects except for those attributable to wear and tear consistent with age and usage of such review assets and comment). If any except for such materials are manufactured by defects as do not and will not in the aggregate impair the ability to use such Third Party contract manufacturer, Intellia shall pass through to Regeneron such Regeneron Product specific warranties as Intellia receives from such Third Party contract manufacturer assets in connection with respect thereto solely to the extent permitted under Intellia’s agreement with such Third Party contract manufacturer or, if not permitted, Intellia shall provide substantially similar warranties with respect to any supply hereunder as are provided by any such Third Party contract manufacturer to Intelliathis Agreement.