Common use of Third Party Suppliers Clause in Contracts

Third Party Suppliers. The Parties contemplate that Lilly will assemble, package and label the Devices (“Final Assembly Activities”) and that component parts for the Devices will be provided to Lilly by Third Party suppliers (“Third Party Suppliers”). The Committee shall be responsible for overseeing negotiations for additional supply contracts with Third Party Suppliers where the Third Party Supplier will be material to the Collaboration, and Lilly shall provide Amylin with the opportunity to review such contracts reasonably in advance of execution, provided that Lilly may redact confidential information unrelated to the supply of component parts for the Devices from the copies of such contracts it provides to Amylin. Lilly shall use its Commercially Reasonable Efforts to cause Third Party Suppliers to fulfill their obligations under their agreements with Lilly and to make available component parts for the Devices to the Collaboration as contemplated by this Agreement. The Parties agree that Lilly will not be liable to Amylin, its Affiliates or their respective directors, officers, shareholders, employees or agents for any Third Party Suppliers’ failure to deliver or failure of any Device as a result of components of the Device manufactured by Third Party Suppliers or the failure of such components to comply with applicable Specifications, any representations or warranties of such Third Party Supplier or Applicable Laws, except to the extent such failure to comply is the result of Lilly’s gross negligence or willful misconduct. In the event Lilly receives any indemnification payments or other recovery from Third Parties performing services on behalf of Lilly for Manufacture of Devices containing Product, such amounts shall be shared equally by the Parties. To the extent legally or contractually permissible, Lilly shall obtain a written assignment of all patent rights and know-how that such Third Parties may develop by reason of work performed under this Agreement. Pre-filled cartridges containing drug shall be provided by a supplier mutually acceptable to the Parties, and Lilly shall have no liability under this Agreement for any delay in the availability of cartridges or any defect in the cartridge or drug.

Third Party Suppliers. The Parties contemplate acknowledge that Lilly will assembleeach Party may contract with Third Parties to fulfill their obligations to Manufacture and supply Licensed Products or Components hereunder (each, package and label the Devices (a “Final Assembly ActivitiesCMO”) and that component parts for subject to the Devices will be provided approval of such CMO (unless such CMO is an Existing CMO) by the Joint Manufacturing Committee pursuant to Lilly by Third Party suppliers Section 3.3.3(b)(8). Set forth in Schedule 6.7 are Mersana’s CMOs providing any Licensed Product Manufacturing critical service or product as of the Effective Date (the “Third Party SuppliersExisting CMOs”). The Committee Parties hereby agree that each Existing CMO is deemed to be an Approved CMO solely for performance of Manufacturing of Licensed Products and Components, as the case may be, within the scope of the applicable Existing CMO Agreement. Through the Joint Manufacturing Committee, each Party shall be responsible for overseeing negotiations for additional supply contracts with Third keep the other informed of all activities of its CMOs and material information related to Manufacturing Licensed Products or Components. Each Party Suppliers where the Third Party Supplier will be material to the Collaboration, and Lilly shall provide Amylin the other Party with the opportunity reasonable access to review its CMOs, including permitting and enabling such contracts reasonably other Party to accompany such Party in advance of execution, provided that Lilly may redact confidential information unrelated to the supply of component parts for the Devices from the copies of such contracts it provides to Amylin. Lilly shall use its Commercially Reasonable Efforts audits and inspections and using reasonable efforts to cause Third its CMOs to permit such other Party Suppliers to fulfill their obligations under their conduct audits and inspections, as well as for regulatory purposes and technical transfer and including using reasonable efforts to amend any existing agreements with Lilly and its CMOs to make available component parts for the Devices to the Collaboration as contemplated by enable compliance with this AgreementSection 6.7. The Parties agree that Lilly will not be liable to Amylin, its Affiliates or their respective directors, officers, shareholders, employees or agents for any Third Party Suppliers’ failure to deliver or failure coordinate audits and inspections of any Device CMOs through the Joint Manufacturing Committee. Other than agreements in effect as a result of components of the Device manufactured by Third Effective Date with Existing CMOs, each Party Suppliers will provide the other Party with each CMO agreement prior to execution for review and comment and to ensure terms are consistent with the contracting Party’s obligations hereunder and under the Mersana Supply Agreement, the First Supply Chain Supply Agreements and the Mutual Secondary Supply Agreements, as applicable. All CMO agreements in effect, or in substantially final draft, as of the failure Effective Date with Existing CMOs have been provided to Licensee for review prior to the Effective Date (the “Existing CMO Agreements”). Comments received within [***] Business Days will be given good faith consideration; provided, however, that each Party shall have final say with respect to the terms and conditions on which it enters into any commercial supply agreement with any CMO subject to the terms of the Mersana Supply Agreement, First Supply Chain Supply Agreements or Mutual Secondary Supply Agreements, as applicable. At either Party’s request, the other Party shall disclose to the requesting Party the names of such components other Party’s existing, back-up or alternative CMOs for Licensed Products and Components. Such requesting Party shall not contact any of the other Party’s CMOs or enter into any agreements with such existing and back-up or alternative CMOs to comply with applicable Specifications, any representations Manufacture Licensed Products (or warranties of such Third Party Supplier or Applicable LawsComponents) on the requesting Party’s behalf, except as may be permitted above, [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the extent such failure to comply is Commission. coordinated through the result of Lilly’s gross negligence Joint Manufacturing Committee or willful misconduct. In permitted under the event Lilly receives any indemnification payments Mersana Supply Agreement, First Supply Chain Supply Agreements or other recovery from Third Parties performing services on behalf of Lilly for Manufacture of Devices containing Product, such amounts shall be shared equally by the Parties. To the extent legally or contractually permissible, Lilly shall obtain a written assignment of all patent rights and know-how that such Third Parties may develop by reason of work performed under this Agreement. Pre-filled cartridges containing drug shall be provided by a supplier mutually acceptable to the Parties, and Lilly shall have no liability under this Agreement for any delay in the availability of cartridges or any defect in the cartridge or drugMutual Secondary Supply Agreements.

Third Party Suppliers. The Takeda acknowledges that MTEM may contract with Third Parties contemplate that Lilly will assembleto fulfill its obligations to Manufacture and for Supply hereunder (each such Third Party, package and label the Devices (a “Final Assembly ActivitiesCMO”) and that component parts for the Devices will be provided to Lilly by Third Party suppliers (“Third Party Suppliers”). The Committee shall be responsible for overseeing negotiations for additional supply contracts with Third Party Suppliers where the Third Party Supplier will be material subject to the Collaboration, and Lilly shall provide Amylin with the opportunity to review such contracts reasonably in advance of execution, provided that Lilly may redact confidential information unrelated to the supply of component parts for the Devices from the copies approval of such contracts it provides CMO by the Joint Manufacturing Committee pursuant to Amylin. Lilly shall use its Commercially Reasonable Efforts to cause Third Party Suppliers to fulfill their obligations under their agreements with Lilly and to make available component parts for the Devices to the Collaboration as contemplated by this AgreementSection 5.4.2. The Parties hereby agree that Lilly each Approved CMO is approved solely for performance of Manufacturing of Supply within the scope of the applicable CMO agreement as approved by the Joint Manufacturing Committee. Through the Joint Manufacturing Committee, MTEM will keep Takeda informed of all activities of its CMOs and material information related to Manufacturing Discovery Material or Development Materials, as the case may be. With respect to Takeda Development Material, MTEM will provide Takeda with reasonable access to its CMOs, including permitting and enabling Takeda to accompany MTEM in audits and inspections and using reasonable Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. efforts to cause its CMOs to permit Takeda to conduct audits and inspections, as well as for regulatory purposes and technical transfer. The Parties will coordinate audits and inspections of CMOs through the Joint Manufacturing Committee. MTEM will provide Takeda with each CMO agreement prior to execution for review and comment and to ensure terms are consistent with MTEM’s obligations hereunder and under the Supply Agreement. Comments received [***] will be given good faith consideration. MTEM will not materially change any agreement with an Approved CMO as it relates to Supply, including any change to the criteria agreed upon by the Parties through the Joint Manufacturing Committee to which Supply should conform to be liable considered acceptable for its intended use, except in accordance with the Quality Agreement and otherwise subject to Amylin, its Affiliates or their respective directors, officers, shareholders, employees or agents for any Third Party Suppliers’ failure to deliver or failure of any Device as a result of components agreement of the Device manufactured by Third Party Suppliers or the failure of such components to comply with applicable Specifications, any representations or warranties of such Third Party Supplier or Applicable Laws, except to the extent such failure to comply is the result of Lilly’s gross negligence or willful misconduct. In the event Lilly receives any indemnification payments or other recovery from Third Parties performing services on behalf of Lilly for Manufacture of Devices containing Product, such amounts shall be shared equally by the Parties. To the extent legally or contractually permissible, Lilly shall obtain a written assignment of all patent rights and know-how that such Third Parties may develop by reason of work performed under this Agreement. Pre-filled cartridges containing drug shall be provided by a supplier mutually acceptable to the Parties, and Lilly shall have no liability under this Agreement for any delay in the availability of cartridges or any defect in the cartridge or drugJoint Manufacturing Committee.

Third Party Suppliers. The Takeda acknowledges that MTEM may contract with one or more Third Parties contemplate that Lilly will assembleto fulfill its obligations to Manufacture hereunder (each such Third Party, package and label the Devices (a “Final Assembly ActivitiesContract Manufacturing Organization” or “CMO”) and that component parts for the Devices will be provided to Lilly by Third Party suppliers (“Third Party Suppliers”). The Committee shall be responsible for overseeing negotiations for additional supply contracts with Third Party Suppliers where the Third Party Supplier will be material subject to the Collaboration, and Lilly shall provide Amylin with the opportunity to review such contracts reasonably in advance of execution, provided that Lilly may redact confidential information unrelated to the supply of component parts for the Devices from the copies approval of such contracts it provides CMO by the Joint Manufacturing Committee pursuant to Amylin. Lilly shall use its Commercially Reasonable Efforts to cause Third Party Suppliers to fulfill their obligations under their agreements with Lilly and to make available component parts for the Devices to the Collaboration as contemplated by this AgreementSection 5.4.2. The Parties hereby agree that Lilly each approved CMO is approved solely for performance of Manufacturing within the scope of the applicable CMO agreement as approved by the Joint Manufacturing Committee. Through the Joint Manufacturing Committee, MTEM will keep Takeda informed of all activities of its CMOs and material information related to the Manufacturing [***] as the case may be. With respect to [***] MTEM will provide Takeda with reasonable access to its CMOs, including Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. permitting and enabling Takeda to accompany MTEM in audits and inspections and using reasonable efforts to cause its CMOs to permit Takeda to conduct audits and inspections, as well as for regulatory purposes and technical transfer. The Parties will coordinate audits and inspections through the Joint Manufacturing Committee. MTEM will provide Takeda with each CMO agreement prior to execution for review and comment and to ensure terms are consistent with MTEM’s obligations hereunder and under the Supply Agreement. Comments received within [***] of receipt by Takeda will be given good faith consideration. MTEM will not materially change any agreement with an approved CMO as it relates to [***] including any change to the criteria agreed upon by the Parties through the Joint Manufacturing Committee to which [***] should conform to be liable considered acceptable for its intended use, except in accordance with the Quality Agreement and otherwise subject to Amylin, its Affiliates or their respective directors, officers, shareholders, employees or agents for any Third Party Suppliers’ failure to deliver or failure of any Device as a result of components agreement of the Device manufactured by Third Party Suppliers or the failure of such components to comply with applicable Specifications, any representations or warranties of such Third Party Supplier or Applicable Laws, except to the extent such failure to comply is the result of Lilly’s gross negligence or willful misconduct. In the event Lilly receives any indemnification payments or other recovery from Third Parties performing services on behalf of Lilly for Manufacture of Devices containing Product, such amounts shall be shared equally by the Parties. To the extent legally or contractually permissible, Lilly shall obtain a written assignment of all patent rights and know-how that such Third Parties may develop by reason of work performed under this Agreement. Pre-filled cartridges containing drug shall be provided by a supplier mutually acceptable to the Parties, and Lilly shall have no liability under this Agreement for any delay in the availability of cartridges or any defect in the cartridge or drugJoint Manufacturing Committee.

Third Party Suppliers. The Takeda acknowledges that MTEM may contract with Third Parties contemplate that Lilly will assembleto fulfill its obligations to Manufacture and for Supply hereunder (each such Third Party, package and label the Devices (a “Final Assembly ActivitiesCMO”) and that component parts for the Devices will be provided to Lilly by Third Party suppliers (“Third Party Suppliers”). The Committee shall be responsible for overseeing negotiations for additional supply contracts with Third Party Suppliers where the Third Party Supplier will be material subject to the Collaboration, and Lilly shall provide Amylin with the opportunity to review such contracts reasonably in advance of execution, provided that Lilly may redact confidential information unrelated to the supply of component parts for the Devices from the copies approval of such contracts it provides CMO by the Joint Manufacturing Committee pursuant to Amylin. Lilly shall use its Commercially Reasonable Efforts to cause Third Party Suppliers to fulfill their obligations under their agreements with Lilly and to make available component parts for the Devices to the Collaboration as contemplated by this AgreementSection [Error! Reference source not found.]. The Parties hereby agree that Lilly each Approved CMO is approved solely for performance of Manufacturing of Supply within the scope of the applicable CMO agreement as approved by the Joint Manufacturing Committee. Through the Joint Manufacturing Committee, MTEM will keep Takeda informed of all activities of its CMOs and material information related to Manufacturing Discovery Material or Development Materials, as the case may be. With respect to Takeda Development Material, MTEM will provide Takeda with reasonable access to its CMOs, including permitting and enabling Takeda to accompany MTEM in audits and inspections and using reasonable Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. efforts to cause its CMOs to permit Takeda to conduct audits and inspections, as well as for regulatory purposes and technical transfer. The Parties will coordinate audits and inspections of CMOs through the Joint Manufacturing Committee. MTEM will provide Takeda with each CMO agreement prior to execution for review and comment and to ensure terms are consistent with MTEM’s obligations hereunder and under the Supply Agreement. Comments received [***] will be given good faith consideration. MTEM will not materially change any agreement with an Approved CMO as it relates to Supply, including any change to the criteria agreed upon by the Parties through the Joint Manufacturing Committee to which Supply should conform to be liable considered acceptable for its intended use, except in accordance with the Quality Agreement and otherwise subject to Amylin, its Affiliates or their respective directors, officers, shareholders, employees or agents for any Third Party Suppliers’ failure to deliver or failure of any Device as a result of components agreement of the Device manufactured by Third Party Suppliers or the failure of such components to comply with applicable Specifications, any representations or warranties of such Third Party Supplier or Applicable Laws, except to the extent such failure to comply is the result of Lilly’s gross negligence or willful misconduct. In the event Lilly receives any indemnification payments or other recovery from Third Parties performing services on behalf of Lilly for Manufacture of Devices containing Product, such amounts shall be shared equally by the Parties. To the extent legally or contractually permissible, Lilly shall obtain a written assignment of all patent rights and know-how that such Third Parties may develop by reason of work performed under this Agreement. Pre-filled cartridges containing drug shall be provided by a supplier mutually acceptable to the Parties, and Lilly shall have no liability under this Agreement for any delay in the availability of cartridges or any defect in the cartridge or drugJoint Manufacturing Committee.

Third Party Suppliers. The Parties contemplate acknowledge that Lilly Amylin will assembleManufacture the Pen Product and that certain materials, package and label the Devices including active pharmaceutical ingredient (“Final Assembly ActivitiesAPI”) ), diluents and that component parts for the Devices Pen Product and certain testing services will be provided to Lilly purchased by Third Party Amylin from third party suppliers (“Third Party Suppliers”). The Committee MSC shall be responsible for overseeing negotiations for additional any supply contracts agreements with Third Party Suppliers where not already in place as of the Third Party Supplier will be material Effective Date (including any amendments, modifications or extensions of those already in place) in accordance with the Letter Agreement between Amylin and Lilly dated January 30, 2004 except that the references to the Collaboration, and Lilly shall provide Joint Commercialization Committee in the letter are hereby replaced by MSC. Amylin with the opportunity to review such contracts reasonably in advance of execution, provided that Lilly may redact confidential information unrelated to the supply of component parts for the Devices from the copies of such contracts it provides to Amylin. Lilly shall use its Commercially Reasonable Efforts to cause all Third Party Suppliers to fulfill their obligations under their agreements with Lilly and to make available component parts for the Devices to the Collaboration as contemplated by this AgreementAmylin. The Parties agree that Lilly Amylin will not be liable to AmylinLilly, its Affiliates or and their respective directors, officers, shareholders, employees or agents for any Third Party Suppliers’ failure to deliver or failure of any Device Pen Product as a result of materials or components of the Device manufactured by Third Party Suppliers or the failure of such materials or components to comply with applicable Specifications, any representations or warranties of such Third Party Supplier or Applicable Laws, except to the extent such failure to comply is the result of Lilly’s gross negligence or willful misconduct. In the event Lilly Amylin receives any indemnification payments or other recovery from Third Parties Party Suppliers performing services on behalf of Lilly for Manufacture of Devices containing ProductAmylin, such amounts shall be shared equally by divided between Amylin and Lilly in proportion to their respective shares, at the Partiestime of the payment, of U.S. EQW Gross Profit and OUS EQW Gross Profit specifically associated with sales of Pen Product (as such terms are defined in Exhibit E of the Vial Supply Agreement) (less any royalty obligation to Amylin from Lilly) under the Collaboration Agreement, as amended. To the extent legally or contractually permissible, Lilly Amylin shall obtain a written assignment of all patent rights and know-how that such Third Parties Party Suppliers may develop by reason of work performed under this Agreement. Pre-filled cartridges containing drug shall be provided by a supplier mutually acceptable to the Parties, and Lilly shall have no liability under this Agreement for any delay in the availability of cartridges or any defect in the cartridge or drug.