Common use of Third Party Suppliers Clause in Contracts

Third Party Suppliers. The Parties acknowledge that each Party may contract with Third Parties to fulfill their obligations to Manufacture and supply Licensed Products or Components hereunder (each, a “CMO”) subject to the approval of such CMO (unless such CMO is an Existing CMO) by the Joint Manufacturing Committee pursuant to 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 “Existing CMOs”). The 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 keep the other informed of all activities of its CMOs and material information related to Manufacturing Licensed Products or Components. Each Party shall provide the other Party with reasonable access to its CMOs, including permitting and enabling such other Party to accompany such Party in audits and inspections and using reasonable efforts to cause its CMOs to permit such other Party to conduct audits and inspections, as well as for regulatory purposes and technical transfer and including using reasonable efforts to amend any existing agreements with its CMOs to enable compliance with this Section 6.7. The Parties will coordinate audits and inspections of CMOs through the Joint Manufacturing Committee. Other than agreements in effect as of the Effective Date with Existing CMOs, each Party 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 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 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 Manufacture Licensed Products (or Components) on the requesting Party’s behalf, except as may be permitted above, coordinated through the Joint Manufacturing Committee or permitted under the Mersana Supply Agreement, First Supply Chain Supply Agreements or Mutual Secondary Supply Agreements.

Third Party Suppliers. The Parties acknowledge contemplate that each 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 may contract suppliers (“Third Party Suppliers”). The Committee shall be responsible for overseeing negotiations for additional supply contracts with Third Parties 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 Manufacture and supply Licensed Products or Components hereunder (each, a “CMO”) subject make available component parts for the Devices to the approval of such CMO (unless such CMO is an Existing CMO) Collaboration as contemplated by the Joint Manufacturing Committee pursuant to 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 “Existing CMOs”)this Agreement. The Parties hereby agree that each Existing CMO is deemed Lilly will not be liable to be an Approved CMO solely Amylin, its Affiliates or their respective directors, officers, shareholders, employees or agents for performance any Third Party Suppliers’ failure to deliver or failure of Manufacturing any Device as a result of Licensed Products and Components, as the case may be, within the scope components of the Device manufactured by Third Party Suppliers or the failure of such components to comply with applicable Existing CMO 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. Through the Joint Manufacturing Committee, each Party Pre-filled cartridges containing drug shall keep the other informed of all activities of its CMOs and material information related to Manufacturing Licensed Products or Components. Each Party shall provide the other Party with reasonable access to its CMOs, including permitting and enabling such other Party to accompany such Party in audits and inspections and using reasonable efforts to cause its CMOs to permit such other Party to conduct audits and inspections, as well as for regulatory purposes and technical transfer and including using reasonable efforts to amend any existing agreements with its CMOs to enable compliance with this Section 6.7. The Parties will coordinate audits and inspections of CMOs through the Joint Manufacturing Committee. Other than agreements in effect as of the Effective Date with Existing CMOs, each Party 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 Effective Date with Existing CMOs have been be provided to Licensee for review prior by a supplier mutually acceptable to the Effective Date (the “Existing CMO Agreements”). Comments received within [***] Business Days will be given good faith consideration; providedParties, however, that each Party and Lilly shall have final say with respect to no liability under this Agreement for any delay in the terms and conditions on which it enters into availability of cartridges or any commercial supply agreement with any CMO subject to defect in the terms of the Mersana Supply Agreement, First Supply Chain Supply Agreements cartridge 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 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 Manufacture Licensed Products (or Components) on the requesting Party’s behalf, except as may be permitted above, coordinated through the Joint Manufacturing Committee or permitted under the Mersana Supply Agreement, First Supply Chain Supply Agreements or Mutual Secondary Supply Agreementsdrug.

Third Party Suppliers. The Parties acknowledge Takeda acknowledges that each Party MTEM may contract with Third Parties to fulfill their its obligations to Manufacture and supply Licensed Products or Components for Supply hereunder (eacheach such Third Party, a “CMO”) subject to the approval of such CMO (unless such CMO is an Existing CMO) by the Joint Manufacturing Committee pursuant to 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 “Existing CMOs”)[Error! Reference source not found.]. The Parties hereby agree that each Existing Approved CMO is deemed to be an Approved CMO approved solely for performance of Manufacturing of Licensed Products and Components, as the case may be, Supply within the scope of the applicable Existing CMO Agreementagreement as approved by the Joint Manufacturing Committee. Through the Joint Manufacturing Committee, each Party shall MTEM will keep the other Takeda informed of all activities of its CMOs and material information related to Manufacturing Licensed Products Discovery Material or ComponentsDevelopment Materials, as the case may be. Each Party shall With respect to Takeda Development Material, MTEM will provide the other Party Takeda with reasonable access to its CMOs, including permitting and enabling such other Party Takeda to accompany such Party MTEM in audits and inspections and using reasonable efforts to cause its CMOs to permit such other Party Takeda to conduct audits and inspections, as well as for regulatory purposes and technical transfer and including using reasonable efforts to amend any existing agreements with its CMOs to enable compliance with this Section 6.7transfer. The Parties will coordinate audits and inspections of CMOs through the Joint Manufacturing Committee. Other than agreements in effect as of the Effective Date with Existing CMOs, each Party MTEM will provide the other Party Takeda with each CMO agreement prior to execution for review and comment and to ensure terms are consistent with the contracting PartyMTEM’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 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. MTEM will not materially change any agreement with an Approved CMO as it relates to Supply, however, that each Party shall have final say with respect including any change to the terms and conditions on which it enters into any commercial supply agreement with any CMO subject to criteria agreed upon by 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 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 Manufacture Licensed Products (or Components) on the requesting Party’s behalf, except as may be permitted above, coordinated Parties through the Joint Manufacturing Committee or permitted under to which Supply should conform to be considered acceptable for its intended use, except in accordance with the Mersana Supply Agreement, First Supply Chain Supply Agreements or Mutual Secondary Supply AgreementsQuality Agreement and otherwise subject to agreement of the Joint Manufacturing Committee.

Third Party Suppliers. The Parties acknowledge Takeda acknowledges that each Party MTEM may contract with one or more Third Parties to fulfill their its obligations to Manufacture and supply Licensed Products or Components hereunder (eacheach such Third Party, a “Contract Manufacturing Organization” or “CMO”) subject to the approval of such CMO (unless such CMO is an Existing CMO) by the Joint Manufacturing Committee pursuant to 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 “Existing CMOs”)5.4.2. The Parties hereby agree that each Existing approved CMO is deemed to be an Approved CMO approved solely for performance of Manufacturing of Licensed Products and Components, as the case may be, within the scope of the applicable Existing CMO Agreementagreement as approved by the Joint Manufacturing Committee. Through the Joint Manufacturing Committee, each Party shall MTEM will keep the other Takeda informed of all activities of its CMOs and material information related to the Manufacturing Licensed Products or Components[***] as the case may be. Each Party shall With respect to [***] MTEM will provide the other Party Takeda with reasonable access to its CMOs, including permitting and enabling such other Party Takeda to accompany such Party MTEM in audits and inspections and using reasonable efforts to cause its CMOs to permit such other Party Takeda to conduct audits and inspections, as well as for regulatory purposes and technical transfer and including using reasonable efforts to amend any existing agreements with its CMOs to enable compliance with this Section 6.7transfer. The Parties will coordinate audits and inspections of CMOs through the Joint Manufacturing Committee. Other than agreements in effect as of the Effective Date with Existing CMOs, each Party MTEM will provide the other Party Takeda with each CMO agreement prior to execution for review and comment and to ensure terms are consistent with the contracting PartyMTEM’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 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 of receipt by Takeda will be given good faith consideration; provided, however, that each Party shall have final say . MTEM will not materially change any agreement with respect an approved CMO as it relates to [***] including any change to the terms and conditions on which it enters into any commercial supply agreement with any CMO subject to criteria agreed upon by 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 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 Manufacture Licensed Products (or Components) on the requesting Party’s behalf, except as may be permitted above, coordinated Parties through the Joint Manufacturing Committee or permitted under to which [***] should conform to be considered acceptable for its intended use, except in accordance with the Mersana Supply Agreement, First Supply Chain Supply Agreements or Mutual Secondary Supply AgreementsQuality Agreement and otherwise subject to agreement of the Joint Manufacturing Committee.

Third Party Suppliers. The Parties acknowledge that each Amylin will Manufacture the Pen Product and that certain materials, including active pharmaceutical ingredient (“API”), diluents and component parts for the Pen Product and certain testing services will be purchased by Amylin from third party suppliers (“Third Party may contract Suppliers”). The MSC shall be responsible for overseeing negotiations for any supply agreements with Third Parties to fulfill their obligations to Manufacture and supply Licensed Products or Components hereunder (each, a “CMO”) subject to the approval of such CMO (unless such CMO is an Existing CMO) by the Joint Manufacturing Committee pursuant to Section 3.3.3(b)(8). Set forth Party Suppliers not already in Schedule 6.7 are Mersana’s CMOs providing any Licensed Product Manufacturing critical service or product place as of the Effective Date (including any amendments, modifications or extensions of those already in place) in accordance with the “Existing CMOs”)Letter Agreement between Amylin and Lilly dated January 30, 2004 except that the references to the Joint Commercialization Committee in the letter are hereby replaced by MSC. Amylin shall use its Commercially Reasonable Efforts to cause all Third Party Suppliers to fulfill their obligations under their agreements with Amylin. The Parties hereby agree that each Existing CMO is deemed Amylin will not be liable to Lilly, its Affiliates and their respective directors, officers, shareholders, employees or agents for any Third Party Suppliers’ failure to deliver or failure of any Pen Product as a result of materials or components 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. In the event Amylin receives any indemnification payments or other recovery from Third Party Suppliers performing services on behalf of Amylin, such amounts shall be an Approved CMO solely for performance divided between Amylin and Lilly in proportion to their respective shares, at the time of Manufacturing the payment, of Licensed Products U.S. EQW Gross Profit and ComponentsOUS 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 case may beextent legally or contractually permissible, within the scope of the applicable Existing CMO Agreement. Through the Joint Manufacturing Committee, each Party Amylin shall keep the other informed obtain a written assignment of all activities patent rights and know-how that such Third Party Suppliers may develop by reason of its CMOs and material information related to Manufacturing Licensed Products or Components. Each Party shall provide the other Party with reasonable access to its CMOs, including permitting and enabling such other Party to accompany such Party in audits and inspections and using reasonable efforts to cause its CMOs to permit such other Party to conduct audits and inspections, as well as for regulatory purposes and technical transfer and including using reasonable efforts to amend any existing agreements with its CMOs to enable compliance with work performed under this Section 6.7. The Parties will coordinate audits and inspections of CMOs through the Joint Manufacturing Committee. Other than agreements in effect as of the Effective Date with Existing CMOs, each Party 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 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 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 Manufacture Licensed Products (or Components) on the requesting Party’s behalf, except as may be permitted above, coordinated through the Joint Manufacturing Committee or permitted under the Mersana Supply Agreement, First Supply Chain Supply Agreements or Mutual Secondary Supply Agreements.

Third Party Suppliers. The Parties acknowledge that each Amylin will Manufacture the EQW Product and that certain materials, including active pharmaceutical ingredient, diluents and component parts for the EQW Product and certain testing services will be purchased by Amylin from third party suppliers (“Third Party may contract Suppliers”). The MSC shall be responsible for overseeing negotiations for any supply agreements with Third Parties to fulfill their obligations to Manufacture and supply Licensed Products or Components hereunder (each, a “CMO”) subject to the approval of such CMO (unless such CMO is an Existing CMO) by the Joint Manufacturing Committee pursuant to Section 3.3.3(b)(8). Set forth Party Suppliers not already in Schedule 6.7 are Mersana’s CMOs providing any Licensed Product Manufacturing critical service or product place as of the Effective Date (including any amendments, modifications or extensions of those already in place) in accordance with the “Existing CMOs”)Letter Agreement between Amylin and Lilly dated January 30, 2004 except that the references to the Joint Commercialization Committee in the letter are hereby replaced by MSC. Amylin shall use its Commercially Reasonable Efforts to cause all Third Party Suppliers to fulfill their obligations under their agreements with Amylin. The Parties hereby agree that each Existing CMO is deemed Amylin will not be liable to Lilly, its Affiliates and their respective directors, officers, shareholders, employees or agents for any Third Party Suppliers’ failure to deliver or failure of any EQW Product as a result of materials or components 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. In the event Amylin receives any indemnification payments or other recovery from Third Party Suppliers performing services on behalf of Amylin, such amounts shall be an Approved CMO solely for performance divided between Amylin and Lilly in proportion to their respective shares, at the time of Manufacturing the payment, of Licensed Products U.S. EQW Gross Profit and ComponentsOUS EQW Gross Profit (less any royalty obligation to Amylin from Lilly) under the Collaboration Agreement, as amended. To the case may beextent legally or contractually permissible, within the scope of the applicable Existing CMO Agreement. Through the Joint Manufacturing Committee, each Party Amylin shall keep the other informed obtain a written assignment of all activities patent rights and know-how that such Third Party Suppliers may develop by reason of its CMOs and material information related to Manufacturing Licensed Products or Components. Each Party shall provide the other Party with reasonable access to its CMOs, including permitting and enabling such other Party to accompany such Party in audits and inspections and using reasonable efforts to cause its CMOs to permit such other Party to conduct audits and inspections, as well as for regulatory purposes and technical transfer and including using reasonable efforts to amend any existing agreements with its CMOs to enable compliance with work performed under this Section 6.7. The Parties will coordinate audits and inspections of CMOs through the Joint Manufacturing Committee. Other than agreements in effect as of the Effective Date with Existing CMOs, each Party 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 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 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 Manufacture Licensed Products (or Components) on the requesting Party’s behalf, except as may be permitted above, coordinated through the Joint Manufacturing Committee or permitted under the Mersana Supply Agreement, First Supply Chain Supply Agreements or Mutual Secondary Supply Agreements.

Third Party Suppliers. The Parties acknowledge Takeda acknowledges that each Party MTEM may contract with Third Parties to fulfill their its obligations to Manufacture and supply Licensed Products or Components for Supply hereunder (eacheach such Third Party, a “CMO”) subject to the approval of such CMO (unless such CMO is an Existing CMO) by the Joint Manufacturing Committee pursuant to 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 “Existing CMOs”)5.4.2. The Parties hereby agree that each Existing Approved CMO is deemed to be an Approved CMO approved solely for performance of Manufacturing of Licensed Products and Components, as the case may be, Supply within the scope of the applicable Existing CMO Agreementagreement as approved by the Joint Manufacturing Committee. Through the Joint Manufacturing Committee, each Party shall MTEM will keep the other Takeda informed of all activities of its CMOs and material information related to Manufacturing Licensed Products Discovery Material or ComponentsDevelopment Materials, as the case may be. Each Party shall With respect to Takeda Development Material, MTEM will provide the other Party Takeda with reasonable access to its CMOs, including permitting and enabling such other Party Takeda to accompany such Party MTEM in audits and inspections and using reasonable efforts to cause its CMOs to permit such other Party Takeda to conduct audits and inspections, as well as for regulatory purposes and technical transfer and including using reasonable efforts to amend any existing agreements with its CMOs to enable compliance with this Section 6.7transfer. The Parties will coordinate audits and inspections of CMOs through the Joint Manufacturing Committee. Other than agreements in effect as of the Effective Date with Existing CMOs, each Party MTEM will provide the other Party Takeda with each CMO agreement prior to execution for review and comment and to ensure terms are consistent with the contracting PartyMTEM’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 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. MTEM will not materially change any agreement with an Approved CMO as it relates to Supply, however, that each Party shall have final say with respect including any change to the terms and conditions on which it enters into any commercial supply agreement with any CMO subject to criteria agreed upon by 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 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 Manufacture Licensed Products (or Components) on the requesting Party’s behalf, except as may be permitted above, coordinated Parties through the Joint Manufacturing Committee or permitted under to which Supply should conform to be considered acceptable for its intended use, except in accordance with the Mersana Supply Agreement, First Supply Chain Supply Agreements or Mutual Secondary Supply AgreementsQuality Agreement and otherwise subject to agreement of the Joint Manufacturing Committee.

Third Party Suppliers. The Parties acknowledge a) This Agreement is subject to the requirements and policies of the applicable Third Party Suppliers which may be imposed and updated by such Third Party Suppliers from time to time, including, but not limited to, reporting requirements and the clauses set forth on Attachment A hereto. Licensee shall have sole responsibility for complying with all applicable Third Party Supplier requirements which are imposed on Licensee, and neither Vendor nor any of its Affiliates shall bear any responsibility for any fees or other requirements that each may be imposed on Licensee by any Third Party may contract Supplier, except as otherwise expressly specified in a Schedule. Licensee shall be responsible for the payment of all applicable Third Party Supplier fees that are billed either to Vendor or directly to Licensee by the Third Party Suppliers that result from Licensee’s (and as applicable its clients’) use of the Services, together with Third Parties any related administrative costs of Vendor. b) Licensee acknowledges that where access to fulfill their obligations to Manufacture and supply Licensed Products or Components hereunder (each, a “CMO”) some Data is subject to the approval of such CMO (unless such CMO is an Existing CMO) by the Joint Manufacturing Committee pursuant to 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 “Existing CMOs”). The 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 AgreementThird Party Supplier, Vendor may not be able to supply such Data until such approval is granted. Through Licensee further acknowledges that it may be required to enter into and maintain direct agreements (including the Joint Manufacturing Committeepayment of licensing fees) with the Third Party Suppliers for the receipt of certain Data from Vendor. Where any Third Party Supplier requires Licensee to enter into such an agreement, each Licensee shall, upon written request of Vendor, supply a copy of such agreement to Vendor, and Vendor shall not be obligated to provide the Service or Data until it receives the applicable agreement or confirmation from the relevant Third Party Supplier that Licensee is duly licensed. In addition, in the event of any termination of Licensee’s agreement with the Third Party Supplier, Licensee shall keep notify Vendor immediately and Vendor may suspend or terminate access to the other informed relevant Data. c) Vendor’s ability to grant Licensee rights relating to the Services is contingent upon all rights, titles, licenses, permissions and approvals obtained by Vendor from its Third Party Suppliers pertaining to the Services remaining in full force and effect. In the event that certain of all activities Vendor’s rights, titles, licenses, permissions or approvals pertaining to the Services from its Third Party Suppliers are altered, cancelled, terminated, rescinded or not renewed, or whenever the terms of its CMOs and material information related to Manufacturing Licensed Products or Components. Each Party shall provide the other Party with reasonable access to its CMOs, including permitting and enabling such other Party to accompany such Party in audits and inspections and using reasonable efforts to cause its CMOs to permit such other Party to conduct audits and inspections, as well as for regulatory purposes and technical transfer and including using reasonable efforts to amend any existing agreements with its CMOs to enable compliance with this Section 6.7. The Parties will coordinate audits and inspections of CMOs through the Joint Manufacturing Committee. Other than agreements in effect as of the Effective Date with Existing CMOs, each applicable Third Party 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 PartySuppliers require such discontinuance: (i) Licensee’s obligations hereunder and under the Mersana Supply Agreement, the First Supply Chain Supply Agreements and the Mutual Secondary Supply Agreements(and, as applicable. All CMO agreements in effect, or in substantially final draft, as its clients’) rights to use the affected portions of the Effective Date with Existing CMOs Services may be subject to change or termination, including, in some cases, automatic termination and (ii) Vendor may alter or terminate provision of Data or that portion of the Services that relates to such discontinuance. In each such instance neither Vendor nor the applicable Third Party Supplier shall have any liability other than for Vendor to make a pro- rata refund to Licensee of any fees that 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 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 Manufacture Licensed Products (or Components) on the requesting Party’s behalf, except as may be permitted above, coordinated through the Joint Manufacturing Committee or permitted under the Mersana Supply Agreement, First Supply Chain Supply Agreements or Mutual Secondary Supply Agreementsprepaid.