Common use of Technology Transfer Clause in Contracts

Technology Transfer. Beginning on the Effective Date, Manufacturer and Purchaser shall use commercially reasonable and diligent efforts to initiate, implement and complete a technology transfer to Purchaser’s Facility (the “Technology Transfer”) to enable Purchaser to manufacture (or have manufactured) each Product on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer shall include the following activities: (i) Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision of equipment suitable for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity.

Technology Transfer. Beginning 7.1 If for any reason EDT is unable to manufacture Product or provide sufficient quantity of Product to meet SM’s Minimum Purchase Requirements under this Agreement, after advance written notice to EDT from SM and an opportunity to cure not to exceed an additional ***, SM shall have the right to manufacture, or have manufactured by any substitute manufacturer, the Product, in addition to its other rights and privileges under this Agreement. In such event, EDT shall assist SM in qualifying a second source for the active ingredients in Product (excluding microsponge), providing technical assistance and documentation as necessary, including such manufacturing technology and know-how so as to permit another entity to manufacture such active ingredients, and EDT agrees to cooperate with SM to facilitate any technology transfer (excluding microsponge) required in furtherance of the foregoing. SM’s Minimum Purchase Requirements, and payment obligations to EDT pursuant to this Agreement, shall be temporarily suspended until EDT or the Contract Manufacturer can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by SM with the substitute manufacturer 7.2 EDT shall provide SM with data on the Effective Datechemical and physical properties, Manufacturer toxicity, and Purchaser handling, storing, and shipping information for any materials supplied to SM by EDT and any other information available to EDT that is necessary for the safe conduct of the manufacturing of the Product by SM or the substitute manufacturer. EDT shall use commercially reasonable supply SM with pertinent information regarding health or safety hazards to workers relating to materials supplied to SM by EDT. EDT shall update all of such information provided to SM as such information becomes available to EDT. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and diligent efforts filed separately with the Commission. 7.3 In the event of any transfer of manufacturing responsibilities pursuant to initiatethis Article 7, implement EDT shall make available to SM, and complete a technology transfer SM shall purchase, SM’s minimum requirements of microsponge components. The Parties shall negotiate in good faith with respect to Purchaser’s Facility (the “Technology Transfer”) appropriate price for such microsponge components, and, in any event, EDT shall offer such microsponge components to enable Purchaser SM on terms no less favorable than the price attributable to manufacture (the microsponge components included in Product previously supplied pursuant to this Agreement. 7.4 At such time as SM shall have the right to manufacture, or have manufactured, the Product in accordance with this Article 7, EDT shall be deemed to have granted to SM a license, under the Patents and Know-How (and any improvement in or modification thereof) each Product on a commercial scaleto make, sufficient to meet Purchaser’s requirements of such have made, use, have used, offer for sale, sell and import the Product for Distribution the Field in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product Territory. Such license shall ***, other than payments for Distribution microsponge components in the Seller Countries, as applicable, which Technology Transfer shall include the following activities: (i) Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision of equipment suitable for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility accordance with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity7.3 above.

Technology Transfer. Beginning on Subject to the Effective Dateterms and conditions of this Agreement (including, Manufacturer without limitation, Article 5 hereof), commencing promptly after the Amendment Date and Purchaser throughout the Term, TGC shall use commercially reasonable provide to a Third Party contract manufacturing organization or contract research organization (as applicable) designated by Celladon (each, a “Celladon Designee”) all manufacturing and diligent efforts other technology and know-how in TGC’s possession (and, if not owned by TGC, that TGC has a right to initiatedisclose), implement that is necessary to practice the Manufacturing Process and complete a technology transfer to Purchaser’s Facility manufacture and test the Mydicar pre-bulk drug substance manufactured hereunder (the “Technology Transfer”) to enable Purchaser to manufacture (or have manufactured) each Product on a commercial scale), sufficient to meet Purchaser’s requirements of such Product for Distribution as more fully described below and in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in Development Plan. It is contemplated that the Seller Countries, as applicable, which Technology Transfer shall include the following activities: (i) Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision of equipment suitable for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply AgreementCelladon Designee [*]; provided, however, if that TGC shall not be responsible for any such activity solely supports delays or failures to complete the Technology Transfer prior to the end of the Term to the extent caused by [*]. It is the intention of the parties that the Technology Transfer will enable the Celladon Designee(s) to replicate the Manufacturing Process to manufacture of Seller Products for Distribution and test Mydicar in the Seller Countriessame manner as TGC manufactures Mydicar pursuant to this Agreement and in the same manner as TGC tests or has tested Mydicar as of the Amendment Date or during the Term. The Technology Transfer shall include at least the following activities during the Term: (a) TGC shall provide to Celladon or a Celladon Designee the existing analytical methods for conformance testing of Mydicar, including [*] (b) TGC shall provide to Celladon or a Celladon Designee [*] in all such API shall be provided cases (i) as are necessary to Purchaser by Seller at no cost; provided furthermanufacture Mydicar as manufactured hereunder, howeverto test Mydicar or to support regulatory filings for Mydicar, that, if any such activity is substantially and (but not solelyii) related to the manufacture of Seller Products for Distribution extent in the Seller Countries possession and is also required for the manufacture control of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activityTGC; (ixc) following completion of the activities described TGC shall provide [*] in clause (vii), Purchaser’s submission of an application order to the FDA for Regulatory Approval enable such Celladon Designee to manufacture Products, for Distribution in the United States, at Purchaser’s Facility;Mydicar as manufactured hereunder and to test Mydicar [*] (xd) following completion of the activities described in clause (viii), Manufacturer’s submission, on TGC shall provide Celladon or a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEACelladon Designee [*]; and (xiiie) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities TGC shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity.[*]

Technology Transfer. Beginning on (a) Sublicensee acknowledges and agrees that ECC has delivered and made to Sublicensee a disclosure of a general introduction to the Effective DateTechnology and to its commercial feasibility prior to the execution of this Agreement. Except to the extent such information falls within one or more of the exceptions to the definition of "Confidential Information", Manufacturer all information disclosed by ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and Purchaser shall use commercially reasonable be deemed to be confidential. The timing and diligent efforts extent of additional disclosure by ECC to initiateSublicensee shall be as set forth in subparagraph 22(b) hereof. (b) Upon execution of this Agreement, implement and complete a technology transfer ECC shall provide Sublicensee with copies of the patents listed in Section B of Exhibit "B" hereto. Beyond that, ECC shall not be required to Purchaser’s Facility (provide additional information concerning, or disclosure of, the “Technology Transfer”) to enable Purchaser Sublicensee until Sublicensee provides to manufacture (or have manufactured) each Product on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer shall include the following activities: ECC (i) Purchaser’s installation written notice of ER Line 2 promptly following receipt at Purchaser’s Facility Sublicensee's intent to commercialize a Product, which written notice shall include detailed specifications for the designated Product, and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision evidence, reasonably satisfactory to ECC, of equipment suitable for Sublicensee's intent to commercialize the manufacture designated Product in the form of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance written documentation of technology transfer orders placed by Sublicensee of the manufacturing processes for both equipment needed by Sublicensee to produce and commercialize the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution designated Product or in the Seller Countries, which forecast shall be updated quarterly during form of written documentation from Sublicensee confirming the Term; (v) Manufacturer’s transfer dedication and/or modification of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities existing equipment necessary to prepare Purchaser’s Facility for CII products and submission to produce the DEA designated Product. Within ninety (90) days after ECC's receipt of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study items described in the first sentence of Section 4.2(dpreceding sentence, ECC shall provide to Sublicensee the following additional disclosure: (w) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required a Product specific recipe for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation production of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; designated Product; (x) following completion Product specific process specifications for the production of the activities described designated Product; (y) copies of all patent applications listed in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application the Exhibits hereto that ECC deems relevant to the applicable Regulatory Authorities in each production of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) designated Product; and (xz) with respect to each country; (xii) the Parties’ development a list of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility known raw materials suppliers and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activitypreferred equipment vendors.

Technology Transfer. Beginning on (a) Upon the Effective Datecompletion of Development Phase for each Product, Cardinal Health shall assist Purchaser in qualifying a second source selected by Purchaser (“Substitute Manufacturer”) to manufacture such Products in a tube presentation for Purchaser, providing technical assistance and documentation as necessary, at Purchaser’s expense. Such assistance shall include such manufacturing technology and know-how so as to permit the Substitute Manufacturer and to Manufacture such Product in the tube presentation. Cardinal Health agrees to cooperate with Purchaser shall use commercially reasonable and diligent efforts to initiate, implement and complete a facilitate any technology transfer to Purchaser’s Facility the Substitute Manufacturer required in furtherance of the foregoing. The Substitute Manufacturer shall be used to produce a Product for sale only in the circumstances as set forth in Section 18(b) below. For purposes of clarity, Cardinal Health shall not be required to transfer technology related to the DelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Prior to such transfer, the Substitute Manufacturer shall be required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreement. (the “Technology Transfer”b) If for any reason Cardinal Health is unable to enable supply any Product to Purchaser to manufacture (or have manufactured) each provide sufficient quantity of Product on a commercial scale, sufficient to meet Purchaser’s requirements of Minimum Purchase Requirements under this Agreement, after advance written notice to Cardinal Health from Purchaser and an opportunity to cure not to exceed an additional ***, Purchaser shall have the right to manufacture, or have manufactured by the Substitute Manufacturer, the Product in a tube presentation, provided that such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer right shall not include the following activities:right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and payment obligations to Cardinal Health pursuant to this Agreement, shall be temporarily suspended until Cardinal Health can resume its manufacturing obligations or the expiration of any substitute manufacturing or supply agreement entered into by Purchaser with the substitute manufacturer. Notwithstanding the foregoing, Cardinal Health shall have no obligation to transfer DelPouch packaging components, equipment or related technology to any third party. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. (ic) Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility Cardinal Health shall provide Purchaser with data on the chemical and such Purchaser’s Facility being appropriately updated physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to receive ER Line 2; (ii) Purchaser’s provision of equipment suitable Purchaser by Cardinal Health and any other information available to Cardinal Health that is necessary for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance of technology transfer safe conduct of the manufacturing processes for both of the ER Products and IR Products;applicable Product by Purchaser or the Substitute Manufacturer. Cardinal Health shall supply Purchaser with pertinent information regarding health or safety hazards to workers relating to materials supplied to Purchaser by Cardinal Health. Cardinal Health shall update all of such information provided to Purchaser as such information becomes available to Cardinal Health. (ivd) ManufacturerIn the event of any transfer of manufacturing responsibilities pursuant to this Article 18, Cardinal Health shall make available to Purchaser, and Purchaser shall purchase, Purchaser’s provision of a forecast of Seller’s and its Affiliates’ anticipated minimum requirements of Seller Products Microsponge components entrapped with the appropriate active and inactive ingredients, as the case may be. The Parties shall negotiate in good faith with respect to the appropriate price for Distribution such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the Seller Countriesprice attributable to the Microsponge components included in Product previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, which forecast equipment or related technology. (e) At such time as Purchaser shall have the right to manufacture, or have manufactured, any Product in accordance with this Article 18, Cardinal Health shall be updated quarterly during the Term; (v) Manufacturerdeemed to have granted to Purchaser a license under all of Cardinal Health’s transfer of all manufacturing patents and related know-how (and technical information related any improvement or modification thereof) to Productsmake, including all have made, use, have used, offer for sale, and import such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution Product in the United StatesTerritory, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products but only for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt that Cardinal Health is unable to supply the Products in accordance with the terms of the Regulatory Approvals described in clauses (ix) this Agreement, and (xi) with respect to each country; (xii) the Parties’ development of a transition plan EpiQuin Products, only for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution use in the United States field of pigmentation disorders, and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant only to the API Supply Agreement; providedextent such Product is available by prescription, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially and (but not solelyii) related with respect to the manufacture of Seller Products Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Such license shall bear no royalties, other than payments for Distribution Microsponge components in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activityaccordance with Section 18(d) above.

Technology Transfer. Beginning on (a) Sublicensee acknowledges and agrees that ECC has delivered and made to Sublicensee a disclosure of a general introduction to the Effective DateTechnology and to its commercial feasibility prior to the execution of this Agreement. Except to the extent such information falls within one or more of the exceptions to the definition of "Confidential Information", Manufacturer all information disclosed by ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and Purchaser shall use commercially reasonable be deemed to be confidential. The timing and diligent efforts extent of additional disclosure by ECC to initiateSublicensee shall be as set forth in subparagraph 22(b) hereof. (b) Upon execution of this Agreement, implement and complete a technology transfer ECC shall provide Sublicensee with copies of the patents listed in Section B of Exhibit "B" hereto. Beyond that, ECC shall not be required to Purchaser’s Facility (provide additional information concerning, or disclosure of the “Technology Transfer”) to enable Purchaser Sublicensee until Sublicensee provides to manufacture (or have manufactured) each Product on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer shall include the following activities: ECC (i) Purchaser’s installation written notice of ER Line 2 promptly following receipt at Purchaser’s Facility Sublicensee's intent to commercialize a Product, which written notice shall include detailed specifications for the designated Product, and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision evidence, reasonably satisfactory to ECC, of equipment suitable for Sublicensee's intent to commercialize the manufacture designated Product in the form of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance written documentation of technology transfer orders placed by Sublicensee of the manufacturing processes for both equipment needed by Sublicensee to produce and commercialize the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution designated Product or in the Seller Countries, which forecast shall be updated quarterly during form of written documentation from Sublicensee confirming the Term; (v) Manufacturer’s transfer dedication and/or modification of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities existing equipment necessary to prepare Purchaser’s Facility for CII products and submission to produce the DEA designated Product. Within ninety (90) days after ECC's receipt of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study items described in the first sentence of Section 4.2(dpreceding sentence, ECC shall provide to Sublicensee the following additional disclosure: (w) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required a Product specific recipe for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation production of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; designated Product; (x) following completion Product specific process specifications for the production of the activities described designated Product; (y) copies of all patent applications listed in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application the Exhibits hereto that ECC deems relevant to the applicable Regulatory Authorities in each production of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) designated Product; and (xz) with respect to each country; (xii) the Parties’ development a list of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility known raw materials suppliers and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activitypreferred equipment vendors.

Technology Transfer. Beginning on (a) Seller shall reasonably cooperate with and shall make its personnel available at all reasonable times to ensure the Effective Date, Manufacturer and Purchaser shall use commercially reasonable and diligent efforts to initiate, implement prompt and complete a technology transfer to Purchaser’s Facility Buyer of all Transferred Know-How, up to a maximum combined resource commitment of {*} until a maximum of {*} from Closing Date (the “Technology TransferTech Transfer Period”). In connection with the foregoing, Seller shall, at its sole cost and expense (except for the payment required pursuant to Section 6.3(b)) to enable Purchaser to manufacture (or have manufactured) each Product on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in during the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Tech Transfer shall include the following activities: Period: (i) Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2; {*}, (ii) Purchasermake introductions to, arrange for site visits with and, as appropriate, audits of any of Seller’s provision of equipment suitable for vendors and/or suppliers vending to and supplying the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; Business, and (iii) Purchaser’s performance of technology undertake such other activities as are necessary to effect the transfer of the manufacturing processes for both Transferred Know-How (collectively, the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related activities referred to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence two (2) sentences of this Section 4.2(d6.3(a) are hereinafter referred to as the “Tech Transfer Process”). Buyer acknowledges that Seller has publicly announced a lay-off, and that Seller has informed Buyer that the layoff includes scientific personnel familiar with the Acquired Assets, who will not be employed by Seller beyond January 2009. While Seller will {*} assist Seller in the completion of any remaining technology transfer {*} and only during an additional {*}, the parties intend that barring unforeseen circumstances the technology transfer should be completed within Tech Transfer Period. During the Tech Transfer Period, Buyer shall compile a reasonably detailed written list (the “Transferred Know-How List”) of the Know-How that falls within the definition of ‘Transferred Know-How Category’ and is either (a) reflected in the documentation Seller is required to provide to Buyer under this Agreement (or has been provided to Buyer as part of the due diligence process prior to the Closing Date) or (b) provided to Buyer through the Tech Transfer Process. Buyer shall provide such Transferred Know-How List to Seller {*}. {*}. The Transferred Know-How List shall not be deemed final until agreed to in writing by Buyer and Seller. (b) In connection with the foregoing, Buyer shall pay to Seller an amount equal to {*} of which {*} shall be performed using API supplied paid at the Closing and {*} shall be paid on the earlier of: (i) the {*} anniversary of the Closing or (ii) the date that Buyer provides written notice to Purchaser pursuant to Seller that it no longer requires the API Supply Agreement; provided, however, if any such activity solely supports the manufacture technology transfer services of Seller Products for Distribution as set forth in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity; (ix) following completion of the activities described in clause (viiSection 6.3(a), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity.

Technology Transfer. Beginning on On or promptly after the Effective Date, Manufacturer and Purchaser ViroPharma shall use commercially reasonable and diligent efforts to initiate, implement and arrange for a complete a technology transfer to PurchaserSchering or its designated Affiliate (a) such data and information in ViroPharma’s Facility possession reasonably requested by Schering related to the processes and procedures for the manufacture, testing, handling, storage, formulation and packaging of the bulk active Compound and the finished Products, (b) the specifications and release testing for the Compound and Products, (c) complete copies of the CMC sections for all of ViroPharma’s INDs for the Compound and/or Products, and (d) samples of all available reference standards for the Compound and Products, including any known impurities and/or metabolites (the “Technology TransferTransfer Materials”). Within seven (7) business days after delivery of the Transfer Materials by ViroPharma to enable Purchaser Schering, Schering shall inform ViroPharma of whether additional Transfer Materials are required, and if so, shall describe with particularity such additionally required Transfer Materials. The terms of the immediately preceding sentence shall also apply to any later deliveries of Transfer Materials delivered to Schering at their request. If Schering does not provide such notice to ViroPharma within such seven (7) business day period, then Schering shall be deemed to have such received such Transfer Materials required for it to make the determination regarding the Specifications described in Section 5.2 below. During the [***] period immediately following the Effective Date, ViroPharma shall, upon request, transfer to Schering any additional information described in Section 5.1(a) above not previously provided to Schering, and ViroPharma shall also, upon request by Schering, make reasonably available ViroPharma’s employees to Schering to discuss matters relating to the processes and procedures for the manufacture, testing, handling, storage, formulation and packaging of the bulk active Compound and the finished Products, and shall assist Schering in contacting ViroPharma’s Third Party manufacturing contractors involved with the manufacture of the Compound and/or Product, all as reasonably necessary to [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. advise and assist Schering or its designated Affiliate in the technology transfer, and the start-up and validation of the manufacturing process for the Compound and/or Products. Such access to personnel shall be during normal business hours and Schering shall pay ViroPharma for the reasonable travel costs and other out-of-pocket expenses incurred by such personnel, as well as a reasonable hourly rate to be agreed to by the Parties for the time of such personnel in excess of two hundred (200) hours during such [***] period, at Schering’s request in providing such advice and assistance. Following the successful completion of the technology transfer provided for under this Section 5.1, Schering (or have manufacturedits designated Affiliate or Third Party contractor) each Product on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer shall include the following activities: (i) Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision of equipment suitable be responsible for the manufacture of IR Products at Purchaserall of Schering’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance of technology transfer requirements for supplies of the manufacturing processes Compound and the Product for both the ER Products and IR Products; (iv) Manufacturer’s provision Territory in excess of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall initial supplies to be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of ViroPharma under Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity.5.2

Technology Transfer. Beginning on the Effective Date, Manufacturer and Purchaser shall use commercially reasonable and diligent efforts 9.1 In addition to initiate, implement and complete a any technology transfer to Purchaser’s Facility (the “Technology Transfer”) to enable Purchaser to manufacture (or have manufactured) each Product on a commercial scalecontemplated by any Co-Development Plan, sufficient to meet Purchaser’s requirements following completion of such Product for Distribution in the United States any Co-Development Plan and Seller’s (and its Affiliates’) requirements as part of each Seller Product for Distribution in the Seller Countriesany Co-Commercialisation Plan, as applicable, which Technology Transfer shall include the following activitiesAdaptimmune will: (ia) Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility reasonably assist Bellicum in establishing a […***…] for any Therapy comprising a Bellicum Candidate, and such Purchaser’s Facility being appropriately updated will allow and enable Bellicum to receive ER Line 2; work with […***…] (ii) Purchaser’s provision of equipment suitable for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall extent relevant). Such assistance will include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA[…***…]; and (xiiib) Purchaser’s installation provide ongoing technical assistance in relation to Bellicum's development and manufacturing of ER Line 1 the Bellicum Candidates and performance Therapies comprising a Bellicum Candidate as reasonably requested from time to time and during the Term. The details of all activities (including all qualification what technical assistance and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence transfer of Section 4.2(d) and technology will be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall required from Adaptimmune will be provided to Purchaser agreed upon by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation as part of a technology transfer plan to be initially prepared by Bellicum and approved by the JDC. The costs of such activitytechnical assistance and transfer shall be considered to be a Development Cost and subject to reimbursement in accordance with Article 10. Any technology transfer obligations and provision of confidential information will be subject to any Third Party restrictions relevant to such technology transfer and provision of confidential information. 9.2 In addition to any technology transfer contemplated by any Co-Development Plan, following completion of any Co-Development Plan and as part of any Co-Commercialisation Plan, Bellicum will: (a) reasonably assist Adaptimmune in establishing a […***…] for any Therapy comprising an Adaptimmune Candidate, and will allow and enable Adaptimmune to work with […***…] (to the extent relevant). Such assistance will include […***…]; and (b) provide ongoing technical assistance in relation to Adaptimmune's development and manufacturing of the Adaptimmune Candidates and Therapies comprising an Adaptimmune Candidate as reasonably requested from time to time and during the Term. The details of what technical assistance and transfer of technology will be required from Bellicum will be agreed upon by the Parties as part of a technology transfer plan to be initially prepared by Adaptimmune and approved by the JDC. The costs of such technical assistance and transfer shall be considered to be a Development Cost and subject to reimbursement in accordance with Article 10. Any technology transfer obligations and provision of confidential information will be subject to any Third Party restrictions relevant to such technology transfer and provision of confidential information

Technology Transfer. Beginning on Without prejudice to the Effective DateSupplier’s rights under this Agreement, Manufacturer Prestige may in its sole discretion and Purchaser at any time elect to implement the transfer of Know-how (save to the extent such Know-how comprises Intellectual Property that is made solely by the Supplier and/or its Affiliates and which is capable of being used independently of Prestige’s Intellectual Property and which shall use commercially reasonable and diligent efforts remain the property of the Supplier (or its Affiliates) pursuant to initiate, implement and complete a technology transfer Clause 20.10) relating to Purchaser’s Facility the Manufacture of the Products (the “Technology TransferManufacturing Know-How”) from the Supplier (or its Affiliates) to Prestige or one of Prestige’s Affiliates or a designated contract manufacturer by providing written notification to the Supplier at any time. Following such notice the Supplier (or its Affiliates) shall fully cooperate with Prestige with regard to the transfer and provide all necessary, reasonably required and customary assistance to Prestige to enable Purchaser Prestige to manufacture complete the transfer in a timely and effective manner. Without limitation to the foregoing the following provisions shall apply in the event of a transfer contemplated by this Clause 26: (A) upon notice of transfer under this Clause 26 Prestige and the Supplier shall (or have manufacturedshall procure that its Affiliates will) each agree a transfer plan which addresses, if required, reduction of production volumes and draw down of any Materials, any remaining Product and all other issues requiring consideration for the completion of such transfer in a timely and effective manner; (B) the Supplier shall (or shall procure that its Affiliates will) provide all such reasonable assistance with respect to the transfer of processes equivalent to those employed by the Supplier (or its Affiliates) during the Term of this Agreement (i.e., on a commercial scale, sufficient “like-for-like” basis); (C) Prestige will be responsible for all activities related to meet Purchaser’s requirements the development and preparation of data for use in regulatory submissions in connection with such Product transfer and the Supplier shall (or shall procure that its Affiliates will) without charge provide Prestige with copies of all documentation held by the Supplier (or its Affiliates) and necessary or otherwise reasonably requested by Prestige for Distribution in such purpose; (D) the United States and Seller’s Supplier (and its Affiliates’) requirements shall reasonably co-operate with Prestige in transferring the Manufacturing Know-How including making available to Prestige appropriate employees of each Seller Product for Distribution the Supplier (or its Affiliates) who are engaged in the Seller Countries, as applicable, which Technology Transfer shall include the following activities: (i) Purchaser’s installation Manufacture of ER Line 2 promptly following receipt at Purchaser’s Facility Product to provide information and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision of equipment suitable guidance for the manufacture transfer process, including consulting services, to the extent reasonably necessary for the completion of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products Manufacturing Know-How in a timely and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEAefficient manner; and (xiiiE) Purchaser’s installation Prestige shall pay the reasonable and properly incurred actual incremental costs of ER Line 1 the Supplier and performance its Affiliates in providing Prestige with assistance pursuant to sub-Clauses (B) and (D) above. Notwithstanding the transfer of all activities any Product under this Clause 26, the Supplier shall remain fully liable under the terms of this Agreement (including liability to any Governmental Entity) for all qualification and validation activitiesProducts which the Supplier (or its Affiliates) necessary to obtain Regulatory Approval to manufacture ER Products has Manufactured for Distribution in Prestige under the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence terms of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply this Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity.

Technology Transfer. Beginning on Prior to the Effective Datedate of termination of this Agreement (or as soon as possible after termination under Section 5.2), Manufacturer and Purchaser shall use commercially reasonable and diligent efforts to initiateCELLSCRIPT shall, implement and complete a technology at the request of Argos, transfer to Purchaser’s Facility Argos or to a designee of Argos the Process for Production of the Argos Product and Critical Starting Materials for the Argos Product, including all manufacturing technology and know-how related thereto (the “Technology Transfer”) ), it being understood that CELLSCRIPT shall have no obligation to enable Purchaser transfer any technology or know-how that is not owned by Argos (such as, but not limited to, CELLSCRIPT Information and Materials, including proprietary technology or know-how related to manufacture (Kits, enzymes, RNA [**], or have manufactured) each Product on a commercial scale, sufficient to meet Purchaser’s requirements methods of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements use of each Seller Product for Distribution in the Seller Countries, as applicable, which any thereof). Technology Transfer shall include at least the following activities: (ia) PurchaserCELLSCRIPT shall provide all pertinent information necessary or useful to manufacture the Argos Product and Critical Starting Materials for the Argos Product and to support regulatory filings for the Argos Product and Critical Starting Materials for the Argos Product, including without limitation analytical testing methods, protocols, process descriptions, batch records, manufacturing documentation, and other process and manufacturing data and documentation, provided that said pertinent information shall not include CELLSCRIPT Information and Materials, CELLSCRIPT’s installation of ER Line 2 promptly following receipt at PurchaserTechnology, or CELLSCRIPT’s Facility Kits, SOPs, analytical testing methods, protocols, process descriptions, batch records, manufacturing documentation, and such Purchaser’s Facility being appropriately updated to receive ER Line 2other process and manufacturing data and documentation that are not specifically for the Argos Product or Critical Starting Materials for the Argos Product; (iib) PurchaserCELLSCRIPT shall provide training sessions and reasonable assistance and cooperation at CELLSCRIPT’s provision site(s) of equipment suitable manufacture, in a manner that does not unreasonably interfere with CELLSCRIPT’s other business activities, in order to train Argos or its designee how to manufacture the Argos Product and Critical Starting Materials for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective DateArgos Product; (iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity.

Technology Transfer. Beginning on Prior to manufacturing the Effective DateProduct, Manufacturer and Purchaser shall use commercially reasonable and diligent efforts to initiate, implement and complete a technology transfer to Purchaser’s Facility (the “Technology Transfer”) to enable Purchaser to manufacture (or have manufactured) each Product on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer shall include the following activities: (i) Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision of equipment suitable for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall process will be performed using API supplied from Purchaser to SWI. Purchaser pursuant shall disclose (and provide copies, as applicable) to the API Supply Agreement; (viii) Purchaser’s performance of SWI all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) information related to the manufacture of Seller Products for Distribution the Product in the Seller Countries and Purchaser’s possession, that is also required for the manufacture of Products the Product by SWI (collectively “Manufacturing Technology”); provided that any such information is used solely for Distribution the purpose of manufacturing the Product in accordance with this Agreement. SWI acknowledges that such Manufacturing Technology is and shall remain the sole property of Purchaser and/or its Affiliates, and nothing herein shall be deemed to convey to SWI any right therein except as required for the purpose of manufacturing the Product in accordance with this Agreement. The steps, planning and obligations of the Parties regarding the transfer of the Manufacturing Technology for such Product are set forth in the United Statestechnology transfer master plan attached in Exhibit D (the “Technology Transfer Master Plan”). Provided that Purchaser supply SWI with the needed amount of Compound at *** to SWI, SWI will manufacture the Parties shall agree upon an appropriate allocation required number of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution Batches as outlined in the United States, at Purchaser’s Facility; (x) following completion Technology Transfer Master Plan and a minimum of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, *** validation Batches of an application to the applicable Regulatory Authorities in each of the Seller Countries Product. Purchaser shall be responsible for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product any and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) all regulatory requirements with respect to each country; (xii) the Parties’ development Product. SWI shall provide to Purchaser data required by Purchaser to qualify SWI’s facility as per the Technology Transfer Master Plan. Upon request, Purchaser will provide SWI with, assistance or on-site support as may be reasonably required by SWI in connection with the transfer of the manufacturing technology. Such assistance will be provided *** for a transition plan for DEA Procurement Quota for purposes number of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution days as set forth in the United States and to manufacture extended release Seller Products for Distribution in Technology Transfer Master Plan. Purchaser shall support the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study one-time costs as described in the first sentence Technology Transfer Master Plan and purchase from SWI each validation Batch that meets the Specifications at the Price set forth in Exhibit B. If any of Section 4.2(dthe validation Batches of a Product does not comply with the Specifications, Supplier shall have *** (***) months to re-manufacture and be performed using API supplied deliver the number of validation Batch(es) that failed to meet the Specifications. If SWI is unable within that *** (***)-month period to manufacture and deliver to Purchaser pursuant the validation Batch(es), Section 9.2(c) shall apply. Purchaser will be reimbursed for *** any validation Batches that fail to meet the API Supply Agreement; providedSpecifications, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countriesevent that such failure is due to SWI’s mistake, such API shall be provided negligence or failure to Purchaser by Seller at no cost; provided furtherfollow Purchaser’s instructions. In the event any validation batches fail to meet the Specifications for any other reason, howeverexcept for Purchaser’s mistake, that if negligence or failure to provide SWI with any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation portion of the costs of such activityManufacturing Technology, SWI will ***.

Technology Transfer. Beginning on the Effective Date, Manufacturer and Purchaser (a) Toshiba shall use commercially all reasonable and diligent efforts to initiatedevelop, implement and, in exchange for the payments made by SanDisk under the Common R&D Agreement, upon successful development of 0.21, 0.16, 0.13 * micron process technology applicable to the manufacturing and complete testing of NAND Flash Memory Products ("NAND PROCESS TECHNOLOGY") that can be implemented in a commercially viable manner, Toshiba shall deliver such technology and all improvements thereto * developed by Toshiba during the term of the Common R&D Agreement, to each of the DSC and Yokkaichi foundry facilities and such other manufacturing facilities as may hereafter be agreed upon by the Parents. Timing of the delivery of technology transfers shall be based on, among other things, available capacity and shall be in accordance with the decision to be made from time to time by the Management Committee. The * INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. parties intend that the Yokkaichi and DSC facilities should run the same technologies in similar time frames. (b) Whenever a technology transfer to Purchaser’s Facility (the “is required hereunder, Toshiba shall deliver such level of NAND Process Technology Transfer”) to enable Purchaser to manufacture (or have manufactured) each Product on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer shall include the following activities: (i) Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision of equipment suitable for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities manufacturing facility as would be normal practice by the Toshiba Semiconductor Company whenever it transfers a technology to a new manufacturing facility or transfers a new or advanced technology to an existing manufacturing facility in each order to achieve successful implementation of the Seller Countries for Regulatory Approval newly transferred technology. (c) A technology transfer hereunder shall be deemed complete when the transferred technology passes a reasonable qualification procedure to be mutually agreed upon by Toshiba and SanDisk. (d) Following the Closing, Toshiba shall use its best efforts to assist DSC in achieving the same productivity in the manufacturing of Products as achieved at the Yokkaichi facility. However, the parties understand and agree that Toshiba does not warrant that the DSC facility will be able to manufacture Seller Products, for Distribution in such country, the same quality and yield as experienced at Purchaser’s Facility;the Yokkaichi facility. (xie) on a country-by-country basis, Purchaser’s scale-up The costs of Product and Seller Product manufacturing at Purchaser’s Facilityall technology transfers described in this Section 7.01 shall be borne by Toshiba or by DSC as set forth in SCHEDULE 7.01, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect such expenses to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which be borne by DSC shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution included in the United States and to manufacture extended release Seller Products for Distribution Start-Up Costs as defined in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity7.02.

Technology Transfer. Beginning Upon determination by the Development Committee that a Product based on a Feasible Prototype is ready for commercialization, C▇▇▇ will have the option but not the obligation to manufacture such Product, or to have such Product manufactured by a third party. Cardica will continue to supply to C▇▇▇, upon C▇▇▇’▇ request and at a cost of [*] per unit, such additional units of the Product over the [*] units described in Section 5.2(C) above as C▇▇▇ may reasonably request for the further testing [*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. and development of the Product. Upon the first FDA Approval of a Product in the Field that is based on a Feasible Prototype that the Development Committee determines is ready for commercialization, C▇▇▇ will have the sole responsibility for manufacturing such Product, or having such Product manufactured, at its sole expense. Upon C▇▇▇’▇ request, to enable C▇▇▇ to assume such responsibility, Cardica will transfer to C▇▇▇, at no additional cost, all equipment, including all pre-production tooling, and Cardica Know-How, including but not limited to, all trade secret, manufacturing and supplier information included therein, related to the Products that is reasonably necessary for C▇▇▇ to manufacture such Product (“Transferred Product”). Upon request from C▇▇▇, Cardica will provide, at no additional cost, reasonable technical assistance to C▇▇▇ for the Transferred Product based on the Effective Date, Manufacturer and Purchaser shall use commercially reasonable and diligent efforts to initiate, implement and complete a technology transfer to Purchaser’s Facility (mutual availability of the “Technology Transfer”) to enable Purchaser to manufacture (or have manufactured) each Product on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicableparties, which Technology Transfer shall include the following activities: (assistance may include: i) Purchaser’s installation training of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision of equipment suitable for C▇▇▇ personnel in connection with the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iiiTransferred Product, ii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly during the Term; (v) Manufacturer’s transfer of all manufacturing know-how and technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution in the United States, at Purchaser’s Facility, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports advice concerning the manufacture of Seller Products for Distribution Transferred Product, and iii) testing of sample Transferred Product to verify that such Transferred Product complies with applicable specifications established by the Development Committee to confirm successful transfer of technology to C▇▇▇ hereunder. Additionally, on C▇▇▇’▇ request, the parties will negotiate the terms under which Cardica may provide engineering services to assist C▇▇▇ in the Seller Countries, such API shall be provided design and modification of Transferred Product to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries meet customer and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval by the DEA; and (xiii) Purchaser’s installation of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activityregulatory requirements.

Technology Transfer. Beginning on (a) Within ninety (90) days of the Effective Date, Manufacturer Cytokinetics shall, and Purchaser shall use commercially reasonable cause its Affiliates to, at its own cost and diligent efforts expense, deliver to initiate(at Bayer’s direction) Bayer or its designated Affiliate, implement true and complete a copies of all Cytokinetics Know-How that are necessary or reasonably useful (as reasonably determined by Cytokinetics) for Bayer to initiate Development of the Licensed Product in the Field in the Licensed Territory pursuant to the Development Plan as specified in the initial plan for technology transfer attached to Purchaser’s Facility this Agreement as Schedule 3.9 (such plan, the “Technology Transfer Plan” and such initial technology transfer, the “Initial Technology Transfer”). Within three (3) months following such Initial Technology Transfer, Bayer may identify any additional Cytokinetics Know-How that Bayer reasonably believes is missing from such Initial Technology Transfer and is necessary or reasonably useful for Bayer to enable Purchaser initiate Development of the Licensed Product in the Field in the Licensed Territory pursuant to manufacture the Development Plan and, upon such identification by Bayer, Cytokinetics will provide such missing information if it exists and is in Cytokinetics’ Control. (or have manufacturedb) each Product Thereafter, on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, as applicable, which Technology Transfer shall include the following activities: (i) Purchaser’s installation of ER Line 2 promptly following receipt at Purchaser’s Facility and such Purchaser’s Facility being appropriately updated to receive ER Line 2; (ii) Purchaser’s provision of equipment suitable for the manufacture of IR Products at Purchaser’s Facility as soon as possible following the Effective Date; (iii) Purchaser’s performance of technology transfer of the manufacturing processes for both the ER Products and IR Products; (iv) Manufacturer’s provision of a forecast of Seller’s and its Affiliates’ anticipated requirements of Seller Products for Distribution in the Seller Countries, which forecast shall be updated quarterly continuing basis during the Term;, Cytokinetics shall, without any additional compensation, and shall cause its Affiliates to, promptly disclose and deliver to Bayer or its designated Affiliate or Sublicensee, as Bayer may reasonably request, true and complete copies of all written, graphic or electronic embodiments of all additional Cytokinetics Technology that are necessary or reasonably useful for Bayer to initiate Development of the Licensed Product in the Field in the Licensed Territory (whether existing as of the Effective Date or coming into Cytokinetics’ Control thereafter) that have not been previously provided to Bayer (or its Affiliate or Sublicensee). In particular, from time to time during the Term, Cytokinetics shall notify Bayer of any new Cytokinetics Technology that come into Cytokinetics’ Control to the extent reasonably useful for the Development of the Licensed Product in the Licensed Territory. (vc) ManufacturerUpon Bayer’s transfer reasonable request, Cytokinetics shall, without any additional compensation, provide Bayer with up to [*] of all manufacturing know-how and technical information related to Productsassistance in connection with such Initial Technology Transfer, including all such know-how and reasonable access to Cytokinetics’ technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the License; (vi) if other CII products are manufactured at Purchaser’s Facility, Purchaser’s submission to the DEA of all documentation required to register Purchaser’s Facility with respect to tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA; (vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for Distribution personnel involved in the United Statesresearch and Development of the Compound and Licensed Product. If Bayer requests additional technical assistance [*], at Purchaser’s FacilityCytokinetics shall provide such technical assistance, using the equipment at Purchaser’s Facility to manufacture IR Products and ER Line 2 to manufacture ER Products, which activities provided that Bayer shall include stability and bioequivalence studies with respect to registration/validation batches of Products manufactured at Purchaser’s Facility and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; (viii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Seller Products for Distribution in the Seller Countries, in Purchaser’s Facility and using the equipment at Purchaser’s Facility to manufacture immediate release Seller Products and ER Line 2 to manufacture extended release Seller Products, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and shall be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that, if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required reimburse Cytokinetics on a quarterly basis for the manufacture of Products for Distribution in documented, reasonable cost incurred by Cytokinetics to provide such additional technical assistance, calculated on the United States, the Parties shall agree upon an appropriate allocation basis of the costs of such activity; (ix) following completion of the activities described in clause (vii), Purchaser’s submission of an application to the FDA for Regulatory Approval to manufacture Products, for Distribution in the United States, at Purchaser’s Facility; (x) following completion of the activities described in clause (viii), Manufacturer’s submission, on a country-by-country basis, of an application to the applicable Regulatory Authorities in each of the Seller Countries for Regulatory Approval to manufacture Seller Products, for Distribution in such country, at Purchaser’s Facility; (xi) on a country-by-country basis, Purchaser’s scale-up of Product and Seller Product manufacturing at Purchaser’s Facility, and Manufacturer’s corresponding wind-down of Product manufacturing at Manufacturer’s Facility, within a reasonable period of time following receipt of the Regulatory Approvals described in clauses (ix) and (x) with respect to each country; (xii) the Parties’ development of a transition plan for DEA Procurement Quota for purposes of discontinuation of Product manufacturing at Manufacturer’s Facility and transition of all Product manufacturing to Purchaser’s Facility, which shall be subject to approval FTE Rate multiplied by the DEA; and (xiii) Purchaser’s installation number of ER Line 1 and performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture ER Products for Distribution in the United States and to manufacture extended release Seller Products for Distribution in the Seller Countries in Purchaser’s Facility using ER Line 1, which activities shall include stability studies and the bioequivalence study described in the first sentence of Section 4.2(d) and be performed using API supplied to Purchaser pursuant to the API Supply Agreement; provided, however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall be provided to Purchaser by Seller at no cost; provided further, however, that if any such activity is substantially (but not solely) related to the manufacture of Seller Products for Distribution in the Seller Countries and is also required for the manufacture of Products for Distribution in the United States, the Parties shall agree upon an appropriate allocation of the costs of such activityCytokinetics FTEs.