Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.
Appears in 3 contracts
Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Technology Transfer. Subject During the term of this Agreement, Gilead will make the following technology transfers available to Licensee:
(a) Within ninety (90) days following the Effective Date, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead as of the Effective Date relating to the manufacture of Sof and Sof Product to the extent and in the manner specified in Appendix 3 hereto.
(b) Within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for a Sof/LDV Product, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of LDV and Sof/LDV Product to the extent and in the manner specified in Appendix 3 hereto.
(c) Within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for an LDV Product, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of LDV Product to the extent and in the manner specified in Appendix 3 hereto. With respect to each of the foregoing technology transfers, Licensee shall notify Gilead of its desire to receive such technology transfer within the time period therefor, and following receipt of such notice Gilead will promptly make the applicable technology transfer. If Licensee does not notify Gilead of its desire to receive a particular technology transfer within the time period therefor, then Gilead will be under no obligation to make such technology transfer. The know-how transferred to Licensee pursuant to the terms of the Development Supply Agreementthis Section 5.5 shall be sufficient to enable Licensee to manufacture API, Sof Product, Sof/LDV Product and LDV Product, as soon as reasonably practicableapplicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Knowat commercial-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activitiesscale quantities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam Gilead shall have no obligations further obligation to transfer any other know-how under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCothis Agreement.
Appears in 3 contracts
Sources: License Agreement, License Agreement, License Agreement
Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreementthis Agreement (including, without limitation, Article 5 hereof), commencing promptly after the Amendment Date and throughout the Term, TGC shall provide to a Third Party contract manufacturing organization or contract research organization (as applicable) designated by Celladon (each, a “Celladon Designee”) all manufacturing and other technology and know-how in TGC’s possession (and, if not owned by TGC, that TGC has a right to disclose), that is necessary to practice the Manufacturing Process and to manufacture and test the Mydicar pre-bulk drug substance manufactured hereunder (the “Technology Transfer”), as more fully described below and in the Development Plan. It is contemplated that the Celladon Designee [*]; provided, however, that TGC shall not be responsible for any 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 and test Mydicar in the same 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 any required consents of [*]
(b) TGC shall provide to Celladon or a Celladon Designee [*] in all such Third Party cases (i) as are necessary to manufacture Mydicar as manufactured hereunder, to test Mydicar or to support regulatory filings for Mydicar, and MedCo’s written agreement (ii) to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided extent in the immediately preceding sentence, MedCo possession and control of TGC;
(c) TGC shall be solely responsible for contracting with provide [*] in order to enable such Third Party manufacturer Celladon Designee to manufacture Mydicar as manufactured hereunder and to test Mydicar [*]
(and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3d) for the supply of such Licensed Product and Alnylam TGC shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam provide Celladon or a Celladon Designee [*]; and
(e) TGC shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.[*]
Appears in 2 contracts
Sources: Manufacturing Agreement, Manufacturing Agreement (Targeted Genetics Corp /Wa/)
Technology Transfer. Subject In the event that QIAGEN is unable to supply the Product in accordance with any purchase order, or otherwise in accordance with the terms of the Development Supply this Agreement, within sixty (60) days after the firm delivery date for such purchase order, then upon ArcherDX's written request QIAGEN shall (i) grant to ArcherDX, and hereby grants to ArcherDX, a worldwide, royalty-free (except royalty-bearing licenses from third parties in effect and disclosed to ArcherDX in advance of such license grant) non-exclusive right and license, with the right to grant sublicenses solely for the purpose of complying with technology transfer obligations under the Third Party agreements, under all relevant, QIAGEN intellectual property to make, have made, use, import and export Products; and (ii) provide, or release from Escrow, to ArcherDX or its designee (which may include another manufacturer or a Third Party to a ArcherDX agreement) with all assistance and materials, including but not limited to SOPs, formulations, know-how, processes, batch records and other documents and materials as soon as ArcherDX may reasonably practicablerequest, but to enable ArcherDX or a Third Party to manufacture the Products, provided that QIAGEN shall not be obliged to expense more than 160 hours of working time for such assistance. Notwithstanding the foregoing, ArcherDX shall use commercially reasonable efforts not to accept technology transfer obligations in no event later than future Third Party Agreements. Each of ArcherDX and any Third Party that ArcherDX designates to manufacture the fifth (5th) anniversary Products must also agree in writing with QIAGEN to observe the terms of this Agreement relating to confidentiality of Products and QIAGEN's proprietary rights and information transferred pursuant to this Section 2.14, in particular, the Effective Date, Alnylam shall initiate identification and protection of QIAGEN trade secrets. ArcherDX or its designee may continue to exercise the licensed rights provided in this Section 2.14 only until QIAGEN notifies ArcherDX that it is again able to supply ArcherDX's Products requirements and has successfully delivered Products from two consecutive purchase orders after such notification in full conformity with this Agreement. If a technology transfer to MedCoprovision is invoked in an agreement by ArcherDX, or to its and at the request of the Third Party manufacturer(s) of Licensed which invoked the technology transfer provision, QIAGEN shall use commercially reasonable efforts to enter into an agreement to supply Product, selected by MedCo and reasonably acceptable on essentially equal terms as, to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of other party in the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoAgreement.
Appears in 2 contracts
Sources: Supply and Manufacturing Agreement (ArcherDX, Inc.), Supply and Manufacturing Agreement (ArcherDX, Inc.)
Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of Beginning on the Effective Date, Alnylam Manufacturer and Purchaser shall initiate use commercially reasonable and diligent efforts to initiate, implement and complete a technology transfer to MedCoPurchaser’s Facility (the “Technology Transfer”) to enable Purchaser to manufacture (or have manufactured) each Product on a commercial scale, or sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Third Party manufacturer(sAffiliates’) requirements of Licensed Producteach Seller Product for Distribution in the Seller Countries, selected by MedCo 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 reasonably acceptable such Purchaser’s Facility being appropriately updated to Alnylam, receive ER Line 2;
(ii) Purchaser’s provision of Alnylam Know-How that is reasonably necessary or useful equipment suitable for the Manufacture 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 Licensed Productmanufacturing 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 shall make available its personnel on a reasonable basis technical information related to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expenseProducts, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred 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 such Manufacturing technology transfer within [***] days after receipt tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of an invoice therefor. Alnylam all activities necessary to prepare Purchaser’s Facility for CII products and its Affiliates shall keep complete and accurate records in sufficient detail submission to enable the payments payable hereunder to be determined. Alnylam shall not be DEA of all documentation required to perform technology transfer register Purchaser’s Facility with the DEA;
(vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to more than one Third Party manufacturer obtain Regulatory Approval to manufacture Products for each stage 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 Licensed Product supply chain API Supply Agreement;
(i.e.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, Bulk Drug Substancein 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, Bulk Drug Product which activities shall include stability studies and Finished Product). Promptly after MedCo’s written requestthe 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, Alnylam however, if any such activity solely supports the manufacture of Seller Products for Distribution in the Seller Countries, such API shall use Commercially Reasonable Efforts be provided to assign to MedCo Purchaser by Seller at no cost; provided further, however, that, if any manufacturing agreement between Alnylam and a Third Party that such activity is solely substantially (but not solely) related to the manufacture of Licensed 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. Such assignment , 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 terms DEA; and
(xiii) Purchaser’s installation of ER Line 1 and conditions 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 agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoactivity.
Appears in 2 contracts
Sources: Transitional Supply Agreement (Depomed Inc), Transitional Supply Agreement (Depomed Inc)
Technology Transfer. Subject 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 chemical and physical properties, toxicity, and 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 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 filed separately with the Commission.
7.3 In the event of any transfer of manufacturing responsibilities pursuant to this Article 7, EDT shall make available to SM, and SM shall purchase, SM’s minimum requirements of microsponge components. The Parties shall negotiate in good faith with respect to the appropriate price for such microsponge components, and, in any event, EDT shall offer such microsponge components to SM on terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later less favorable than the fifth (5th) anniversary of price attributable to the Effective Date, Alnylam microsponge components included in Product previously supplied pursuant to this Agreement.
7.4 At such time as SM shall initiate a technology transfer have the right to MedComanufacture, or have manufactured, the Product in accordance with this Article 7, EDT shall be deemed to its Third Party manufacturer(s) of Licensed Producthave granted to SM a license, selected by MedCo under the Patents and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary (and any improvement in or useful modification thereof) to make, have made, use, have used, offer for sale, sell and import the Product for the Manufacture of Field in the Licensed Product, and Territory. Such license shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records , other than payments for microsponge components in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting accordance with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo7.3 above.
Appears in 2 contracts
Sources: Manufacturing and Supply Agreement (Skinmedica Inc), Manufacturing and Supply Agreement (Skinmedica Inc)
Technology Transfer. Subject (a) Sublicensee acknowledges and agrees that ECC has delivered and made to Sublicensee a disclosure of a general introduction to the terms Technology 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 Development Supply exceptions to the definition of "Confidential Information", all information disclosed by ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and shall be deemed to be confidential. The timing and extent of additional disclosure by ECC to Sublicensee shall be as set forth in subparagraph 22(b) hereof.
(b) Upon execution of this Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary ECC shall provide Sublicensee with copies of the Effective Datepatents listed in Section B of Exhibit "B" hereto. Beyond that, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam ECC shall not be required to perform technology transfer provide additional information concerning, or disclosure of, the Technology to more than one Third Party manufacturer Sublicensee until Sublicensee provides to ECC (i) written notice of Sublicensee's intent to commercialize a Product, which written notice shall include detailed specifications for each stage the designated Product, and (ii) evidence, reasonably satisfactory to ECC, of Sublicensee's intent to commercialize the designated Product in the form of written documentation of orders placed by Sublicensee of the Licensed equipment needed by Sublicensee to produce and commercialize the designated Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided or in the immediately form of written documentation from Sublicensee confirming the dedication and/or modification of existing equipment necessary to produce the designated Product. Within ninety (90) days after ECC's receipt of the items described in the preceding sentence, MedCo ECC shall be solely responsible for contracting with such Third Party manufacturer provide to Sublicensee the following additional disclosure: (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3w) a Product specific recipe for the supply production of such Licensed the designated Product; (x) Product specific process specifications for the production of the designated Product; (y) copies of all patent applications listed in the Exhibits hereto that ECC deems relevant to the production of the designated Product; and Alnylam shall have no obligations under such agreement between MedCo (z) a list of known raw materials suppliers and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCopreferred equipment vendors.
Appears in 2 contracts
Sources: Sublicense Agreement (Earthshell Container Corp), Sublicense Agreement (Earthshell Container Corp)
Technology Transfer. Subject to the terms of the Development Supply Agreement31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within MARKED BY [***] days after receipt of an invoice therefor], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform Clause 31.5, facilitate a one-time technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain Purchaser (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Productor Purchaser’s designee) (the “Technology Transfer”). Promptly after MedCo’s written request, Alnylam The Parties shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and create a Third Party that is solely related technology transfer plan relating to the manufacture Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of Licensed Products. Such assignment the Products and (unless initiated pursuant to Clause 31.2) shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and conditions GSK Intellectual Property in accordance with the Technology Transfer Plan and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A) or Clause 37.2, the Technology Transfer Plan will survive for [***] from such agreementtermination or expiration date. For clarity, including the Purchaser shall not be required to reimburse GSK for any required consents Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will be unable to meet, any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the part of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such Third Party and MedCo’s written agreement failure is not due to assume all the obligations any act or omission of Alnylam under such agreement Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)), Purchaser shall be undertaken after such assignment, but Alnylam shall remain solely responsible for relieved of its obligations under Clause 4.1 to purchase certain requirements for Products from GSK, as set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and one Technology Transfer in respect of Commercial Products, such agreement arising prior to such assignment. Except as provided in that:
(A) the immediately preceding sentence, MedCo shall be solely responsible for contracting with such recipient Third Party manufacturer and/or manufacturing site of a Technology Transfer in respect of Commercial API may be a different from the recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(and B) if any Technology Transfer has been initiated in respect of Commercial API pursuant to a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other Third Party manufacture provision of Clause 31.1 (but this is without prejudice to whom Alnylam has initiated technology transfer as set forth the Purchaser’s rights to implement a Technology Transfer in this Section 5.3respect of Commercial Products pursuant to any provision of Clause 31.1); and
(C) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain if any such consent Technology Transfer has been initiated in respect of Commercial Products pursuant to a form reasonably acceptable provision of Clause 31.1, no additional Technology Transfer in respect of Commercial Products may subsequently be initiated or required pursuant to MedCothe same or any other provision of Clause 31.1 (but this is without prejudice to the Purchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 2 contracts
Sources: Commercial Manufacturing and Supply Agreement (Roivant Sciences Ltd.), Commercial Manufacturing and Supply Agreement (Dermavant Sciences LTD)
Technology Transfer. Subject 2.1 As soon as possible following the execution of this Agreement, Genable shall provide to Spark, unless it has already done so prior to the terms execution of the Development Supply this Agreement, data regarding GT038, as soon as Genable determines may reasonably practicablebe required by Spark to successfully perform the Manufacturing Services. The foregoing data shall include, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be limited to:-
(i) appropriate in-vitro and in-vivo analytical methods and procedures;
(ii) information as to handling and storage conditions; and
(iii) the desired Specifications for the Product.
2.2 It is acknowledged by the Parties that the Genable Assays shall be required by Spark in order to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product Manufacturing Services. Genable and Finished Product). Promptly after MedCo’s written request, Alnylam Spark shall use Commercially Reasonable Efforts to assign complete the transfer of the Genable Assays to MedCo Spark within [**] months of the execution of this Agreement. The Genable Assays shall remain the sole property of Genable at all times. Spark covenants and undertakes to Genable to maintain the Genable Assays in confidence and not to use the Genable Assays for any other purpose other than the manufacture of the Product pursuant to this Agreement.
2.3 It is acknowledged by the Parties that the Spark Assays shall be required by Spark in order to perform the Manufacturing Services. Spark warrants to Genable that the Spark Assays are functioning and qualified/validated as appropriate to the stage of development for the purpose of manufacturing agreement between Alnylam and biological for human use. The Spark Assays shall remain the sole property of Spark at all times.
2.4 Spark shall only be entitled to outsource assay testing to a Third Party that is solely related listed in Exhibit E or to a Third Party approved by Genable, such approval not to be unreasonably withheld or delayed.
2.5 Each of the Parties shall bear all of their own expenses in relation to the performance of the services set out in this Section 2.
2.6 Spark shall remain the sole owner of the Spark Intellectual Property. Genable shall remain the sole owner of the Genable Intellectual Property.
2.7 Spark shall remain the sole owner of the Spark Improvements. Any Spark Improvements which are made jointly by at least one employee/consultant of Spark and at least one employee/consultant of Genable shall be assigned to Spark by Genable at Spark’s request
2.8 Genable shall remain the sole owner of the Genable Improvements. Any Genable Improvements which are made jointly by at least one employee/consultant of Genable and at least one employee/consultant of Spark shall be assigned to Genable by Spark at Genable’s request.
2.9 Spark grants to Genable an [**] to the Spark Improvements as are made jointly by at least one employee/consultant of Spark and at least one employee/consultant of Genable for use with GT038.
2.10 Genable grants to Spark an [**] to the Genable Improvements as are made jointly by at least one employee/consultant of Genable and at least one employee/consultant of Spark for the manufacture of Licensed Products. Such assignment AAV-based therapeutic products; provided however, that any such use shall be subject to the terms and conditions provisions of such agreement, including any required consents Clause 3.4 of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoLicence Agreement.
Appears in 2 contracts
Sources: Manufacturing Agreement (Spark Therapeutics, Inc.), Manufacturing Agreement (Spark Therapeutics, Inc.)
Technology Transfer. Subject (a) Upon the completion 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 terms of Substitute Manufacturer to Manufacture such Product in the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a tube presentation. Cardinal Health agrees to cooperate with Purchaser to facilitate any technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture Substitute Manufacturer required in furtherance of the Licensed Productforegoing. 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, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam Cardinal Health shall not be required to perform transfer technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed ProductsDelPouch or Microsponge, except to the extent necessary to fill Microsponge entrapped with active and inactive ingredients into a tube. Such assignment Prior to such transfer, the Substitute Manufacturer shall be subject required to sign a confidentiality and non-use agreement at least as restrictive as that set forth in Section 15 of this Agreement.
(b) If for any reason Cardinal Health is unable to supply any Product to Purchaser or provide sufficient quantity of Product to meet Purchaser’s 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 terms right to manufacture, or have manufactured by the Substitute Manufacturer, the Product in a tube presentation, provided that such right shall not include the right to manufacture the Microsponge or DelPouch. Purchaser’s Minimum Purchase Requirements, and conditions of such agreementpayment obligations to Cardinal Health pursuant to this Agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible 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 contracting Confidential Treatment and filed separately with such Third Party manufacturer the Commission.
(c) Cardinal Health shall provide Purchaser with data on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to Purchaser by Cardinal Health and any other Third Party manufacture information available to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) Cardinal Health that is necessary for the safe conduct of the manufacturing of the 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 Licensed information provided to Purchaser as such information becomes available to Cardinal Health.
(d) In 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 minimum requirements of 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 such Microsponge components, and, in any event, Cardinal Health shall offer such Microsponge components to Purchaser on terms no less favorable than the price attributable to the Microsponge components included in Product and Alnylam previously supplied pursuant to this Agreement. Cardinal Health shall have no obligations with respect to sale of DelPouch components, 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 deemed to have granted to Purchaser a license under all of Cardinal Health’s patents and related know-how (and any improvement or modification thereof) to make, have made, use, have used, offer for sale, and import such agreement between MedCo Product in the Territory, but only for such period of time that Cardinal Health is unable to supply the Products in accordance with the terms of this Agreement, and (i) with respect to the EpiQuin Products, only for use in the field of pigmentation disorders, and only to the extent such Third Party manufacturerProduct is available by prescription, and (ii) with respect to the Benzoyl Peroxide Products, only to the extent such Product is available by prescription. Alnylam Such license shall use Commercially Reasonable Efforts to obtain any such consent bear no royalties, other than payments for Microsponge components in a form reasonably acceptable to MedCoaccordance with Section 18(d) above.
Appears in 2 contracts
Sources: License and Supply Agreement (Skinmedica Inc), License and Supply Agreement (Skinmedica Inc)
Technology Transfer. Subject 30.1 If:
(A) GSK will not be supplying Products for Commercialisation pursuant to the terms of the Development Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam GSK shall initiate facilitate a one-time technology transfer to MedCo, the Purchaser (or to its Third Party manufacturer(sPurchaser’s designee) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for (the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product“Technology Transfer”). Promptly after MedCo’s written request, Alnylam The Parties shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and create a Third Party that is solely related technology transfer plan relating to the manufacture Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of Licensed the Products. Such assignment , and shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and conditions of such agreementGSK Intellectual Property in accordance with the Technology Transfer Plan and the timelines, including any required consents of such Third Party formats, and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignmentother guidelines set forth therein. Except as provided for a Technology Transfer pursuant to Clause 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 12 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the immediately preceding sentencecircumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, MedCo or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be solely responsible relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoProducts from GSK.
Appears in 2 contracts
Sources: Clinical Manufacturing and Supply Agreement (Roivant Sciences Ltd.), Clinical Manufacturing and Supply Agreement (Dermavant Sciences LTD)
Technology Transfer. Subject 3.1 WAKUNAGA shall transfer as promptly after the Effective Date as possible to MELINTA on an “as is” basis (i) complete copies of all of its files relating to the terms Wakunaga Patents, (ii) copies of written documentation relating to the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How Wakunaga Proprietary Information that is reasonably necessary or useful for MELINTA to perform its obligations or exercise its rights under this Agreement, and, to the Manufacture extent that Abbott transfers same to WAKUNAGA with the right to disclose to MELINTA, (iii) copies of all files relating to the Abbott Patents, and (iv) copies of all Abbott Proprietary Information received pursuant to the Termination Agreement.
3.2 WAKUNAGA shall, to the extent within the scope of the Licensed ProductWakunaga Patents, and Wakunaga Proprietary Information, Abbott Patents and/or Abbott Proprietary Information, provide MELINTA with technical support during the term of this Agreement under the conditions set forth in this Section 3.2. WAKUNAGA personnel shall make available its personnel on a reasonable basis not be required to consult with MedCo provide MELINTA or such Third Party manufacturer(sany Sublicensee of MELINTA in excess of ten (10) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred days of support with respect to such Manufacturing technology transfer within the subject matter of this Agreement which may occur at any time following the Effective Date. In the event that, subject to WAKUNAGA’s prior consent after negotiation between the Parties, which consent shall not be unreasonably withheld, WAKUNAGA will provide support in excess of ten (10) days of support, MELINTA hereby agrees to pay or have MELINTA Sublicensee pay WAKUNAGA at the rate of [***] days after receipt (or such other reasonable rate as notified by WAKUNAGA upon thirty (30) days’ prior written notice) for time spent by WAKUNAGA personnel in connection with any support services requested by MELINTA or any MELINTA Sublicensee. WAKUNAGA personnel for the foregoing technical support may include up to forty (40) hours of an invoice therefor. Alnylam time of AbbVie personnel at WAKUNAGA’s sole discretion, or such other amount as agreed by AbbVie, and its Affiliates all such personnel shall keep complete sign reasonable and accurate records in sufficient detail to enable customary confidentiality agreements as reasonably agreed by the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e.Parties.
3.3 WAKUNAGA shall, Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts reasonable efforts to assign cause AbbVie to, take all commercially reasonable steps necessary to MedCo any manufacturing agreement between Alnylam provide declarations, consents and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreementsignatures, including any as well as perform all other activities reasonably required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply transfer of Proprietary Information as per Sections 3.1 and 3.2 above. The Parties recognize that WAKUNAGA cannot assure MELINTA that AbbVie will comply with all such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCorequests.
Appears in 2 contracts
Sources: License Agreement (Melinta Therapeutics, Inc. /New/), License Agreement (Melinta Therapeutics, Inc. /New/)
Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s 's expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s 's written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s 's written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.
Appears in 2 contracts
Sources: License and Collaboration Agreement (Medicines Co /De), License and Collaboration Agreement (Medicines Co /De)
Technology Transfer. Subject to 6.01 Within 60 days after the terms execution of the Development Supply this Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and ETHYPHARM shall make available to HMRI all of the ETHYPHARM TECHNOLOGY. The exact manner by which this disclosure shall occur will be decided by the technical personnel of HMRI after consultation with the technical personnel of ETHYPHARM. The goal of this disclosure shall be to provide the information it requires in order to be able to receive rapid approval of the DOSAGE FORM by the FDA. This disclosure will include, but not be limited to, information regarding the composition of the formulation, all biostudies carried out on the formulations including summaries as well as raw data, methods of manufacture, quality control assays, methods of storing, methods of packaging, etc. This disclosure will include written materials (in English) prepared by ETHYPHARM personnel, visits by HMRI personnel to ETHYPHARM’s facilities and visits by ETHYPHARM’s personnel to HMRI’s facilities in the. United States.
6.02 HMRI will reimburse ETHYPHARM for the reasonable and customary expenses associated with the technology transfer. These expenses include internal costs, such as employee salaries and external costs, such as the travel expenses. ETHYPHARM will obtain HMRI’s approval prior to incurring any expenses associated with the technology transfer. The technical personnel of HMRI will determine the most appropriate mechanism for estimating and approving costs associated with the technology transfer after consultation with ETHYPHARM. ETHYPHARM will submit invoices to HMRI detailing its personnel expenses for the technology transfer on a reasonable basis to consult monthly basis. HMRI will reimburse ETHYPHARM for its expenses associated with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] 30 days after of its receipt of an invoice thereforthe invoice.
6.03 HMRI will be responsible for obtaining the appropriate approvals by the FDA in the TERRITORY. Alnylam HMRI will use its best efforts to file the supplemental NDA on the initial DOSAGE FORM rapidly, and its Affiliates shall keep complete and accurate records will have the supplemental NDA filed by July 1, 1998. HMRI will also be responsible for manufacturing the DOSAGE FORMS for sale in sufficient detail to enable the payments payable hereunder to be determinedTERRITORY. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage After completion of the Licensed Product supply chain (i.e.TECHNOLOGY TRANSFER, Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts ETHYPHARM agrees to assign continue to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related provide technical support to HMRI throughout the manufacture term of Licensed Products. Such assignment shall be subject to the terms and conditions of such this agreement, including any required consents when requested by HMRI.
6.04 During the period in which HMRI is seeking FDA approval of such Third Party and MedCo’s written agreement to assume all the obligations DOSAGE FORM, HMRI will keep ETHYPHARM advised of Alnylam under such agreement to be undertaken after such assignmentthe status of the regulatory submission. Once final approval of the FDA is obtained for said DOSAGE FORM, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in HMRI will launch the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply product within 90 days of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoreceiving final approval.
Appears in 1 contract
Sources: Non Exclusive License Agreement (Biovail Corp International)
Technology Transfer. Subject to Under the terms of the Development Commercial Supply Agreement, as soon as reasonably practicableGSK will have the right, but in no event later than the fifth (5th) anniversary at its election, to receive technology transfer from Gilead of the Effective Date, Alnylam shall initiate manufacturing processes for bulk ADV and Licensed Products used by Gilead's Third-Party suppliers [ * ] if GSK makes an election to manufacture either bulk ADV or finished Licensed Product either for China or for the GSK Territory as a technology transfer whole as provided herein. GSK may elect to MedCo, or to its Third Party manufacturer(s) of manufacture either bulk ADV and finished Licensed Product, selected by MedCo and reasonably acceptable to Alnylamor finished Licensed Product alone, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred each case with respect to China alone, and also with respect to the entire GSK Territory (less China, if GSK made such Manufacturing election for China prior to making such election for the entire GSK Territory). For an initial transfer of manufacturing processes as to which GSK has not elected to assume responsibility in the GSK Territory previously, GSK shall give at least [ * ] written notice to commence such transfer, and the Parties will complete transfer of all such relevant information to GSK within [ * ] after the date of commencement of transfer, subject to acceptance criteria as more fully set forth in the Commercial Supply Agreement. GSK shall [ * ] in relation to any such technology transfer. Such [ * ] shall comprise [ * ] Such [ * ] shall also be documented and subject to audit by GSK. For the avoidance of doubt, GSK shall remain obligated to purchase amounts of bulk ADV and Licensed Products for which it submits binding forecasts or orders pursuant to the Commercial Supply Agreement, notwithstanding any election it makes hereunder. If GSK separately exercises its right to manufacture hereunder with respect to China, and later with respect to the remainder of the GSK Territory (or vice versa), then Gilead shall only be obligated to provide GSK with technology transfer within [***of any improvements Controlled by Gilead to the manufacturing process earlier transferred to GSK that have been implemented by Gilead's Third-Party suppliers [ * ] days after receipt Similarly, if GSK separately exercises its right to manufacture hereunder with respect to bulk ADV, and later with respect to finished Licensed Products, then Gilead shall only be obligated to provide GSK with technology transfer of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail any improvements Controlled by Gilead to enable the payments payable hereunder manufacturing process earlier transferred to be determined. Alnylam GSK that have been implemented by Gilead's Third-Party suppliers [ * ] Except as expressly provided herein, Gilead shall not be required to perform provide further technology transfer to more than one Third for process changes that Gilead or its Third-Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCosuppliers develop or implement.
Appears in 1 contract
Technology Transfer. Subject to the terms of Upon determination by the Development Supply AgreementCommittee that a Product based on a Feasible Prototype is ready for commercialization, as soon as reasonably practicable, C▇▇▇ will have the option but in no event later than not the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer obligation to MedComanufacture such Product, or to its Third Party manufacturer(shave 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 Licensed 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, selected by MedCo 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 reasonably acceptable to Alnylam, of Alnylam Cardica Know-How How, including but not limited to, all trade secret, manufacturing and supplier information included therein, related to the Products that is reasonably necessary or useful 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 Manufacture Transferred Product based on the mutual availability of the Licensed parties, which assistance may include: i) training of C▇▇▇ personnel in connection with the manufacture of Transferred Product, ii) advice concerning the manufacture of Transferred Product, and shall make available its personnel 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 a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written C▇▇▇’▇ request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to parties will negotiate the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement under which Cardica may provide engineering services to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided assist C▇▇▇ in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (design and any other Third Party manufacture modification of Transferred Product to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product meet customer and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoregulatory requirements.
Appears in 1 contract
Sources: License, Development and Commercialization Agreement (Cardica Inc)
Technology Transfer. Subject to After the terms Effective Date and promptly upon written request by Metagenomi (and in any event within ninety (90) days following designation of the Development Supply Agreementapplicable CMO (as defined below), as soon as reasonably practicableprovided that such CMO is able to support this timeline), but in no event later than the fifth (5th) anniversary Acuitas will conduct a single full transfer of the Effective Datethen-current formulation process, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo raw materials supply and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful analytical characterization for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage manufacture of the Licensed Product supply chain (i.e.the “Transferred Technology”), Bulk Drug Substanceto Metagenomi or a single cGMP contract manufacturing organization (“CMO”) designated by Metagenomi and subject to Acuitas’ prior written consent, Bulk Drug Product and Finished Productwhich will not be unreasonably withheld, conditioned or delayed the (“Technology Transfer”) pursuant to a mutually agreed plan (the “Technology Transfer Plan”). Promptly after MedCo’s written requestFor clarity, Alnylam shall use Commercially Reasonable Efforts it will not be unreasonable for Acuitas to assign withhold consent if it provides credible evidence that the CMO is subject to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related Deficiency. Acuitas consents to the CMOs set forth on Appendix 2.3. (Acuitas will provide reasonable assistance to enable such CMO to manufacture such Licensed Product. Initiation of such technology transfer will be determined by Metagenomi and will be for the then- current formulation of Licensed ProductsProduct. Such assignment shall Acuitas will be subject reimbursed for such activities by Metagenomi on an FTE basis and Metagenomi will also be responsible for all external costs incurred by Acuitas relating to transfer of Licensed Product formulation to such CMO, provided such costs have been approved by Metagenomi in advance. For clarity, the terms then-current formulation of Licensed Product will mean a single LNP formulation previously tested by Metagenomi in accordance with the Workplan (as defined in the Development and conditions Option Agreement). Once such Licensed Product formulation is transferred to such CMO, Metagenomi will assume responsibilities for future manufacturing of such agreementLicensed Product. If Metagenomi determines, including any required consents of such Third Party in Metagenomi’s sole discretion, that Metagenomi has a bona fide reason to engage a subsequent, additional or different CMO (the “Subsequent CMO”) after the Initial Technology Transfer, Acuitas will provide reasonable assistance to Metagenomi and MedCo’s written agreement the Subsequent CMO to assume all the obligations of Alnylam under such agreement to be undertaken after such assignmenttransfer Know- How relating then-current formulation process, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentenceraw materials supply, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) analytical characterization for the supply manufacture of such Licensed Product (a “Subsequent Technology Transfer” and Alnylam shall have no obligations under together with the Initial Technology Transfer, the “Technology Transfer”). Acuitas will provide reasonably requested ongoing technical support if requested by Metagenomi with such agreement between MedCo support reimbursed on a reasonable time, materials, and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoFTE basis.
Appears in 1 contract
Technology Transfer. Subject A. In addition to the terms granting of the Development Supply Agreementaforesaid licenses under the Technology, as soon as reasonably practicableupon Effective Date of this Agreement and the payment of the portion of the License Fee described in Paragraph III.A. above Tessera will transfer to Licensee, but in no event not later than the fifth thirty (5th30) anniversary of days from the Effective Date, Alnylam shall initiate a technology transfer to MedCocertain of the Technology, or to its Third Party manufacturer(s) of Licensed Productincluding certain TCC package specifications, selected by MedCo Standards and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful certain Technical Information for the Manufacture TCC packages licensed herein.
B. Tessera will make available on at least a semiannual basis, improvements which have been reduced to practice including changes and modifications in Standards, methods, materials and specifications during the term of this Agreement through Tessera’s regularly published Technical Briefing Bulletin or substantially equivalent method. Notwithstanding the foregoing, Tessera is under no obligation to transfer and/or license any information whether confidential, proprietary or otherwise that it may be prohibited from transferring to Licensee by contract with a third party or applicable law. In the case Tessera proposes to transfer proprietary or Confidential information to Licensee, Tessera will first provide Licensee a non-confidential outline of the Licensed Productproposed Confidential information, but shall not undertake or complete any transfer unless it first receives Licensee’s written acknowledgment and approval. Notwithstanding any provision to the contrary, Tessera shall not be under any obligation to transfer or disclose actual patent applications or related documents to Licensee.
C. For a period of up to twelve (12) months commencing with the Effective Date of this Agreement, and shall according to a mutually agreeable time schedule and manpower assignment schedule, Tessera will make certain of its engineering staff available at its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expenseSan ▇▇▇▇ facilities for transfer activities, including joint activities with Licensee’s engineers, as may be necessary in accordance with mutual agreement of the Costs reasonably parties to successfully complete the Technology transfer; provided, Tessera shall provide up to sixty (60) working man days of engineering support during first twelve month period for such transfer activity. If at the end of such transfer activity, Licensee has a good faith belief that more training is needed in certain technical areas, Licensee shall specifically define such technical areas to Tessera in writing and Tessera shall then provide up to an additional thirty (30) working man-days of engineering support for the Licensee defined technical areas during first twelve month period for such transfer activity. Licensee agrees to pay all reasonable coach class air travel and hotel charges incurred by Alnylam Tessera personnel in connection with such technology transfer activitiesengineering support performed at any of Licensee’s facilities outside of San ▇▇▇▇. MedCo Additional engineering interactions, conducted to collaborate on technical issues of mutual concern, shall reimburse Alnylam such Costs incurred with respect be supported by each party at its own expense.
D. Additional engineering support (not to such Manufacturing technology transfer within exceed sixty (60) working days) beyond the initial twelve month period for an additional twelve (12) month period may be made available, according to a mutually agreeable time schedule and manpower assignment schedule, at a per diem rate of US $[***] days after receipt of an invoice therefor. Alnylam per support engineer, plus reasonable air travel and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCohotel charges.
Appears in 1 contract
Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5tha) anniversary Within ninety (90) days of the Effective Date, Alnylam Cytokinetics shall, and shall initiate a technology transfer cause its Affiliates to, at its own cost and expense, deliver to MedCo(at Bayer’s direction) Bayer or its designated Affiliate, or to its Third Party manufacturer(s) true and complete copies of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam all Cytokinetics Know-How that is reasonably 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 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 initiate Development of the Licensed Product in the Field in the Licensed Territory pursuant to the Development Plan and, upon such identification by Bayer, Cytokinetics will provide such missing information if it exists and is in Cytokinetics’ Control.
(b) Thereafter, on a 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 Manufacture Development of the Licensed ProductProduct in the Licensed Territory.
(c) Upon Bayer’s reasonable request, and shall make available its personnel on a reasonable basis Cytokinetics shall, without any additional compensation, provide Bayer with up to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam [*] of technical assistance in connection with such technology transfer activitiesInitial Technology Transfer, including reasonable access to Cytokinetics’ technical personnel involved in the research and Development of the Compound and Licensed Product. MedCo If Bayer requests additional technical assistance [*], Cytokinetics shall provide such technical assistance, provided that Bayer shall reimburse Alnylam Cytokinetics on a quarterly basis for the documented, reasonable cost incurred by Cytokinetics to provide such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable additional technical assistance, calculated on the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage basis of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to FTE Rate multiplied by the manufacture number of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoCytokinetics FTEs.
Appears in 1 contract
Sources: Collaboration and License Agreement (Cytokinetics Inc)
Technology Transfer. Subject 3.1 Initial Technology Transfer. Schedule D, attached hereto, identifies specific components of technology Controlled by Alnylam or its Affiliates that Alnylam believes may be reasonably required or useful to effect the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, Monsanto (or to its Third Party manufacturer(sdesignated Affiliate(s)) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How Intellectual Property that is reasonably necessary or useful for the Manufacture exercise of Monsanto’s rights under the Licensed Product, and shall make available its personnel on licenses granted pursuant to Section 2.1(a). Within a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within period of [**] following the Effective Date (the “Technology Identification Period”), Monsanto shall identify which specific components of technology listed in Schedule D that Monsanto wishes to receive under the technology transfer process described in this Section 3.1 and shall notify Alnylam thereof by identifying such desired components of technology in Schedule I attached hereto. As soon as reasonably practical, but in no event later than [**] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage end of the Licensed Product supply chain Technology Identification Period (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Productthe “Initial Technology Transfer Period”). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to deliver the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer documentation for each item as set forth in this Schedule I (which may be amended from time to time by mutual agreement of the Parties, the “Technology Transfer Plan”). During the [**] day period following the Initial Technology Transfer Period (the “Technology Transfer Definition Period”), the Parties will discuss and mutually agree upon the training processes and activities, and the requisite number of Alnylam personnel to conduct such activities, for each item set forth in the Technology Transfer Plan and amend the Technology Transfer Plan to include such training processes and activities and personnel commitment and budget for such activities (as described in Section 5.3) for 3.2 below). During the supply [**] month period following the completion of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. the Technology Transfer Definition Period (“Technology Training Period”), Alnylam shall use Commercially Reasonable Efforts to obtain make available to Monsanto such number of technical personnel as may be set forth in the Technology Transfer Plan to answer any questions or provide training and instruction as set forth in the Technology Transfer Plan concerning the items delivered pursuant to this Section 3.1, in connection with Monsanto’s Discovery, Development, Commercialization and Manufacture of Licensed Products hereunder. Upon Alnylam’s belief that it has completed its technology transfer activities under the Technology Transfer Plan, Alnylam shall so notify Monsanto in writing and no later than [**] days after receipt of such consent notice from Alnylam Monsanto shall notify Alnylam in a form reasonably acceptable writing as to MedCowhether or not Monsanto agrees that Alnylam has completed its technology transfer activities under the Technology Transfer Plan. If Monsanto fails to provide such notice to Alnylam within such time period, then Monsanto shall be deemed to agree that Alnylam’s activities under the Technology Transfer Plan are completed. In the event that Monsanto notifies Alnylam in writing within such time period that it does not agree that such activities have been completed, then the Parties will discuss the items in dispute and work in good faith to amicably resolve the situation as promptly as possible, but in no event later than [**] days after Alnylam’s receipt of Monsanto’s notice.
Appears in 1 contract
Sources: License and Collaboration Agreement
Technology Transfer. Subject During the term of this Agreement, Cytocom will make the following technology transfers available to Licensee:
(a) Within ninety (90) days following the Effective Date, Cytocom will make a one-time technology transfer available to Licensee of know-how owned or controlled by Cytocom as of the Effective Date relating to the manufacture of NTX and NTX Product to the extent and in the manner specified in Appendix 3 hereto.
(b) Within ninety (90) days following Cytocom’s receipt of marketing approval from the FDA for a NTX/M▇▇▇ Product, Cytocom will make a one-time technology transfer available to Licensee of know-how owned or controlled by Cytocom relating to the manufacture of M▇▇▇ and NTX/M▇▇▇ Product to the extent and in the manner specified in Appendix 3 hereto.
(c) Within ninety (90) days following Cytocom’s receipt of marketing approval from the FDA for an M▇▇▇ Product, Cytocom will make a one-time technology transfer available to Licensee of know-how owned or controlled by Cytocom relating to the manufacture of M▇▇▇ Product to the extent and in the manner specified in Appendix 3 hereto. With respect to each of the foregoing technology transfers, Licensee shall notify Cytocom of its desire to receive such technology transfer within the time period therefor, and following receipt of such notice Cytocom will promptly make the applicable technology transfer. If Licensee does not notify Cytocom of its desire to receive a particular technology transfer within the time period therefor, then Cytocom will be under no obligation to make such technology transfer. The know-how transferred to Licensee pursuant to the terms of the Development Supply Agreementthis Section 5.5 shall be sufficient to enable Licensee to manufacture API, NTX Product, NTX/M▇▇▇ Product and M▇▇▇ Product, as soon as reasonably practicableapplicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Knowat commercial-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activitiesscale quantities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam Cytocom shall have no obligations further obligation to transfer any other know-how under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCothis Agreement.
Appears in 1 contract
Technology Transfer. Subject 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the terms roadmap as described in Annex 1. The Technology Transfer to Biovac will comprise of the Development Supply AgreementTechnology Transfer Package 1, as described in Annex 3, called “mRNA technology for R&D”, which will be provided by Afrigen and includes a documentation package and a technology platform hands-on demonstration training at Afrigen. Content of Technology Transfer Package 1 will be made accessible to Biovac as soon as reasonably practicableinformation is available. The Parties will meet and confer following the Effective Date to agree on a Technology Transfer Plan setting out the timeline for the delivery of Technical Transfer Package 1, but as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Technology Transfer Plan”). Before Technology Transfer activities take place, Biovac will access an introduction to the mRNA technology training provided by Afrigen (timelines to be agreed upon between the Parties) and associated training material (Introduction to the mRNA Technology Package).
2.2 The Parties acknowledge that the timelines agreed in no a Technology Transfer Plan are of paramount importance for planning purposes. In the event later than that the fifth (5th) anniversary agreed timelines of any section of a Technology Transfer Plan changes after being agreed between the Parties, for any reason whatsoever including an Event of Force Majeure, the Parties agree to meet and discuss the potential changes and how it can be accommodated within any commercial obligations or other commitments which a Party may have towards a Third Party. While every reasonable effort will be made to accommodate changes to agreed timelines, the Parties agree and acknowledge that this cannot be guaranteed. If any amended timelines cannot be met by either Party, the Parties undertake to apply commercially reasonable efforts to continue the Project on amended timelines as soon as feasible.
2.3 The Technology Transfer of Technology Transfer Package 1 shall be considered complete by the Parties when Biovac has implemented the Technology and the Parties are satisfied that the production of the Effective Dateselected mRNA vaccine candidate meets the requirements outlined in the Technology Transfer Plan.
2.4 As part of Technology Transfer Package 1, Alnylam MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to Biovac, as follows:
(a) Training at Afrigen’s site by sending qualified Biovac personnel to Afrigen’s site for training on documentation and manufacturing process and analytics.
(b) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(c) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Biovac Facility, additional on-site training at Afrigen) be requested by Biovac beyond Sections 2.4(a)-(b), Biovac shall initiate a technology bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof. MPP undertakes to:
3.1 Work with WHO to assess Biovac capabilities and identify actions and deliverables for the Technology Transfer to Biovac to proceed, as well as to convene appropriate expertise to support Technology Transfer to Biovac, as feasible and may be necessary.
3.2 Ensure Biovac is provided with the Technology reasonably necessary to fulfil the transfer of Technology Transfer Package 1, as contemplated in Annexes 1 and 3 herein.
3.3 Work with WHO to MedCofacilitate the strengthening of the Relevant Regulatory Authority as may be required in the Territory to enable Regulatory Approval of the vaccine and facilitate WHO pre-qualification.
3.4 Provide IP analysis on the Technology, or as practicable and appropriate, and endeavour to its Third Party manufacturer(s) provide better visibility on freedom to operate analyses in the Territory.
3.5 Monitor the activities of Licensed ProductBiovac and the parties to other Programme Agreements to ensure good coordination and facilitate the sharing of data, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably and IP as provided for in this Agreement and other Programme Agreements.
3.6 In consultation with WHO, design and draft any further governance or technology transfer documents and provide on-going technical support as necessary or useful for and as feasible to fulfil the Manufacture objectives of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including Agreement within the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoagreed timeframes.
Appears in 1 contract
Technology Transfer. Subject During the ***** transition period, as applicable, described in paragraph (vii) above, the Parties shall agree upon and implement a reasonable technology transfer plan pursuant to an appropriate technology transfer agreement between the Party(ies) Controlling the technology to be transferred (whether such Party has previously terminated this Agreement or is a Terminating Party for purposes of this Schedule D, the “Technology Party”), any Terminating Party and Tanox, to enable Tanox or a chosen contract manufacturer (reasonably acceptable to the terms applicable Terminating Party(ies) and the Technology Party(ies)) to Manufacture the applicable Active Product following the cessation of the Development Supply Agreementforegoing supply period without interruption in supply requirements. Such technology transfer agreement shall include an obligation on the Terminating Party(ies) to physically transfer such technology and a license from the Technology Party and the Terminating Party(ies) to Manufacture such Active Product in the United States or Europe under Anti-IgE Patents, Company Information, and Know-How Controlled by the Terminating Party(ies) at the effective date of termination (or, if the Technology Party is not a Terminating Party, by the Technology Party as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCoeffective date of its termination of the Agreement) which are reasonably required, or to its Third the extent they are used as at the effective date of termination, to Manufacture Active Products. Such license shall not be sublicensable; however, if, at a later date, Tanox desires to change contract manufacturers, the Technology Party manufacturer(sand Terminating Party shall allow the assignment of such technology transfer agreement with such new contract manufacturer, provided that there shall be no obligation on the Terminating Party(ies) of Licensed Product, selected by MedCo to physically transfer such technology for a second time and that such new manufacturer is reasonably acceptable to Alnylamthe Technology Party. Such license A shall not extend to patents, of Alnylam Knowpatent applications, know-How that is reasonably necessary or useful for the Manufacture how, and materials not in existence as of the Licensed Productdate of termination, but shall include patents claiming priority back to any patents or patent applications covering Active Products as of the effective date of termination; and B shall extend to patents, patent applications, know-how, and shall make available its personnel on a reasonable basis materials only to consult with MedCo the extent the Terminating Party(ies) has the right to grant such right without incurring any royalty or such other payment obligation to any Third Party manufacturer(s) with respect thereto, all at MedCo’s expenseunless Tanox agrees to fully reimburse such royalty or other payment obligation in which case such Third Party rights shall be included in the license grant to the extent of the Terminating Party(ies) rights to do so. For the avoidance of doubt, including if Genentech is not a Terminating Party for purposes of this Schedule D, Novartis shall not provide to Tanox the Costs reasonably incurred information and materials received by Alnylam it from Genentech under the Technology Transfer Agreement unless: (1) Genentech has given its written consent thereto, or (2) Genentech has not agreed in connection writing (with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect copies to such Manufacturing technology transfer both Novartis and Tanox), within [***] days ** after Genentech’s receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage a copy of the Licensed Product supply chain Novartis notice to Tanox under clause (i.e.vii) above, Bulk Drug Substanceto comply with the provisions of this clause (viii), Bulk Drug Product and Finished Product). Promptly after MedCo’s written requestto transfer such information and materials to Tanox, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and as if Genentech were a Third Terminating Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCohereunder.
Appears in 1 contract
Technology Transfer. Subject Without prejudice to the terms Supplier’s rights under this Agreement, Prestige may in its sole discretion and 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 remain the property of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth Supplier (5thor its Affiliates) anniversary of the Effective Date, Alnylam shall initiate a technology transfer pursuant to MedCo, or Clause 20.10) relating to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed ProductProducts (“Manufacturing 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 Prestige to complete the transfer in a timely and effective manner. Without limitation to the foregoing the following provisions shall make available 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 shall procure that its personnel Affiliates will) 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 reasonable basis “like-for-like” basis);
(C) Prestige will be responsible for all activities related to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam development and preparation of data for use in regulatory submissions in connection with such technology transfer activities. MedCo and the Supplier shall reimburse Alnylam (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 such Costs purpose;
(D) the Supplier (and its Affiliates) shall reasonably co-operate with Prestige in transferring the Manufacturing Know-How including making available to Prestige appropriate employees of the Supplier (or its Affiliates) who are engaged in the Manufacture of Product to provide information and guidance for the transfer process, including consulting services, to the extent reasonably necessary for the completion of the transfer of the Manufacturing Know-How in a timely and efficient manner; and
(E) Prestige shall pay the reasonable and properly incurred with respect to such Manufacturing technology transfer within [***] days after receipt actual incremental costs of an invoice therefor. Alnylam the Supplier and its Affiliates in providing Prestige with assistance pursuant to sub-Clauses (B) and (D) above. Notwithstanding the transfer of any Product under this Clause 26, the Supplier shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to remain fully liable under the terms and conditions of such agreement, this Agreement (including liability to any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3Governmental Entity) for all Products which the supply Supplier (or its Affiliates) has Manufactured for Prestige under the terms of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCothis Agreement.
Appears in 1 contract
Sources: Transitional Manufacturing and Supply Agreement (Prestige Brands Holdings, Inc.)
Technology Transfer. Subject SEATTLE GENETICS possesses confidential and proprietary technical information not in the public domain that is necessary to the process of manufacturing the Product, including without limitation in process assays, methods, formulas, specifications, processes and know-how (the "SEATTLE GENETICS Information"), that is the subject of various patents, patents applications and Know-How owned or controlled by SEATTLE GENETICS ("the "SEATTLE GENETICS Intellectual Property", and collectively with the SEATTLE GENETICS Information, the "SEATTLE GENETICS Technology"). SEATTLE GENETICS Information shall be included in a technology transfer dossier to be shared with Gensia Sicor.
2.2.1 Gensia Sicor and SEATTLE GENETICS will mutually develop a Master Batch Record for the Product following the technical specifications, methods and know-how provided by SEATTLE GENETICS.
2.2.2 SEATTLE GENETICS will transfer to Gensia Sicor appropriate methods and in process assays for manufacturing the Product. Such methods and in process assays, being reviewed and agreed to by SEATTLE GENETICS, will be confirmed, or if requested, validated by Gensia Sicor for their application to the finished Product.
2.2.3 A protocol describing distribution of Product will be provided to Gensia Sicor by SEATTLE GENETICS for review and acceptance prior to commencement of the manufacturing of finished dosage Product. Distribution of clinical Product will be coordinated between Gensia Sicor and SEATTLE GENETICS.
2.2.4 SEATTLE GENETICS hereby grants Gensia Sicor a non-exclusive, non-transferable right under the SEATTLE GENETICS Intellectual Property to use the SEATTLE GENETICS Information solely for the purpose of manufacturing the Product pursuant to the terms of this Agreement. Gensia Sicor (a) acknowledges that SEATTLE GENETICS and/or its licensors retain all ownership rights in and to the Development Supply Agreement, as soon as reasonably practicable, but in no event later SEATTLE GENETICS Technology and (b) agrees not to use the SEATTLE GENETICS Technology for any purpose other than manufacturing the fifth (5th) anniversary Product for SEATTLE GENETICS hereunder. Gensia Sicor agrees to treat all of the Effective Date, Alnylam shall initiate a technology transfer SEATTLE GENETICS Technology as "Confidential Information" pursuant to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activitiesArticle VIII hereof. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam Confidential treatment requested
2.2.5 Either party may jointly or independently make or otherwise acquire rights to non-patentable discoveries, improvements, ideas and its Affiliates shall keep complete other intellectual property rights (including without limitation processes and accurate records methods) or Know-How useful in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage manufacture of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product"Developments"). Promptly after MedCo’s written requestAny Developments conceived, Alnylam fashioned or acquired solely by Gensia Sicor shall be owned solely by Gensia Sicor. Gensia Sicor shall promptly disclose all such Developments, in writing, to SEATTLE GENETICS, and hereby grants to SEATTLE GENETICS a non-exclusive, worldwide, perpetual, royalty-free license, with the right to sublicense, to use Commercially Reasonable Efforts to assign to MedCo each such Development for the development and manufacture of SEATTLE GENETICS' products. Any Developments conceived, fashioned or acquired solely by SEATTLE GENETICS during the term of this Agreement shall be owned solely by SEATTLE GENETICS. Any Developments conceived, fashioned or acquired jointly by employees of Gensia Sicor and employees of SEATTLE GENETICS shall be jointly owned by both parties.
2.2.6 The parties do not expect that any manufacturing agreement between Alnylam and a Third Party that is solely related patentable inventions, discoveries, improvements or ideas relating to the manufacture of Licensed Productsthe Product ("Product Inventions") will be made, conceived or reduced to practice during the course of the work performed under this Agreement. Such assignment However, any Product Inventions that are developed or acquired solely by Gensia Sicor shall be subject owned solely by Gensia Sicor ("Gensia Sicor Product Inventions"). Gensia Sicor shall not use or incorporate any Gensia Sicor Product Inventions in the course of the work performed under this Agreement without first disclosing such Gensia Sicor Product Inventions to SEATTLE GENETICS and obtaining prior written approval from SEATTLE GENETICS, upon which the parties agree to negotiate in good faith the terms and conditions of a license agreement on commercially reasonable terms for such agreement, including any required consents Gensia Sicor Product Inventions. Any Product Inventions developed or acquired solely by SEATTLE GENETICS during the term of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo this Agreement shall be owned solely responsible for contracting with such Third Party manufacturer (by SEATTLE GENETICS. Any Product Inventions developed or acquired jointly by employees of Gensia Sicor and employees of SEATTLE GENETICS shall be jointly owned by both parties. With respect to any other Third Party manufacture filings related to whom Alnylam has initiated technology transfer as set forth jointly owned Inventions, the parties shall work together to identify mutually agreeable intellectual property counsel and shall share equally in this Section 5.3) for all costs of filing any applications and maintaining intellectual property protection. Inventorship shall be determined under U.S. patent law.
2.2.7 During the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts Term, Gensia Sicor agrees not to obtain any such consent in a form reasonably acceptable to MedCo[***].
Appears in 1 contract
Sources: Clinical Supply Agreement (Seattle Genetics Inc /Wa)
Technology Transfer. Subject A. In addition to granting of the aforesaid licenses under the Technology and upon Effective Date of this Agreement and the payment of the Documentation and Royalty Reduction Fee described in Paragraphs III.A. and III.B. above, Tessera will transfer to Licensee the standard documentation for the Technology, including certain TCC package specifications, Standards and Technical Information for the standard TCC packages licensed herein, including those items that are identified in Attachment B to this Agreement.
B. Tessera and Licensee will meet on a mutually agreed upon schedule, to review technical improvements of Tessera and Licensee. In addition, Tessera will make available on at least a semi-annual basis, Tessera derivatives, modifications or improvements which have been reduced to practice including changes and modifications in Standards, methods, and materials during the term of this Agreement through Tessera’s regularly published Technical Briefing Bulletin or substantially equivalent method. Notwithstanding the foregoing, Tessera is under no obligation to transfer and/or license any information whether confidential, proprietary or otherwise that it may be prohibited from transferring to Licensee by contract with a third party or applicable law. Notwithstanding any provision to the terms contrary, Tessera shall not be under any obligation to transfer or disclose actual patent applications or related documents to Licensee hereunder until such application has been allowed by the relevant patent authority.
C. Engineering support from Tessera to Licensee may be made available, according to a mutually agreeable time schedule and manpower assignment schedule, at a per diem rate of the Development Supply AgreementUS $[*] per support engineer, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer plus reasonable air travel and hotel charges. Licensee agrees to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo pay all reasonable coach class air travel and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably hotel charges incurred by Alnylam Tessera personnel in connection with such technology transfer activitiesengineering support performed at any of Licensee’s facilities outside of San ▇▇▇▇. MedCo shall reimburse Alnylam such Costs incurred with respect Additional engineering interactions, whether carried out at Tessera’s facilities or Licensee’s facilities, conducted to such Manufacturing technology transfer within [***] days after receipt collaborate on technical issues of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e.mutual concern, Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject supported by each party at its own expense. Notwithstanding, on a mutually agreed date following the Effective Date and at each party’s own expense, Tessera shall accept up to ten (10) Licensee engineers at Tessera’s facilities for a period of ten (10) consecutive business days for purposes of teaching Licensee’s engineers the terms Technology and conditions of such agreement, including any required consents of such Third Party providing Licensee’s engineers with Technical Information to design and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedComake TCC packages.
Appears in 1 contract
Sources: Limited Tcc™ License Agreement (Tessera Technologies Inc)
Technology Transfer. Subject to During the terms Technology Transfer Term, Genentech and Curis shall perform the obligations and roles of each Party as outlined in the Technology Transfer Plan attached hereto as Exhibit C. During the Technology Transfer Term, Genentech shall appoint a project team leader (PTL) who shall serve as the single point of contact for Curis. Such PTL shall be made available by telephone upon reasonable request and during normal Genentech business hours. Without limiting the generality of the Development Supply Agreementforegoing, during the Technology Transfer Term, Genentech shall, as soon as reasonably practicable, but more fully described in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology Technology Transfer Plan:
2.3.1 transfer to MedCo, or to its Third Party manufacturer(s) of Curis the Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How listed on Exhibit C that is reasonably necessary available in written, graphic, electronic or useful for other recorded form (or true and complete copies thereof). To the Manufacture of extent the Licensed ProductKnow-How listed on Exhibit C exists in electronic form, Genentech may provide the same to Curis in electronic form;
2.3.2 provide to Curis a true and shall make available its personnel on a reasonable basis complete copy of (or electronic access to) the Existing IND, together with copies of material regulatory correspondence sent by Genentech to consult with MedCo the FDA, or such Third Party manufacturer(s) with respect theretoreceived by Genentech from the FDA, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to Licensed Product and minutes of all formal meetings between Genentech and the FDA regarding Licensed Product (if any);
2.3.3 transfer and assign to Curis the Existing IND and execute and deliver such Manufacturing technology assignments, instruments and documents, and take such actions, including filing of such assignments, instruments and documents with the FDA or other Regulatory Authorities, as may be necessary, or as Curis may reasonably request, in order to effect, evidence or record such transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage assignment of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product Existing IND to Curis and Finished Product)in Curis’ name. Promptly after MedCo’s written request, Alnylam Genentech shall use Commercially Reasonable Efforts to assign effect such transfer and assignment of the Existing IND within [**] days after the Effective Date;
2.3.4 transfer to MedCo any manufacturing agreement between Alnylam Curis the quantities of Compound and a Third Party that is solely related Licensed Product specified in Exhibit D (collectively, the “Transferred Materials”), subject to Genentech’s retained rights under Section 3.2.2;
2.3.5 provide Curis with copies of all existing Part I Patents; and
2.3.6 provide reasonable technical assistance to Curis in the practice of the Licensed Know-How transferred to it pursuant to Section 2.3.1, as the same was practiced by or on behalf of Genentech prior to the manufacture of Licensed Products. Such assignment Effective Date; such technical assistance shall be subject coordinated by the PTL and limited to [**] hours per week during the terms and conditions Technology Transfer Term. For clarity, the foregoing technical assistance excludes the performance of such agreementany additional experiments or research activities. Subject to Curis’ payment of the technology transfer fee specified in Section 4.2, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam Genentech shall remain solely responsible for perform its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product 2.3 at Genentech’s sole cost and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoexpense.
Appears in 1 contract
Technology Transfer. Subject In the event either Party gives notice not to renew this Supply Agreement in accordance with Clause 19.1, or on earlier termination of this Supply Agreement pursuant to Clause 19.2 except where SPINCO is the Breaching Party, at SPINCO’s request, AstraZeneca and SPINCO shall cooperate in good faith to agree upon the terms and conditions of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam a written technology transfer plan pursuant to which AstraZeneca and SPINCO shall initiate use reasonable efforts to carry out a reasonable technology transfer to MedCo, or to its a mutually agreed Third Party manufacturer(scontract manufacturer (the “Technology Recipient”) of Licensed Product, selected by MedCo and reasonably acceptable the process for manufacturing the Product but for clarity not information relating to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of ], together with rights to acquire such proprietary media and feeds from an invoice therefor. Alnylam authorized Third Party, as and its Affiliates shall keep complete and accurate records in sufficient detail solely to the extent necessary to enable the payments payable hereunder Technology Recipient to be determined. Alnylam Manufacture the Product (such transfer, the “Technology Transfer”); provided that AstraZeneca shall not be required to perform technology transfer any MedImmune Manufacturing Technology (and SPINCO shall not make or authorize any further transfer) unless the conditions set forth in this Clause 20.2 are satisfied to more than one Third Party manufacturer for each stage of the Licensed Product supply chain AstraZeneca’s reasonable satisfaction.
(i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment a) Any Technology Transfer (or further transfer) shall be subject to (i) AstraZeneca, SPINCO and the Technology Recipient agreeing upon reasonable terms and conditions to ensure the protection of and the proper use of any MedImmune Manufacturing Technology, (ii) the terms and conditions of such agreementany license or other agreement between AstraZeneca or any of its Affiliates or AZ Suppliers and any Third Parties pursuant to which AstraZeneca, including directly or indirectly, controls any required consents MedImmune Manufacturing Technology or which otherwise encumber any rights of such Third Party AstraZeneca or its Affiliates or AZ Suppliers with respect thereto, and MedCo(iii) appropriate grant-back licenses to AstraZeneca with respect to any improvements, modifications, and enhancements in or to the MedImmune Manufacturing Technology.
(b) AstraZeneca has no obligation to disclose or transfer to any Technology Recipient any MedImmune Manufacturing Technology that incorporates or may incorporate AstraZeneca’s written agreement or its Affiliates’ proprietary data, information or know-how or any MedImmune Manufacturing Technology that is not specifically identified and agreed to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo technology transfer plan as being included in the Technology Transfer.
(c) The Technology Recipient shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoAstraZeneca, and in no event shall AstraZeneca be required to transfer the MedImmune Manufacturing Technology to more than one (1) Technology Recipient.
(d) [***]
Appears in 1 contract
Technology Transfer. Subject (a) Toshiba shall use all reasonable efforts to develop, 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 terms manufacturing and 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 Development Supply Common R&D Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary to each of the Effective DateDSC 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, Alnylam among other things, available capacity and shall initiate 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 is required hereunder, Toshiba shall deliver such level of NAND Process Technology to MedCo, the applicable 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 its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable an existing manufacturing facility in order to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture achieve successful implementation of the Licensed Product, and newly transferred technology.
(c) A technology transfer hereunder shall make available its personnel on be deemed complete when the transferred technology passes a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder qualification procedure to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of mutually agreed upon by Toshiba and SanDisk.
(d) Following the Licensed Product supply chain (i.e.Closing, Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam Toshiba shall use Commercially Reasonable Efforts its best efforts to assign 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 MedCo any manufacturing agreement between Alnylam manufacture the same quality and a Third Party that is solely related to yield as experienced at the manufacture Yokkaichi facility.
(e) The costs of Licensed Products. Such assignment all technology transfers described in this Section 7.01 shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer borne by Toshiba or by DSC as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo SCHEDULE 7.01, and such Third Party manufacturer. Alnylam expenses to be borne by DSC shall use Commercially Reasonable Efforts to obtain any such consent be included in a form reasonably acceptable to MedCoStart-Up Costs as defined in Section 7.02.
Appears in 1 contract
Sources: Master Agreement (Sandisk Corp)
Technology Transfer. Subject A. In addition to the terms granting of the Development Supply Agreementaforesaid licenses under the Technology, as soon as reasonably practicableupon Effective Date of this Agreement and the payment of the portion of the License Fee described in Paragraph III.A. above Tessera will transfer to Licensee, but in no event not later than the fifth thirty (5th30) anniversary of days from the Effective Date, Alnylam shall initiate a technology transfer to MedCocertain of the Technology, or to its Third Party manufacturer(s) of Licensed Productincluding certain TCC package specifications, selected by MedCo Standards and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful certain Technical Information for the Manufacture TCC packages licensed herein.
B. Tessera will make available on at least a semiannual basis, improvements which have been reduced to practice including changes and modifications in Standards, methods, materials and specifications during the term of this Agreement through Tessera's regularly published Technical Briefing Bulletin or substantially equivalent method. Notwithstanding the foregoing, Tessera is under no obligation to transfer and/or license any information whether confidential, proprietary or otherwise that it may be prohibited from transferring to Licensee by contract with a third party or applicable law. In the case Tessera proposes to transfer proprietary or Confidential information to Licensee, Tessera will first provide Licensee a non-confidential outline of the Licensed Productproposed Confidential information, but shall not undertake or complete any transfer unless it first receives Licensee's written acknowledgment and approval. Notwithstanding any provision to the contrary, Tessera shall not be under any obligation to transfer or disclose actual patent applications or related documents to Licensee.
C. For a period of up to twelve (12) months commencing with the Effective Date of this Agreement, and shall according to a mutually agreeable time schedule and manpower assignment schedule, Tessera will make certain of its engineering staff available at its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expenseSan Jose ▇▇▇ilities for transfer activities, including joint activities with Licensee's engineers, as may be necessary in accordance with mutual agreement of the Costs reasonably parties to successfully complete the Technology transfer; provided, Tessera shall provide up to sixty (60) working man days of engineering support during first twelve month period for such transfer activity. If at the end of such transfer activity, Licensee has a good faith belief that more training is needed in certain technical areas, Licensee shall specifically define such technical areas to Tessera in writing and Tessera shall then provide up to an additional thirty (30) working man-days of engineering support for the Licensee defined technical areas during first twelve month period for such transfer activity. Licenser agrees to pay all reasonable coach class air travel and hotel charges incurred by Alnylam Tessera personnel in connection with such technology transfer activitiesengineering support performed at any of Licensee's facilities outside of San Jose. MedCo ▇▇ditional engineering interactions, conducted to collaborate on technical issues of mutual concern, shall reimburse Alnylam such Costs incurred be supported by each party at its own expense.
D. Additional engineering support (not to exceed sixty (60) working days) beyond the initial twelve month period for an additional twelve (12) month period may be made available, according to a mutually agreeable time schedule and manpower assignment schedule, at a per diem rate of US $[*] per support engineer, plus reasonable air travel and hotel charges. Any * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice thereforthe omitted portions. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to Tessera Confidential support or other services required thereafter may be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related provided upon terms mutually agreeable to the manufacture parties.
E. Tessera represents that the Technical information provided hereunder will be prepared with reasonable care and warrants that the Technical Information will, where applicable for similar types of Licensed Products. Such assignment shall TCC or related IC packages, be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all same as the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoTechnical Information used by Tessera.
Appears in 1 contract
Sources: TCC License Agreement (Tessera Inc)
Technology Transfer. Subject 30.1 If:
(A) GSK will not be supplying Products for Commercialisation pursuant to the terms of the Development Commercial Manufacturing and Supply Agreement; or
(B) Clause 30.3 applies; or
(C) Clause 31.6 applies; or
(D) Clause 36.2(ii) applies, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam GSK shall initiate facilitate a one-time technology transfer to MedCo, the Purchaser (or to its Third Party manufacturer(sPurchaser’s designee) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for (the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product“Technology Transfer”). Promptly after MedCo’s written request, Alnylam The Parties shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and create a Third Party that is solely related technology transfer plan relating to the manufacture Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of Licensed the Products. Such assignment , and shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and conditions of such agreementGSK Intellectual Property in accordance with the Technology Transfer Plan and the timelines, including any required consents of such Third Party formats, and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignmentother guidelines set forth therein. Except as provided for a Technology Transfer pursuant to Clause 30.1(C) or 30.1(D), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 12 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 31.3(A) or Clause 36.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 30.1(C) or 30.1(D).
30.2 A Technology Transfer may be implemented in the immediately preceding sentencecircumstances contemplated by Clause 30.1(A) either in anticipation of expiry of this Agreement or in the event of termination of this Agreement.
30.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 30.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, MedCo or notification by GSK that it will be unable to meet, any Firm Order for New Clinical Product; or
(B) a material or repeated failure on the part of GSK to Manufacture New Clinical Product (or, if applicable, New Clinical API) in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure:
(i) has caused (or is reasonably likely to cause) a material delay in Purchaser’s development of Clinical Products; and
(ii) is not due to any act or omission of Purchaser.
30.4 Following a Technology Transfer undertaken pursuant to Clause 30.1(B) or Clause 30.1(C), Purchaser shall be solely responsible relieved of its obligation under Clause 4.1 to purchase [***] of its requirements for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoProducts from GSK.
Appears in 1 contract
Sources: Clinical Manufacturing and Supply Agreement (Dermavant Sciences LTD)
Technology Transfer. Subject (a) At any time prior to the terms initiation of the Development Supply Agreementfirst Phase III Clinical Trial (subject to Brii Bio’s ability to initiate an earlier transfer of Manufacturing Technology as set forth in Schedule 7.1(a) in the event that VBI is delayed by more than six (6) months in meeting its final deliverable obligations set forth therein) for the Licensed Product in the Licensed Territory, as soon as reasonably practicableBrii Bio may elect to have VBI transfer manufacturing responsibility for clinical supply and commercial supply to a Third Party manufacturer either in the VBI Territory or the Licensed Territory (to the extent permitted by Applicable Law) (the “Third Party Manufacturer”); provided that, but in VBI shall have no event later than obligation to commence such transfer until after the fifth (5th) anniversary Collaboration Clinical Trial has been initiated. Once Brii Bio has elected to have VBI initiate such transfer, then VBI will use Commercially Reasonable Efforts to effect a transfer of the Effective DateManufacturing Technology in accordance with the requirements set forth in this Section 7.2(a), Alnylam including the timeframes set forth in the foregoing sentence. The Parties shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or mutually agree upon such Third Party manufacturer(sManufacturer through the JSC, provided that the selection of such Third Party Manufacturer shall be subject to Brii Bio’s final-decision making authority in accordance with Section 4.4(a). Once such selection has been made, the Parties shall enter into a three (3)-party Supply Agreement with such Third Party Manufacturer for commercial supply of Licensed Products solely to Brii Bio; provided that, VBI’s rights under such Third Party Manufacturer supply agreement shall be limited to ensuring that such Third Party Manufacturer (i) with respect thereto, all at MedComaintains the confidentiality of VBI’s expenseConfidential Information, including any information related to the Costs reasonably incurred by Alnylam in connection VBI Technology, (ii) complies with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within VBI’s obligations under the [***] days after receipt of an invoice therefor. Alnylam **], and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the (iii) complies with applicable Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product specifications and Finished Product)Applicable Laws. Promptly after MedCo’s written request, Alnylam VBI shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a fully enable such Third Party that is solely related Manufacturer to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including through the technology transfer requirements set forth in Section 7.2(b) below.
(b) VBI shall promptly, but in any required consents event within thirty (30) days after the execution of such Third Party and MedCoManufacturer supply agreement, commence a transfer of the Manufacturing Technology for the Licensed Product to the Third Party Manufacturer. VBI’s written agreement contribution to assume all the obligations costs relating to transfer of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo Manufacturing Technology shall be solely responsible for contracting with such limited to the provision of the services of VBI staff members. Any additional obligations or costs required to effect transfer of Manufacturing Technology to the Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth Manufacturer shall be borne by Brii Bio. For the avoidance of doubt, nothing in this Section 5.37.2(b) shall require VBI to develop any new Manufacturing Technology applicable to the Novel Composition for use by the Third Party Manufacturer and any such development will be conducted pursuant to a separate agreement between the Parties, provided that, on a calendar year basis, VBI shall provide to the Third Party Manufacturer any updates or improvements to the Manufacturing Technology relating to the Licensed Product that have been developed in the prior calendar year. Brii Bio acknowledges that, as between the Parties, all right, title and interest to such Manufacturing Technology belongs to VBI and that the Third Party Manufacturer will be permitted to use such Manufacturing Technology solely for the supply purpose of such manufacturing the Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts for commercial supply to obtain any such consent in a form reasonably acceptable to MedCoBrii Bio.
Appears in 1 contract
Sources: Collaboration and License Agreement (VBI Vaccines Inc/Bc)
Technology Transfer. Subject Consistent with the principle of avoiding supply disruption and in accordance with the transition plan established pursuant to Section 15.3, Pfizer shall provide Adolor with any then-existing documentation, technical information and other Know-How, in the form and format in which such materials are maintained by Pfizer in the ordinary course of its business (provided that Pfizer shall use commercially reasonable efforts to provide such materials in a form and format useable by Adolor), that are necessary for the manufacture of Named Compounds and Licensed Products. Such documentation, technical information and other Know-How shall include: (a) copies of flow charts of the manufacturing procedures and work instructions related to manufacturing Named Compounds and Licensed Products, (b) a list of all equipment, including the source of the equipment, utilized in the production of Named Compounds and Licensed Products, (c) copies of all current specifications for Named Compounds and Licensed Products, (d) copies of all standard operating procedures for the manufacturing procedures to be transferred, (e) all environmental conditions necessary to manufacture Named Compounds and Licensed Products and copies of any existing external environmental impact studies based on the materials or methods employed in the manufacturing method to be transferred, and (f) such other documentation as the Parties may mutually agree, in each case of the foregoing subsections (a) through (f), that are necessary to manufacture Named Compounds and Licensed Products. In addition, prior to the terms effective date of termination, and for up to ** thereafter, Pfizer shall make available to Adolor, the reasonable assistance of Pfizer’s employees, and shall request that any external Third Party manufacturers be available, to support the transfer of the Development Supply Agreementmanufacturing technology to Adolor. Pfizer shall use commercially reasonable best efforts to ensure that these personnel will cooperate with Adolor in the implementation of the manufacturing technology until such implementation has been completed successfully. Adolor shall reimburse Pfizer or any of Pfizer’s Third Party manufacturers for all reasonable Out-of-Pocket Costs and Expenses incurred pursuant to this Section 15.3.1. Pfizer shall continue to supply Adolor after the effective date of termination with Adolor’s requirements of clinical and commercial quantities of Named Compounds and Licensed Products, pursuant to a supply agreement to be negotiated in good faith by the Parties on “commercially reasonable terms” which agreement will remain in effect until the earlier of (a) the ** of the effective date of termination, and (b) such time as Adolor or a Third Party manufacturer engaged by Adolor is capable of supplying Adolor with its requirements of clinical and commercial quantities of Named Compounds and Licensed Products, provided, however, that Adolor must use its commercially reasonable best efforts to supply or have supplied by a Third Party, Named Compounds and Licensed Products as soon as reasonably practicablepracticable after the effective date of such termination. Solely for purposes of this Section 15.3.1, but in no event later than “commercially reasonable terms” means, with respect to clinical supplies of Named Compounds and Licensed Products, Pfizer’s Manufacturing Costs for such supplies, and with respect to commercial supplies means Pfizer’s Manufacturing Costs plus a reasonable ▇▇▇▇-up, which ▇▇▇▇-up shall not exceed ** prior to the fifth (5th) first anniversary of effective date of termination, ** for the next year and ** the second anniversary of the Effective Dateeffective date of termination, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCothe Parties.
Appears in 1 contract
Technology Transfer. Subject to the terms 5.1 Transfer of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth Vicuron Know-how and Materials.
(5tha) anniversary Within thirty (30) days of the Effective Date, Alnylam Vicuron shall initiate a technology deliver and transfer to MedCoOscient, or to its Third Party manufacturer(s) of Licensed ProductOscient’s designee, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam all Vicuron Know-How that is reasonably necessary how and Materials, Vicuron Licensed Know-how and Materials, and Regulatory Filings to a location designated by Oscient and in accordance with commercially reasonable procedures for a transfer of this type. Vicuron will provide Oscient with all reasonable assistance required to transfer the Vicuron Know-how and Materials, Vicuron Licensed Know-how and Materials, Regulatory Filings and Vicuron Regulatory Approvals, and the benefit thereof, to Oscient or useful for Oscient’s designee. Without limiting the Manufacture generality of the Licensed foregoing, (a) Vicuron shall provide Oscient or its designee with all Information and Materials in its possession necessary to enable it to manufacture the Bulk Compound and Product, and (b) if visits with personnel of Vicuron and its Affiliates are reasonably requested by Oscient for purposes of transferring the Vicuron Know-how and Materials, Vicuron Licensed Know-how and Materials, Regulatory Filings and Vicuron Regulatory Approvals to Oscient or its designee, or for purposes of Oscient’s acquiring expertise on the practical application and use of the Vicuron Know-how and Materials, Vicuron Licensed Know-how and Materials, Regulatory Filings or Vicuron Regulatory Approvals or of assisting Oscient or its designee on issues arising during such transfer and transition, then, on a reasonable schedule to be agreed upon by the Parties, qualified personnel from each Party with appropriate technical or regulatory expertise who are familiar with all aspects of the Vicuron Know-how and Materials, Vicuron Licensed Know-how and Materials, Regulatory Filings and Vicuron Regulatory Approvals shall meet at such facilities or locations as may be mutually agreed upon, and shall participate in telephone conference calls so that the personnel from Vicuron can transfer knowledge to Oscient personnel about manufacture of the Products. The Parties now anticipate that these in-person meetings shall occur at mutually agreed locations and that telephone conference calls shall occur regularly for a period of at least ***** months from the Effective Date, it being agreed that there shall be no more than ***** days of in-person meetings during such *****-month period unless the Parties agree to additional meetings. Notwithstanding the foregoing, until Oscient or its designee *****, Vicuron shall make available its personnel on a reasonable basis to consult with MedCo Oscient Vicuron’s then-current employees or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related then-current consultants who have expertise or knowledge relevant to the manufacture of Bulk Compound on a reasonable schedule to be agreed upon by the Parties. The transfer of Vicuron Know-how and Materials and Vicuron Licensed Products. Such assignment Know-how and Materials to Oscient shall be subject complete only upon Vicuron’s * Confidential information has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. satisfaction of the foregoing requirements. Vicuron and its Affiliates agree to cooperate with Oscient and applicable regulatory authorities to the terms extent reasonably necessary to effect the successful transfer of Regulatory Filings and conditions Vicuron Regulatory Approvals.
(b) As of the Effective Date, Vicuron has designated ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ as its primary contact person and Oscient has designated ▇▇▇▇▇ ▇▇▇▇▇▇▇ as its primary contact person. The primary contact persons shall be responsible for oversight of the interactions and activities described in Section 5.1(a) and shall attempt to resolve any questions that arise during the course of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCotransfer.
Appears in 1 contract
Sources: Assignment and Termination Agreement
Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology In its transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed ProductTechnology to ATS, CMI shall provide such reasonable training and documentation to ATS to enable ATS to obtain ISO 9002 certification and FDA GMP/QSR approval of the Production Line and the Licensed Product made thereon. To the extent that CMI documentation ("CMI Documentation") for the Licensed Technology is to be transferred hereunder, CMI shall provide one (1) legible hard copy of each manual or other documentation package or the electronic files thereof in Microsoft Word or Excel format or such other computer-aided design data used by CMI to manufacture Licensed Product in a format readable using commercially available software. CMI hereby grants ATS a non-exclusive, royalty-free, worldwide license to make, distribute and use such internal copies and derivative works of the CMI Documentation as are reasonably necessary to use the Licensed Technology for the purposes hereof, provided each such copy or derivative work shall retain any CMI copyright, trademark or other proprietary notices as are contained in the original version thereof, and shall make available its personnel on a reasonable basis provided further that ATS agrees to consult with MedCo pay any license fees or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam additional software development costs in connection with such herewith. Within ninety (90) days of the effective date of this Agreement, the parties shall adopt a mutually acceptable training and technology transfer activitiesplan to enable selected ATS managers, engineers and other staff to acquire and master the Licensed Technology, including, where appropriate, a system for CMI to "train the trainers." After the third anniversary date of this Agreement, CMI may notify ATS in writing that it is ready to initiate its transfer to ATS of the Licensed Technology, equipment and machining specifications and operating capability to permit ATS to develop the capability to internally machine graphite parts (the "Graphite Capability"), machine pyrolytic carbon coated parts (the "Pyrolytic Carbon Capability"), and develop its own tooling parts (the "Tooling Capability") (the date of such notification respectively referred to herein as the "Graphite Notice Date", the "Pyrolytic Carbon Notice Date" and the "Tooling Notice Date"). MedCo ATS shall reimburse Alnylam notify CMI in writing within thirty (30) business days of the Graphite Notice Date, the Pyrolytic Carbon Notice Date and the Tooling Notice Date, as applicable, whether it intends to proceed to develop the Graphite Capability, the Pyrolytic Carbon Capability, or the Tooling Capability, as applicable (respectively the "Graphite Decision Date", the "Pyrolytic Carbon Decision Date"and the "Tooling Decision Date"). If ATS fails to provide such Costs incurred with respect a notification, such action shall be deemed to be a decision not to develop such Manufacturing technology capability. After the third anniversary date of this Agreement, ATS may notify CMI in writing that it is ready to receive transfer to ATS of the Graphite Capability, the Pyrolytic Carbon Capability, and the Tooling Capability. CMI will use its best efforts to commence transfer of such capability within [***] days six (6) months after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedConotice from ATS.
Appears in 1 contract
Sources: Carbon Agreement (Ats Medical Inc)
Technology Transfer. Subject Licensee acknowledges that as of the Amended and Restated Effective Date Gilead has made the one-time technology transfers available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of Sof, LDV, Vel, Sof Product, LDV Product, Vel Product, Sof/Vel Product, and Sof/LDV Product, in each case as described in Appendix 3 hereto. Licensee further acknowledges that the foregoing technology transfers are sufficient to enable Licensee to manufacture Sof, LDV, Vel, Sof Product, LDV Product, Vel Product, Sof/Vel Product, and Sof/LDV Product, as applicable, at commercial-scale quantities. Additionally, during the term of this Agreement:
(a) within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for a Sof/Vel/Vox Product, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of such Sof/Vel/Vox Product to the extent and in the manner specified in Appendix 3 hereto, and
(b) within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for a Vox Product, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of such Vox Product, to the extent and in the manner specified in Appendix 3 hereto. With respect to each of the foregoing technology transfers, Licensee shall notify Gilead of its desire to receive such technology transfer within the time period therefor, and following receipt of such notice Gilead will promptly make the applicable technology transfer. If Licensee does not notify Gilead of its desire to receive a particular technology transfer within the time period therefor, then Gilead will be under no obligation to make such technology transfer. The know-how transferred to Licensee pursuant to the terms of the Development Supply Agreementthis Section 5.5 shall be sufficient to enable Licensee to manufacture Vox, Vox Product and Sof/Vel/Vox Product, as soon as reasonably practicableapplicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Knowat commercial-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activitiesscale quantities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam Gilead shall have no obligations further obligation to transfer any other know-how under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCothis Agreement.
Appears in 1 contract
Sources: License Agreement
Technology Transfer. Subject (a) Upon Lavvan’s written request and at Amyris’ cost and expense with regard to Amyris employees and contractors and Lavvan’s cost and expense with regard to all non-Amyris employee costs, including all Contract Manufacturer costs, Amyris shall transfer to Lavvan or an applicable Contract Manufacturer (i) the Commercial Strain and the Technology necessary to produce each applicable Collaboration Cannabinoid; and (ii) all documentation, specifications, approvals, permits, consents and materials related to the terms Technology, including process design schematics and manuals, necessary for Lavvan or such Contract Manufacturer to manufacture the applicable Collaboration Cannabinoid.
(b) Amyris shall cooperate in good faith with Lavvan and/or a Contract Manufacturer to bring about and complete a smooth and orderly transition of the Development Supply AgreementTechnology with respect to each Collaboration Cannabinoid and other information and materials described in Section 3.4.3(a) to enable an applicable Contract Manufacturer to successfully produce the applicable Collaboration Cannabinoid utilizing the Technology. Each Technology Transfer shall include reasonable travel to Lavvan and/or the Contract Manufacturer, as soon as and Amyris shall ensure that Lavvan and/or its Contract Manufacturer(s) have reasonable access to qualified scientists and Representatives of Amyris reasonably practicable, but in no event later than the fifth (5th) anniversary necessary to support an efficient and effective transfer of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Technology. All Know-How that and documentation to be transferred to Lavvan and/or a Contract Manufacturer hereunder shall be provided in electronic form, to the extent such Know-How and documentation is reasonably necessary or useful available in electronic form.
(c) Amyris shall be responsible as Lavvan’s designee for the Manufacture management of such Contract Manufacturer for the period beginning with the delivery of the Licensed Product, initial technology transfer report in respect of such Collaboration Cannabinoid to Lavvan or the applicable Contract Manufacturer and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(sending (i) with respect theretoto CBD one (1) year following the achievement of Milestone 6, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred (ii) with respect to SCC1, one (1) year following the achievement of Milestone 8, or (iii) for each Collaboration Cannabinoid other than CBD and SCC1, upon the achievement of the Commercial Scale Milestone in respect of such Manufacturing technology transfer within [***] days after receipt Collaboration Cannabinoid (“Amyris Management Period”) with respect to manufacturing ramp-up and scaling of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam commercial production; provided that Amyris must receive consent from Lavvan, which consent shall not be required unreasonably withheld, delayed or conditioned, before making or agreeing to perform technology transfer to more than one Third Party manufacturer make any capital expenditures, other expenditures or commitments exceeding $100,000 USD individually or $1,000,000 USD in the aggregate), and Lavvan shall be responsible for each stage the management of such Contract Manufacturer after the expiration of the Licensed Product supply chain Amyris Management Period. Notwithstanding the foregoing, nothing in this Section 3.4.3 shall derogate from Lavvan’s ability to visit and/or maintain a presence at a Contract Manufacturer’s facility, to observe and inspect operations (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of with such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement rights to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except at least as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer expansive as those set forth in Section 3.4.2, mutatis mutandis), and to otherwise exercise its rights under this Section 5.3) for Agreement and its agreement with the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoContract Manufacturer.
Appears in 1 contract
Sources: Research, Collaboration and License Agreement (Amyris, Inc.)
Technology Transfer. Subject 3.1 Lonza is willing to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo facilities and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful implement the Process for the Manufacture of certain Celltech Products.
3.2 Prior to the Licensed Manufacture of a Product, and shall make available its personnel on the parties will undertake Technology Transfer. No Manufacture of a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to will be undertaken after such assignmentunless the relevant Technology Transfer has been completed, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) Clause 3.
3.3 Celltech shall notify Lonza as soon as possible if any Product included in a forecast under Clause 9 is a new Product of a different type to those previously Manufactured by Lonza under this Agreement. If such new Product is to be Manufactured by a Process which is materially different to that shown in the Process Flow Diagram in Schedule 2, and/or may require additional Capital Items for its Manufacture, then the parties shall meet to review any such requirements, and agree on any additional costs necessitated by such requirements. Celltech shall provide such information to Lonza to allow for sufficient order and delivery time for any Capital Item required for Manufacture of the Product.
3.4 No later than six weeks in advance of the agreed date for Lonza to commence Technology Transfer of a Product, Celltech shall supply to Lonza the Celltech Technology necessary to perform the Technology Transfer.
3.5 Celltech shall supply such technical advice and guidance as Lonza may reasonably request and at times to be agreed for the supply purpose of Technology Transfer.
3.6 At Celltech’s request, Lonza shall establish all necessary Analytical Method Transfer Protocols and generate documentation to support the methods established by such Analytical Method Transfer Protocols. On Lonza’s completion of the Analytical Method Transfer Protocols, Lonza shall provide such Analytical Method Transfer Protocol to Celltech in order to allow Celltech to determine if they are acceptable in accordance with cGMP and the terms of the Quality Agreement. If they are acceptable to Celltech, Celltech shall approve the Analytical Method Transfer Protocol by providing written notice to Lonza. If Celltech rejects the Analytical Method Transfer Protocol the parties shall meet to solve any outstanding issues associated with the Analytical Method Transfer Protocol
3.7 Upon receipt of Celltech’s written notice approving the Analytical Method Transfer Protocol, Lonza shall implement the Analytical Method Transfer Protocol, either at Lonza’s facility or at a third party facility (subject to prior written consent of Celltech pursuant to Clause 21.1), and shall prepare and send to Celltech an Analytical Method Transfer Report. If the Analytical Method Transfer Report is acceptable to Celltech in accordance with the terms of the Quality Agreement, Celltech shall approve the Analytical Method Transfer Report by providing written notice to Lonza. If Celltech rejects the Analytical Method Transfer Report, the parties shall meet to solve any outstanding issues associated with the Analytical Method Transfer Report.
3.8 At Celltech’s request, Lonza shall establish all necessary Process Protocols and generate documentation to support the Process. On Lonza’s completion of the Process Protocols, Lonza shall provide a summary in English of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturerProcess Protocols containing sufficient information to enable Celltech to determine if they are acceptable. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably If they are acceptable to MedCoCelltech in accordance with the terms of the Quality Agreement, Celltech shall approve the Process Protocols by providing written notice to Lonza.
3.9 Upon receipt of Celltech’s written notice approving the Process Protocols, Lonza shall implement the Process Protocols at Pilot Scale, and shall demonstrate successful establishment of the Process by performing a minimum of three (3) Pilot Scale fermentations along with all associated Downstream Processing, according to the Process for each Product. The Pilot Scale work will be performed according to the Process Protocol. On completion of the Pilot Scale and successful demonstration of Process Protocol, Lonza shall supply a Process Report to Celltech for its review and approval. If the Process Report is acceptable to Celltech in accordance with the terms of the Quality Agreement, Celltech shall approve the Process Report by providing written notice to Lonza. On a Product by Product basis, Technology Transfer for each Product will be completed when the Process Report has been approved in writing by Celltech to Lonza in accordance with the terms of the Quality Agreement.
3.10 Lonza acknowledges that all Celltech Technology provided by Celltech during the Technology Transfer, including any In-Process Samples produced by Lonza and any Capital Items and Raw Materials purchased by or on behalf of Celltech for the Manufacture of Product, are and shall remain the property of Celltech.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Celltech Group PLC)
Technology Transfer. Subject 9.1 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, Adaptimmune will:
(a) reasonably assist Bellicum in establishing a […***…] for any Therapy comprising a Bellicum Candidate, and will allow and enable Bellicum to work with […***…] (to the terms extent relevant). Such assistance will include […***…]; and
(b) provide ongoing technical assistance in relation to Bellicum's development and manufacturing of the Development Supply Agreement, as soon Bellicum Candidates and Therapies comprising a Bellicum Candidate as reasonably practicable, but in no event later than requested from time to time and during the fifth (5th) anniversary Term. The details of what technical assistance and transfer of technology will be required from Adaptimmune will be agreed upon by the Effective Date, Alnylam shall initiate Parties as part of a technology transfer plan to MedCo, or be initially prepared by Bellicum and approved by the JDC. The costs of such technical assistance and transfer shall be considered to its 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 manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable restrictions relevant to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect and provision of confidential information.
9.2 In addition to such Manufacturing any technology transfer within 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 […***…] days after receipt 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 invoice thereforAdaptimmune Candidate as reasonably requested from time to time and during the Term. Alnylam The details of what technical assistance and its Affiliates shall keep complete and accurate records in sufficient detail to enable transfer of technology will be required from Bellicum will be agreed upon by the payments payable hereunder Parties as part of a technology transfer plan to be determinedinitially prepared by Adaptimmune and approved by the JDC. Alnylam The costs of such technical assistance and transfer shall not be required considered to perform be a Development Cost and subject to reimbursement in accordance with Article 10. Any technology transfer to more than one Third Party manufacturer for each stage obligations and provision of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall confidential information will be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior restrictions relevant to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply and provision of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.confidential information
Appears in 1 contract
Sources: Co Development and Co Commercialisation Agreement (Bellicum Pharmaceuticals, Inc)
Technology Transfer. Subject to the terms of After the Development Supply AgreementTransfer Date, Lpath shall use Commercially Reasonable Efforts to promptly transfer to Merck as soon as reasonably practicablepractical, but in no event later than the fifth (5th) anniversary of the Effective Date***, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam all Lpath Know-How How, including any preclinical data, clinical data, assays and associated materials, protocols, procedures and any other information in Lpath’s possession or control, that is reasonably necessary or useful for to continue or initiate Development of, or in seeking Regulatory Approval for, Licensed Products. For clarity, Lpath shall at all times have the Manufacture right to retain reasonable quantities of the Licensed Producttangible materials (if any) within such Lpath Know-How, and shall make available its personnel on a reasonable basis may use them, and authorize others to consult with MedCo or such Third Party manufacturer(s) with respect theretouse them, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activitiesOcular Products or other products outside the Field. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam Merck shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam cooperate and a Third Party that is solely related to facilitate such transfer, and the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam Parties shall use Commercially Reasonable Efforts to obtain any complete such consent transfer within *** after the Development Transfer Date. Details shall be set forth in a form reasonably acceptable technology transfer plan to MedCobe agreed upon by the Parties (“Technology Transfer Plan”) which plan shall set forth agreed-upon steps for an adequate technology transfer and timelines therefore, an outline of which is attached to this Agreement as Schedule 3.7. In addition, and without limiting the generality of the foregoing, upon Merck’s request Lpath shall (i) promptly assign to Merck all applications and filings made with any Regulatory Authority solely applicable to the Development or Commercialization of Licensed Products in and for the Field (and not applicable to any Ocular Product or other product outside the Field), including any applicable IND and orphan drug designations with respect thereto, (ii) use ***CONFIDENTIAL PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. Commercially Reasonable Efforts to assign to Merck all agreements related solely to the conduct of any Clinical Trial in and for the Field with respect to Licensed Product and to seek any required Third Party consents therefor (provided that such Commercially Reasonable Efforts shall not require Lpath to make payments or provide other consideration to any Third Party in consideration therewith), and (iii) assign to Merck all agreements, if any, related solely to the manufacture, supply or distribution of clinical supplies of Licensed Product for Clinical Trials in the Field (to the extent such agreement is specific to Clinical Trials in the Field, and not related to Ocular Products or other products outside the Field). For clarity, notwithstanding the foregoing, Lpath shall have the right to retain, and shall not be required to assign to Merck, (A) any applications and filings made with any Regulatory Authority related to Ocular Products (including IND number 100786), (B) any agreements which relate to clinical trials of Ocular Products, or (C) any agreement related to the manufacture, supply or distribution of, or which otherwise relate to, Ocular Products or other products outside the Field.
Appears in 1 contract
Sources: License Agreement (Lpath, Inc)
Technology Transfer. Subject to the terms of the Development Supply Agreement, as 3.1 As soon as reasonably practicablepracticable following the date hereof, but in any event no event later than [***] after the fifth date hereof, the Parties will in good faith (5theach acting reasonably) anniversary agree on a formal written plan (the “TT Plan”) for the transitioning of the Effective Date, Alnylam shall initiate a technology transfer Manufacturing Know-How to MedCo, Buyer or to its Third Party manufacturer(s) manufacturer or manufacturers by way of [***] customary technology transfer for packaging (including serialization), and [***] for formulation of the Licensed Product, selected in each case to [***] designated by MedCo Buyer (which may be the same or different facilities for packaging and formulation and which may in each case be owned or operated by Buyer or any contractor or other Third Party designee thereof).
3.2 Each Party shall perform the activities allocated to it in the TT Plan. The methods that will be used to effect the Technology Transfer for Packed Tablets and Bulk Tablets, will include:
3.2.1 the provision of copies of all relevant documentation and data maintained by AstraZeneca in electronic form and in the control of, or reasonably acceptable to Alnylamobtainable by, of Alnylam AstraZeneca which record the Manufacturing Know-How that is reasonably necessary or useful How, including (a) a list of all equipment, components and materials needed for the Manufacture of the Licensed Product, (b) a step-by-step description of the Manufacturing process for the Licensed Product, and shall make available (c) validated analytical methods for the Licensed Product;
3.2.2 the provision of reasonable technical assistance to Buyer or its personnel on nominated Third Party manufacturer or manufacturers to ensure a timely transition of the Manufacture of the Product as set forth in the TT Plan;
3.2.3 access to employees of AstraZeneca and its Affiliates who have knowledge of such steps at AstraZeneca’s (or its Affiliates’) premises or, where reasonably required, at the applicable Buyer facility (but subject to the limitations set forth in this Article 3); and
3.2.4 upon reasonable advance notice and upon a date mutually agreed, support reasonable, scheduled site visits in accordance with the TT Plan subject to AstraZeneca’s then current standards applicable to visitors by appropriate Personnel of Buyer or any of its Affiliates, contractors or Third Party manufacturers.
3.3 Each Party will complete the activities allocated to it in the TT Plan within any timelines set out therein (or for activities for which a timeline has not been allocated, within a reasonable basis time frame). The Technology Transfer shall be completed as soon as reasonably practicable by the Parties, each acting in an expeditious and commercially reasonable manner. In any event, the TT Plan shall require that the Technology Transfer be completed within the Term and, if the Technology Transfer for Packed Tablets is not completed within the Packaging Term or if the Technology Transfer for Bulk Tablets is not completed within the Bulk Supply Term, the obligations of AstraZeneca pursuant to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred this Article 3 with respect to the applicable Technology Transfer shall terminate in all respects; provided that if the applicable Technology Transfer will not be completed within the Packaging Term or Bulk Supply Term, as applicable, due to a breach by AstraZeneca of any of its obligations under this Article 3, the Packaging Term or Bulk Supply Term, as applicable, shall be extended by the number of days of delay in the completion that is attributable to such breach upon notice in writing from Buyer to AstraZeneca.
3.4 The Parties acknowledge that (a) the Parties will be jointly responsible for the development of the TT Plan, (b) Buyer will lead the process for the implementation of the TT Plan for the transitioning of the Manufacturing technology transfer within Know-How to Buyer or to its Third Party manufacturer or manufacturers, and (c) the role of AstraZeneca will be to support Buyer in such implementation activities, in each case as specified in the TT Plan.
3.5 AstraZeneca shall, during the Term, provide up to [***] days after receipt hours of an invoice thereforsupport for the Packaging Technology Transfer and the Formulation Techology Transfer, collectively, pursuant to this Article 3 [***] (“Support Hours”). Alnylam As of the Execution Date, the Support Hours shall be provisionally allocated as follows: up to [***] Support Hours for the Packaging Technology Transfer and up to [***] Support Hours for the Formulation Technology Transfer; provided that Buyer may, at any time and from time to time during the Packaging Term or the Bulk Supply Term, reallocate Support Hours from the Packaging Technology Transfer to the Formulation Technology Transfer, or vice versa, upon written notice to AstraZeneca. If ▇▇▇▇▇, acting reasonably, requires time in addition to complete the Packaging Technology Transfer or the Formulation Technology Transfer, AstraZeneca and Buyer will discuss in good faith Buyer’s requirements and AstraZeneca will use its reasonable efforts to accommodate such request; provided, that the other manufacturing operations of AstraZeneca and its Affiliates are not unduly disrupted by the provision of such additional support. The Parties shall keep complete and accurate records agree in sufficient detail writing to enable the payments payable hereunder terms of any additional support to be determinedprovided by AstraZeneca, including the total number of additional hours of support and the time period over which such additional support shall be provided. Alnylam All such additional support will be provided at Buyer’s cost, [***].
3.6 In respect of all Technology Transfer services provided pursuant to this Supply Agreement, Buyer shall not reimburse AstraZeneca for all reasonable (a) [***], (b) [***] and (c) [***], in each case, reasonably incurred by or on behalf of AstraZeneca and its Affiliates in providing such services. Buyer shall be responsible for the costs of all API or other materials used in connection with any Technology Transfer.
3.7 In no event shall AstraZeneca be required to perform provide technology transfer to assistance for any element of the Manufacturing Know-How more than one [***] during the Technology Transfer process.
3.8 Subject to Sections 3.1 through 3.5, and Section 3.11, Buyer shall be responsible for providing, making available or obtaining in sufficient time as required to meet the TT Plan, all facilities, materials, personnel, consents, approvals, information and other resources necessary to carry out and complete the Technology Transfer. As the success of the implementation of the Technology Transfer process will primarily depend on Buyer or its Third Party manufacturer manufacturer, subject to compliance with AstraZeneca’s obligations under this Supply Agreement, AstraZeneca provides no assurances or guarantees that the formulation or other Manufacturing processes can be [***] transitioned to Buyer or any Third Party.
3.9 In addition to the Technology Transfer, which for each stage clarity does not include a technology transfer for the API, AstraZeneca shall provide such Manufacturing Know-How in its possession and control to the extent requested by Buyer and such information is necessary or reasonably useful in order to assist Buyer in establishing its own supply chain for API.
3.10 While on site at the facilities of the Licensed Product supply chain other Party (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and or a Third Party designated by the other Party), each Party will ensure that is solely it and its Affiliates (and their respective personnel) conduct themselves in such manner as would be reasonably expected in the circumstances and comply with: (a) such of the other Party’s (or relevant Third Party’s) normal and reasonable codes of conduct and security practice (including those related to the manufacture of Licensed Products. Such assignment shall be subject data protection, health and safety, operational and technical security, occupancy, acceptable use and access to buildings) as are brought to the terms relevant person’s attention; (b) the other Party’s (or relevant Third Party’s) reasonable instructions; and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.c)
Appears in 1 contract
Technology Transfer. Subject Upon UGNX’s request and subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful Transfer Restrictions, Mereo shall, in a timely manner conduct and cause its applicable CMOs to conduct, the transfer of the Manufacturing processes for the Manufacture Drug Substance, Licensed Product and placebo for the Licensed Product (each a “Material” and collectively, “Materials”) to one or more CMOs designated by UGNX to allow establishment and validation of the Licensed ProductManufacturing process for the Materials (the “Technology Transfer”), which may include Mereo authorizing its current CMOs to Manufacture the Materials for UGNX using the same processes and activities conducted for Mereo. Such Technology Transfer shall make available include any Manufacturing processes and technology transferred by Novartis (or its personnel on a reasonable basis CMO(s)) to consult with MedCo Mereo (or such Third Party manufacturer(sits CMO(s)) with respect theretoto the Drug Substance or Licensed Product. Mereo shall bear solely its own internal Costs, all at MedCo’s expenseand UGNX shall reimburse Mereo for its out-of-pocket Costs (such as amounts payable to CMOs or other Third Parties), including the Costs reasonably incurred by Alnylam in connection with or on behalf of Mereo or its Affiliates to conduct such technology transfer activitieson Mereo’s behalf. MedCo shall reimburse Alnylam such Costs incurred with respect The Parties will develop and agree on a transition plan to such Manufacturing technology facilitate the Technology Transfer, including, where applicable, to transfer the oversight of the CMO and contract testing labs from Mereo to UGNX (the “Technology Transfer Plan”) within [***] days after receipt following the Effective Date (or such other timeline as may be mutually agreed by the Parties). The Technology Transfer Plan will set forth the roles and responsibilities of an invoice thereforeach Party, and each Party shall perform the activities assigned to it in accordance with the Technology Transfer Plan, consistent with the standards and timelines set forth therein. Alnylam The Parties will coordinate their Manufacturing activities under the Core Development Plan on a monthly basis via teleconference or in person, or more frequently as necessary, to ensure consistent Manufacturing strategies between the Parties and its Affiliates shall keep complete to coordinate Technology Transfer. Prior to conducting any Technology Transfer activities and accurate records in sufficient detail subject to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one applicable Third Party manufacturer for each stage Auditing Restrictions, UGNX shall have the right, upon prior written notice to Mereo, to conduct a Manufacturing/GMP data audit of the Licensed Product supply chain (i.e.Manufacturing, Bulk Drug Substancequality control testing and quality assurance release history and records, Bulk Drug Product all process and Finished Product)method development reports, characterization reports, stability and quality control testing reports. Promptly after MedCoMereo shall reasonably coordinate with UGNX to conduct such audit. UGNX’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture conduct of Licensed Products. Such assignment such audit shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the confidentiality obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting consistent with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as those set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoherein.
Appears in 1 contract
Sources: Collaboration and License Agreement (Mereo Biopharma Group PLC)
Technology Transfer. Subject 9.1 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, Adaptimmune will:
(a) reasonably assist Bellicum in establishing a *** for any Therapy comprising a Bellicum Candidate, and will allow and enable Bellicum to work with *** (to the terms extent relevant). Such assistance will include *** ; and
(b) provide ongoing technical assistance in relation to Bellicum’s development and manufacturing of the Development Supply Agreement, as soon Bellicum Candidates and Therapies comprising a Bellicum Candidate as reasonably practicable, but in no event later than requested from time to time and during the fifth (5th) anniversary Term. The details of what technical assistance and transfer of technology will be required from Adaptimmune will be agreed upon by the Effective Date, Alnylam shall initiate Parties as part of a technology transfer plan to MedCo, or be initially prepared by Bellicum and approved by the JDC. The costs of such technical assistance and transfer shall be considered to its 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 manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable restrictions relevant to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect and provision of confidential information.
9.2 In addition to such Manufacturing any technology transfer within [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 *] days after receipt ** (to the extent relevant). Such assistance will include *** *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. ; and
(b) provide ongoing technical assistance in relation to Adaptimmune’s development and manufacturing of the Adaptimmune Candidates and Therapies comprising an invoice thereforAdaptimmune Candidate as reasonably requested from time to time and during the Term. Alnylam The details of what technical assistance and its Affiliates shall keep complete and accurate records in sufficient detail to enable transfer of technology will be required from Bellicum will be agreed upon by the payments payable hereunder Parties as part of a technology transfer plan to be determinedinitially prepared by Adaptimmune and approved by the JDC. Alnylam The costs of such technical assistance and transfer shall not be required considered to perform be a Development Cost and subject to reimbursement in accordance with Article 10. Any technology transfer to more than one Third Party manufacturer for each stage obligations and provision of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall confidential information will be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior restrictions relevant to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply and provision of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.confidential information
Appears in 1 contract
Sources: Co Development and Co Commercialisation Agreement (Adaptimmune Therapeutics PLC)
Technology Transfer. Subject 4.1 Upon the execution of this Agreement and throughout the term of this Agreement, and in reliance upon the provisions and covenants set forth herein:
4.1.1 ETG shall disclose to CEPHEID and agree to CEPHEID's use, on such terms as are provided herein, all such Technical Data and Technical Know-how relating to the Product as may be reasonably necessary for the discharge by CEPHEID of its responsibilities under this Agreement.
4.1.2 CEPHEID shall disclose to ETG and agree to ETG's use, on such terms as are provided herein, all such Technical Data and Technical Know-how relating to the Product as may be reasonably necessary for the discharge by ETG of its responsibilities under this Agreement.
4.1.3 Should any of the Development Supply Technical Data and Technical Know-how disclosed by the Parties be covered by the License Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreementthe License Agreement will govern the use of the said Technical Data and Technical Know-how, including any required consents except to the extent the Parties agree that said Technical Data and Technical Know-how can and will be used in support of such Third Party the this Agreement and MedCo’s written agreement to assume all the obligations pursuit of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo Product Procurement.
4.2 Technical Data and Technical Know-how exchanged hereunder shall be solely responsible not be used except for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as the purposes expressly set forth in this Agreement. Section 5.3) 15 of this agreement will govern the confidentiality of the Technical Data and Technical Know-how.
4.4 In the event of a termination by ETG either Party of this Agreement as result of a material breach or material default of CEPHEIDby the other Party, CEPHEID Tthe breaching/defaulting Party shall, at no further cost to ETGthe nonbreaching/nondefaulting Party, promptly transfer and agree to ETG's the nonbreaching/nondefaulting Party's use of all hardware and software and any Technical Data and Technical Know-how owned or controlled by CEPHEID the breaching/defaulting Party that is reasonably necessary to enable ETG the nonbreaching/nondefaulting Party independently to perform or have performed by others all requirements set forth in this Agreement that CEPHEID the nonbreaching/nondefaulting Party would have been obligated to perform under any awarded contracts from the Customer for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoProcurement.
Appears in 1 contract
Sources: Teaming Agreement (Cepheid)
Technology Transfer. Subject A. In addition to the terms granting of the Development Supply Agreementaforesaid licenses under the Technology, as soon as reasonably practicableupon Effective Date of this Agreement and the payment of the portion of the License Fee described in Paragraph III.A. above Tessera will transfer to Licensee, but in no event not later than the fifth thirty (5th30) anniversary of days from the Effective Date, Alnylam shall initiate a technology transfer to MedCocertain of the Technology, or to its Third Party manufacturer(s) of Licensed Productincluding certain TCC package specifications, selected by MedCo Standards and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful certain Technical Information for the Manufacture TCC packages licensed herein.
B. Tessera will make available on at least a semiannual basis, improvements which have been reduced to practice including changes and modifications in Standards, methods, materials and specifications during the term of this Agreement through Tessera’s regularly published Technical Briefing Bulletin or substantially equivalent method. Notwithstanding the foregoing, Tessera is under no obligation to transfer and/or license any information whether confidential, proprietary or otherwise that it may be prohibited from transferring to Licensee by contract with a third party or applicable law. In the case Tessera proposes to transfer proprietary or Confidential information to Licensee, Tessera will first provide Licensee a non-confidential outline of the Licensed Productproposed Confidential information, but shall not undertake or complete any transfer unless it first receives Licensee’s written acknowledgment and approval. Notwithstanding any provision to the contrary, Tessera shall not be under any obligation to transfer or disclose actual patent applications or related documents to Licensee.
C. For a period of up to twelve (12) months commencing with the Effective Date of this Agreement, and shall according to a mutually agreeable time schedule and manpower assignment schedule, Tessera will make certain of its engineering staff available at its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expenseSan ▇▇▇▇ facilities for transfer activities, including joint activities with Licensee’s engineers, as may be necessary in accordance with mutual agreement of the Costs reasonably parties to successfully complete the Technology transfer; provided, Tessera shall provide up to sixty (60) working man days of engineering support during first twelve month period for such transfer activity. If at the end of such transfer activity, Licensee has a good faith belief that more training is needed in certain technical areas, Licensee shall specifically define such technical areas to Tessera in writing and Tessera shall then provide up to an additional thirty (30) working man-days of engineering support for the Licensee defined technical areas during first twelve month period for such transfer activity. Licensee agrees to pay all reasonable coach class air travel and hotel charges incurred by Alnylam Tessera personnel in connection with such technology transfer activitiesengineering support performed at any of Licensee’s facilities outside of San ▇▇▇▇. MedCo Additional engineering interactions, conducted to collaborate on technical issues of mutual concern, shall reimburse Alnylam such Costs incurred with respect be supported by each party at its own expense.
D. Additional engineering support (not to such Manufacturing technology transfer within exceed sixty (60) working days) beyond the initial twelve month period for an additional twelve (12) month period may be made available, according to a mutually agreeable time schedule and manpower assignment schedule, at a per diem rate of US $[***] days after receipt of an invoice thereforper support engineer, plus reasonable air travel and hotel charges. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to Any support or other services required thereafter may be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related provided upon terms mutually agreeable to the manufacture parties.
E. Tessera represents that the Technical Information provided hereunder will be prepared with reasonable care and warrants that the Technical Information will, where applicable for similar types of Licensed Products. Such assignment shall TCC or related IC packages, be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all same as the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoTechnical Information used by Tessera.
Appears in 1 contract
Technology Transfer. Subject Within a reasonable period of time (not to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of exceed [REDACTED: Term] after the Effective Date, Alnylam Thera will provide SA with: (i) one copy of all the electronic documentation in CTD format filed with the Food and Drug Administration of the United States of America for the Product, except with respect to the documentation listed in Schedule 2.3, (ii) all the documentation exchanged with Regulatory Authorities in each of the Countries, and (iii) if requested by the Regulatory Authorities of a Country, samples of the Product, the Product in semi-finished form and/or the Compound or excipients . The subsections (i), (ii) and (iii) of this Article 2.3 shall initiate a technology transfer be altogether referred to MedCoas the “Transferred Technology”. The documentation exchanged with Regulatory Authorities in each of the Countries, if any, will not be provided to SA in CTD format and SA shall be responsible to convert such documentation in such format or any other format at the sole cost and expense of SA. Further, SA shall be solely responsible for the translating or having translated any of the documentation transferred to SA correctly. SA shall bear all responsibility for the accuracy of the translation and all of the costs and expenses of translating any document provided by Thera under this Article 2.3 for the purpose of making Regulatory Filings with Regulatory Authorities. Thera, or to its a Third Party manufacturer(s) designated by Thera and acting on behalf of Licensed ProductThera, selected by MedCo shall make certain of its employees who are knowledgeable about the Product and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed ProductTechnology reasonably available to SA for scientific and technical explanations, advice and shall make available related on-site support, if and to the extent reasonably requested by SA, supporting the filing of a MAA in connection with SA’s exercise of its personnel on a reasonable basis rights and obligations under this Agreement. All such Licensed Technology provided to consult with MedCo SA and all information and materials (in whatever form or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expensemedium), including the Costs reasonably incurred by Alnylam electronic documentation in connection CTD format filed with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam the Food and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage Drug Administration of the Licensed Product supply chain (i.e.United States of America for the Product, Bulk Drug Substancetransferred, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture disclosed by or on behalf of Licensed Products. Such assignment Thera hereunder shall be and remain Thera’s Confidential Information, subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoArticle 11.
Appears in 1 contract
Sources: Distribution and Licensing Agreement (Theratechnologies Inc.)