Transfer of Manufacturing Technology. (a) Upon request by BMS, Ambrx shall provide to BMS the Ambrx Manufacturing Technology and Manufacturing Technology Documentation to the extent requested for the purposes of preparing and supporting Regulatory Materials for Compound and Product.
(b) Upon request by BMS for purposes of establishing manufacturing capability for Compound and/or Product, Ambrx shall transfer to BMS (or to a Third Party manufacturer designated by BMS in accordance with Section 6.4) the Ambrx Manufacturing Technology, in order to enable BMS (or its Third Party manufacturer) to use the Ambrx Manufacturing Technology for purposes of the manufacture of the Compounds and/or Products and to replicate the processes employed by or on behalf of Ambrx (including any Third Party manufacturer of Ambrx), provided that Ambrx shall not be obligated to transfer the ReCODE Components to BMS separately from the strains used to express Compounds. Such transfer shall include a written description of such Ambrx Manufacturing Technology (the “Manufacturing Technology Documentation”). As applicable, if requested by BMS, Ambrx shall (and will use Diligent Efforts to ensure that any Ambrx Third Party manufacturer will) cooperate with and provide technical assistance (including on-site assistance) and consultation as reasonably requested by BMS in connection with the transfer and the implementation of such Ambrx Manufacturing Technology by BMS or its Third Party manufacturer, and to enable BMS or its Third Party manufacturer to use such Ambrx Manufacturing Technology to manufacture Compounds and/or Products and to obtain Regulatory Approval for (including the CMC, DMF or other regulatory filings relating thereto) the process for the manufacture of Compounds and/or Products. All such Manufacturing Technology Documentation shall be in the English language, and in sufficient detail and clarity for BMS or its Third Party manufacturer to understand and use the manufacturing processes disclosed thereunder. If available in electronic form, the Manufacturing Technology Documentation shall be provided in electronic format.
(c) For avoidance of doubt, the transfer of Ambrx Manufacturing Technology under Section 6.2(b) shall include the transfer to BMS (or its Third Party manufacturer) of the research cell bank for the production strain for the Compound (and the host/control strain for such production strain). In addition, upon request by BMS, Ambrx shall transfer to BMS available research strains for Compounds (a...
Transfer of Manufacturing Technology. (a) Promptly after the Effective Date, Company shall transfer to Licensee all then-existing and in-process inventory of IMMU-132 (totaling ***) (“Existing Inventory”), including a copy of all supporting batch records, in-process and release testing, GMP certifications and other documentation as reasonably required by Licensee. Company hereby represents and warrants to Licensee that all Existing Inventory has been manufactured and stored in accordance with GMP and all Applicable Laws, and that it complies in all respects with applicable specifications, which will be provided to Licensee as soon as practicable after the Effective Date. Further, Company shall assign and transfer to Licensee any existing manufacturer’s warranty with respect to the Existing Inventory to the extent allowed under any applicable agreement. The transfer price for such Existing Inventory shall be equal to Company’s Fully Burdened Cost of manufacturing, but not to exceed ***. Subject to the provision by Company to Licensee of reasonable documentation demonstrating such costs, such transfer price shall be paid by Licensee no later than *** after receipt of the Existing Inventory.
(b) At Licensee’s request, Company shall, without any further consideration, fully transfer, within a reasonable and expeditious timeframe and in any event to be initiated within *** of the Effective Date, the entirety of the commercial process for the Manufacture of the antibody component of IMMU-132 (i.e., “hRS7”) and all related processes and components, including all Information and Company Know-How used in, necessary for or related to such process, to a contract manufacturer designated by Licensee; provided that at Licensee’s request, Company shall transfer all documents and materials required for implementation of the Manufacture of IMMU-132 as soon as practicable, but no later than *** after the request by Licensee at any time following the Effective Date.
(c) Without limiting the foregoing, Company will ensure that each Facility is ready for Pre-Approval Inspection (PAI) within *** after the submission of the BLA, and the costs of mutually agreed maintenance or upgrades required at each Facility for such Facility to successfully complete PAI will be ***.
(d) After Licensee has notified Company that it is prepared to take over all manufacturing responsibility for Licensed Product, Company shall, to the extent it is legally able, assign, or cause to be assigned, to Licensee all of Company’s and its Affi...
Transfer of Manufacturing Technology. New River, [*], shall be responsible for providing Shire with the documentation, know-how and technical assistance necessary for the successful implementation of the manufacturing process at a location to be designated by Shire. To the extent practicable, New River shall continue to supply Shire with its needs of Collaboration Product under the terms of the Supply Agreement until Shire is capable of doing so.
Transfer of Manufacturing Technology. Following [*] for any Licensed Product, upon Gilead’s written request, GlobeImmune shall (i) transfer to Gilead, or its designee, in accordance with the Technology Transfer Plan, copies of all GlobeImmune Know-How and other Know-How as of the date of transfer that is necessary or reasonably useful for Gilead, or its designee, to [*], and (ii) [*]
Transfer of Manufacturing Technology. The Parties jointly acknowledge that the activities which are the subject of this Section 10.2 are complex, time-consuming, and require good communication to execute successfully in a timely manner. Accordingly, at the time Sublicensee invokes any of these parts, the parties shall form a Manufacturing Steering Team to plan and execute the activities. The reasonable commercial efforts of Sublicensor cannot make up for lack of adequate planning, task definition, and advance notice. It is agreed that the Manufacturing Steering Team meetings shall be held quarterly and its activities shall be governed by Section 3.6.
Transfer of Manufacturing Technology. Reasonably promptly following the Effective Date, the Parties will each perform the activities allocated to it in the Handover Plan relating to the transfer of Manufacturing technology to Allergan. In accordance with the Handover Plan, Molecular Partners shall transfer to Allergan or a Third Party manufacturer designated by Allergan, the process currently employed by or on behalf of Molecular Partners for the Manufacture of Licensed Compounds or Licensed Products. Such transfer shall include the transfer of all Molecular Partners Know-How then Controlled by Molecular Partners that is necessary or reasonably useful for Allergan or such Third Party manufacturer (as applicable) to conduct the Manufacturing process as then being conducted. Molecular Partners shall bear all internal FTE costs incurred by Molecular Partners in performing its activities under the Handover Plan, and Allergan will bear all other costs and expenses incurred by either Party relating to the transfer of the Manufacturing technology to Allergan. In the event that Allergan may reasonably request additional activities relating to such transfer not set forth in the Handover Plan, Molecular Partners will use reasonable efforts to provide such support with such activities to be reimbursed by Allergan at the FTE Rate. Upon Allergan’s request, Molecular Partners will use reasonable efforts to assign to Allergan its rights under its contract manufacturing agreement for Licensed Compounds or Licensed Products listed on Exhibit D and if such agreement cannot be assigned, then Molecular Partners shall reasonably cooperate with Allergan to arrange to continue to provide such services after the Effective Date, at Allergan’s expense. Molecular Partners shall reasonably cooperate with Allergan’s efforts to establish Licensed Compound Manufacture during such applicable transition period and shall not, during such applicable transition period, take any action that could reasonably be expected to have a material adverse impact on the further Manufacture of any Licensed Compound or Licensed Product. For the avoidance of doubt, nothing in this Section 7.3 with respect to Molecular Partners’ obligation to transfer such Molecular Partners Know-How to Allergan shall limit Molecular Partners’ right to use any such Molecular Partners Know-How in order to fulfill Molecular Partners’ obligations in accordance with this Agreement or its right to manufacture products other than Licensed Products.
Transfer of Manufacturing Technology. Amgen shall perform an electronic file transfer of Manufacturing Technology to Anthera or, at Anthera’s request, to the CMO selected by Anthera pursuant to Section 3.2(a) above. If, during the term of this Agreement, Information is identified that was Controlled by Amgen or its Affiliates as of the Effective Date, and should have been included in the Manufacturing Technology provided to Anthera pursuant to this Section 3.2(b)(i) and (ii), but was not previously provided to Anthera pursuant to Section 3.2(b)(i) or (ii), then Amgen will promptly provide such Manufacturing Technology to Anthera.
Transfer of Manufacturing Technology. Third, if CyDex is unable to procure an alternate facility pursuant to clause (i) above or alternate supplier pursuant to clause (ii) above within [***] ([***]) days of the first occurrence of the Failure to Supply event, Company may, by providing written notice of the occurrence of such Failure to Supply, elect to assume manufacturing of Captisol under its Manufacturing License (as defined in paragraph (d)). In the event Company elects to use another supplier to manufacture and supply Captisol pursuant to this Section 3.7(c), CyDex, within sixty (60) days of receipt of Company’s written notice, shall provide Company with the documentation, know-how and technical information that is necessary to make and have made Captisol, and shall fully cooperate with Company in the implementation of the manufacturing process. Company shall pay for (i) CyDex’s reasonable actual out of pocket costs related to such activities, and (ii) the reasonable costs of the time of CyDex’s employees and contractors incurred for such transfer of the manufacturing process at the rate of $[***] per person per hour. To the extent practicable, CyDex shall continue to supply Company with its needs of Captisol under the terms of this Agreement until Company is capable of doing so.
Transfer of Manufacturing Technology. Beginning promptly after Lumena’s exercise of the Compound Manufacturing Option, and continuing for a period of up to [...***...] after Lumena’s exercise of the Compound Manufacturing Option, the Parties shall cooperate to transfer to Lumena or (with prior written notice to Sanofi) its designee, the Sanofi Manufacturing Know-How existing at the time the Compound Manufacturing Option is exercised, at Lumena’s request and expense. Upon Lumena’s exercise of the Compound Manufacturing Option, Lumena itself, or through a Third Party contract manufacturer, shall assume responsibility for CMC Activities with respect to Compound and for the manufacture of Compound. Within [...***...] after Lumena’s exercise of the Compound Manufacturing Option, Sanofi shall transfer to Lumena or its designee, in electronic format, a data package containing such Sanofi Manufacturing Know-How existing at the time the Compound Manufacturing Option is exercised. In addition, during the [...***...] period after Lumena’s exercise of the Compound Manufacturing Option, Sanofi shall make available to Lumena, on a reasonable consultation basis, such advice of its technical personnel as may be reasonably requested by Lumena in connection with such transfer of Sanofi Manufacturing Know-How, up to [...***...] full-time equivalent personnel over such [...***...] period. Lumena agrees to reimburse Sanofi for the reasonable and documented fully-burdened charges for the time and expenses of such personnel when consulting for Lumena (including reasonable documented travel expenses, lodging and meals) incurred by personnel of Sanofi at the request of Lumena while rendering services under this Section 5.3. Lumena acknowledges and agrees that Sanofi may condition its agreement to transfer any Sanofi Manufacturing Know-How to a Third Party manufacturer on the execution of a confidentiality agreement between such Third Party manufacturer and Lumena that contains terms substantially equivalent to those of Article 7 of this Agreement. Lumena and/or its Third Party manufacturer shall use the Sanofi Manufacturing Know-How solely for the purpose of manufacturing Compounds and Licensed Products and performing the CMC Activities, in accordance with the terms and conditions of this Agreement, and for no other purpose.
Transfer of Manufacturing Technology. Upon Hanmi’s written notice to RAPT that Hanmi wishes to initiate transfer of RAPT Manufacturing Technology, RAPT shall and shall cause its Affiliates and RAPT’s possible Third Party manufacturers to disclose and make available to Hanmi or the Affiliate designated by Hanmi, all RAPT Manufacturing Technology that is available in written format on such date (the “Manufacturing Technology Documentation”) as soon as practicable. All such Manufacturing Technology Documentation shall be in the English language, and in sufficient detail and clarity for Hanmi or its Third Party manufacturer to understand and use the manufacturing processes disclosed thereunder. If available in electronic form, the Manufacturing Technology Documentation shall be provided in electronic format. If requested by Hanmi, RAPT shall (and will use Commercially Reasonable Efforts to ensure that any RAPT’s Third Party manufacturer will) reasonably cooperate with Hanmi and provide up to [***] of technical assistance by RAPT’s and RAPT’s Third Party manufacturer’s technical and pilot testing personnel [***] in connection with the transfer and the implementation of such RAPT Manufacturing Technology to and by Hanmi. The cost for RAPT employees providing such assistance (including travel costs for RAPT’s employees incurred in connection with on-site visits to the Territory) shall be [***]; provided that [***], in connection with providing such assistance, subject to [***]. Any assistance in addition to such [***] shall be [***]. RAPT shall make Commercially Reasonable Efforts to ensure that the RAPT Manufacturing Technology is fully and adequately transferred to Hanmi with respect to capacity, Product quality, raw materials consumption, and other parameters agreed upon between the Parties in advance. The Parties shall, within [***] after the Effective Date, enter into a Technology Transfer Agreement setting forth further details regarding the transfer of RAPT Manufacturing Technology consistent with this Section 6.3.
