Transfer of Manufacturing Know-How. Following Acceptance of an IND for a Collaboration Product within a particular Collaboration Program, upon Genzyme’s request, Voyager shall transfer to Genzyme all Know-How Controlled by Voyager during the Term that is necessary or useful to enable the Manufacture of Agreement Products for such Collaboration Program, and not previously transferred to Genzyme under this Agreement, by providing copies or samples of relevant documentation, materials and other embodiments of such Know-How, and by making available its qualified technical personnel on a reasonable basis to consult with Genzyme with respect to such Know-How. Each such Know-How transfer requested by Genzyme (“Technology Transfer”) shall be commenced within a mutually agreed time following Genzyme’s request and conducted pursuant to a mutually-agreed technology transfer plan developed by the Parties for the purpose of ensuring the complete and timely transfer of such Know-How in a manner that is consistent with then-current internal technology transfer corporate standards (or equivalent policy) of Genzyme (to the extent a copy of such standards or equivalent policy has been provided to Voyager). Genzyme will reimburse Voyager for its Development FTE Costs (for Development FTEs directly engaged to perform such Technology Transfer) and Out-of-Pocket Costs incurred in the course of such Technology Transfers, provided that such Out-of-Pocket Costs are incurred in accordance with the mutually-agreed technology transfer plan and Voyager provides an invoice to Genzyme evidencing such costs. Genzyme shall pay such amounts within [***] of receipt of invoice therefor. For clarity, Genzyme may make this request prior to the anticipated Option Exercise Date of a Collaboration Product to enable Manufacturing for the further Development of such Agreement Product following the Option Exercise Date.
Transfer of Manufacturing Know-How. If Fuso manufactures Collaboration Products pursuant to Section 6.1 above, the parties shall negotiate in good faith the compensation to be paid to GenVec for the transfer of process development and manufacturing know-how, and shall cooperate with each other in order that Fuso may initiate manufacture of the Collaboration Product as soon as practicable; provided, GenVec shall not be obligated to transfer any manufacturing knowhow which is subject to a contractual obligation with a third party.
Transfer of Manufacturing Know-How. If ARES TRADING chooses to manufacture the clinical or commercial supply of any Products itself or to obtain it from Third Parties, Intrexon shall make available to ARES TRADING the Intrexon Know-How that is then being used by Intrexon or its Third Party manufacturer in the manufacture of such Products, subject to reasonable restrictions on use and disclosure of such Know-How; provided that Intrexon shall not be obligated to make available to a Third Party, and ARES TRADING shall not have the right to provide to a Third Party, any such Know-How unless such Third Party is a Third Party manufacturer in good standing and with sufficient resources and capabilities for such Third Party to be reasonably successful in manufacturing Products. Within thirty (30) days of such request, Supplier shall provide to ARES TRADING or its designee copies of the physical embodiment of the manufacturing process and related data, including those processes, protocols, procedures, methods, tests and other know-how, necessary to the manufacture of the Product. Supplier shall provide reasonable technical assistance to ARES TRADING or its designee, including: (a) making available a reasonable number of appropriately trained personnel to provide technical assistance with respect to such transfer, (b) using Commercially Reasonable Efforts to promptly assist ARES TRADING or its designee in obtaining all necessary regulatory approvals and/or modifying existing authorizations for the manufacture of Product by ARES TRADING or its designee, (c) supplying analytical test methods and other testing know-how including method validation required to perform release testing or other testing as may be required by applicable regulatory agencies and, (d) upon request by ARES TRADING, providing ARES TRADING or its designee with appropriate quantities of reference standards related to Product in order to facilitate its testing. ARES TRADING shall be responsible for the costs and expenses incurred by Intrexon in performing such technology transfer, including the fully burdened cost of Intrexon personnel directly involved in such technology transfer allocated to efforts spent on such technology transfer.
Transfer of Manufacturing Know-How. BioAtla will also provide to Context copies of all relevant manufacturing data or relevant CMC documents in its possession or otherwise Controlled by BioAtla, in electronic form or other mutually agreeable alternate form within [***] Business Days following the Effective Date, and facilitate access to any Third Party subcontractors (such as CMOs or CROs) for access to relevant manufacturing data or documentation in their possession.
Transfer of Manufacturing Know-How. As part of the Initial Technology Transfer, in accordance with the Technology Transfer Plan, Paratek will make available to Zai the Paratek Know-How that constitutes the then-current process used by Paratek or its Third Party manufacturer in the manufacture of Licensed Products. In addition, as per the Continuing Technology Transfer, Paratek will provide reasonable technical assistance regarding such manufacturing related Paratek Know-How as requested by Zai in accordance with Section 4.1. Zai will be responsible for the costs and expenses incurred by Paratek in performing such part of the Technology Transfer in accordance with Section 4.3. After the completion of such part of the Initial Technology Transfer, each Party will promptly notify the other Party of any changes in its manufacturing process for the Licensed Products and upon such other Party’s request, will provide reasonable assistance to enable such other Party to implement such changes, with each Party bearing its own costs.
Transfer of Manufacturing Know-How. Grünenthal shall supply OMP with the available manufacturing know-how and technical assistance to manufacture Product, including the Grünenthal (Non-ADF SR-Matrix, the Grünenthal formulation currently used in clinical trials) slow release formulation and/or Grünenthal-ADF-Formulation, if so decided by the Parties according to Section 12.1(b), if OMP decides to Commercialize such formulation. Such transfer shall occur in sufficient time to enable the execution of respective activities of the Regulatory Approval Preparation Plan according to the timetables, recited therein, or the appropriate regulatory filings and commercial launch in OMP´s Territory.
Transfer of Manufacturing Know-How. In the event of a Failure to Supply or termination by BioCardia pursuant to Section 11.2.1, upon BioCardia’s request, (a) Biomet shall promptly make available to BioCardia or its designee access to all Licensed Know-How owned or controlled by Biomet and its Affiliates that are necessary for the manufacturing of the Product or any of its components (collectively, “Manufacturing Know-How”); (b) Biomet shall provide advice and consultation to BioCardia or its designee to enable BioCardia or its designee to manufacture the Product without charge to BioCardia; provided that BioCardia shall reimburse Biomet for reasonable out-of-pocket expenses incurred by Biomet in connection with such advice and consultation. In the event that BioCardia changes manufacturers as a result of the transfer of Manufacturing Know-How in this Section 2.7, BioCardia agrees that it assumes all responsibilities for securing regulatory clearance/approval as applicable in all countries.
Transfer of Manufacturing Know-How. If Servier notifies Miragen that it chooses to manufacture the clinical or commercial supply of the Licensed Oligos and Licensed Products, Miragen shall make available to Servier Miragen Know-How that is then being used by Miragen or its Third Party manufacturer in the manufacture of the Licensed Oligos and Licensed Products. In addition, Miragen shall provide reasonable technical assistance as requested by Servier in connection with such technology transfer. Servier shall be responsible for the costs and expenses incurred by Miragen in performing such technology transfer, including the fully burdened cost of Miragen personnel directly involved in such technology transfer allocated to efforts spent on such technology transfer, provided such costs and expenses are detailed in a mutually agreed budget prior to the technology transfer. If so requested by Miragen at a later stage, Servier shall make available to Miragen Servier Know-How that is then being used by Servier or its Third Party manufacturer in the manufacture of the Licensed Oligos and Licensed Products. In addition, Servier shall provide reasonable technical assistance as requested by Miragen in connection with such technology transfer. Miragen shall be responsible for the costs and expenses incurred by Servier in performing such technology transfer, including the fully burdened cost of Servier personnel directly involved in such technology transfer allocated to efforts spent on such technology transfer, provided such costs and expenses are detailed in an approved budget prior to the technology transfer.
Transfer of Manufacturing Know-How. Upon Sanofi’s request, RevMed shall transfer to Sanofi or its designee Know-How Controlled by RevMed that is necessary or useful to enable the Manufacture of each SHP2 Inhibitor that is nominated or designated as a Development Candidate pursuant to Section 4.3, Development Candidate and Product, including regulatory starting materials and key starting materials, as set forth in this Section 7.2. Sanofi may also request such Know-How for backup SHP2 Inhibitors that Sanofi is considering for nomination or designation as a Development Candidate, and RevMed shall transfer such Know-How to Sanofi (to the extent any exists). RevMed shall (a) at [***] cost, provide copies or samples of relevant documentation (including, but not limited to, documentation listed in Exhibit K of the Correspondence), materials and other embodiments of such Know-How, (b) at [***] cost (calculated on [***]), make available RevMed’s qualified technical employees, and use Commercially Reasonable Efforts to make available the qualified technical personnel of RevMed’s independent manufacturing contractors, in each case, on a reasonable basis to consult with Sanofi or its designee with respect to such Know-How, and (c) if requested by Sanofi, at [***] cost, use Commercially Reasonable Efforts to support Sanofi in the establishment of its own supply agreements with Third Party suppliers of RevMed.
Transfer of Manufacturing Know-How. During a period ending [*] months following the Effective Date, such period to be extended up to an additional [*] months by mutual agreement of Meiji and Licensee if reasonably necessary (such agreement not to be unreasonably withheld), Meiji shall, upon request by Licensee, and [*] except for the reimbursement of expenses as provided in subsection (c) below, transfer and furnish the Manufacturing Know-How existing as of the Effective Date to Licensee and the Third-Party Manufacturer(s) selected by Licensee, in a manner to be mutually agreed upon, and shall provide all necessary and useful technical assistance and training to facilitate the Third-Party Manufacturer(s)' use of such Manufacturing Know-How and their effective and efficient manufacture of Bulk and/or Product. The transfer of such Manufacturing Know-How will occur by means of (i) qualified technical personnel of the Third-Party Manufacturer(s) (and, in Licensee's discretion, its representatives and consultants) visiting Meiji's facilities and/or, (ii) at Licensee's request, by Xxxxx dispatching qualified technical personnel to the facilities of the Third-Party Manufacturer(s), subject to the following conditions in subsections (a) - (c) below. In addition to such visits, qualified Meiji personnel shall, via telephone or e-mail, provide consultation with respect to such Manufacturing Know-How from time to time in response to reasonable requests from the Third-Party Manufacturer(s) or Licensee:
