Tech Transfer Sample Clauses

Tech Transfer. In addition to the provisions of Section 2.4.7, within 30 days of Celgene’s request, Acceleron, at no cost to Celgene, shall commence the transfer to Celgene of relevant Acceleron Technology necessary for Celgene to perform its obligations or exercise its rights hereunder and will use Commercially Reasonable Efforts to complete such transfer in a timely fashion. In addition, at no cost to Celgene, Acceleron shall make its personnel reasonably available for meetings or teleconferences to support and assist Celgene in the Development, Manufacture, and Commercialization of the Licensed Product or Licensed Compound.

Tech Transfer. 4.5.1 To facilitate the establishment of AbbVie’s second supply source of ribavirin tablets in twice daily and once daily dosage forms, within *** days of the Effective Date, the Parties shall enter into a tech transfer plan (the “Tech Transfer Plan”). The Tech Transfer Plan will include provisions requiring Company to make available to AbbVie copies of the physical embodiment of those processes, protocols, procedures, methods, tests and other information, relating specifically to the Manufacturing of Product. Company shall provide reasonable assistance in order to facilitate the establishment of a back-up supplier or the transfer of Manufacturing of the Product to AbbVie or such other Third Party that AbbVie designates. Notwithstanding the foregoing, the Parties acknowledge that Kadmon shall not be able to provide access to the DMF for the Company’s current API CMO. 4.5.2 At AbbVie’s request, and coordinated through the JPMT established under the License Agreement, Company shall cause appropriate employees and representatives of Company and its appropriate Affiliates to meet with the employees of AbbVie or its designee at appropriate locations, from time to time, as reasonably requested by AbbVie, to facilitate the transfer of Manufacturing process. Company shall also take all actions reasonably necessary to effectuate the royalty free transfer from Company or any of its CMOs (including Approved Subcontractors) to AbbVie or such Third Party supplier selected by AbbVie of Intellectual Property Rights owned or controlled by Company that are reasonably necessary and useful to Manufacture Product so as to enable AbbVie or such Third Party supplier to Manufacture Product. Company shall also cooperate with AbbVie CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION to promptly prepare and file all necessary regulatory submissions to accommodate such alternative supply arrangements. 4.5.3 In connection with the activities undertaken by Company under the Tech Transfer Plan, AbbVie shall reimburse Company’s (a) pre-approved travel expenses (undertaken in accordance with applicable AbbVie travel policies); (b) personnel expenses incurred on-site at AbbVie’s or its designee’s facility(ies) at a fully burdened rate equal to $200/hour; and (c) any actual, reasonable and documented costs ...

Tech Transfer. Celgene may request, in the form of written notice to Acceleron, a transfer of relevant Acceleron Technology (a) with respect to all Clinical Supplies upon Celgene’s election pursuant to Section 2.4.2(b) to assume Manufacturing responsibilities for all Clinical Supplies, (b) with respect to Clinical Supplies of a Licensed Compound or Licensed Product prior to or following the initiation of a Phase 2 Clinical Trial of such Licensed Compound or Licensed Product, with the costs of such other transfer shared in accordance with Section 5.5.1, (c) to the second source identified pursuant to Section 2.4.1, or (d) at such other time as is requested by Celgene, with the costs of such other transfer shared in accordance with Section 5.5.1. Within thirty (30) days of Celgene’s request, Acceleron shall commence the transfer to Celgene (or a Third Party selected by Celgene to Manufacture), at no cost to Celgene (unless the transfer is to a Third Party selected by Celgene), of relevant Acceleron Technology, including a chemistry, manufacturing, and controls (CMC) package and relevant manufacturing information, necessary for Celgene to Manufacture the applicable Clinical Supplies and Commercial Supplies and will use Commercially Reasonable Efforts to complete such transfer in a timely fashion. In addition, at no cost to Celgene, Acceleron shall make its personnel reasonably available for meetings or teleconferences to support and assist Celgene in the Manufacture of the Licensed Product or Licensed Compound.

Tech Transfer. Within 30 days of Celgene’s request, Acceleron shall commence the transfer to Celgene (or a Third Party selected by Celgene to Manufacture), at no cost to Celgene (unless the transfer is to a Third Party selected by Celgene), of relevant Acceleron Technology, including a chemistry, manufacturing, and controls (CMC) package and relevant manufacturing information, necessary for Celgene to Manufacture Clinical Supplies and Commercial Supplies and will use Commercially Reasonable Efforts to complete such transfer in a timely fashion. In addition, at no cost to Celgene, Acceleron shall make its personnel reasonably available for meetings or teleconferences to support and assist Celgene in the Manufacture of the Licensed Product or Licensed Compound.

Tech Transfer. Upon AstraZeneca’s request, Targacept shall, and shall cause any Third Party that Manufactures Ispronicline Capsules, Ispronicline API, any Collaboration Compound or any Candidate Drug under contract with Targacept to, provide AstraZeneca with all reasonable assistance required by AstraZeneca in order to transfer the Manufacturing process for Ispronicline Capsules, Ispronicline API, such Collaboration Compound or such Candidate Drug to AstraZeneca or its designee. Without limiting the generality of the foregoing, Targacept shall, and shall cause such Third Parties to: 16.15.1 from time to time upon AstraZeneca’s request, make available to AstraZeneca or its designee all documentation, records, and know-how owned or controlled by Targacept and such Third Parties relating to the Manufacturing process for Ispronicline Capsules, Ispronicline API, such Collaboration Compound or such Candidate Drug, including documentation constituting material support, performance advice, shop practice, specifications as to materials to be used, control methods and any other material that is necessary or useful to enable AstraZeneca or such designee to use and practice the Manufacturing process for Ispronicline Capsules, Ispronicline API, such Collaboration Compound or such Candidate Drug; 16.15.2 cause all appropriate employees and representatives of Targacept and such Third Parties to meet with employees or representatives of AstraZeneca or its designee at the Manufacturing facility of AstraZeneca or its designee, from time to time at mutually convenient times, to assist with the working up and use of the Manufacturing process for Ispronicline Capsules, Ispronicline API, such Collaboration Compound or such Candidate Drug and with the training of AstraZeneca’s or its designee’s personnel to the extent necessary or useful to enable AstraZeneca or such designee to use and practice the Manufacturing process for Ispronicline Capsules, Ispronicline API, such Collaboration Compound or such Candidate Drug; 16.15.3 take such steps as are necessary or useful to assist in reasonable respects AstraZeneca or its designee in obtaining any necessary license, permit or approval from any Regulatory Authority with respect to AstraZeneca’s or its designee’s Manufacture of Ispronicline Capsules, Ispronicline API, such Collaboration Compound or such Candidate Drug; and 16.15.4 provide such other assistance as AstraZeneca may reasonably request to enable AstraZeneca or its designee to use and prac...

Tech Transfer. If any of the events described in Section 11.1 above occur during the first five (5) years after First Commercial Sale of the affected Recro Product, then: 11.3.1 Within thirty (30) days of Customer’s request, Supplier shall transfer to Customer or its designee (the “Tech Transferee”), subject, if the Tech Transferee is a Third Party, to such Tech Transferee executing and delivering to Orion a confidentiality agreement in the form attached to the License Agreement as Schedule 2.3 thereto, all Orion Know-How reasonably necessary for Customer or such designee to Manufacture the API, provided that Customer shall reimburse Supplier for reasonable and customary expenses actually incurred by Supplier in doing so; and 11.3.2 Supplier hereby grants to Customer and the Tech Transferee a worldwide, royalty-free, right and license, for the remainder of the Term (or, if longer, the remainder of the Term of the License Agreement), under the Orion Know-How and the Orion Patent Rights, for the sole purpose of using, making or having made quantities of API for incorporation in the Recro Products for Commercialization in the Recro Territory in accordance with and subject to the License Agreement and qualification of such alternative manufacturing sites, including a right to reference the Regulatory Filings.

Tech Transfer. 11.1 When any of the events described in clauses (a) to (e) in Section 2.2 occurs, if requested by Healios, ATHX shall promptly begin to provide and transfer to Healios or its Affiliate any and all data, information, know-how or technology required for manufacturing the Products for the Primary Field for the Territory and support Healios so that Healios may make or have made such Products for the Primary Field for the Territory (collectively “Manufacturing Information”). Manufacturing Information shall include, without limitation, any confidential manufacturing dossier such as all specifications, SOPs and testing reports. Manufacturing Information shall cover any and all information that ATHX provides to at least one of the Third Party Manufacturer(s) of the subject Product during all or part of the term of this Agreement. If requested by Healios, ATHX will use commercially reasonable efforts to facilitate an arrangement between Healios and a Third Party Manufacturer that ATHX retains for the manufacturing of Product provided to Healios, so that [*]. Such transfer of Manufacturing Information (the “Tech Transfer”) shall be deemed completed if Healios becomes ready to manufacture or have manufactured the subject Product for the requirement in the Territory. 11.2 Notwithstanding Section 11.1 above, any of the events described in clauses (a) or (b) in Section 2.2 occurs, Healios may provide ATHX with notice thereof and its intent to exercise its rights under Section 11.1. If ATHX demonstrates within 30 days after receipt of such notice that ATHX is able to supply Healios with the subject Product for the Primary Field in the Territory [*], then Healios may not exercise such rights. If ATHX fails to so demonstrate, Healios may exercise such rights. In response to exercise of such rights by Healios upon or after ATHX’s failure to so demonstrate under this Section 11.2, ATHX shall assume the obligations as set forth in Section 11.1. 11.3 The Parties shall make their reasonable efforts, and shall reasonably cooperate with each other, so that the Tech Transfer may be completed as soon as reasonably possible after any of (a) to (e) in Section 2.1 occurs. 11.4 ATHX shall be responsible for the costs of ATHX and its Affiliates in connection with the Tech Transfer described in Section 11.1. Healios shall be responsible for the costs of Healios and its Affiliates in connection with the Tech Transfer described in Section 11.1 and any associated costs of Healios’ designat...

Tech Transfer. In the event Amerimmune timely exercises the Option, and periodically thereafter following a reasonable request from Amerimmune, as soon as reasonably practical Histogen shall transfer to Amerimmune, at no cost to Histogen, copies of all Histogen Know-How and Histogen Collaboration Intellectual Property to the extent not previously provided to Amerimmune. In addition, Histogen shall provide reasonable assistance, including making its personnel reasonably available for meetings or teleconferences to answer questions and provide technical support to Amerimmune with respect to the use of such transferred Know-How in the Development, Manufacture, and Commercialization of Products. The costs and expense incurred by either Party in connection with such assistance shall constitute Development Costs.

Tech Transfer. For any Product to which the exclusivity set forth Section 3.1 applies, at any time after expiration of the Exclusivity Period, and for any Product not subject to the exclusivity set forth in Section 3.1 or in furtherance of Client’s right to engage a second-source and/or back-up supplier for any and all Products at any time, Client may provide Provider with a written of “Transfer Election.” Upon receipt of a Transfer Election notice, Provider shall, with the respect to the Product or Products that are the subject of the Transfer Election: (a) transfer to Client or Client’s designee all know-how, information, techniques, methods processes, data, documentation and other intangible technology and (b) provide technology transfer assistance to Client, or to Client’s designee, including assistance to procure such equipment and other tangible materials, in each case as is reasonably necessary or useful for Client or its designee to conduct the manufacturing process(es) for the Product. In connection with such transfer Provider shall assist Client or its designee to implement and establish such manufacturing process(es) at Client or its designee’s facility, including by making employees of appropriate skill and experience available to Customer or its designee to consult with and assist Client or its designee in such implementation. After such transfer, Provider shall comply with Client’s reasonable supplemental requests for information necessary or useful for such implementation of such manufacturing process(es). Unless otherwise set forth in the applicable Work Order or agreed by the parties in writing, Client will reimburse Provider for all reasonable and documented time spent by Provider’s personnel to perform activities set forth in this Section (on an FTE basis) and reasonable out-of-pocket costs incurred by Provider to perform activities set forth in this Section.

Tech Transfer. As soon as reasonably practical after the Effective Date and thereafter upon Celgene’s reasonable request during the Term, Agios shall transfer to Celgene[**] copies of all Agios Know-How and Agios Collaboration Know-How related to the Licensed Product, to the extent not previously transferred to Celgene. Upon Agios’ reasonable request during the Term, Celgene shall transfer to Agios[**] copies of all Celgene Know-How and Celgene Collaboration Know-How related to the Licensed Product, to the extent not previously transferred to Agios. In addition, each Party shall provide reasonable assistance, including making its personnel reasonably available for meetings or teleconferences to answer questions and provide technical support to the other Party with respect to the use of such transferred Know-How in the Development, Manufacture and Commercialization of Licensed Products. The costs and expense incurred by either Party in connection with such assistance shall constitute Development Costs.