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. Promptly following the Effective Date, Pfenex and Hospira shall develop and reasonably agree through the Executive Steering Committee on a plan, which plan shall (a) be consistent in form and scope of those technology transfer plans used by Pfenex in connection with its transfer of the process related to both Drug Substance and Product to Third Parties prior to the Signature Date (access to which was provided to Hospira prior to the Signature Date) and (b) include the information, which information will be formatted, in each case as summarized in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement (the “Technical Transfer Plan”) of the activities to be conducted by each Party to facilitate Hospira’s or the Designated Product Manufacturer’s establishment of manufacturing capabilities for the Drug Substance and Product, including transfer of the Manufacturing Strain; provided, that Hospira or the Designated Product Manufacturer shall agree in writing to (i) maintain physical control over the Manufacturing Strain at all times and (ii) not to alter or modify the Manufacturing Strain in any manner. Such Technical Transfer Plan shall provide, among other things, that (A) Pfenex shall, as soon as practicable, deliver to Hospira or the Designated Product Manufacturer the Pfenex Know-How (which for clarity shall not include any equipment but shall include the manufacturing processes for the Drug Substance and Product (including analytical methods with respect thereto), Manufacturing Strain and methods and protocols for assessing the quality of and releasing Product) in the possession of Pfenex and/or its current manufacturer of Drug Substance and Product and reasonably necessary for Hospira or the Designated Product Manufacturer to (I) obtain all required Regulatory Approvals with respect to the manufacture of Product and (II) manufacture the Drug Substance and Product, and (B) each Party shall make available its personnel reasonably necessary for the performance by it of its respective obligations set forth in the Technical Transfer Plan. The Technical Transfer Plan shall also include a target completion date prior to the initiation of the Comparative Clinical Study upon which target completion date Pfenex’s activities and obligations under the Technical Transfer Plan shall end. In connection therewith, Pfenex and Hospira shall form a joint technology transfer committee, consisting of an equal number of repres...
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. 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. 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. 15.1 Subject to Section 15.2, when any of (a) to (d) in Section 2.1 occurs or it is reasonably expected that any of (a) to (d) in Section 2.1 will occur, ATHX shall immediately begin to provide and transfer to CHUGAI or its Affiliate any and all data, information, know-how or technology required for manufacturing the Product for the Field for the Territory and support CHUGAI so that CHUGAI may make or have made the Product for the 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 Product during all or part of the term of this Agreement. Such transfer of Manufacturing Information (the “Tech Transfer”) shall be deemed completed if CHUGAI becomes ready to manufacture or have manufactured the Product for the requirement in the Territory.
15.2 Notwithstanding Section 15.1 above, when (a) in Section 2.1 occurs or it is reasonably expected (a) in Section 2.1 will occur, CHUGAI may provide ATHX with notice thereof and its intent to exercise its rights under Section 15.1 as well as Sections 2.1(ii) and 3.1(ii). If ATHX demonstrates within forty-five (45) days after receipt of such notice that ATHX is able to supply CHUGAI with the Product for the Field in the Territory with satisfactory quality and in a stable and continual manner, then CHUGAI may not exercise such rights. If ATHX fails to so demonstrate or CHUGAI determines to exercise such rights without notice of this Section 15.2, CHUGAI may exercise such rights. In response to CHUGAI’s exercise of such rights upon or after ATHX’s failure to so demonstrate under this Section 15.2, ATHX shall assume the obligations as set forth in Section 15.1.
15.3 The Parties shall make their reasonable efforts, and shall reasonably cooperate with each other, so that the Tech Transfer may be completed within two (2) years from the time when any of (a) to (d) in Section 2.1 occurs or it is reasonably expected that any of the those events will occur.
Tech Transfer. As soon as reasonably practical after the Effective Date and thereafter upon Amerimmune’s reasonable request during the Research Term, Histogen shall transfer to Amerimmune, at no cost to Amerimmune, copies of all Histogen Know-How that are related to the Product and necessary for the Clinical Trial(s), to the extent not previously transferred 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 Development and regulatory matters and the use of such transferred Know-How in the Development of Products. The Out-of-Pocket Costs, as indicated with reasonable supporting evidence, incurred by Histogen in connection with such assistance shall be reimbursed to Histogen from any monies from Third Parties (including without limitation, any grants).
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.
