Technology Transfer. 31.1 If:
(A) Clause 31.2 applies; 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) 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 Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in the Manufacture of 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 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 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 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
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Technology Transfer. Beginning on the Effective Date, Manufacturer and Purchaser shall use commercially reasonable and diligent efforts to initiate, implement and complete a technology transfer to Purchaser’s Facility (the “Technology Transfer”) to enable Purchaser to manufacture (or have manufactured) each Product on a commercial scale, sufficient to meet Purchaser’s requirements of such Product for Distribution in the United States and Seller’s (and its Affiliates’) requirements of each Seller Product for Distribution in the Seller Countries, 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 such Purchaser’s Facility being appropriately updated to receive ER Line 2;
(ii) Purchaser’s provision of equipment suitable for the 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 manufacturing 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 technical information related to Products, including all such know-how and technical information provided by Grünenthal GmbH to Manufacturer and its Affiliates pursuant to the 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 tapentadol or, if no CII products are manufactured at Purchaser’s Facility, Purchaser’s performance of all activities necessary to prepare Purchaser’s Facility for CII products and submission to the DEA of all documentation required to register Purchaser’s Facility with the DEA;
(vii) Purchaser’s performance of all activities (including all qualification and validation activities) necessary to obtain Regulatory Approval to manufacture Products for 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 F...
Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke will receive an introduction to the mRNA technology training provided by Afrigen. WHO will engage with the Spoke to discuss requirements for investments and workforce development to enable readiness at the Spoke Facilities to receive the Technology Transfer. In addition, WHO will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by Spoke. The Technology Transfer will be offered as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be ag...
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.
Technology Transfer. 3.1 Unless any event described in Article 2.2 or 2.3 of this Agreement occurs, all of the technology required to be purchased for any of Party B’s business shall be provided by Party A on an exclusive basis. Party A will try its best to develop and transfer to Party B the technology that is required for Party B’s business and owned by Party A.
3.2 The Parties shall negotiate with each other to enter into specific technology transfer contracts to expressly specify the detail matters such as the technology to be transferred, transfer fees and payment.
Technology Transfer. The Parties expressly agree that they shall work together to transfer the Manufacturing Process to the Facility, including implementing the technology transfer plan set forth in Project Plan. Customer shall fully support such technology transfer as reasonably requested by Lonza.
Technology Transfer. At Pfizer’s request, Licensee shall make available to Pfizer all currently available records and data which exist and are Controlled by Licensee as of the effective date of termination and are necessary or reasonably useful for Pfizer to continue using, Developing, Commercializing and Manufacturing the Products.
Technology Transfer. 1. Recognising the importance of cooperation and technical assistance in the field of technology transfer, including automatisation processes, the Parties agree to cooperate in promoting the transfer of technology through academic or professional programmes dedicated to the transfer of knowledge between them.
2. The European Union shall facilitate and promote the access of Cuba to research and development programmes targeting, inter alia, technology development.
Technology Transfer. If Rhythm elects to Manufacture Product, or to have Product Manufactured by a third party, then Manufacturer will provide to Rhythm or its designee, all Manufacturing information, including, without limitation, documentation, technical assistance, materials and cooperation by appropriate employees of Manufacturer as Rhythm or its designee may reasonably require in order to Manufacture Product. Rhythm will compensate Manufacturer and/or its Affiliates, for such assistance at the hourly-rate(s) set forth in the applicable Work Order, or such other reasonable rate(s) as the parties may agree in writing, and shall reimburse to Manufacturer and/or its Affiliates all travel and lodging expenses incurred for the same provided that they have been approved in advance by Rhythm.
Technology Transfer. To the extent reasonably necessary for the Company to exercise its rights and perform its obligations under this Agreement, promptly after the Effective Date, Licensor shall provide to the Company one (1) copy of each physical embodiment of the Licensed Intellectual Property controlled by Licensor on the Effective Date (and, from time to time thereafter during the Term, promptly after Licensor obtains control of any additional Licensed Intellectual Property).
