Technical Transfer Sample Clauses

Technical Transfer. Upon reasonable request from MTPC, Neurocrine shall forthwith and cooperate with MTPC or its designated manufacturer and provide MTPC or its designated manufacturer with technical assistance, with respect to Neurocrine Technology in order to enable MTPC to use such Neurocrine Technology to manufacture and produce the API and Drug Product. Neurocrine shall use commercially reasonable efforts to complete such technical transfer within […***…] after such request. Upon reasonable request from MTPC, Neurocrine shall forthwith and cooperate with MTPC or its designated analytical testing facility and provide MTPC or its designated analytical testing facility with technical assistance, with respect to Neurocrine Technology in order to enable MTPC to use such Neurocrine Technology to analyze the API and Drug Product. Neurocrine shall use commercially reasonable efforts to complete such technical transfer within […***…] after such request. MTPC shall reimburse all reasonable internal (at a fully-burdened rate) and external costs incurred by Neurocrine to conduct such activities under this Section 7.4, provided that items and costs of such activities shall be discussed and agreed upon in advance between the Parties.

Technical Transfer. Seller shall use its good faith efforts to assist Buyer in completing the Technical Transfer.

Technical Transfer. 11.3.1 Alnylam acknowledges and agrees that the transfer of Confidential Information and Intellectual Property owned or controlled by Tekmira and necessary for the Manufacture of a specific Product shall be used by the recipient of such Confidential Information and Intellectual Property (be it Alnylam or a Back-Up Manufacturer, or otherwise) solely for the purpose of Manufacturing the specific Product for which the Technical Transfer was conducted. For avoidance of doubt Alnylam acknowledges and agrees that: (a) the Confidential Information and Intellectual Property owned or controlled by Tekmira and necessary for the Manufacture of a specific Product encompassed in any Technical Transfer by Tekmira can only be used: (i) by the recipient of the Technical Transfer, (ii) solely for the Manufacture or regulatory approval of the specific Product which formed the subject of the Technical Transfer and not for any other product (or Product), and (iii) where Alnylam is the recipient of any such Confidential Information and Intellectual Property, [**]; (b) the transfer by Tekmira of Tekmira Confidential Information and Tekmira Intellectual Property for the Manufacture of a specific Product does not grant to the recipient of such Technical Transfer any right or license of any kind to conduct further transfer of Tekmira Confidential Information and Tekmira Intellectual Property to any Person, for any purpose; and (c) prior to the provision of any Methods under Section 11.2 or of any Technical Transfer or any other Tekmira Confidential Information and Tekmira Intellectual Property to any Third Party, including without limitation an alternate supplier, such Third Party shall be required to execute and deliver to Tekmira the written agreement(s) of such Third Party to be bound by the foregoing provisions of this Section 11.3.1 and by Article 14 of this Agreement, explicitly for the benefit of Tekmira, which agreement(s) must be in form and substance reasonably acceptable to Tekmira. 11.3.2 Tekmira will perform each Technical Transfer in accordance with Technical Transfer protocols to be established between Tekmira and each Back-Up Manufacturer, with Alnylam’s approval, which approval shall not unreasonably withheld or delayed, all of which protocols and other documentation arising from the performance Technical Transfer activities shall constitute the Confidential Information of Tekmira.

Technical Transfer. BVL shall assist Customer in transferring the Manufacturing Process to at least one Alternate Source by providing such technical assistance and documentation as necessary at reasonable fees mutually agreed upon by the Parties. BVL shall provide such assistance at no charge in the event that Customer is qualifying such Alternate Source due to a breach of this Agreement by BVL, including without limitation, a failure by BVL to fulfill its supply obligations hereunder for any reason other than a Customer breach or Force Majeure. No Confidential Information of BVL shall be disclosed to such Alternate Source, it being understood that any Product-specific information contained in the Master Production Record for Product is not Confidential Information of BVL and may be disclosed to the Alternate Source.

Technical Transfer. Upon expiration or termination of this Agreement for any reason, upon Sponsor’s written request, at Sponsor’s reasonable cost and expense and subject to a Change Order, Fujifilm shall: i. initiate a technical transfer of the Manufacturing Process to a third-party Contract Manufacturing Organization specified by Sponsor; provided, however, that in no event shall Fujifilm be required to (x) assign or license any Fujifilm Intellectual Property Rights to such third party outside of the scope set forth in Section 13(b) of this Agreement or Section 10(b) of the MBSA in respect of Scope of Work #1 or any future Change Orders or Scopes of Work (as defined in the MBSA) relating to the Product, or (y) assign, license or disclose to such third party any know-how or business information that, in Fujifilm’s reasonable assessment, may diminish its competitive position against such third party. ii. provide Sponsor with Manufacturing Process Materials specified in Attachment 1, to the extent such materials have been generated under the Agreement, constitute Sponsor-specific work output, and have not been provided to Sponsor in any form prior to such expiry or termination. Notwithstanding the foregoing, Fujifilm’s obligations under this Section 25(b) will not apply if this Agreement is terminated by Fujifilm under under Section 17(b) or Section 24(b) hereof or if the parties mutually agree in writing not to renew this Agreement, which writing expressly states that this Section 25(b) will not apply.

Technical Transfer. For all processes related to the Product developed outside of Patheon, the Client will provide technical information to support a technical transfer, including development reports, critical Deviations and OOS, related CAPA, and other relevant aspects of the product performance history.

Technical Transfer. In the event of expiration or earlier termination of this Agreement, Client may, at its sole expense and by written notice to Company, seek reasonable assistance from Company with respect to the transfer to another manufacturer or third party of the then-current process for Manufacturing API and/or Drug Product (“Technology Transfer”). Following Company’s receipt of this notice, the Parties will establish, in good faith, a schedule and plan to effect the Technology Transfer and Company will thereafter reasonably cooperate with Client in implementing the plan. Upon written approval of the project plan by the Parties and agreed payment schedule to Company by Client, Company shall perform the related activities reasonably necessary to effect such Technology Transfer in a timely manner. As part of the Technology Transfer, Company will make available for collection one (1) copy of all Documentation (to the extent not previously delivered to Client) generated pursuant to the Manufacturing Services up to the date of termination or expiration of this Agreement including Batch records, development reports and production process documentation.

Technical Transfer. Accordingly, the Parties will commence technical transfer activities [***] with the goal of enabling ▇▇▇▇▇▇▇ to supply Product for Commercialization in the Territory at Product launch and, as soon as practicable, to serve as a secondary source for Product for Commercialization outside the Territory as described in Section 4.5(d). In the event the Joint Manufacturing Committee determines that ▇▇▇▇▇▇▇’▇ progress under the Technical Transfer Plan (as defined in Section 4.5(b)) [***] Vertex shall [***] to supply Product to ▇▇▇▇▇▇▇ in accordance with the terms of the Supply Agreement (as defined in Section 4.5(a)).

Technical Transfer. Horizon shall provide to sanofi-aventis US or its designated Affiliate without any cost or expense to sanofi-aventis US and such Affiliate, all analytical, manufacturing, technical and other methods, processes, records and Know-How in Horizon’s control and necessary or useful to enable sanofi-aventis US or such Affiliate to produce the Product in conformance with the Product Specifications and current Good Manufacturing Practice, including, but not limited to, any manufacturing instructions, specifications (including, without limitation, Product Specifications, starting material specifications, and specifications for the Product or any intermediate version of the Product), development reports, production summaries, regulatory filings, validation reports, quality control and quality assurance documents, analytical methods and validation reports and any production or development batch records (the “Technical Transfer”). Should sanofi-aventis US or its designated Affiliate reasonably require any analytical, manufacturing, technical and other methods, processes, records and Know-How to perform its obligations under this Agreement, Horizon is responsible for obtaining such information at its own cost and providing it to sanofi-aventis US or such Affiliate as promptly as reasonably practicable. A preliminary manufacturing process description is attached hereto as Exhibit 1. The Parties acknowledge that a final manufacturing process has not yet been developed. Accordingly, the Parties agree that, to the extent that the definitive manufacturing process or final Product Specifications have an adverse financial impact on the projected costs set forth in Section 4 hereto, including, without limitation, any supply price, each Party agrees to negotiate revisions to such costs in good faith. To the extent that, despite good faith efforts, the Parties cannot reach agreement on modified costs, either Party may terminate this agreement.