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:
Technical Transfer. In the event that DSP wishes to commence the Manufacture of the Compound and/or Product itself (including having the Product Manufactured), DSP shall raise the issue to the JSC for consultation with Intercept with respect to the timing and other related details of the Technical Transfer of the Intercept Manufacturing Technology so to enable DSP to Manufacture or have Manufactured the Compound and the Product for Commercialization in the Territory.
Technical Transfer. During the [**] day period after the Effective Date, but in no event beyond [**], Achillion shall promptly transfer, and shall use commercially reasonable efforts to cause its Third Party contractors under applicable Existing Third Party Agreements of Achillion (including the Current Manufacturing Contracts) to transfer (as permitted by and subject to the terms and conditions of any applicable Existing Third Party Agreement of Achillion or as otherwise expressly permitted by the applicable Third Party), to Janssen and/or its designated Affiliate and/or Third Party subcontractor records or copies of all CMC Know-How relating to any Achillion Single API incorporated into any Licensed Product, and within the Achillion Background Know-How, to the extent such Know-How is in Achillion’s possession or can be obtained by Achillion expending commercially reasonable efforts to obtain such Know-How in the possession of any such Third Party contractor. All such CMC Know-How within the Achillion Background Know-How transferred hereunder or developed in the Development Program shall be treated by each Party as the other Party’s trade secret Confidential Information under Article XI of this Agreement. The JSC shall oversee such transfer in a manner that ensures the timely and efficient transition to Janssen and its Affiliates or subcontractors of all such CMC Know-How within the Achillion Background Know-How relating to the Manufacture of any Achillion Single APIs developed as of the Effective Date necessary or useful for the Manufacture or characterization of such Licensed Product in accordance with Applicable Laws for Development, Commercialization and other purposes as contemplated hereunder. Achillion shall bear internal expenses incurred by Achillion in transferring any such Know-How during the [**] day transition period (but in no event beyond [**]) pursuant to this Section 7.1.2 (including any payments due to its counterparties under any Current Manufacturing Contracts or Pre-Existing Licenses from Third Parties), except as may be otherwise agreed by the Parties in the Manufacturing Agreement.
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. As promptly as practicable after the Effective Date, but in any event within [***] after the Effective Date, MedImmune shall transfer, or shall cause to be transferred, to Licensee via the electronic data room established by MedImmune in connection with the negotiation of this Agreement or any other method as mutually agreed between the Parties copies of the technical documents set forth on Schedule 3.1.1 (the “Technical Transfer Documents”). MedImmune shall ensure that such technical documents in the electronic data room are downloadable and printable and that downloaded and printed versions of such technical documents do not bear any watermark. For clarity, MedImmune shall have no obligation to perform a Manufacturing technology transfer with respect to any Licensed Compound or Licensed Product; provided, however, that the transfer pursuant to this Section 3.1.1 includes the identification of, and written documentation with respect to, the assay(s) used for stability testing of MEDI2452, in each case to the extent included in the Technical Transfer Documents. MedImmune provides no assurances or guarantee that the Technical Transfer Documents alone will, following such transfer, enable Licensee to Manufacture successfully any Licensed Compound or any Licensed Product.
Technical Transfer. Within sixty (60) days of the Effective Date, MPC shall provide to LICENSEE copies in English of all substantive or material information (in electronic format where available), relating to the following: (1) pre-clinical and clinical data and other know-how compiled as of the Effective Date with respect to the Compounds, including any and all data which MPC reasonably considers necessary for LICENSEE to file an IND with the FDA, and (2) all prior correspondence with the FDA or other regulatory equivalent for countries in the LICENSEE Territory other than the United States related to the Compound. MPC acknowledges and agrees that timing shall be of the essence in complying with its obligations under this Section 3.5. Notwithstanding anything to the contrary contained herein, if FDA or equivalent regulatory agency outside the US makes a specific request for information, MPC, as soon as practical but in no event later than 15 days after such request, must provide to LICENSEE such information, to the extent that it is or was in MPC’s possession or control at any time, and to the extent such information has not already been transferred to LICENSEE.
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.
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. 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.