Transfer of Manufacturing Processes Sample Clauses

Transfer of Manufacturing Processes. Without limiting Section 4.1.1, at the Manufacturing Working Group’s direction, Licensor shall, and shall cause its Affiliates and Third Party manufacturers to, (a) transfer to AbbVie or its designee all Licensor Know-How relating to the Manufacture of the Initial Licensed Product using the Initial Licensed Compound as of the time of such transfer (the “Drug Product Manufacturing Process”) and (b) transfer to AbbVie or its designee all Licensor Know-How relating to the current Manufacture of the Initial Licensed Compound as drug substance as of the time of such transfer (the “Drug Substance Manufacturing Process”) and provide such support as may be necessary or [****] useful to AbbVie or its designee to use and practice the Drug Product Manufacturing Process or the Drug Substance Manufacturing Process, as applicable, including by (x) causing all appropriate employees of Licensor and its Affiliates to, and [****] to cause the relevant Representatives (other than employees) or Third Party manufacturers of Licensor or its Affiliates, to meet with employees or representatives of AbbVie (or its designee) at the applicable manufacturing facility at mutually convenient times to (i) assist with the working up and use of the Drug Product Manufacturing Process or the Drug Substance Manufacturing Process, as applicable, and with the training of the personnel of AbbVie (or its designee) to the extent necessary or reasonably useful to enable AbbVie (or its designee) to use and practice the Drug Product Manufacturing Process or the Drug Substance Manufacturing Process, as applicable, and (ii) support and execute the transfer of all applicable analytical methods and the validation thereof (including all applicable Licensor Know-How, methods, validation documents and other documentation, materials and sufficient supplies of all primary and other reference standards) and (y) making available documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to materials to be used and control methods, in each case, that are necessary or reasonably useful to enable AbbVie (or its designee) to use and practice the Drug Product Manufacturing Process or the Drug Substance Manufacturing Process, as applicable; provided that (A) if, notwithstanding Licensor’s use of [****] efforts or [****], as applicable, to provide all such Licensor Know-How related to the Drug Product Manufacturing Process or Drug Substance Manufac...
Sample 1
AutoNDA by SimpleDocs
Transfer of Manufacturing Processes. 6.1 Bachem shall transfer to Thera, from time to time and on a timely basis, all of Bachem Know-How during the Term of this Agreement.
Sample 1
Transfer of Manufacturing Processes. Amgen shall transfer the Manufacturing Processes to the CMO(s) (as such term is defined in Exhibit H hereto). The rights and obligations of the Parties with respect to such transfer, together with a scope of Amgen’s technology transfer plan, are set forth in Exhibit H, which is incorporated by reference into this Agreement. Upon Amylin’s reasonable request, Amgen shall provide reasonable consultation services (by teleconference or in-person during regular business hours and upon reasonable advance notice) to support such transfer of the Manufacturing Processes, which may include performing activities specified in Exhibit H as requested by Amylin, Amgen’s participation in meetings or teleconferences with Amylin or the CMO, preparation for such meetings or teleconferences, and time spent responding to other questions or requests of Amylin or the CMO on manufacturing or quality-related matters (but shall not include the fill and finish services for the clinical supply of A-100 Leptin as set forth in Section 3.3 below). Amgen shall provide up to [*] [*] of such services to support the transfer under Section 3.1(a) and this Section 3.2(b) without additional payment under this Agreement. Time required beyond [*] shall be paid by Amylin at the FTE Rate. In addition, Amylin shall reimburse Amgen for all reasonable external expenses, including supplies and raw materials to be purchased for the demonstration of the production process, travel, per diem and lodging for meetings and site visits (including expenses incurred during the [*] of support). All such travel expenses will be charged in accordance with Amgen’s then-current travel policy. Amgen shall invoice Amylin no more frequently than quarterly for FTE costs and reimbursable expenses incurred under this Section 3.2(b), and THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [*] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Amylin shall pay such invoiced amounts within [*] of receipt of each such invoice. Amgen’s obligation to provide manufacturing assistance or related technical support will expire on the earlier of (i) [*] after the completion of the Drug Substance pilot runs at the designated CMO (as set forth in Exhibit H), or (ii) [*].
Sample 1

Related to Transfer of Manufacturing Processes

  • Transfer of Materials In the event Acceleron exercises its rights pursuant to Section 10.5.1, Celgene shall negotiate in good faith with Acceleron regarding Celgene transferring to Acceleron, at Acceleron’s cost, materials developed under this Agreement in the course of Developing and Commercializing Licensed Compounds or Licensed Products that are directly related to Licensed Compounds or Licensed Products to the extent provided in and in accordance with such agreement.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Manufacturing Rights Manufacturing Rights will be governed by Attachment 6.

  • Manufacture (a) Manufacturer shall only manufacture the specific number of Products as requested by Company and at no time shall manufacture excess goods or overruns. Manufacturer shall not sell any Products bearing the Trademarks to any third parties without the express written consent of Company.

  • Supply of Materials Unless the parties otherwise agree in a Work Order, Manufacturer will supply, in accordance with the relevant approved raw material specifications, all materials to be used by Manufacturer in the performance of Services under a Work Order other than the Rhythm Materials specified in such Work Order. Rhythm or its designees will provide Manufacturer with the Rhythm Materials. Manufacturer agrees (a) to account for all Rhythm Materials, (b) not to provide Rhythm Materials to any third party (other than an Affiliate acting as a permitted subcontractor) without the express prior written consent of Rhythm, (c) not to use Rhythm Materials for any purpose other than conducting the Services, including, without limitation, not to analyze, characterize, modify or reverse engineer any Rhythm Materials or take any action to determine the structure or composition of any Rhythm Materials unless required * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. pursuant to a signed Work Order, and (d) to destroy or return to Rhythm all unused quantities of Rhythm Materials according to Rhythm’s written directions.

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!