Technology Transfer to Contract Manufacturing Organization Sample Clauses

Technology Transfer to Contract Manufacturing Organization. Prior to Verve’s exercise of an Option for a Licensed Product, Acuitas will be responsible for the RNA-LNP formulation, including analytical testing and documentation for all Licensed Products directed to Reserved Targets. Following the execution of a Non-Exclusive License Agreement, Acuitas will transfer all Know-How relating to the then-current formulation process for the manufacture of such Licensed Product to Verve or to a single contract manufacturing organization (a “CMO”) which will be determined by Verve (and reasonably acceptable to Acuitas). In the event the transfer of such Know-How is to a CMO the information will also be copied to Verve. For clarity, to be reasonably acceptable to Acuitas such proposed CMO must not be subject to a Deficiency. Acuitas will provide reasonable assistance to enable Verve or such CMO to manufacture such Licensed Product. Initiation of such technology transfer will be determined by Verve and will be for the then current formulation of the Licensed Product. Specifically, in the event that Additional Development Studies for a Licensed Product are undertaken, Verve will notify Acuitas once a formulation is selected for technology transfer. Acuitas will be reimbursed for such activities by Verve on an FTE basis and Verve will also be responsible for all external costs incurred by Acuitas relating to transfer of the Licensed Product formulation to Verve or a GMP manufacturer provided such costs have been approved by Verve in advance. Once the Licensed Product formulation is transferred to Verve or the CMO, Verve will assume responsibilities for future manufacturing of Licensed Product. Acuitas will provide ongoing technical support if requested by Verve with such support reimbursed on a time, materials and FTE basis.
Sample 1Sample 2See All (4)
AutoNDA by SimpleDocs
Technology Transfer to Contract Manufacturing Organization. Following CureVac’s exercise of an Option and entry into a License Agreement, Arcturus will use Diligent Efforts to transfer the formulation process for the Licensed Products that are intended to express the intended Target to a reputable and competent GMP manufacturer selected by CureVac and reasonably acceptable to Arcturus. Arcturus and CureVac will agree on a technology transfer or other means to support availability of Licensed Products as part of the License Agreement. Specifically, the License Agreement will provide that upon written request by CureVac, Arcturus will conduct a technology transfer to CureVac and/or its designee(s). Such designee(s) may be an Affiliate, sublicensee or Third Party manufacturers, and which Third Party manufacturers may also be a backup manufacturer or a second manufacturer of Licensed Products as required for the applicable transferee of the then-current process.
Sample 1Sample 2
Technology Transfer to Contract Manufacturing Organization. Following CureVac’s exercise of an Option, Acuitas will be responsible to transfer the formulation process for that Licensed Product to a GMP manufacturer. In order to ensure a smooth transfer of themanufacturing process upon Option Notice, at CureVac’s discretion the Parties will perform some preparatory technology transfer activities, to a GMP manufacturer that is reasonably acceptable to Acuitas, such technology transfer starting after the Effective Date. The activities to be performed with respect to such technology transfer, the rights and obligations of the Parties, and the reimbursement of Acuitas for such technology transfer activities are set forth in the Technology Transfer Agreement in Exhibit 3.1 (f) hereto, and will be otherwise governed by the terms and conditions of this Agreement.
Sample 1
Technology Transfer to Contract Manufacturing Organization. Prior to GreenLight’s exercise of an Option for a Licensed Product, Acuitas will be responsible for the [***], including analytical testing and documentation for all Licensed Products directed to Reserved Targets. Following the completion of the Workplan for a Licensed Product and execution of a Non-Exclusive License Agreement, Acuitas will promptly (and in any event within ninety (90) days following designation by GreenLight of an applicable cGMP contract manufacturing organization (together with GreenLight as a manufacturer, for purposes of this Section 3.1(f), a “CMO”), provided such CMO is able to support this timeline) initiate the conduct of a single technology transfer of Know-How relating to the then-current formulation process, raw materials supply, and analytical characterization for the manufacture of such Licensed Product to a CMO determined by GreenLight and subject to Acuitas’ prior written consent, which will not be unreasonably withheld, conditioned or delayed. Acuitas will exercise Diligent Efforts to enable the CMO to manufacture such Licensed Product. Initiation of such technology transfer will be determined by GreenLight and will be for the then current formulation of the Licensed Product. For clarity, the then current formulation of the Licensed Product shall mean a single LNP formulation previously tested by GreenLight in accordance with the Workplan and as determined by GreenLight. Once the Licensed Product formulation is transferred to a CMO, GreenLight will assume responsibilities for future manufacturing of Licensed Product. Acuitas will provide ongoing technical support including assistance with any IND filings if requested by GreenLight with such support reimbursed on a time, materials and FTE basis.
Sample 1

Related to Technology Transfer to Contract Manufacturing Organization

  • 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.

  • 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.

  • 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.

  • 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.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • 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 and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Development Services Licensee may from time to time wish to augment the RMSS product with additional functionality or utility, or to integrate it with Licensee systems from other sources, and for such purposes may request the provision of development services from RMSS.

  • Collaboration Management Promptly after the Effective Date, each Party will appoint a person who will oversee day-to-day contact between the Parties for all matters related to the management of the Collaboration Activities in between meetings of the JSC and will have such other responsibilities as the Parties may agree in writing after the Effective Date. One person will be designated by Merck (the “Merck Program Director”) and one person will be designated by Moderna (the “Moderna Program Director,”) together will be the “Program Directors”. Each Party may replace its Program Director at any time by notice in writing to the other Party. Any Program Director may designate a substitute to temporarily perform the functions of that Program Director by written notice to the other Party. The initial Program Directors will be: For Moderna: [***] For Merck: [***]

  • Business Development Company Status The Company, during a period of at least 12 months from the Closing Time, will use its commercially reasonable efforts to maintain its status as a business development company; provided, however, the Company may cease to be, or withdraw its election as, a business development company, with the approval of the board of directors and a vote of stockholders as required by Section 58 of the 1940 Act or any successor provision.

Time is Money Join Law Insider Premium to draft better contracts faster.