Common use of Manufacturing Technology Transfer Clause in Contracts

Manufacturing Technology Transfer. All manufacturing Neurocrine Technology transfer activities will be Transition Program or Collaborative Development Program activities, as the case may be. Upon receipt of written notice from Abbott, Neurocrine shall use Commercially Reasonable Efforts to make available or to cause to be made available to Abbott or its designee, all manufacturing Neurocrine Technology, including, product manufacturing, packaging and sterilization specifications, utilities and process equipment information, and other technical information, relating to the manufacture of the *** Confidential Treatment Requested Products, then within Neurocrine’s possession or Control, and shall thereafter render such assistance to Abbott or its designee as would allow Abbott or its designee to manufacture the Products (such transfer, the “Manufacturing Technology Transfer”). If any manufacturing Neurocrine Technology is within the control or possession of a Third Party pursuant to a Third Party Manufacturing Contract, Neurocrine shall use Commercially Reasonable Efforts to obtain the cooperation and assistance of such Third Party in such Manufacturing Technology Transfer. The Manufacturing Technology Transfer shall include the successful completion of installation qualification, operational qualification, performance qualification and process validation of the manufacturing process at the facility designated by Abbott. In connection with the Manufacturing Technology Transfer, Neurocrine and/or its Third Party manufacturer shall (i) deliver a comprehensive manual in English setting forth in detail the techniques, processes, documentation and know-how that are reasonably necessary or directly useful in the manufacture of Products then within either Neurocrine’s possession or control and (ii) make available to Abbott at a site designated by Abbott the services of such personnel of Neurocrine’s as Abbott may reasonably request in order to assist Abbott in establishing the manufacturing facility.

Appears in 3 contracts

Samples: Collaboration Agreement, Collaboration Agreement (Neurocrine Biosciences Inc), Collaboration Agreement (Neurocrine Biosciences Inc)

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Manufacturing Technology Transfer. All manufacturing Neurocrine Technology transfer activities will be Transition Without limiting the provisions of Section 5.10 (Information Sharing to Enable Exploitation of Licensed Compounds and Licensed Products), on a Research Program-by-Research Program or Collaborative Development Program activitiesbasis, as at the case may be. Upon receipt request of written notice from AbbottBMS, Neurocrine Avidity shall provide, and shall use Commercially Reasonable Efforts to make available or cause its Third Party manufacturers to cause provide to be made available to Abbott BMS (or its designee), all a full manufacturing Neurocrine Technologytechnology transfer (including providing assistance as reasonably requested by BMS in connection with such transfer) of Avidity Know-How to enable BMS (or its Affiliate or designated Third Party manufacturer, including, product manufacturing, packaging and sterilization specifications, utilities and process equipment informationas applicable) to implement the Avidity Manufacturing Process for, and other technical informationto otherwise Manufacture, relating to the manufacture of the *** Confidential Treatment Requested Products, then within Neurocrine’s possession or Control, and shall thereafter render such assistance to Abbott or its designee as would allow Abbott or its designee to manufacture the Licensed Products (including any Licensed Compound contained therein) from such transferResearch Program at the facilities designated by BMS (each, the a “Manufacturing Technology Transfer”). Prior to initiating such Manufacturing Technology Transfer, the Parties (through the JTTSSC) will promptly develop and agree upon a plan for conducting such Manufacturing Technology Transfer, including a timeline for completing activities set forth therein (the “Manufacturing Technology Transfer Plan”). Avidity shall initiate such requested Manufacturing Technology Transfer promptly (and in all cases within [***]) after the Manufacturing Technology Transfer Plan is agreed upon by the Parties and shall complete such transfer in accordance with the Manufacturing Technology Transfer Plan on the timeline set forth therein. If any manufacturing Neurocrine requested by BMS, such Manufacturing Technology is within the control Transfer Plan shall include (a) facilitating BMS (or possession of a its Affiliate) entering into agreements with applicable Third Party pursuant suppliers relating to a Licensed Compounds or Licensed Products, and (b) Avidity (and its Affiliates and Third Party manufacturers) providing to BMS (or its Affiliate or designated Third Party manufacturer, as applicable) all test results, records and other documentation related to the Manufacture of Licensed Compounds and Licensed Products, which shall be provided in English. Without limiting the generality of the foregoing, until such time as BMS (or its designee) is able to Manufacture GMP-grade clinical quantities of the applicable Licensed Compound or Licensed Product, as applicable (the “Manufacturing ContractTransition Period”), Neurocrine (i) at the request of BMS, Avidity shall use make available its (and its Affiliates’) employees (subject to the reasonable availability of such employees) and consultants (including using Commercially Reasonable Efforts to obtain the cooperation and assistance cause personnel of such Third Party in such Manufacturing Technology Transfer. The Manufacturing Technology Transfer shall include the successful completion of installation qualification, operational qualification, performance qualification and process validation of the manufacturing process at the facility designated by Abbott. In connection with the Manufacturing Technology Transfer, Neurocrine and/or its Third Party manufacturer shall contract manufacturers to be made available) to BMS (iand its designees) deliver a comprehensive manual to provide reasonable consultation and technical assistance (including visitation to facilities) in English setting forth in detail order to assist with the techniques, processes, documentation implementation of the Manufacture (including with respect to the Avidity Manufacturing Process) of such Licensed Compound and know-how that are reasonably necessary Licensed Product by BMS (or directly useful its designee) and to assist BMS (or its designee) in the manufacture start-up of Products then within either Neurocrine’s possession or control its Manufacture of such Licensed Compound and Licensed Product, as applicable, as well as Manufacturing process development for such Licensed Compound and Licensed Product and (ii) make available in addition to Abbott the foregoing clause (i), at a site designated by Abbott the services request of such personnel of Neurocrine’s as Abbott may reasonably request in order to assist Abbott in establishing the manufacturing facilityBMS, [***].

Appears in 1 contract

Samples: Research Collaboration and License Agreement (Avidity Biosciences, Inc.)

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