Finished Manufacture definition
Examples of Finished Manufacture in a sentence
Collaborator shall permit the Regulatory Authority(ies) in the Exelixis Territory to conduct inspections of Collaborator, its Affiliates, Sublicensees, or subcontractors (including Clinical Trial sites) relating to Product Development under the GDP or the Finished Manufacture of the Finished Product, and shall ensure that such Affiliates, Sublicensees, and subcontractors permit such inspections.
Exelixis (through one or more Third Party contract manufacturers) shall be exclusively responsible for the supply of Supplied Product to Collaborator and Collaborator shall be exclusively responsible, at its expense, for the Finished Manufacture of the Finished Product.
Collaborator shall be solely responsible for obtaining, at its expense, any licenses deemed by it to be necessary or desirable to such formulation and/or any aspect of the Finished Manufacture which is different from that utilized for the Product by Affymax and/or its Third Party Partners for use in the Affymax Territory.
In any event, each Party shall notify the other Party within forty-eight (48) hours of receipt of notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities being used to conduct manufacture of Bulk API or Finished Manufacture of the Finished Product.
Collaborator shall notify Affymax within forty-eight (48) hours of receipt of notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities being used to conduct Finished Manufacture of the Finished Product.
Affymax shall reasonably cooperate with Takeda for such purposes, which cooperation shall include the transfer to Takeda of technology Controlled by Affymax relating to activities that were conducted by Affymax as of the Effective Date and thereafter, if any, with respect to any such Finished Manufacture.
The Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus provided to Affymax or used by Takeda for the U.S. Development, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Product supplied to Affymax or used by Takeda, shall be included in the Development Expenses.
Takeda shall be responsible for the Manufacturing Development for the Finished Manufacture, itself or through a Third Party contract manufacturer.
Takeda shall be responsible for Finished Manufacture and Packaging of Drug Product for use in the Takeda Territory and Ovid shall be responsible for Finished Manufacture and Packaging of Drug Product for use in the Ovid Territory, in each case, under the oversight of the JMC, and pursuant to the Manufacturing Plan.
Collaborator shall be solely responsible for obtaining, at its expense, any licenses deemed by it to be necessary or desirable to such formulation and/or any aspect of the Finished Manufacture which is different from that utilized for the Product pursuant to the Global Agreement for use in the Affymax Territory.