Registration Batches definition

Registration Batches means those units of the Product that have been produced by Aesica for the purposes of enabling validation of the Product by a Regulator;
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Registration Batches has the meaning set forth in Section 5.1. 1.88 “Regulatory Approval” means any approvals (including applications therefore, supplements and amendments thereto and pricing and reimbursement approvals), licenses, registrations, or authorizations of any Regulatory Authority, necessary for the Development, Commercialization, Supply, manufacture, testing, labeling, packaging, or shipping of the Product in the Territory, including the approval for clinical trials and the Marketing Authorization(s) for the Product. 1.89 “Regulatory Approval Application” means any filings submitted to a Regulatory Authority in the Territory, in each case, with all additions, deletion or supplements thereto, for Regulatory Approval of the Product in the Territory. 1.90 “Regulatory Authority” means any national, regional, state, provincial or local regulatory agency, department, bureau, commission, council or other governmental authority in the Territory involved in the granting of approvals (including pricing and reimbursement approvals), licenses, registrations or authorizations for the marketing, sale, manufacturing, testing, labeling, storage, handling, packaging, shipping or supply the Product, including the NMPA, and any other body or any health regulatory authority(ies) in the Territory that is equivalent to the United States Food and Drug Administration (and its successor agencies or departments) and holds responsibility for granting Regulatory Approval for the Product, and any successor(s) thereto having substantially the same functions.
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Registration Batches means those manufacturing batches of Licensed Product the characterization of which is included in (or intended to be included in) the application for US Marketing Authorization (NDA) for such Licensed Product.
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Examples of Registration Batches in a sentence

  • For Registration Batches packaged by Gilead, Eyetech will pay (to the extent not already paid prior to the Effective Date) Gilead an additional packaging charge of $[**] (i.e., $[**] per single shift of packaging activities) per lot.

  • Each invoice issued by Gilead hereunder shall specify, at a minimum, the Price in respect of the Product delivered, or, for Registration Batches and Process Validation Batches, the applicable charges; and the quantity of the Product delivered.

  • For Registration Batches tested by Gilead, Eyetech will pay (to the extent not already paid prior to the Effective Date) an additional testing batch charge of $[**] per lot.

  • Gilead will deliver entire Registration Batches of the Product, bulk packaged only, CPT to the finished packaging site designated by Eyetech (Incoterms 2000) and will deliver partial Registration Batches of the Product FCA Gilead's San Dimas facility (Incoterms 2000).

  • The price for up to [***] Registration Batches for use in FDA NDA submission shall be [***] per Product/Registration Batch.

  • THERAVANCE shall be responsible for supply of worldwide requirements of Licensed Product for Studies supporting Initial Indications and the Registration Batches thereof as well as all other supply for the Initial Indications in the US up through delivery of the First Commercial Sale Stock.

  • Each shipment of Clinical Samples or Registration Batches shall be accompanied by a certificate of analysis describing all current requirements of the specifications and results of tests performed certifying that the quantities of Product supplied have been manufactured, controlled and released according to the Specifications and all applicable cGMPs at the Production Site.

  • Core Tech shall provide the following services in relation to the approval of a Fentanyl Transdermal System, equivalent, according to the U.S. FDA, to the brand product Duragesic®, manufactured by a division of J▇▇▇▇▇▇ and J▇▇▇▇▇▇.: · cGMP Manufacturing of Clinical and Registration Batches (1 x 25k batch each) placebo, 12.5, 25, 50, 75, 100 μg/hr, QC Release of Clinical and Registration batches; · Pivotal Bioequivalence Study (XX subjects to complete) - Duragesic® (25μg/hr, 10 cm2, 0.6 mg/24hr) vs.

  • Subject to THERAVANCE providing to ASTELLAS a commercially validated process for finished Licensed Product manufacture, ASTELLAS shall obtain supply of Licensed Product for Commercial purposes following Marketing Authorization, including Licensed Product for clinical studies of Other Indications once the Registration Batches of Licensed Product are complete and subject to the fulfillment of any orders that may be pending at that time under Section 9.02(c).

  • THERAVANCE shall be responsible for supply of worldwide requirements of API Compound for Studies supporting Initial Indications and the Registration Batches thereof as well as all other supply for the Initial Indications in the US up through delivery of the First Commercial Sale Stock.


More Definitions of Registration Batches

Registration Batches means that batch or batches of Atamestane drug substance and/or drug product made under GMP conditions that is or are necessary to support the filing of a marketing application or a new drug application for Licensed Product.
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Related to Registration Batches

  • Registration decal means an adhesive sticker produced by the department and issued by the

  • Registration Form means a book voter registration form and a by-mail voter

  • Registration Books means the records maintained by the Trustee pursuant to Section 2.08 for the registration and transfer of ownership of the Bonds.

  • Registration Process means the online account opening procedure followed by the Client in order to open a trading account with the Company.

  • Registration Application means an application for registration of this Agreement as a planning agreement on the title of the Land pursuant to Section 7.6 of the Act in a form approved by the Registrar General;