Biological License Application definition
Examples of Biological License Application in a sentence
The goal of this project is to develop an efficacious hybridoma-based idiotype vaccine to produce long-term disease-free survival in follicular B-cell lymphoma patients who have attained a complete clinical response from chemotherapy and to compile data required to support a Biological License Application (BLA) to the U.S. Food and Drug Administration (FDA) for hybridoma-based idiotype follicular B-cell lymphoma vaccine.
Miltenyi shall in no way be held responsible for any refusal by any Regulatory Authority or ethics committee to grant permission to conduct a clinical trial(s) and/or for any refusal by any Regulatory Authority to grant approval under an Investigational New Drug Application (IND) or under a Biological License Application (BLA) or for compassionate use for a Autolus Product.
Failure for Company to achieve the specific Diligence Requirement under Section 3.1(f) shall not result in termination of this Agreement, but such failure shall restrict Company’s License Territory to the specific Major Market Country for which it has filed for a Biological License Application pursuant to the Diligence Requirement under Section 3.1 (e).
With respect to any CLINICAL PRODUCT for which any MILESTONE PAYMENT has been made, LICENSEE and any SUB-LICENSEE shall have no obligation to make the same MILESTONE PAYMENT when and if such party makes any filing (including amendments to the applicable Biological License Application) or obtains any approvals related to the use of the same CLINICAL PRODUCT for indications additional to the indication for which the first MILESTONE PAYMENT(S) for such CLINICAL PRODUCT was (were) made.
The Parties shall fully cooperate in good faith, and shall provide all reasonable assistance and information, in a timely manner, to each other, to obtain and maintain all Regulatory Approvals that are required to manufacture, distribute, use or sell the Products, including without limitation the preparation, filing and maintenance of any U.S. Biological License Application or European Marketing Authorization (or equivalent in other jurisdictions).
BMPI and Chiron are parties to an exclusive, Clinical Manufacturing Supply Agreement effective March 28, 2001, under which Chiron has manufactured and supplied BMPI with purified bulk recombinant human platelet derived growth factor (PDGF), as described in Chiron's FDA-approved Biological License Application therefor ("CHIRON'S BLA"), for use in product development and clinical testing and in the Fields (as defined below).
Under the Original Agreement Novartis had manufactured and supplied BMTI with Product consisting of purified bulk recombinant human platelet growth factor as described in Novartis' FDA — approved Biological License Application therefor, for use in the Exclusive Fields (as defined in the Agreement).
Under the Original Agreement Novartis has manufactured and supplied BMTI with a Product consisting of purified bulk recombinant human platelet derived growth factor (“PDGF”), as described in Novartis' FDA-approved Biological License Application therefor (“Novartis' BLA”), for use in the Exclusive Fields (as defined below).
Product recalls involving any Product for which the Company has applied for or obtained an Investigational New Drug (IND) application or a Biological License Application (BLA) under United States law or a non-United States Marketing Authorization, that is sold to a Customer in [9.1 and 9.2] Very detailed reporting requirements here due to industry regulations.
Institution will retain organized original patient, laboratory and test article inventory records relating to the Clinical Trial for not less then five (5) years following notification by Sponsor that (a) all Product investigations have been discontinued or that (b) the FDA has approved the Biological License Application for the Product.