Registration Batch definition
Examples of Registration Batch in a sentence
This option applies to drug product required for manufacture of the first Registration Batch and for subsequent development and commercialization of Licensed Product.
This option applies to drug substance required for manufacture of the first Registration Batch and for subsequent development and commercialization of Licensed Product.
The manufacture of drug substance for use in development prior to the manufacture of the first Registration Batch is covered by the terms of Section 4 of this Agreement.
Each Registration Batch consists of approximately [**] units (i.e., single dose units) of Product that Gilead has tested in-process in accordance with the Specifications in the Product Supplement.
Each Product in a Registration Batch consists of 0.3 mg, 1 mg or 3mg of Macugen as requested by Eyetech.
The manufacture of drug product for use in Development prior to the manufacture of the first Registration Batch is covered by the terms of Section 4 of this Agreement.
Aesica shall be entitled to invoice for each Registration Batch in accordance with the terms of this Agreement.
For the sake of clarity, we hereby exercise again our option pursuant to Section 5.1 of the License Agreement to manufacture drug substance for the Licensed Product (as defined in the License Agreement) required for manufacture of the first Registration Batch (as defined in the License Agreement).
If, as a result of such inspection, Customer or its designee discovers that any Clinical Sample or Registration Batch delivered by Aesica under this Agreement fails to conform with the Specifications or otherwise fails to conform to the warranties given by Aesica (Section 13) (“Rejected Goods”), Customer or such designee may reject such Product by providing Aesica written notice thereof within sixty (60) days after Customer’s or its designee’s receipt of such Product.