cGMP Product definition

cGMP Product means Product which is required under Schedule 2 to be manufactured in accordance with cGMP.

cGMP Product means Product which may be required under Technology Development Contracts to be manufactured in accordance with cGMP.

cGMP Product means Product manufactured under a cGMP Batch.

Examples of cGMP Product in a sentence

• HEMISPHERX shall solely be responsible for the manufacturing, fill & finish, labeling and, if applicable, stockpiling of cGMP grade Product in compliance with the Quality Agreement attached as Exhibit 5, and shall exert its reasonable commercial best efforts to provide quantities of cGMP Product sufficient to meet the requirements of the EAP.

• Each shipment of cGMP Product will follow the criteria and contain the documents set forth in the Quality Agreement.

• The normalized cost to income ratio in 1H/21 was at 43.4%, slightly increased from 41.4% in 1H/20.

• Subject to Clause 2, if such tests show that the Product does not comply with the Testing Summary (in respect of product from a Pilot Batch after the Initial Phase) or the Specification (in respect of cGMP Product), Customer shall give Lonza written notice thereof within sixty (60) days from the date of Delivery and shall return such Product to Lonza’s premises for further testing.

• Each shipment of cGMP Product will include a Certificate of Analysis, a Confirmation of Compliance and such other documentation as reasonably required to meet all applicable statutory and regulatory requirements.

More Definitions of cGMP Product

cGMP Product means a Product manufactured (or to be manufactured, as the context requires) under cGMP conditions;

cGMP Product means all Product which is defined in individual Purchase Orders, Work Order(s) and/or this Agreement to be manufactured in accordance with cGMP.

cGMP Product means a Licensed Product compliant with current Good Manufacturing Practices established by the Applicable Regulatory Authority.

cGMP Product means Product which may be required under SOW to be manufactured in accordance with cGMF.

cGMP Product means Product that is required under this Agreement or a SOW to be manufactured in accordance with cGMP; for purposes of clarity, all Product manufactured under this Agreement or a SOW shall be manufactured under cGMP unless expressly agreed otherwise in a SOW for development work.

cGMP Product means Product which is required under Work Orders to be manufactured in accordance with CGMP.

cGMP Product means Product which is required under Schedule 2 to be manufactured in accordance with cGMP; *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2 Execution Copy "COO" means chief operating officer;