Annual Product Review Report means the annual product review report prepared by Patheon as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e);
Annual Product Review Report means the annual product review report prepared by Patheon or an Affiliate of Patheon as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e);
Annual Product Review Report means the annual product review report as described in 21 CFR, Section 211.180(e);
Examples of Annual Product Review Report in a sentence
At the Client’s request, Patheon will provide a copy of the Patheon standard Annual Product Review Report to the Client at no additional cost unless otherwise specified in Schedule B.
More Definitions of Annual Product Review Report
Annual Product Review Report means the annual product review report prepared by Manufacturer regarding the Supplied Product as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e), and any other similar reports that may be required by Applicable Laws;
Annual Product Review Report means the annual product review report prepared by Patheon or an Affiliate of Patheon as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e) and respective EU laws, directives and regulations;
Annual Product Review Report means the annual product review report, which will be prepared by Patheon, as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e); "Annual Report" means the annual report to the FDA, which is required to be prepared and filed by Client, regarding the Product as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2); "Annual Volume" means the minimum volume of Product to be manufactured in any Year of this Agreement as set forth in Schedule B; "Applicable Laws" means all applicable federal, state and local laws, rules, regulations and requirements; -2- [*] = 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. Master Manufacturing Services Agreement "Authority" means any governmental or regulatory authority, department, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal; “Batch” means a specific quantity of Active Material and Components that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture; “Xxxx Back Items” means the expenses for all third party supplier fees for the purchase or use of columns, standards, non-standard tooling, non-standard pallets, non-standard PAPR or PPE suits (where applicable) and other project-specific items necessary for Patheon to perform the Manufacturing Services, and which are not included as Components, as may be specified in the Product Agreement for a Product; “Breach Notice” has the meaning specified in Section 8.2(a); "Business Day" means a day other than a Saturday, Sunday or a day that is a statutory holiday in the country where the Manufacturing Site is located, unless another country is specified in the Product Agreement; “Capital Equipment Agreement” means a separate agreement that the parties may enter into that will address responsibility for the purchase of capital equipment and facility modifications that may be required to perform the Manufacturing Services under a particular Product Agreement; "cGMPs" means, as applicable, current good manufacturing practices as described in the laws of the applicable jurisdiction, including without limitation:
Annual Product Review Report means the annual product review report prepared by CCX or an Affiliate of CCX as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e) and respective EU laws, directives and regulations;
Annual Product Review Report means the annual product review report as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e); [ * ] = 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.
Annual Product Review Report means the annual product review report prepared by SPT as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e), as amended.
Annual Product Review Report means the annual product review report prepared by Patheon as described in Title 21 of the United States Code of