Product CPP definition

Product CPP means a certificate of pharmaceutical product, issued by the relevant Canadian Governmental Authority in a format recommended by the World Health Organization for the Product manufactured in Canada, which establishes the status of the Product in Canada, indicates the manufacturer of the Product complies with cGMP, and is inspected regularly by the Canadian national health authorities.
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Examples of Product CPP in a sentence

  • At Kadmon’s request and to the extent required by Kadmon to provide clinical trial supplies of Product, Abbvie shall supply Kadmon necessary product approval reference, product release information including Certificates of Analysis (CofA), and Certificates of Pharmaceutical Product (CPP) where available, to support Kadmon’s ability to provide Product for clinical trials.

  • Exclusivity Except for the Product, CPP would not develop or commercialize in the Territory (i) any product with both of the Active Ingredients (or where both Active Ingredients are co-packaged or co-marketed) for use in the Field, or (ii) any product that uses any Active Ingredient (whether both or a single Active Ingredient) for the treatment of FAP.

  • All FPPs should have a Certificate of Pharmaceutical Product (CPP) according to the WHO Certification Scheme, or an equivalent, issued by the National Regulatory Authorities and specified in the relevant WHO Technical Report Series.

  • In light of the foregoing, and upon Topotarget’s request, Spectrum agrees to reasonably cooperate with Topotarget in obtaining, and Spectrum will use Commercially Reasonable Efforts to obtain, from the FDA or other Regulatory Authority a Certificate of Pharmaceutical Product (CPP) with respect to Product manufactured by any Third Party manufacturers engaged by Spectrum to produce commercial supplies of API and/or Product.

  • To the extent that CPP orders any Product in amounts which would require sanofi-aventis to manufacture less than a standard Batch for the Product, CPP and sanofi-aventis shall agree upon the price for such Product produced in such reduced Batch prior to commencement of production.

  • For Commercial Product, CPP shall submit each Purchase Order to Sanofi-aventis at least one hundred and twenty (120) days in advance of the earliest delivery date requested in the Purchase Order and for Clinical Product at least one hundred and eighty (180) days in advance.

  • Unicycive shall also provide marketed Certificate of Pharmaceutical Product (CPP) for the Licensed Product to Lotus as soon as reasonably possible.

Related to Product CPP

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate):

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Product Candidate means, [***].