Packaging and Labeling definition
Packaging and Labeling means primary, secondary, or tertiary packaging and labeling of a Licensed Product (in its commercial packaging presentation) for sale or use in a country, including the Approved Labeling and insertion of materials such as patient inserts, patient medication guides, and professional inserts and any other written, printed, or graphic materials accompanying such Licensed Product and any brand security or anti-counterfeiting measures included in the packaging elements for such Licensed Product considered to be part of the finished packaged Licensed Product, and all testing and release thereof.
Packaging and Labeling means secondary packaging, labeling, and serializing (as required by Applicable Law) Product.
Packaging and Labeling means, with respect to a SYNGAP1 Co-Co Product, primary, secondary, or tertiary packaging and labeling of such SYNGAP1 Co-Co Product (in its commercial packaging presentation) for sale or use in the Territory, consistent with respect to the applicable SYNGAP1 Co-Commercialization Plan, including the Approved Labeling and insertion of materials such as patient inserts, patient medication guides, and professional inserts and any other written, printed, or graphic materials accompanying such SYNGAP1 Co-Co Product and any brand security or anti-counterfeiting measures included in the packaging elements for such SYNGAP1 Co-Co Product considered to be part of the finished packaged SYNGAP1 Co-Co Product, and all testing and release thereof.
Examples of Packaging and Labeling in a sentence
Kissei must consult with Viridian during the development of the Approved Labeling for the Licensed Products in the Territory, and provide Viridian with the opportunity to review and provide comments on, all Licensed Product look and feel of Packaging and Labeling (including providing Viridian the right to review all mockups thereof prior to submission thereof to the Regulatory Authorities in the Territory).
Kissei will be solely responsible for all costs and expenses associated with Packaging and Labeling the Licensed Products received from Viridian as necessary to Commercialize the Licensed Products in the Territory, including any costs or expenses associated with any label changes or remanufacturing of any Licensed Product due to changes requested or required by any Regulatory Authority in the Territory.
Kissei, in its capacity as manufacturer and MAA holder, will be responsible for the elaboration and filing of packaging artworks and mock-ups, and for the routine maintenance and production of Packaging and Labeling components for the Licensed Products for the Territory in or outside the Territory.
More Definitions of Packaging and Labeling
Packaging and Labeling means primary, secondary, or tertiary packaging and labeling of a Glucagon Product (in its commercial packaging presentation) for sale or use in a country, including the Approved Labeling and insertion of materials such as patient inserts, patient medication guides, and professional inserts and any other written, printed, or graphic materials accompanying such Glucagon Product and any brand security or anti-counterfeiting measures included in the packaging elements for such Glucagon Product considered to be part of the finished packaged Glucagon Product, and all testing and release thereof.
Packaging and Labeling means the preparation of Units of Product in final finished packaged form ready for commercial sale in the Territory in accordance with the Packaging and Labeling Instructions.
Packaging and Labeling means primary, secondary, or tertiary packaging and labeling of the Licensed Product (in its commercial packaging presentation) for sale or use in the Territory, including the Approved Labeling and insertion of materials such as patient inserts, patient medication guides, and professional inserts and any other written, printed, or graphic materials accompanying the Licensed Product and any brand security or anti-counterfeiting measures included in the packaging elements for the Licensed Product considered to be part of the finished packaged Licensed Product, and all testing and release thereto.
1. 101 “[**]” means [**].
1. 102 “[**] Agreement” means that certain [**] Agreement, dated as of [**], by and between Akebia and [**].
1. 103 “[**] Patent Rights” means any and all Akebia Patent Rights that are Controlled by Akebia pursuant to the [**] Agreement
1. 104 “[**] Royalty Term” means on a country-by country basis, the period commencing on the date of First Commercial Sale of the first Licensed Product in such country and expiring upon the expiration of the last Valid Claim included in the [**] Patent Rights in such country.
Packaging and Labeling means secondary packaging, labeling, and serializing (as required by Applicable Law) for the Product. 1.81 “Party Combination Study” means any Clinical Trial regarding the combination (including co-administration or other coordinated use) of (a) the Product, on the one hand, and (b) one or more other products developed and/or commercialized by or on behalf of a Party or its Affiliates (including products co-developed by a Party or its Affiliate and a Third Party). A Party Combination Study involving a product developed and/or commercialized by or on behalf of (i) SGI (including products co-developed by SGI or its Affiliate and a Third Party) is referred to herein as an “SGI Party Combination Study” and (ii) Genmab (including products co-developed by Genmab or its Affiliate and a Third Party) is referred to herein as a “Genmab Party Combination Study.” 1.82 “Party Major Market Commercialization Plan” means the Genmab Major Market Commercialization Plan and the SGI Major Market Commercialization Plan, individually or collectively, as the context requires. 1.83 “Party Major Market(s)” means (a) with respect to Genmab, the Genmab Major Market, and (b) with respect to SGI, the SGI Major Markets, individually or collectively, as the context requires. 1.84 “Party Major Market Plans” means the Party Major Market Commercialization Plans and the Party Major Market Medical Affairs Plans, individually or collectively, as the context requires. 1.85 “Party Major Market Medical Affairs Plan” means the Genmab Major Market Medical Affairs Plan and the SGI Major Market Medical Affairs Plan, individually or collectively, as the context requires. 1.86 “Party Tactical Matters” means, with respect to a Party, such Party’s operational or tactical-level actions and decisions with respect to matters and functions allocated or delegated to such Party pursuant to (i) a Combined Major Market Plan, (ii) a Party Major Market Plan, (iii) the US Coordination Plan, or (iv) otherwise pursuant to this Agreement with respect to the Product (including, generally, Commercialization activities, Manufacturing activities, and Medical Affairs Activities with respect to the Product) to the extent that such actions or decisions are consistent with the terms of this Agreement, the scope of such allocation or delegation, Applicable Law, and the Combined Major Market Plans, Party Major Market Plans, and US Coordination Plan, including the tactical and strategic matters described in such plans, in each ...
Packaging and Labeling shall have the meaning set forth in Section 5.5.
Packaging and Labeling means finished product packaging and labeling and holding (including storage) of a Licensed Product in the Territory. When used as a verb, “Package and Label” means to engage in Packaging and Labeling.
Packaging and Labeling means primary, secondary, or tertiary packaging and labeling of a DT Co-Co Product (in its commercial packaging presentation) for sale or use in the Territory, consistent with respect to the Commercialization Plan, including the Approved Labeling and insertion of materials such as patient inserts, patient medication guides, and professional inserts and any other written, printed, or graphic materials accompanying such DT Co-Co Product and any brand security or anti-counterfeiting measures included in the packaging elements for such DT Co-Co Product considered to be part of the finished packaged DT Co-Co Product, and all testing and release thereof.