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, 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.
Packaging and Labeling means secondary packaging, labeling, and serializing (as required by Applicable Law) Product.
Examples of Packaging and Labeling in a sentence
Compliance with all federal, state, and local laws and regulations concerning Packaging and Labeling shall be the sole responsibility of COMPANY, provided that DPT purchases such Packaging and Labeling as provided in paragraph 2.2 (c) hereof.
COMPANY shall provide DPT with Specifications (including art proofs) for Packaging and Labeling, and DPT shall purchase, at the expense of COMPANY, Packaging and Labeling in accordance with the Specifications.
COMPANY shall be responsible for any additional charges (including, but not limited to, items such as brokerage fees, courier expenses, duty fees payable, etc.) that are incurred in the procurement of any materials and/or Packaging and Labeling components as detailed in the immediately preceding sub-sections (a), (b) and (c); required for the manufacture of the Products, irrespective of which party to the Agreement is responsible for supplying such items.
Licensee or its designated Third Party shall ensure that all such Packaging and Labeling complies with Applicable Laws, GMPs and the Regulatory Approvals for the Product in the Territory, including the Product Specifications.
Licensee or its designated Third Party shall ensure that all such Packaging and Labeling complies with Applicable Law, GMPs and the Regulatory Approvals for the Product, including the Product Specifications.
More Definitions of Packaging and Labeling
Packaging and Labeling means primary, secondary, or tertiary packaging and labeling of a 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 a Product and any brand security or anti-counterfeiting measures included in the packaging elements for a Product considered to be part of the finished packaged Product, and all testing and release thereof.
Packaging and Labeling means secondary packaging, labeling, and serializing (as required by Applicable Law) for the Product.
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 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.
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 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 shall have the meaning set forth in Section 5.5.