Purchased Regulatory Documentation means, with respect to the Product and the Authorized Generic Product, all (a) documentation comprising the Purchased Regulatory Approvals, (b) correspondence and reports exclusively related to the Product or the Authorized Generic Product in the Territory and necessary to, or otherwise limiting the ability to, commercially distribute, sell or market the Product in the Territory as of the Closing Date submitted to or received from Governmental Authorities (including minutes and official contact reports relating to any communications with any Governmental Authority) and, to the extent related exclusively to the Territory, relevant supporting documents with respect thereto, including all regulatory drug lists, materials submitted to FDA under FDA Form 2253, final versions of advertising and promotion materials, and adverse drug experience reports (periodic and expedited) and Adverse Event files and (c) data (including clinical and pre-clinical data) referenced in any of the foregoing that relates exclusively to the Territory, in each case ((a), (b) and (c)), (x) to the extent in the possession or Control of Seller or any of its Affiliates and (y) excluding the Excluded Items.
Purchased Regulatory Documentation means, with respect to the Products, all documentation comprising the Purchased Regulatory Approvals related to the Products and the Territory: (a) original NDAs and associated amendments, any post-approval correspondence and any official correspondence and reports submitted to or received from Governmental Authorities (including minutes and official contact reports relating to any communications with any Governmental Authority); (b) copies of all clinical studies performed in association and in support of the Purchased Regulatory Approvals, (c) copies of all periodic safety reports (PBRER, PSUR or PADERs) submitted to the FDA, (d) relevant supporting documents with respect to such correspondence and reports, including all regulatory drug lists, materials submitted to FDA under FDA Form 2253, final versions of advertising and promotion materials, and adverse drug experience reports (periodic and expedited), and (e) the Purchased Information, in each case, (x) to the extent in the possession or Control of Sellers or any of their respective Affiliates as of the Closing Date and (y) excluding the Excluded Items and all intellectual property rights of Sellers or their respective Affiliates or their respective licensors contained or depicted therein.
Purchased Regulatory Documentation means, with respect to the Product, all (a) documentation comprising the Purchased Regulatory Approvals, (b) correspondence and reports exclusively related to the Product in the Territory and necessary to, or otherwise limiting the ability to, commercially distribute, sell or market the Product in the Territory as of the Closing Date submitted to or received from Governmental Authorities (including minutes and official contact reports relating to any communications with any Governmental Authority) and, to the extent related exclusively to Territory, relevant supporting documents with respect thereto, including all regulatory drug lists, materials submitted to FDA under FDA Form 2253, final versions of advertising and promotion materials, and adverse drug experience reports (periodic and expedited), and (c) data (including commercial, clinical and pre-clinical data) referenced in any of the foregoing that relates exclusively to the Product in the Territory, in each case ((a) and (b)), to the extent in the possession or Control of Seller or any of its Affiliates, but excluding, in all cases, the Excluded Items, and in each case, in the form currently maintained by Seller (e.g., electronic).
Examples of Purchased Regulatory Documentation in a sentence
The Purchased Inventory (a) is of a good and merchantable quality and is usable or saleable in the ordinary course of the Product Business (other than any Purchased Inventory as to which no value is ascribed in accordance with Section 2.5.3), (b) complies in all material respects with applicable Law and the specifications therefor included in the Purchased Regulatory Documentation, and (c) was Manufactured in all material respects with applicable Law and applicable Product Registrations.
Effective from and after the Closing, Buyer hereby grants to any Person Exploiting or Manufacturing the product described on Schedule 5.13.2, a perpetual, irrevocable, worldwide, non-exclusive, royalty-free and non-transferable license and right of reference (with a right to grant sublicenses and further rights of reference) to the Purchased Regulatory Documentation and Buyer Regulatory Documentation, as may be necessary to Exploit and Manufacture the product described on Schedule 5.13.2.
Sellers shall use their commercially reasonable efforts to assist Bxxxx in remedying any such problems or issues (if any) with respect to the Purchased Regulatory Documentation as soon as reasonably practicable following Sellers’ receipt of Buyer’s notice of the same.
Any such copies of the Purchased Regulatory Documentation and the Purchased Product Records retained by Seller shall be considered Confidential Information of Buyer and subject to Section 5.4.
Sellers shall use their commercially reasonable efforts to assist Buyer in remedying any such problems or issues (if any) with respect to the Purchased Regulatory Documentation as soon as reasonably practicable following Sellers’ receipt of Buyer’s notice of the same.
More Definitions of Purchased Regulatory Documentation
Purchased Regulatory Documentation means, (a) with respect to each Product in the Territory, all (i) documentation comprising the Purchased Marketing Authorizations for such Product, (ii) data (including clinical and pre-clinical data) exclusively related to such Product and the Territory contained in any of the Purchased Marketing Authorizations and (iii) correspondence and reports (A) exclusively related to such Product and the Territory, (B) reasonably necessary to Exploit such Product in the Territory as Exploited by Seller and its Affiliates as of Closing Date and(C) submitted to or received from Regulatory Authorities in the Territory (including minutes and official contact reports relating to any communications with any Regulatory Authority) and relevant supporting documents submitted to or received from Regulatory Authorities in the Territory with respect thereto, including final versions of advertising and promotion documents, Product Labeling used as of the Closing Date, copies of complaint files, in each case, to the extent owned and maintained by, and in the possession or under the Control of, Seller or any of its Affiliates and in the format maintained by Seller or its applicable Affiliates (but excluding any Excluded Communications, and it being further understood that a transfer of Purchased Regulatory Documentation under Section 2.1.1(c) does not include an assignment of any Intellectual Property Rights in such Purchased Regulatory Documentation (but without affecting any implied rights)) and (b) the data relating to the Products contained in the Global Safety Database maintained by Seller and its applicable Affiliates.
Purchased Regulatory Documentation means, all (a) documentation comprising the Purchased Product Registrations and (b) to the extent owned by and in the possession or Control of, and in such form as maintained by, any Divesting Entity, exclusively or primarily related to any Product and the applicable Field and the applicable Territory for such Product and necessary to, or otherwise limiting the ability to, Exploit or Manufacture such Product in such Field and Territory, (i) correspondence and reports submitted to or received from Governmental Authorities, (ii) other dossiers or compilations necessary to obtain or maintain any Purchased Product Registrations with regard to such Product, (iii) literature safety reports and documents relating to good manufacturing practices or issues, animal clinical trials, animal research, including laboratory and target animal research and all veterinary master files contained or referenced in the Purchased Product Registrations with regard to such Product and (iv) data (including clinical and pre-clinical data) referenced in any of the documentation and materials referred to in the preceding clauses (a), (b)(i) and (b)(ii), in each case (clauses (a) and (b)), excluding the Excluded Assets and all intellectual property rights of any Third Party contained or depicted therein.
Purchased Regulatory Documentation means, (a) with respect to each Product in the Territory, all (i) documentation comprising the Purchased Marketing Authorizations for such Product, (ii) data (including clinical and pre-clinical data) exclusively related to such Product and the Territory contained in any of the Purchased Marketing Authorizations and (iii) correspondence and reports (A) exclusively related to such Product and the Territory, (B) reasonably necessary to Exploit such Product in the Territory as Exploited by Seller and its Affiliates as of Closing Date and (C) submitted to or received from Regulatory Authorities in the Territory (including minutes and official contact reports relating to any communications with any Regulatory Authority) and relevant supporting documents submitted to or received from Regulatory Authorities in the Territory with respect thereto, including final versions of advertising and promotion documents, Product Labeling used as of the Closing Date, copies of complaint files, in each case, to the extent owned and maintained by, and in the possession or under the Control of, Seller or any of its Affiliates and in the format maintained by Seller or its applicable Affiliates (but excluding any Excluded Communications, and it being further understood that a transfer of Purchased Regulatory Documentation under Section 2.1.1(c) does not include an assignment of any Intellectual Property Rights in such Purchased Regulatory Documentation (but without affecting any implied rights)) and (b) the data relating to the Products contained in the Global Safety Database maintained by Seller and its applicable Affiliates.
Purchased Regulatory Documentation means, with respect to the Product, all (a) documentation comprising the Purchased Regulatory Approvals and associated Regulatory Submissions, (b) correspondence and reports primarily related to the Product in the Territory and necessary to, or otherwise limiting the ability to, commercially distribute, sell or market the Product in the Territory as of the Closing Date submitted to or received from Governmental Authorities (including minutes and official contact reports relating to any communications with any Governmental Authority) and, to the extent related primarily to the
Purchased Regulatory Documentation has the meaning set forth in Section 2.1.1(b).
Purchased Regulatory Documentation means, with respect to any RPGR Product, all (a) applications for and documentation comprising the Regulatory Filings for any RPGR Product; (b) material correspondence submitted to or received from Governmental Authorities in connection with the Regulatory Filings for any RPGR Product; and (c) source Clinical Study data and safety data submitted to Regulatory Authorities in connection with the Regulatory Filings for any RPGR Product, in each case ((a), (b) or (c)), to the extent (i) owned (or purported to be owned) by, and in the possession or control of, Seller (or any of its Affiliates) as of the Closing (or, in connection with any Clinical Trial for any RPGR Product ongoing as of the Closing and generated pursuant to the Amended and Restated Transition Services Agreement, after the Closing), and (ii) primarily related to any RPGR Product (or the Exploitation thereof); provided, however, in each case ((a), (b) or (c)), excluding (A) any laboratory notebooks, internal audit reports or batch records (other than those batch records contained in the Regulatory Filings); and (B) any applications, documents, correspondence or data that constitute embodiments of Manufacturing Intellectual Property or Seller [***] Technology.
Purchased Regulatory Documentation means [***].