Product Books and Records means the Books and Records of Seller relating primarily to the Products, the Business or the Acquired Assets.
Product Books and Records means all of the Books and Records relating exclusively to the Products or that are necessary for the conduct of the Business in the Territory, Including the Product Marketing Materials but excluding the Excluded Books and Records.
Product Books and Records means copies of all files, documents, instruments, papers, books and records, whether on paper or in electronic form in a Database (but if in electronic format, not including any related software), owned or Controlled by the Elan Companies or their respective Affiliates and necessary for or to the extent related to the development of the Product or a Current Product Improvement or the sale, marketing or distribution of the Product or a Current Product Improvement in the Territory, including (a) all market research, marketing plans, media plans, advertising, customer marketing records, call lists or similar materials, pricing lists, current and prospective customer lists and records, including principal contacts, addresses, telephone numbers, purchasing history and payment information, and promotional and marketing books and records, (b) any documentation evidencing or embodying the Product Intellectual Property, and (c) any documentation to the extent related to investigations being conducted with respect to the Product or a Current Product Improvement, including pursuant to a Development Contract, or to the receipt or maintenance of regulatory approvals for the Product or a Current Product Improvement in the Territory (including study protocols, study plans, pre-clinical and clinical study test results and data, and investigator and study site lists and contact reports), but excluding any such items set forth on Schedule 1.01(e) of the Elan Company Disclosure Schedule that (i) any applicable Law prohibits their transfer, (ii) any transfer thereof would subject the Elan Companies or any of their respective Affiliates to any Liability or (iii) are tax files, documents, instruments, papers, books and records.
Examples of Product Books and Records in a sentence
After such three (3) year period, before either party shall dispose of any such Books and Records, it shall provide to the other party at least ninety (90) calendar days’ prior written notice to such effect, and such party shall be given an opportunity, at its sole cost and expense, to remove and retain all or any part of such Product Books and Records (other than the Excluded Books and Records).
EPI will provide the same information to Acquiror on the same basis with respect to Products sold by EPI prior to the Closing to the extent that such information is not included in the Product Books and Records.
Seller shall use its commercially reasonable efforts to identify and locate any Product Books and Records or Regulatory Documentation that relate to the Rhofade Product outside of the United States and shall deliver such items at the Closing to the extent so identified and located prior to Closing.
Seller may transfer copies or originals of the Product Books and Records and Regulatory Information at its election, unless Purchaser reasonably requests an original copy of any such Product Books and Records and Regulatory Information.
Notwithstanding anything to the contrary contained in this Agreement, EPI may retain, at its expense, archival copies of all Assumed Contracts, Product Books and Records and other documents or materials conveyed hereunder; provided, however, that EPI shall maintain such items in accordance with the provisions of Section 8.04.
More Definitions of Product Books and Records
Product Books and Records means all books, records and recorded information, including, but not limited to, laboratory books, batch records, stability data and pre-clinical and clinical studies and regulatory files and supplier lists, held in Seller’s name or in any Affiliate’s or licensor’s name on Seller’s behalf and in each case used primarily in, necessary to or related directly to the research, development, manufacture, use, sale or importation of the Product.
Product Books and Records means all books, records, files, documentation, correspondence, training materials, artwork, labeling, lists and other materials, including research information, information relating to clinical trials, sales and promotional literature, manuals, data (including, pre-clinical and clinical data), sales and purchase correspondence, lists of present and former suppliers, list of present and former customers and personnel and employment records, in each case whether in hard copy or computer format, exclusively used or held for exclusive use in the Rhofade Business or with respect to any prescription or over-the-counter drug product for topical application solely to treat facial redness due to rosacea or any product containing oxymetazoline for the treatment of facial redness due to rosacea by application to the skin, including Rhofade Product; provided, that any portion of the books, records or other items that are subject to restrictions on transfer pursuant to HIPAA or other applicable regulations regarding personally identifiable information or subject to Seller’s privacy policies regarding personally identifiable information with respect to which transfer would require any Regulatory Authorization under Applicable Law may be redacted by Seller only to the extent required to comply with Applicable Law. For the avoidance of doubt, (x) books and records relating to performance ratings or assessments of employees of Seller and its Affiliates shall not be deemed to be Product Books and Records unless such records are required to be transferred to Buyer pursuant to Applicable Law, and (y) Seller and its Affiliates shall be entitled to retain any copies of the Product Books and Records to the extent and only for the period required under Applicable Law.
Product Books and Records means all books, records, files, documentation, correspondence, training materials, artwork, labeling, lists and other materials, including research information, information relating to clinical trials, sales and promotional literature, manuals, data
Product Books and Records means the Books and Records relating to the Products or that are necessary for the continuation of the operations and reporting obligations with respect to the Products and the Business or that are necessary to identify and protect the rights with respect to the Products, Purchased Assets or the Business to be acquired by Buyer pursuant to this Agreement, including without limitation all clinical data relating to the Products and those Books and Records set forth on Schedule 1.01(f) but excluding any portion of such material which does not relate to the Products.
Product Books and Records means all books, records, files, documentation, correspondence, training materials, artwork, labeling, lists and other materials, including research information, information relating to clinical trials, sales and promotional literature, manuals, data (including, pre-clinical and clinical data), sales and purchase correspondence, lists of present and former suppliers, list of present and former customers and personnel and employment records, in each case whether in hard copy or computer format, exclusively used or held for exclusive use in the Rhofade Business or with respect to any prescription or over-the-counter drug product for topical application solely to treat facial redness due to rosacea or any product containing oxymetazoline for the treatment of facial redness due to rosacea by application to the skin, including Rhofade Product; provided, that any portion of the books, records or other items that are subject to restrictions on transfer pursuant to HIPAA or other applicable regulations regarding personally identifiable information or subject to Seller’s privacy policies regarding personally identifiable information with respect to which transfer would require any Regulatory Authorization under Applicable Law may be redacted by Seller only to the extent required to comply with Applicable Law. For the avoidance of doubt, (x) books and records relating to performance ratings or assessments of employees of Seller and its Affiliates shall not be deemed to be Product Books and Records unless such records are required to be transferred to Buyer pursuant to Applicable Law, and (y) Seller and its Affiliates shall be entitled to retain any copies of the Product Books and Records to the extent and only for the period required under Applicable Law. Confidential and Proprietary CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Product Books and Records has the meaning ascribed to it in Section 1.01(a)(viii).
Product Books and Records means all books, records, files, documentation, correspondence, training materials, artwork, labeling, lists and other materials, including research information, information relating to clinical trials, sales and promotional literature, manuals, data CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. OMISSIONS ARE DESIGNATED [***] (including, pre-clinical and clinical data), sales and purchase correspondence, lists of present and former suppliers, list of present and former customers, chemistry, manufacturing and controls data and documentation (including, but not limited to, batch records, master batch production records, standard operating procedures that specifically pertain to the RHOFADE Product, testing logs, sample logs, laboratory logs, and stability logs, preclinical and clinical studies and tests), in each case whether in hard copy or computer format, exclusively used or held for exclusive use in the RHOFADE Business or with respect to any prescription or over-the-counter drug product for topical application solely to treat facial redness due to rosacea or any product containing oxymetazoline for the treatment of facial redness due to rosacea by application to the skin, including the RHOFADE Product, and all records maintained under record keeping or reporting requirements of the FDA or any Governmental Authority with respect to the RHOFADE Product; provided, that any portion of the books and records or other items that are subject to restrictions on transfer pursuant to HIPAA or other applicable regulations regarding personally identifiable information with respect to which transfer would require any Governmental Authority to approve under applicable Law may be redacted by Seller only to the extent required to comply with applicable Law. For the avoidance of doubt, Seller and its Affiliates shall be entitled to retain any copies of the Product Books and Records to the extent and only for the period required under applicable Law.