Product Records means the books, documents, records and files exclusively related to the Product, but excluding lab notebooks.
Product Records means all books and records Controlled by Seller or any of its Affiliates relating to, and reasonably necessary to Exploit, any Seller Product or to perform research and development activities with respect to any Seller Product, or to conduct the Product Business, as Exploited, performed or conducted (as applicable) as of the Closing Date and other than the Regulatory Documentation, but excluding, in all cases, (a) all books, documents, records and files prepared in connection with or relating to the Transactions contemplated under this Agreement, including bids received from Third Parties and strategic, financial or Tax analyses relating to the divestiture of the Purchased Assets, the Assumed Liabilities, the Product, the Third Generation Product or the Product Business; (b) all books, documents, records and files to the extent related to the Manufacture of the Product or the Third Generation Product; (c) trade secrets of Third Parties; (d) any attorney work product, attorney-client communications and other items protected by established legal privilege, unless the books and records can be transferred without losing such privilege; (e) human resources and any other employee books and records, other than any such books and records relating solely to any Product Business Employee who accepts an offer of employment with Purchaser; (f) any financial, Tax and accounting records to the extent not related to the Product, the Third Generation Product, or any other Purchased Asset; and (g) any items to the extent applicable Law prohibits their transfer or where transfer thereof would subject Seller or any of its Affiliates to any Liability. It is hereby clarified that a particular book or record may include information that does not constitute Product Records as well as information that constitutes Product Records and Seller may redact the portion of such book or record that does not constitute Product Records before delivering to Purchaser the portion of such book or record that constitutes Product Records.
Product Records means, in whatever medium (e.g., audio, visual, print or electronic) relating to the Product or the Product Line Business: (a) any and all data and correspondence supporting and/or utilized or made in connection with obtaining and/or maintaining any of the Registrations and/or the drug master file for the Product, (b) raw and/or analysis data for pivotal trials and integrated summaries (ISE/ISS) and all bio-analytical data in SAS transport, PC SAS Version 6.06, or above, or other agreed format, (c) all clinical data (phase I — IV), (d) all data from ongoing development of the compound utilized in the Product (including marketing studies), (e) programs (analysis, reports and supporting documentation) for trials for which data is provided, (f) copies of SAS libraries (with non-exclusive rights to use same) from Seller’s analysis programs relating to the Product, and (g) all books and records owned by Seller relating to the Product (which shall be copies to the extent not exclusive to the Product), including copies of all customer and supplier lists, account lists, call data, sales history, call notes, research data, marketing studies, consultant reports, physician databases, and correspondence (including invoices) with respect to the Product, and all complaint files and adverse event reports and files, and (h) copies of all data and information in the possession of Seller relating to the activities of Organon and/or IHS or other entity providing support services to Seller which relate to the Product, including for commercial rebates, discounts, administrative fees, chargebacks and/or Government Rebates; provided, however, that (i) in each case, Seller may exclude any Excluded Intellectual Property contained therein, (ii) Seller may retain: (A) a copy of any such books and records to the extent necessary for Tax, accounting, litigation or other valid business purposes other than the conduct of any business competitive with the Product or the Product Line Business, (B) a copy of all such books and records which relate to the Excluded Assets, and (C) all books, documents, records and files (1) prepared in connection with the Transactions, including bids received from other parties and strategic, financial or Tax analyses relating to the divestiture of the Purchased Assets, the Assumed Liabilities, the Product and the Product Line Business, or (2) maintained by Seller and/or its Representatives, agents or licensees in connection with their respective Tax, legal,...
Examples of Product Records in a sentence
Supplier shall not alter, destroy or otherwise dispose of any Product Records without CCI’s prior written authorization.
Supplier shall retain (and shall require any affiliates and subcontractors to retain) all Product Records for a period of time equivalent to one year past the design and expected life of the Product or the medical device in which the Product is intended to be included, which is not less than seven (7) years following Product manufacture.
Supplier shall provide copies of any or all Product Records to CCI within three (3) business days from the date of CCI’s written request for any Product Records.
All provisions which by their nature must continue after the Agreement expires or is terminated, including the Indemnification, Ownership of Materials/Work Product, Records, Governing Law, and Attorney Fees, shall survive the Agreement and remain in full force and effect.
In furtherance hereof, the Sellers covenant and agree to deliver tangible copies of the Purchased Product Records and the Purchased Regulatory Documents in accordance with Section 4.6.3 to the extent electronic copies of such Purchased Product Records and the Purchased Regulatory Documents have not been or will not be made available to Buyer.
More Definitions of Product Records
Product Records means all files, documents, instruments, papers, books and records Controlled by Seller and/or any of its Affiliates, whether in electronic or tangible form, that relate primarily to the Product, the Product Business and/or the Product Intellectual Property, including, without limitation, any and all pricing lists, customer lists, vendor lists, financial data, research and development files, marketing materials, regulatory files, adverse event reports and files; equipment specifications; analytical specifications and validation reports; Product batch records; bills of material; packaging specifications; approved and rejected vendor lists and audits; Product complaints, clinical studies and all documentation relating thereto; all documentation associated with the Product Intellectual Property; copies of all filings (and supporting documentation) with Governmental Authorities, including, but not limited to, any and all Product NDAs and BLAs; component and labeling purchasing specifications; packaging and quality control SOPs; stability data, records, charts, reports and applicable SOPs; quality assurance/control data, records, charts, reports, and applicable SOPs; budgets; pricing guidelines; ledgers; journals; Assumed Contracts; Promotional Materials; operating data and plans; sales data; target lists; file histories, file wrappers, correspondence, application documents, registration documents, search reports, documents concerning the prosecution history, enforcement or maintenance of rights, or restrictions on use, with respect to the Product Intellectual Property, whether or not required to be kept or maintained under any Law; but excluding (i) the Excluded Data and Materials and (ii) any items to the extent that any Applicable Law prohibits their transfer.
Product Records means all books and records relating exclusively to the Product in the Horizon Territory or to the Product Business (other than the Regulatory Documentation) to the extent owned by or maintained by or on behalf of AstraZeneca or any of its Affiliates, but excluding, in all cases, the following books, documents, records and files (a) all books, documents, records and files prepared for the transactions contemplated under this Agreement, including bids received from Third Parties and strategic, financial or Tax analyses relating to the divestiture of the Purchased Assets, the Assumed Liabilities, the Product and the Product Business (b) all books, documents, records and files related solely to the Manufacture of the Product, (c) any attorney work product, attorney client communications and other items protected by established legal privilege, unless the books and records can be transferred without losing such privilege, (d) human resources and any other employee books and records, (e) any financial, Tax and accounting records to the extent not related to the Product in the Horizon Territory, (f) all books and records related to the Merck Patents or the Merck Parties, and (g) any items to the extent applicable Law prohibits their transfer.
Product Records means, in any written or electronic form, all (a) books and records to the extent [*] related to a Product or to the Product Business (other than the Regulatory Documentation) and to the extent in the possession or control of Merck Serono or any of its Affiliates and reasonably necessary to Exploit a Product as Exploited, or expected to be Exploited, by or on behalf of Merck Serono as of the Transfer Time, including customer lists, vendor and supplier lists and correspondence, and training materials, and (b) of the following items to the extent related to a Product: (i) copies of all applicable technical reports, including characterization reports and development reports, (ii) data contained in laboratory notebooks related to a Product, and (iii) batch documentation (including copies of executed batch records and disposition packages) for the Inventory. Product Records shall not include (x) human resources and any other employee books and records, (y) any financial, Tax and accounting records to the extent not related to a Product, and (z) any items to the extent Law prohibits their transfer.
Product Records means all files, reports, books, records, documents and similar materials owned or in the possession of Seller or its Affiliates relating solely to (a) the Purchased Assets and (b) the Products in the Territory, including its marketing, promotion, sale, regulatory approval, packaging, labeling, import or export, including any customer and supplier lists, marketing studies and assets, consultant reports, regulatory correspondence and other materials, medical information training materials and information, and all pharmacovigilance materials, in each case that relate solely to the Product.
Product Records means to the extent permitted under and consistent with the requirements of applicable Law, all books and records relating
Product Records means all books and records of Seller or its Affiliates or Mallinckrodt or its Affiliates necessary for Buyer or its Affiliates to conduct the Product Business as contemplated by this Agreement and the Ancillary Agreements (for the avoidance of doubt, excluding any reimbursement records and contracts).
Product Records means all Books and Records related to the Acquired Technology, including copies of all customer and supplier lists, account lists, call data, sales histories, call notes, marketing studies, consulting reports, physician databases, and correspondence with respect to the Acquired Technology to the extent maintained by the Seller Parties, and all complaint files and adverse event files with respect to the Acquired Technology.