Product Records Sample Clauses
Product Records. All Product Records have been made available by Seller to Purchaser for examination and copying, and all Product Records are complete and correct in all material respects and have been maintained in accordance with reasonable industry standards.
Product Records. Company will maintain accurate and complete records related to its activities under this Agreement. These records include records related to distribution of Products, including COAs and APM.
Product Records. At the Closing, or as soon as possible thereafter, Seller shall transfer to Purchaser, to the extent in Seller’s actual possession, the original copies of the Product Records and Assumed Contracts. Seller may retain one (1) archival copy of the Product Records and Assumed Contracts solely for archival purposes or as required by Applicable Law. Prior to delivering or making available any Product Records to Purchaser, Seller shall be entitled to redact therefrom any information that does not relate to the Product Business.
Product Records. The Client shall maintain at the manufacturing facility, records for three (3) prior years of production, shipment, inventory, and purchase records applicable to the materials and components used in the manufacture of the certified product. Upon request, the Client shall provide NAT full access to such records.
Product Records. Impax shall maintain all records necessary to comply with the Laws and in accordance with the Health Regulations. In addition, Impax shall prepare and adhere to batch process documentation consistent with the Impax Know-How, and in accordance with its normal procedures, including without limitation quality control records and all raw data relating to each batch processed. Specifically, but without limitation, Impax shall maintain complete and accurate records reasonably necessary to support cGMPs and other applicable regulatory requirements in the Territory, including without limitation quality control records. All such records shall be available for inspection, and audit by Schering (at its expense) and its representatives and agents, including Schering's auditors upon reasonable request during normal business hours. All such records shall be maintained for the longest period as may be required by the Laws; provided, however, that all records relating to the Manufacture, testing, stability oversight and quality control of each batch of the Product shall be retained at least until the third anniversary of the end of the approved shelf life for all Product from such batch. Impax shall provide Schering on a periodic basis, and at least annually, such information concerning Product, production batches, yields and quality status as is specified in the Health Registrations (commonly referred to as Annual Product Reviews) and as may be reasonably requested by Schering from time to time. Prior to destruction of any record, Impax shall give notice to Schering, which shall have the right to request and retain such record.
Product Records. (a) Since November 19, 2004, all of the Product Records have been maintained in accordance, in all material respects, with applicable Law and generally accepted business practices. Seller has made true, complete and accurate copies of the Product Records available to Purchaser.
(b) Without limiting the foregoing, Seller has provided Purchaser with true, complete and accurate copies of those Product Records set forth on Schedule 4.14(b) of the Seller Disclosure Schedule.
(c) Except as set forth on Schedule 4.14(c) of the Seller Disclosure Schedule, to Seller’s Knowledge, no legal opinions or draft legal opinions material to the Product Intellectual Property have been excluded pursuant to subsection (ii) of the Product Records definition (other than those relating to the Transaction as set forth in subsection (i)(A) of the definition of Product Records).
Product Records. Upon completion of each of the shipments or upon the * release by WuXi PharmaTech as described above, and as may be requested by Vertex, WuXi PharmaTech will provide to Vertex copies of pertinent production records, data and summary reports from the production generated in connection with the applicable shipment.
Product Records. 12.1 The Supplier agrees that it will provide UoA, within one (1) month of each anniversary of the Commencement Date, a report that lists:
(a) each Product [(excluding consumables)] that has been provided by the Supplier under this Agreement;
(b) the Product's specific location within UoA premises;
(c) the Product's valuation, at the date of the report; and
(d) the Product code and operation manual name.
Product Records. On or as reasonably practicable following the Effective Date, Regeneron will use Commercially Reasonable Efforts to provide Kiniksa or its designee with access to all Product Records in Regeneron’s possession or that may be readily available to Regeneron, excluding Product Records relating to the Retained Field or the Regeneron Retained EEO Field. In addition, no later than [***] days after the Effective Date, Regeneron shall deliver or cause to be delivered to Kiniksa electronically or EXW (Incoterms 2010) (if in physical form) all Product Records in Regeneron’s possession or that may be readily available to Regeneron, excluding Product Records relating to the Regeneron Field or the Regeneron Retained EEO Field.
Product Records. 10.1.1 Supplying Party shall possess and retain detailed written records of all Supplying Party activities relating to the Product, including but not limited to documents concerning the design, development, composition, manufacture, testing, quality, validation, traceability, remanufacture, packaging, labeling, inspection, and shipping activities relating to the Product (collectively referred to as the “Product Records”).
10.1.2 Product Records also include all documents required by this Agreement, the Supply Agreement and applicable QS Regulations/cGMPs, including, but not limited to, the compilation of documents comprising a design history file (“DHF”), device history record (“DHR”) and device master record (“DMR”) as those terms are defined in 21 CFR 820.3.