Common use of Records; Compliance; Reports Clause in Contracts

Records; Compliance; Reports. Impax shall itself, or through CSO, employ a program, including record keeping, for handling, storing, distributing and using samples of the Shire Product which shall comply with all applicable Law. Upon receipt of any shipment of samples of the Shire Product, Impax shall assume all risk in relation to such samples, including without limitation, responsibility for distributing, storing and using such samples in compliance with the PDMA and other applicable Laws. For purposes of complying with the foregoing, Shire designates Impax as an authorized distributor of samples of the Shire Product. During the Term and for a period of not less than three (3) years thereafter, on twenty-four (24) hours notice from Shire, Impax shall provide, or procure that its Affiliates provide, Shire (or its nominee) access to any records or reports relating to the receipt, storage or distribution of samples of the Shire Product. In an emergency, including without limitation, a suspected loss or diversion of samples of Shire Product, Impax shall use its best efforts to provide Shire (or its nominee) immediate access to any records or reports relating to the receipt, storage or distribution of samples of the Shire Product. In the event that Impax or CSO discovers the loss of any samples of Shire Product, Impax shall within twenty-four (24) hours, report such loss to the appropriate Shire representative. Shire shall then be responsible for reporting the theft or loss to the appropriate Regulatory Authority.