Compliance with PDMA Sample Clauses

Compliance with PDMA. Reliant shall require all Sales Representatives to comply with applicable Sections of the Prescription Drug Marketing Act of 1987, as amended, the applicable regulations promulgated thereunder (“PDMA”), state laws and regulations governing the storage and distribution of pharmaceutical samples. Sales Representatives shall also comply with the Sample Accountability Policies and Procedures of Novartis including those set forth in Schedule 4.14. All such policies in effect as of the New Effective Date are attached to this Agreement as Schedule 4.14, and any modifications thereto shall be delivered to Reliant promptly, and in any event not less than seven (7) days prior to effectiveness of such modifications.

Compliance with PDMA. (a) CV Therapeutics shall be an “Authorized Distributor of Record” for the Product for purposes of the requirements of the PDMA and shall comply with the PDMA, FDA regulations and applicable State law requirements regarding the Marketing, sale and distribution of the Product, including, without limitation, applicable wholesale drug distribution licensing guidelines and requirements. Solvay shall have the right to audit the records and inspect the facilities of any warehouse or distribution agent identified by CV Therapeutics under Section 11.2 for the storage and distribution of Samples, on advance written notice to CV Therapeutics and during regular business hours. Upon request by Solvay, CV Therapeutics shall provide Solvay with copies of such agent’s State registration certificate as a licensed distribution center and State board of pharmacy inspection report. CV Therapeutics understands that no Samples shall be shipped until such agent is verified by Solvay to be in PDMA compliance. (b) Each Party shall take all steps necessary to ensure that each Party’s PSR and each member of its Sales Management Team complies with the requirements of the PDMA, all regulations promulgated thereunder and each State’s companion PDMA statutes and regulations that relate to the distribution of Samples of a prescription drug product. This compliance includes, but is not limited to, obtaining written requests, obtaining the licensed healthcare professional’s signature for all Samples delivered, ensuring validity of the practitioner’s State license, storage of all Samples at label conditions and sending all documentation to the Party in a timely manner for retention. (c) Each Party shall take all steps necessary to ensure that each Party’s PSR and each member of its Sales Management Team complies with all applicable rules and policies concerning all aspects of the storage, handling and distribution of Samples. This compliance includes, but is not limited to, distribution to all PSRs and all members of Sales Management Teams an appropriate “Sample Accountability System,” adherence to the provisions contained therein, and attendance by each Party’s PSRs and Sales Management Team at training classes on procedures for storage, handling and distribution of Samples. (d) CV Therapeutics shall notify Solvay promptly upon learning that any Samples shipped by Solvay to CV Therapeutics have been lost or have not been received as scheduled. (e) CV Therapeutics shall notify Solvay promp...