Common use of Third Party Communications Clause in Contracts

Third Party Communications. a. VCS shall communicate to CLIENT and, to the extent specified below, Novartis, all comments, complaints, requests and inquiries received from the medical profession, Governmental Authorities or other third parties relating to a Product. All responses to such communications shall be handled solely by CLIENT, and VCS shall cooperate with and assist CLIENT to the extent deemed necessary by CLIENT to respond fully to such communications. Product complaint reports received by VCS which are not deemed to be an Adverse Event shall (i) with respect to VOLTAREN®, be reported by VCS to Novartis (at Novartis Consumer Health, Inc., 000 Xxxxxxx Xxxxx, Parsippany, NJ 07054-0622), with a copy to CLIENT, and (ii) with respect to any other Product, be reported by VCS to CLIENT (at Endo Pharmaceuticals, 000 Xxxx Xxxx., Xxxxxx Xxxx, XX 19317), in each case within fifteen (15) days of receipt by VCS. VCS shall promptly forward to CLIENT any information, including, but not limited to, initial and follow up reports, that becomes known to VCS from any source in any form relating to any Adverse Event or any Adverse Event with an associated product quality complaint for any Product as soon as it becomes available, but in any event within twenty-four (24) hours of becoming aware of such information, by transmitting it to the Endo Triage Line at 1-800-462-3636. VCS shall also (i) in the case of VOLTAREN®, notify Novartis, with a copy to CLIENT, and (ii) in the case of any other Product, notify CLIENT, of any communication received from any Governmental Authority relating to any Adverse Event or other safety issue for any Product, within twenty-four (24) hours of receiving such communication, by transmitting it to the Endo Triage Line at 1-800-462-3636 and by transmitting any written communication documentation and a written synopsis of any oral communication to Novartis’ Global Head, Drug Safety and Pharmacovigilance (to the extent relating to VOLTAREN®) or Endo’s Pharmacovigilance Group, as applicable. VCS shall provide to Novartis and CLIENT all reasonable assistance and take all actions reasonably requested by Novartis and CLIENT (at CLIENT’s cost) that are necessary to enable Novartis and CLIENT to comply with any Law applicable to the Products and any conditions or obligations relating to any approval. Such assistance and actions will include compliance with the terms of any Pharmacovigilance Agreement entered into by and between CLIENT and Novartis (a copy of which shall be provided by CLIENT to VCS) to the extent that the terms of such agreement supersede the applicable terms of the Novartis Agreement. b. CLIENT shall reimburse VCS for all reasonable actual out-of-pocket expenses incurred by VCS in connection with responses to subpoenas and other similar legal orders issued to VCS in respect to the Services performed under this Agreement. However, CLIENT shall have no obligation to reimburse VCS for any such expenses (and to the extent paid by CLIENT to VCS, shall be repaid by VCS to CLIENT upon demand) arising out of, in connection with or otherwise relating to actions or omissions of VCS or its employees, officers, directors and/or affiliates that violate this Agreement or applicable Law. c. CLIENT shall provide VCS with a written policy setting forth all of VCS’ responsibilities and obligations with respect to third party communications, Adverse Events and compliance with any Pharmacovigilance Agreement (as set forth in this Section 6.4). CLIENT shall be solely responsible for securing Novartis’ consent to utilize its Customer Relationship Center and for authorizing VCS’ personnel to contact Novartis as set forth in this Section 6.4 and as shall be provided in the aforementioned written policy. CLIENT shall train VCS’ Personnel regarding compliance with such policy and any modifications or changes to such policy shall be communicated by CLIENT to VCS (in writing). Any additional cost incurred by VCS in connection with complying with a modified or changed policy and additional costs incurred by VCS for training its personnel concerning such modified or changed policy, shall be borne by CLIENT.