Pharmaco-vigilance responsibility Clause Samples

Pharmaco-vigilance responsibility. Unless otherwise agreed in any definitive agreement executed by the Parties pursuant to Section 2.10, Licensee shall be responsible for reporting to Regulatory Authorities in the Territory any adverse * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. experience and safety issues for Licensed Product in compliance with the requirements of the applicable laws, rules and regulations.