CLINICAL/REGULATORY PROGRAM Sample Clauses

CLINICAL/REGULATORY PROGRAM. The initial program will be proposed by Genetronics. The Advisory Committee shall be responsible for managing and reviewing the clinical and regulatory program in the Territory for use of the Drug Delivery System in the Field (the "Clinical/Regulatory Program"). The Clinical/Regulatory Program shall be the regulatory strategy which is adopted as the Clinical/Regulatory Program by the Advisory Committee, subject to approval by Ethicon. Such program is to be in writing and to be continually reviewed and revised as necessary by the Advisory Committee, subject to approval by Ethicon. Within 90 days of the Effective Date, the Advisory Committee shall prepare and submit to Ethicon for its approval a strategy for the initial Clinical/Regulatory Program for a period (to be designated by the Advisory Committee) following the Effective Date, including a budget of clinical costs for such period. With respect to the Clinical/Regulatory Program, Ethicon shall have review and approval rights for all significant correspondence and filings received from or made to any governmental entity.