Common use of Approval of the PRODUCT Clause in Contracts

Approval of the PRODUCT. Following, and subject to, the successful completion of the development to the reasonable satisfaction of EAGLE and XXXXXX according to the criteria to be developed by the DEVELOPMENT COMMITTEE, including obtaining favorable patent opinions and successful completion of any required pivotal biostudy, as applicable EAGLE shall prepare and submit the ANDA or 505(b)(2) for the PRODUCTS to the FDA as soon as reasonably practical. XXXXXX shall use commercially reasonable efforts to assist EAGLE in the preparation and filing of the ANDA or 505(b)(2) applications and any follow-up communications with the FDA and shall promptly comply with all of EAGLE’s reasonable requests for information relating thereto. Each of the PARTIES shall promptly provide the other and the DEVELOPMENT COMMITTEE with copies of all documents and correspondence received from regulatory authorities that relate to obtaining MARKETING AUTHORIZATION and each of the PARTIES shall use commercially reasonable efforts to obtain permission for the other party to attend all meetings with regulatory authorities in respect thereof. EAGLE shall use commercially reasonable efforts to obtain PRODUCT approval on a timely schedule (given the timing and limitations of the regulatory process in each country within the TERRITORY).

Approval of the PRODUCT. Following, and subject to, the successful completion of the development to the reasonable satisfaction of EAGLE and XXXXXX according to the criteria to be developed by the DEVELOPMENT COMMITTEE, including obtaining favorable patent opinions and successful completion of any required pivotal biostudy, as applicable EAGLE shall prepare and submit the ANDA or 505(b)(2) for the PRODUCTS to the FDA as soon as reasonably practical. XXXXXX shall use commercially reasonable efforts to assist EAGLE in the preparation and filing of the ANDA or 505(b)(2) applications and any follow-up communications with the FDA and shall promptly comply with all of EAGLE’s ’ s reasonable requests for information relating thereto. Each of the PARTIES shall promptly provide the other and the DEVELOPMENT COMMITTEE with copies of all documents and correspondence received from regulatory authorities that relate to obtaining MARKETING AUTHORIZATION and each of the PARTIES shall use commercially reasonable efforts to obtain permission for [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. the other party to attend all meetings with regulatory authorities in respect thereof. thereof EAGLE shall use commercially reasonable efforts to obtain PRODUCT approval on a timely schedule (given the timing and limitations of the regulatory process in each country within the TERRITORY).