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 SCIDOSE 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 for the THIRD AND FOURTH PRODUCTS to the FDA as soon as reasonably practical. SCIDOSE shall use commercially reasonable efforts to assist EAGLE in the preparation and filing of the 505(b)(2) or ANDA 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.

Approval of the PRODUCT. Following, and subject to, the successful completion of the development to the reasonable satisfaction of EAGLE and SCIDOSE 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 505(b)(2) for the THIRD AND FOURTH PRODUCTS to the FDA as soon as reasonably practical. SCIDOSE shall use commercially reasonable efforts to assist EAGLE in the preparation and filing of the 505(b)(2) or ANDA 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.