COOPERATION WITH GOVERNMENTAL REQUIREMENTS. The Parties shall cooperate with one another as may be reasonably necessary or appropriate to satisfy all governmental requirements and obtain all needed permits, approvals and licenses with respect to the manufacture, storage, packaging and sale of the Product. Such cooperation shall include, without limitation, communicating with regulatory authorities and making available as promptly as practicable all information, documents and other materials which result from the performance by sanofi-aventis of its services hereunder which Horizon is required to submit or which Horizon may otherwise reasonably request in connection with governmental filings relating to the Product. The costs and expenses of such cooperation, if applicable, shall be subject to the Parties’ mutual written agreement. Notwithstanding the foregoing, it shall be the responsibility of (i) Horizon to obtain and maintain all such permits, approvals and licenses which are specific to the Product, and (ii) sanofi-aventis to obtain and maintain all such permits, approvals and licenses which are generally required for the Production Site.
COOPERATION WITH GOVERNMENTAL REQUIREMENTS. The parties shall cooperate with one another as may be reasonably necessary or appropriate to satisfy all governmental requirements and obtain all needed permits, approvals and licenses with respect to the manufacture, storage, packaging and sale of the Products. Such cooperation shall include, without limitation, communicating with Regulatory Authorities and making available as promptly as reasonably practicable all information, documents and other materials which result from the performance by ANI of its obligations hereunder which JDS is required to submit. The costs and expenses of such cooperation, if applicable, shall be subject to the parties’ mutual agreement. JDS shall be responsible for all regulatory reporting of Products. ANI shall assist JDS by providing necessary support and information and shall prepare the annual cGMP Products reviews.
COOPERATION WITH GOVERNMENTAL REQUIREMENTS. The Parties shall cooperate with one another as may be reasonably necessary or appropriate to satisfy all governmental requirements and obtain all needed permits, approvals and licenses with respect to the development, manufacture, storage, packaging, marketing and sale of the Aventis Products. Such cooperation shall include, without limitation, communicating with regulatory authorities and making available as promptly as practicable all information, documents and other materials which result from the performance by Inyx of its services hereunder which Aventis is required to submit or which Aventis may otherwise reasonably request in connection with governmental filings relating to the Aventis Products. The costs and expenses of such cooperation, if applicable, shall be subject to the Parties’ mutual agreement.
COOPERATION WITH GOVERNMENTAL REQUIREMENTS. The parties shall cooperate with one another as may be reasonably necessary or appropriate to satisfy all governmental requirements and obtain all needed permits, approvals and licenses with respect to the manufacture, storage, packaging and sale of the Products. Such cooperation shall include, without limitation, communicating with Regulatory Authorities and making available as promptly as reasonably practicable all information, documents and other materials which result from the performance by ANI of its obligations hereunder which ALAVEN is required to submit. The costs and expenses of such cooperation, if applicable, shall be subject to the parties’ mutual agreement. ALAVEN shall be responsible for all regulatory reporting of Products. ANI shall assist ALAVEN by providing necessary support and information and shall prepare the annual cGMP Products reviews.
COOPERATION WITH GOVERNMENTAL REQUIREMENTS. The Parties shall cooperate with one another as may be reasonably necessary or appropriate to satisfy all governmental requirements and obtain all needed permits, approvals and licenses with respect to the manufacture and supply of the Active Ingredient. Such cooperation shall include, without limitation but strictly in regards to United States territories, communicating with regulatory authorities and making available as promptly as practicable all information, documents and other materials which result from the performance by SAD of its services hereunder which Buyer is required to submit or which Buyer may otherwise reasonably request in connection with governmental filings relating to the Active Ingredient. The costs and expenses of such cooperation, if applicable, shall be subject to the Parties’ mutual agreement. Notwithstanding the foregoing, it shall be the responsibility of (i) Buyer to obtain and maintain all such permits, approvals and licenses which are specific to the Active Ingredient or the Product, and (ii) SAD to obtain and maintain all such permits, approvals and licenses which are generally required for the Production Site and to maintain the Drug Master File in respect of the Active Ingredient.
COOPERATION WITH GOVERNMENTAL REQUIREMENTS. If Federal funds are used to finance any portion of a Project, all requirements resulting from the use of Federal funds are hereby automatically incorporated into a Task Work Order for a Project. The Consultant shall cooperate fully with MPO, City if Augusta, the United States of America, and the State of Georgia, consultants on adjacent projects, construction Contractors, local government officials, utility companies, and others, as may be directed by the MPO. Such cooperation shall include attendance at meetings, discussions, and hearings, as may be requested by the MPO, furnishing plans, documents, and other data produced in the course of Work on the Project, as may be requested from time to time by the MPO to affect such cooperation and compliance with all directives issued by the MPO in accordance with this Agreement. It is understood and agreed that MPO, City of Augusta, the United States of America, and the State of Georgia will have access to the Work and be furnished information as directed by the MPOs and the Consultant’s time in retrieving such information will be compensated. Consultant shall provide documents and cooperate with the MPO so the MPO is in compliance with any intergovernmental agreement with City of Augusta, the United States of America, and the State of Georgia, and any other federal, state, or local agencies and departments.
COOPERATION WITH GOVERNMENTAL REQUIREMENTS
