Common use of Reasonable Cooperation Clause in Contracts

Reasonable Cooperation. (a) Each Party shall provide the other Party with all reasonable assistance requested by the other Party with respect to the foregoing clinical development and regulatory activities, including, but not limited to, promptly providing the other Party with any and all authorizations, approvals, certificates of free sale, and other information, documents, materials and assistance reasonably required by the other Party to file, obtain, and maintain Regulatory Approval for the Product. The Party providing such assistance shall be reimbursed by the other Party for its reasonable out-of-pocket costs and expenses. (b) If SuperGen so requests and Xxxxxx so agrees, Xxxxxx shall perform certain clinical research services for particular clinical studies to be conducted by SuperGen, subject to the terms and conditions of a separate agreement between the Parties including, but not limited to, the provision for an appropriate fee to be paid Xxxxxx for its services thereunder. (c) SuperGen shall provide to Xxxxxx, at SuperGen's expense, the dossier SuperGen uses for obtaining U.S. Regulatory Approval, along with any and all other data, information and materials reasonably requested by Xxxxxx for obtaining Regulatory Approval from the EMEA for the Product. (d) In connection with its NDA for the Product in the U.S. Territory, and with Xxxxxx'x NDAs for the Product in the International Territory, SuperGen shall take any and all actions necessary or reasonably requested by Xxxxxx in order to qualify Xxxxxx as a secondary manufacturing source for the Product in the Territories, solely for the purpose of enabling Xxxxxx to exercise its rights pursuant to Article 8.5 below without delay or impediment in the supply of Product to Xxxxxx for Sale in the Territories. (e) Within four (4) months of the Effective Date, the respective pharmacovigilance groups of each Party shall prepare and enter into a separate agreement relating to the exchange of adverse event information.

Reasonable Cooperation. (a) Each Party shall provide the other Party with all reasonable assistance requested by the other Party with respect to the foregoing clinical development and regulatory activities, including, but not limited to, promptly providing the other Party with any and all authorizations, approvals, certificates of free sale, and other information, documents, materials and assistance reasonably required by the other Party to file, obtain, and maintain Regulatory Approval for the Product. The Party providing such assistance shall be reimbursed by the other Party for its reasonable out-of-pocket costs and expenses. (b) If SuperGen so requests and Xxxxxx so agrees, Xxxxxx shall perform certain clinical research services for particular clinical studies to be conducted by SuperGen, subject to the terms and conditions of a separate agreement between the Parties including, but not limited to, the provision for an appropriate fee to be paid Xxxxxx for its services thereunder. (c) SuperGen shall provide to Xxxxxx, at SuperGen's expense, the dossier SuperGen uses for obtaining U.S. Regulatory Approval, along with any and all other data, information and materials reasonably requested by Xxxxxx for obtaining Regulatory Approval from the EMEA for the Product. (d) In connection with its NDA for the Product in the U.S. Territory, and with Xxxxxx'x NDAs for the Product in the International Territory, SuperGen shall take any and all actions necessary or reasonably requested by Xxxxxx in order to qualify Xxxxxx as a secondary manufacturing source for the Product in the Territories, solely for the purpose of enabling Xxxxxx to exercise its rights pursuant to Article 8.5 below without delay or impediment in the supply of Product to Xxxxxx for Sale in the Territories. . 14 <PAGE> CONFIDENTIAL TREATMENT REQUESTED (e) Within four (4) months of the Effective Date, the respective pharmacovigilance groups of each Party shall prepare and enter into a separate agreement relating to the exchange of adverse event information.