Common use of Regulatory Filings; Clinical Trials Clause in Contracts

Regulatory Filings; Clinical Trials. Agile shall, at its own expense, draft, submit and maintain any appropriate NDA for the Product, including all amendments and supplements *Confidential Treatment Requested. to the FDA, and use reasonable efforts to obtain FDA approval for the commercialization of the Product as progress under the Development Program permits. Agile shall also be responsible, at its own expense, for any pre-clinical, clinical and other trials and tests of the Product, except as expressly stated otherwise in the Development Program. In the event Agile desires to obtain regulatory approval of the Product outside of the United States, such efforts will be at Agile’s cost and expense unless otherwise negotiated. With respect to filings reasonably required by Agile in connection with regulatory approval matters (including without limitation any updates to the CMC information) and any recordkeeping, audits and inspections required, or requests or inquiries made, by regulatory authorities relating to the manufacture of the Product by Corium hereunder, Corium will reasonably and timely cooperate with Agile to provide such information and support as Agile shall reasonably request. Reasonable costs incurred by Corium in supporting Agile’s regulatory activities described in this Section 2.9 shall be reimbursed by Agile.

Regulatory Filings; Clinical Trials. Agile shall, at its own expense, draft, submit and maintain any appropriate NDA for the Product, including all amendments and supplements *Confidential Treatment Requested. to the FDA, and use reasonable efforts to obtain FDA approval for the commercialization of the Product as progress under the Development Program permits. Agile shall also be responsible, at its own expense, for any pre-clinical, clinical and other trials and tests of the Product, except as *Confidential Treatment Requested. expressly stated otherwise in the Development Program. In the event Agile desires to obtain regulatory approval of the Product outside of the United States, such efforts will be at Agile’s cost and expense unless otherwise negotiated. With respect to filings reasonably required by Agile in connection with regulatory approval matters (including without limitation any updates to the CMC information) and any recordkeeping, audits and inspections required, or requests or inquiries made, by regulatory authorities relating to the manufacture of the Product by Corium hereunder, Corium will reasonably and timely cooperate with Agile to provide such information and support as Agile shall reasonably request. Reasonable costs incurred by Corium in supporting Agile’s regulatory activities described in this Section 2.9 shall be reimbursed by Agile.