Common use of Regulatory Submissions Clause in Contracts

Regulatory Submissions. MMD shall provide TKT with copies of all submissions to United States drug regulatory authorities. Upon the reasonable request of TKT, MMD shall also provide TKT with copies of all submissions to drug regulatory authorities of other countries and the results of all clinical trials conducted by, or under the supervision of, MMD with respect to GA-EPO; provided, however, that MMD reserves the right to assess reasonable copying charges for any such materials requested by TKT which exceed approximately two cartons of material.

Appears in 2 contracts

Samples: License Agreement (Transkaryotic Therapies Inc), License Agreement (Transkaryotic Therapies Inc)

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Regulatory Submissions. MMD shall provide TKT with copies of all submissions to United States drug regulatory authorities. Upon the reasonable request of TKT, MMD shall also provide TKT with copies of all submissions to drug regulatory authorities of other countries and the results of all clinical trials conducted by, or under the supervision of, MMD with respect to GA-EPO* ; provided, however, that MMD reserves the right to assess reasonable copying charges for any such materials requested by TKT which exceed approximately two cartons of material.

Appears in 2 contracts

Samples: License Agreement (Transkaryotic Therapies Inc), License Agreement (Transkaryotic Therapies Inc)

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