Trial Master File. Promptly following the Effective Date, OPKO will establish and maintain a trial master file (to the extent they not already established and maintained for any applicable Trial) for any Trials in the format as agreed upon by the JDC (each a “Trial Master File”). Notwithstanding anything to the contrary herein, OPKO will not be permitted to delegate its rights and obligations pursuant to this Section 4.5.4 to any Third Parties without the prior approval of the JDC, except OPKO may delegate its rights and obligations pursuant to this Section 4.5.4 to any of its Affiliates provided that OPKO retains accountability following such delegation.
Appears in 2 contracts
Sources: Development and Commercialization License Agreement, Development and Commercialization License Agreement (Opko Health, Inc.)
Trial Master File. Promptly following the Original Effective Date, OPKO will establish and maintain a trial master file (to the extent they not already established and maintained for any applicable Trial) for any Trials *** in the format as agreed upon by the JDC (each a “Trial Master File”). Notwithstanding anything to the contrary herein, OPKO will not be permitted to delegate its rights and obligations pursuant to this Section 4.5.4 to any Third Parties without the prior approval of the JDC, except OPKO may delegate its rights and obligations pursuant to this Section 4.5.4 to any of its Affiliates provided that OPKO retains accountability following such delegation.
Appears in 1 contract
Sources: Development and Commercialization License Agreement (Opko Health, Inc.)