Common use of Termination for Receipt of Not Approvable Letter Clause in Contracts

Termination for Receipt of Not Approvable Letter. In the event ------------------------------------------------ Adolor receives a not approvable letter from the FDA pursuant to 21 C.F.R.(S)314.120 for the POI Product, Adolor shall promptly notify GSK of the receipt of such not approvable letter and GSK shall, during the sixty (60) days after notice of receipt of such not approvable letter, have the right to terminate this Agreement with respect to all Adolor Products in both the United States and the ROW upon one hundred twenty (120) days prior written notice to Adolor. For the avoidance of doubt, in the event that GSK exercises its termination right pursuant to this Section 16.5.1, GSK shall retain all of its rights to the GI Products, and remain subject to its obligations, under this Agreement.

Appears in 2 contracts

Samples: Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp)

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Termination for Receipt of Not Approvable Letter. In the event ------------------------------------------------ Adolor GSK receives a not approvable letter from the FDA pursuant to 21 C.F.R.(S)314.120 C.F.R. (S) 314.120 for the POI OBD Chronic Product, Adolor GSK shall promptly notify GSK Adolor of the receipt of such not approvable letter and GSK shalland, during the sixty (60) days after notice of receipt of such not approvable letter, have the right to terminate this Agreement with respect to all Adolor Products the OBD Chronic Product in both the United States and the ROW upon one hundred twenty (120) days prior written notice to Adolor. For the avoidance of doubt, in the event that GSK exercises its termination right pursuant to this Section 16.5.116.6.1, GSK shall retain all of its rights to the Adolor Products and the GI ProductsProducts other than the OBD Chronic Product, and remain subject to its obligations, under this Agreement.

Appears in 2 contracts

Samples: Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp)

Termination for Receipt of Not Approvable Letter. In the event ------------------------------------------------ Adolor receives a not approvable letter from the FDA pursuant to 21 C.F.R.(S)314.120 for the POI Product**, Adolor shall promptly notify GSK of the receipt of such not approvable letter and GSK shall, during the sixty (60) days after notice of receipt of such not approvable letter, have the right to terminate this Agreement with respect to all Adolor Products ** in both the United States and the ROW upon one hundred twenty (120) days prior written notice to Adolor. For the avoidance of doubt, in the event that GSK exercises its termination right pursuant to this Section 16.5.1, GSK shall retain all of its rights to the GI Products**, and remain subject to its obligations, under this Agreement.

Appears in 1 contract

Samples: Collaboration Agreement (Adolor Corp)

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Termination for Receipt of Not Approvable Letter. In the event ------------------------------------------------ Adolor GSK receives a not approvable letter from the FDA pursuant to 21 C.F.R.(S)314.120 C.F.R. (S) 314.120 for the POI Product**, Adolor GSK shall promptly notify GSK Adolor of the receipt of such not approvable letter and GSK shalland, during the sixty (60) days after notice of receipt of such not approvable letter, have the right to terminate this Agreement with respect to all Adolor Products the ** in both the United States and the ROW upon one hundred twenty (120) days prior written notice to Adolor. For the avoidance of doubt, in the event that GSK exercises its termination right pursuant to this Section 16.5.116.6.1, GSK shall retain all of its rights to the Adolor Products and the GI ProductsProducts other than the **, and remain subject to its obligations, under this Agreement.

Appears in 1 contract

Samples: Collaboration Agreement (Adolor Corp)

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