Common use of Clinical Trials Not Approved by the JDC Clause in Contracts

Clinical Trials Not Approved by the JDC. In the event that Genentech proposes a particular clinical trial as part of a Development Plan (other than a clinical trial proposed for C2B8 prior to the First New Product FDA Approval) and such trial is not approved by the JDC within thirty (30) days of the date that such trial was proposed to the JDC (or in the event such trial was proposed to the JDC other than at a meeting of the JDC, within thirty (30) days of the date that the JDC first meets (whether in person or by teleconference) following the date such trial was proposed to the JDC), then Genentech shall have the right to conduct such trial at its own expense. During such thirty (30) day period, Genentech shall timely provide all information reasonably requested by any member of the JDC that would be material to making a determination as whether such proposed clinical trial should be approved. If in such circumstance, Genentech elects to conduct such trial within a reasonable period of time thereafter, and such trial meets all of its primary endpoints, then IDEC shall reimburse Genentech for [CONFIDENTIAL TREATMENT REQUESTED] of the Development Costs related to such trial that IDEC would otherwise have been responsible for if the JDC had approved such trial (i.e., [CONFIDENTIAL TREATMENT REQUESTED] the total Development Costs). ARTICLE 5 COMMERCIALIZATION

Appears in 1 contract

Samples: Collaboration Agreement (Idec Pharmaceuticals Corp / De)

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Clinical Trials Not Approved by the JDC. In the event that Genentech proposes a particular clinical trial as part of a Development Plan (other than a clinical trial proposed for C2B8 prior to the First New Product FDA ApprovalApproval ) and such trial is not approved by the JDC within thirty (30) days of the date that such trial was proposed to the JDC (or in the event such trial was proposed to the JDC other than at a meeting of the JDC, within thirty (30) days of the date that the JDC first meets (whether in person or by teleconference) following the date such trial was proposed to the JDC), then Genentech shall have the right to conduct such trial at its own expense. During such thirty (30) day period, Genentech shall timely provide all information reasonably requested by any member of the JDC that would be material to making a determination as whether such proposed clinical trial should be approved. If in such circumstance, Genentech elects to conduct such trial within a reasonable period of time thereafter, and such trial meets all of its primary endpoints, then IDEC shall reimburse Genentech for [CONFIDENTIAL TREATMENT REQUESTED*] of the Development Costs related to such trial that IDEC would otherwise have been responsible for if the JDC had approved such trial (i.e., i.e[CONFIDENTIAL TREATMENT REQUESTED*] the total Development Costs). ARTICLE 5 COMMERCIALIZATION.

Appears in 1 contract

Samples: Collaboration Agreement (Genentech Inc)

Clinical Trials Not Approved by the JDC. In the event that Genentech proposes a particular clinical trial as part of a Development Plan (other than a clinical trial proposed for C2B8 prior to the First New Product FDA Approval) and such trial is not approved by the JDC within thirty (30) days of the date that such trial was proposed to the JDC (or in the event such trial was proposed to the JDC other than at a meeting of the JDC, within thirty (30) days of the date that the JDC first meets (whether in person or by teleconference) following the date such trial was proposed to the JDC), then Genentech shall have the right to conduct such trial at its own expense. During such thirty (30) day period, Genentech shall timely provide all information reasonably requested by any member of the JDC that would be material to making a determination as whether such proposed clinical trial should be approved. If in such circumstance, Genentech elects to conduct such trial within a reasonable period of time thereafter, and such trial meets all of its primary endpoints, then IDEC shall reimburse Genentech for [CONFIDENTIAL TREATMENT REQUESTED**] of the Development Costs related to such trial that IDEC would otherwise have been responsible for if the JDC had approved such trial (i.e., [CONFIDENTIAL TREATMENT REQUESTED**] the total Development Costs). ARTICLE 5 COMMERCIALIZATION.

Appears in 1 contract

Samples: Collaboration Agreement (Biogen Idec Inc.)

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Clinical Trials Not Approved by the JDC. In the event that Genentech proposes a particular clinical trial as part of a Development Plan (other than a clinical trial proposed for C2B8 prior to the First New Product FDA ApprovalApproval ) and such trial is not approved by the JDC within thirty (30) days of the date that such trial was proposed to the JDC (or in the event such trial was proposed to the JDC other than at a meeting of the JDC, within thirty (30) days of the date that the JDC first meets (whether in person or by teleconference) following the date such trial was proposed to the JDC), then Genentech shall have the right to conduct such trial at its own expense. During such thirty (30) day period, Genentech shall timely provide all information reasonably requested by any member of the JDC that would be material to making a determination as whether such proposed clinical trial should be approved. If in such circumstance, Genentech elects to conduct such trial within a reasonable period of time thereafter, and such trial meets all of its primary endpoints, then IDEC shall reimburse Genentech for [CONFIDENTIAL TREATMENT REQUESTED] of the Development Costs related to such trial that IDEC would otherwise have been responsible for if the JDC had approved such trial (i.e., [CONFIDENTIAL TREATMENT REQUESTED] the total Development Costs). ARTICLE 5 COMMERCIALIZATION.

Appears in 1 contract

Samples: Collaboration Agreement (Idec Pharmaceuticals Corp / De)

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