Ongoing Development Activities. Except as set forth below, ▇▇▇▇▇▇▇ shall have no further obligation to conduct Development activities with respect to a Compound or Product after the date of notice of termination. After the Opt-In Date, if ▇▇▇▇▇▇▇ is conducting any Development activity with respect to a Compound or Product on the date of notice of termination, then Theravance shall notify ▇▇▇▇▇▇▇ within [***] after the notice of termination: (i) with regard to any Clinical Trial, whether Theravance elects to have ▇▇▇▇▇▇▇ (A) complete such Clinical Trial on behalf of Theravance (unless ▇▇▇▇▇▇▇ reasonably believes there is a Material Safety Issue that should prevent the continuation of such Clinical Trial), (B) wind down such Clinical Trial as soon as practicable, subject to compliance with ethical and legal requirements or (C) transfer such Clinical Trial to Theravance as soon as practicable; and (ii) with regard to any other Development activity, whether Theravance elects to have ▇▇▇▇▇▇▇ wind down or transfer such activity to Theravance. Notwithstanding the foregoing, if ▇▇▇▇▇▇▇ terminates this Agreement pursuant to Section 11.3, 11.4 or 11.5, then this Section 11.6(b) shall not apply and ▇▇▇▇▇▇▇ shall wind down any ongoing Development activities as soon as practicable after the date of notice of termination, subject to compliance with ethical and legal requirements; and each Party shall bear its own expenses incurred pursuant to such wind down. After the Opt-In Date: (i) If Theravance notifies ▇▇▇▇▇▇▇ of its election to have ▇▇▇▇▇▇▇ complete a Clinical Trial on behalf of Theravance, ▇▇▇▇▇▇▇ and Theravance will, as necessary, negotiate in good faith a separate agreement pursuant to which ▇▇▇▇▇▇▇ would complete such Clinical Trial. If the Parties fail to reach agreement within [***] after Theravance makes such election, ▇▇▇▇▇▇▇ may wind down such Clinical Trial, subject to compliance with ethical and legal requirements or, if requested by Theravance, transfer such Clinical Trial to Theravance. (ii) If Theravance notifies ▇▇▇▇▇▇▇ of its election to have ▇▇▇▇▇▇▇ wind down such Clinical Trial or other Development activity (or fails to provide notice within such [***] period), then ▇▇▇▇▇▇▇ shall wind-down such Clinical Trial or Development activity as soon as practicable, subject to compliance with ethical and legal requirements. (iii) If Theravance notifies ▇▇▇▇▇▇▇ of its election to have ▇▇▇▇▇▇▇ transfer such Clinical Trial or other Development activity to Theravance, then ▇▇▇▇▇▇▇ shall use Commercially Reasonable Efforts to transfer, and Theravance shall use Commercially Reasonable Efforts to assume, such Clinical Trial or other Development activity as promptly as practicable (and, in any event, [***]) after the effective date of termination. (iv) The costs of ongoing Clinical Trials or other Development activity contemplated by this Section 11.6(b) shall be borne as follows:
Appears in 1 contract
Sources: License and Collaboration Agreement (Theravance Biopharma, Inc.)
Ongoing Development Activities. Except as set forth below, ▇▇▇▇▇▇▇ shall have no further obligation to conduct Development activities with respect to a Compound or Product after the date of notice of termination. After the Opt-In Date, if ▇▇▇▇▇▇▇ is conducting any Development activity with respect to a Compound or Product on the date of notice of termination, then Theravance shall notify ▇▇▇▇▇▇▇ within [***] after the notice of termination: (i) with regard to any Clinical Trial, whether Theravance elects to have ▇▇▇▇▇▇▇ (A) complete such Clinical Trial on behalf of Theravance (unless ▇▇▇▇▇▇▇ reasonably believes there is a Material Safety Issue that should prevent the continuation of such Clinical Trial), (B) wind down such Clinical Trial as soon as practicable, subject to compliance with ethical and legal requirements or (C) transfer such Clinical Trial to Theravance as soon as practicable; and (ii) with regard to any other Development activity, whether Theravance elects to have ▇▇▇▇▇▇▇ wind down or transfer such activity to Theravance. Notwithstanding the foregoing, if ▇▇▇▇▇▇▇ terminates this Agreement pursuant to Section 11.3, 11.4 or 11.5, then this Section 11.6(b) shall not apply and ▇▇▇▇▇▇▇ shall wind down any ongoing Development activities as soon as practicable after the date of notice of termination, subject to compliance with ethical and legal requirements; and each Party shall bear its own expenses incurred pursuant to such wind down. After the Opt-In Date:
(i) If Theravance notifies ▇▇▇▇▇▇▇ of its election to have ▇▇▇▇▇▇▇ complete a Clinical Trial on behalf of Theravance, ▇▇▇▇▇▇▇ and Theravance will, as necessary, negotiate in good faith a separate agreement pursuant to which ▇▇▇▇▇▇▇ would complete such Clinical Trial. If the Parties fail to reach agreement within [***] after Theravance makes such election, ▇▇▇▇▇▇▇ may wind down such Clinical Trial, subject to compliance with ethical and legal requirements or, if requested by Theravance, transfer such Clinical Trial to Theravance.
(ii) If Theravance notifies ▇▇▇▇▇▇▇ of its election to have ▇▇▇▇▇▇▇ wind down such Clinical Trial or other Development activity (or fails to provide notice within such [***] period), then ▇▇▇▇▇▇▇ shall wind-down such Clinical Trial or Development activity as soon as practicable, subject to compliance with ethical and legal requirements.
(iii) If Theravance notifies ▇▇▇▇▇▇▇ of its election to have ▇▇▇▇▇▇▇ transfer such Clinical Trial or other Development activity to Theravance, then ▇▇▇▇▇▇▇ shall use Commercially Reasonable Efforts to transfer, and Theravance shall use Commercially Reasonable Efforts to assume, such Clinical Trial or other Development activity as promptly as practicable (and, in any event, [***]) after the effective date of termination.
(iv) The costs of ongoing Clinical Trials or other Development activity contemplated by this Section 11.6(b) shall be borne as follows:
1. By Theravance after the effective date of termination, [***].
2. By Theravance after the effective date of termination, [***]. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
3. In accordance with Section 6.3, with [***].
a. Except with respect to the wind-down of a Clinical Trial in accordance with Section 11.6(b)(ii), for a total of [***] after the notice of termination delivered pursuant to Section 11.2; or
b. With respect to the wind-down of a Clinical Trial in accordance with Section 11.6(b)(ii), [***].
(v) If ▇▇▇▇▇▇▇ terminates this Agreement pursuant to Section 11.2 after commercial launch of the Initial Product, [***].
Appears in 1 contract
Sources: License and Collaboration Agreement (Theravance Biopharma, Inc.)