Winding-Down of Development Activities. Without prejudice to Section 14.5(c), in the event there are any on-going Clinical Trials of the Licensed Product being conducted by or on behalf of Lian in the Field in the Terminated Region, the Parties shall work together in good faith to adopt a plan to wind down such Development activities in an orderly fashion, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of the Licensed Product, and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems, in compliance with all Applicable Laws.
Winding-Down of Development Activities. In the event there are any on-going clinical trials of the Licensed Product in the Field in the Territory,
(i) The Parties shall work together in good faith to adopt, and AcelRx shall have the final decisional power with respect to, a plan to wind down the development activities in an orderly fashion, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of the Licensed Product and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and in compliance with all Applicable Laws, provided that AcelRx shall not use its decision power to increase Grünenthal’s costs in winding down such development activities;
(ii) Each Party shall perform its outstanding non-cancellable obligations under the Development Plan that existed or accrued prior to the notice date of termination; and
(iii) All costs and expenses incurred from the effective date of the termination notice in winding down the development activities of Territory Specific Trials with respect to the applicable the Licensed Product(s) shall be borne solely by Grünenthal, of US-specific trials by AcelRx and for all other trials the costs shall be split equally between the Parties; provided, however, that in no case shall Grünenthal be obligated to pursue or support such activities for a period exceeding twelve (12) months after the date of notice of such termination.
Winding-Down of Development Activities. In the event there are any on-going clinical trials of the applicable Licensed Product(s) in the Field in the Territory,
(i) The Parties shall work together in good faith to adopt, and Grünenthal shall have the final decisional power with respect to, a plan to wind down the development activities in an orderly fashion, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of the Licensed Products and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and in compliance with all Applicable Laws;
(ii) Each Party shall perform its outstanding non-cancellable obligations under the Development Plan that existed or accrued prior to the notice date of termination; and
(iii) All costs and expenses incurred from the effective date of the termination notice in winding down the development activities with respect to the applicable Licensed Product shall be borne solely by AcelRx; provided, however, that in no case shall AcelRx be obligated to pursue or support such activities for a period exceeding twelve (12) months after the date of notice of such termination.
Winding-Down of Development Activities. In the event there are any on-going clinical trials or other development work with respect to a Product in the Territory:
(i) The Parties shall work together in good faith to adopt, and Arena shall have the final decisional power with respect to, a plan to wind-down such clinical trials or other development work in an orderly fashion or, at Arena’s election, promptly transition such clinical trials or other development work activities to Arena or its designee, including the transfer to Arena of any Development Data then in Eisai’s or its Affiliate’s possession that has not previously been transferred (or developed) by Arena, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of a Product, and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and in compliance with all Applicable Laws; and
(ii) All costs and expenses incurred from the effective date of the termination notice in winding-down or transitioning the clinical trials or other development work with respect to a Product shall be borne 100% by Arena, except to the extent that the termination of the Agreement is by Arena under Section 12.2(a)(ii), 12.2(a)(iii), or Section 12.6 or by Eisai under Section 12.2(a)(iv) or Section 12.5, in which case Eisai shall pay for its share (under the applicable terms of this Agreement with respect to the Parties’ sharing of Development Costs, which terms shall survive until completion of all such payments by Eisai) of the Development Costs incurred during the period of wind-down or transition under Section 13.2(a)(i).
Winding-Down of Development Activities. In the event there are any on-going clinical trials of the applicable Product in the Field in the Territory,
(i) The Parties shall work together in good faith to adopt, and BLS shall have the final decisional power with respect to, a plan to wind-down the development activities in an orderly fashion, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of the Product and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and in compliance with all Applicable Laws;
(ii) Each Party shall perform its outstanding non-cancellable obligations under the Development Plan that existed or accrued prior to the notice date of termination; and
(iii) All Costs and Expenses incurred from the effective date of the termination notice in winding-down the development activities with respect to the applicable Product shall be allocated in accordance with Section 4.8 unless the Parties agree otherwise in writing; provided, however, that in no case shall ACADIA be obligated to pursue or support such activities for a period exceeding […***…] months after the date of notice of such termination.
Winding-Down of Development Activities. In the event there are any on-going clinical trials of the Product in the U.S.:
(i) The Parties shall negotiate in good faith and adopt a plan to wind-down the development activities in an orderly fashion, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of the Product and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and in compliance with all Applicable Laws, in a timely manner (the “Wind-Down Period”);
(ii) Each Party shall perform its outstanding non-cancellable obligations with respect to the Product that existed or accrued prior to the date of termination; and
(iii) All costs and expenses incurred from the effective date of the termination notice during the Wind-Down Period with respect to the Product shall be [ * ] in the event the agreement is terminated by Teva pursuant to Section 13.3(a) or without cause pursuant to Section 13.3(b).
Winding-Down of Development Activities. In the event there are any on-going clinical trials of the Product in the U.S.:
(i) The Parties shall work together in good faith to adopt, and Alexza shall have the final decision-making power with respect to, a plan to wind-down the development activities in an orderly fashion, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of the Product and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and in compliance with all Applicable Laws, in the Wind-Down Period;
(ii) Teva shall perform its outstanding non-cancellable obligations under the Development Plan and Commercialization Plan, as applicable, that existed or accrued prior to the notice date of termination; and
(iii) All costs and expenses incurred from the effective date of the termination notice during the Wind-Down Period with respect to the Product shall be [ * ] notwithstanding that Article 4 provides otherwise.
Winding-Down of Development Activities. In the event there are any on-going clinical trials of the applicable Product in the Field in the Territory,
(i) The Parties shall work together in good faith to adopt, and ACADIA shall have the final decisional power with respect to, a plan to wind-down the development activities in an orderly fashion or, at ACADIA’s election, promptly transition such development activities to ACADIA or its designee, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of the Product and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and in compliance with all Applicable Laws;
(ii) Each Party shall perform its outstanding non-cancellable obligations under the Development Plan that existed or accrued prior to the notice date of termination; and
(iii) All Costs and Expenses incurred from the effective date of the termination notice in winding-down or transitioning the development activities with respect to the Product shall be allocated in accordance with Section 4.8 unless the Parties agree otherwise in writing; provided, however, that in no case shall BLS be obligated to pursue or support such activities for a period exceeding […***…] months after the date of notice of such termination.
Winding-Down of Development Activities. In the event there are any on- going clinical trials of the applicable Licensed Product(s) in the Field in the Territory,
(i) The Parties will work together in good faith to adopt, and Teijin will have the final decisional making authority with respect to, a plan to wind down the Development activities in an orderly fashion, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of the Licensed Products and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and in compliance with all Applicable Laws;
(ii) Each Party will perform its outstanding non-cancellable obligations under this Agreement that existed or accrued prior to the notice date of termination; and
(iii) All costs and expenses incurred from the effective date of the termination notice in winding down the Development activities with respect to the applicable Licensed Product will be borne solely by Nativis; provided, however, that in no case will Nativis be obligated to pursue or support such activities for a period exceeding twelve (12) months after the date of notice of such termination.
Winding-Down of Development Activities. In the event there are any on-going clinical trials of Product in the Field in the Territory:
(A) The Parties shall work together in good faith to adopt, and Sanofi shall have the final decision-making authority with respect to, a plan to wind-down the Development activities in an orderly fashion, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of Product and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and in compliance with all Applicable Laws. Sanofi shall provide to MannKind (or its designee) all information reasonably necessary to allow MannKind to report government pricing and comply with Applicable Law. During the wind-down period, Sanofi shall work with MannKind and the applicable Government Health Care Programs to transition the Product from Sanofi’s Government Health Care Program Contracts for the Product bearing the Sanofi NDC to MannKind’s Government Health Care Program Contracts for the Product bearing the MannKind NDC (or the NDC of MannKind’s designee) as necessary. The wind-down plan shall further clarify the Parties’ respective financial obligations as to allocation of any rebates or chargebacks accrued with respect to Product sold or dispensed during the Wind-down Period (provided, however, that Sanofi shall remain solely liable for such payments as may be accrued, but not yet paid, as of the effective date of termination of this Agreement); and
(B) All costs and expenses incurred from the effective date of the termination in winding-down the Development activities with respect to the applicable Product and otherwise carrying out the plan described in Section 13.4(a)(i)(A) shall be borne solely by MannKind unless the Parties agree otherwise in writing.
