Common use of Product Commercialization Plans Clause in Contracts

Product Commercialization Plans. No later than [********] after the date of submission to the FDA of the first NDA for a Product, AstraZeneca shall prepare and provide to Targacept for its review and comment a Product Commercialization Plan for such Product, and thereafter AstraZeneca shall promptly provide Targacept with an update or amendment thereto [********] (which for clarity may be to simply continue with the then-current Product Commercialization Plan); provided that if such Product Commercialization Plan is for a Co-Promoted Product, such Product Commercialization Plan and each such update and amendment thereto, in each case solely relating to the Co-Promotion Territory, shall be submitted to the CCC. Within [********] after the delivery of any such Product Commercialization Plan (or update or amendment thereto, or if AstraZeneca does not elect to update or amend any such Product Commercialization Plan in a given year, written notice of such election) to Targacept, Targacept shall have the right to request a meeting with [********] for the applicable Product (or such other officer with comparable seniority and responsibility with respect to AstraZeneca’s promotional activities as AstraZeneca may designate in writing to Targacept from time to time) to discuss such Product Commercialization Plan (or update or amendment thereto or, with respect to a given year, the lack thereof). [********], AstraZeneca shall deliver written notice to Targacept as to whether AstraZeneca shall prepare and deliver, in AstraZeneca’s sole discretion, a revised Product Commercialization Plan (or revised update or amendment thereto), which revised plan shall be delivered to Targacept no later than [********]. Targacept shall have ten (10) Business Days after delivery of (a) written notice that AstraZeneca elects not to prepare a revised Product Commercialization Plan (or revised update or amendment thereto) or (b) a revised Product Commercialization Plan (or revised update or amendment thereto), as applicable, to deliver written notice to AstraZeneca maintaining that the activities allocated to AstraZeneca under such Product Commercialization Plan (or update or amendment thereto) or revision of any of the foregoing, even if conducted diligently, would not satisfy AstraZeneca’s diligence obligations under this Agreement with respect to the Commercialization of such Product, and thereupon Targacept shall have the right to refer such matter to [********](or such other officer with comparable seniority and responsibility with respect to AstraZeneca’s promotional activities 1. In the event that Targacept fails to (x) request a meeting with [********] for the applicable Product within [********] after delivery of the relevant Product Commercialization Plan, (y) deliver written notice to AstraZeneca of its objection to such Product Commercialization Plan within [********] after delivery by AstraZeneca of written notice that there will not be a revised Product Commercialization Plan or of a revised Product Commercialization Plan, or (z) submit such matter to accelerated arbitration in accordance with Section 14.3 within [********], Targacept shall [********] the exercise by AstraZeneca of Commercially Reasonable Efforts to perform its activities under such Product Commercialization Plan (or such plan as updated or amended)[********] with respect to the Commercialization of such Product and [********] with respect thereto (but, for purposes of clarity, Targacept [********] with respect to [********] under any such Product Commercialization Plan (or any such update or amendment thereto) and shall not thereafter be [********] to [********]; provided that, with respect to any such Product Commercialization Plan (or any such update or amendment thereto), the foregoing [********] Targacept shall apply only to [********] until the [********] on which [********], whereupon the procedures set forth in this Section shall be repeated.

Product Commercialization Plans. No later than [(a) Within * (********] ) days after the date Initiation of submission a Phase 3 Clinical Trial with respect to the FDA of the first NDA for a each Licensed Product, AstraZeneca DS shall prepare and provide to Targacept for its review and comment a Product Commercialization Plan for such Product, and thereafter AstraZeneca shall promptly provide Targacept with an update or amendment thereto [********] (which for clarity may be to simply continue with the then-current Product Commercialization Plan); provided that if such Product Commercialization Plan is for a Co-Promoted Product, such Product Commercialization Plan and each such update Licensed Product and amendment theretoprovide reasonable opportunity for ARQULE, but in each case solely relating no event less than * (*) days prior to the Co-Promotion Territory, shall be submitted to the CCC. Within [********] after the delivery presentation of any such Product Commercialization Plan to the JEC, to provide comment on the Product Commercialization Plan. For example, should a Phase 3 Clinical Trial be Initiated on *, the Product Commercialization Plan shall have been prepared by DS on or before *, and subsequently shared with ARQULE at least * (or update or amendment thereto, or if AstraZeneca does not elect *) days prior to update or amend any presentation of such Product Commercialization Plan in a given yearto the JEC, written notice of such election) which if shared on *, may be presented to Targacept, Targacept the JEC anytime after *. DS shall have reasonably consider ARQULE’s comments and DS shall approve the right to request a meeting with [********] for Product Commercialization Plan. DS shall inform the applicable Product (or such other officer with comparable seniority and responsibility JEC with respect to AstraZeneca’s promotional activities as AstraZeneca may designate all significant Commercialization decisions to be made by DS with respect to such Licensed Product. The Product Commercialization Plan shall be updated by DS, not less than annually, and DS shall provide reasonable opportunity for ARQULE, but in writing no event less than * (*) days prior to Targacept from time presentation to time) the JEC, to discuss provide comment on such Product Commercialization Plan (or update or amendment thereto or, with respect to a given year, the lack thereof)Plan. [********], AstraZeneca DS shall deliver written notice to Targacept as to whether AstraZeneca reasonably consider ARQULE’s comments and DS shall prepare and deliver, in AstraZeneca’s sole discretion, a revised approve such Product Commercialization Plan (or revised update or amendment thereto), which revised plan shall be delivered to Targacept no later than [********]. Targacept shall have ten (10) Business Days after delivery of (a) written notice that AstraZeneca elects not to prepare a revised Product Commercialization Plan (or revised update or amendment thereto) or Plan. (b) a revised Product Commercialization Plan (or revised update or amendment thereto), as applicable, to deliver written notice to AstraZeneca maintaining that the activities allocated to AstraZeneca under such Product Commercialization Plan (or update or amendment thereto) or revision of any of the foregoing, even if conducted diligently, would not satisfy AstraZeneca’s diligence obligations under this Agreement with respect to the Commercialization of such Product, and thereupon Targacept shall have the right to refer such matter to [********](or such other officer with comparable seniority and responsibility with respect to AstraZeneca’s promotional activities 1. In the event that Targacept fails to (x) request a meeting with [********] ARQULE timely exercises the Co-Commercialization Option, the review and approval process for the applicable Product within [********] after delivery of the relevant Product Commercialization PlanPlan for each Licensed Product shall conform to the review and approval process set out in Section 3.5.1(a) above, (y) deliver written notice to AstraZeneca except that DS shall prepare the portion of its objection to such Product Commercialization Plan within [********] after delivery by AstraZeneca of written notice that there will not be a revised Product Commercialization Plan or of a revised Product Commercialization Plan, or (zPlan(s) submit such matter relating to accelerated arbitration in accordance with Section 14.3 within [********], Targacept shall [********] the exercise by AstraZeneca of Commercially Reasonable Efforts to perform its activities under such Product Commercialization Plan (or such plan as updated or amended)[********] with respect to the Co-Commercialization of such Product and [********] Co-Commercialized Licensed Products in the Co-Commercialization Territory with respect thereto (but, for purposes of clarity, Targacept [********] with respect to [********] under any such Product Commercialization Plan (or any such update or amendment thereto) and shall not thereafter be [********] to [********]; provided that, with respect to any such Product Commercialization Plan (or any such update or amendment thereto), the foregoing [********] Targacept shall apply only to [********] until the [********] on which [********], whereupon the procedures set forth in this Section shall be repeatedadvanced input from ARQULE.

Product Commercialization Plans. No later than [********] after the date of submission to the FDA of the first NDA for a Product, AstraZeneca shall prepare and provide to Targacept for its review and comment a Product Commercialization Plan for such Product, and thereafter AstraZeneca shall promptly provide Targacept with an update or amendment thereto [********] (which for clarity may be to simply continue with the then-current Product Commercialization Plan); provided that if such Product Commercialization Plan is for a Co-Promoted Product, such Product Commercialization Plan and each such update and amendment thereto, in each case solely relating to the Co-Promotion Territory, shall be submitted to the CCC. Within [********] after the delivery of any such Product Commercialization Plan (or update or amendment thereto, or if AstraZeneca does not elect to update or amend any such Product Commercialization Plan in a given year, written notice of such election) to Targacept, Targacept shall have the right to request a meeting with [********] for the applicable Product (or such other officer with comparable seniority and responsibility with respect to AstraZeneca’s promotional activities as AstraZeneca may designate in writing to Targacept from time to time) to discuss such Product Commercialization Plan (or update or amendment thereto or, with respect to a given year, the lack thereof). [********], AstraZeneca shall deliver written notice to Targacept as to whether AstraZeneca shall prepare and deliver, in AstraZeneca’s sole discretion, a revised Product Commercialization Plan (or revised update or amendment thereto), which revised plan shall be delivered to Targacept no later than [********]. Targacept shall have ten (10) Business Days after delivery of (a) written notice that AstraZeneca elects not to prepare a revised Product Commercialization Plan (or revised update or amendment thereto) or (b) a revised Product Commercialization Plan (or revised update or amendment thereto), as applicable, to deliver written notice to AstraZeneca maintaining that the activities allocated to AstraZeneca under such Product Commercialization Plan (or update or amendment thereto) or revision of any of the foregoing, even if conducted diligently, would not satisfy AstraZeneca’s diligence obligations under this Agreement with respect to the Commercialization of such Product[********], and thereupon Targacept shall have the right to refer such matter to [********] for resolution. If such matter remains unresolved by [********], such dispute shall be referred to an Expert for resolution in accordance with Section 14.3 (or accelerated arbitration). For purposes of clarity, during any such other officer with comparable seniority and responsibility with respect to AstraZeneca’s promotional activities 1dispute period, AstraZeneca shall [********]. In the event that Targacept fails to (x) request a meeting with [********] for the applicable Product within ], (y) [********] after delivery of the relevant Product Commercialization Plan, (y) deliver written notice to AstraZeneca of its objection to such Product Commercialization Plan within [********] after delivery by AstraZeneca of written notice that there will not be a revised Product Commercialization Plan or of a revised Product Commercialization Plan], or (z) submit such matter to accelerated arbitration in accordance with Section 14.3 within [********], Targacept shall [********] the exercise by AstraZeneca of Commercially Reasonable Efforts to perform its activities under such Product Commercialization Plan (or such plan as updated or amended)[********] with respect to the Commercialization of such Product and [********] with respect thereto (but, for purposes of clarity, Targacept [********] with respect to [********] under any such Product Commercialization Plan (or any such update or amendment thereto) and shall not thereafter be [********] to [********]; provided that, with respect to any such Product Commercialization Plan (or any such update or amendment thereto), the foregoing [********] Targacept shall apply only to [********] until the [********] on which [********], whereupon the procedures set forth in this Section shall be repeated.