Product Commercialization Plans. Within [***] days after the Initiation of a Phase III Clinical Trial with respect to each Development Candidate that is not being Co-Developed, MERCK shall prepare and provide to the JSC for its review a Product Commercialization Plan for each Product Derived from such Development Candidate, and shall inform the JSC with respect to all significant Commercialization decisions to be made with respect to such Product.
Product Commercialization Plans. Distributor’s right to sell into certain countries is limited by regulatory clearances available for sale of the Products into such country. The countries into which the Products will be sold will be mutually agreed upon between the Parties and laid down in Attachment 6 – Countries for sale of the Products, provided that Supplier will be solely responsible to drive regulatory clearance of the Product and Disposables in such countries, and the Parties agree to enter the US Territory as a first priority. Detailed product commercialization plans in targeted markets will be jointly agreed between the Parties in Attachments 2 and 3 along with deciding on relevant business metrics and minimum requirements for each such territory/market to be documented in Attachment 7. Each product commercialization plan may be amended by mutual agreement of the Parties. It is anticipated that each product commercialization plan (including any mutually-agreed amendments thereto) shall include anticipated milestones and responsibilities to be conducted by the Parties for the applicable territory/market. Once the product commercialization plan is mutually-agreed for a particular territory/market, each Party shall use reasonable efforts to conduct the activities assigned to such Party under such plan.
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 re...
Product Commercialization Plans. Subject to Section 4.11.1(c), if ELAN alone (rather than with or through a Sublicensee) is marketing a Co-Developed Product, within [***] days after the Initiation of the first Phase III Clinical Trial for a Co-Developed Product, ELAN shall prepare and provide to the JPT for its review and discussion a Product Commercialization Plan for each Co-Developed Product in the applicable Co-Development Territory(ies), Indication and formulation, and shall update and submit such Product Commercialization Plan to the JPT for review and discussion not less than annually; provided, that, ELAN shall use Commercially Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 51 Reasonable Efforts to include the obligations set forth in this Section 4.4 in each Sublicense Agreement.
Product Commercialization Plans. Subject to resolution of disputes as set forth in Section 2.1.5, the JCC shall prepare, and/or direct the preparation of, and approve a Product Commercialization Plan for each Product, at such time as the JSC may direct. Each such Product Commercialization Plan shall be updated and approved at such time as the JCC may determine, not less than annually.
Product Commercialization Plans. Within (deleted text — time period) after the Initiation of the first Phase III Clinical Trial for the Product, if ELAN alone is marketing the Product, (or if ELAN is marketing through a Sublicensee or Co-promoter to the extent permitted by any applicable agreements with the Sublicensee or Co-promoter), ELAN shall prepare and provide to the JLT for its review and discussion a Product Commercialization Plan for the Product in the applicable countries in the Territory, and shall update and submit such Product Commercialization Plan to the JLT for review and discussion not less than annually; (deleted text — party responsibility for pricing).
Product Commercialization Plans. (a) Within * (*) days after the Initiation of a Phase 3 Clinical Trial with respect to each Licensed Product, DS shall prepare a Product Commercialization Plan for each such Licensed Product and provide reasonable opportunity for ARQULE, but in no event less than * (*) days prior to 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 * (*) days prior to presentation of such Product Commercialization Plan to the JEC, which if shared on *, may be presented to the JEC anytime after *. DS shall reasonably consider ARQULE’s comments and DS shall approve the Product Commercialization Plan. DS shall inform the JEC with respect to 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 no event less than * (*) days prior to presentation to the JEC, to provide comment on such Product Commercialization Plan. DS shall reasonably consider ARQULE’s comments and DS shall approve such Product Commercialization Plan.
Product Commercialization Plans. Within ("deleted text") after the Initiation of the first Phase III Clinical Trial for the Product, ("deleted text"), ELAN shall prepare and provide to the JLT for its review and discussion a Product Commercialization Plan for the Product in the applicable countries in the Territory, and shall update and submit such Product Commercialization Plan to the JLT for review and discussion not less than annually; ("deleted text").
Product Commercialization Plans. Within * (*) days after the Initiation of a Phase 3 Clinical Trial with respect to each Licensed Product, DS shall, with advance input from ARQULE, prepare and provide to the JSC for its review a Product Commercialization Plan for each such Licensed Product, and shall inform the JSC with respect to all significant Commercialization decisions to be made with respect to such Licensed Product. The Product Commercialization Plan shall be updated and reviewed at such times as the JSC may determine, not less than annually.
Product Commercialization Plans. At least [****] months in advance of the anticipated approval of a MAA for a Product anywhere in the Territory, Astellas shall prepare a detailed plan for Commercialization activities for such Product in applicable Major Market Countries for the period through launch, consistent with the diligence requirements in Section 5.1.1 and submit such plan to the JSC for review and comment. Thereafter, at least [****] days prior to the beginning of each following Fiscal Year, Astellas shall prepare an update for each such plan annually and submit such update to the JSC for review and comment. The Parties acknowledge that the comments of the JSC with respect to any plan are solely advisory in nature. Each plan shall include a description of the Commercialization activities to be conducted thereunder. Astellas may review each plan on an ongoing basis and make changes thereto, provided that it keep the JSC reasonably informed with respect to such changes and seek its comments with respect thereto.
