Initial Commercialization Plan. Licensee shall provide Licensor with the plan for commercialization of the Licensed Product in the Territory (the “Commercialization Plan”) and carry out all commercialization activities with respect to the Licensed Product in the Territory. The initial Commercialization Plan shall be provided to Licensor within ninety (90) days from the expected First Commercial Sale date within the Territory.
Initial Commercialization Plan. No later than eighteen (18) months prior to the anticipated commercial launch of the Product in the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for the Territory on a country-by-country basis. The Commercialization Plan shall include the details of activities to be performed by Licensee, its Affiliates and/or Sublicensees relative to the applicable stage of Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) during the time period covered by such Commercialization Plan and subsequent time periods.
Initial Commercialization Plan. Promptly following the JSC’s request for a Commercialization Plan for a particular Collaboration Product and at least [ * ] prior to the then-current date of expected Regulatory Approval for such Collaboration Product in the Field, the Lead Commercialization Party in the United States for such Collaboration Product, with strategic guidance from the JSC, shall prepare the initial Commercialization Plan for such Collaboration Product and submit such plan to the JCC for review and, following such review, to the JSC for its review and approval. The Parties agree and acknowledge that any such Commercialization Plan will reasonably allocate all Commercialization activities between the Parties, giving equal consideration to each Party’s abilities when making such allocation.
Initial Commercialization Plan. (i) Subject to Sections 2.8 and 2.12, Commercialization of Products shall be governed by a Commercialization Plan (the “Commercialization Plan”) that describes the Commercialization activities (including pre-launch and launch activities, if applicable) to be undertaken with respect to the Licensed Products in the ROW Territory, which shall include an [**] budget of Commercialization Expenses (“Commercialization Budget”) and anticipated timelines for performance.
Initial Commercialization Plan. No later than [***] months prior to the anticipated submission of the first NDA for the first Shared Product (as set forth in the Development Plan) for Regulatory Approval from the FDA in the US Territory or any other Regulatory Authority in the ROW Territory, as applicable, the applicable Lead Party (after good faith consultation with the other party) will prepare its portion of an initial Commercialization plan for the US Territory and ROW Territory (the “Commercialization Plan”) for Shared Products covering the first [***] years after First Commercial Sale of any Shared Product in such Party’s territory, and the JCC will review and approve such initial Commercialization Plan. Thereafter, the Lead Party (after good faith consultation with the other Party) will update the applicable portion of the Commercialization Plan (for the current Calendar Year and the [***] succeeding Calendar Years) each Calendar Year, and the JCC will review and approve any such update or other amendment to the Commercialization Plan. Either Party may request at any time that the JCC consider and approve other updates to the Commercialization Plan.
Initial Commercialization Plan. (i) Commercialization under each Co-Commercialized Program in the US Territory and each Split Program shall be governed by a Commercialization Plan (the “Commercialization Plan”) that describes the Commercialization activities (including pre-launch and launch activities, if applicable) to be undertaken with respect to each such Licensed Product. Except as provided in Section 6.1(c)(i) above or Section 6.2(a)(ii) below, the Commercialization Plan need not include a budget.
Initial Commercialization Plan. On an annual basis, Pfizer shall prepare a commercialization plan with respect to the Commercialization of the Product in the Field in the Territory pursuant to this Agreement (the “Commercialization Plan”). The initial Commercialization Plan for the Product for the first full calendar year of this Agreement (including any additional period from the Effective Date through the end of the initial calendar year) is attached to this Agreement as Schedule 6.2.1 (the “Initial Commercialization Plan”).
Initial Commercialization Plan. On an annual basis commencing with the Calendar Year in which the first filing for Regulatory Approval in the Field in the Territory is expected to be made, Licensee shall prepare a commercialization plan with respect to the Commercialization of the Product in the Field in the Territory pursuant to this Agreement (the “Commercialization Plan”). The initial Commercialization Plan (i.e., for the Product for the Calendar Year in which the Regulatory Approval is expected to be received) will be prepared by Licensee (the “Initial Commercialization Plan”) at an appropriate and agreed time following the Effective Date [***] and shall be subject to approval by the JCC in accordance with the provisions of Section 3.2.4.
Initial Commercialization Plan. The initial Commercialization Plan (including Commercialization Budget) for the Licensed Product shall be prepared jointly by the Parties and submitted to the JCC for its review (and ultimately submitted to the JSC for its review and approval) at least [ * ] prior to the anticipated issuance of the first Marketing Authorization by a Regulatory Authority for such Licensed Product (each, an “Initial Commercialization Plan”). The Initial Commercialization Plan for the Licensed Product shall be effective from the date approved by the JSC until amended and updated by the JCC, and approved by the JSC, in accordance with this Agreement. For the avoidance of doubt, no Commercialization of the Licensed Product in the Territory shall occur unless and until the JSC approves the Initial Commercialization Plan with respect thereto. 6.2.3
Initial Commercialization Plan. On an annual basis, Actelion shall prepare a commercialization plan with respect to the Commercialization of the Finished Product in the Field in the Territory pursuant to this Agreement (the “Commercialization Plan”). The initial Commercialization Plan for the Finished Product for the first full calendar year of this Agreement (including any additional period from the Effective Date through the end of the initial calendar year) (i) for Canada shall be prepared by Actelion and provided to Auxilium within thirty (30) days after the Effective Date and (ii) for each other country in the Territory shall be prepared by Actelion and provided to Auxilium within one-hundred and eighty (180) days after the Effective Date (the “Initial Commercialization Plan”).
