Initial Commercialization Plan Clause Samples

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. 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. 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. (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. (ii) Commencing no later than [**] months prior to the anticipated commercial launch of the first Co-Commercialized Product in the US Territory and thereafter at least [**] days prior to the start of each Calendar Year, Celgene shall prepare a Commercialization Plan for each Co-Commercialized Product in the US Territory in the next Calendar Year. Such Commercialization Plan for each Co-Commercialized Product shall include a budget for Field-Based Costs of Agios and shall include in reasonable detail the type and allocation of Commercialization Activities between the Parties with respect to such Co-Commercialized Product in the US Territory pursuant to Section 6.3. (iii) Commencing no later than [**] months prior to the anticipated commercial launch of the first Split Product in the Territory and thereafter at least [**] days prior to the start of each Calendar Year, Agios with respect to the US Territory and Celgene with respect to the ROW Territory shall prepare the initial Commercialization Plan for each Split Product, with input and guidance from the JDC and JCC. Such Commercialization Plan shall describe Commercialization activities to be undertaken by Agios in the US Territory and Celgene in the ROW Territory. In connection with JCC approval under Section 6.2(b) below, Agios shall have final decision-making authority with respect to any matters to the extent related to the US Territory, Celgene shall have final decision-making authority with respect to any matters to the extent related to the ROW Territory, and neither Party (nor the JCC) may amend the Commercialization Plan as it relates to the other Party’s portion of the Territory except by Mutual Consent.

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. (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. (ii) Commencing no later than [**] months prior to the anticipated commercial launch of the first Licensed Product in the ROW Territory and thereafter at least [**] days prior to the start of each Calendar Year, Agios shall prepare the initial Commercialization Plan for each Licensed Product, with input and guidance from the JDC, JCC and the Finance Working Group. Such Commercialization Plan shall describe Commercialization activities to be undertaken by the Parties in the ROW Territory.

Initial Commercialization Plan. Subject to Section 2.2 and Section 2.3, Commercialization of Licensed Products shall be governed by a Commercialization Plan (the “Commercialization Plan”), for each of the US Territory and the ROW Territory that, collectively, describe the Commercialization activities (including pre-launch and launch activities, if applicable) to be undertaken with respect to the Licensed Products in the Territory, which shall include an annual budget of Commercialization Expenses (“Commercialization Budget”) and anticipated timelines for performance.

Initial Commercialization Plan. On an annual basis, Asahi 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 will be prepared by Asahi (the “Initial Commercialization Plan”) at least eighteen (18) months prior to the expected launch date of the Product in the Field in the Territory.