For the U. S. The strategy for the commercial launch of the Product in the U.S. shall be described in a comprehensive plan that describes the pre-launch, launch and subsequent Commercialization activities and budget for the Product (including, if available, advertising, education, planning, marketing, sales force training and allocation, distribution, pricing, and reimbursement) (the "U.S. Commercialization Plan"). The JSC shall establish appropriate subcommittee(s) at least thirty-six (36) months prior to the then-current date of expected Regulatory Approval for such Product in the U.S. in the Field as determined in accordance with then-current U.S. Development Plan (such date, the "U.S. Approval Date"). The JSC and its subcommittees shall develop and approve an initial U.S. Commercialization Plan at least twenty-four (24) months prior to the U.S. Approval Date. The initial U.S. Commercialization Plan and subsequent revisions thereto, which revisions shall be approved by the JSC from time to time, shall contain such information as the JSC believes necessary for the successful commercial launch of such Product in the U.S. in the Field in each of the Initial Indications and shall generally conform to the level of detail utilized by the Parties in preparation of their own product commercialization plans. The U.S. Commercialization Plan shall be deemed Confidential Information of both Parties, and each Party shall use such U.S. Commercialization Plan only to the extent necessary to carry out its Commercialization activities for the Product. From time to time as reasonably necessary during the term of Commercialization of a Product in the U.S., the JSC shall update the U.S. Commercialization Plan (it being understood that Affymax shall be responsible for generating draft updates relating to the Renal Indications and Takeda shall be responsible for generating draft updates relating to the Oncology Indications, for review and approval by the JSC).
For the U. S. BI will provide Micromet with an initial overview of estimated Commercialization activities in the U.S., containing such information as reasonably necessary for Micromet to evaluate whether to opt out of its co-promotion right pursuant to Section 4.5.2 (including, by way of example, information regarding the target markets, anticipated detailing efforts and allocations, etc.), at least [***] ( [***] ) [***] prior to the then-current date of expected Marketing Approval for a Product in the U.S. After Micromet has indicated to BI that it does not want to opt-out of the co-promotion in U.S. according to Section 4.5.2, the Parties will enter into good faith negotiations on the Co-Promotion Agreement drafted by BI according to Section 4.5.1. After execution of the Co-Promotion Agreement BI will provide a more detailed U.S. Commercialization Plan, which will be further discussed by the JCPT and approved by the JSC sufficiently prior to the U.S. Approval Date. Such detailed U.S. Commercialization Plan will contain such information as the JSC believes necessary for the successful commercial launch of such Product in the U.S. in the Field in each of the applicable indications and will generally conform to the level of detail utilized by the Parties in preparation of their own product commercialization plans. The U.S. Commercialization Plan will be deemed Confidential Information of both Parties, and each Party will use such U.S. Commercialization Plan only to the extent necessary to carry out its Commercialization activities for the Product. From time to time as reasonably necessary, the JSC will update the U.S. Commercialization Plan (it being understood that BI will be primarily responsible for generating such draft updates for review and approval by the JSC).
