Common use of Commercialization Plan Clause in Contracts

Commercialization Plan. (a) Unless and until either Party has exercised its Opt-Out Right, commencing no later than [**] prior to the anticipated launch of the first Licensed Product, the Parties shall prepare and deliver to the JCT an initial written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable, but excluding Manufacturing activities which shall be addressed as set forth in Article VI) to be undertaken with respect to Licensed Product(s) in the United States in the next Calendar Year and the dates by which such activities are targeted to be accomplished (as such plan may be updated or amended from time to time in accordance with this Agreement, the “Commercialization Plan”). The Commercialization Plan (including the budget) shall allocate activities between the Parties, and shall contain sufficient detail with respect to Commercialization tactics and other matters to enable the JCT to conduct a meaningful review of the Commercialization Plan. The Parties shall seek to finalize the initial Commercialization Plan for the United States no later than [**] prior to launch of the first Licensed Product in the United States. It is intended that the Commercialization Plan will contemplate that the Parties will co-promote Licensed Product in the United States in a manner that reflects each Parties’ capabilities and that is consistent with each Parties’ promotional efforts for its own products of similar market potential. The Parties shall negotiate in good faith a co-promotion agreement that is consistent with the terms of this Agreement, taking into account the Parties’ respective capabilities, including terms related to term of co-promotion activities, auditing of sales details, mechanisms to address underperformance and failure to perform details at agreed upon levels, sales force training, and other customary terms, with a view to finalizing and entering into such co-promotion agreement as soon as reasonably practicable.

Appears in 2 contracts

Samples: Collaboration Agreement (Arrowhead Research Corp), Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

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Commercialization Plan. (a) Unless As further described in this section 7.4, the strategy for the commercial launch of, and until either Party has exercised its Optsubsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “ Commercialization Plan ”) for such Commercialization Territory that describes: (a) the pre-Out Rightlaunch, commencing no later than launch and subsequent Commercialization activities for such Joint Product in the Commercialization Territory Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [**] prior *]. (including promotional messaging, branding (including Product Trademarks), pricing, advertising, planning, marketing, sales force training); (b) key tactics for implementing those activities; (c) the responsibilities for implementing those activities assigned to the anticipated launch each of the first Licensed Parties; (d) the Detailing plan (including the number of Sales Representatives to be provided by the Parties and the number of PDEs required to be performed by the Parties in each applicable country in the Commercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties). The Parties may agree on a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan and all subsequent revisions thereto shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint Product. The Parties acknowledge that certain items of the Commercialization Plan may not be amenable to determination at the time the Commercialization Plan is initially drafted. In such event, the Parties shall prepare and deliver amend such plan pursuant to the JCT an initial written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable, but excluding Manufacturing activities which shall be addressed as set forth in Article VISection 7.4(b) to be undertaken with respect to Licensed Product(s) in include such items when appropriate. In the United States in the next Calendar Year event of any inconsistency between a Commercialization Plan and the dates by which such activities are targeted to be accomplished (as such plan may be updated or amended from time to time in accordance with this Agreement, the “Commercialization Plan”). The Commercialization Plan (including the budget) shall allocate activities between the Parties, and shall contain sufficient detail with respect to Commercialization tactics and other matters to enable the JCT to conduct a meaningful review of the Commercialization Plan. The Parties shall seek to finalize the initial Commercialization Plan for the United States no later than [**] prior to launch of the first Licensed Product in the United States. It is intended that the Commercialization Plan will contemplate that the Parties will co-promote Licensed Product in the United States in a manner that reflects each Parties’ capabilities and that is consistent with each Parties’ promotional efforts for its own products of similar market potential. The Parties shall negotiate in good faith a co-promotion agreement that is consistent with the terms of this Agreement, taking into account the Parties’ respective capabilities, including terms related to term of co-promotion activities, auditing of sales details, mechanisms to address underperformance and failure to perform details at agreed upon levels, sales force training, and other customary terms, with a view to finalizing and entering into such co-promotion agreement as soon as reasonably practicableAgreement shall control.

Appears in 1 contract

Samples: Collaboration Agreement (Reata Pharmaceuticals Inc)

Commercialization Plan. (a) Unless and until either Party has exercised its OptDuring the Co-Out RightPromotion Term, commencing no later than [**] prior to all commercialization of Licensed Products in the anticipated launch of Asthma Field in the first Licensed Product, the Parties shall prepare and deliver to the JCT an initial written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable, but excluding Manufacturing activities which U.S. Territory shall be addressed as set forth in Article VI) conducted pursuant to be undertaken with respect to Licensed Product(s) in the United States in the next Calendar Year and the dates by which such activities are targeted to be accomplished a commercialization plan (as such plan may be updated or amended from time to time in accordance with this Agreement, the “Commercialization Plan”), which shall set forth the anticipated activities (including without limitation market studies, launch plans, Detailing and Promotion) and timelines, shall allocate responsibility for carrying out such activities between PDL and Roche, and shall include an associated budget. No later than [*] after [*] for a Licensed Product, and on an annual basis thereafter until the end of the Co-Promotion Term, PDL (or, at the JDC’s election, a subcommittee established by the JDC) shall submit to the JDC an initial or updated Commercialization Plan, which the JDC and JSC shall review and the JSC (after consulting with the JDC) shall approve or reject on a timely basis. It is understood that the initial Commercialization Plan may be very preliminary but nevertheless shall be effective for the purposes of commencing the Party’s sharing of Operating Expenses. Each updated Commercialization Plan shall include the plan for Detailing and Promotion activities for the Licensed Product in the Asthma Field in the U.S. Territory for the next [*] and timelines for performing such activities. Once approved by the JSC, such updated Commercialization Plan shall become effective and supersede the previous Commercialization Plan as of the date of such approval or at such other time decided by the JSC. The JSC shall not approve an updated Commercialization Plan (including that is inconsistent with or contradicts the budget) shall allocate activities between terms of this Agreement without the written consent of the Parties, and shall contain sufficient detail with respect to Commercialization tactics and other matters to enable the JCT to conduct a meaningful review of the Commercialization Plan. The Parties shall seek to finalize the initial Commercialization Plan for the United States no later than [**] prior to launch of the first Licensed Product in the United States. It is intended that event of any inconsistency between the Commercialization Plan will contemplate that the Parties will co-promote Licensed Product in the United States in a manner that reflects each Parties’ capabilities and that is consistent with each Parties’ promotional efforts for its own products of similar market potential. The Parties shall negotiate in good faith a co-promotion agreement that is consistent with this Agreement, the terms of this Agreement, taking into account the Parties’ respective capabilities, including terms related to term of co-promotion activities, auditing of sales details, mechanisms to address underperformance and failure to perform details at agreed upon levels, sales force training, and other customary terms, with a view to finalizing and entering into such co-promotion agreement as soon as reasonably practicableAgreement shall prevail.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Protein Design Labs Inc/De)

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Commercialization Plan. (a) Unless and until either Party has exercised its Opt-Out Right, commencing Commencing no later than [**] prior to the anticipated launch of the first Licensed Product, the Parties Cubist shall prepare and deliver to the JCT an initial JCT, by no later than [**] of each Calendar Year, a written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable, but excluding Manufacturing activities which shall be addressed as set forth in Article VI) to be undertaken with respect to Licensed Product(s) Product in the United States Profit-Share Territory in the next Calendar Year and the dates by which such activities are targeted to be accomplished (as such plan may be updated or amended from time to time in accordance with this Agreementeach, the a “Commercialization Plan”). The Commercialization Plan (including the budget) shall allocate activities between the Parties, and shall contain sufficient detail with respect to Commercialization tactics and other matters to enable the JCT to conduct a meaningful review of the Commercialization Plan. The Parties , and the JCT shall seek to finalize approve the initial first Commercialization Plan for the United States Profit-Share Territory no later than [**] prior to launch of the first Licensed Product in the United StatesProfit-Share Territory. It is intended that Thereafter, the JCT shall review the Commercialization Plan will contemplate that not less frequently than annually and shall develop Commercialization Plan updates, which shall include updated budgets for the Parties will coProfit-promote Licensed Product Share Territory, for each Calendar Year. Cubist may also develop and submit to the JCT for review from time to time other proposed substantive amendments to the Commercialization Plan. Amendments and updates to the Commercialization Plan, including any budgets for the Profit-Share Territory contained in the United States Commercialization Plan, shall not be effective without the approval of the JCT. Notwithstanding anything in this Agreement to the contrary, if Cubist engages or uses a manner that reflects each Parties’ capabilities and Third Party to perform any Commercialization activities in the Profit-Share Territory under circumstances where such Third Party will be granted a sublicense under Alnylam Technology or where there will be a material penalty for early termination that is consistent inconsistent with each Parties’ promotional efforts for its own products of similar market potential. The Parties shall negotiate in good faith a co-promotion agreement that is consistent with the terms of this Agreementindustry standards, taking into account the Parties’ respective capabilities, including terms related to term of co-promotion activities, auditing of sales details, mechanisms to address underperformance and failure to perform details at agreed upon levels, sales force training, and other customary terms, with a view to finalizing and entering into such co-promotion agreement as soon as reasonably practicable[**].

Appears in 1 contract

Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

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