Common use of Genzyme Territory Commercialization Plan Clause in Contracts

Genzyme Territory Commercialization Plan. No less than [***] in advance of the reasonably expected first Regulatory Approval in the Genzyme Territory with respect to a Split Territory Licensed Product, and on an annual basis thereafter, Genzyme shall prepare and deliver to the PSC responsible for such Split Territory Licensed Product for review a reasonable written plan that summarizes the Commercialization activities to be undertaken with respect to such Split Territory Licensed Product in the Genzyme Territory in the next Calendar Year and, to the extent commercially reasonable, Genzyme’s plans to obtain further Regulatory Approvals and Commercialize such Split Territory Licensed Product in countries in the Genzyme Territory in which Genzyme is not then Commercializing such Split Territory Licensed Product, and the dates by which such activities are targeted to be accomplished (the “Genzyme Territory Commercialization Plan”). Each Genzyme Territory Commercialization Plan shall be consistent with the requirements of the most recent Global Commercialization Strategy approved by the PSC. The Genzyme Territory Commercialization Plan for a Split Territory Licensed Product shall subsequently be updated and modified by Genzyme, from time to time at its discretion and no less frequently than once per Calendar Year, based upon, among other things, Genzyme’s Commercialization activities with respect to such Split Territory Licensed Product in the Genzyme Territory, a copy of which updated plan will be provided to the PSC responsible for such Split Territory Licensed Product. Notwithstanding the foregoing, in the event of any disagreement between the Parties regarding the Genzyme Territory Commercialization Plan for a Split Territory Licensed Product pursuant to Section 9.3.8 (PSC Decision-Making), the Genzyme representatives on the PSC responsible for such Split Territory Licensed Product shall have final decision-making authority over the preparation and updating of such Genzyme Territory Commercialization Plan, provided that such decisions do not materially adversely affect the Commercialization of such Split Territory Licensed Product in the Voyager Territory. For clarity, this Section 7.1.3 will CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. apply with respect to HD Licensed Products in all countries in the Genzyme Territory other than the United States if Genzyme exercises the Co-Co Option.

Genzyme Territory Commercialization Plan. No less than [***] months in advance of the reasonably expected first Regulatory Approval in the Genzyme Territory with respect to a Split Territory Co-Co Licensed Product, and on an annual basis thereafter, Genzyme shall prepare and deliver to the PSC PJSC responsible for such Split Territory Co-Co Licensed Product for review a reasonable written plan that summarizes the Commercialization activities to be undertaken with respect to such Split Territory Co-Co Licensed Product in the Genzyme Territory in the next Calendar Year and, to the extent commercially reasonable, Genzyme’s plans to obtain further Regulatory Approvals and Commercialize such Split Territory Co-Co Licensed Product in countries in the Genzyme Territory in which Genzyme is not then Commercializing such Split Territory Co-Co Licensed Product, and the dates by which such activities are targeted to be accomplished (the “Genzyme Territory Commercialization Plan”). Each Genzyme Territory Commercialization Plan shall be consistent with the requirements of the most recent initial Global Commercialization Strategy approved by the PSCPJSC pursuant to Section 4.1.1 (Global Commercial Strategy) or the most recently approved by the PJSC without the use of tie-break authority pursuant to Section 5.7.3 (Tie-Breaking). The Genzyme Territory Commercialization Plan for a Split Territory Co-Co Licensed Product shall subsequently be updated and modified by Genzyme, from time to time at its discretion and no less frequently than once per Calendar Year, based upon, among other things, Genzyme’s Commercialization activities with respect to such Split Territory Co-Co Licensed Product in the Genzyme Territory, a copy of which updated plan Genzyme will be provided provide to the PSC PJSC responsible for such Split Territory Co-Co Licensed Product. Notwithstanding the foregoing, in the event of any disagreement between the Parties regarding the Genzyme Territory Commercialization Plan for a Split Territory Licensed Product pursuant to Section 9.3.8 (PSC Decision-Making), the Genzyme representatives on the PSC responsible for such Split Territory Licensed Product shall have final decision-making authority over the preparation and updating of such Genzyme Territory Commercialization Plan, provided that such decisions do not materially adversely affect the Commercialization of such Split Territory Licensed Product in the Voyager Territory. For clarity, this Section 7.1.3 will CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. apply with respect to HD Licensed Products in all countries in the Genzyme Territory other than the United States if Genzyme exercises the Co-Co Option.

Genzyme Territory Commercialization Plan. No less than [***] months in advance of the reasonably expected first Regulatory Approval in the Genzyme Territory with respect to a Split Territory Regional Licensed Product, and on an annual basis thereafter, Genzyme shall prepare and deliver to the PSC PJSC responsible for such Split Territory Regional Licensed Product for review a reasonable written plan that summarizes the Commercialization activities to be undertaken with respect to such Split Territory Regional Licensed Product in the Genzyme Territory in the next Calendar Year and, to the extent commercially reasonable, Genzyme’s plans to obtain further Regulatory Approvals and Commercialize such Split Territory Regional Licensed Product in countries in the Genzyme Territory in which Genzyme is not then Commercializing such Split Territory Regional Licensed Product, and the dates by which such activities are targeted to be accomplished (the “Genzyme Territory Commercialization Plan”). Each Genzyme Territory Commercialization Plan shall be consistent with the requirements of the most recent initial Global Commercialization Strategy or the most recently approved by the PSCPJSC[***]. The Genzyme Territory Commercialization Plan for a Split Territory Regional Licensed Product shall subsequently be updated and modified by Genzyme, from time to time at its discretion and no less frequently than once per Calendar Year, based upon, among other things, Genzyme’s Commercialization activities with respect to such Split Territory Regional Licensed Product in the Genzyme Territory, a copy of which updated plan Genzyme will be provided provide to the PSC PJSC responsible for such Split Territory Regional Licensed Product. Notwithstanding the foregoing, in the event of any disagreement between the Parties regarding the Genzyme Territory Commercialization Plan for a Split Territory Licensed Product pursuant to Section 9.3.8 (PSC Decision-Making), the Genzyme representatives on the PSC responsible for such Split Territory Licensed Product shall have final decision-making authority over the preparation and updating of such Genzyme Territory Commercialization Plan, provided that such decisions do not materially adversely affect the Commercialization of such Split Territory Licensed Product in the Voyager Territory[***]. For clarity, this Section 7.1.3 will CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED1934. apply with respect to HD Licensed Products in all countries in the Genzyme Territory other than the United States if Genzyme exercises the Co-Co Option.REGIONAL LICENSE TERMS