Examples of Genzyme Territory in a sentence
Genzyme shall be solely responsible, at its expense, for all Commercialization activities relating to Split Territory Licensed Products in the Genzyme Territory.
Genzyme will be responsible for the creation, preparation, production, reproduction and filing with the applicable Regulatory Authorities, of relevant written sales, promotion and advertising materials relating to each Split Territory Licensed Product for use in the Genzyme Territory (“Genzyme Territory Promotional Materials”).
Genzyme shall present each Genzyme Territory Development Plan and any proposed amendments thereto to the applicable PSC at least [***] days in advance of implementation of the Genzyme Territory Development Plan, and following review and approval by the PSC, shall then be attached to the PSC meeting minutes and deemed to be attached hereto as the applicable Schedule.
In scale-free networks the slope of the power-law describing the distribution is named γ.
Genzyme will own all INDs, BLAs and related regulatory documentation submitted to any Regulatory Authority in the Genzyme Territory with respect to any Licensed Product as well as any drug master files maintained by or on behalf of Genzyme anywhere in the world with respect to any Licensed Product.
In addition, upon request of either Party (on behalf of itself or a Sublicensee), the other Party shall obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Split Territory Licensed Products in the Genzyme Territory or the Voyager Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments).
The initial Genzyme Territory Development Plan for each Split Territory Licensed Product shall be prepared by Genzyme and, following review and approval by the PSC, shall then be attached to the PSC meeting minutes and deemed to be and attached hereto as Schedules 5.2.7-1, 5.2.7-2 and so forth, sequentially in order of the Option Exercise Date for the Split Territory Licensed Product that is the subject of such Genzyme Territory Development Plan.
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Voyager hereby appoints Genzyme as Voyager’s agent for all matters related to each Licensed Product involving Regulatory Authorities in the Genzyme Territory and ending on the date that the transfer of all INDs and related regulatory documents filed with or submitted to any Regulatory Authority in the Genzyme Territory that related to such Licensed Product becomes effective, and Genzyme hereby accepts such appointment.
Each Genzyme Territory Development Plan shall set forth a rolling written work plan and time table with respect to the Development of and Secondary Indication Studies for the applicable Split Territory Licensed Product from the Option Exercise Date until the later of (a) [***] from date of such plan, and (b) receipt of Regulatory Approval for such Split Territory Licensed Product.