Voyager Territory Clause Samples

Voyager Territory. (a) Within [***] after receipt of any Material Communication from a Regulatory Authority in the Voyager Territory with respect to any Split Territory Licensed Product, Voyager will provide Genzyme, through its Alliance Manager, with a brief written description of the principal issues raised in such Material Communication. Upon Genzyme’s reasonable request after receiving a notice from Voyager in accordance with the immediately preceding sentence, Voyager will provide to Genzyme complete copies of such correspondence within a reasonable period of time following such request. Voyager will allow Genzyme a reasonable opportunity to review and comment on Voyager’s proposed response to any Material Communications with any Regulatory Authority in the Voyager Territory with respect to any Split Territory Licensed Product in advance of the transmission of such response, and Voyager will reasonably consider all comments timely provided by Genzyme in connection therewith. (b) Within [***] after receipt of any Material Communications from a Regulatory Authority in the Voyager Territory related to a Clinical Study hold or potential Clinical Study hold for safety reasons or for a potential withdrawal from the market for a safety issue or a report of a serious safety finding by a Regulatory Authority, Voyager will provide Genzyme, through its Alliance Manager, with a brief written description of the principal issues raised in such Material Communication. 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.

Voyager Territory. With respect to each Split Territory Licensed Product, Voyager will allow Genzyme a reasonable opportunity to review and comment on all filings and other submissions to Regulatory Authorities in the Voyager Territory related to such Split Territory Licensed Product in advance of submission of any such filings, and Voyager will reasonably consider all comments timely provided by Genzyme in connection therewith. With respect to each Split Territory Licensed Product, Voyager shall provide Genzyme with prompt written notice of each of the following events (but in any event within [***]) after the occurrence of such event in the Voyager Territory: (i) the filing of any IND for such Split Territory Licensed Products; (ii) the submission of any filings or applications for Regulatory Approval (including orphan drug applications and designations) of such Split Territory Licensed Product to any Regulatory Authority; and (iii) receipt or denial of Regulatory Approval for such Split Territory Licensed Product; provided, however, that in all circumstances, Voyager shall inform Genzyme of such event prior to public disclosure of such event by Voyager.

Voyager Territory. Voyager shall provide Genzyme with reasonable advance notice of all formal meetings and teleconferences with Regulatory Authorities in the Voyager Territory pertaining to any Split Territory Licensed Product, or with as much advance notice as practicable under the circumstances. Voyager shall use reasonable efforts, to the extent reasonably practicable, to permit Genzyme to have, at Genzyme’s expense, mutually acceptable representatives of Genzyme attend as observers, such formal meetings and teleconferences with Regulatory Authorities in the Voyager Territory pertaining to such Split Territory Licensed Product provided, however, that Voyager shall not be obligated to change or re-schedule any such meeting in order to accommodate the schedule of Genzyme’s representatives.

Voyager Territory. Pursuant to the Split Territory Global Development Plan for a Split Territory Licensed Product and, except as otherwise provided in such Split Territory Global Development Plan, Voyager will be solely responsible for all regulatory matters relating to such Split Territory Licensed Product in the Voyager Territory, including (i) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority in the Voyager Territory with respect to Split Territory Licensed Products; (ii) interfacing, corresponding and meeting with each Regulatory Authority in the Voyager Territory with respect to Split Territory Licensed Products; (iii) seeking and maintaining all 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. regulatory filings in the Voyager Territory with respect to Split Territory Licensed Products; and (iv) maintaining and submitting all records required to be maintained or required to be submitted to any Regulatory Authority in the Voyager Territory with respect to Split Territory Licensed Products.