Genzyme Territory Sample Clauses

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

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

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

Genzyme Territory. (a) Within [***] after receipt of any Material Communication from the EMA with respect to any Licensed Product or, if Genzyme has exercised the Co-Co Option, from the FDA with respect to any HD Licensed Product, Genzyme will provide Voyager, through its Alliance Manager, with a brief written description in English, of the principal issues raised in such Material Communication with the EMA or FDA, as applicable. Upon Voyager’s reasonable request after receiving a notice from Genzyme in accordance with the immediately preceding sentence, Genzyme will provide to Voyager complete copies of such correspondence of any such Material Communication within a reasonable period of time following such request. Genzyme will allow Voyager a reasonable opportunity to review and comment on Genzyme’s proposed response to any Material Communications with the EMA with respect to any Split Territory Licensed Product or, if Genzyme has exercised the Co-Co Option, with the FDA with respect to any HD Licensed Product, in advance of the transmission of such response, and Genzyme will reasonably consider all comments timely provided by Voyager in connection therewith. (b) Within [***] after receipt of any Material Communications from the EMA or FDA or local Regulatory Authority related to a Clinical Study hold or potential Clinical Study 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, Genzyme will provide Voyager, through its Alliance Manager, with a brief written description in English, of the principal issues raised in such Material Communication with the EMA, FDA or local Regulatory Authority, as applicable.

Genzyme Territory. Genzyme shall be responsible for manufacturing or procuring sufficient quantities of Product for commercial sale in the Genzyme Territory. Upon request of Genzyme, Osiris shall use commercially reasonable efforts to facilitate the supply of Product to Genzyme under the terms of the supply agreement existing as of the Effective Date between Osiris and Osiris’ Third Party manufacturer, Lonza Group Ltd., or any other Third Party manufacturer that Osiris has engaged to produce Product during the Term. In the event that Osiris is producing Product for use in the Osiris Territory, at Genzyme’s request, Osiris shall negotiate with Genzyme in good faith to manufacture and supply Product for commercial sale in Genzyme’s Territory. At Genzyme’s request, Osiris shall provide to Genzyme, at Genzyme’s cost, all information, technology, training and assistance as is reasonably necessary for Genzyme to manufacture Product for commercial sale in the Genzyme Territory. Genzyme shall enter into commercially reasonable confidentiality agreements with such Third Party manufacturers containing terms no less stringent than those set forth in Article 9 of this Agreement.

Genzyme Territory. Subject to the provisions of any In-License, Genzyme shall have the first right to initiate an Infringement Action anywhere in the world against any Third Party with respect to any Competitive Infringement in the Genzyme Territory of any Alnylam Product-Specific Patent, Joint Collaboration IP or Alnylam Collaboration IP, or, with Alnylam’s prior written consent, Alnylam Core Technology Patent or Alnylam Know-How. Alnylam will consider in good faith any request from Genzyme to initiate an Infringement Action against any Third Party with respect to a Competitive Infringement in the Genzyme Territory of any Alnylam Core Technology Patent Right or Alnylam Know-How; provided, however, that Alnylam shall not be required to initiate any such Infringement Action or permit Genzyme to initiate any such Infringement Action.

Genzyme Territory. Genzyme shall report to the PJSC responsible for a Co-Co Licensed Product in writing, by no later than each [***] following the first Regulatory Approval of such Co-Co Licensed Product in the Field in the Genzyme Territory (for the period ending December 31 of the prior Calendar Year), summarizing in reasonable detail Genzyme’s Commercialization activities for such Co-Co Licensed Product in the Genzyme Territory performed to date (or updating such report for activities performed since the last such report was given hereunder, as applicable). In addition, Genzyme shall provide Alnylam with written notice of the First Commercial Sale of each Co-Co Licensed Product in the Genzyme Territory within [***] days after such event; provided, however, that in all circumstances, Genzyme shall inform Alnylam of such event prior to public disclosure of such event by Genzyme. Genzyme shall provide such other information to the PJSC responsible for a Co-Co Licensed Product as Alnylam may reasonably request with respect to Commercialization of such Co-Co Licensed Product and shall keep such PJSC reasonably informed of Genzyme’s Commercialization activities in the Genzyme Territory with respect to such Co-Co Licensed Product.