Genzyme Territory Sample Clauses

Genzyme Territory. Genzyme shall be solely responsible, at its expense, for all Commercialization activities relating to Split Territory Licensed Products in the Genzyme Territory.
Sample 1Sample 2Sample 3See All (5)
AutoNDA by SimpleDocs
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.
Sample 1Sample 2Sample 3See All (4)
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.
Sample 1Sample 2Sample 3See All (4)
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.
Sample 1Sample 2Sample 3See All (4)
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.
Sample 1Sample 2Sample 3See All (4)
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.
Sample 1
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.
Sample 1
AutoNDA by SimpleDocs
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.
Sample 1

Related to Genzyme Territory

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Territory 33.1 This Agreement applies to the territory in which CenturyLink operates as an ILEC in the State. CenturyLink shall be obligated to provide services under this Agreement only within this territory. 33.2 Notwithstanding any other provision of this Agreement, CenturyLink may terminate this Agreement as to a specific operating territory or portion thereof pursuant to Section 6.7 of this Agreement.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Joint Patent Rights If not already established under the Research Collaboration Agreement, prior to either Party filing any Patent Right disclosing Joint Program Technology or Joint Probody Platform Improvements, the Parties shall establish a patent committee (the “Patent Committee”) comprised of at least one (1) representative of each Party for the purpose of facilitating the preparation, filing, prosecution, maintenance and defense of Joint Patent Rights. As agreed upon by the Parties, meetings of the Patent Committee may be face-to-face or may be conducted by teleconferences or videoconferences, from time to time as needed. The Patent Committee will be the forum through which the Parties coordinate their respective obligations to each other described in Sections 5.2.2 and 5.2.3 hereof and in this Section. In the event the Parties conceive or generate any Joint Program Technology or Joint Probody Platform Improvements, the Parties shall promptly meet to discuss and determine, based on mutual consent, whether to seek patent protection thereon, which Party will control filing, prosecution and maintenance of such patents and how to pay for the filing, prosecution and maintenance of such patents. It is presumed that ImmunoGen will control filing, prosecution and maintenance of Joint Patent Rights claiming Joint Program Technology or Joint Conjugation Probody Platform Improvements, and that CytomX will control filing, prosecution and maintenance of Joint Patent Rights claiming Joint Unconjugated Probody Platform Improvements. Neither Party will file any Joint Patent Right without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed. The Party controlling filing and prosecution of any such Joint Patent Right (a) shall keep the other Party informed regarding each Patent Right, (b) shall consider in good faith any recommendations made by the other Party in regard to the filing, prosecution or maintenance of any such Patent Right and (c) shall not unreasonably refuse to incorporate any recommendations made by the other Party in regard to such filing, prosecution or maintenance.

  • Competing Products The provisions of Section 21 are set forth on attached Exhibit H and are incorporated in this Section 21 by this reference.

  • Licensed Patent Rights The term “Licensed Patent Rights” shall mean rights arising out of or resulting from:

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!