CELGENE Territory Sample Clauses

CELGENE Territory. CELGENE and its Affiliates shall take the lead in all pricing and reimbursement approval proceedings relating to the Licensed Products in the CELGENE Territory. CELGENE shall consult with EPIZYME through the JCC with respect to pricing and reimbursement approvals in the CELGENE Territory.
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CELGENE Territory. Subject to CELGENE’s reasonable discretion, EPIZYME will have the right to fully participate in all material meetings and other material contact with Regulatory Authorities pertaining to the Development, Manufacture and Commercialization of the Licensed Products and related Diagnostic Products or Regulatory Approvals in the EMA and in the Major EU Countries, Canada, China, India, Japan and Mexico (such countries being referred to hereinafter as “Major License Countries”) upon prior reasonable written request, and in all other countries of the CELGENE Territory upon mutual agreement of the Parties, in each case, on a Licensed Product-by-Licensed Product basis, from and after Achievement of Proof of Concept of such Licensed Product. CELGENE shall provide EPIZYME with reasonable advance written notice of all such meetings and other contact and advance copies of all material related documents and other material relevant information relating to such meetings or such other contact. CELGENE and EPIZYME shall discuss any material documents or other material correspondence that CELGENE is planning to submit in connection with Regulatory Approvals from the Major License Countries including the proposed labeling for the Licensed Products and related Diagnostic Products. Upon EPIZYME’s reasonable written request therefor, CELGENE shall provide EPIZYME with drafts of such documents or correspondence sufficiently in advance of submission so that EPIZYME may review and comment on such documents and such other correspondence and have a reasonable opportunity to influence the substance of such submissions in a manner consistent with the goal of obtaining optimal Regulatory Approvals as quickly as reasonably practicable, which comments shall be considered in good faith by CELGENE. EPIZYME shall not have the right to approve the proposed labeling or any other regulatory filings or submissions for the Licensed Products and related Diagnostic Products in the CELGENE Territory. CELGENE shall promptly provide to EPIZYME copies of any material documents or other material correspondence pertaining to the Licensed Product or related Diagnostic Product in the EMA or the Major License Countries and shall promptly provide to EPIZYME all proposed labeling, in each case received from the Regulatory Authorities in the Major License Countries. Upon EPIZYME’s reasonable written request, CELGENE shall provide EPIZYME with any English translations of the documents and correspondence describe...
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CELGENE Territory. Following Achievement of Proof of Concept of a Licensed Compound or Licensed Product, CELGENE shall have the sole right to prepare, file and maintain all regulatory filings (including pricing and reimbursement approvals) and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of such Licensed Compounds, Licensed Products and related Diagnostic Products in the Field in the CELGENE Territory. CELGENE shall own all such regulatory filings and Regulatory Approvals relating to such Licensed Compounds, Licensed Products and related Diagnostic Products in the CELGENE Territory. Subject to Sections 2.7.3(c) and 6.6, to the extent permitted by applicable Laws and following Achievement of Proof of Concept of a Licensed Compound or Licensed Product, EPIZYME shall assign and transfer to CELGENE all regulatory filings and Regulatory Approvals in the CELGENE Territory that relate to such Licensed Compound, Licensed Product and related Diagnostic Product.
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CELGENE Territory. As between the Parties, subject to the terms of the Agreement, CELGENE shall have the sole right and responsibility for the development and related manufacturing activities (subject to Sections 4.5 and 6.1.1) in connection with such Development Candidate and its corresponding Licensed Products and Diagnostic Products in the Field in the CELGENE Territory and, with respect to Non-[*] DCs, in the SUTRO Territory through U.S. IND Clearance. CELGENE will, itself or through its Affiliates or Sublicensees, exercise Commercially Reasonable Efforts to clinically develop each such Development Candidate, Licensed Products and Diagnostic Products in the Field in the CELGENE Territory; it being understood and agreed that, as of any time during the Term, the exercise of Commercially Reasonable Efforts by CELGENE (itself or through its Affiliates or Sublicensees) with respect to any Development Candidate and its corresponding Licensed Products and Diagnostic Products included in any BAC/ADC Program shall be deemed to satisfy the requirement to exercise Commercially Reasonable Efforts by CELGENE (itself or through its Affiliates or Sublicensees) with respect to each other Development Candidate and its corresponding Licensed Products and Diagnostic Products included in each such Program. In addition to the reporting requirements set forth in Section 3.1.3, at least once per Calendar Year, CELGENE shall provide to SUTRO a reasonably detailed report regarding CELGENE’s development activities, which shall include with respect to the prior twelve (12) month-period an update of any Clinical Trials conducted by CELGENE, its Affiliates or Sublicensees with respect to all Development Candidates and a description of INDs and XXXx filed and Regulatory Approvals obtained by CELGENE, its Affiliates or Sublicensees for all Development Candidates and Licensed Products. Notwithstanding the foregoing, CELGENE’s reporting obligations under this Section 3.1.1 shall terminate upon a Business Combination of SUTRO.
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CELGENE Territory. As between the Parties, subject to the terms of the Agreement, CELGENE shall have the sole right and responsibility for the commercialization and related manufacturing activities (subject to Article 6) in connection with such Development Candidate and its corresponding Licensed Products and Diagnostic Products in the Field in the CELGENE Territory. CELGENE will, itself or through its Affiliates or Sublicensees, exercise Commercially Reasonable Efforts to commercialize such Development Candidate, Licensed Products and Diagnostic Products in the Field in the CELGENE Territory; it being understood and agreed that, as of any time during the Term, the exercise of Commercially Reasonable Efforts by CELGENE (itself or through its Affiliates or Sublicensees) with respect to any Development Candidate and its corresponding Licensed Products and Diagnostic Products included in any BAC/ADC Program shall be deemed to satisfy the requirement to exercise Commercially Reasonable Efforts by CELGENE (itself or through its Affiliates or Sublicensees) with respect to each other Development Candidate and its corresponding Licensed Products and Diagnostic Products included in each such Program. In addition to the reporting requirements set forth in Section 3.2.3, at least once per Calendar Year, CELGENE shall provide to SUTRO a reasonably detailed report regarding CELGENE’s commercialization activities for such prior twelve (12) month-period, including notice of the First Commercial Sale of any Licensed Product by CELGENE, its Affiliates or Sublicensees on a country-by-country basis in the CELGENE Territory.
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CELGENE Territory. Unless otherwise expressly authorized by CELGENE in writing, SUTRO shall not (i) actively seek prospective purchasers for any Licensed Product for use in the CELGENE Territory, (ii) engage in any advertising or promotional activities relating to any Licensed Product directed primarily to prospective purchasers for use in the CELGENE Territory, or (iii) solicit orders from any prospective purchaser for sale and use in the CELGENE Territory. If SUTRO receives any unauthorized order from a prospective purchaser for the CELGENE Territory, SUTRO shall promptly refer that order to CELGENE and shall not accept any such orders. SUTRO shall not sell any Licensed Product to a purchaser if SUTRO knows that such purchaser intends to resell or otherwise distribute or provide such Licensed Product to a prospective purchaser for use in the CELGENE Territory.
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CELGENE Territory. Following IND Clearance for a Development Candidate anywhere in the CELGENE Territory, CELGENE shall have the sole right to prepare, file and maintain all Regulatory Materials (including pricing and reimbursement approvals) necessary for the development, manufacture or commercialization of such Development Candidate, its corresponding Licensed Products and Diagnostic Products, in the Field in the CELGENE Territory, provided, however, that SUTRO shall have the sole right to prepare, file and maintain any SUTRO Expression DMF. CELGENE shall own all such Regulatory Materials relating to such Development Candidate, Licensed Products and Diagnostic Products in the CELGENE Territory (excluding for clarity any SUTRO Expression DMF).
Sample 1
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CELGENE Territory. On a Non-[*] DC-by-Non-[*] DC basis, after IND Clearance for such Non-[*] DC in the SUTRO Territory, SUTRO may participate in material meetings with Regulatory Authorities pertaining to the development, manufacture and commercialization of such Non-[*] DC and its corresponding Licensed Products and Diagnostic Products, or Regulatory Approvals thereof, in the CELGENE Territory. CELGENE shall provide SUTRO with reasonable advance written notice of all such meetings and other contact and advance copies of all material related documents and other material relevant information relating to such meetings or such other contact. SUTRO and CELGENE shall discuss any material documents or other material correspondence that CELGENE is planning to submit in connection with Regulatory Approvals in the CELGENE Territory sufficiently in advance of submission so that SUTRO may review and comment on such documents and such other correspondence including in each case the proposed labeling for the corresponding Licensed Products and Diagnostic Products. SUTRO shall not have the right to approve the proposed labeling or any other regulatory filings or submissions for the corresponding Licensed Products and Diagnostic Products except with respect to (A) worldwide, for all BACs and ADCs prior to Nomination as a Development Candidate and (B) in the SUTRO Territory, limited to Non-[*] DCs following IND Clearance. CELGENE shall promptly provide to SUTRO copies of any material documents or other material correspondence pertaining to the corresponding Licensed Products and Diagnostic Products in the CELGENE Territory, on a Non-[*] DC-by-Non-[*] DC basis, and shall promptly provide to SUTRO all proposed labeling, in each case received from the Regulatory Authorities in the CELGENE Territory. Notwithstanding the foregoing, SUTRO’s rights, and CELGENE’s obligations, under this Section 4.2.1 shall terminate upon a Business Combination of SUTRO.
Sample 1
CELGENE Territory. From and after the completion of the first Phase 1 Clinical Trial for a Licensed Compound Directed to DOT1L, or if EPIZYME exercises a EPIZYME Post-EOP1 Clinical Opt-Out pursuant to Section 2.5, CELGENE shall have the sole right to prepare, file and maintain all regulatory filings (including pricing and reimbursement approvals) and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of all Licensed Compounds and Licensed Products Directed to DOT1L and all related Diagnostic Products in the Field in the CELGENE Territory, and to the extent permitted by applicable Laws and to the extent not assigned and transferred as of the Effective Date, EPIZYME shall assign and transfer to CELGENE, within [**] days after the completion of such Phase 1 Clinical Trial or after such EPIZYME Post-EOP1 Clinical Opt-Out or such EPIZYME Late Stage Opt-Out, all regulatory filings and Regulatory Approvals in the CELGENE Territory that relate to any and all Licensed Compounds and Licensed Products directed to DOT1L and all related Diagnostic Products. From and after the completion of the first Phase 1 Clinical Trial for a Licensed Compound Directed to DOT1L, or after such EPIZYME Post-EOP1 Clinical Opt-Out or such EPIZYME Late Stage Opt-Out, CELGENE shall own all such regulatory filings and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of Licensed Compounds, Licensed Products and related Diagnostic Products in the CELGENE Territory.
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Related to CELGENE Territory

  • 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 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.

  • 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.

  • 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.

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

  • 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.

  • Licensed Patents 9.1.1 Oculis shall be responsible for and shall have the exclusive right with respect to, the preparation, filing, prosecution, protection, maintenance and enforcement of all Patent Rights in respect of the Licensed Technology in its discretion using its patent counsel. Oculis shall consult with Accure with respect thereto, supply Accure with a copy of the application as filed, together with notice of its filing date and serial number; and keep Accure advised of the status of actual and prospective Patent Right filings, including office actions, and keep Accure informed about and provide copies of all the relevant information exchanged between Oculis and the different Industrial or Intellectual Property Registration Offices regarding the prosecution, maintenance, defense and enforcement of the Licensed Patents. The cost and expense of filing, prosecuting, maintaining and enforcing all Licensed Patents shall be borne by Oculis. Accure shall, and hereby procures its personnel will, provide all requested information and perform all acts reasonably requested by Oculis in connection with the prosecution, maintenance, defense or enforcement of the Licensed Technology. Without limiting the foregoing, Accure and its Affiliates may not file for further Patent Rights relating to Licensed Technology. 9.1.2 Should Oculis not be interested in the prosecution, defense and maintenance of any or all of the Licensed Patents, and/or Xxxxxx decides not to pay all reasonable and necessary expenses with respect to the prosecution, defense or maintenance of any Licensed Patent before any upcoming deadline, Oculis shall give reasonable advance notice to Accure (no less than [***]), and subsequent to such notice Accure shall act as it deems appropriate in connection with the prosecution, defense and maintenance of the Licensed Patents at their discretion and at their own cost. As from such notification, Oculis shall not be responsible for costs associated with such Licensed Patents, and, where such notification is provided following such time as Xxxxxx assumes responsible for performing patenting matters as set forth above, Oculis shall not be responsible for the preparation, filing, prosecution, protection and maintenance of the mentioned Licensed Patents and such Patent Rights shall cease to be Licensed Patents and the provisions of Agreement shall be of no further effect with respect to such patent and/or country of the Territory.

  • Patent Rights The State and the U. S. Department of Transportation shall have the royalty free, nonexclusive and irrevocable right to use and to authorize others to use any patents developed by the Engineer under this contract.

  • 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).

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