Clinical Trials in the Territory Sample Clauses

Clinical Trials in the Territory. Fuso shall have the first right, but not the obligation to manufacture Collaboration Products for use in clinical trials and commercials sales in the Territory, on a Collaboration Product-by-Collaboration Product basis, subject to GenVec's approval not to be unreasonably withheld. GenVec's decision to approve or disapprove manufacturing by Fuso shall be based on Fuso's ability to manufacture the applicable Collaboration Product and/or the period Fuso may require to establish an approved manufacturing facility. If Fuso elects not to manufacture such Collaboration Products, or GenVec does not approve of manufacture of such Collaboration Product by Fuso, GenVec shall have the first right, but not the obligation to manufacture Collaboration Products for use in clinical trials and commercial sales in the Territory, on a Collaboration Product-by-Collaboration Product basis, subject to Fuso's approval, not to be unreasonably withheld. Fuso's decision to approve or disapprove manufacturing by GenVec shall be based on GenVec's ability to cost effectively manufacture the applicable Collaboration Product. In the event that GenVec declines to manufacture a particular Collaboration Product, or Fuso does not approve of the manufacture of such Collaboration Product by GenVec, then, subject to Section 6.1.2, Fuso may select a third party contract manufacturer ("Contract Manufacturer"), reasonably acceptable to GenVec, to manufacture such Collaboration Product.
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Clinical Trials in the Territory. Except as contemplated by the Global Studies and such other Phase 3 Clinical Trials being conducted by or on behalf of Coherus in support of Regulatory Approvals or Pricing and Reimbursement Approvals in the Territory, [***].
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Clinical Trials in the Territory. Lithera shall have the right to conduct at its own costs Clinical Trials in the Territory as part of its Global Clinical Trial Program. NovaMedica shall have the right to conduct at its own costs Clinical Trials in the Territory which are necessary to obtain Regulatory Approval in each country in the Territory. All clinical data and reports related to Clinical Trials conducted by NovaMedica for the Covered Products in the Territory shall be owned by NovaMedica, and NovaMedica shall have full use, for any purpose consistent with this Agreement, of all such data and reports related to Clinical Trials for the Covered Products and/or Compound. All clinical data and reports related to Clinical Trials conducted by Lithera for the Covered Products in the Territory shall be owned by Lithera, and Lithera shall provide NovaMedica with all such clinical data and reports for NovaMedica’s use, for any purpose consistent with this Agreement, of all such data and reports related to Clinical Trials for the Covered Products in the Territory.
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Clinical Trials in the Territory. Fuso shall have the first right, but not the obligation to * in clinical trials in the Territory, on a Collaboration Product-by-Collaboration Product basis, subject to GenVec's approval not to be unreasonably withheld. GenVec's decision to approve or disapprove * Fuso shall be based on Fuso's * and/or the period Fuso may require to *. If Fuso elects not to * such *, or GenVec does not approve of * of such * Fuso, GenVec shall have the first right, but not the obligation, to * in clinical trials in the Territory, on a Collaboration Product-by-Collaboration Product basis, subject to Fuso's approval, not to be unreasonably withheld. Fuso's decision to approve or disapprove * GenVec shall be based on GenVec's ability to * the *. In the event that GenVec declines to * a particular *, or Fuso does not approve of the * of such * by GenVec, then, subject to Section 6.2, Fuso may * reasonably acceptable to GenVec, to * such *. GenVec and Fuso agree to reasonably cooperate to ensure the availability of Collaboration Products for Phase I and Phase II clinical studies in the Territory.
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Clinical Trials in the Territory. Fuso shall have the first right, but not the obligation to *, on a Collaboration Product-by-Collaboration Product basis, subject to GenVec's approval not to be unreasonably withheld. GenVec's decision to approve or disapprove * shall be based on *. If Fuso elects not to *, or GenVec does not approve of *, GenVec shall have the first right, but not the obligation to *, on a Collaboration Product-by-Collaboration Product basis, subject to Fuso's approval, not to be unreasonably withheld. Fuso's decision to approve or disapprove * shall be based on *. In the event that GenVec declines to *, or Fuso does not approve of the *, then, subject to Section 6.1.2, Fuso may *, reasonably acceptable to GenVec, to *.
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Clinical Trials in the Territory. NovaMedica, itself or through one or more Third Parties selected by NovaMedica, shall have the sole authority and the exclusive right to conduct, in the Territory, all Clinical Trials and non-clinical studies NovaMedica believes appropriate to obtain Regulatory Approvals for the Covered Product in the Territory, subject to, and in accordance with the provisions of the TTA, including, but not limited to, Section 2.1(c) thereof. Marinus shall use Commercially Reasonable Efforts to include sites in the Russian Federation in its Phase IIb Clinical Trial for its first Indication of the Covered Product in order to obtain a Regulatory Approval of such Covered Product outside the Territory and conduct such Clinical Trial at its own costs. All clinical data and reports related to Clinical Trials conducted by NovaMedica for the Covered Products in the Territory shall be owned by NovaMedica, and NovaMedica shall have full use, for any purpose consistent with this Agreement, of all such data and reports related to Clinical Trials for the Covered Products, and NovaMedica shall provide Marinus with all such clinical data and reports for use by Marinus in a timely manner, as provided herein and in the TTA. All clinical data and reports related to Clinical Trials conducted by Marinus for the Covered Products in the Territory shall be owned by Marinus, and Marinus shall provide NovaMedica with all such clinical data and reports for NovaMedica’s use, for any purpose consistent with this Agreement, of all such data and reports related to Clinical Trials for the Covered Products in the Territory.
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Clinical Trials in the Territory. Fuso shall have the first -------------------------------- right, but not the obligation [*]. [*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. [*]
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Clinical Trials in the Territory. Regado will conduct at its own costs Clinical Trials in the Territory as part of its Global Clinical Trial Program. NovaMedica shall have the right to conduct at its own costs additional Clinical Trials in the Territory which are necessary to obtain Regulatory Approval in each country in the Territory. All clinical data and reports related to Clinical Trials conducted by NovaMedica for the Covered Products in the Territory shall be owned by NovaMedica, and NovaMedica shall have full use, for any purpose consistent with this Agreement, of all such data and reports related to Clinical Trials for the Covered Products and/or Compound. NovaMedica shall provide Regado with all such clinical data and reports for Regado’s use, for any purpose consistent with this Agreement and TTA outside of the Territory. All clinical data and reports related to Clinical Trials conducted by Regado for the Covered Products in the Territory shall be owned by Regado, and Regado shall provide NovaMedica with all such clinical data and reports for NovaMedica’s use, for any purpose consistent with this Agreement and the TTA and of all such data and reports related to Clinical Trials for the Covered Products in the Territory.
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Clinical Trials in the Territory 
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Related to Clinical Trials in the Territory

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • 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.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

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