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 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 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 6.2, Fuso may select a third party contract manufacturer ("Contract Manufacturer"), reasonably acceptable to GenVec, to manufacture such Collaboration Product. 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. 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 *, 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. 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 6.1.2, Fuso may *, reasonably acceptable to GenVec, to * such *.
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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. 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 
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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 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.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

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