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Rights to Clinical Data Sample Clauses

Rights to Clinical Data. PRONOVA currently has rights to clinical data with respect to Other Products currently in existence or under development from its, licensees and partners, which PRONOVA is not prevented from disclosing to RELIANT. Hereafter, PRONOVA shall use commercially reasonable efforts to obtain rights to clinical data for any Other Products from its licensees and partners. If PRONOVA obtains rights to such clinical data that PRONOVA is not prevented from disclosing to RELIANT, RELIANT will, for regulatory filing or promotional purposes only in the Territory, receive a fully paid up royalty free license to use and cross reference the clinical data from planned and ongoing studies related to such Other Products by PRONOVA and/or its partners. RELIANT shall use commercially reasonable efforts to obtain rights to clinical data for the Product from its Affiliates and partners. If RELIANT has rights to such clinical data that RELIANT is not prevented from disclosing to PRONOVA, RELIANT hereby grants to PRONOVA a fully paid up royalty free license to use and cross reference clinical data for the Product from RELIANT’s own and/or its partners’ clinical studies for regulatory filing and promotional purposes outside the Territory only. A list of current clinical trials and PRONOVA’s rights to these is set out in Schedule 3.6.
Rights to Clinical Data. 2.5.1 During the Term, Argos shall share with Green Cross, on a [**] basis, its available, unblinded Clinical Data and available study updates (e.g., enrollment, subject demographics, IDMC interim reviews) with respect to the Licensed Product generated during any Clinical Studies (including without limitation Phase II(b) Studies, Phase III Studies and Post Approval Studies). Green Cross shall be entitled to reference such Clinical Data in any Regulatory Approval submissions for the Licensed Product by Green Cross and its Related Parties in the Green Cross Territory. 2.5.2 During the Term, Green Cross shall share with Argos, on a [**] basis, its available, unblinded Clinical Data with respect to the Licensed Product generated during any Clinical Studies (including without limitation Phase II(b) Studies, Phase III Studies and Post Approval Studies). Argos shall be entitled to reference such Clinical Data in any Regulatory Approval submissions by Argos and its Related Parties in the Argos Territory. 2.5.3 Argos will promptly notify Green Cross in writing (“Argos Product Notice”) prior to entering into bona fide negotiations with a Third Party for Development and Commercialization rights in the Green Cross Territory to any product utilizing the Argos Technology other than the Licensed Product (an “ Follow-on Licensed Product”). Such Argos Product Notice shall include material information relating to such Follow-on Licensed Product that Green Cross may reasonably need in order for Green Cross to evaluate the Follow-on Licensed Product. Green Cross shall have [**] days after receipt of the Argos Product Notice to notify Argos in writing of its interest in such Follow-on Licensed Product in the Green Cross Territory. If Green Cross notifies Argos in writing within such [**] day period that it is interested in such Follow-on Licensed Product in the Green Cross Territory, then the Parties shall promptly commence good faith negotiations for a period of up to [**] months after Green Cross receives the Argos Product Notice in an effort to reach a mutually acceptable definitive agreement (or amendment to this Agreement) for such Follow-on Licensed Product in the Green Cross Territory. If (x) Green Cross does not notify Argos in writing within such [**] day period that it is interested in such Follow-on Licensed Product, or (y) despite each Party’s good faith efforts, Argos and Green Cross are not able to reach agreement on and execute a definitive agreement within such...
Rights to Clinical DataDuring the Term, China Company shall share with Argos and the Argos Regional Partners, on a quarterly basis, any available, unblinded China Company Data with respect to a Licensed Product (including, without limitation, a Licensed Product treating an Infectious Disease Indication permitted pursuant to Section 2.6) generated during any Clinical Studies (including without limitation Phase I Studies, Phase II Studies, Phase III Studies and Post Approval Studies). Argos and the Argos Regional Partners shall be entitled to reference such China Company Data in any Regulatory Approval submissions by Argos and its Related Parties in the Argos Territory. Subject to China Company´s compliance with the terms of the Agreement, including meeting agreed-upon Development milestones and Commercialization sales targets set from time to time by the JSC, in case any Argos Regional Partner is developing a product using the Technology in the Field (including any new Infectious Disease Indication that is added to the Field pursuant to Section 2.6), Argos shall, and shall use its commercially reasonable best effort to cause such Argos Regional Partner to, provide and make available to China Company, on a quarterly basis, any available, unblinded Argos Data with respect to a Licensed Product (including, without limitation, a Licensed Product treating an Infectious Disease Indication added to the Field pursuant to Section 2.6) generated during any Clinical Studies (including without limitation Phase I Studies, Phase II Studies, Phase III Studies and Post Approval Studies), subject, however, to any conditions placed on China Company’s use of such Argos Data by the applicable Argos Regional Partner. Upon a Change of Control of Argos, China Company and Argos (or its successor) shall negotiate in good faith to continue Argos' obligations pursuant to this Section 2.5.

Related to Rights to Clinical Data

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company 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, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical 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.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Technical Data For the purpose of this Agreement, "TECHNICAL DATA" shall mean all information of the Company in written, graphic or tangible form relating to any and all products which are developed, formulated and/or manufactured by the Company, as such information exists as of the Effective Date or is developed by the Company during the term hereof.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • 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.

  • Product Data Illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by Developer to illustrate a material, product, or system for some portion of the Work.

  • Manufacturing Technology Transfer Except as the Committee ------------ --------------------------------- may otherwise agree in writing, in order to effectuate an orderly transition of the uninterrupted availability of Product to LILLY for purposes contemplated under this Agreement, MEGABIOS, at least ninety (90) days prior to completion of the Project or completion of Phase I Clinical Trials, whichever is earlier, shall transfer to LILLY all information and instructions concerning the manufacturing process and related matters in MEGABIOS' possession which may be necessary for LILLY to manufacture Product (including information regarding obtaining necessary Lipids related thereto) for clinical trials and commercialization as contemplated hereunder including, but not limited to, analytical and manufacturing methods. MEGABIOS shall also provide assistance (in the form of consultation) to LILLY with respect to manufacturing matters for a period of [ * ] months after completion of the initial transfer of information and instructions as provided below. Such transfer and assistance by MEGABIOS will be referred to herein as the "Manufacturing Transfer." All such information, methods and instructions transferred to LILLY under this Section 4.3 shall be referred to herein as the "Manufacturing Information," and shall be maintained in confidence by LILLY pursuant to Section 7.1, except that LILLY's obligation to maintain in confidence such Manufacturing Information shall survive for ten (10) years following expiration or termination of this Agreement. LILLY agrees that it will use all such transferred Manufacturing Information only for the manufacture of the Products and shall not disclose or transfer such Manufacturing Information to any third party manufacturer except as provided in Section 2.10. MEGABIOS shall provide, and bear its costs for, up to [ * ] FTEs for a period of up to [ * ] months [ * ] in aggregate) to accomplish the Manufacturing Transfer. Such FTEs, at LILLY's request, shall include visits to LILLY's facilities by MEGABIOS personnel including up to [ * ] from MEGABIOS' head of manufacturing. MEGABIOS shall furnish any additional reasonable assistance beyond the assistance described above regarding manufacturing matters that LILLY may request and that MEGABIOS is able to provide, for up to [ * ] after the initial transfer of Manufacturing Information, providing that LILLY [ * ] incurred with respect to such additional assistance.

  • Third Party Data Any statistical, industry-related and market-related data, which are included in the Disclosure Package and the Prospectus, is based on or derived from sources that the Company reasonably and in good faith believes to be reliable and accurate, and such data agrees with the sources from which it is derived, and the Company has obtained the written consent for the use of such data from such sources to the extent required.

  • 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.