Publication of Study Results Sample Clauses

Publication of Study Results. GSK represents that it generally seeks publication of the results of all GSK-Sponsored interventional Research in peer-reviewed, searchable journals and imposes specified timeframes for the drafting and submission of manuscripts following completion of a study. For purposes of these publication requirements, GSK’s publication policy includes certain GSK-Sponsored observational Research studies and certain GSK-Sponsored meta-analyses and pooled analyses. In addition, GSK represents that it has established policies and “operating practices” governing scientific engagement, which included detailed directions regarding publications. Among other things, the operating practices require the implementation of data dissemination plans that establish prospective publication strategies for GSK-Sponsored Research and address requirements for appropriateness, accuracy, and balance in publications of GSK-Sponsored Research. In all publications about GSK- Sponsored Research, GSK shall acknowledge its role as the funding source. In addition, GSK represents that it has established policies, systems, and practices designed to ensure that adverse event data is properly reported to the FDA. In addition, GSK requires investigators to report study-related information and data, GlaxoSmithKline LLC Corporate Integrity Agreement including data about adverse events before receiving final payment from GSK. The standards, policies, and practices described above shall hereafter be referred to collectively as the “Research and Publication Practices.” GSK shall maintain its Research and Publication Practices (or standards and practices substantially equivalent to those set forth above) for studies initiated or completed after the Effective Date for the term of the CIA. To the extent that GSK intends to materially change these Research and Publication Practices, it shall notify the OIG about the change 30 days in advance of the effective date of the change;
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Publication of Study Results. 1) The full or partial results of the Study shall not be presented or published or otherwise made public by the Medical Care Institution or the Principal Investigator unless prior written Sponsor’s permission is obtained.
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Publication of Study Results. Pfizer supports the exercise of academic freedom and has no objection to publication by Principal Investigator of the results of the Study based on information collected or generated by Principal Investigator, whether or not the results are favorable to the Pfizer Drug. Requirements associated with such publications are set forth in Section 15 (Publications) of the agreement between CRO and Principal Investigator. 15.
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Publication of Study Results. The Company recognizes that under the Group policy, the results of the Study must be published and agrees that researchers engaged in the Study reserve the right, and are entitled, to present and publish Data at symposia, national or regional professional meetings, and to publish in a journal or otherwise, of their own choosing, methods and results of the Study undertaken under the Agreement, subject to the requirements of this Section 3.
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Publication of Study Results. 1) The full or partial results of the Study shall not be presented or published or otherwise made public by the Institution or the Principal Investigator unless prior written Sponsor’s permission is obtained in compliance with the terms herein. 2) The Parties agree that the Study is part of a multicentre study and it is the intent of the Parties that the first publication and/or presentation of the results of the Study will be made in conjunction with the presentation of a joint, multicentre publication of the complete multicentre study results. 3) Being subject to Sponsor’s written consent, Institution and the Principal Investigator will not submit for publication or presentation until publication of multicentre study results prior to any of following alternatives: a) Sponsor’s confirmation there will be no multicentre publication; or b) eighteen (18) months after the completion of the data analysis for the entire multicentre Study. 4) The Institution and the Principal Investigator will provide a copy of the publication or presentation 60 days before submission for 5) Zdravotnícke zariadenie a Hlavný skúšajúci sú povinní poskytnúť Zadávateľovi primeranú súčinnosti pri podávaní a uplatňovaní prípadných patentových prihlášiek vo vzťahu k Vynálezom, a to na náklady Zadávateľa. Čl. XIV. Publikovanie výsledkov Klinického skúšania 1) Výsledky Klinického skusania alebo ich časť nebudú Zdravotníckym zariadením či Hlavným skúšajúcim prezentované ani publikované či inak zverejňované bez predchájúceho písomneho súhlasu Zadávateľa v súlade s podmienkami v tejto Zmluve. 2) Zmluvné strany súhlasia s tým, xx Xxxxxxxx skusanie je súčasťou multicentrického klinického skusania a že zámerom Zmluvných xxxxx xx, aby k prvému publikovaniu a/alebo prezentovaniu výsledkov Klinického skusania došlo v rámci spoločného multicentrického uverejnenia výsledkov multicentrického klinického skusania ako celku. 3) Bez písomného súhlasu Zadávateľa Zdravotnícke zariadenie a Hlavný skúšajúci neposkytnú výsledky Klinického skusnaia k publikovaniu či zverejneniu, dokiaľ nedôjde k zverejneniu výsledkov multicentrického klinického skusania ako celku alebo predtým, než nastane niektorá z následujúcich alternatív: a) Zadávateľ potvrdí, že nebude vykonaná žiadna multicentrická publikácia alebo b) uplynie osemnásť (18) mesiacov od ukončenia analýz dát v rámci multicentrického klinického skusania ako celku. 4) Zdravotnícke zariadenie a Hlavný skúšajúci poskytnú Zadávateľovi k schváleniu kópiu publiká...
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Publication of Study Results. Pfizer supports the exercise of academic freedom and has no objection to publication by Principal Investigator of the results of the 15.1
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Publication of Study Results. The ability to timely publish research results is a key principle of academic freedom. Accordingly, HMH clinical trial agreements must contain publication clauses which allow HMH to publish research and study data results within a reasonable amount of time after the termination of the clinical trial. However, reasonable restrictions, such as a limited period of time for sponsor review of the publication for patent protection, are permissible.
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Publication of Study Results mimo jiné, vyplněných eCRFs a jakýchkoli dalších výkazů, zpracovaných Zdravotnickým zařízením, Hlavním zkoušejícím a/nebo Výzkumným personálem v průběhu Studie, jsou výlučným vlastnictvím Zadavatele a budou sbírána, zpracována, uchovávána a hlášena podle Protokolu a příslušných právních předpisů.
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Publication of Study Results 
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Related to Publication of Study Results

  • 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.

  • 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.

  • Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.

  • Development Records (a) Borrower shall keep and maintain at the principal place of business of the Borrower set forth in Section 6.11 below, or elsewhere with the County's written consent, full, complete and appropriate books, records and accounts relating to the Development. Borrower shall cause all books, records and accounts relating to its compliance with the terms, provisions, covenants and conditions of the Loan Documents to be kept and maintained in accordance with generally accepted accounting principles consistently applied, and to be consistent with requirements of this HOME Regulatory Agreement. Borrower shall cause all books, records, and accounts to be open to and available for inspection and copying by HUD, the County, its auditors or other authorized representatives at reasonable intervals during normal business hours. Borrower shall cause copies of all tax returns and other reports that Borrower may be required to furnish to any government agency to be open for inspection by the County at all reasonable times at the place that the books, records and accounts of Borrower are kept. Borrower shall preserve such records for a period of not less than five (5) years after their creation in compliance with all HUD records and accounting requirements. If any litigation, claim, negotiation, audit exception, monitoring, inspection or other action relating to the use of the County Loan is pending at the end of the record retention period stated herein, then Borrower shall retain the records until such action and all related issues are resolved. Borrower shall cause the records to include all invoices, receipts, and other documents related to expenditures from the County Loan funds. Borrower shall cause records to be accurate and current and in a form that allows the County to comply with the record keeping requirements contained in 24 C.F.R. 92.508. Such records are to include but are not limited to:

  • Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.

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