Trial Results Sample Clauses

Trial Results. After analysis of Trial Data from all sites is complete, SPONSOR will provide Principal Investigator and Institution with a summary of the overall results of the Trial. If the results show that Human Subject safety could be adversely affected, SPONSOR, in consultation with the IRB/IEC as appropriate, will cooperate with Principal Investigator and Institution to ensure that those results are appropriately communicated to the Human Subjects by Principal Investigator and/or Institution during the 2 year period following the close of the Trial.
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Trial Results. Each Party shall provide the other Parties ------------- with the right to review any contents of public disclosures, prepared by or otherwise under the control of such Party, to the extent that they are contractually permitted to do so, regarding the results of [*] pursuant to this Section 4.11. Each Party shall consider in good faith incorporating any comments or amendments that the other Parties propose to such contents.
Trial Results. From January 1, 2010 through September 30, 2013, 112 smoking and health, Xxxxx Progeny and health-care cost recovery cases in which RJR Tobacco or B&W were defendants were tried, including 12 trials for cases where mistrials were declared in the original proceedings. Verdicts in favor of RJR Tobacco, B&W and, in some cases, RJR Tobacco, B&W and other defendants, were returned in 56 cases, including 21 mistrials, tried in Florida (52), Missouri (1) and West Virginia (4). Verdicts in favor of the plaintiffs were returned in 52 cases tried in Florida, one in Connecticut, and one in New York. Two cases in Florida were dismissed during trial. In the third quarter of 2013, five Xxxxx Progeny cases in which RJR Tobacco was a defendant were tried:
Trial Results. Xxxxxxxx will also be entitled to publish with respect to the results of the PROSERA Phase 3 Study and any associated pre-clinical research associated with Licensed Compound or Licensed Products, in its ordinary course, subject to prior review, comment and approval (not to be unreasonably withheld, delayed or conditioned) by Xxxxxx (with the proposed publication to be provided to Chiesi not less than 30 days prior to intended submission). Notwithstanding anything in this Agreement to the contrary, each Party will be entitled to disclose, without the consent of or any notification to the other Party, any pharmacovigilance information originating from itself, its Affiliates, and the other Party with Regulatory Authorities, investigators, ethical committees and internal review boards, and any other Third Parties that have a need to know such information according to each Party’s risk management and adverse event reporting requirements provided that such disclosure complies with applicable Law.
Trial Results. “TRS”) At the end of the Study, approximately twelve (12) months after the last Study Subject last visit for the overall Study, Sponsor will develop a summary of the trial results to be shared with the Study Subjects. The TRS will translate the technical results into easy to understand language. Sponsor will consult with the Site to confirm the number of copies required and translations. Based on the information provided by the Site, Sponsor, directly or through a third party vendor, will mail the TRS to the Site or provide the link to the public website where the TRS will be located. The Site or designee will be responsible to mail the TRS or provide the link to the Study Subjects or provide it to the Study Subjects directly if applicable. 1.6 Výsledky klinického hodnocení („VKH“) Na konci Studie, přibližně dvanáct (12) měsíců po poslední návštěvě posledního Subjektu studie v celé Studii, vypracuje Zadavatel přehled výsledků klinického hodnocení, který poskytne Subjektům studie. VKH budou interpretovat odborné výsledky ve snadno srozumitelném jazyce. Zadavatel se s Místem provádění klinického hodnocení domluví na potřebném počtu výtisků a překladu tohoto přehledu. Na základě informací poskytnutých Místem provádění klinického hodnocení zašle Zadavatel přímo nebo prostřednictvím svého smluvního dodavatele poštou výtisky VKH Místu provádění klinického hodnocení nebo mu poskytne odkaz na veřejně přístupný web, kam budou VKH umístěny. Místo provádění klinického hodnocení nebo jím pověřená osoba bude zodpovídat za rozeslání VKH Subjektům studie nebo je Subjektům studie případně přímo předá.
Trial Results. “TRS”) At the end of the Study, approximately twelve (12) months after the last Study Subject last visit for the overall Study, Sponsor will develop a summary of the trial results to be shared with the Study Subjects. The TRS will translate the technical results into easy to understand language. Sponsor will consult with the pro edukativní účely, a (ii) pro přípravu publikací v souladu s Článkem 5 “Práva na zveřejnění”.
Trial Results 
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  • Financial Statements; No Material Adverse Change All financial statements relating to Borrower which have been or may hereafter be delivered by Borrower to Lender have been prepared in accordance with GAAP and fairly present the financial condition and the results of operation of Borrower as at the dates and for the periods set forth therein. Except as disclosed in any interim financial statements furnished by Borrower to Lender prior to the date of this Agreement, there has been no material adverse change in the assets, liabilities, properties and condition, financial or otherwise, of Borrower, since the date of the most recent audited financial statements furnished by Borrower to Lender prior to the date of this Agreement.

  • Regulatory Activities Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.

  • Regulatory Actions The following provisions shall be applicable to the parties to the extent that they are required to be included in employment agreements between a savings bank and its employees pursuant to Section 563.39(b) of the Office of Thrift Supervision (“OTS”) Rules and Regulations, 12 C.F.R. §563.39(b), or any successor thereto, and shall be controlling in the event of a conflict with any other provision of this Agreement, including without limitation Section 5 hereof.

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