Reporting Serious Adverse Events 86 Sample Clauses

Reporting Serious Adverse Events 86. 9.2.1.1. Reporting of Disease Progression 87 9.2.2. Reporting a Pregnancy 87 10. STUDY ACTIVITIES 88 10.1. Screening Visit 88 10.1.1. Standard of Care Assessments 88 10.2. End of Treatment Visit 88 10.3. Follow-up Assessments 89 10.3.1. Safety Follow-up 89 10.3.2. Response Follow-up 89 10.3.3. PFS2 and Survival Follow-up 89 11. STATISTICAL METHODS 89 11.1. Sample Size 90 11.2. Stratification 91 11.3. Pharmacokinetic Analyses 91 11.4. Safety Analyses 91 11.5. Efficacy 91 11.5.1. Primary Efficacy Analysis 91 11.5.1.1. Progression-Free Survival 91 11.5.2. Secondary Efficacy Endpoints 92 11.5.2.1. Objective Response Rate 92 11.5.2.2. Overall Survival 92 11.5.2.3. Patient Reported Outcomes 92 11.6. Interim Analysis 92 11.7. Patient-reported Outcomes 93 11.8. Multiple Comparisons 93 11.8.1. Multiple Comparisons for Primary Efficacy Endpoint 93 11.8.2. Multiple Comparisons for Key Secondary Efficacy Endpoints 93 12. QUALITY CONTROL AND ASSURANCE 94 12.1. Recording of Data and Data Quality Assurance 94
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Related to Reporting Serious Adverse Events 86

  • Confidential Information “Confidential Information” shall mean (i) Highly Confidential Information (as defined below), (ii) any other technology, software development tools, methodologies, processes, algorithms, test data sets and test data cases and related documentation that CI Plus LLP provides to Licensee hereunder in order to facilitate Licensee’s exercise of its rights and performance of its obligations hereunder, and (iii) any other information of CI Plus LLP and information of Licensee, each of which is clearly marked as “Confidential” or a similar expression when disclosed in written or electronic form, or indicated as “Confidential” when disclosed orally and confirmed in writing within thirty (30) calendar days after such disclosure. “Confidential Information” shall not include information which: (a) was in the possession of, or was known by, the receiving party ("Recipient") prior to its receipt from the disclosing party (“Discloser), without an obligation owed to Discloser, or its licensors, to maintain its confidentiality; (b) is or becomes generally known to the public without violation of this Agreement by the “Recipient”; (c) is obtained by Recipient from a third party, without an obligation owed to such third party to keep such information confidential; or (d) is independently developed by Recipient without use of any Confidential Information of the other party. Recipient agrees that it shall use reasonable care to keep the Confidential Information of the other party strictly confidential and not disclose it to any other person except to its Affiliates and its and their respective employees, contractors, consultants, agents, customers and representatives (other than Members) who have a “need to know” for the purposes of this Agreement and are obligated by Licensee to be bound by the same confidentiality obligation which Recipient is bound by under this Exhibit H, provided however that Recipient may disclose Highly Confidential Information only in accordance with Section 2 of this Exhibit H. Recipient shall be responsible for any breach of such confidentiality obligation by such parties, including former employees, Affiliates, contractors, consultants, agents, customers (other than Members) and representatives. Recipient shall protect the Confidential Information of the other party with the same degree of care as it normally uses in the protection of its own similar confidential and proprietary information, but in no case with any less than reasonable care. Notwithstanding anything in this Exhibit H to the contrary, Confidential Information may be disclosed by Recipient pursuant to the order or requirements of a court or governmental administrative agency or other governmental body of competent jurisdiction, provided that (x) Discloser has been notified of such a disclosure request immediately after Recipient knows such order or requirements in order to afford Discloser reasonable opportunity to obtain a protective order or otherwise prevent or limit the scope of such disclosure to the extent permitted by law and (y) Recipient cooperates in good faith with such efforts by Discloser. The obligations under this Exhibit H shall terminate three years after the date of the last shipment of product using the Licensed Technology by Licensee or any other licensee of the Licensed Technology; provided that Sections 2.0(b), 2.0(c), and 3.0 in this Exhibit H shall cease to apply when the Recipient has returned all tangible embodiments of Licensed Technology in its possession to the Discloser.

  • Force Majeure If by reason of Force Majeure, either party hereto shall be rendered unable wholly or in part to carry out its obligations under this Agreement then such party shall give notice and full particulars of Force Majeure in writing to the other party within a reasonable time after occurrence of the event or cause relied upon, and the obligation of the party giving such notice, so far as it is affected by such Force Majeure, shall be suspended during the continuance of the inability then claimed, except as hereinafter provided, but for no longer period, and such party shall endeavor to remove or overcome such inability with all reasonable dispatch. Choice of Law The Agreement between the Vendor and TIPS/ESC Region 8 and any addenda or other additions resulting from this procurement process, however described, shall be governed by, construed and enforced in accordance with the laws of the State of Texas, regardless of any conflict of laws principles. Venue, Jurisdiction and Service of Process Any Proceeding arising out of or relating to this procurement process or any contract issued by TIPS resulting from or any contemplated transaction shall be brought in a court of competent jurisdiction in Camp County, Texas and each of the parties irrevocably submits to the exclusive jurisdiction of said court in any such proceeding, waives any objection it may now or hereafter have to venue or to convenience of forum, agrees that all claims in respect of the Proceeding shall be heard and determined only in any such court, and agrees not to bring any proceeding arising out of or relating to this procurement process or any contract resulting from or any contemplated transaction in any other court. The parties agree that either or both of them may file a copy of this paragraph with any court as written evidence of the knowing, voluntary and freely bargained for agreement between the parties irrevocably to waive any objections to venue or to convenience of forum. Process in any Proceeding referred to in the first sentence of this Section may be served on any party anywhere in the world. Venue for any dispute resolution process, other than litigation, between TIPS and the Vendor shall be located in Camp or Xxxxx County, Texas.

  • Termination for Convenience TIPS may, by written notice to Vendor, terminate this Agreement for convenience, in whole or in part, at any time by giving thirty (30) days’ written notice to Vendor of such termination, and specifying the effective date thereof.

  • Audits No more than once a year, or following unauthorized access, upon receipt of a written request from the LEA with at least ten (10) business days’ notice and upon the execution of an appropriate confidentiality agreement, the Provider will allow the LEA to audit the security and privacy measures that are in place to ensure protection of Student Data or any portion thereof as it pertains to the delivery of services to the LEA . The Provider will cooperate reasonably with the LEA and any local, state, or federal agency with oversight authority or jurisdiction in connection with any audit or investigation of the Provider and/or delivery of Services to students and/or LEA, and shall provide reasonable access to the Provider’s facilities, staff, agents and XXX’s Student Data and all records pertaining to the Provider, LEA and delivery of Services to the LEA. Failure to reasonably cooperate shall be deemed a material breach of the DPA.

  • Confidentiality (a) Subject to Section 7.15(c), during the Term and for a period of three

  • GRIEVANCE PROCEDURE 7.01 For purposes of this Agreement, a grievance is defined as a difference arising between the parties relating to the interpretation, application, administration or alleged violation of the Agreement including any question as to whether a matter is arbitrable.

  • Background Purchaser wishes to purchase a Revenue Sharing Note issued by the Company through xxx.Xxxxxxxx.xxx (the “Site”).

  • Definitions As used in this Agreement, the following terms shall have the following meanings:

  • Limitation of Liability No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.

  • Compliance with Laws Comply in all material respects with the requirements of all Laws and all orders, writs, injunctions and decrees applicable to it or to its business or property, except in such instances in which (a) such requirement of Law or order, writ, injunction or decree is being contested in good faith by appropriate proceedings diligently conducted; or (b) the failure to comply therewith could not reasonably be expected to have a Material Adverse Effect.

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