Study Results and Data Sample Clauses

Study Results and Data. (a) Institution and Investigator will make the results and all data and all “Study Documentation” (meaning all eCRFs, records, notes, reports and data relating to the Study in any form, all recorded original observations and notations of Study activities, and all reports and records necessary for the evaluation of the Study whether in written, electronic or other tangible form) available to MedImmune and/or its designated representatives, the European Medicines Agency and in accordance with applicable legal requirements of regulatory agences in Czech Republic. MedImmune will own all data and results and will have the right to use the results and data for all purposes including but not limited to seeking regulatory approval from the FDA and other such agencies. Institution and Investigator will ensure accurate and timely collection, recording, and submission of Study Data. MedImmune or its designated representatives including CRO may, if allowed by legal regulations, request copies of Study subject
Sample 1Sample 2
AutoNDA by SimpleDocs
Study Results and Data. (a) Institution and Investigator will make the results and all data and all “Study Documentation” (meaning all eCRFs, records, notes, reports and data relating to the Study in any form, all recorded original observations and notations of Study activities, and all reports and records necessary for the evaluation of the Study whether in written, electronic or other tangible form) available to MedImmune and/or its designated representatives, the European Medicines Agency and in accordance with applicable legal requirements of regulatory agences in Czech Republic. MedImmune will own all data and results and will have the right to use the results and data for all purposes including but not limited to seeking regulatory approval from the FDA and other such agencies. Institution and Investigator will ensure accurate and timely collection, recording, and submission of Study Data. MedImmune or its designated representatives including CRO may, if allowed by legal regulations, request copies of Study subject medical records, including but not limited to medical chart information if necessary to comply with applicable laws and regulations. For the avoidance of doubt, Study subject medical records, including medical chart information and any original source documents prepared by the Institution or Investigator relating to the Study remain the property of Institution.
Sample 1Sample 2
Study Results and Data. (a) Institution and Investigator will make the results and all data and all “Study Documentation” (meaning all eCRFs, records, notes, reports and data relating to the Study in any form, all recorded original observations and notations of Study activities, and all reports and records necessary for the evaluation of the Study whether in written, electronic or other tangible form) available to MedImmune and/or its designated representatives, and to the FDA, the European Medicines Agency and similar regulatory agencies in other countries, as required. MedImmune will own all data and results and will have the right to use the results and data for all purposes including but not limited to seeking regulatory approval from the FDA and other such agencies. Institution and Investigator
Sample 1

Related to Study Results and Data

  • Information and Data ‌ Upon request of the Union, the Employer agrees to furnish the Union with the following information: budgets for the Board of Regents; budgets for each College; public information used in the preparation of budgets as provided by law such as salaries; minutes of meetings of the Board; policies of the Board of Regents which apply to faculty members. Voluminous information shall be made available for inspection or will be provided at reproduction cost.

  • Background Data The Disclosing Party's Background Data, if any, will be identified in a separate technical document.

  • Books, Records and Regulatory Filings (a) The Sub-Adviser agrees to maintain and to preserve for the applicable periods any such records as are required to be maintained by the Sub-Adviser with respect to the Fund by the 1940 Act and rules adopted thereunder, and by any other applicable laws, rules and regulations. The Sub-Adviser further agrees that all records that it maintains for the Fund are the property of the Fund and it will promptly surrender any of such records upon request; provided, however, that the Sub-Adviser may retain copies of such records for the applicable periods they are required by law to be retained, and thereafter shall destroy such records. (b) The Sub-Adviser agrees that it shall furnish to regulatory authorities having the requisite authority any information or reports in connection with its services hereunder that may be requested in order to determine whether the operations of the Fund are being conducted in accordance with applicable laws, rules and regulations. (c) The Sub-Adviser shall make all filings with the SEC required of it pursuant to Section 13 of the 1934 Act with respect to its duties as are set forth herein. The Sub-Adviser also shall make all required filings on Schedule 13D or 13G and Form 13F (as well as other filings triggered by ownership in securities under other applicable laws, rules and regulations) in respect of the Portfolio as may be required of the Fund due to the activities of the Sub-Adviser. The Sub-Adviser shall be the sole filer of Form 13F with respect to the Portfolio of the Fund.

  • Regulatory Materials (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Data To permit evaluation of requests under paragraph (c) of this clause based on unreasonable cost, the Contractor shall include the following information and any applicable supporting data based on the survey of suppliers: Foreign (Nondesignated Country) and Domestic Construction Materials Cost Comparison Construction material description Unit of measure Quantity Cost (dollars) * Item 1: Foreign construction material Domestic construction material Item 2 Foreign construction material Domestic construction material [List name, address, telephone number, and contact for suppliers surveyed. Attach copy of response; if oral, attach summary.][Include other applicable supporting information.] [* Include all delivery costs to the construction site.]

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

  • 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.

  • How to Update Your Records You agree to promptly update your registration records if your e-mail address or other information changes. You may update your records, such as your e-mail address, by using the Profile page.

  • BID TABULATION AND RESULTS Bid tabulations shall be available thirty (30) days after opening on the Orange County website at: xxxx://xxxx.xxxx.xxx/orangebids/bidresults/results.asp or upon notice of intended action, whichever is sooner.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!