Global Safety Database; Clinical Database Sample Clauses

Global Safety Database; Clinical Database. (a) Within [***] days after the later of (i) the execution of the Pharmacovigilance Agreement and (ii) the Completion of the Ongoing Trial, Novartis shall transfer to Pharming data for the Licensed Compound and Licensed Products in Novartis’ global safety database in accordance with the Transition Plan, understanding that certain information will be redacted or retained by Novartis in accordance applicable data privacy laws.
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Related to Global Safety Database; Clinical Database

  • 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.

  • 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.

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work.

  • Technology Research Analyst Job# 1810 General Characteristics Maintains a strong understanding of the enterprise’s IT systems and architectures. Assists in the analysis of the requirements for the enterprise and applying emerging technologies to support long-term business objectives. Responsible for researching, collecting, and disseminating information on emerging technologies and key learnings throughout the enterprise. Researches and recommends changes to foundation architecture. Supports research projects to identify and evaluate emerging technologies. Interfaces with users and staff to evaluate possible implementation of the new technology in the enterprise, consistent with the goal of improving existing systems and technologies and in meeting the needs of the business. Analyzes and researches process of deployment and assists in this process.

  • Database The LERG is available through Telcordia. ICONN is available through the Qwest web site.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Data Encryption Contractor must encrypt all State data at rest and in transit, in compliance with FIPS Publication 140-2 or applicable law, regulation or rule, whichever is a higher standard. All encryption keys must be unique to State data. Contractor will secure and protect all encryption keys to State data. Encryption keys to State data will only be accessed by Contractor as necessary for performance of this Contract.

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

  • 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.

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