Use of Unpublished Clinical Data Sample Clauses

Use of Unpublished Clinical Data. The Parties shall mutually agree as to the timing and nature of disclosure of unpublished clinical data for the Product to any Third Party, except that a Party may disclose such portion of the unpublished clinical data to the extent such disclosure is reasonably necessary in the following situations: 1) to the extent such disclosure is required to clinical sites in accordance with the applicable clinical trial agreements for the Product clinical trials outside the Territory; 2) to the extent such disclosure is required to comply with Applicable Laws or is in connection with Regulatory Materials or communications with Regulatory Authorities outside the Territory; 3) to the extent such disclosure is required to Regulatory Authorities in compliance with a Party’s policies and procedures relating to pharmacovigilance and adverse event reporting for the Product; or 4) to the extent such disclosure is expressly permitted under Section 9.3 of the Option Agreement, provided that the Parties shall mutually agree on any disclosures of clinical data for filing or prosecuting Patents in accordance with Section 4.2.
Sample 1
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Use of Unpublished Clinical Data. Neither Party shall disclose any unpublished Korean Clinical Data and other documentation prepared specifically for use in connection with the Korean Phase 1a/1b Trial to any Third Party, except that a Party may disclose such portion of the unpublished Korean Clinical Data to the extent such disclosure is reasonably necessary in the following situations: (i) to the extent the Parties agree to such disclosure; (ii) in the case of GCC, to the extent such disclosure is required to clinical sites in accordance with the applicable clinical trial agreements for the Korean Phase 1a/1b Trial; (iii) in the case of GCC, to the extent such disclosure is required to comply with Applicable Laws or is in connection with Regulatory Materials or communications with Regulatory Authorities in the Republic of Korea regarding the Product or the Korean Phase 1a/1b Trial; (iv) to the extent such disclosure is required to Regulatory Authorities in compliance with a Party’s policies and procedures relating to pharmacovigilance and adverse event reporting for the Product; or (v) to the extent such disclosure is expressly permitted under Section 9.3 of the Option Agreement, provided that the Parties shall mutually agree on any disclosures of Korean Clinical Data for filing or prosecuting Patents in accordance with Section 5.2.
Sample 1

Related to Use of Unpublished Clinical Data

  • Technical Data For the purpose of this Agreement, "TECHNICAL DATA" shall mean all information of the Company in written, graphic or tangible form relating to any and all products which are developed, formulated and/or manufactured by the Company, as such information exists as of the Effective Date or is developed by the Company during the term hereof.

  • 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.

  • 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.

  • Marketing Materials (a) During the term of this Agreement, the Sub-Adviser agrees to furnish the Manager at its principal office for prior review and approval by the Manager all written and/or printed materials, including but not limited to, PowerPointÒ or slide presentations, news releases, advertisements, brochures, fact sheets and other promotional, informational or marketing materials (the “Marketing Materials”) for internal use or public dissemination, that are produced or are for use or reference by the Sub-Adviser, its affiliates or other designees, broker-dealers or the public in connection with the Series, and Sub-Adviser shall not use any such materials if the Manager reasonably objects in writing within five business days (or such other period as may be mutually agreed) after receipt thereof. Marketing Materials may be furnished to the Manager by first class or overnight mail, facsimile transmission equipment, electronic delivery or hand delivery. (b) During the term of this Agreement, the Manager agrees to furnish the Sub-Adviser at its principal office all prospectuses, proxy statements, reports to shareholders, or Marketing Materials prepared for distribution to shareholders of each Series, or the public that refer to the Sub-Adviser in any way, prior to the use thereof, and the Manager shall not use any such materials if the Sub-Adviser reasonably objects in writing within five business days (or such other period as may be mutually agreed) after receipt thereof. The Sub-Adviser’s right to object to such materials is limited to the portions of such materials that expressly relate to the Sub-Adviser, its services and its clients. The Manager agrees to use its reasonable best efforts to ensure that materials prepared by its employees or agents or its affiliates that refer to the Sub-Adviser or its clients in any way are consistent with those materials previously approved by the Sub-Adviser as referenced in the first sentence of this paragraph. Marketing Materials may be furnished to the Sub-Adviser by first class or overnight mail, facsimile transmission equipment, electronic delivery or hand delivery.

  • Information Technology The following applies to all contracts for information technology commodities and contractual services. “Information technology” is defined in section 287.012(15), F.S., to have the same meaning as provided in section 282.0041, F.S.

  • Training Materials Training Materials will be provided for each student. Training Materials may be used only for either (i) the individual student’s reference during Boeing provided training and for review thereafter or (ii) Customer’s provision of training to individuals directly employed by the Customer.

  • DRUG AND ALCOHOL FREE WORKPLACE 20.1 All employees must report to work in a condition fit to perform their assigned duties unimpaired by alcohol or drugs.

  • Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.

  • Statistical, Demographic or Market-Related Data All statistical, demographic or market-related data included in the Registration Statement, the Disclosure Package or the Prospectus are based on or derived from sources that the Company believes to be reliable and accurate and all such data included in the Registration Statement, the Disclosure Package or the Prospectus accurately reflects the materials upon which it is based or from which it was derived.

  • Root-­‐zone Information Publication ICANN’s publication of root-­‐zone contact information for the TLD will include Registry Operator and its administrative and technical contacts. Any request to modify the contact information for the Registry Operator must be made in the format specified from time to time by ICANN at xxxx://xxx.xxxx.xxx/domains/root/.

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