Study Protocols Sample Clauses

Study Protocols. 11.1 In the event Celestial and/or BWTP proposes to sponsor or conduct any study of a Medicinal Product, it shall first draft and provide copies of the proposed study protocols for such study including all documents associated with such study protocols, including but not limited to all investigator’s brochures (“Study Protocols”) to GSK for comment and afford GSK a period of [**] Days to review such draft Study Protocols. Copies of the draft Study Protocols shall be provided by secure email or, if that is not possible, by fax.
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Study Protocols. The conduct of inhalation exposures will be performed according to the following test guideline concerning repeated dose inhalation toxicity studies: - Organization for Economic Cooperation and Development (OECD), OECD Guidelines for Testing of Chemicals, Section 4: Health Effects, No. 413 "Sub-Chronic Inhalation Toxicity: 90-day Study" adopted 07 September 2009. In addition the study was carried out taking into account the following guidelines: - Organization for Economic Cooperation and Development (OECD), OECD Guidelines for Testing of Chemicals, Section 4: Health Effects, Method 453 "Combined Chronic Toxicity/Carcinogenicity Study in Rodents" adopted 07 Sep 2009. - Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Part B.33.: Combined Chronic Toxicity/Carcinogenicity Test - US Environmental Protection Agency (EPA), Health Effects Test Guidelines OPPTS870.4300, Combined Chronic Toxicity/Carcinogenicity, EPA 712-C-98-212, August 1998 In deviation to the guidelines, only females were exposed, because female rats are considered to be slightly more sensitive concerning carcinogenicity after inhalation exposure to dust aerosols (Xxxxxx et al. 2000). The chronic study was started with 100 rats per dose group. 50 animals per dose group were sacrificed after 24 months. The remaining animals are currently kept exposure-free till natural death or till month 30. The intention for this extension is to enhance study sensitivity. It is known that a relevant portion of particle induced tumours become detectable first rather late in rats. The study sensitivity to detect lung tumours will be further enhanced by an extended lung histopathology as 60 instead of 6 slices will be studied per lung. Satellite groups were sacrificed after 12 months (chronic group with 10 animals per dose for histopathology) and after 3 months, 12 months, and 24 months (for kinetic/organ burden evaluations). Results for 3 months have been reported in deliverables .4.3 and 4.4. Main exposure groups are used for histopathology examinations (carcinogenicity groups). Post-exposure animals are sacrificed and examined after 30 months or if the only 25% or less animals are still alive. Animals of each group which die during the exposure or post-exposure period are examined as well.
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Study Protocols. The conduct of inhalation exposures will be performed according to the following test guideline concerning repeated dose inhalation toxicity studies: - Organization for Economic Cooperation and Development (OECD), OECD Guidelines for Testing of Chemicals, Section 4: Health Effects, No. 413 "Sub-Chronic Inhalation Toxicity: 90-day Study" adopted 07 September 2009. In addition the study was carried out taking into account the following guidelines: - Organization for Economic Cooperation and Development (OECD), OECD Guidelines for Testing of Chemicals, Section 4: Health Effects, Method 453 "Combined Chronic Toxicity/Carcinogenicity Study in Rodents" adopted 07 Sep 2009. - Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Part B.33.: Combined Chronic Toxicity/Carcinogenicity Test - US Environmental Protection Agency (EPA), Health Effects Test Guidelines OPPTS870.4300, Combined Chronic Toxicity/Carcinogenicity, EPA 712-C-98-212, August 1998 In deviation to the guidelines, only females were exposed, because female rats are considered to be slightly more sensitive concerning carcinogenicity after inhalation exposure to dust aerosols (Xxxxxx et al. 2000).
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Study Protocols. Endorecherche shall be responsible (at its own expense) for the design of all preclinical and clinical studies involving Acolbifene to be undertaken during the Option Period. Endorecherche shall provide Schering with advance copies of all protocols for proposed studies involving Acolbifene in order to provide Schering a reasonable opportunity to review and comment on the protocol and study design. Schering shall provide any comments to the protocol within thirty (30) days of receipt and Endorecherche shall consider in good faith any comments made by Schering with respect to the protocols and/or study design.
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Study Protocols. Institution shall be responsible (at its own expense) for the design of all preclinical and clinical studies involving Materials to be undertaken in connection with the Project. Institution shall provide Company with advance copies of all protocols for proposed studies involving Materials in order to provide Company a reasonable opportunity to review and comment on the protocol and study design which must be found acceptable by Company. Company shall provide any comments to the protocol within thirty (30) days of receipt and Institution shall consider in good faith any comments made by Company with respect to the protocols and/or study design which must be found acceptable by Company. In addition, Company shall have the right to operate clinical monitoring of the study through its own personnel and at its own expenses, while the Research program is being conducted. Moreover, Institution shall submit to Company, for approval, all case record forms and formularies before starting the study.
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Study Protocols. At the first occurrence of an SAE in a particular clinical trial, the Party reporting the SAE shall make available to the other Party a copy of the relevant Study Protocol. This is to provide a clear understanding of the nature of the exposure to the Product and to allow a meaningful interpretation of the SAE.
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Study Protocols. Protocols for the studies are attached hereto as Exhibit A.
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Study Protocols. The services to be conducted under this Project Agreement include advancing the Product through the conduct of the [***] listed below. [***] Note that it is anticipated that support of this program will be expanded by amendment, to include – among other potential activities – [***], and through completion of the NDA supporting activities, when those details and timing are understood. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. EXHIBIT B EIGER - RRD PRODUCT DEVELOPMENT TEAM [***] The PDT outlined above may be amended from time to time for the most effective use of resources to develop the Program. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. EXHIBIT C DEVELOPMENT ADVISORY COMMITTEE CHARTER
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Related to Study Protocols

  • Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Research Records Each Party shall maintain records of each Research Program (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Research Program. All laboratory notebooks shall be maintained for no less than the term of any Patent issuing therefrom. All other records shall be maintained by each Party during the relevant Research Term and for [**] thereafter. All such records of a Party shall be considered such Party’s Confidential Information.

  • 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, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; 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 materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • 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.

  • Advertising and Promotional Materials The Purchaser acknowledges and agrees that the Vendor shall have the right to use drawings, photographs, videos or other depictions of the interior and/or exterior of the Dwelling and/or the Subdivision or any components or features thereof in any promotional or advertising materials without notice to or consent from the Purchaser being required in any manner whatsoever.

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