Study Protocols Clause Samples

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 (▇▇▇▇▇▇ 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.

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.

Study Protocols. Protocols for the studies are attached hereto as Exhibit A.

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. [***] The PDT outlined above may be amended from time to time for the most effective use of resources to develop the Program.

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.

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.