Conduct of Studies. All studies, research and testing done by or on behalf of each Party under this Agreement shall be performed in strict compliance with any applicable federal, state, or local laws, rules, and regulations governing the conduct of studies, research, and testing at the site where such studies, research, and testing are being conducted.
Conduct of Studies. All work done in connection with the Project shall be carried out in strict compliance with all applicable laws, regulations, or guidelines governing the conduct of research at the site where such studies are being conducted.
Conduct of Studies. All work done in connection with the ------------ ------------------- Project shall be carried out in compliance with any federal, state, or local laws, regulations, or guidelines governing the conduct of research at the site where such work is being conducted. In addition, any laboratory animals covered by this Agreement shall be provided humane care and treatment in accordance with the most acceptable current veterinary practices.
Conduct of Studies. All studies done in connection with the Research Program shall be carried out in compliance with any federal, state or local laws, regulations, or guidelines governing the conduct of research at the site where such studies are being conducted, including those applicable to the care and use of experimental animals. In addition, all animals involved in the Research Program shall be provided humane care and treatment in accordance with generally acceptable current veterinary practices.
Conduct of Studies. (i) Kamada is in the process of conducting the Phase II/III Clinical Study necessary for the receipt of the EU Centralized Approval. Kamada shall bear all costs and expenses related to such Phase II/III Clinical Study. It is clarified that Kamada cannot guarantee the success or the results of the study. Kamada shall, at all times during the conduct of the Phase II/III Clinical Study, keep Chiesi reasonably and promptly informed of all material activities and results thereunder and consult with Chiesi as reasonably requested by Chiesi. Kamada shall comply with all Applicable Laws and Guidelines applicable to the conduct of such Phase II/III Clinical Study.
(ii) Kamada shall conduct Phase IV Clinical Studies, if such studies are required by the EMA in order to maintain the EU Centralized Approval for the Product. The costs and expenses related to any and all the Phase IV Clinical Studies shall by distributed as follows:
(A) Kamada shall bear the initial [*****] and (B) Kamada and Chiesi shall equally bear any additional costs and expenses beyond the initial [*****]. Kamada shall submit to Chiesi for review and approval, such approval not to be unreasonably withheld, conditioned or denied, each of the above Phase IV Clinical Study plans and protocols in advance, while Kamada shall, at all times during the conduct of the Phase IV Clinical Studies, keep Chiesi reasonably and promptly informed of all material activities and results thereunder and shall consult with Chiesi as reasonably requested by Chiesi. Kamada shall comply with all Applicable Laws and Guidelines applicable to the conduct of such Phase IV Clinical Studies.
(iii) Notwithstanding clause (ii) above, Chiesi shall conduct any additional Clinical Studies required by any Regulatory Authorities for: (A) obtaining any Regulatory Approval for the Product in the Territory in countries that are not covered under the EU Centralized Approval, and (B) marketing purposes (collectively, the “Additional Clinical Studies”). Chiesi shall bear all costs and expenses related to such Additional Clinical Studies. Kamada shall confirm each Clinical Study plan and protocol used for each Additional Clinical Study in advance and shall use its Commercially Reasonable Efforts to provide the related support required for the Additional Clinical Studies, including the supply to Chiesi [*****] 4 mL vials of Product necessary for the conduct of the Additional Clinical Studies, and of additional 4 mL vials of Product necessary f...
Conduct of Studies. 4.1 Studies
(a) DBCTM will procure and manage the performance of the Studies in accordance with the details set out in Annexure 1.
(b) The details of the Studies, including the Scope and Estimated Study Costs, are set out in Annexure 1 and the Scope and Estimated Study Costs have been agreed by the Access Seeker and DBCTM (and each of the Underwriting Parties).
(c) DBCTM will use its reasonable endeavours to conduct the Studies in accordance with Annexure 1 and will keep the Access Seeker informed as to the progress of the Studies in accordance with this Agreement.
Conduct of Studies. 5.1. For each Study, FORENAP shall ensure that the Principal Investigator and all members of the Study Staff are appropriately qualified, trained, and experienced for the Services they perform. For the avoidance of doubt, FORENAP shall be solely responsible for each Study for the actions or omissions of the Principal Investigator and all members of the Study Staff. FORENAP shall not utilize or engage in any capacity in the performance of Services any person or entity debarred or disqualified from participating in the conduct or reporting of human clinical trials by the FDA or any Review Body.
5.2. FORENAP agrees to use its best efforts to ensure the continuity of competent personnel to provide Services under each Work Order. FORENAP reserves the right to change any assigned personnel provided that:
5.2.1 at least two (2) weeks prior notice in writing of such proposed change is given to THE SPONSOR;
5.2.2 personnel proposed for replacement shall have substantially equivalent qualifications as the personnel being replaced; and
5.2.3 THE SPONSOR shall have the right to meet any replacement personnel prior to his or her appointment and approve or reject such personnel. Such approval shall not be unreasonably withheld by THE SPONSOR.
5.3. FORENAP may enter into agreements with third parties, such as laboratory service providers, as may be necessary to perform Services, but only if THE SPONSOR shall have given prior written consent. FORENAP shall ensure that the terms and conditions of each such permitted agreement, if any, are consistent with the terms of this Master Agreement and the applicable Work Order and enable FORENAP to comply with its obligations herein (including those related to confidentiality, publication and intellectual property).
5.4. FORENAP shall not commence recruitment of subjects for any Study under any Work Order until it (or, if applicable THE SPONSOR has received the approval of all Review Bodies for such Study. MASTER CLINICAL SERVICES AGREEMENT FORENAP PHARMA – TARGACEPT
5.5. FORENAP shall ensure that the facilities, including any equipment, for each Study are adequate for the proper conduct of the Study.
5.6. For each Study, FORENAP shall (i) complete all Case Report Forms promptly, (ii) review such Case Report Forms for accuracy and completeness, and (iii) compile and submit all data in a timely manner and otherwise in accordance with the Protocol.
5.7. THE SPONSOR shall provide to FORENAP all Materials to be provided by THE SPONSOR ...
Conduct of Studies. Xxxxxx shall conduct the post-marketing clinical studies required by Regulatory Authorities for the Product in the Field in the Xxxxxx Territory which shall follow the clinical study plan which shall be attached hereto as Exhibit 8.1(a) (collectively, the “Clinical Studies”). Promptly following the execution of this Agreement, the Parties shall meet in good faith to draft Exhibit 8.1(a) based upon input from both of the Parties and the FDA (as applicable) and complete such exhibit as promptly as possible. Upon completion of the exhibit, it shall be acknowledged as the final exhibit in writing by both Parties and at such time shall be attached hereto and incorporated herein by reference. Kamada shall be obligated to use its Best Efforts to provide the related support required for Regulatory Approval for the continued marketing of the Product in the Xxxxxx Territory. In connection therewith, the Parties shall at all times during the conduct of the Clinical Studies keep each other reasonably informed of all activities thereunder, and consult with each other as reasonably requested by the other Party. The JSC (as hereinafter defined) shall determine each Party’s responsibilities with respect to all Clinical Studies, provided that Xxxxxx shall be responsible for the conduct of all Clinical Studies. Xxxxxx shall comply with all laws and regulations applicable to the conduct of such Clinical Studies.
Conduct of Studies. ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information has been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Conduct of Studies. All work and investigations done in connection with the Research shall be carried out in compliance with any federal, state or local laws, regulations, or [ * ] = 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 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED. guidelines governing the conduct of research at the site where such work is being conducted. Each Party agrees to provide the other with all safety and other handling information and instructions available to the disclosing Party relating to all materials transmitted to the other Party hereunder.
