RETURN OF STUDY MATERIALS. If the parties agree that the return of such Study Drug is not practicable or is prohibited under local laws or regulations, any remaining or expired Study Drug will be destroyed in full compliance with applicable laws and regulations by either (a) the Pharmacy, provided that Pharmacy has the necessary facilities, expertise and regulatory approvals required to destroy Study Drug; or (b) by a third party contracted by the Pharmacy (approved by Sponsor in its reasonable discretion), provided that the Pharmacy is identified as the generator of the Study Drug and further provided that the Pharmacy confirms that the third party has the necessary facilities, expertise and regulatory approvals required to destroy Study Materials. Upon any such destruction by Pharmacy or by a third party, Pharmacy will promptly provide Sponsor with a certificate of destruction or similar document verifying the final disposition of the Study Drug. Sponsor shall pay Pharmacy for any destruction and/or return of Study Drug in this section. CONTACT PERSONS Investigator as an employee of Institution (Investigator and Institution as listed in the table below), will be responsible for the conduct of the Study. Any notice given in connection with this Agreement shall, unless otherwise provided herein, be in writing and shall be delivered personally, or sent by registered mail or transmitted by PDF to the address given in this Agreement: If to Pharmacy: If to Institution: If to Sponsor: If to Investigator: If to Inven2: Inven2 AS Xxxxxxxxxxxxx 00 0000 Xxxx, Xxxxxx Att: Xxxx Xxxxx If to Study nurse or any other relevant personnel: MONITORING AND ACCESS Pharmacy shall, during the Study, permit Sponsor and its designee(s) and representatives of competent authorities to access Pharmacy’s premises to inspect and monitor provision of the Services, as well as to audit records relating to the Services to verify Pharmacy’s compliance with the obligations herein and with applicable laws and regulations. Such access should be arranged at mutually convenient times. The monitor is at his/her first visit at the Pharmacy required to sign a confidentiality disclosure agreement, limiting disclosure of information regarding the Pharmacy, its activities and the staff of the Pharmacy, which the monitor will/may get access to during visits at the Pharmacy.
RETURN OF STUDY MATERIALS. If the parties agree that the return of such Study Drug is not practicable or is prohibited under local laws or regulations, any remaining or expired Study Drug will be destroyed in full compliance with applicable laws and regulations by either (a) the Pharmacy, provided that Pharmacy has the necessary facilities, expertise and regulatory approvals required to destroy Study Drug; or (b) by a third party contracted by the Pharmacy (approved by Sponsor in its reasonable discretion), provided that the Pharmacy is identified as the generator of the Study Drug and further provided that the Pharmacy confirms that the third party has the necessary facilities, expertise and regulatory approvals required to destroy Study Materials. Upon any such destruction by Pharmacy or by a third party, Pharmacy will promptly provide Sponsor with a certificate of destruction or similar document verifying the final disposition of the Study Drug. Sponsor shall pay Pharmacy for any destruction and/or return of Study Drug in this section.
RETURN OF STUDY MATERIALS. Within 20 days following the conclusion or premature termination of the Study or termination of this Agreement, Sponsor will instruct Site to return or destroy unused study materials, including Test Article, clinical supplies, CRFs and equipment furnished by Sponsor. Within 30 days thereafter, Site will comply with Sponsor’s instructions. Sponsor will provide shipping materials and pay Site’s out-of-pocket shipping costs. During the Study, Site may return unused materials to Sponsor with prior Sponsor approval.
