completion of the obligations of the Parties under this Agreement or earlier termination in accordance with this Section 10 whichever occurs first.

10.2 This Agreement may be terminated by either Party at any time in the exercise of its sole discretion upon thirty (30) calendar days prior written notice to the other Party without justifying the reasons for termination.

10.3 Notwithstanding the above, Sponsor or Institution/Investigator may immediately terminate the Study if any patient safety, laws or regulations are violated. Upon receipt of notice of termination, Institution/Investigator agrees to promptly terminate the conduct of the Study to the extent medically permissible for any individual who participates in the Study. The total sums payable by Sponsor pursuant to this Agreement shall be equitably prorated for actual work performed to the date of termination.

10.4 Institution/Investigator shall immediately deliver to Sponsor all Data generated as a direct result of the Study and shall, at Sponsor’s expense return to Sponsor or destroy upon instructions of the Sponsor, all unused Study Product, all documents, materials and equipment provided by Sponsor and all Sponsor Confidential Information, as defined in Section 3, at the earlier of the conclusion of the Study or termination of this Agreement. This provision does not apply to those documents that should be maintained and retained by Institution/Investigator at Institution, as defined in the Protocol and as requested by applicable laws and regulations.

10.5 The rights and obligations of the Parties which by intent or meaning have validity beyond termination as set forth above, including, but not limited to, rights with respect to patent rights, ownership of Inventions, confidentiality, liability limitations, indemnification and insurance, and publication shall survive five (5) years after the termination or expiration of this Agreement.

### 11. Applicable Law and Regulations

11.1 The Parties shall comply with all applicable national and international laws, regulations and guidelines, especially those governing the conduct of clinical trials, dealings in medicinal products, responsibilities of clinical investigators, informed consents, protection and privacy of personal data and storage of data and records, including, without limitation, the ICH Guidelines and the European Guidelines on Good Clinical Practice (hereinafter referred to as “ICH-GCP”), Good Laboratory Practice, the revised versions of the Declaration of Helsinki Directive 95/46/EC and Directive 2001/20/EC of the European Parliament and of the Council, and professional industry association regulations.

11.2 The Parties agree that the collection, processing and disclosure of personal data and medical information related to the Study subject, and personal data related to Investigator and any investigational staff (e.g., name, hospital or clinic address and phone number, curriculum vitae) are subject to compliance with applicable personal data protection and security laws and regulations. Institution/Investigator shall not disclose to the Sponsor the identity of the subjects or information from which the identity of the subject can be deduced without prior written consent of the subject.

11.3 Institution/Investigator agrees to inform the investigational staff that their personal data may be collected. In such case the Sponsor may transmit such personal data to other affiliates or group companies and their respective agents worldwide. Nonetheless, Sponsor will apply adequate privacy safeguards to protect such personal data. Personal data may also be disclosed as required by individual regulatory agencies or applicable law, such as to report serious adverse events.

11.4 The Institution confirms that neither it, and to the best of its knowledge nor any of its investigators, employees, agents or other personnel providing services for the Study

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