Common use of TERMINATION OR SUSPENSION – PRACTICAL CONSEQUENCES AND OBLIGATIONS FOR THE PARTIES AND THE INVESTIGATOR Clause in Contracts

TERMINATION OR SUSPENSION – PRACTICAL CONSEQUENCES AND OBLIGATIONS FOR THE PARTIES AND THE INVESTIGATOR. Upon any termination or suspension of this Agreement or the Study, the INSTITUTION and the INVESTIGATOR will comply with the provisions of the Protocol pertaining notably to the practical consequences of such termination or suspension. Immediately upon receipt of a notice of termination or suspension, the INVESTIGATOR and the INSTITUTION shall stop enrolling Study Participants into the Study, shall cease conducting procedures on Study Participants already enrolled in the Study as directed by the SPONSOR, to the extent medically and ethically permissible, and shall refrain from incurring additional costs and expenses to the extent possible. In the event the Study is terminated or suspended for other reasons than the Study Participants’ safety or public health motivations, but also in case of the end of the Study, the SPONSOR and the INVESTIGATOR shall discuss the on-going treatment needs of the Study Participants and will, if appropriate given the circumstances of the Study termination, agree on a plan for discontinuing treatment of Study Drug to ensure enrolled Study Participants have adequate continuum of care during the reasonable period necessary to organise and provide an alternative treatment to ensure the Study Participant’s safety. In the event this Agreement or the Study is terminated, the INSTITUTION and the INVESTIGATOR shall stop the Study as expeditiously as possible and in accordance with Article 5.4.3 and all applicable national and local laws, regulations and guidelines. The INSTITUTION and the INVESTIGATOR undertake not to start any work not already engaged.

TERMINATION OR SUSPENSION – PRACTICAL CONSEQUENCES AND OBLIGATIONS FOR THE PARTIES AND THE INVESTIGATOR. Upon any termination or suspension of this Agreement or the Study, the INSTITUTION and the INVESTIGATOR will comply with the provisions of the Protocol pertaining notably to the practical consequences of such termination or suspension. Immediately upon receipt of a notice of termination or suspension, the INVESTIGATOR and the INSTITUTION shall stop enrolling Study Participants into the Study, shall cease conducting procedures on Study Participants already enrolled in the Study as directed by the SPONSOR, to the extent medically and ethically permissible, and shall refrain from incurring additional costs and expenses to the extent possible. In the event the Study is terminated or suspended for other reasons than the Study Participants’ safety or public health motivations, but also in case of the end of the Study, the SPONSOR and the INVESTIGATOR shall discuss the on-going treatment needs of the Study Participants and will, if appropriate given the circumstances of the Study termination, agree on a plan for discontinuing treatment of Study Drug to ensure enrolled Study Participants have adequate continuum of care during the reasonable period necessary to organise and provide an alternative treatment to ensure the Study Participant’s safety. In the event this Agreement or the Study is terminated, the INSTITUTION and the INVESTIGATOR shall stop the Study as expeditiously as possible and in accordance with Article 5.4.3 5.4.3. and all applicable national and local laws, regulations and guidelines. The INSTITUTION and the INVESTIGATOR undertake not to start any work not already engaged. For the purposes of this Agreement, the following is and shall be considered throughout and during a period [xx years – needs to be between five (5) and ten (10) years (depending on the type of study)] after the term or termination of this Agreement as confidential information (hereinafter referred to as “CONFIDENTIAL INFORMATION”), whether marked as “confidential” or not, all information received by the SPONSOR from the INSTITUTION and/or INVESTIGATOR, including but not limited to proprietary information, trade secret, data, Know-How (hereafter “INSTITUTION’s CONFIDENTIAL INFORMATION”); all information received by the INSTITUTION and/or the INVESTIGATOR from the SPONSOR, including but not limited to proprietary information, trade secret, data, Know-How (hereafter “SPONSOR’s CONFIDENTIAL INFORMATION”); all data, databases, documents, reports and other information developed with respect to the Study or in the performance of or as a result of the Study by the SPONSOR, the INSTITUTION or the INVESTIGATOR or their respective employees, agents, Subcontractors or Study Participants. CONFIDENTIAL INFORMATION notably includes but is not limited to, (i) the terms of this Agreement, (ii) the CRF, (iii) the Protocol, (iv) the Investigator's Brochure (“IB”) and (v) any information identified as confidential or proprietary at the time of disclosure by the disclosing Party or which should be reasonably considered confidential by its nature, without prejudice to INSTITUTION’s and INVESTIGATOR’s right to publish the Study Results in accordance with Article 6.3. CONFIDENTIAL INFORMATION does not include information that: at the time of disclosure thereof is or thereafter becomes part of the public domain through no breach, fault or omission of the receiving Party or of their respective employees, agents, Subcontractors or participants; at the time of disclosure thereof by the disclosing Party, is already in the receiving Party's lawful possession as evidenced by the receiving Party's competent written records and not subject to prior confidentiality obligations; the receiving Party receives from a third party who has the right to disclose the same and who did not obtain such information in violation of the disclosing Party’s rights; is independently developed by the receiving Party without the use of CONFIDENTIAL INFORMATION as evidenced by the receiving Party's written records and is not subject to confidentiality obligations; the receiving Party is required to disclose by applicable law, by a court or by a governmental authority, provided that the receiving Party (i) promptly notifies the disclosing Party of such requirement prior to disclosure –to the extent reasonably and legally permissible - in order to allow them the opportunity to oppose the requirement or seek an appropriate protective order; (ii) discloses only that CONFIDENTIAL INFORMATION required to comply with the legal requirement and (iii) continues to maintain the confidentiality of this CONFIDENTIAL INFORMATION with respect to all other third parties. The burden of proving the applicability of any of these exceptions resides with the receiving Party.