Common use of Sponsor Clause in Contracts

Sponsor. [OPTIONAL CLAUSE] The SPONSOR hereby delegates in accordance with the Belgian Civil Code to [INSERT NAME CRO, ADDRESS] (“CRO”) the performance of certain SPONSOR tasks . The SPONSOR is also entitled to delegate, in accordance with the Belgian Civil Code, the performance of certain (additional) tasks to any other person(s) of its choice during the course of the Study. The SPONSOR remains liable for the performance of the tasks by the CRO. The SPONSOR shall duly inform the INSTITUTION and the INVESTIGATOR of any change in the delegation/mandate accordingly. Any change of CRO during the course of the Study shall be notified in writing by the SPONSOR to the INSTITUTION and the INVESTIGATOR. As an exception to Article 11.2, such notification can be given by ordinary mail or electronic mail. For the purposes of this Agreement, the SPONSOR is responsible for the manufacturing, packaging, labelling, QP release, import and/or supply of the Study Drug and shall obtain or shall ensure that the third party entrusted with any of these six tasks obtains from the authorities the necessary authorisation pertaining thereto. The SPONSOR assumes product liability to the extent applicable, and in accordance with the Applicable Laws. The SPONSOR will provide the Study Drug free of charge. Prior to the commencement of the Study the SPONSOR shall ensure that: for the initial and continuing review, positive opinions of the appropriate ethics committee are obtained by the INVESTIGATOR or INVESTIGATOR’s authorized representative (except in the case of a CTR/MDR study where approvals must be obtained by the SPONSOR), and all necessary authorizations of the relevant health or regulatory authorities are obtained.

Sponsor. [OPTIONAL CLAUSE] The SPONSOR hereby mandates/delegates in accordance with the Belgian Civil Code to [INSERT NAME CRO, ADDRESS] (“CRO”) the performance of certain SPONSOR tasks the monitoring and verification of the data obtained within the scope of the Study. The SPONSOR is also entitled to delegate/mandate, in accordance with the Belgian Civil Code, the performance of certain (additional) these tasks to any other person(s) of its choice during the course of the Study. The SPONSOR remains liable for the performance of the tasks by the CRO. The SPONSOR shall duly inform the INSTITUTION and the INVESTIGATOR of any such change in the delegation/mandate accordingly. Any change of CRO during the course of the Study shall be notified in writing by the SPONSOR to the INSTITUTION and the INVESTIGATOR. As an exception to Article 11.210.2, such notification can be given by ordinary mail, electronic mail or electronic mailtelefax. For the purposes of this Agreement, the SPONSOR is responsible for the manufacturing, packaging, labelling, QP release, import and/or supply of the Study Drug and shall obtain or shall ensure that the third party entrusted with any of these six four tasks obtains from the authorities the necessary authorisation pertaining thereto. The SPONSOR assumes product liability to the extent applicable, and in accordance with the Applicable Lawsapplicable legislation. The SPONSOR will provide the Study Drug free of charge. Prior to the commencement of the Study the The SPONSOR shall ensure that: that for the initial and continuing review, positive opinions of the appropriate ethics committee are obtained by the INVESTIGATOR or INVESTIGATOR’s authorized representative (except in the case of a CTR/MDR study where approvals must be obtained by the SPONSOR), and all necessary authorizations of the relevant health or regulatory authorities are obtained, prior to the commencement of the Study. The SPONSOR shall notify to and seek approval of the competent authorities and the INVESTIGATOR must notify to and seek positive opinion of the ethics committee for any substantial amendment of the Protocol. The SPONSOR shall ensure that relevant parties shall be notified of the end or suspension of the Study. The SPONSOR will be responsible for ensuring that all safety reporting to the relevant health authorities and ethics committees is performed according to Applicable Laws. After analysis of Study Data from all sites is complete, the SPONSOR will provide INVESTIGATOR with a summary of the overall Study results. If the Study results could affect the safety of Study Participants, the SPONSOR, in consultation with the ethics committee, will cooperate with the INVESTIGATOR to ensure that those results are appropriately communicated to the Study Participants during a [2 (two) year] period following the closure of the Study. During and for a period of [specify a period of time appropriate to the specific study, for example, at least 2 (two) years after the completion of the study; or specify a triggering event, for example completion of data analysis], the SPONSOR shall ensure to report promptly (or in a timely manner appropriate to the level of risk involved) to the INVESTIGATOR any information that could directly affect the health or safety of past or current Study Participants or influence the conduct of the Study, including but not limited to the Study results and information in site monitoring reports and data safety monitoring committee reports as required by the Protocol. In each case, the INVESTIGATOR and the INSTITUTION shall be free to communicate these findings to each Study Participants and the responsible ethics committee.

Sponsor. [OPTIONAL CLAUSE] The SPONSOR hereby delegates in accordance with the Belgian Civil Code to [INSERT NAME CRO, ADDRESS] (“CRO”) the performance of certain SPONSOR tasks . The SPONSOR is also entitled to delegate, in accordance with the Belgian Civil Code, the performance of certain (additional) tasks to any other person(s) of its choice during the course of the Study. The SPONSOR remains liable for the performance of the tasks by the CRO. The SPONSOR shall duly inform the INSTITUTION and the INVESTIGATOR of any change in the delegation/mandate accordingly. Any change of CRO during the course of the Study shall be notified in writing by the SPONSOR to the INSTITUTION and the INVESTIGATOR. As an exception to Article 11.2., such notification can be given by ordinary mail or electronic mail. For the purposes of this Agreement, the SPONSOR is responsible for the manufacturing, packaging, labelling, QP release, import and/or supply of the Study Drug and shall obtain or shall ensure that the third party entrusted with any of these six tasks obtains from the authorities the necessary authorisation pertaining thereto. The SPONSOR assumes product liability to the extent applicable, and in accordance with the Applicable Laws. The SPONSOR will provide the Study Drug free of charge. Prior to the commencement of the Study the SPONSOR shall ensure that: for the initial and continuing review, positive opinions of the appropriate ethics committee are obtained by the INVESTIGATOR or INVESTIGATOR’s authorized representative (except in the case of a CTR/MDR study where approvals must be obtained by the SPONSOR)representative, and all necessary authorizations of the relevant health or regulatory authorities are obtained.

Sponsor. [OPTIONAL CLAUSE] The SPONSOR hereby delegates in accordance with the Belgian Civil Code to [INSERT NAME CRO, ADDRESS] (“CRO”) the performance of certain SPONSOR tasks . The SPONSOR is also entitled to delegate, in accordance with the Belgian Civil Code, the performance of certain (additional) tasks to any other person(s) of its choice during the course of the Study. The SPONSOR remains liable for the performance of the tasks by the CRO. The SPONSOR shall duly inform the INSTITUTION and the INVESTIGATOR of any change in the delegation/mandate accordingly. Any change of CRO during the course of the Study shall be notified in writing by the SPONSOR to the INSTITUTION and the INVESTIGATOR. As an exception to Article 11.2, such notification can be given by ordinary mail or electronic mail. For the purposes of this Agreement, the SPONSOR is responsible for the manufacturing, packaging, labelling, QP release, import and/or supply of the Study Drug and shall obtain or shall ensure that the third party entrusted with any of these six tasks obtains from the authorities the necessary authorisation pertaining thereto. The SPONSOR assumes product liability to the extent applicable, and in accordance with the Applicable Laws. The SPONSOR will provide the Study Drug free of charge. Prior to the commencement of the Study the SPONSOR shall ensure that: for the initial and continuing review, positive opinions of the appropriate ethics committee are obtained by the INVESTIGATOR or INVESTIGATOR’s authorized representative (except in the case of a CTR/MDR study where approvals must be obtained by the SPONSOR)representative, and all necessary authorizations of the relevant health or regulatory authorities are obtained.

Sponsor. [OPTIONAL CLAUSE] The SPONSOR hereby delegates in accordance with the Belgian Civil Code to [INSERT NAME CRO, ADDRESS] (“CRO”) the performance of certain SPONSOR tasks . The SPONSOR is also entitled to delegate, in accordance with the Belgian Civil Code, the performance of certain (additional) tasks to any other person(s) of its choice during the course of the Study. The SPONSOR remains liable for the performance of the tasks by the CRO. The SPONSOR shall duly inform the INSTITUTION and the INVESTIGATOR of any change in the delegation/mandate accordingly. Any change of CRO during the course of the Study shall be notified in writing by the SPONSOR to the INSTITUTION and the INVESTIGATOR. As an exception to Article 11.2, such notification can be given by ordinary mail or electronic mail. For the purposes of this Agreement, the SPONSOR is responsible for the manufacturing, packaging, labelling, QP release, import and/or supply of the Study Drug and shall obtain or shall ensure that the third party entrusted with any of these six tasks obtains from the authorities the necessary authorisation pertaining thereto. The SPONSOR assumes product liability to the extent applicable, and in accordance with the Applicable Laws. The SPONSOR will provide the Study Drug free of charge. Prior to the commencement of the Study the SPONSOR shall ensure ensure, under its entire responsibility that: for the initial and continuing review, positive opinions of the appropriate ethics committee are obtained by the INVESTIGATOR or INVESTIGATOR’s authorized representative (except in the case of a CTR/MDR study where approvals must be obtained by the SPONSOR)representative, and all necessary authorizations of the relevant health or regulatory authorities are obtained.