Common use of Study Protocol Clause in Contracts

Study Protocol. CRO shall prepare Study Protocol according to the latest version of the template of CRO or SPONSOR and any additional requirement from SPONSOR for SPONSOR's review and approval on the date of signing the SOW and provide Study Protocol to SPONSOR within thirty (30) days after the effective date of this Agreement. The Protocol will specify the Study design, objectives, inclusion and exclusion criteria, procedures for reporting adverse events, statistical analysis and other relevant issues. All changes, alterations and/or modifications in the Protocol shall be signed by both CRO and SPONSOR and shall be deemed incorporated into the Protocol. In addition, if, pursuant to the applicable policies/regulations of the Institutional Review Board/Independent Ethics Committee (IRB/IEC), any changes, alterations and/or modifications to the Protocol require the approval of the IRB/IEC, then CRO shall promptly obtain such approval. SPONSOR shall have the right at any time and from time to time to initiate changes, alterations and/or modifications to the Protocol as SPONSOR may deem necessary or appropriate, including, without limitation, suspending the Study temporarily or permanently. CRO is responsible for the application for IRB/IEC approval, including preparation and submission of the requested documents, communication with corresponding authority and obtaining approval as per the applicable policies/regulations. SPONSOR shall assist CRO to obtain this approval. CRO shall conduct the Study in compliance with the approved Protocol by IRB/IEC, and shall obey to any requirement and perform required adjustment by the IRB/IEC if any non-compliance occurred before/during the conduct of the Study. CRO shall delegate personnel on behalf of SPONSOR if requested and provide the relevant information (e.g. membership lists, meeting minutes, correspondence, etc) asked by SPONSOR or regulatory authorities in case of need. CRO shall prepare the Written Informed Consent forms (if applicable) both in English and local language (if applicable) according to the latest version of the template of CRO and provide the SPONSOR with such forms for its review and approval. CRO shall not enroll any subject in a Study unless and until it has received and certified the same in writing to SPONSOR documentation evidencing that the IRB/IEC has reviewed and approved the Protocol and the Informed Consent Form. CRO shall ensure that all subjects are in compliance with all of the Protocol requirements. It is CRO’s responsibility to promptly notify SPONSOR and the IRB/IEC of any significant deviation from the Protocol and any unanticipated or severe or serious Adverse Event within the timeframe specified by the Protocol and as per applicable guidelines. For each Project, CRO or SPONSOR shall prepare a set of Case Report Forms (if applicable), based on the Study Protocol. CRO shall complete the Case Report Forms (if applicable) and shall perform in-house monitoring according to current Standard Operating Procedures. CRO shall provide the SPONSOR with draft Case Report Forms (if applicable) for SPONSOR's review and approval prior to the Study or any revision during the Study. CRO shall provide all the completed scan copies of Case Report Forms to SPONSOR after completion of the Study and the final report are completed. CRO shall keep original copy of CRF and shall share electronic copy of CRF with SPONSOR while SPONSPOR also has the rights to keep original copy of CRF if any regulatory authority requires. For each Project, SPONSOR will supply to CRO a mutually agreed amount/quantity of the Study Product as well as the Innovator Product to enable completion of the study as well as for any quantity needed for retention samples. Further, CRO should apply for an import license and communicate with local regulatory authority about the importing application on behalf of SPONSOR, where required. SPONSOR agrees to pay and be responsible for all Customs Duties and charges with relevant invoices. In event the SPONSOR requires or the CRO pays the Customs Duties and charges for the Study Product then SPONSOR agrees to indemnify and reimburse within fifteen (15) days of the customs duty claim along with any other penalties/interest/or any other charges levied presently or in future for any amount claimed by Custom department due to SPONSOR’s reason in reference to this Study.

Study Protocol. CRO shall prepare Study Protocol according to the latest version of the template of CRO or SPONSOR and any additional requirement from SPONSOR for SPONSOR's review and approval on the date of signing the SOW and provide Study Protocol to SPONSOR within thirty (30) days after the effective date of this Agreement. .. The Protocol will specify the Study design, objectives, inclusion and exclusion criteria, procedures for reporting adverse events, statistical analysis and other relevant issues. All changes, alterations and/or modifications in the Protocol shall be signed by both CRO and SPONSOR and shall be deemed incorporated into the Protocol. In addition, if, pursuant to the applicable policies/regulations policies of the Institutional Review Board/Independent Ethics Committee (IRB/the “IEC”), any changes, alterations and/or modifications to the Protocol require the approval of the IRB/IEC, then CRO shall promptly obtain such approval. SPONSOR shall have the right at any time and from time to time to initiate changes, alterations and/or modifications to the Protocol as SPONSOR may deem necessary or appropriate, including, without limitation, suspending the Study temporarily or permanently. For each Project, CRO or Sponsor shall prepare Study Protocol according to the latest version of the template of CRO or Sponsor on the date of signing the SOW. If CRO is responsible for the application for IRB/IEC approval, including preparation and submission of the requested documents, communication with corresponding authority and obtaining approval as per the applicable policies/regulations. SPONSOR shall assist CRO to obtain this approval. CRO shall conduct preparing prepare the Study in compliance protocol Protocol it and will provide the SponsorSPONSOR with the approved draft Study Protocol by IRB/IEC, for SponsorSPONSOR's review and shall obey to any requirement and perform required adjustment by the IRB/IEC if any non-compliance occurred before/during the conduct of the Study. CRO shall delegate personnel on behalf of SPONSOR if requested and provide the relevant information (e.g. membership lists, meeting minutes, correspondence, etc) asked by SPONSOR or regulatory authorities in case of needapproval. CRO shall prepare the Written Informed Consent forms (if applicable) both in English and local language (if applicable) according to the latest version of the template of CRO and provide the SPONSOR SponsorSPONSOR with such forms for its review and approval. CRO shall conduct the Study, at its research facility, of such products as SPONSOR may specify in writing from time to time, in accordance with the terms of this Agreement, the applicable SOW, any applicable Protocol for the Study, GCP, GLP, the ICH Guidelines and all applicable laws, rules, guidance’s, regulations in Canada and the local country where the Study is conducted. CRO shall not enroll any subject in a Study unless and until it has received and certified the same in writing to SPONSOR documentation evidencing that the IRB/IEC has reviewed and approved the Protocol and the Informed Consent Form. CRO shall ensure that all subjects are in compliance with all of the Protocol requirements. It is CRO’s responsibility to promptly notify SPONSOR and the IRB/IEC of any significant deviation from the Protocol and any unanticipated or severe or serious Adverse Event within the timeframe specified by the Protocol and as per applicable guidelines. For each Project, CRO or SPONSOR shall prepare a set of Case Report Forms (if applicable), based on the Study Protocol. CRO shall complete the Case Report Forms (if applicable) and shall perform in-house monitoring according to current Standard Operating Procedures. CRO shall provide the SPONSOR with draft Case Report Forms (if applicable) for SPONSOR's review and approval prior to the Study or any revision during the Study. CRO shall provide all the completed scan copies of Case Report Forms to SPONSOR after completion of the Study and the final report are completed. CRO shall keep original copy of CRF and shall share electronic copy of CRF with SPONSOR while SPONSPOR also has the rights to keep original copy of CRF if any regulatory authority requires. For each Project, SPONSOR will supply to CRO a mutually agreed amount/quantity of the Study Product as well as the Innovator Product to enable completion of the study as well as for any quantity needed for retention samples. Further, CRO should apply for an import license and communicate with local regulatory authority about the importing application on behalf of SPONSOR, where required. SPONSOR agrees to pay and be responsible for all Customs Duties and charges with relevant invoices. In event the SPONSOR requires or the CRO pays the Customs Duties and charges for the Study Product then SPONSOR agrees to indemnify and reimburse within fifteen (15) days of the customs duty claim along with any other penalties/interest/or any other charges levied presently or in future for any amount claimed by Custom department due to SPONSOR’s reason in reference to this Study.

Study Protocol. CRO shall prepare Study Protocol according to the latest version of the template of CRO or SPONSOR and any additional requirement from SPONSOR for SPONSOR's review and approval on the date of signing the SOW and provide Study Protocol to SPONSOR within thirty (30) days after the effective date of this Agreement. The Protocol will specify the Study design, objectives, inclusion and exclusion criteria, procedures for reporting adverse events, statistical analysis and other relevant issues. All changes, alterations and/or modifications in the Protocol shall be signed by both CRO and SPONSOR and shall be deemed incorporated into the Protocol. In addition, if, pursuant to the applicable policies/regulations of the Institutional Review Board/Independent Ethics Committee (IRB/IEC)Independent Ethics Committee (the “IEC”), any changes, alterations and/or modifications to the Protocol require the approval of the IRB/IEC, then CRO shall promptly obtain such approval. SPONSOR shall have the right at any time and from time to time to initiate changes, alterations and/or modifications to the Protocol as SPONSOR may deem necessary or appropriate, including, without limitation, suspending the Study temporarily or permanently. CRO is responsible for the application for IRB/IEC approval, including preparation and submission of the requested documents, communication with corresponding authority and obtaining approval as the IRB/IEC safeguard the rights, safety, and well-being of all trial subjects as per the applicable policies/regulations. SPONSOR shall assist CRO to obtain this approval. CRO shall conduct the Study in compliance with the approved Protocol by IRB/IEC, and shall obey to adjust as requestedobey to any requirement and perform required adjustment by the IRB/IEC if any non-compliance occurred before/during the conduct of the Study. CRO shall delegate personnel on behalf of SPONSOR if requested and provide the relevant information (e.g. membership lists, meeting minutes, correspondence, etc) asked by SPONSOR or regulatory authorities in case of need. CRO shall prepare the Written Informed Consent forms (if applicable) both in English and local language (if applicable) according to the latest version of the template of CRO and provide the SPONSOR with such forms for its review and approval. CRO shall not enroll any subject in a Study unless and until it has received and certified the same in writing to SPONSOR documentation evidencing that the IRB/IEC has reviewed and approved the Protocol and the Informed Consent Form. CRO shall ensure that all subjects are in compliance with all of the Protocol requirements. It is CRO’s responsibility to promptly notify SPONSOR and the IRB/IEC of any significant deviation from the Protocol and any unanticipated or severe or serious Adverse Event within the timeframe specified by the Protocol and as per applicable guidelines. For each Project, CRO or SPONSOR shall prepare a set of Case Report Forms (if applicable), based on the Study Protocol. CRO shall complete the Case Report Forms (if applicable) and shall perform in-house monitoring according to current Standard Operating Procedures. CRO shall provide the SPONSOR with draft Case Report Forms (if applicable) for SPONSOR's review and approval prior to the Study or any revision during the Study. CRO shall provide all the completed scan copies of Case Report Forms to SPONSOR after completion of the Study and the final report are completed. CRO shall keep original copy of CRF and shall share electronic copy of CRF with SPONSOR while SPONSPOR also has the rights to keep original copy of CRF if any regulatory authority requires. For each Project, SPONSOR will supply to CRO a mutually agreed amount/quantity of the Study Product as well as the Innovator Product to enable completion of the study as well as for any quantity needed for retention samples. Further, CRO should apply for an import license and communicate with local regulatory authority about the importing application on behalf of SPONSOR, where required. SPONSOR agrees to pay and be responsible for all Customs Duties and charges with relevant invoices. In event the SPONSOR requires or the CRO pays the Customs Duties and charges for the Study Product then SPONSOR agrees to indemnify and reimburse within fifteen (15) days of the customs duty claim along with any other penalties/interest/or any other charges levied presently or in future for any amount claimed by Custom department due to SPONSOR’s reason in reference to this Study.