Common use of Development Work Clause in Contracts

Development Work. 4.1 During the OPTION PERIOD, TRIANGLE shall diligently conduct DEVELOPMENT WORK in TERRITORY. Before commencement of DEVELOPMENT WORK, a protocol including timetable of DEVELOPMENT WORK shall be submitted in writing by TRIANGLE to MITSUBISHI and shall be approved by MITSUBISHI which approval shall not be unreasonably withheld. TRIANGLE may appoint as a Contract Research Organization a third party who shall be approved by MITSUBISHI in advance which approval shall not be unreasonably withheld (hereinafter referred to as "AUTHORIZED CRO") to perform DEVELOPMENT WORK. Upon request of MITSUBISHI before its approval, TRIANGLE shall disclose to MITSUBISHI the contents of a contract to be executed with a potential AUTHORIZED CRO and shall properly consider such comments as MITSUBISHI may make. Notwithstanding the foregoing, TRIANGLE shall file by itself IND and CTX and contact the relevant governmental agencies. TRIANGLE shall consult with MITSUBISHI in determining the expected efficacy and safety level in the Phase I and Phase IIa studies as set forth in Appendix A. 4.2 MITSUBISHI agrees to bear the out-of-pocket costs incurred by TRIANGLE in engaging AUTHORIZED CRO to perform DEVELOPMENT WORK in accordance with the approved protocol. MITSUBISHI shall pay to TRIANGLE such costs within thirty (30) days from presentation by TRIANGLE of each invoice for such work provided that MITSUBISHI's payment of such costs shall not exceed One Million Six Hundred Thousand U.S. Dollars ($1,600,000) in total. TRIANGLE agrees to bear any other costs and expenses incurred by it in connection with performance of DEVELOPMENT WORK. 4.3 MITSUBISHI shall supply TRIANGLE, without charge, with amounts of BULK MATERIAL or clinical trial material as reasonably demonstrated by TRIANGLE to be necessary for DEVELOPMENT WORK. BULK MATERIAL or clinical trial material supplied by MITSUBISHI shall meet the specifications to be mutually agreed upon. In the event that a lot of BULK MATERIAL or clinical trial material supplied by MITSUBISHI does not meet such specifications, TRIANGLE shall so notify MITSUBISHI within thirty (30) days from the receipt of such BULK MATERIAL or clinical trial material and return it to MITSUBISHI with documentation of the failure to meet specifications. MITSUBISHI shall replace such defective BULK MATERIAL or clinical trial material and pay for all shipping costs for such defective BULK MATERIAL or clinical trial material. 4.4 TRIANGLE shall give MITSUBISHI written reports on the progress of DEVELOPMENT WORK for each [ * ] and within reasonable period after the end of each [ * ] period, TRIANGLE shall disclose to MITSUBISHI all data and information obtained through DEVELOPMENT WORK during the preceding [ * ] period. In reviewing the reports by TRIANGLE, MITSUBISHI may comment on the progress of DEVELOPMENT WORK and TRIANGLE shall properly consider such comments. 4.5 TRIANGLE shall hold MITSUBISHI harmless from any claim, loss, damages or liabilities caused by it or incurred in connection with performance of DEVELOPMENT WORK except for any claim, loss, damages or liabilities attributable to a defect in BULK MATERIAL or clinical trial material supplied by MITSUBISHI, attributable to an error in the TECHNICAL INFORMATION supplied by MITSUBISHI or resulting from the negligence or willful misconduct of MITSUBISHI or its agents or employees. MITSUBISHI agrees to give TRIANGLE prompt written notice of any matter for which it intends to seek indemnification, to allow TRIANGLE to control the defense and settlement of such matter and to cooperate with TRIANGLE in the investigation and defense of such matter. 4.6 TRIANGLE agrees that MITSUBISHI shall have the right, without any compensation to TRIANGLE, to use all data and information obtained by TRIANGLE through the evaluation and DEVELOPMENT WORK hereunder, whether patentable or not, for purpose of development, registration and commercialization of PRODUCT outside TERRITORY together with the right of sublicense to a third party. It is, however, understood that upon termination of this Agreement without the execution of LICENSE AGREEMENT, TRIANGLE agrees to assign all the title and ownership to such data and information to MITSUBISHI, without charge.

Development Work. 4.1 During VIVUS shall, at its own cost and expense, conduct the OPTION PERIOD, TRIANGLE shall diligently conduct DEVELOPMENT WORK to seek REGULATORY APPROVAL of the PRODUCTS in the TERRITORY. Before commencement of DEVELOPMENT WORKVIVUS shall not, a protocol including timetable of however, be responsible for DEVELOPMENT WORK as it relates to seeking REGULATORY APPROVAL of the PRODUCTS outside the TERRITORY or the manufacturing scale-up and 12 -11- production of validation batches of the BULK DRUG TABLETS (or the BULK DRUG SUBSTANCE where applicable). Rather, such shall be submitted in writing by TRIANGLE to MITSUBISHI TANABE's responsibility at its own costs and expense. Such work as the manufacturing scale-up, production of validation batches and the manufacture of the BULK DRUG TABLETS and BULK DRUG SUBSTANCE shall be approved carried out by MITSUBISHI which TANABE using reasonable commercial efforts and in a timely manner in accordance with the DEVELOPMENT PLAN so as not to delay VIVUS' initiation of CLINICAL STUDIES, filing of DRUG APPROVAL APPLICATIONS or launch of the PRODUCTS. It is understood and agreed by the Parties that VIVUS may conduct its activities under this Article 5 by itself or through its designees, subject to TANABE's prior approval, such approval shall not to be unreasonably withheld. TRIANGLE may appoint as a Contract Research Organization a third party who TANABE agrees to act promptly in evaluating potential designees and in no case shall be approved take more than ten (10) business days to render its decision. 5.2 CLINICAL STUDIES Protocols. VIVUS shall inform TANABE, in writing, of the draft protocol for such CLINICAL STUDIES for TANABE's review and consideration, before commencement of any CLINICAL STUDIES for the COMPOUND or the PRODUCTS conducted by MITSUBISHI in advance which approval shall not be unreasonably withheld (hereinafter referred to as "AUTHORIZED CRO") to perform DEVELOPMENT WORK. Upon request of MITSUBISHI before its approval, TRIANGLE shall disclose to MITSUBISHI the contents of a contract to be executed with a potential AUTHORIZED CRO and shall properly consider such comments as MITSUBISHI may make. Notwithstanding the foregoing, TRIANGLE shall file by itself IND and CTX and contact the relevant governmental agencies. TRIANGLE shall consult with MITSUBISHI in determining the expected efficacy and safety level it in the Phase I TERRITORY. Once so informed, TANABE will have ten (10) business days to review and Phase IIa studies as set forth in Appendix A. 4.2 MITSUBISHI agrees provide comments on the draft protocol. In addition, should TANABE request any change or addition to bear such draft protocol for the out-of-pocket costs incurred by TRIANGLE in engaging AUTHORIZED CRO to perform purpose of using the data generated under the DEVELOPMENT WORK in accordance with the approved protocol. MITSUBISHI TERRITORY for TANABE's development outside the TERRITORY, then TANABE shall pay to TRIANGLE such costs within thirty (30) days from presentation by TRIANGLE of each invoice for such work provided that MITSUBISHI's payment of such costs shall not exceed One Million Six Hundred Thousand U.S. Dollars ($1,600,000) in total. TRIANGLE agrees to bear any other costs and expenses incurred by it in connection with performance of DEVELOPMENT WORK. 4.3 MITSUBISHI shall supply TRIANGLE, without charge, with amounts of BULK MATERIAL or clinical trial material as reasonably demonstrated by TRIANGLE to be necessary for DEVELOPMENT WORK. BULK MATERIAL or clinical trial material supplied by MITSUBISHI shall meet the specifications to be mutually agreed upon. In the event that a lot of BULK MATERIAL or clinical trial material supplied by MITSUBISHI does not meet such specifications, TRIANGLE shall so promptly notify MITSUBISHI within thirty (30) days from the receipt of such BULK MATERIAL or clinical trial material and return it to MITSUBISHI with documentation of the failure to meet specifications. MITSUBISHI shall replace such defective BULK MATERIAL or clinical trial material and pay for all shipping costs for such defective BULK MATERIAL or clinical trial material. 4.4 TRIANGLE shall give MITSUBISHI written reports on the progress of DEVELOPMENT WORK for each [ * ] and within reasonable period after the end of each [ * ] period, TRIANGLE shall disclose to MITSUBISHI all data and information obtained through DEVELOPMENT WORK during the preceding [ * ] period. In reviewing the reports by TRIANGLE, MITSUBISHI may comment on the progress of DEVELOPMENT WORK and TRIANGLE shall properly consider such comments. 4.5 TRIANGLE shall hold MITSUBISHI harmless from any claim, loss, damages or liabilities caused by it or incurred in connection with performance of DEVELOPMENT WORK except for any claim, loss, damages or liabilities attributable to a defect in BULK MATERIAL or clinical trial material supplied by MITSUBISHI, attributable to an error in the TECHNICAL INFORMATION supplied by MITSUBISHI or resulting from the negligence or willful misconduct of MITSUBISHI or its agents or employees. MITSUBISHI agrees to give TRIANGLE prompt written notice of any matter for which it intends to seek indemnification, to allow TRIANGLE to control the defense and settlement of such matter and to cooperate with TRIANGLE in the investigation and defense of such matter. 4.6 TRIANGLE agrees that MITSUBISHI shall have the right, without any compensation to TRIANGLE, to use all data and information obtained by TRIANGLE through the evaluation and DEVELOPMENT WORK hereunder, whether patentable or not, for purpose of development, registration and commercialization of PRODUCT outside TERRITORY together with the right of sublicense to a third party. It is, however, understood that upon termination of this Agreement without the execution of LICENSE AGREEMENT, TRIANGLE agrees to assign all the title and ownership VIVUS to such data effect, and information VIVUS shall accommodate such request to MITSUBISHIthe extent such request is reasonably acceptable by VIVUS. If such request causes additional costs to VIVUS, without charge.TANABE shall reimburse such additional costs to VIVUS in full. 5.3

Development Work. 4.1 During 5.1 TAKEDA and PENINSULA shall establish a joint committee (hereinafter called "JC") which will discuss and decide upon the OPTION PERIODdevelopment plan and strategy for the Product in the Territory, TRIANGLE shall diligently conduct DEVELOPMENT WORK and will coordinate the development activities undertaken by PENINSULA for the Product with the development activities undertaken by TAKEDA to generate data necessary to obtain Registration of the Product in TERRITORYthe TAKEDA Territory. Before commencement of DEVELOPMENT WORK, a protocol including timetable of DEVELOPMENT WORK The JC shall be submitted comprised of an equal number of members from TAKEDA and PENINSULA, which number of members shall initially be a total of four (4), and will meet semi-annually at alternating home office locations, or such other locations as the parties agree, or by teleconference. Each party shall bear its own costs associated with attendance at JC meetings. The JC shall keep minutes of all JC meetings in writing order to confirm the matters discussed and the decisions reached at such meetings. If the JC is unable to agree on a development plan or strategy for the Product, the senior management of TAKEDA and PENINSULA shall discuss the issue in attempt to resolve the dispute. However, if the parties are unable to resolve such dispute, PENINSULA shall have the right to make all final decisions regarding the development plan and strategy for the Product in the Territory; provided that for clarity TAKEDA shall have the right to make final decisions regarding the manufacture of the Compound and any other development work conducted by TRIANGLE TAKEDA, if any, except as otherwise expressly provided in this Agreement with respect to MITSUBISHI Compound supplied to PENINSULA. The JC may discuss and decide upon other issues with regard to the Compound and/or the Product that the parties mutually agree to have decided by the JC. 5.2 TAKEDA acknowledges and agrees that it shall use diligent efforts to conduct and complete, at its expense and pursuant to protocols determined by the JC, the preclinical studies of the Compound as described in the attached Schedule V (the "Studies"), within the time frame for such studies set forth in Schedule V, which Studies are reasonably anticipated to be required by Regulatory Authorities in both the Territory and Japan in order for the Compound to be approved for use in human clinical trials. For clarity, TAKEDA shall have no obligation under this Agreement to conduct any preclinical studies of the Compound other than the Studies and TAKEDA's obligation is to conduct the Studies pursuant to the protocol to be separately determined by JC. It is understood that TAKEDA makes no warranties with respect to the Studies, including without limitation a warranty that PENINSULA will be able to successfully develop the Compound using the results of the Studies. However, if reasonably requested by PENINSULA, TAKEDA shall use diligent efforts to conduct any additional preclinical studies on the Compound that are required by any Regulatory Authority in the Territory at PENINSULA's expense. TAKEDA shall disclose to PENINSULA in English all Information resulting from the Studies and any other preclinical studies conducted by TAKEDA under this Section 5.2 promptly after the completion of such studies. Except as otherwise provided above, PENINSULA shall be responsible for conducting, at PENINSULA's expense, any additional preclinical and clinical studies, as Development Work, that are required by Regulatory Authorities in the Territory, that are not Studies. 5.3 Upon PENINSULA's reasonable request and to the extent that TAKEDA has available inventory of Compound on the Effective Date, TAKEDA shall promptly supply to PENINSULA that quantity of Compound necessary to conduct the following preclinical studies of the Compound: (a) [ * ] study of the Compound [ * ], (b) [ * ] study of the Compound [ * ], and (c) [ * ] study of the Compound [ * ]. All Compound supplied to PENINSULA by TAKEDA under this Section 5.3 shall be supplied [ * ] to PENINSULA. Promptly after the Effective Date, the Parties shall determine the specific quantity of Compound to be supplied by TAKEDA, the delivery date for such Compound, and other details for such supply. 5.4 PENINSULA shall undertake the Development Work as soon as possible necessary to obtain the Registration for the Major Market Countries promptly. In addition, PENINSULA shall use commercially reasonable efforts to undertake Development Work necessary to obtain Registration in such other countries in the Territory where PENINSULA elects to do so based on its sound business judgment in light of the economic opportunities for sales of the Product in such other countries. PENINSULA will report to TAKEDA on its development progress, including without limitation its decision to seek Registration in certain country(ies), from time to time, but no less frequently than semi-annually in order for TAKEDA to confirm the status of development of the Product. 5.5 The Development Work shall be conducted by PENINSULA at its sole cost, risk and responsibility. Upon the request of TAKEDA and at TAKEDA's expense, PENINSULA shall allow TAKEDA representative(s), approved in advance by MITSUBISHI which PENINSULA, such approval shall not to be unreasonably withheld, to attend PENINSULA's meetings concerning development [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. TRIANGLE may appoint as a Contract Research Organization a third party who and/or marketing of the Product (including internal meetings and meetings with investigators). All TAKEDA representatives that attend such meetings shall be approved bound by MITSUBISHI obligations of confidentiality consistent with the obligations contained in advance which approval Article 14. 5.6 PENINSULA shall not use commercially reasonable efforts to conduct all Development Work and compile the Results in accordance with ICH guidelines so that the Results may be unreasonably withheld (hereinafter referred to as "AUTHORIZED CRO") to perform DEVELOPMENT WORK. Upon request of MITSUBISHI before its approval, TRIANGLE shall disclose to MITSUBISHI the contents of a contract to be executed with a potential AUTHORIZED CRO and shall properly consider such comments as MITSUBISHI may make. Notwithstanding the foregoing, TRIANGLE shall file accepted by itself IND and CTX and contact the relevant governmental agencies. TRIANGLE shall consult with MITSUBISHI in determining the expected efficacy and safety level Regulatory Authorities in the Phase I TAKEDA Territory. PENINSULA shall, free of charge and Phase IIa studies without delay, provide TAKEDA with all the Results in English. TAKEDA shall have the right to use, and cause any third parties who have a license under the Patents and Manufacturing Know-How to develop, manufacture, or commercialize the Compound and/or the Product in the TAKEDA Territory to use, the Results to develop, manufacture, offer for sale or sell the Product in the TAKEDA Territory, including without limitation to pursue Registration in the TAKEDA Territory, free of charge, subject to the rights granted to PENINSULA hereunder. In addition, for the limited purpose of evaluating and determining its interest for the Option Countries as set forth in Appendix A. 4.2 MITSUBISHI agrees to bear the out-of-pocket costs incurred by TRIANGLE in engaging AUTHORIZED CRO to perform DEVELOPMENT WORK in accordance with the approved protocol. MITSUBISHI shall pay to TRIANGLE such costs within thirty (30) days from presentation by TRIANGLE of each invoice for such work provided that MITSUBISHI's payment of such costs shall not exceed One Million Six Hundred Thousand U.S. Dollars ($1,600,000) in total. TRIANGLE agrees to bear any other costs and expenses incurred by it in connection with performance of DEVELOPMENT WORK. 4.3 MITSUBISHI shall supply TRIANGLESection 2.3, without charge, with amounts of BULK MATERIAL or clinical trial material as reasonably demonstrated by TRIANGLE to be necessary for DEVELOPMENT WORK. BULK MATERIAL or clinical trial material supplied by MITSUBISHI shall meet the specifications to be mutually agreed upon. In the event that a lot of BULK MATERIAL or clinical trial material supplied by MITSUBISHI does not meet such specifications, TRIANGLE shall so notify MITSUBISHI within thirty (30) days from the receipt of such BULK MATERIAL or clinical trial material and return it to MITSUBISHI with documentation of the failure to meet specifications. MITSUBISHI shall replace such defective BULK MATERIAL or clinical trial material and pay for all shipping costs for such defective BULK MATERIAL or clinical trial material. 4.4 TRIANGLE shall give MITSUBISHI written reports on the progress of DEVELOPMENT WORK for each [ * ] and within reasonable period after the end of each [ * ] period, TRIANGLE shall disclose to MITSUBISHI all data and information obtained through DEVELOPMENT WORK during the preceding [ * ] period. In reviewing the reports by TRIANGLE, MITSUBISHI may comment on the progress of DEVELOPMENT WORK and TRIANGLE shall properly consider such comments. 4.5 TRIANGLE shall hold MITSUBISHI harmless from any claim, loss, damages or liabilities caused by it or incurred in connection with performance of DEVELOPMENT WORK except for any claim, loss, damages or liabilities attributable to a defect in BULK MATERIAL or clinical trial material supplied by MITSUBISHI, attributable to an error in the TECHNICAL INFORMATION supplied by MITSUBISHI or resulting from the negligence or willful misconduct of MITSUBISHI or its agents or employees. MITSUBISHI agrees to give TRIANGLE prompt written notice of any matter for which it intends to seek indemnification, to allow TRIANGLE to control the defense and settlement of such matter and to cooperate with TRIANGLE in the investigation and defense of such matter. 4.6 TRIANGLE agrees that MITSUBISHI TAKEDA shall have the rightright to use and cause any third party who is the candidate company to develop, without any compensation to TRIANGLEoffer for sale and/or sell the Product in the Option Countries, to use all data the Results and any other information obtained by TRIANGLE through the evaluation and DEVELOPMENT WORK hereunder, whether patentable which would be necessary or not, useful for purpose of development, registration and commercialization of PRODUCT outside TERRITORY together with the right of sublicense to a third party. It is, however, understood that upon termination of this Agreement without the execution of LICENSE AGREEMENT, TRIANGLE agrees to assign all the title and ownership to such data and information to MITSUBISHI, without chargepurpose.

Development Work. 4.1 During 5.1 TAKEDA and PENINSULA shall establish a joint committee (hereinafter called "JC") which will discuss and decide upon the OPTION PERIODdevelopment plan and strategy for the Product in the Territory, TRIANGLE shall diligently conduct DEVELOPMENT WORK and will coordinate the development activities undertaken by PENINSULA for the Product with the development activities undertaken by TAKEDA to generate data necessary to obtain Registration of the Product in TERRITORYthe TAKEDA Territory. Before commencement of DEVELOPMENT WORK, a protocol including timetable of DEVELOPMENT WORK The JC shall be submitted comprised of an equal number of members from TAKEDA and PENINSULA, which number of members shall initially be a total of four (4), and will meet semi-annually at alternating home office locations, or such other locations as the parties agree, or by teleconference. Each party shall bear its own costs associated with attendance at JC meetings. The JC shall keep minutes of all JC meetings in writing order to confirm the matters discussed and the decisions reached at such meetings. If the JC is unable to agree on a development plan or strategy for the Product, the senior management of TAKEDA and PENINSULA shall discuss the issue in attempt to resolve the dispute. However, if the parties are unable to resolve such dispute, PENINSULA shall have the right to make all final decisions regarding the development plan and strategy for the Product in the Territory; provided that for clarity TAKEDA shall have the right to make final decisions regarding the manufacture of the Compound and any other development work conducted by TRIANGLE TAKEDA, if any, except as otherwise expressly provided in this Agreement with respect to MITSUBISHI Compound supplied to PENINSULA. The JC may discuss and decide upon other issues with regard to the Compound and/or the Product that the parties mutually agree to have decided by the JC. 5.2 TAKEDA acknowledges and agrees that it shall use diligent efforts to conduct and complete, at its expense and pursuant to protocols determined by the JC, the preclinical studies of the Compound as described in the attached Schedule V (the "Studies"), within the time frame for such studies set forth in Schedule V, which Studies are reasonably anticipated to be required by Regulatory Authorities in both the Territory and Japan in order for the [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Compound to be approved for use in human clinical trials. For clarity, TAKEDA shall have no obligation under this Agreement to conduct any preclinical studies of the Compound other than the Studies and TAKEDA's obligation is to conduct the Studies pursuant to the protocol to be separately determined by JC. It is understood that TAKEDA makes no warranties with respect to the Studies, including without limitation a warranty that PENINSULA will be able to successfully develop the Compound using the results of the Studies. However, if reasonably requested by PENINSULA, TAKEDA shall use diligent efforts to conduct any additional preclinical studies on the Compound that are required by any Regulatory Authority in the Territory at PENINSULA's expense. TAKEDA shall disclose to PENINSULA in English all Information resulting from the Studies and any other preclinical studies conducted by TAKEDA under this Section 5.2 promptly after the completion of such studies. Except as otherwise provided above, PENINSULA shall be responsible for conducting, at PENINSULA's expense, any additional preclinical and clinical studies, as Development Work, that are required by Regulatory Authorities in the Territory, that are not Studies. 5.3 Upon PENINSULA's reasonable request and to the extent that TAKEDA has available inventory of Compound on the Effective Date, TAKEDA shall promptly supply to PENINSULA that quantity of Compound necessary to conduct the following preclinical studies of the Compound: (a) [*] study of the Compound [*], (b) [*] study of the Compound [*], and (c) [*] study of the Compound [*]. All Compound supplied to PENINSULA by TAKEDA under this Section 5.3 shall be supplied [*] to PENINSULA. Promptly after the Effective Date, the Parties shall determine the specific quantity of Compound to be supplied by TAKEDA, the delivery date for such Compound, and other details for such supply. 5.4 PENINSULA shall undertake the Development Work as soon as possible necessary to obtain the Registration for the Major Market Countries promptly. In addition, PENINSULA shall use commercially reasonable efforts to undertake Development Work necessary to obtain Registration in such other countries in the Territory where PENINSULA elects to do so based on its sound business judgment in light of the economic opportunities for sales of the Product in such other countries. PENINSULA will report to TAKEDA on its development progress, including without limitation its decision to seek Registration in certain country(ies), from time to time, but no less frequently than semi-annually in order for TAKEDA to confirm the status of development of the Product. 5.5 The Development Work shall be conducted by PENINSULA at its sole cost, risk and responsibility. Upon the request of TAKEDA and at TAKEDA's expense, PENINSULA shall allow TAKEDA representative(s), approved in advance by MITSUBISHI which PENINSULA, such approval shall not to be unreasonably withheld, to attend PENINSULA's meetings concerning development and/or marketing of the Product (including internal meetings and meetings with investigators). TRIANGLE may appoint as a Contract Research Organization a third party who All TAKEDA representatives that attend such meetings shall be approved bound by MITSUBISHI obligations of confidentiality consistent with the obligations contained in advance which approval Article 14. 5.6 PENINSULA shall not use commercially reasonable efforts to conduct all Development Work and compile the Results in accordance with ICH guidelines so that the Results may be unreasonably withheld (hereinafter referred to as "AUTHORIZED CRO") to perform DEVELOPMENT WORK. Upon request of MITSUBISHI before its approval, TRIANGLE shall disclose to MITSUBISHI the contents of a contract to be executed with a potential AUTHORIZED CRO and shall properly consider such comments as MITSUBISHI may make. Notwithstanding the foregoing, TRIANGLE shall file accepted by itself IND and CTX and contact the relevant governmental agencies. TRIANGLE shall consult with MITSUBISHI in determining the expected efficacy and safety level Regulatory Authorities in the Phase I TAKEDA Territory. PENINSULA shall, free of charge and Phase IIa studies without delay, provide TAKEDA with all the Results in English. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. TAKEDA shall have the right to use, and cause any third parties who have a license under the Patents and Manufacturing Know-How to develop, manufacture, or commercialize the Compound and/or the Product in the TAKEDA Territory to use, the Results to develop, manufacture, offer for sale or sell the Product in the TAKEDA Territory, including without limitation to pursue Registration in the TAKEDA Territory, free of charge, subject to the rights granted to PENINSULA hereunder. In addition, for the limited purpose of evaluating and determining its interest for the Option Countries as set forth in Appendix A. 4.2 MITSUBISHI agrees to bear the out-of-pocket costs incurred by TRIANGLE in engaging AUTHORIZED CRO to perform DEVELOPMENT WORK in accordance with the approved protocol. MITSUBISHI shall pay to TRIANGLE such costs within thirty (30) days from presentation by TRIANGLE of each invoice for such work provided that MITSUBISHI's payment of such costs shall not exceed One Million Six Hundred Thousand U.S. Dollars ($1,600,000) in total. TRIANGLE agrees to bear any other costs and expenses incurred by it in connection with performance of DEVELOPMENT WORK. 4.3 MITSUBISHI shall supply TRIANGLESection 2.3, without charge, with amounts of BULK MATERIAL or clinical trial material as reasonably demonstrated by TRIANGLE to be necessary for DEVELOPMENT WORK. BULK MATERIAL or clinical trial material supplied by MITSUBISHI shall meet the specifications to be mutually agreed upon. In the event that a lot of BULK MATERIAL or clinical trial material supplied by MITSUBISHI does not meet such specifications, TRIANGLE shall so notify MITSUBISHI within thirty (30) days from the receipt of such BULK MATERIAL or clinical trial material and return it to MITSUBISHI with documentation of the failure to meet specifications. MITSUBISHI shall replace such defective BULK MATERIAL or clinical trial material and pay for all shipping costs for such defective BULK MATERIAL or clinical trial material. 4.4 TRIANGLE shall give MITSUBISHI written reports on the progress of DEVELOPMENT WORK for each [ * ] and within reasonable period after the end of each [ * ] period, TRIANGLE shall disclose to MITSUBISHI all data and information obtained through DEVELOPMENT WORK during the preceding [ * ] period. In reviewing the reports by TRIANGLE, MITSUBISHI may comment on the progress of DEVELOPMENT WORK and TRIANGLE shall properly consider such comments. 4.5 TRIANGLE shall hold MITSUBISHI harmless from any claim, loss, damages or liabilities caused by it or incurred in connection with performance of DEVELOPMENT WORK except for any claim, loss, damages or liabilities attributable to a defect in BULK MATERIAL or clinical trial material supplied by MITSUBISHI, attributable to an error in the TECHNICAL INFORMATION supplied by MITSUBISHI or resulting from the negligence or willful misconduct of MITSUBISHI or its agents or employees. MITSUBISHI agrees to give TRIANGLE prompt written notice of any matter for which it intends to seek indemnification, to allow TRIANGLE to control the defense and settlement of such matter and to cooperate with TRIANGLE in the investigation and defense of such matter. 4.6 TRIANGLE agrees that MITSUBISHI TAKEDA shall have the rightright to use and cause any third party who is the candidate company to develop, without any compensation to TRIANGLEoffer for sale and/or sell the Product in the Option Countries, to use all data the Results and any other information obtained by TRIANGLE through the evaluation and DEVELOPMENT WORK hereunder, whether patentable which would be necessary or not, useful for purpose of development, registration and commercialization of PRODUCT outside TERRITORY together with the right of sublicense to a third party. It is, however, understood that upon termination of this Agreement without the execution of LICENSE AGREEMENT, TRIANGLE agrees to assign all the title and ownership to such data and information to MITSUBISHI, without chargepurpose.

Development Work. 4.1 During 5.1 TAKEDA and PENINSULA shall establish a joint committee (hereinafter called “JC”) which will discuss and decide upon the OPTION PERIODdevelopment plan and strategy for the Product in the Territory, TRIANGLE shall diligently conduct DEVELOPMENT WORK and will coordinate the development activities undertaken by PENINSULA for the Product with the development activities undertaken by TAKEDA to generate data necessary to obtain Registration of the Product in TERRITORYthe TAKEDA Territory. Before commencement of DEVELOPMENT WORK, a protocol including timetable of DEVELOPMENT WORK The JC shall be submitted comprised of an equal number of members from TAKEDA and PENINSULA, which number of members shall initially be a total of four (4), and will meet semi-annually at alternating home office locations, or such other locations as the parties agree, or by teleconference. Each party shall bear its own costs associated with attendance at JC meetings. The JC shall keep minutes of all JC meetings in writing order to confirm the matters discussed and the decisions reached at such meetings. If the JC is unable to agree on a development plan or strategy for the Product, the senior management of TAKEDA and PENINSULA shall discuss the issue in attempt to resolve the dispute. However, if the parties are unable to resolve such dispute, PENINSULA shall have the right to make all final decisions regarding the development plan and strategy for the Product in the Territory; provided that for clarity TAKEDA shall have the right to make final decisions regarding the manufacture of the Compound and any other development work conducted by TRIANGLE TAKEDA, if any, except as otherwise expressly provided in this Agreement with respect to MITSUBISHI Compound supplied to PENINSULA. The JC may discuss and decide upon other issues with regard to the Compound and/or the Product that the parties mutually agree to have decided by the JC. 5.2 TAKEDA acknowledges and agrees that it shall use diligent efforts to conduct and complete, at its expense and pursuant to protocols determined by the JC, the preclinical studies of the Compound as described in the attached Schedule V (the “Studies”), within the time frame for such studies set forth in Schedule V, which Studies are reasonably anticipated to be required by Regulatory Authorities in both the Territory and Japan in order for the Compound to be approved for use in human clinical trials. For clarity, TAKEDA shall have no obligation under this Agreement to conduct any preclinical studies of the Compound other than the Studies and TAKEDA’s obligation is to conduct the Studies pursuant to the protocol to be separately determined by JC. It is understood that TAKEDA makes no warranties with respect to the Studies, including without limitation a warranty that PENINSULA will be able to successfully develop the Compound using the results of the Studies. However, if reasonably requested by PENINSULA, TAKEDA shall use diligent efforts to conduct any additional preclinical studies on the Compound that are required by any Regulatory Authority in the Territory at PENINSULA’s expense. TAKEDA shall disclose to PENINSULA in English all Information resulting from the Studies and any other preclinical studies conducted by TAKEDA under this Section 5.2 promptly after the completion of such studies. Except as otherwise provided above, PENINSULA shall be responsible for conducting, at PENINSULA’s expense, any additional preclinical and clinical studies, as Development Work, that are required by Regulatory Authorities in the Territory, that are not Studies. 5.3 Upon PENINSULA’s reasonable request and to the extent that TAKEDA has available inventory of Compound on the Effective Date, TAKEDA shall promptly supply to PENINSULA that quantity of Compound necessary to conduct the following preclinical studies of the Compound: (a) four (4) week intravenous toxicity study of the Compound in rats with a four (4) week recovery period, (b) three (3) month intravenous toxicity study of the Compound in rats with a four (4) week recovery period, and (c) three (3) month intravenous toxicity study of the Compound in cynomolgus monkeys with a four (4) week recovery period. All Compound supplied to PENINSULA by TAKEDA under this Section 5.3 shall be supplied at no cost to PENINSULA. Promptly after the Effective Date, the Parties shall determine the specific quantity of Compound to be supplied by TAKEDA, the delivery date for such Compound, and other details for such supply. 5.4 PENINSULA shall undertake the Development Work as soon as possible necessary to obtain the Registration for the Major Market Countries promptly. In addition, PENINSULA shall use commercially reasonable efforts to undertake Development Work necessary to obtain Registration in such other countries in the Territory where PENINSULA elects to do so based on its sound business judgment in light of the economic opportunities for sales of the Product in such other countries. PENINSULA will report to TAKEDA on its development progress, including without limitation its decision to seek Registration in certain country(ies), from time to time, but no less frequently than semi-annually in order for TAKEDA to confirm the status of development of the Product. 5.5 The Development Work shall be conducted by PENINSULA at its sole cost, risk and responsibility. Upon the request of TAKEDA and at TAKEDA’s expense, PENINSULA shall allow TAKEDA representative(s), approved in advance by MITSUBISHI which PENINSULA, such approval shall not to be unreasonably withheld, to attend PENINSULA’s meetings concerning development and/or marketing of the Product (including internal meetings and meeting with investigators). TRIANGLE may appoint as a Contract Research Organization a third party who All TAKEDA representatives that attend such meetings shall be approved bound by MITSUBISHI obligations of confidentiality consistent with the obligations contained in advance which approval Article 14. 5.6 PENINSULA shall not use commercially reasonable efforts to conduct all Development Work and compile the Results in accordance with ICH guidelines so that the Results may be unreasonably withheld (hereinafter referred to as "AUTHORIZED CRO") to perform DEVELOPMENT WORK. Upon request of MITSUBISHI before its approval, TRIANGLE shall disclose to MITSUBISHI the contents of a contract to be executed with a potential AUTHORIZED CRO and shall properly consider such comments as MITSUBISHI may make. Notwithstanding the foregoing, TRIANGLE shall file accepted by itself IND and CTX and contact the relevant governmental agencies. TRIANGLE shall consult with MITSUBISHI in determining the expected efficacy and safety level Regulatory Authorities in the Phase I TAKEDA Territory. PENINSULA shall, free of charge and Phase IIa studies without delay, provide TAKEDA with all the Results in English. TAKEDA shall have the right to use, and cause any third parties who have a license under the Patents and Manufacturing Know-How to develop, manufacture, or commercialize the Compound and/or the Product in the TAKEDA Territory to use, the Results to develop, manufacture, offer for sale or sell the Product in the TAKEDA Territory, including without limitation to pursue Registration in the TAKEDA Territory, free of charge, subject to the rights granted to PENINSULA hereunder. In addition, for the limited purpose of evaluating and determining its interest for the Option Countries as set forth in Appendix A. 4.2 MITSUBISHI agrees to bear the out-of-pocket costs incurred by TRIANGLE in engaging AUTHORIZED CRO to perform DEVELOPMENT WORK in accordance with the approved protocol. MITSUBISHI shall pay to TRIANGLE such costs within thirty (30) days from presentation by TRIANGLE of each invoice for such work provided that MITSUBISHI's payment of such costs shall not exceed One Million Six Hundred Thousand U.S. Dollars ($1,600,000) in total. TRIANGLE agrees to bear any other costs and expenses incurred by it in connection with performance of DEVELOPMENT WORK. 4.3 MITSUBISHI shall supply TRIANGLESection 2.3, without charge, with amounts of BULK MATERIAL or clinical trial material as reasonably demonstrated by TRIANGLE to be necessary for DEVELOPMENT WORK. BULK MATERIAL or clinical trial material supplied by MITSUBISHI shall meet the specifications to be mutually agreed upon. In the event that a lot of BULK MATERIAL or clinical trial material supplied by MITSUBISHI does not meet such specifications, TRIANGLE shall so notify MITSUBISHI within thirty (30) days from the receipt of such BULK MATERIAL or clinical trial material and return it to MITSUBISHI with documentation of the failure to meet specifications. MITSUBISHI shall replace such defective BULK MATERIAL or clinical trial material and pay for all shipping costs for such defective BULK MATERIAL or clinical trial material. 4.4 TRIANGLE shall give MITSUBISHI written reports on the progress of DEVELOPMENT WORK for each [ * ] and within reasonable period after the end of each [ * ] period, TRIANGLE shall disclose to MITSUBISHI all data and information obtained through DEVELOPMENT WORK during the preceding [ * ] period. In reviewing the reports by TRIANGLE, MITSUBISHI may comment on the progress of DEVELOPMENT WORK and TRIANGLE shall properly consider such comments. 4.5 TRIANGLE shall hold MITSUBISHI harmless from any claim, loss, damages or liabilities caused by it or incurred in connection with performance of DEVELOPMENT WORK except for any claim, loss, damages or liabilities attributable to a defect in BULK MATERIAL or clinical trial material supplied by MITSUBISHI, attributable to an error in the TECHNICAL INFORMATION supplied by MITSUBISHI or resulting from the negligence or willful misconduct of MITSUBISHI or its agents or employees. MITSUBISHI agrees to give TRIANGLE prompt written notice of any matter for which it intends to seek indemnification, to allow TRIANGLE to control the defense and settlement of such matter and to cooperate with TRIANGLE in the investigation and defense of such matter. 4.6 TRIANGLE agrees that MITSUBISHI TAKEDA shall have the rightright to use and cause any third party who is the candidate company to develop, without any compensation to TRIANGLEoffer for sale and/or sell the Product in the Option Countries, to use all data the Results and any other information obtained by TRIANGLE through the evaluation and DEVELOPMENT WORK hereunder, whether patentable which would be necessary or not, useful for purpose of development, registration and commercialization of PRODUCT outside TERRITORY together with the right of sublicense to a third party. It is, however, understood that upon termination of this Agreement without the execution of LICENSE AGREEMENT, TRIANGLE agrees to assign all the title and ownership to such data and information to MITSUBISHI, without chargepurpose.