Common use of Development Work Clause in Contracts

Development Work. 3.1 Licensee shall use its commercially reasonable efforts to develop and register the Products for the Selected Indications in the Territory at its sole expense ("Development Work"). 3.2 If, within one (1) year after the United Stated Food and Drug Administration ("FDA") accepts of Licensee's filing of its Registration for a Product, Licensor has not commenced the registration process, or initiated clinical development activities, for such Product within the European Union, Licensee will attempt in good faith to secure a licensee therefor. If Licensor does not enter into a license agreement for the commercialization of such Product within one (1) year after the first commercial sale of such Product in the United States, Licensor shall notify Licensee and the Parties shall undertake good faith negotiations to expand Licensee's Territory upon mutually agreeable terms. For the avoidance of doubt, the Parties agree that there is no obligation on either Party to conclude an agreement for the expansion of the Territory. (a) Licensor shall have the exclusive right to use all information and data developed by or on behalf of Licensee or any of its sublicensees (including but not limited to Licensee's Marketing Partner, as defined below) under this Agreement for applying for Registrations of the Products outside of the Territory. Upon Licensor's request, Licensee will provide reasonable scientific consulting support free of charge, subject to the provisions of Article 5 below relating to "Royalties", to Licensor for the preparation of such Registrations, and Licensee shall deliver to Licensor an electronic copy (in pdf format) of all portions of Licensee's New Drug Application for a Product submitted by Licensee to the FDA in electronic form, and a paper copy of all remaining portions. (b) Licensee shall have the exclusive right for each Product developed by or on behalf of Licensor to use all information and data developed by or on behalf of Licensor for applying for Registrations of the Products in the Territory. 3.4 Each Party shall have and retain sole and exclusive title to all inventions and discoveries which are made, conceived, reduced to practice or generated by its own employees or agents in the course of, or as a result of, activities pursuant to this Agreement. Licensor shall have an exclusive unrestricted right outside the Territory, to make, have made, use, market and sell products containing inventions and discoveries relating to the Compounds and/or the Products developed under this Agreement by Licensee, or developed on behalf of Licensee by (a) its Marketing Partner, or (b) any of Licensee's other sublicensees and to which Licensee has the right to grant an exclusive, unrestricted license to Licensor (provided that Licensee shall use its good faith effort to secure from such sublicensees sufficient rights to such discoveries and inventions to enable Licensor to make, have made, use, market and sell products containing such inventions and discoveries outside the Territory) (collectively, the "Licensee Discoveries and Inventions"), subject to royalty payment as provided in Article 5 below, provided that no other remuneration shall be due to Licensee by Licensor for such use.

Development Work. 3.1 Licensee 5.1 TAKEDA and PENINSULA shall establish a joint committee (hereinafter called "JC") which will discuss and decide upon the development plan and strategy for the Product in the Territory, 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 the TAKEDA Territory. The JC shall be 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 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 TAKEDA, if any, except as otherwise expressly provided in this Agreement with respect to 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 develop and register the Products for the Selected Indications 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 expense cost, risk and responsibility. Upon the request of TAKEDA and at TAKEDA's expense, PENINSULA shall allow TAKEDA representative(s), approved in advance by PENINSULA, such approval not to be unreasonably withheld, to attend PENINSULA's meetings concerning development and/or marketing of the Product ("Development Work"including internal meetings and meetings with investigators). All TAKEDA representatives that attend such meetings shall be bound by obligations of confidentiality consistent with the obligations contained in Article 14. 3.2 If5.6 PENINSULA shall use commercially reasonable efforts to conduct all Development Work and compile the Results in accordance with ICH guidelines so that the Results may be accepted by Regulatory Authorities in the TAKEDA Territory. PENINSULA shall, within one (1) year after free of charge and without delay, provide TAKEDA with all the United Stated Food 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 Drug Administration ("FDA") accepts of Licensee's filing of its Registration for cause any third parties who have a Productlicense under the Patents and Manufacturing Know-How to develop, Licensor has not commenced the registration processmanufacture, or initiated clinical development activities, for such Product within commercialize the European Union, Licensee will attempt in good faith to secure a licensee therefor. If Licensor does not enter into a license agreement for Compound and/or the commercialization of such Product within one (1) year after the first commercial sale of such Product in the United States, Licensor shall notify Licensee and the Parties shall undertake good faith negotiations TAKEDA Territory to expand Licensee's Territory upon mutually agreeable terms. For the avoidance of doubtuse, the Parties agree that there is no obligation on either Party Results to conclude an agreement develop, manufacture, offer for sale or sell the expansion of Product in the TAKEDA Territory. (a) Licensor shall have , including without limitation to pursue Registration in the exclusive right to use all information and data developed by or on behalf of Licensee or any of its sublicensees (including but not limited to Licensee's Marketing PartnerTAKEDA Territory, as defined below) under this Agreement for applying for Registrations of the Products outside of the Territory. Upon Licensor's request, Licensee will provide reasonable scientific consulting support free of charge, subject to the provisions of Article 5 below relating rights granted to "Royalties"PENINSULA hereunder. In addition, to Licensor for the preparation limited purpose of such Registrationsevaluating and determining its interest for the Option Countries as set forth in Section 2.3, and Licensee shall deliver to Licensor an electronic copy (in pdf format) of all portions of Licensee's New Drug Application for a Product submitted by Licensee to the FDA in electronic form, and a paper copy of all remaining portions. (b) Licensee TAKEDA shall have the exclusive right for each Product developed by or on behalf of Licensor to use all information and data developed by or on behalf of Licensor cause any third party who is the candidate company to develop, offer for applying for Registrations of sale and/or sell the Products Product in the Territory. 3.4 Each Party shall have and retain sole and exclusive title to all inventions and discoveries which are made, conceived, reduced to practice or generated by its own employees or agents in the course of, or as a result of, activities pursuant to this Agreement. Licensor shall have an exclusive unrestricted right outside the TerritoryOption Countries, to make, have made, use, market use the Results and sell products containing inventions and discoveries relating to the Compounds and/or the Products developed under this Agreement by Licensee, any other information which would be necessary or developed on behalf of Licensee by (a) its Marketing Partner, or (b) any of Licensee's other sublicensees and to which Licensee has the right to grant an exclusive, unrestricted license to Licensor (provided that Licensee shall use its good faith effort to secure from such sublicensees sufficient rights to such discoveries and inventions to enable Licensor to make, have made, use, market and sell products containing such inventions and discoveries outside the Territory) (collectively, the "Licensee Discoveries and Inventions"), subject to royalty payment as provided in Article 5 below, provided that no other remuneration shall be due to Licensee by Licensor useful for such usepurpose.

Development Work. 3.1 Licensee 4.1 During the OPTION PERIOD, TRIANGLE shall use 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 commercially reasonable efforts approval, TRIANGLE shall disclose to develop MITSUBISHI the contents of a contract to be executed with a potential AUTHORIZED CRO and register shall properly consider such comments as MITSUBISHI may make. Notwithstanding the Products for foregoing, TRIANGLE shall file by itself IND and CTX and contact the Selected Indications relevant governmental agencies. TRIANGLE shall consult with MITSUBISHI in determining the expected efficacy and safety level in the Territory at its sole expense 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 ("Development Work")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. 3.2 If4.3 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 one thirty (130) year 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 United Stated Food end of each [ * ] period, TRIANGLE shall disclose to MITSUBISHI all data and Drug Administration ("FDA") accepts information obtained through DEVELOPMENT WORK during the preceding [ * ] period. In reviewing the reports by TRIANGLE, MITSUBISHI may comment on the progress of Licensee's filing 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 Registration agents or employees. MITSUBISHI agrees to give TRIANGLE prompt written notice of any matter for a Productwhich it intends to seek indemnification, Licensor has not commenced to allow TRIANGLE to control the registration process, or initiated clinical development activities, for such Product within the European Union, Licensee will attempt in good faith to secure a licensee therefor. If Licensor does not enter into a license agreement for the commercialization defense and settlement of such Product within one (1) year after matter and to cooperate with TRIANGLE in the first commercial sale investigation and defense of such Product in the United States, Licensor shall notify Licensee and the Parties shall undertake good faith negotiations to expand Licensee's Territory upon mutually agreeable terms. For the avoidance of doubt, the Parties agree that there is no obligation on either Party to conclude an agreement for the expansion of the Territorymatter. (a) Licensor 4.6 TRIANGLE agrees that MITSUBISHI shall have the exclusive right right, without any compensation to TRIANGLE, to use all data and information obtained by TRIANGLE through the evaluation and data developed by DEVELOPMENT WORK hereunder, whether patentable or on behalf not, for purpose of Licensee or any development, registration and commercialization of its sublicensees (including but not limited PRODUCT outside TERRITORY together with the right of sublicense to Licensee's Marketing Partnera third party. It is, as defined below) under however, understood that upon termination of this Agreement for applying for Registrations without the execution of LICENSE AGREEMENT, TRIANGLE agrees to assign all the Products outside of the Territory. Upon Licensor's request, Licensee will provide reasonable scientific consulting support free of charge, subject to the provisions of Article 5 below relating to "Royalties", to Licensor for the preparation of such Registrations, title and Licensee shall deliver to Licensor an electronic copy (in pdf format) of all portions of Licensee's New Drug Application for a Product submitted by Licensee to the FDA in electronic form, and a paper copy of all remaining portions. (b) Licensee shall have the exclusive right for each Product developed by or on behalf of Licensor to use all information and data developed by or on behalf of Licensor for applying for Registrations of the Products in the Territory. 3.4 Each Party shall have and retain sole and exclusive title to all inventions and discoveries which are made, conceived, reduced to practice or generated by its own employees or agents in the course of, or as a result of, activities pursuant to this Agreement. Licensor shall have an exclusive unrestricted right outside the Territory, to make, have made, use, market and sell products containing inventions and discoveries relating to the Compounds and/or the Products developed under this Agreement by Licensee, or developed on behalf of Licensee by (a) its Marketing Partner, or (b) any of Licensee's other sublicensees and to which Licensee has the right to grant an exclusive, unrestricted license to Licensor (provided that Licensee shall use its good faith effort to secure from such sublicensees sufficient rights ownership to such discoveries data and inventions information to enable Licensor to makeMITSUBISHI, have made, use, market and sell products containing such inventions and discoveries outside the Territory) (collectively, the "Licensee Discoveries and Inventions"), subject to royalty payment as provided in Article 5 below, provided that no other remuneration shall be due to Licensee by Licensor for such usewithout charge.

Development Work. 3.1 Licensee 5.1 TAKEDA and PENINSULA shall establish a joint committee (hereinafter called “JC”) which will discuss and decide upon the development plan and strategy for the Product in the Territory, 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 the TAKEDA Territory. The JC shall be 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 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 TAKEDA, if any, except as otherwise expressly provided in this Agreement with respect to 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 develop and register the Products for the Selected Indications 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 expense cost, risk and responsibility. Upon the request of TAKEDA and at TAKEDA’s expense, PENINSULA shall allow TAKEDA representative(s), approved in advance by PENINSULA, such approval not to be unreasonably withheld, to attend PENINSULA’s meetings concerning development and/or marketing of the Product ("Development Work"including internal meetings and meeting with investigators). All TAKEDA representatives that attend such meetings shall be bound by obligations of confidentiality consistent with the obligations contained in Article 14. 3.2 If5.6 PENINSULA shall use commercially reasonable efforts to conduct all Development Work and compile the Results in accordance with ICH guidelines so that the Results may be accepted by Regulatory Authorities in the TAKEDA Territory. PENINSULA shall, within one (1) year after free of charge and without delay, provide TAKEDA with all the United Stated Food Results in English. TAKEDA shall have the right to use, and Drug Administration ("FDA") accepts of Licensee's filing of its Registration for cause any third parties who have a Productlicense under the Patents and Manufacturing Know-How to develop, Licensor has not commenced the registration processmanufacture, or initiated clinical development activities, for such Product within commercialize the European Union, Licensee will attempt in good faith to secure a licensee therefor. If Licensor does not enter into a license agreement for Compound and/or the commercialization of such Product within one (1) year after the first commercial sale of such Product in the United States, Licensor shall notify Licensee and the Parties shall undertake good faith negotiations TAKEDA Territory to expand Licensee's Territory upon mutually agreeable terms. For the avoidance of doubtuse, the Parties agree that there is no obligation on either Party Results to conclude an agreement develop, manufacture, offer for sale or sell the expansion of Product in the TAKEDA Territory. (a) Licensor shall have , including without limitation to pursue Registration in the exclusive right to use all information and data developed by or on behalf of Licensee or any of its sublicensees (including but not limited to Licensee's Marketing PartnerTAKEDA Territory, as defined below) under this Agreement for applying for Registrations of the Products outside of the Territory. Upon Licensor's request, Licensee will provide reasonable scientific consulting support free of charge, subject to the provisions of Article 5 below relating rights granted to "Royalties"PENINSULA hereunder. In addition, to Licensor for the preparation limited purpose of such Registrationsevaluating and determining its interest for the Option Countries as set forth in Section 2.3, and Licensee shall deliver to Licensor an electronic copy (in pdf format) of all portions of Licensee's New Drug Application for a Product submitted by Licensee to the FDA in electronic form, and a paper copy of all remaining portions. (b) Licensee TAKEDA shall have the exclusive right for each Product developed by or on behalf of Licensor to use all information and data developed by or on behalf of Licensor cause any third party who is the candidate company to develop, offer for applying for Registrations of sale and/or sell the Products Product in the Territory. 3.4 Each Party shall have and retain sole and exclusive title to all inventions and discoveries which are made, conceived, reduced to practice or generated by its own employees or agents in the course of, or as a result of, activities pursuant to this Agreement. Licensor shall have an exclusive unrestricted right outside the TerritoryOption Countries, to make, have made, use, market use the Results and sell products containing inventions and discoveries relating to the Compounds and/or the Products developed under this Agreement by Licensee, any other information which would be necessary or developed on behalf of Licensee by (a) its Marketing Partner, or (b) any of Licensee's other sublicensees and to which Licensee has the right to grant an exclusive, unrestricted license to Licensor (provided that Licensee shall use its good faith effort to secure from such sublicensees sufficient rights to such discoveries and inventions to enable Licensor to make, have made, use, market and sell products containing such inventions and discoveries outside the Territory) (collectively, the "Licensee Discoveries and Inventions"), subject to royalty payment as provided in Article 5 below, provided that no other remuneration shall be due to Licensee by Licensor useful for such usepurpose.

Development Work. 3.1 Licensee 5.1 TAKEDA and PENINSULA shall establish a joint committee (hereinafter called "JC") which will discuss and decide upon the development plan and strategy for the Product in the Territory, 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 the TAKEDA Territory. The JC shall be 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 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 TAKEDA, if any, except as otherwise expressly provided in this Agreement with respect to 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 develop and register the Products for the Selected Indications 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 expense cost, risk and responsibility. Upon the request of TAKEDA and at TAKEDA's expense, PENINSULA shall allow TAKEDA representative(s), approved in advance by PENINSULA, such approval 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. and/or marketing of the Product ("Development Work"including internal meetings and meetings with investigators). All TAKEDA representatives that attend such meetings shall be bound by obligations of confidentiality consistent with the obligations contained in Article 14. 3.2 If5.6 PENINSULA shall use commercially reasonable efforts to conduct all Development Work and compile the Results in accordance with ICH guidelines so that the Results may be accepted by Regulatory Authorities in the TAKEDA Territory. PENINSULA shall, within one (1) year after free of charge and without delay, provide TAKEDA with all the United Stated Food Results in English. TAKEDA shall have the right to use, and Drug Administration ("FDA") accepts of Licensee's filing of its Registration for cause any third parties who have a Productlicense under the Patents and Manufacturing Know-How to develop, Licensor has not commenced the registration processmanufacture, or initiated clinical development activities, for such Product within commercialize the European Union, Licensee will attempt in good faith to secure a licensee therefor. If Licensor does not enter into a license agreement for Compound and/or the commercialization of such Product within one (1) year after the first commercial sale of such Product in the United States, Licensor shall notify Licensee and the Parties shall undertake good faith negotiations TAKEDA Territory to expand Licensee's Territory upon mutually agreeable terms. For the avoidance of doubtuse, the Parties agree that there is no obligation on either Party Results to conclude an agreement develop, manufacture, offer for sale or sell the expansion of Product in the TAKEDA Territory. (a) Licensor shall have , including without limitation to pursue Registration in the exclusive right to use all information and data developed by or on behalf of Licensee or any of its sublicensees (including but not limited to Licensee's Marketing PartnerTAKEDA Territory, as defined below) under this Agreement for applying for Registrations of the Products outside of the Territory. Upon Licensor's request, Licensee will provide reasonable scientific consulting support free of charge, subject to the provisions of Article 5 below relating rights granted to "Royalties"PENINSULA hereunder. In addition, to Licensor for the preparation limited purpose of such Registrationsevaluating and determining its interest for the Option Countries as set forth in Section 2.3, and Licensee shall deliver to Licensor an electronic copy (in pdf format) of all portions of Licensee's New Drug Application for a Product submitted by Licensee to the FDA in electronic form, and a paper copy of all remaining portions. (b) Licensee TAKEDA shall have the exclusive right for each Product developed by or on behalf of Licensor to use all information and data developed by or on behalf of Licensor cause any third party who is the candidate company to develop, offer for applying for Registrations of sale and/or sell the Products Product in the Territory. 3.4 Each Party shall have and retain sole and exclusive title to all inventions and discoveries which are made, conceived, reduced to practice or generated by its own employees or agents in the course of, or as a result of, activities pursuant to this Agreement. Licensor shall have an exclusive unrestricted right outside the TerritoryOption Countries, to make, have made, use, market use the Results and sell products containing inventions and discoveries relating to the Compounds and/or the Products developed under this Agreement by Licensee, any other information which would be necessary or developed on behalf of Licensee by (a) its Marketing Partner, or (b) any of Licensee's other sublicensees and to which Licensee has the right to grant an exclusive, unrestricted license to Licensor (provided that Licensee shall use its good faith effort to secure from such sublicensees sufficient rights to such discoveries and inventions to enable Licensor to make, have made, use, market and sell products containing such inventions and discoveries outside the Territory) (collectively, the "Licensee Discoveries and Inventions"), subject to royalty payment as provided in Article 5 below, provided that no other remuneration shall be due to Licensee by Licensor useful for such usepurpose.