Common use of Development Work Clause in Contracts

Development Work. 2.1 Details of the development are set forth in the SOW. Design requirements may be changed by mutual written agreement of the Parties; however, Customer understands and agrees that such changes may result in additional charges. 2.2 The development shall be completed when Customer notifies TAEC that the Prototype received by Customer meets the Specifications, when Customer executes the Prototype Approval Signoff. 2.3 If the Prototypes do not conform to the agreed specification and TAEC agrees that the nonconformance is due to TAEC’s error, TAEC will make all commercially-reasonable efforts to expedite delivery of conforming Prototypes. 2.4 If Customer requests any modifications to the Specifications, TAEC agrees to complete the modification as soon as is reasonably practicable after TAEC has agreed to the modification. For the avoidance of doubt, the parties expressly agree that TAEC shall have no obligation to commence a modification unless and until the parties have agreed on adjustments in schedule, costs, or other applicable provisions. 2.5 If TAEC assembles and manufactures any goods at Customer’s request before Customer has issued its written approval via Prototype Approval Signoff, Customer understands and agrees that they will be done on a Risk Production order basis, with Customer responsible for all assembly and production costs. 2.6 Products will be tested to the developed test program resulting from the simulation database. Changes to the test program after sample or production initiation may result in production lead-time delays. 2.7 Each delivery of Products shall be initiated by Customer’s written or electronic notification that a Purchase Order (“Purchase Order”) will be forthcoming. Customer shall send a written Purchase Order to TAEC within five (5) working days of the verbal notice. Each Purchase Order shall identify the Products ordered; indicate the requested quantity and a mutually agreed upon price; and specify the requested delivery date. 2.8 Design initiation shall commence when Customer issues a Purchase Order for the NRE charge. The Purchase Order shall refer to the applicable DPA, and shall include the words: “This Purchase Order represents acceptance of the terms and conditions in the Design And Production Agreement between the issuer and Toshiba America Electronic Components, Inc.” 2.9 TAEC shall supply Products to Customer based on production Purchase Orders that support a six (6) month rolling forecast.

Development Work. 2.1 Details VIVUS shall, at its own cost and expense, conduct the DEVELOPMENT WORK to seek REGULATORY APPROVAL of the development are set forth PRODUCTS in the SOWTERRITORY. Design requirements may VIVUS shall not, however, be changed by mutual written agreement responsible for DEVELOPMENT WORK as it relates to seeking REGULATORY APPROVAL of the Parties; howeverPRODUCTS 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, Customer understands and agrees that such changes may result in additional charges. 2.2 The development shall be completed when Customer notifies TAEC 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 carried out by 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 not to be unreasonably withheld. TANABE agrees to act promptly in evaluating potential designees and in no case shall take more than ten (10) business days to render its decision. 5.2 CLINICAL STUDIES Protocols. VIVUS shall inform TANABE, in writing, of the Prototype received 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 Customer meets it in the SpecificationsTERRITORY. Once so informed, when Customer executes TANABE will have ten (10) business days to review and provide comments on the Prototype Approval Signoff. 2.3 If draft protocol. In addition, should TANABE request any change or addition to such draft protocol for the Prototypes do not conform purpose of using the data generated under the DEVELOPMENT WORK in the TERRITORY for TANABE's development outside the TERRITORY, then TANABE shall promptly notify VIVUS to such effect, and VIVUS shall accommodate such request to the agreed specification and TAEC agrees that the nonconformance is due to TAEC’s error, TAEC will make all commercially-reasonable efforts to expedite delivery of conforming Prototypes. 2.4 If Customer requests any modifications to the Specifications, TAEC agrees to complete the modification as soon as extent such request is reasonably practicable after TAEC has agreed acceptable by VIVUS. If such request causes additional costs to the modificationVIVUS, TANABE shall reimburse such additional costs to VIVUS in full. For the avoidance of doubt, the parties expressly agree that TAEC shall have no obligation to commence a modification unless and until the parties have agreed on adjustments in schedule, costs, or other applicable provisions. 2.5 If TAEC assembles and manufactures any goods at Customer’s request before Customer has issued its written approval via Prototype Approval Signoff, Customer understands and agrees that they will be done on a Risk Production order basis, with Customer responsible for all assembly and production costs. 2.6 Products will be tested to the developed test program resulting from the simulation database. Changes to the test program after sample or production initiation may result in production lead-time delays. 2.7 Each delivery of Products shall be initiated by Customer’s written or electronic notification that a Purchase Order (“Purchase Order”) will be forthcoming. Customer shall send a written Purchase Order to TAEC within five (5) working days of the verbal notice. Each Purchase Order shall identify the Products ordered; indicate the requested quantity and a mutually agreed upon price; and specify the requested delivery date. 2.8 Design initiation shall commence when Customer issues a Purchase Order for the NRE charge. The Purchase Order shall refer to the applicable DPA, and shall include the words: “This Purchase Order represents acceptance of the terms and conditions in the Design And Production Agreement between the issuer and Toshiba America Electronic Components, Inc.” 2.9 TAEC shall supply Products to Customer based on production Purchase Orders that support a six (6) month rolling forecast.5.3

Development Work. 2.1 Details 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 SOW. Design requirements may Territory and Japan in order for the Compound to be changed by mutual written agreement of the Parties; however, Customer understands and agrees that such changes may result approved for use in additional charges. 2.2 The development shall be completed when Customer notifies TAEC that the Prototype received by Customer meets the Specifications, when Customer executes the Prototype Approval Signoff. 2.3 If the Prototypes do not conform to the agreed specification and TAEC agrees that the nonconformance is due to TAEC’s error, TAEC will make all commercially-reasonable efforts to expedite delivery of conforming Prototypes. 2.4 If Customer requests any modifications to the Specifications, TAEC agrees to complete the modification as soon as is reasonably practicable after TAEC has agreed to the modificationhuman clinical trials. For the avoidance of doubtclarity, the parties expressly agree that TAEC TAKEDA shall have no obligation under this Agreement to commence 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 modification unless and until the parties have agreed on adjustments in schedule, costs, or other applicable provisions. 2.5 If TAEC assembles and manufactures any goods at Customer’s request before Customer has issued its written approval via Prototype Approval Signoff, Customer understands and agrees warranty that they PENINSULA will be done 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 a Risk Production order basis, with Customer responsible for the Compound that are required by any Regulatory Authority in the Territory at PENINSULA’s expense. TAKEDA shall disclose to PENINSULA in English all assembly and production costs. 2.6 Products will be tested to the developed test program Information resulting from the simulation databaseStudies and any other preclinical studies conducted by TAKEDA under this Section 5.2 promptly after the completion of such studies. Changes 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 test program 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 sample or production initiation may result in production lead-time delaysthe 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. 2.7 Each delivery 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 Products 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 initiated conducted by CustomerPENINSULA at its sole cost, risk and responsibility. Upon the request of TAKEDA and at TAKEDA’s written or electronic notification that a Purchase Order (“Purchase Order”) will expense, PENINSULA shall allow TAKEDA representative(s), approved in advance by PENINSULA, such approval not to be forthcoming. Customer shall send a written Purchase Order unreasonably withheld, to TAEC within five (5) working days attend PENINSULA’s meetings concerning development and/or marketing of the verbal noticeProduct (including internal meetings and meeting with investigators). Each Purchase Order All TAKEDA representatives that attend such meetings shall identify be bound by obligations of confidentiality consistent with the Products ordered; indicate the requested quantity and a mutually agreed upon price; and specify the requested delivery dateobligations contained in Article 14. 2.8 Design initiation 5.6 PENINSULA shall commence when Customer issues 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, free of charge and 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 Purchase Order 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 NRE charge. The Purchase Order limited purpose of evaluating and determining its interest for the Option Countries as set forth in Section 2.3, TAKEDA shall refer have the right to use and cause any third party who is the applicable DPAcandidate company to develop, and shall include offer for sale and/or sell the words: “This Purchase Order represents acceptance of the terms and conditions Product in the Design And Production Agreement between Option Countries, to use the issuer Results and Toshiba America Electronic Components, Inc.” 2.9 TAEC shall supply Products to Customer based on production Purchase Orders that support a six (6) month rolling forecastany other information which would be necessary or useful for such purpose.