Common use of Development in the Field in the Territory Clause in Contracts

Development in the Field in the Territory. (a) The Development of Licensed Products in the Field in the Territory shall be governed by the Development Plan, and no Licensee Entity may Develop any Licensed Product in the Field in the Territory other than in accordance with the Development Plan, or as otherwise approved by Tetraphase in advance in writing. The initial framework for the Development Plan is attached to this Agreement as Exhibit B. The Parties shall, through the JDC, adopt the initial Development Plan within [**] days after the Effective Date, and once the JDC adopts such initial Development Plan it will be attached (or deemed attached) to this Agreement as Exhibit C. The JDC shall periodically review the Development Plan and determine whether to update the Development Plan. A Party may also develop and submit to the JDC from time to time proposed substantive amendments to the Development Plan. The JDC shall review such proposed amendments and may approve such proposed amendments or any other proposed amendments that the JDC may consider from time to time in its discretion and, upon any such approval by the JDC, the Development Plan shall be amended accordingly. (b) If, at any time during the Term, Tetraphase notifies Licensee in writing that it plans to conduct, for any Licensed Product, a multi-region clinical trial that includes activities in the Territory, the Parties shall, subject to Section 4.05 (Development Costs)), amend the Development Plan to include such activities in the Territory, and Tetraphase shall grant to Licensee any rights required to enable Licensee to conduct such activities. (c) Licensee shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the activities assigned to it in the Development Plan, in each case in accordance with Section 4.03 (Standards of Conduct). (d) Licensee shall use Commercially Reasonable Efforts to obtain, or cause to be obtained, Regulatory Approval and, if applicable, Reimbursement Approval, for a Licensed Product in the Field in each Jurisdiction in the Territory.

Development in the Field in the Territory. Unless otherwise agreed in writing between the Parties, AzurRx shall conduct the Development of the Product in the Field for the Territory at AzurRx’s sole cost and solely pursuant to a development plan and budget approved by the JSC, subject to Section 2.5 (the “Development Plan”). The Development Plan shall: (a) The set forth in reasonable detail the Clinical Trials and Development of Licensed Products activities to be conducted by AzurRx relating to the Compound or any Product, including the specific Clinical Trials and Development activities required for obtaining and maintaining Regulatory Approval in the Field in the Territory shall be governed by the Development Planand anticipated timelines with respect thereto, and no Licensee Entity may Develop any Licensed Product (b) set forth the regulatory strategy for obtaining and maintaining Regulatory Approvals for the Product(s) in each country in the Field in the Territory other than in accordance with the Development Plan, or as otherwise approved by Tetraphase in advance in writingTerritory. The initial framework for Development Plan shall be provided to the JSC within ninety (90) days of the Effective Date. The Development Plan shall be the Confidential Information of AzurRx, provided that the non-use restrictions set forth in Section 10.1 shall not apply to such information. Notwithstanding the foregoing, the Development Plan is attached may not be shared with any sublicensees of FWB without the consent of AzurRx not to this Agreement as Exhibit B. The Parties shallbe unreasonably withheld or delayed. FWB, directly or through its representatives on the JDCJSC, adopt the initial Development Plan within [**] days after the Effective Date, and once the JDC adopts such initial Development Plan it will be attached (or deemed attached) to this Agreement as Exhibit C. The JDC shall periodically review may provide comments on the Development Plan and determine whether to update the Development Plan. A Party may also develop and submit to the JDC from time to time proposed substantive amendments as appropriate, including proposals to the add Clinical Trials and other Development Plan. The JDC shall review such proposed amendments and may approve such proposed amendments or any other proposed amendments that the JDC may consider from time to time in its discretion and, upon any such approval by the JDC, the Development Plan shall be amended accordingly. (b) If, at any time during the Term, Tetraphase notifies Licensee in writing that it plans to conduct, for any Licensed Product, a multi-region clinical trial that includes activities in support of obtaining Regulatory Approval in the Territory, Field for the Parties shall, applicable jurisdiction which proposals are subject to AzurRx’s decision-making authority set forth in Section 4.05 (Development Costs)), amend the Development Plan to include such activities in the Territory, and Tetraphase shall grant to Licensee any rights required to enable Licensee to conduct such activities. (c) Licensee 2.5. AzurRx shall use Commercially Reasonable Efforts to execute Develop the Product(s) in the US and the European Union or in three of the five Major Countries, and to performachieve the milestones set forth herein with respect to: (i) at least one Product in the COVID Field and (ii) at least one Product in the ICI-AC Field. Operational or tactical level decisions necessary to execute Development activities pursuant to the Development Plan shall be within the decision-making authority of AzurRx; provided that all such decisions shall be consistent with the terms of this Agreement, or cause to be performedApplicable Law, the activities assigned Development Plan and the decisions of the JSC, subject to it Section 2.5. Within thirty (30) days of the Effective Date, FWB shall deliver and provide to AzurRx such manufacturing process information Controlled by FWB with respect to the Product, to the extent not already provided to or otherwise in the Development Planpossession or Control of AzurRx as necessary in order to enable AzurRx to replicate the manufacturing process for the Product, as such process and Product exist as of the Effective Date without charge to AzurRx. In the event AzurRx needs additional support from FWB, AzurRx shall reimburse FWB for FWB’s personnel costs measured at a reasonable FTE rate and the out-of-pocket costs incurred by FWB or its Affiliates in connection with the provision of such assistance. In addition, within ten (10) days following the Effective Date, FWB shall transfer to AzurRx the applicable IND(s) and shall also provide copies of Regulatory Materials for the Development, Commercialization and other Exploitation of the Products, in each case in accordance with Section 4.03 (Standards of Conduct). (d) Licensee shall use Commercially Reasonable Efforts to obtain, or cause to be obtained, Regulatory Approval and, if applicable, Reimbursement Approval, for a Licensed Product in the Field in each Jurisdiction in the Territory.

Development in the Field in the Territory. (a) Within [**] after the Effective Date, Licensee shall present the Development Plan, which shall be prepared based on and in accordance with the Initial Development Outline, to the JDC for approval. The Development of Licensed Products in the Field in the Territory shall be governed by the Development Plan, and no Licensee Entity may Develop any Licensed Product in the Field in the Territory other than in accordance with the Development Plan, or as otherwise approved by Tetraphase Agios in advance in writing. The initial framework Each Development Plan shall provide for each Local Study, Joint Global Study, investigator sponsored trial and registry study to be conducted in the Territory and shall at least contain the Development Plan is attached to this Agreement as Exhibit B. The Parties shallactivities set forth in the Initial Development Outline, through the JDC, adopt the initial unless otherwise approved by Agios in advance in writing. Each Development Plan within [**] days after shall reflect Licensee’s participation in the Effective Date, and once the JDC adopts such initial Development Plan it will be attached (or deemed attached) to this Agreement as Exhibit C. Joint Global Studies. The JDC shall periodically review the Development Plan and determine whether to update the Development Plan. A Each Party may also develop and submit to the JDC from time to time proposed substantive amendments to the Development Plan. The JDC shall review such proposed amendments and may approve such proposed amendments or any other proposed amendments that the JDC may consider from time to time in its discretion and, upon any such approval by the JDC, the Development Plan shall be amended accordingly. The Development Plan shall, at all times, only permit the Licensee Entities to Develop Licensed Products in the Initial Indications and any additional indication as approved by both Licensee and Agios in advance in writing (each such additional indication, an “Additional Indication”). (b) If, at any time during Each Local Study or Joint Global Study conducted in the Term, Tetraphase notifies Territory shall be conducted in accordance with the Development Plan and the study protocol approved by the JDC. Licensee shall be responsible for Local Studies in writing that it plans to conduct, the Territory and the Parties will be responsible for any Licensed Product, a multi-region clinical trial that includes implementation activities in the Territory, Territory as to each Joint Global Study as determined by the Parties shall, subject JDC. Licensee shall be responsible for paying a portion of the costs of activities with respect to Section 4.05 (Development Costs)), amend the Development Plan to include such activities each Joint Global Study in the Territory, Territory in accordance with Section 8.03(b) and Tetraphase shall grant bear all costs of activities with respect to Licensee any rights required to enable Licensee to conduct such activitieseach Local Study. (c) Licensee agrees that the [**] Trial shall be a Joint Global Study. Promptly after the Effective Date, the Parties shall collaborate to transfer certain responsibilities for the [**] Trial in the Territory to Licensee. (d) If Licensee does not agree to participate in any Global Study, then (i) Agios may, itself or with or through any other Agios Entity, perform such Global Study in the Territory and (ii) Section 8.03(c) shall apply with respect to such Global Study. (e) Licensee shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the activities assigned to it in the Development Plan, in each case in accordance with Section 4.03 4.04 (Standards of Conduct). Licensee shall use Commercially Reasonable Efforts to participate in each Global Study requested by Agios. (df) Licensee shall use Commercially Reasonable Efforts to obtain, or cause to be obtained, Regulatory Approval and, if applicable, Reimbursement Approval, for a Licensed Product in the Field each Initial Indication and Additional Indication in each Jurisdiction of (i) Mainland China, (ii) Taiwan and (iii) Hong Kong and Macau (with it being agreed that, if Regulatory Approval is obtained in Hong Kong, Licensee shall not also be required to separately obtain Regulatory Approval in Macau), including by providing all necessary resourcing required to seek and maintain Regulatory Approval and, if applicable, Reimbursement Approval for a Licensed Product. (g) To the extent permissible under applicable Law, Agios or its designee shall own all biological samples obtained in connection with any Global Study, and, at Agios’ request, Licensee shall transfer to Agios or its designee any such biological samples in Licensee’s possession or control. If applicable Law prohibits such ownership or transfer, the Parties will work together to provide Agios or its designee with rights and access to such biological samples as close to those described in the Territorypreceding sentence as is permitted by applicable Law.