Common use of Development Plan Clause in Contracts

Development Plan. Promptly after the execution of this Agreement, on a Collaboration Product-by-Collaboration Product basis, Pieris and Stelis BioPharma shall jointly prepare a mutually-agreed written work plan for any Collaboration Product(s) that sets out in reasonable detail the development activities to be conducted by each Party and its designees [***] for any Collaboration Product(s), as well as the location, protocol, budget and timelines for completion of various tasks therefor (each, a “Development Plan”); provided, however, that the Development Plan for Product 1 shall be in accordance with the framework plan set forth in Exhibit I. Each Development Plan shall be subject to the JSC’s approval. Upon the JSC’s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, neither Party shall have any obligation with respect to any activity except as set forth in a Development Plan; provided, however, that unless and until the Parties sign a Development Plan, the Parties shall use good faith efforts to prepare and agree on the Development Plan for Product 1 with respect to activities beyond those referred to in Exhibit I within [***] days from the Effective Date. Each Development Plan will be updated and approved semi-annually by the JSC and shall be consistent with the general allocation of responsibilities described in Article 3.2 below. Without limiting the foregoing, any material modifications or additions to any Development Plan shall be first approved by JSC prior to its implementation. Each Party shall perform its obligations allocated to it under each Development Plan in accordance with the terms and conditions of this Agreement (including the diligence requirement set forth in Article 9), the applicable Development Plan and all Applicable Laws.

Development Plan. Promptly after the execution of this Agreement, on a Collaboration Product-by-Collaboration Product basis, Pieris Pfenex and Stelis BioPharma Agila shall jointly prepare a mutually-agreed written work plan for any Collaboration Product(s) that sets out in reasonable detail the development activities to be conducted by each Party and its designees [***] for the Successful Completion of the first Phase I Clinical Trial for any Collaboration Product(s), as well as the location, protocol, budget and timelines for completion of various tasks therefor (each, a “Development Plan”); provided, however, that the Development Plan for Product 1 shall be in accordance with the framework plan set forth in Exhibit I. . Each Development Plan shall be subject to the JSC’s approval. Upon the JSC’s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, unless and until the Parties sign the Development Plan for any Collaboration Product, neither Party shall have any obligation with respect to any activity except as set forth in a Development Planproduct hereunder; provided, however, that unless and until the earlier of (a) the Parties sign a Development PlanPlan therefor or (b) either Party provides sixty (60) days’ prior written notice to the other Party of its intent to exclude a product described in Section 1.6(a) — (e), the Parties shall use good faith efforts to prepare and agree on the Development Plan for Product 1 with respect therefor prior to activities beyond those referred to the date specified in Exhibit I within [***] days 1 (as may be amended from time to time by the Effective DateParties). Each Development Plan will be updated and approved semi-annually by the JSC and shall be consistent with the general allocation of responsibilities described in Article Section 3.2 below. Without limiting the foregoing, any material modifications or additions to any Development Plan (including any proposed change(s) to any Third Party designee) shall be first approved by JSC prior to its implementation. Each Party shall perform its obligations allocated to it under each Development Plan in accordance with the terms and conditions of this Agreement (including the diligence requirement set forth in Article 9)8), the applicable Development Plan and all Applicable Laws.

Development Plan. Promptly after (a) The Development Plan shall include the execution of this Agreementscientific, on a Collaboration Productexperimental, process development, non-by-Collaboration Product basisclinical, Pieris clinical and Stelis BioPharma shall jointly prepare a mutually-agreed written work plan regulatory activities, goals and timelines for any Collaboration Product(s) that sets out in reasonable detail the development activities of the Licensed Product for the coming Year in the Territory (in the case of PHARMAENGINE) and the Retained Territory (in the case of HERMES). The Development Plan shall be updated annually and be finalized only after review by JDC. The Development Plan in all other provisions under this Agreement shall mean the finalized Development Plan reviewed by JDC. The annual Development Plan of each of the Parties shall be submitted to be conducted by each Party JDC for discussion and its designees review prior to [***] in each Year (the deadline for any Collaboration Product(ssubmitting the initial Development Plan may be determined by JDC if necessary). (b) Under the auspices of each of the Parties, as well the Parties shall have the following responsibilities: (1) Each of the Parties shall be responsible for the preparation of all protocols and the conduct of all activities for which such Party is designated as the location, protocol, budget and timelines Party responsible for completion of various tasks therefor (each, a “Development Plan”); provided, however, that such activities in the Development Plan for Product 1 or the determination of JDC; (2) PHARMAENGINE shall be responsible for preparing all necessary applications for regulatory approval of the Licensed Products in the countries in the Territory for which PHARMAENGINE is designated as the Party responsible for such preparation in the Development Plan or the determination of JDC, and PHARMAENGINE shall also be responsible to conduct all communications with the regulatory authorities in the Territory during the registration process. HERMES shall be responsible for preparing all necessary applications for regulatory approval of the Licensed Products in the Retained Territory for which HERMES is designated as the Party responsible for such preparation in the Development Plan or the determination of JDC, and HERMES shall also be responsible to conduct all communications with the Regulatory Authorities in the Retained Territory during the registration process; and (3) Each of the Parties shall provide all technical data and support necessary to assist the responsible Party to prepare such applications. (c) PHARMAENGINE shall use its best efforts to implement the development of the Licensed Product in the Territory in accordance with the framework plan timeline(s) approved by JDC or set forth in Exhibit I. Each Development Plan shall be subject to the JSC’s approval. Upon the JSC’s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, neither Party shall have any obligation with respect to any activity except as set forth in a Development Plan; provided, however, that unless and until the Parties sign a Development Plan, the Parties shall use good faith efforts to prepare and agree on the Development Plan for Product 1 with respect to activities beyond those referred to in Exhibit I within [***] days from the Effective Date. Each Development Plan will be updated and approved semi-annually by the JSC and shall be consistent with the general allocation of responsibilities described in Article 3.2 below. Without limiting the foregoing, any material modifications or additions to any Development Plan shall be first approved by JSC prior to its implementation. Each Party shall perform its obligations allocated to it under each Development Plan in accordance with the terms and conditions of this Agreement (including Agreement. PHARMAENGINE shall further require its Sub-licensee in the diligence requirement set forth Territory to use its best efforts to develop the Licensed Product in Article 9), the applicable Development Plan and all Applicable LawsTerritory.

Development Plan. Promptly after (a) The Development of the execution of Compounds and Collaboration Products under this Agreement, on Agreement (the “Development Program”) shall be conducted pursuant to a comprehensive written Development plan (the “Development Plan”). The Development Plan for each Compound and corresponding Collaboration Product-by-Collaboration Product basis, Pieris Products shall set forth the timeline and Stelis BioPharma shall jointly prepare a mutually-agreed written work plan for any Collaboration Product(sdetails of: (i) that sets out in reasonable detail the development all preclinical and clinical Development activities to be conducted by the Parties as necessary to generate data sufficient to meet the requirements for Marketing Approval of such Compound and corresponding Collaboration Products for each Party of the Indications as agreed by the Parties and its designees [***] for any Collaboration Product(s), as well as set forth in the location, protocol, budget and timelines for completion of various tasks therefor (each, a “Development Plan”); provided, however, (ii) the protocol synopsis for each clinical trial included in such Development Plan; (iii) a Manufacturing plan; and (iv) any other Development activities that the Parties agree to pursue in collaboration for such Compound and corresponding Collaboration Products. The Parties agree that: (A) the Development Plan will contain detailed plans for Product 1 shall be in accordance at least [ * ] covered by the Development Plan, and summary plans for periods thereafter, and (B) the budget associated with the framework plan set forth in Exhibit I. Each such Development Plan shall be subject to the JSC’s approvalapproval process set forth in Section 6.2(b). The Development Plan shall include a coordinated development and regulatory strategy, including the Parties’ respective roles in the development of each Collaboration Product and the countries in which Development of Collaboration Product will occur. The Development Plan shall also set forth: (1) a detailed budget of the Development activities to be [ * ]; (2) if Cytokinetics has exercised the Cytokinetics Co-Funding Option for a Collaboration Product and [ * ] for such Collaboration Product, a detailed budget for [ * ] of such Collaboration Product in the [ * ] Indications (the “[ * ]”); and (3) if [ * ] Indication [ * ] the Collaboration and [ * ] for such [ * ] Indication, a detailed budget for such [ * ] Indication Development Work (the “[ * ] Indication Development Budget”). Upon the JSCother Party’s approval of a reasonable request, each Party shall [ * ] Development activities under the Development Plan, such . The [ * ] shall be included in the Development Plan and [ * ] shall be signed subject to JDC approval. [ * ] = Certain confidential information contained in this document, marked by a duly authorized representative from brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. (b) The JDC shall update the Development Plan (including [ * ], as applicable) at least annually, with such annual update to be finally approved no later than [ * ] of the preceding Astellas’ fiscal year, provided that [ * ] Indication [ * ] subject to the [ * ] the JDC (and [ * ] Indication [ * ] after [ * ] for such Indication. By [ * ] of each Party and attached hereto as a part of this Agreement. For calendar year, [ * ] Development activities are [ * ] the avoidance of doubt, neither Party shall have any obligation with respect to any activity except as set forth in a Development Plan; provided, however, that unless and until the Parties sign a updated Development Plan, the Parties JDC shall agree upon a proposed [ * ] for the following Astellas fiscal year. Astellas shall use good faith efforts to [ * ]. From time to time during the Term, the JDC shall prepare amendments, as appropriate, to the then-current Development Plan (including [ * ], as applicable), including adding additional Compounds and agree on Collaboration Products as well as additional Indications added to the Collaboration pursuant to Article 4. The JDC shall have the right to approve updates and amendments to the Development Plan (including [ * ], as applicable), provided that [ * ] subject to the [ * ] the JDC (and [ * ] for Product 1 with respect to activities beyond those referred to in Exhibit I within [***] days from the Effective Datesuch Indication. Each Development Plan will be updated and Once approved semi-annually by the JSC and shall be consistent with the general allocation of responsibilities described in Article 3.2 below. Without limiting the foregoingJDC, any material modifications or additions to any such revised Development Plan shall be first approved by JSC replace the prior to its implementation. Each Party shall perform its obligations allocated to it under each Development Plan. (c) If the terms of the Development Plan in accordance with contradict, or create inconsistencies or ambiguities with, the terms and conditions of this Agreement, then the terms of this Agreement (including the diligence requirement set forth in Article 9), the applicable Development Plan and all Applicable Lawsshall govern.

Development Plan. The Parties have agreed on an initial, high-level Development Plan, attached as Exhibit A, that describes the general nature of the development activities contemplated under this Option Agreement and the responsibilities of the Parties with respect thereto, as applicable (the “Initial Development Plan”). Promptly after the execution of this AgreementExecution Date, on a Collaboration Product-by-Collaboration Product basis, Pieris and Stelis BioPharma shall jointly prepare a mutually-agreed written work plan for in any Collaboration Product(s) that sets out in reasonable detail the development activities to be conducted by each Party and its designees event no later than [***] thereafter, the Parties shall negotiate in good faith and agree in writing on a reasonably detailed, updated development plan (the “Full Form Development Plan”) for any Collaboration Product(sthe conduct of development activities with respect to the Products in the Field in the Territory that (a) is consistent with the Initial Development Plan, (b) describes the MPAG Activities (the costs and expenses for which shall be borne by MPAG, subject to Section 4.5) and the Novartis Activities (the costs and expenses for which shall be borne by Novartis), as well as and (c) includes the locationapplicable concept sheet or synopsis for the Clinical Trials to be conducted under the Development Plan (the Initial Development Plan together with the Full Form Development Plan all updates and amendments to either of them, protocol, budget and timelines for completion of various tasks therefor (each, a the “Development Plan”); provided. Within [***] from the Execution Date, however, that the Parties will negotiate in good faith to include MP0423 in the Development Plan and to apportion costs for Product 1 development activities in respect of MP0423 appropriately. In negotiating the Development Plan, each Party shall use good faith efforts to agree on the contents of the Development Plan and shall not without reason withhold, condition, or delay their consent to the Development Plan. For clarity, and notwithstanding anything to the contrary in this Option Agreement: (i) this Option Agreement does not limit in any way MPAG’s right or ability to perform any pre-clinical, clinical, and non-clinical development activities for the Products at MPAG’s sole cost and expense, provided, that MPAG shall not, without the prior written consent of Novartis, initiate any Clinical Trial in respect of either of the Products that is not contemplated by the Development Plan; and (ii) neither Party shall be in accordance with the framework plan required to undertake any activities, including, as applicable MPAG Activities or Novartis Activities, that are not set forth in Exhibit I. Each Development Plan shall be subject to the JSC’s approval. Upon the JSC’s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, neither Party the Initial Development Plan shall have any obligation with respect to any activity except serve as set forth in a Development Plan; provided, however, that unless and until the Parties sign a Development Plan, the Parties shall use good faith efforts to prepare and agree on the Development Plan to the extent required for Product 1 with respect to activities beyond those referred to in Exhibit I within [***] days from the Effective Date. Each purposes of this Option Agreement until such time as the Parties agree a new Development Plan will be updated and approved semi-annually by the JSC and shall be consistent with the general allocation of responsibilities described in Article 3.2 below. Without limiting the foregoing, any material modifications or additions pursuant to any Development Plan shall be first approved by JSC prior to its implementation. Each Party shall perform its obligations allocated to it under each Development Plan in accordance with the terms and conditions of this Agreement (including the diligence requirement set forth in Article 9), the applicable Development Plan and all Applicable LawsSection 4.2.

Development Plan. Promptly (a) The Parties will collaborate and use diligent efforts to develop the Product with the intent of obtaining regulatory approval for interstate transport, distribution, sale, promotion, labeling and marketing the Product in the Territory as soon as reasonably practicable. Each Party will assure that its Product development responsibilities hereunder are carried out adhering to ethical and safety standards and in compliance with material provisions of all applicable laws, regulations, standards, and guidelines in force in the Territory. BioNumerik and Takeda hereby agree that the development of the Product will be initially focused on the field of oncology. (b) The development of the Product will be conducted pursuant to a mutually agreed development plan for non-clinical and clinical studies, including Phase III and IV Studies, which will specify in detail all planned development activities and priorities, time frames for completion of activities, which Party or third party is to be responsible for each activity, and any other items reasonably required by the Parties (the "Development Plan"). The Development Plan must be approved by both Parties prior to the commencement of the non-clinical and clinical studies and may be modified at any time by mutual written agreement of the Parties through the Joint Steering Committee described in Article XIII, Section 13.1. An outline of the Development Plan is attached to this Agreement in Exhibit B and includes a summary synopsis, a timeline, and an annual budget estimate. BioNumerik will prepare and submit a draft of the Development Plan to Takeda for consultation and approval within two (2) months after the execution Effective Date and the draft of this Agreementthe Development Plan will be substantially the same as set forth in Exhibit B. (c) A Party will have the obligation to promptly inform the other Party, on a Collaboration Product-by-Collaboration Product basisas soon as the notifying Party becomes aware, Pieris and Stelis BioPharma shall jointly prepare a mutually-agreed written work plan for any Collaboration Product(s) that sets out of an expected excess of development costs over the annual budget in reasonable detail the development activities to be conducted Development Plan by each Party and its designees greater than [***] of such annual budget or of such otherwise agreed upon plan by the Parties. The Parties will consult with each other regarding the reasons for any Collaboration Product(s), as well as and the location, protocol, budget and timelines for completion handling of various tasks therefor (each, a “Development Plan”); providedsuch expected excess. It is understood, however, that BioNumerik will use Commercially Diligent Efforts in conducting the activities under the Development Plan, including monitoring the costs thereof to stay within the annual budget. Any Party that is responsible for creating an excess or monetary loss caused by its negligent conduct for a particular project will be responsible for correcting the loss at its own expense to the extent such cost was caused by its negligent conduct. Notwithstanding the foregoing, the Parties are encouraged to regularly consider and discuss activities that would result in new indications or expand the market opportunity for the Product and to propose such matters for consideration by the Joint Steering Committee. (d) Unless otherwise agreed upon by the Parties, the Development Plan for Product 1 shall will include the following studies, all of which will be included in accordance with the framework plan budget set forth in Exhibit I. Each Development Plan shall be subject to the JSC’s approval. Upon the JSC’s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, neither Party shall have any obligation with respect to any activity except as set forth in a Development Plan; provided, however, that unless and until the Parties sign a Development Plan, the Parties shall use good faith efforts to prepare and agree on the Development Plan for Product 1 with respect to activities beyond those referred to in Exhibit I within [**]: [**] days from the Effective DateCERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Each Development Plan will be updated and approved semi-annually by the JSC and shall be consistent with the general allocation of responsibilities described in Article 3.2 belowCONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Without limiting the foregoing, any material modifications or additions to any Development Plan shall be first approved by JSC prior to its implementation[**] [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Each Party shall perform its obligations allocated to it under each Development Plan in accordance with the terms and conditions of this Agreement (including the diligence requirement set forth in Article 9), the applicable Development Plan and all Applicable LawsCONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

Development Plan. Promptly after the execution of this Agreement, on a Collaboration Product-by-Collaboration Product basis, Pieris and Stelis BioPharma shall jointly prepare a mutually-agreed written work plan for any Collaboration Product(s(a) that sets out in reasonable detail the development activities to be conducted by each Party and its designees [***] for any Collaboration Product(s), as well as the location, protocol, budget and timelines for completion of various tasks therefor (each, a “Development Plan”); provided, however, that the Development Plan for Product 1 shall be in accordance with the framework plan set forth in Exhibit I. Each Development Plan shall be subject to the JSC’s approval. Upon the JSC’s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, neither Party shall have any obligation with respect to any activity except as set forth in a Development Plan; provided, however, that unless and until the Parties sign a Development Plan, the Parties shall use good faith efforts to prepare and agree on the Development Plan for Product 1 with respect to activities beyond those referred to in Exhibit I within Within [***] days from following the Effective Date. Each Exercise Date with respect to a given Collaboration Candidate, ONO will prepare and provide to the JSC an update to its proposed activities under the Joint Development Plan pursuant to which ONO will be updated conduct Research and approved semi-annually by Development in the ONO Territory, and FATE will prepare and provide to the JSC and shall be consistent with (i) an update to its proposed activities under the general allocation of responsibilities described in Article 3.2 below. Without limiting the foregoing, any material modifications or additions to any Joint Development Plan shall be first approved pursuant to which FATE will conduct Research and Development in the FATE Territory, for such Collaboration Product on an Indication-by-Indication basis, as applicable and (ii) a process development and manufacturing plan for all non-clinical and clinical Materials of Collaboration Products for use both by JSC prior to its implementationONO in the ONO Territory and by FATE in the FATE Territory. Each Party will prepare and provide a budget and estimated timeline with respect to its proposed activities under the Joint Development Plan. (b) ONO and FATE will discuss in good faith through the JSC, and use Commercially Reasonable Efforts to reach an agreement on, the Joint Development Plan, including but not limited to: (i) [***], (ii) and (iii) [***]. (c) During each Calendar Year, each Party shall perform provide its obligations allocated to it under each updates on the Joint Development Plan for the upcoming year covering activities [***] so that the Parties may agree on such update by [***] that year, and each Party shall continue to provide to the other Party, through the JSC, regular updates from time to time to its proposed activities under the Joint Development Plan, as applicable. Each Party will consider in good faith the other Party's comments on such proposed activities and any updates thereto. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission. (d) If the JSC fails to agree, after the use of Commercially Reasonable Efforts in an attempt to reach an agreement between the Parties regarding the Joint Development Plan, notwithstanding the provisions of Article 12 (Dispute Resolution), the decision shall be made in accordance with the terms and conditions of this Agreement Section 4.1.8 (including the diligence requirement set forth in Article 9Decision-Making; Limitations on JSC), the applicable Development Plan and all Applicable Lawsprovided however, [***].

Development Plan. Promptly (a) The Parties will collaborate and use diligent efforts to develop the Product with the intent of obtaining regulatory approval for interstate transport, distribution, sale, promotion, labeling and marketing the Product in the Territory as soon as reasonably practicable. Each Party will assure that its Product development responsibilities hereunder are carried out adhering to ethical and safety standards and in compliance with material provisions of all applicable laws, regulations, standards, and guidelines in force in the Territory. BioNumerik and Takeda hereby agree that the development of the Product will be initially focused on the field of oncology. (b) The development of the Product will be conducted pursuant to a mutually agreed development plan for non-clinical and clinical studies, including Phase III and IV Studies, which will specify in detail all planned development activities and priorities, time frames for completion of activities, which Party or third party is to be responsible for each activity, and any other items reasonably required by the Parties (the "Development Plan"). The Development Plan must be approved by both Parties prior to the commencement of the non-clinical and clinical studies and may be modified at any time by mutual written agreement of the Parties through the Joint Steering Committee described in Article XIII, Section 13.1. An outline of the Development Plan is attached to this Agreement in Exhibit B and includes a summary synopsis, a timeline, and an annual budget estimate. BioNumerik will prepare and submit a draft of the Development Plan to Takeda for consultation and approval within two (2) months after the execution Effective Date and the draft of the Development Plan will be substantially the same as set forth in Exhibit B. (c) A Party will have the obligation to promptly inform the other Party, as soon as the notifying Party becomes aware, of an expected excess of development costs over the annual budget in the Development Plan by greater than [**] of such annual budget or of such otherwise agreed upon plan by the Parties. The Parties will consult with each other regarding the reasons for and the handling of such expected excess. It is understood, however, that BioNumerik will use Commercially Diligent Efforts in conducting the activities under the Development Plan, including monitoring the costs thereof to stay within the annual budget. Any Party that is responsible for creating an excess or monetary loss caused by its negligent conduct for a particular project will be responsible for correcting the loss at its own expense to the extent such cost was caused by its negligent conduct. Notwithstanding the foregoing, the Parties are encouraged to regularly consider and discuss activities that would result in new indications or expand the market opportunity for the Product and to propose such matters for consideration by the Joint Steering Committee. (d) Unless otherwise agreed upon by the Parties, the Development Plan will include the following studies, all of which will be included in the budget set forth in the Development Plan: (i) A [**] study of [**] TAVOCEPT versus [**] in patients with [**]. This study will have clearly defined safety and efficacy endpoints, and will involve intrapatient controls and crossover design involving the comparative analysis of [**] TAVOCEPT. The initiation and priority of this Agreement, on a Collaboration Product-by-Collaboration Product basis, Pieris and Stelis BioPharma shall jointly prepare a mutually-agreed written work plan for any Collaboration Product(s) that sets out in reasonable detail study will be dependent upon near term FDA responses to BioNumerik's discussions regarding the development activities to be conducted by each Party and its designees [**]; (ii) A [**] study of TAVOCEPT in patients with [**] who will be treated with [**] TAVOCEPT or [**] in combination with [**]. This trial will be designed to have adequate statistical power [**] for the primary safety endpoint that will be either: (1)[**]; or (2)[**], and for the primary safety endpoint, which will evaluate [**]. With regard to the safety endpoint, the analysis methodology that will be applied is [**] that will be discussed and agreed to by the Regulatory Authority and BioNumerik. The initiation of this study will be a priority for BioNumerik to design and implement within the first [**] months after the Effective Date; and, (iii) Both Parties will closely collaborate regarding obtaining any Collaboration Product(s)necessary information regarding potentially [**] in the Final Drug Report as defined in 21 CFR 312 with the objective of addressing potentially important specification matters regarding the Final Drug Report and its impurity profile. In the event that Takeda and/or BioNumerik believe it is important to complete the following steps, they will collaborate together on the following: 1. Takeda will synthesize and purify or procure adequate quantities of test articles, which may include [**]. 2. BioNumerik, in consultation with Takeda and subject to prior FDA discussion and agreement, will design and complete Good Laboratory Practices safety evaluation of the test articles in one or two species of animals (e.g., rat and dog) with the objective of evaluating the [**] of such test articles in a [**] study in animals, as well as the location, protocol, budget and timelines for completion of various tasks therefor (each, a “Development Plan”); provided, however, that the Development Plan for Product 1 shall be in accordance with the framework plan set forth in Exhibit I. Each Development Plan shall be subject to the JSC’s approval. Upon the JSC’s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, neither Party shall have any obligation with respect to any activity except as set forth in a Development Plan; provided, however, that unless and until the Parties sign a Development Plan, the Parties shall use good faith efforts to prepare and agree on the Development Plan for Product 1 with respect to activities beyond those referred to in Exhibit I within conducting [**] of such test articles, as well as a [**] days from study. 3. The results of such studies will be discussed by BioNumerik and Takeda. [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 4. The initiation of these studies will be a priority for both Parties to design and implement within the first [**] months after the Effective Date. Each Development Plan will be updated and approved semi-annually by the JSC and shall be consistent with the general allocation of responsibilities described in Article 3.2 below[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Without limiting the foregoing, any material modifications or additions to any Development Plan shall be first approved by JSC prior to its implementationCONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Each Party shall perform its obligations allocated to it under each Development Plan in accordance with the terms and conditions of this Agreement (including the diligence requirement set forth in Article 9), the applicable Development Plan and all Applicable Laws.22

Development Plan. Promptly after the execution of this Agreement, on a Collaboration Product-by-Collaboration Product basis, Pieris Pfenex and Stelis BioPharma Agila shall jointly prepare a mutually-agreed written work plan for any Collaboration Product(s) that sets out in reasonable detail the development activities to be conducted by each Party and its designees [***] for the Successful Completion of the first Phase I Clinical Trial for any Collaboration Product(s), as well as the location, protocol, budget and timelines for completion of various tasks therefor [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (each, a “Development Plan”); provided, however, that the Development Plan for Product 1 shall be in accordance with the framework plan set forth in Exhibit I. . Each Development Plan shall be subject to the JSC’s approval. Upon the JSC’s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, unless and until the Parties sign the Development Plan for any Collaboration Product, neither Party shall have any obligation with respect to any activity except as set forth in a Development Planproduct hereunder; provided, however, that unless and until the earlier of (a) the Parties sign a Development PlanPlan therefor or (b) either Party provides sixty (60) days’ prior written notice to the other Party of its intent to exclude a product described in Section 1.6(a) — (e), the Parties shall use good faith efforts to prepare and agree on the Development Plan for Product 1 with respect therefor prior to activities beyond those referred to the date specified in Exhibit I within [***] days 1 (as may be amended from time to time by the Effective DateParties). Each Development Plan will be updated and approved semi-annually by the JSC and shall be consistent with the general allocation of responsibilities described in Article Section 3.2 below. Without limiting the foregoing, any material modifications or additions to any Development Plan (including any proposed change(s) to any Third Party designee) shall be first approved by JSC prior to its implementation. Each Party shall perform its obligations allocated to it under each Development Plan in accordance with the terms and conditions of this Agreement (including the diligence requirement set forth in Article 9)8), the applicable Development Plan and all Applicable Laws.