Common use of Development Plan Clause in Contracts

Development Plan. The Parties shall conduct the Development Activities in accordance with the Development Plan and as further specified in this Agreement. The Development Plan shall set forth, among other things, the following Development Activities: (a) preclinical studies, toxicology studies, pharmaco-economic studies and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, in each case, together with all protocols, endpoints and investigators conducting such trials; (b) Non-NDA Studies and Post-Marketing Authorization Trials and studies; (c) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals; (d) the Joint Development Budget and the qualification of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity); (e) the allocation of the Joint Development Activities to be conducted by each Party and the timeline for completing such Joint Development Activities; (f) the plans and timeline for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals in the Territories; (g) the Manufacturing Development Activities and other Manufacturing process development activities (including CMC related activities), as well as the plans, amounts and timelines for the Manufacture and supply of Product, Placebo, combination and comparator products necessary for the Development, taking into account the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required for the performance of the Development Plan. For the avoidance of doubt, the Development Plan shall include also Trials and regulatory plans of the Parties with respect to Sole Funded Development Activities and shall not be limited to the Co-Commercialization Territory. The Initial Development Plan attached hereto as EXHIBIT 6 shall be updated in accordance with this Section 3.3 within [***] days of the Effective Date.

Development Plan. (a) The Parties shall conduct the Development Activities in accordance with the Development Plan shall include the scientific, experimental, process development, non-clinical, clinical and as further specified regulatory activities, goals and timelines for the development of the Licensed Product for the coming Year in this Agreementthe Territory (in the case of PHARMAENGINE) and the Retained Territory (in the case of HERMES). The Development Plan shall set forth, among be updated annually and be finalized only after review by JDC. The Development Plan in all other things, provisions under this Agreement shall mean the following finalized Development Activities: (a) preclinical studies, toxicology studies, pharmaco-economic studies Plan reviewed by JDC. The annual Development Plan of each of the Parties shall be submitted to JDC for discussion and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, review prior to [**] in each case, together with all protocols, endpoints and investigators conducting such trials;Year (the deadline for submitting the initial Development Plan may be determined by JDC if necessary). (b) Non-NDA Studies Under the auspices of each of the Parties, the Parties shall have the following responsibilities: (1) Each of the Parties shall be responsible for the preparation of all protocols and Post-Marketing Authorization Trials the conduct of all activities for which such Party is designated as the Party responsible for such activities in the Development Plan 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 studies;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) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals; (d) PHARMAENGINE shall use its best efforts to implement the Joint Development Budget and the qualification of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity); (e) the allocation development of the Joint Development Activities to be conducted by each Party and the timeline for completing such Joint Development Activities; (f) the plans and timeline for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals Licensed Product in the Territories; (gTerritory in accordance with the timeline(s) the Manufacturing Development Activities and other Manufacturing process development activities (including CMC related activities), as well as the plans, amounts and timelines for the Manufacture and supply of Product, Placebo, combination and comparator products necessary for the Development, taking into account the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required for the performance of the Development Plan. For the avoidance of doubt, approved by JDC or set forth in the Development Plan shall include also Trials and regulatory plans of the Parties with respect to Sole Funded Development Activities and shall not be limited to the Co-Commercialization Territory. The Initial Development Plan attached hereto as EXHIBIT 6 shall be updated in accordance with the terms of this Section 3.3 within [***] days of Agreement. PHARMAENGINE shall further require its Sub-licensee in the Effective DateTerritory to use its best efforts to develop the Licensed Product in the Territory.

Development Plan. (a) The plan for the development of Product as agreed to by the Parties shall (including timelines therein) is set forth in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement (such plan as set forth in the memorandum, the “Initial Development Plan” and together with any updates thereto in accordance herewith, the “Development Plan,” and the conduct of the activities under the Development Activities in accordance with Plan, the “Development Plan and as further specified in this AgreementProgram”). The Development Plan shall set forth, among other things, the following Development Activities: includes (ai) preclinical studies, toxicology studies, pharmaco-economic studies and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, in each case, together with all protocols, endpoints and investigators conducting such trials; (b) Non-NDA Studies and Post-Marketing Authorization Trials and studies; (c) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals; (d) the Joint Development Budget and the qualification of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity); (e) the allocation of the Joint Development Activities Party’s responsibilities for those activities to be conducted by each Party and the timeline performed in regards to obtaining Regulatory Approval for completing such Joint Development Activities; (f) the plans and timeline for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals in the Territories; (g) the Manufacturing Development Activities and other Manufacturing process development activities (Product, including CMC related activities), as well as the plans, amounts and timelines for the Manufacture initiation and supply completion of Productsuch activities, Placebo, combination and comparator products necessary for the Development, taking into account the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required for the performance of the Development Plan. For the avoidance of doubt, the Development Plan shall include also Trials and regulatory plans of the Parties with respect to Sole Funded Development Activities and shall not be limited to the Co-Commercialization Territory. The Initial Development Plan attached hereto as EXHIBIT 6 shall be updated in accordance with this Section 3.3 within [***] days 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. (ii) annual budgeted Program Related Costs for Product for each Annual Period and (iii) the target dates for the submission of an application and other Regulatory Materials for the Regulatory Approval of Product in each Major Market. Pfenex and Hospira shall cooperate with one another to update and/or amend the Development Plan and/or Product Data Sheet from time to time at the request of a Party by such Party’s submission of the Effective proposed amendment to the Executive Steering Committee. Within ten (10) Business Days following the submission by a Party of any such proposed amendment to the Development Plan and/or Product Data Sheet, the Executive Steering Committee shall decide whether to approve such amendment, or a modified version thereof. Notwithstanding the above, Hospira shall have the right to make updates and/or amendments to the Initial Development Plan and any updated Development Plan without submitting such changes to the Executive Steering Committee so long as such updates and/or amendments do not result in a delay to any “Finish Date” to a Critical Task (as defined in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement). The Parties shall refer to the most current Development Plan when identifying the applicable Finish Date with respect to a Critical Task. In all events Hospira shall promptly notify the Project Lead for the Development Program at Pfenex of such updates and amendments. Such notice may be provided by email to the Project Lead. Except as set forth in this Section 3.2(a), neither the Development Plan nor Product Data Sheet may be amended without the prior documented approval of the Executive Steering Committee (subject to the limitations on Hospira’s final decision making authority as set forth in Section 3.2(b) below). (b) Hospira shall not have the right to exercise its final decision-making authority within the Executive Steering Committee with respect to amendments to the Development Plan in a manner (x) that would cause a material delay in the timelines set forth in the Initial Development Plan (for clarity, the timelines in the Initial Development Plan for a particular activity shall be subject to extension for matters beyond the reasonable control of the Party responsible for the particular activity (e.g., delays related to clinical hold by a Regulatory Agency); provided, that such Party uses Commercially Reasonable Efforts to mitigate any such delay and such extension shall be limited to the period necessary to accommodate such delay), (y) that is inconsistent terms of this Agreement, or (z) that would unilaterally impose any material obligation on Pfenex (including causing Pfenex to incur or share any cost that is not provided for in the Development Plan or this Agreement as of the date hereof); provided, that Pfenex shall not unreasonably withhold, condition or delay the consent to perform activities requested by Hospira that are necessary or useful for the development of Product and Pfenex is in the unique position of being able to perform such activities and Hospira agrees to reimburse Pfenex’s internal and external costs incurred in connection with the performance of such activities (which in the case of internal costs shall be determined in accordance with GAAP).

Development Plan. The Development of each Licensed Product in the Field under this Agreement shall be conducted pursuant to a comprehensive written Development plan (the “Development Plan”). Each Development Plan shall set forth the timeline and details of all non-clinical and clinical Development activities: (a) to be conducted by the Parties shall conduct the Development Activities as necessary to generate data useful for both Parties to obtain Regulatory Approval of such Licensed Product [*] = Certain confidential information contained in accordance this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. by both the EMA and FDA for any indication in the Field that the Parties agree to pursue; and (b) any other Development Plan and as further specified activities that the Parties agree to pursue in this Agreementcollaboration for such Licensed Product in the Field in the Territory. The Development Plan shall also set forth, among other things, forth the following budget of such Development Activities: (a) preclinical studies, toxicology studies, pharmaco-economic studies and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, in each case, together with all protocols, endpoints and investigators conducting such trials; (b) Non-NDA Studies and Post-Marketing Authorization Trials and studies; (c) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals; (d) the Joint Development Budget and the qualification of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity); (e) the allocation of the Joint Development Activities activities to be conducted carried out by each Party and the timeline for completing such Joint Development Activities; (f) the plans and timeline for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals in the Territories; (g) the Manufacturing Development Activities and other Manufacturing process development activities (including CMC related activities), as well as the plans, amounts and timelines for the Manufacture and supply of Product, Placebo, combination and comparator products necessary for the Development, taking into account the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required for the performance of the Development Plan. For the avoidance of doubt, the Development Plan shall include also Trials and regulatory plans of the Parties with respect to Sole Funded (the “Development Activities and shall not be limited to the Co-Commercialization TerritoryBudget”). The Initial Development Plan attached hereto as EXHIBIT 6 shall be updated in accordance with this Section 3.3 within [***] days As of the Effective Date, the Parties have agreed upon a sample Development Plan for a particular Licensed Product that directly and selectively modulates a Target that is member of the microRNA 208/499 target family, which plan is attached to this Agreement as Exhibit D, includes only the pre-clinical Development activities for such Licensed Product and shall be updated as provided below. The JRDC shall prepare and submit to the JSC for review and approval the initial Development Plan for each Selected Licensed Product promptly upon the JRDC’s selection of such Selected Licensed Product. From time to time during the Term (no less than once per year), the JRDC shall prepare an update and amendment, as appropriate, to each then-current Development Plan (including Development Budget) and shall submit such updates and amendments to the JSC for review and approval. Once approved by the JSC, each such revised Development Plan shall replace the prior Development Plan for such Licensed Product. If the terms of the Development Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern.

Development Plan. (a) The Development of the Compounds and Collaboration Products under this 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 Products shall set forth the timeline and details of: (i) 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 of the Indications as agreed by the Parties and set forth in the Development Plan; (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 shall conduct the Development Activities in accordance with agree that: (A) the Development Plan will contain detailed plans for at least [ * ] covered by the Development Plan, and as further specified summary plans for periods thereafter, and (B) the budget associated with such Development Plan shall be subject to the approval process set forth in this AgreementSection 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, among 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 other thingsParty’s reasonable request, each Party shall [ * ] Development activities under the following Development Activities: Plan. The [ * ] shall be included in the Development Plan and [ * ] shall be subject to JDC approval. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (ai) preclinical studies, toxicology studies, pharmaco-economic studies not material and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, in each case, together with all protocols, endpoints and investigators conducting such trials;(ii) would likely cause competitive harm if publicly disclosed. (b) NonThe 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 calendar year, [ * ] Development activities are [ * ] the updated Development Plan, the 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-NDA Studies current Development Plan (including [ * ], as applicable), including adding additional Compounds and Post-Marketing Authorization Trials 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 studies;amendments to the Development Plan (including [ * ], as applicable), provided that [ * ] subject to the [ * ] the JDC (and [ * ] for such Indication. Once approved by the JDC, such revised Development Plan shall replace the prior Development Plan. (c) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals; (d) If the Joint Development Budget and the qualification of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity); (e) the allocation of the Joint Development Activities to be conducted by each Party and the timeline for completing such Joint Development Activities; (f) the plans and timeline for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals in the Territories; (g) the Manufacturing Development Activities and other Manufacturing process development activities (including CMC related activities), as well as the plans, amounts and timelines for the Manufacture and supply of Product, Placebo, combination and comparator products necessary for the Development, taking into account the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required for the performance terms of the Development Plan. For the avoidance of doubtPlan contradict, or create inconsistencies or ambiguities with, the Development Plan terms of this Agreement, then the terms of this Agreement shall include also Trials and regulatory plans of the Parties with respect to Sole Funded Development Activities and shall not be limited to the Co-Commercialization Territory. The Initial Development Plan attached hereto as EXHIBIT 6 shall be updated in accordance with this Section 3.3 within [***] days of the Effective Dategovern.

Development Plan. The Parties will agree to a comprehensive development plan for Licensed Products in the Field in the Territory (the "Development Plan"), which shall conduct be prepared by the JPC and approved by the JSC, and is designed to generate the preclinical, clinical, chemistry manufacturing and controls ("CMC"), and regulatory data and information required for filing and approval of a U.S. IND application and a U.S. NDA and the foreign equivalent applications for each ROW Country for which the JSC determines to proceed with Development Activities of Licensed Products in accordance with the Field (as applicable). A preliminary Development Plan for the initial U.S. Development program for the Licensed Product in the Field and its associated budget will be separately agreed upon by the Parties in writing prior to or at the Effective Date (the "Preliminary Development Plan"). The Parties acknowledge that, although the Phase 3 Clinical Trial of the Licensed Product in the Field for post-acute care of COPD ("PAC Trial") is included in the documents setting forth the Preliminary Development Plan, the inclusion of the PAC Trial or any other Development activities related to post-acute care in the Development Plan to be implemented under this Agreement shall be contingent upon further refinement of the protocol, discussions with the FDA, further cost/benefit analysis and approval by the JSC. Accordingly, as further specified in this Agreementof the Effective Date, THERAVANCE shall not be obligated to perform, and MYLAN shall not be obligated to pay for, the PAC Trial, and any such obligations shall be subject to the foregoing contingencies, including approval by the JSC. The full Development Plan shall set forthwill contain, among other things, the following Development Activitiesat a minimum: (a) preclinical studiesa prioritized list of indications for which the Parties intend to seek Marketing Authorization for the Licensed Products in the Field, toxicology studies, pharmaco-economic studies and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, in each case, together with all protocols, endpoints and investigators conducting timelines for such trials;activities; ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. ​ (b) Non-NDA Studies the configurations of Licensed Product in the Field, including Combination Licensed Product(s), that will be Developed by the Parties for the Territory, and Post-Marketing Authorization Trials and studiestimelines for such Development; (c) regulatory plans Protocol synopses that meet the standards for registration of non-clinical, pre-clinical and other elements clinical trials in the Countries in which the Parties intend to conduct the trials of obtaining and maintaining Regulatory ApprovalsLicensed Product in the Field that are described in such protocols; (d) Complete study protocols, including statistical analysis plans, for the Joint Development Budget non-clinical, pre-clinical studies and clinical trials to be executed by the qualification Parties or their representatives with respect to Licensed Products in the Field, and timelines for the conduct of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (such study and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity)trial; (e) the allocation Regulatory strategy to coordinate submissions of Regulatory Filings, including NDAs and Marketing Authorization Applications, in each of the Joint Development Activities to be conducted by each Party applicable Countries, and the timeline timelines for completing such Joint Development Activitiessubmissions; (f) the plans Manufacturing strategy for clinical supply and timeline transition and scale up to commercial supply for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals Licensed Product in the Territories;Field in the Territory, including development of a harmonized manufacturing package for registration and approval, and any bridging studies necessary in connection with a change of manufacturer for commercial supply; and (g) the Manufacturing A detailed Development Activities Budget setting forth all anticipated Development Expenses by trial and other Manufacturing process development activities (including CMC related activities), as well as the plans, amounts and timelines for the Manufacture and supply of Product, Placebo, combination and comparator products necessary for the Development, taking into account the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required for the performance of the Development Plan. For the avoidance of doubt, the Development Plan shall include also Trials and regulatory plans of the Parties with respect to Sole Funded Development Activities and shall not be limited to the Co-Commercialization Territory. The Initial Development Plan attached hereto as EXHIBIT 6 shall be updated in accordance with this Section 3.3 within [***] days of the Effective DateCalendar Quarter.

Development Plan. The Parties All Development of the Specialty Product in and for the Territory shall conduct be conducted pursuant to a written development plan which sets forth the Development Activities in accordance with the Development Plan timeline and as further specified in this Agreement. The Development Plan shall set forth, among other things, the following Development Activities: (a) preclinical details of all non-clinical and clinical studies, toxicology studies, pharmaco-economic studies regulatory affairs strategy and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, in each case, together with all protocols, endpoints and investigators conducting such trials; (b) Non-NDA Studies and Post-Marketing Authorization Trials and studies; (c) regulatory plans activities and other elements Development activities to be conducted by or on behalf of a Party or its Affiliate in connection with obtaining and maintaining Regulatory Approvals; (d) the Joint Development Budget and the qualification of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity); (e) the allocation of the Joint Development Activities to be conducted by each Party and the timeline for completing such Joint Development Activities; (f) the plans and timeline for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals in the Territories; Territory (g) the Manufacturing “Development Activities Plan”). As soon as practicable after the Effective Date, the JDC shall discuss and other Manufacturing process development activities prepare, and the JSC shall approve, the initial Development Plan pursuant to Section 3.3. From time to time (including CMC related activitiesat least on an annual basis), the JDC shall prepare amendments and updates, as well as appropriate, to the plansthen-current Development Plan, amounts and timelines shall submit such amendments and updates to the JSC for review, discussion and approval pursuant to Section 3.3. If the Manufacture terms of the Development Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. For more clarity, the special considerations and supply of Product, Placebo, combination commonly accepted industry standards or practices with regard to the Development in China shall be specifically and comparator products necessary for the Development, taking duly taken into account in discussing, preparing and approving the respective supply chain Development timelines and inventory of stock; and (h) the number of FTEs required for the performance of the Development Plan. . Under the oversight of the JDC, each Party or its Affiliate shall conduct Development activities in and for the Territory in accordance with, and as assigned to such Party under, the Development Plan, in good scientific manner, and in compliance with all Applicable Laws, including applicable national and international guidelines such as ICH, GCP, GLP and GMP. Without limiting the foregoing, each Party shall use Commercially Reasonable Efforts to accomplish the Development work assigned to such Party under each Development Plan in accordance with the timelines specified therein. In the event Licensee, prior to receipt of the first Regulatory Approval in the Territory, discontinues all or substantially all Development activities set forth in the Development Plan for a period of three (3) consecutive months, other than for reasons, being judged by the commonly accepted standards or practices in pharmaceutical industry of Territory, that are commercially impracticable or outside Licensee’s control (such as due to Regulatory Authority requirements or delays), then, without prejudice or limitation to Teva’s other termination rights hereunder, Teva shall have the right in its sole discretion, upon thirty (30) days’ written notice to Licensee, to terminate this Agreement with respect to the given Specialty Product, provided however, that Teva has called for the consultation(s) on such Development discontinuation but both Parties are still unable to reach a solution within three (3) months as from the date of the first consultation. For the avoidance of doubtdoubtExcept as stated in the foregoing, the termination right set forth in this Section 4.3 is not intended in any manner to inform or restrict Teva’s other termination rights hereunder in any manner or degree, or set any threshold by which such other termination rights are to be judged or characterized, except that such Development discontinuance is caused by the reasons imputable to Teva (such as Teva’s delay in its responsible Development or other breach of this Agreement), in which case the termination right set forth in this Section 4.3 shall not be applicable or enforced, and both Parties shall, at the reasonable request of Licensee, be obligated to renegotiate on the affected Development timelines and regulatory approvals milestones in good faith. Each Party may perform Development work for which it is responsible under the Development Plan through one or more subcontractors or consultants, provided that the contracting Party shall include also Trials and regulatory plans of the Parties with respect remain responsible for any obligations that have been delegated or subcontracted to Sole Funded Development Activities any subcontractor, and shall not be limited to responsible for the Co-Commercialization Territoryperformance of its subcontractors. The Initial Development Plan attached hereto as EXHIBIT 6 Upon reasonable notice during regular business hours, Teva shall be updated entitled to audit such Licensee subcontractors at Teva’s sole cost and expense, and Licensee shall be obligated to include such audit right of Teva in accordance its agreements with this Section 3.3 within [***] days of the Effective Datesuch subcontractors.

Development Plan. The Parties shall conduct A. Within [*****] after the Development Activities Effective Date (and taking into consideration the requirement of completing the task set forth in accordance this Section 4.1(A) in order that the parties may comply with the Development Plan obligations set forth in Section 4.1(B)), NABI will perform a CMC audit of the Facility and provide FRESENIUS with a detailed list of all items that NABI reasonably believes will need to be addressed and remedied in connection with the Facility before the first day of the second full calendar quarter prior to the planned submission to the US FDA of a Reviewable BLA in order that the Facility will be approved by the US FDA for the production of Licensed Product for marketing and distribution in the USA. The parties will negotiate the reasonableness, content and timing of the items specified by NABI during the thirty (30) days after delivery of the list to FRESENIUS. If the parties come to mutual agreement, then the items and time frames will be incorporated into and become part of the FRESENIUS Scheduled Obligations contemplated by Section 4.1(B) below. Failing such agreement each party will, upon the request of the other party, appoint an independent credentialed examiner or inspector familiar with FDA requirements for manufacturing facilities and request such appointed persons to designate a third person who will act as the arbiter (the “Arbiter”). The Arbiter will be asked to resolve the differences between the parties and establish a definitive list of items to be remedied in the Facility in order that the same may comply with FDA requirements as then in existence for a manufacturing facility which will be examined in connection with a Reviewable BLA. Such determination will be final and binding on the parties and the cost for the services of the Arbiter shall be shared equally between the parties. FRESENIUS shall make such upgrades to the Facility as agreed by the parties or fixed by the Arbiter and as further specified may be subsequently required by the US FDA during the term of this Agreement in this Agreementorder that the Facility will be, and will remain, approved by the US FDA for the production of Licensed Product for marketing and distribution in the USA. B. Within [*****] after FRESENIUS delivers to NABI all of the clinical data required to be delivered pursuant to section 3.5(A), NABI shall meet with appropriate officials of the US FDA and determine the most efficient means of completing the studies which are necessary to commercialize the Licensed Product. Within sixty (60) days after the meeting with the US FDA, representatives of FRESENIUS and NABI shall meet with the Steering Committee and describe and discuss NABI’s strategy for development (clinical and regulatory) and commercialization of the Licensed Product in the Territory. The Development Plan parties shall set forth, among other things, discuss in good faith the following Development Activities: registration strategy and clinical studies that shall be undertaken to obtain marketing authorization in the Territory (astarting with the U.S.) preclinical studies, toxicology studies, pharmaco-economic studies and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, in each case, together with all protocols, endpoints and investigators conducting such trials; establish specific milestones for: (b) Non-NDA Studies and Post-Marketing Authorization Trials and studies; (c) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals; (di) the Joint Development Budget actions to be taken by NABI in order to assure efficient and the qualification of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity); (e) the allocation expeditious approval of the Joint Development Activities to be conducted by each Party and the timeline Licensed Product for completing such Joint Development Activities; (f) the plans and timeline for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals commercial sale in the Territories; (g) the Manufacturing Development Activities U.S. and other Manufacturing process development activities (including CMC related activities), as well as the plans, amounts and timelines a time table for the Manufacture realization thereof (collectively, “NABI’s Scheduled Obligations”); and supply of Product, Placebo, combination and comparator products necessary for (ii) based on the Development, taking into account time table developed by the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required parties for the performance of various items necessary to obtain approval of the Development PlanLicensed Product and depending on the time line for NABI to reasonably comply with NABI’s obligations, (x) the actions to be taken by FRESENIUS to upgrade the Facility to comply with the applicable US FDA manufacturing standards and the time table for the completion thereof as provided by Section 4.1(A) above; and (y) the date by which FRESENIUS will deliver to NABI whatever non-clinical (including toxicology and pharmacology (animal data)) package is required by the US FDA, which date may not be later than the first day of the second full calendar quarter prior to the planned submission to the US FDA of a Reviewable BLA (collectively the “FRESENIUS Scheduled Obligations”). For Upon agreement and approval by the avoidance of doubtSteering Committee, the Development Plan actions comprising and the time lines for completing the NABI Scheduled Obligations and the FRESENIUS Scheduled Obligations shall be a part of this Agreement as if set forth herein. The registration strategy shall include also Trials and regulatory plans continuation of the Parties with respect to Sole Funded Development Activities lung transplant study currently underway and shall not be limited to shall, at the Co-Commercialization Territory. The Initial Development Plan attached hereto as EXHIBIT 6 option of NABI, specify whether the clinical studies for the SOT indication and the SCT indication shall be updated undertaken sequentially or contemporaneously in accordance with this Section 3.3 light of the estimated cost thereof and the mutual intention of the parties that the registration strategy shall be focused on minimizing the time to obtain necessary approvals in the Territory for the Licensed Product. C. FRESENIUS shall use commercially reasonable means to deliver to NABI, within [*****] days of the Effective Date, all the clinical data for ATG, and the clinical data for Global ATG that is relevant to NABI’s planned conduct of clinical studies and BLA submission to the US FDA and which, in either case, is in the possession or control of FRESENIUS (including the CRF and other pertinent files) together with such documents as may be necessary to reference any filing with the US FDA for approval of the Licensed Product as the same may exist on the Effective Date. D. In the event of a disagreement between the parties with respect to the strategy or time table in the Territory, the NABI Scheduled Obligations, the FRESENIUS Scheduled Obligations or any supplemental agreement to be entered into regarding safety or quality, the parties shall first meet and confer and endeavor in good faith to resolve the disagreement. If the disagreement persists, the parties will elevate the discussion to the Steering Committee. If the Steering Committee cannot resolve the issue, the parties will elevate the discussion to their respective CEOs for resolution. If the disagreement cannot be resolved by the CEOs, NABI shall have the final deciding vote with respect thereto (except with respect to the Facility upgrade which is governed by Section 4.1(A), the content and date for delivery of the toxicology package which are governed by Section 4.1(B)(y) , any supplemental agreement to be entered into regarding quality, and the other FRESENIUS Scheduled Obligations). E. NABI shall at all times during the development phase as well as during the commercialization process, give prompt written notice to FRESENIUS of any substantive, content-driven notices or communications (other than purely scheduling or administrative items) between NABI and regulatory agencies regarding the Licensed Product. Prior to any substantive, content-driven communications with the US FDA, the FRESENIUS members of the project team shall have reasonable notice of, and the opportunity to discuss, all matters in accordance with Section 4.6. NABI shall allow FRESENIUS the right, at its sole cost, to participate along with NABI in any meetings or conference calls with the US FDA and all other regulatory agencies, provided that NABI will have the final say in all matters to be communicated to the US FDA with respect to the Licensed Product. F. FRESENIUS shall at all times during the development phase as well as during the commercialization process, give prompt written notice to NABI of any substantive, content-driven notices or communications between FRESENIUS and regulatory agencies regarding the safety and efficacy of Global ATG or the Licensed Product or the US FDA qualification of the Facility.

Development Plan. The Parties Attached as Schedule 3.2(a) is the initial Development Plan (the “Initial Development Plan”), which contains detailed provisions governing all clinical development, budgets and timelines, Manufacturing, and regulatory work expected, as of the Effective Date, to be performed by BDSI and Endo to obtain initial Regulatory Approval of Product in the U.S., provided that, notwithstanding anything to the contrary, BDSI’s obligations under the Initial Development Plan shall conduct be limited to the Development Activities in accordance with performance of the Clinical Trials***, described therein as being performed by BDSI (the “Initial BDSI Trials”), ***. Endo shall provide BDSI a period of not more than *** to provide substantive comments on any amendments to the Development Plan and protocols for Clinical Trials. Endo shall give good faith consideration to all substantive comments timely provided by BDSI and shall revise the Development Plan, such amendments and each such protocol to reflect any such comments provided by BDSI that Endo, in its reasonable discretion, shall deem necessary or appropriate. As long as further specified Product is being developed, the JDC shall review the Development Plan at least annually and may, from time to time, provide comments to and/or revise the Development Plan in a manner consistent with the terms of this Agreement and the goals of the Parties’ collaborative development of Product. The final determination as to what changes and/or revisions shall be made to any Development Plan shall be made by the JDC and will be subject to the provisions of Section 2.3 in the case of any deadlock among the members of the JDC. ***. Once approved in accordance with this Agreement, a revised Development Plan shall replace the prior Development Plan. The Development Plan shall set forth, among other thingsin no event be amended in a manner that would require either Party to perform any assignment or task in a manner that would violate any applicable law or regulation. In the event of a change in any applicable law or regulation, the following Development Activities: (a) preclinical studies, toxicology studies, pharmaco-economic studies and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, Parties shall work together in each case, together with all protocols, endpoints and investigators conducting such trials; (b) Non-NDA Studies and Post-Marketing Authorization Trials and studies; (c) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals; (d) the Joint Development Budget and the qualification of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity); (e) the allocation of the Joint Development Activities good faith to be conducted by each Party and the timeline for completing such Joint Development Activities; (f) the plans and timeline for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals in the Territories; (g) the Manufacturing Development Activities and other Manufacturing process development activities (including CMC related activities), as well as the plans, amounts and timelines for the Manufacture and supply of Product, Placebo, combination and comparator products necessary for the Development, taking into account the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required for the performance of the Development Plan. For the avoidance of doubt, amend the Development Plan shall include also Trials and regulatory plans of to enable each Party to comply fully with such law or regulation. If such amendment is not approved, the Parties with respect to Sole Funded Development Activities and shall not affected Party would be limited to excused from performing any activity specified in the Co-Commercialization Territory. The Initial Development Plan attached hereto as EXHIBIT 6 shall be updated that would violate or result in accordance with this Section 3.3 within [***] days a violation of the Effective Dateany applicable law or regulation.

Development Plan. The Parties will agree to a comprehensive development plan for Licensed Products in the Field in the Territory (the “Development Plan”), which shall conduct be prepared by the JPC and approved by the JSC, and is designed to generate the preclinical, clinical, chemistry manufacturing and controls (“CMC”), and regulatory data and information required for filing and approval of a U.S. IND application and a U.S. NDA and the foreign equivalent applications for each ROW Country for which the JSC determines to proceed with Development Activities of Licensed Products in accordance with the Field (as applicable). A preliminary Development Plan for the initial U.S. Development program for the Licensed Product in the Field and its associated budget will be separately agreed upon by the Parties in writing prior to or at the Effective Date (the “Preliminary Development Plan”). The Parties acknowledge that, although the Phase 3 Clinical Trial of the Licensed Product in the Field for post-acute care of COPD (“PAC Trial”) is included in the documents setting forth the Preliminary Development Plan, the inclusion of the PAC Trial or any other Development activities related to post-acute care in the Development Plan to be implemented under this Agreement shall be contingent upon further refinement of the protocol, discussions with the FDA, further cost/benefit analysis and approval by the JSC. Accordingly, as further specified in this Agreementof the Effective Date, THERAVANCE shall not be obligated to perform, and MYLAN shall not be obligated to pay for, the PAC Trial, and any such obligations shall be subject to the foregoing contingencies, including approval by the JSC. The full Development Plan shall set forthwill contain, among other things, the following Development Activitiesat a minimum: (a) preclinical studiesa prioritized list of indications for which the Parties intend to seek Marketing Authorization for the Licensed Products in the Field, toxicology studies, pharmaco-economic studies and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, in each case, together with all protocols, endpoints and investigators conducting timelines for such trials;activities; ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. (b) Non-NDA Studies the configurations of Licensed Product in the Field, including Combination Licensed Product(s), that will be Developed by the Parties for the Territory, and Post-Marketing Authorization Trials and studiestimelines for such Development; (c) regulatory plans Protocol synopses that meet the standards for registration of non-clinical, pre-clinical and other elements clinical trials in the Countries in which the Parties intend to conduct the trials of obtaining and maintaining Regulatory ApprovalsLicensed Product in the Field that are described in such protocols; (d) Complete study protocols, including statistical analysis plans, for the Joint Development Budget non-clinical, pre-clinical studies and clinical trials to be executed by the qualification Parties or their representatives with respect to Licensed Products in the Field, and timelines for the conduct of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (such study and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity)trial; (e) the allocation Regulatory strategy to coordinate submissions of Regulatory Filings, including NDAs and Marketing Authorization Applications, in each of the Joint Development Activities to be conducted by each Party applicable Countries, and the timeline timelines for completing such Joint Development Activitiessubmissions; (f) the plans Manufacturing strategy for clinical supply and timeline transition and scale up to commercial supply for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals Licensed Product in the Territories;Field in the Territory, including development of a harmonized manufacturing package for registration and approval, and any bridging studies necessary in connection with a change of manufacturer for commercial supply; and (g) the Manufacturing A detailed Development Activities Budget setting forth all anticipated Development Expenses by trial and other Manufacturing process development activities (including CMC related activities), as well as the plans, amounts and timelines for the Manufacture and supply of Product, Placebo, combination and comparator products necessary for the Development, taking into account the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required for the performance of the Development Plan. For the avoidance of doubt, the Development Plan shall include also Trials and regulatory plans of the Parties with respect to Sole Funded Development Activities and shall not be limited to the Co-Commercialization Territory. The Initial Development Plan attached hereto as EXHIBIT 6 shall be updated in accordance with this Section 3.3 within [***] days of the Effective DateCalendar Quarter.

Development Plan. The Parties shall conduct the Development Activities in accordance with the Development Plan and as further specified in this Agreement. The Development Plan shall set forth, among other things, the following Development Activities: (a) preclinical studies, toxicology studies, pharmaco-economic studies and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, in each case, together with all protocols, endpoints and investigators conducting such trials; (b) Non-NDA Studies and Post-Marketing Authorization Trials and studies; (c) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals; (d) the Joint Development Budget and the qualification of each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity); (e) the allocation of the Joint Development Activities to be conducted by each Party and the timeline for completing such Joint Development Activities; (f) the plans and timeline for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals in the Territories; (g) the Manufacturing Development Activities and other Manufacturing process development activities (including CMC related activities), as well as the plans, amounts and timelines for the Manufacture and supply of Product, Placebo, combination and comparator products necessary for the Development, taking into account the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required for the performance of the Development Plan. For the avoidance of doubt, the Development Plan shall include also Trials and regulatory plans of the Parties with respect to Sole Funded Development Activities and shall not be limited to the Co-Commercialization Territory. The Initial Development Plan attached hereto as EXHIBIT 6 shall be updated in accordance with this Section 3.3 within Within [***] days following the 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 conduct Research and Development in the ONO Territory, and FATE will prepare and provide to the JSC (i) an update to its proposed activities under the Joint Development Plan 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 ONO in the Effective DateONO 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 provide its 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 Section 4.1.8 (Decision-Making; Limitations on JSC), provided however, [***].

Development Plan. The Parties shall conduct the Development Activities in accordance with Attached as Schedule 3.3(b)(i) is the Development Plan (the “Development Plan”), which contains a detailed list of Athenex Studies, provisions governing all regulatory work expected as of the Execution Date, all Development and as further specified in this Agreementregulatory milestones, the corresponding timelines to conduct all such activities and the corresponding allocation of responsibilities between the Parties to conduct all such activities. The Development Plan shall set forth, among other things, be amended to include any additional study necessary for the following Development Activities: (a) preclinical studies, toxicology studies, pharmaco-economic studies and Trials evaluating the safety and/or efficacy including Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Pivotal Trials, in each case, together with all protocols, endpoints and investigators conducting such trials; (b) Non-NDA Studies and Post-Marketing Authorization Trials and studies; (c) regulatory plans and other elements purposes of obtaining and maintaining Regulatory Approvals; (d) Approval for the Joint Development Budget and Current Product in the qualification of Field in the U.S. For this purpose, each Development Activity as a Joint Development Activity, a Manufacturing Development Activity, a MorphoSys Funded Development Activity or a COMPANY Funded Development Activity (and within this qualification whether such COMPANY Funded Development Activity is a COMPANY Discretionary Manufacturing Activity); (e) Party shall provide the allocation of the Joint Development Activities to be conducted by each other Party and the timeline Joint Steering Committee as soon as possible following it becoming reasonably apparent to such Party that additional studies will be required for completing such Regulatory Approval, any proposed amendments to the Development Plan and protocols for additional Athenex Studies proposed to be included therein. Each Party and the Joint Steering Committee shall give good faith consideration to all substantive comments timely provided by a Party with respect thereto and the Joint Steering Committee will adapt the Development Activities; (f) Plan as needed to include any such additional requirement for Regulatory Approval for the plans and timeline for preparing the necessary Regulatory Materials/Pricing Materials and for obtaining and/or maintaining Regulatory Approvals/Pricing Approvals Current Product in the Territories; (g) Field in the Manufacturing U.S. Once approved in accordance with this Agreement, a revised Development Activities and other Manufacturing process development activities (including CMC related activities), as well as Plan shall replace the plans, amounts and timelines for the Manufacture and supply of Product, Placebo, combination and comparator products necessary for the Development, taking into account the respective supply chain timelines and inventory of stock; and (h) the number of FTEs required for the performance of the prior Development Plan. The Development Plan shall in no event be amended in a manner that would require either Party to perform any assignment or task in a manner that would violate any applicable Law. In the event of a change in any applicable Law, the Parties shall work together in good faith to amend the Development Plan to enable each Party to comply fully with such Law. If such amendment is not approved, the affected Party would be excused from performing any activity specified in the Development Plan that would violate or result in a violation of any applicable Law. For the avoidance certainty, changes of doubt, the Development Plan shall include also Trials be treated as changes of this License Agreement and regulatory plans will be subject to a written separate document signed by authorized representatives of the Parties with respect to Sole Funded Development Activities each Party and shall not be limited to the Co-Commercialization Territory. The Initial Development Plan attached hereto as EXHIBIT 6 shall be updated in accordance with this Section 3.3 within [***] days of the Effective Dateappended hereto.