Common use of Development Plan Clause in Contracts

Development Plan. The Parties’ respective responsibilities for the Development of the Collaboration Compounds and the Products are set forth in this Article 4. As of the Execution Date, the Parties have agreed upon a Development Plan for the Development of Product(s), attached to this Agreement as Exhibit A. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to the Development Plan for Development of a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All Development Plans must require periodic reassessment and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities shall be subject to the approval of the JDC in view of then applicable scientific, clinical, safety, [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. financial and commercial factors. The Development Plan shall allocate Development activities between the Parties, based on the following principles: (i) with respect to Product(s) comprising the Lead Compound, Portola will be the lead Party for Development activities [*]; (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until [*] for such Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be the lead party for [*] for the Products; and (v) Portola shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of the Development Activities according to the Development Plan and within the Development Budget. In the course of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduct certain specific Development activities, and the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetings.

Development Plan. The Parties’ respective responsibilities Promptly after the execution of this Agreement, on a Collaboration Product-by-Collaboration Product basis, Pfenex and 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 Development Successful Completion of the first Phase I Clinical Trial for any Collaboration Compounds Product(s), as well as the location, protocol, budget and timelines for completion of various tasks therefor (each, a “Development Plan”). Each Development Plan shall be subject to the Products are set forth 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 product hereunder; provided, however, that unless and until the earlier of (a) the Parties sign a Development Plan 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 this Article 4. As of the Execution DateSection 1.6(a) — (e), the Parties have agreed upon a shall use good faith efforts to prepare and agree on Development Plan for therefor prior to the Development of Product(s), attached to this Agreement date specified in Exhibit 1 (as Exhibit A. The Development Plan may be revised amended from time to time by the JDCParties). Either Party may propose modifications to the Each Development Plan for Development of a Product, including clinical trial plans will be updated and time lines, approved semi-annually by the JSC and such proposed modifications shall be subject consistent with the general allocation of responsibilities described in Section 3.2 below. Without limiting the foregoing, any material modifications or additions to review and approval by the JDC, provided that with respect to a Material any Development Plan Amendment, a (including any proposed change(s) to any Third Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All Development Plans must require periodic reassessment and re-approval (each a “Go/No-go Decision”designee) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities shall be subject first approved by JSC prior to the approval of the JDC its implementation. Each Party shall perform its obligations allocated to it under each Development Plan in view of then applicable scientific, clinical, safety, [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately accordance with the Securities terms and Exchange Commission pursuant to Rule 406 conditions of this Agreement (including the Securities Act of 1933diligence requirement set forth in Article 8), as amended. financial and commercial factors. The Development Plan shall allocate Development activities between the Parties, based on the following principles: (i) with respect to Product(s) comprising the Lead Compound, Portola will be the lead Party for Development activities [*]; (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until [*] for such Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be the lead party for [*] for the Products; and (v) Portola shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of the Development Activities according to the applicable Development Plan and within the Development Budget. In the course of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduct certain specific Development activities, and the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetingsall Applicable Laws.

Development Plan. Within thirty (30) days after the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development activities with respect to the Product pursuant to this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties’ respective responsibilities for , shall be deemed effective (the “Initial Development of Plan”). During the Collaboration Compounds and the Products are Term, except as may be expressly set forth in this Article 4. As of Agreement and the Execution DateDevelopment Plan agreed to by the Parties, the Anji Pharma Related Parties shall have agreed upon a sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the Development of Product(s), attached to this Agreement as Exhibit A. The following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may be revised from time to time by time, at its election and sole discretion, revise the JDC. Either Party may propose modifications Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of a ProductLipimetiX shall require the prior written approval of LipimetiX, including clinical trial plans and time lines(b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and such proposed modifications (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to review and LipimetiX’s approval by rights in the JDCimmediately preceding sentence, provided upon written approval of LipimetiX. If LipimetiX believes that with respect a change to a Material the Development Plan Amendmentwould be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, a Party may propose the Parties shall discuss such modifications directly concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the JSCDevelopment Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. Upon approval by In the JDC (or JSC, as applicable), such modifications shall become part event of any inconsistency between the Development Plan. All Development Plans must require periodic reassessment Plan and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as this Agreement, the JDC in its discretion deems appropriate, at which point continuation terms of relevant Development activities this Agreement shall be subject to the approval of the JDC in view of then applicable scientific, clinical, safety, [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. financial and commercial factorsprevail. The Development Plan shall allocate Development activities between the Parties, based on the following principles: (i) with respect to Product(s) comprising the Lead Compound, Portola will be the lead Party for Development activities [*]; (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until [*] for such Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be the lead party for [*] for the Products; and (v) Portola shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance considered Confidential Information of the Development Activities according to the Development Plan and within the Development Budget. In the course of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduct certain specific Development activities, and the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetingsAnji Pharma.

Development Plan. The Parties’ respective responsibilities for the Development of each Licensed Product in the Collaboration Compounds and Field under this Agreement shall be conducted pursuant to a comprehensive written Development plan (the Products are “Development Plan”). Each Development Plan shall set forth in this Article 4. As the timeline and details of the Execution Date, all non-clinical and clinical Development activities: (a) to be conducted by the Parties have agreed upon a Development Plan as necessary to generate data useful for the Development both Parties to obtain Regulatory Approval of Product(s), attached to this Agreement as Exhibit A. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to the Development Plan for Development of a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All Development Plans must require periodic reassessment and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities shall be subject to the approval of the JDC in view of then applicable scientific, clinical, safety, Licensed Product [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and is filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. financial by both the EMA and commercial factorsFDA for any indication in the Field that the Parties agree to pursue; and (b) any other Development activities that the Parties agree to pursue in collaboration for such Licensed Product in the Field in the Territory. The Development Plan shall allocate also set forth the budget of such Development activities between to be carried out by the PartiesParties (the “Development Budget”). As of the Effective Date, based on the following principles: (i) with respect 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 Product(s) comprising this Agreement as Exhibit D, includes only the Lead Compound, Portola will be the lead Party for pre-clinical Development activities [*]; (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until [*] for such Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec Licensed Product and shall be the lead party for [*] for the Products; and (v) Portola shall be the lead Party [*]updated as provided below. The lead Party JRDC shall prepare and submit to the JSC for review and approval the initial Development activities pertaining Plan for each Selected Licensed Product promptly upon the JRDC’s selection of such Selected Licensed Product. From time to any Product time during the Term (no less than once per year), the JRDC shall have 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 primary responsibility JSC for review and approval. Once approved by the performance JSC, each such revised Development Plan shall replace the prior Development Plan for such Licensed Product. If the terms of the Development Activities according to Plan contradict, or create inconsistencies or ambiguities with, the Development Plan and within terms of this Agreement, then the Development Budget. In the course terms of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduct certain specific Development activities, and the other Party this Agreement shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetingsgovern.

Development Plan. The Parties’ respective responsibilities for the Development of the Collaboration Compounds and Licensed Products shall be governed by the Products are Development Plan, and the Parties may not Develop any Collaboration Compound or Licensed Product other than in accordance with the Development Plan or as set forth in this Article 4Section 2.2.3(c) or Section 2.3. As Each Party shall use Commercially Reasonable Efforts to conduct all their Development activities relating to Licensed Products in accordance with the Development Plan. Summit shall prepare the initial draft of the Execution Date, initial [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Parties have agreed upon a Commission. Development Plan for review and approval by the JSC. The JSC shall be responsible for approving the initial Development Plan. Unless otherwise approved by the JSC, the Development Plan shall include in reasonable detail (a) all Development activities reasonably anticipated to be undertaken by each Party, (b) the endpoints for all Clinical Studies contemplated by such plan, (c) which Clinical Study is intended to be a Pivotal Clinical Study, (d) all regulatory activities and interactions anticipated to be conducted by each Party in support of Product(sRegulatory Approval of each Licensed Product, including all planned regulatory filings to be submitted in connection with such approvals, (e) a good faith non-binding estimate of the dates on which the Parties expect to achieve each milestone event set forth in TABLE 8.2.1, and, if applicable, TABLE 8.2.2 and TABLE 8.2.3 and (f) a budget for all Development Costs. The JSC shall approve the initial Development Plan within ninety (90) days after the Effective Date in accordance with Section 5.3.1(a), and once the JSC approves such initial Development Plan, it will be attached to this Agreement as Exhibit A. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to the Development Plan for Development of a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All Development Plans must require periodic reassessment and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities shall be subject to the approval of the JDC in view of then applicable scientific, clinical, safety, [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. financial and commercial factors. The Development Plan shall allocate Development activities between the Parties, based on the following principles: (i) with respect to Product(s) comprising the Lead Compound, Portola will be the lead Party for Development activities [*]; (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until [*] for such Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be the lead party for [*] for the Products; and (v) Portola shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of the Development Activities according to the Development Plan and within the Development Budget. In the course of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduct certain specific Development activities, and the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetings.A.

Development Plan. (a) The Parties’ respective responsibilities for the Development of the Collaboration 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 are 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 this Article 4. As of the Execution Date, 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 have agreed upon a Development Plan agree to pursue in collaboration for the Development of Product(s), attached to this Agreement as Exhibit A. such Compound and corresponding Collaboration Products. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to Parties agree that: (A) the Development Plan will contain detailed plans for Development of a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval at least [ * ] covered by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All , and summary plans for periods thereafter, and (B) the budget associated with such Development Plans must require periodic reassessment and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities Plan shall be subject to the approval 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 other Party’s reasonable request, each Party shall [ * ] Development activities under the Development Plan. The [ * ] shall be included in the Development Plan and [ * ] shall be subject to JDC in view of then applicable scientific, clinical, safety, [*approval. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. financial and commercial factors. The Development Plan shall allocate Development activities between the Parties, based on the following principles: because it is both (i) with respect to Product(s) comprising the Lead Compound, Portola will be the lead Party for Development activities [*]; not material and (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until [*] for such Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be the lead party for [*] for the Products; and (v) Portola shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of the Development Activities according to the Development Plan and within the Development Budget. In the course of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduct certain specific Development activities, and the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetingswould likely cause competitive harm if publicly disclosed.

Development Plan. The Parties’ respective responsibilities for the All Development of the Collaboration Compounds Specialty Product in and for the Products are set Territory shall be conducted pursuant to a written development plan which sets forth the timeline and details of all non-clinical and clinical studies, regulatory affairs strategy and activities and other Development activities to be conducted by or on behalf of a Party or its Affiliate in this Article 4connection with obtaining and maintaining Regulatory Approvals in the Territory (the “Development Plan”). As of soon as practicable after the Execution Effective Date, the Parties have agreed upon a JDC shall discuss and prepare, and the JSC shall approve, the initial Development Plan for the Development of Product(s), attached pursuant to this Agreement as Exhibit A. The Development Plan may be revised from Section 3.3. From time to time by (at least on an annual basis), the JDCJDC shall prepare amendments and updates, as appropriate, to the then-current Development Plan, and shall submit such amendments and updates to the JSC for review, discussion and approval pursuant to Section 3.3. Either Party may propose modifications 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. For more clarity, the special considerations and commonly accepted industry standards or practices with regard to the Development Plan for Development of a Product, including clinical trial plans and time lines, and such proposed modifications in China shall be subject to review specifically and approval by duly taken into account in discussing, preparing and approving the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part timelines of the Development Plan. All Performance . Under the oversight of the JDC, each Party or its Affiliate shall conduct Development Plans must require periodic reassessment activities in and re-approval 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 (each a “Go/No-go Decision”3) after each clinical trial consecutive months, other than for reasons, being judged by the commonly accepted standards or at practices in pharmaceutical industry of Territory, that are commercially impracticable or outside Licensee’s control (such times as due to Regulatory Authority requirements or delays), then, without prejudice or limitation to Teva’s other termination rights hereunder, Teva shall have the JDC right in its discretion deems appropriatesole discretion, at which point continuation of relevant Development activities shall be subject upon thirty (30) days’ written notice to the approval of the JDC in view of then applicable scientificLicensee, clinical, safety, [*] = Certain confidential information contained in to terminate this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. financial and commercial factors. The Development Plan shall allocate Development activities between the Parties, based on the following principles: (i) Agreement with respect to Product(sthe given Specialty Product, provided however, that Teva has called for the consultation(s) comprising on such Development discontinuation but both Parties are still unable to reach a solution within three (3) months as from the Lead Compounddate of the first consultation. For the avoidance of doubtExcept as stated in the foregoing, Portola will 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 lead 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 activities [*]; (ii) with respect Plan through one or more subcontractors or consultants, provided that the contracting Party shall remain responsible for any obligations that have been delegated or subcontracted to any Product comprising a Back-Up Compoundsubcontractor, Portola will be the lead Party for Development activities until [*] for such Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec and shall be the lead party for [*] for the Products; and (v) Portola shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility responsible for the performance of the Development Activities according its subcontractors. Upon reasonable notice during regular business hours, Teva shall be entitled to the Development Plan audit such Licensee subcontractors at Teva’s sole cost and within the Development Budget. In the course of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduct certain specific Development activitiesexpense, and the other Party Licensee shall have the be obligated to include such audit right to accept or reject of Teva in its agreements with such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetingssubcontractors.

Development Plan. The Parties’ respective responsibilities Promptly after the execution of this Agreement, on a Collaboration Product-by-Collaboration Product basis, Pfenex and 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 Development Successful Completion of the first Phase I Clinical Trial for any Collaboration Compounds and the Products are set forth in this Article 4. As of the Execution Date, the Parties have agreed upon a Development Plan for the Development of Product(s), attached to this Agreement as Exhibit A. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to the Development Plan for Development of a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All Development Plans must require periodic reassessment and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times well as the JDC in its discretion deems appropriatelocation, at which point continuation protocol, budget and timelines for completion of relevant Development activities shall be subject to the approval of the JDC in view of then applicable scientific, clinical, safety, various tasks therefor [*] = Certain confidential information contained in this document, marked by brackets, document has been omitted and filed separately with the Securities and Exchange Commission pursuant Commission. Confidential treatment has been requested with respect to Rule 406 of the Securities Act of 1933omitted portions. (each, as amendeda “Development Plan”). financial and commercial factors. The Each Development Plan shall allocate be subject to the JSC’s approval. Upon the JSC’s approval of a Development activities between 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 Partiesavoidance of doubt, based on unless and until the following principles: (i) with respect to Product(s) comprising Parties sign the Lead CompoundDevelopment Plan for any Collaboration Product, Portola will be the lead neither Party for Development activities [*]; (ii) shall have any obligation with respect to any Product comprising product hereunder; provided, however, that unless and until the earlier of (a) the Parties sign a Back-Up CompoundDevelopment Plan 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), Portola the Parties shall use good faith efforts to prepare and agree on Development Plan therefor prior to the date specified in Exhibit 1 (as may be amended from time to time by the Parties). Each Development Plan will be updated and approved semi-annually by the lead Party for JSC and shall be consistent with the general allocation of responsibilities described in Section 3.2 below. Without limiting the foregoing, any material modifications or additions to any Development activities until [*] for such Product; Plan (iii) Portola has the right (but not the obligationincluding any proposed change(s) to be the lead any Third Party for Development activities [*]; (ivdesignee) Biogen Idec 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 lead party for [*] for terms and conditions of this Agreement (including the Products; and (v) Portola shall be diligence requirement set forth in Article 8), the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of the Development Activities according to the applicable Development Plan and within the Development Budget. In the course of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduct certain specific Development activities, and the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetingsall Applicable Laws.

Development Plan. (a) The Parties’ respective responsibilities for the Development of the Collaboration Compounds and Collaboration Products under this Agreement (the Products are set forth in this Article 4“Development Program”) shall be conducted pursuant to a comprehensive written Development plan (the “Development Plan”). As of the Execution Date, the Parties have agreed upon a The Development Plan for each Compound and corresponding Collaboration Products shall set forth the timeline and details of: (i) all preclinical and clinical Development of Product(s), attached activities to this Agreement as Exhibit A. The Development Plan may be revised from time to time conducted by the JDC. Either Party may propose modifications Parties as necessary to generate data sufficient to meet the Development Plan requirements for Development Marketing Approval of a Product, including clinical trial plans such Compound and time lines, and such proposed modifications shall be subject to review and approval corresponding Collaboration Products for each of the Indications as agreed by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All Development Plans must require periodic reassessment Parties and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities shall be subject to the approval of the JDC in view of then applicable scientific, clinical, safety, [*set [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 rule 24b-2 of the Securities Exchange Act of 19331934, as amended. financial CONFIDENTIAL forth in the Development Plan; (ii) the protocol synopsis for each clinical trial included in such Development Plan; (iii) a Manufacturing plan; and commercial factors(iv) any other Development activities that the Parties agree to pursue in collaboration for such Compound and corresponding Collaboration Products. Except for the initial Development Plan attached as Exhibit H, (A) the Development Plan will contain detailed plans for at least [*] covered by the Development Plan, and summary plans for periods thereafter, and (B) the budget associated with such Development Plan shall be subject to the approval process set forth in Section 5.2(b). The Development Plan shall allocate 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 the detailed budget of the Development activities between the Parties, based on the following principles: (i) with respect to Product(s) comprising the Lead Compound, Portola will be the lead Party for Development activities [*]; (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until . Upon [*] for such Product; (iii) Portola has Development activities under the right (but not Development Plan. The [*] shall be included in the obligation) Development Plan and shall be subject to JDC approval. The initial focus of the Development Program shall be the lead Party conduct of Phase 1 Clinical Trials and Phase 2 readiness activities for Development activities the Lead Compound in 2013, with the [*] the Lead Compound [*]; (iv) Biogen Idec shall be . As of the lead party for Effective Date, the Parties have agreed upon an initial Development Plan and [*] for the Products; Lead Compound for the period starting from the Effective Date and (v) Portola shall be the lead Party ending on [*]. The lead Party for Development activities pertaining , which are attached to any Product shall this Agreement as Exhibit H, which will be deemed to have been approved by the primary responsibility for the performance of the Development Activities according to the Development Plan and within the Development Budget. In the course of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduct certain specific Development activities, and the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetingsJDC.

Development Plan. (a) The Parties’ respective responsibilities for the Development of the Collaboration 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 are 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 this Article 4. As of the Execution Date, 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 have agreed upon a Development Plan agree to pursue in collaboration for the Development of Product(s), attached to this Agreement as Exhibit A. such Compound and corresponding Collaboration Products. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to Parties agree that: (A) the Development Plan will contain detailed plans for Development of a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval at least [*] covered by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All , and summary plans for periods thereafter, and (B) the budget associated with such Development Plans must require periodic reassessment and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities Plan shall be subject to the approval of the JDC process set forth in view of then applicable scientific, clinical, safety, [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. financial and commercial factorsSection 6.2(d). The Development Plan shall allocate 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 between the Parties, based on the following principles: (i) with respect to Product(s) comprising the Lead Compound, Portola will be the lead Party for Development activities [*]; (ii2) with respect to any if Cytokinetics has exercised the Cytokinetics Co-Funding Option for a Collaboration Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until and [*] for such Collaboration Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be the lead party , a detailed budget for [*] for of such Collaboration Product in the Products[*] Indications (the [*]); and (v3) Portola if [*] Indication [*] the Collaboration and [*] for such [*] Indication, a detailed budget for such [*] Indication Development Work (the “[*] Indication Development Budget”). Upon the other Party’s reasonable request, each Party shall [*] Development activities under the Development Plan. The [*] shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of the Development Activities according to included in the Development Plan and within [*] shall be subject to JDC approval. For reference, the Development Budget. In the course of fulfilling its role Plan in effect as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request Amendment Effective Date is [*] which was approved by the other Party to conduct certain specific Development activities, JDC and signed by the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola JDC co-chairs in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetings[*].

Development Plan. The Parties’ respective 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 Date, and in any 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 the conduct of development activities with respect to the Products in the Field in the Territory that (a) is consistent with the Initial Development of Plan, (b) describes the Collaboration Compounds MPAG Activities (the costs and expenses for which shall be borne by MPAG, subject to Section 4.5) and the Products are set forth in this Article 4Novartis Activities (the costs and expenses for which shall be borne by Novartis), and (c) includes the applicable 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, the “Development Plan”). As of Within [***] from the Execution Date, the Parties have agreed upon a Development Plan for the Development of Product(s), attached will negotiate in good faith to this Agreement as Exhibit A. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to include MP0423 in the Development Plan and to apportion costs for 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 a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval by the JDC, provided that with respect to a Material Development Plan Amendmentand shall not without reason withhold, a Party may propose such modifications directly condition, or delay their consent to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All Development Plans must require periodic reassessment For clarity, and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities shall be subject notwithstanding anything to the approval of the JDC in view of then applicable scientific, clinical, safety, [*] = Certain confidential information contained contrary in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. financial and commercial factors. The Development Plan shall allocate Development activities between the Parties, based on the following principlesOption Agreement: (i) with 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 to Product(s) comprising of either of the Lead Compound, Portola will be Products that is not contemplated by the lead Party for Development activities [*]Plan; and (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead neither Party for Development activities until [*] for such Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be required to undertake any activities, including, as applicable MPAG Activities or Novartis Activities, that are not set forth in a Development Plan. For the lead party for [*] for avoidance of doubt, the Products; and (v) Portola Initial Development Plan shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of the Development Activities according to serve as the Development Plan and within to the Development Budget. In extent required for the course purposes of fulfilling its role this Option Agreement until such time as the lead developing Party for Parties agree a particular Product in a particular Indication and during a particular stage new Development Plan pursuant to the terms of the Product Development, a Party may request the other Party to conduct certain specific Development activities, and the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetingsthis Section 4.2.

Development Plan. The Parties’ respective responsibilities for Subject to and in accordance with this Article 4 (Development), each Party shall be responsible for, and shall use Commercially Reasonable Efforts to, complete the Development of the Collaboration Compounds and the Products are set forth activities allocated to such Party in this Article 4. As of the Execution Date, the Parties have agreed upon a Development Plan for the Development of Product(s), attached to this Agreement as Exhibit A. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to the Development Plan for in accordance with the timelines set forth therein. The initial Development of a ProductPlan, including clinical trial plans and time linesattached hereto as Exhibit B (the “Development Plan”), and such proposed modifications shall be subject to review and approval by the JDC, provided that with respect to a Material each subsequent Development Plan Amendmentshall include (i) a reasonably detailed and written plan for any Development activities and Clinical Trials to be conducted by or on Epirus’s behalf in order to obtain Regulatory Approval to market the Licensed Products in the Field in a harmonized clinical development program for the [***] as well as a plan for regulatory activities in such countries (it being agreed and understood that (x) the Regulatory Approval timeline under such Plan shall not be adversely impacted as a result of [***] being included therein, a Party may propose such modifications directly to (y) any separate [***] or otherwise outside of the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications Territory shall become not be part of the Development Plan. All Development Plans must require periodic reassessment [***] hereunder and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities shall be subject solely for [***] and (z) Partner shall be entitled to reference to the approval of the JDC in view of then applicable scientific, clinical, safety, resulting [***] = Certain confidential information contained and/or ex-Territory. data solely for use in this documentthe Territory) (“Global Development Activities”), marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. financial and commercial factors. The Development Plan shall allocate Development activities between the Parties, based on the following principles: (i) with respect to Product(s) comprising the Lead Compound, Portola will be the lead Party for Development activities [*]; (ii) with respect to a reasonably detailed and written plan for any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until [*] and Clinical Trials to be conducted in order to obtain Regulatory Approval to market the Licensed Products in the Field in any country in the Territory that are not Global Development Activities as well as a plan for such Product; regulatory activities with the EMA and other Regulatory Authorities in the Territory (the “Local Development Activities”) and (iii) Portola has the right a rolling five (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be the lead party for [*] 5)-year budget for the Products; and (v) Portola shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of the Global Development Activities according and the Local Development Activities (the “Development Budget”). During the Term, the JMC shall review and prepare updates to the Development Plan and within Development Budget on an annual basis, or more frequently as determined by the JMC ; provided, however, that any increases to the Development Budget. In the course Budget in excess of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage [***] of the Product Development, a Party may request most recent Development Budget approved by the other Party JMC without Epirus’s use of its deciding vote pursuant to conduct certain specific Development activities, and Section 3.2.3(c) (Matters Reserved for Epirus) shall require approval of Partner’s representative on the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetingsJMC.