Common use of Development Plan Clause in Contracts

Development Plan. Genentech shall use Commercially Reasonable and Diligent Efforts to create a Development Plan (which shall be attached as Exhibit E hereto) within sixty (60) days and no later than ninety (90) days from the Effective Date, which may be modified by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description of the studies set forth in Section 3.4(b)(i) in a timely manner. TolerRx shall have the opportunity to provide input and suggestions with regard to the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof. For avoidance of doubt, the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by the JSC in the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes shall be deemed to be excluded from the Development Plan.

Development Plan. Genentech shall use Commercially Reasonable 2.1 ADCT and Diligent Efforts ADAGENE agree to create a conduct the Development Plan as set forth in Annex 1 and in accordance with the terms and conditions of this Agreement. The Parties acknowledge and agree that the Development Plan shall divided in up to three proof of concept development programs, namely the [***] PoC, the [***] PoC and [***], as detailed in Annex 1. Prom time to time during the Term, ADCT shall have the right to modify the Development Plan by written notice to ADAGENE, provided that any such modification that would result in a material increase of ADAGENE’s obligations (which including unreimbursed expenses from ADCT) under the Development Plan shall be attached require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the [***] PoC upon the Effective Date of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as Exhibit E hereto) specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within sixty (60) days and no later than ninety of completion of [***] PoC (90) days from the Effective Date, which may be modified by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description of the studies set forth in Section 3.4(b)(i) in a timely manner. TolerRx shall have the opportunity to provide input and suggestions with regard to the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii“[***] PoC Initiation Notice”). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof[***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt, ADCT is under no obligation to initiate the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by [***] PoC under this Agreement. 2.1.3 Within [***] from the JSC in the written minutes date of the applicable JSC meeting; anything not approved by [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the JSC in Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such written minutes information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be excluded the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the Development Planlist of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriate. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Development Plan. Genentech Within […***…] days of the delivery of the Exhibit D Documents pursuant to the first sentence of Section 2.1, UroGen shall use Commercially Reasonable and Diligent Efforts to create deliver a copy of its proposed written plan describing in reasonable detail the proposed program of its initial Development for the first therapeutic indication of the Licensed Product(s). The initial Development Plan will focus on anticipated […***…] and […***…] (“Early Stage Development”) with an overview of UroGen’s […***…] and […***…] for Licensed Products (“Development Plan”) for Agenus’ review. During Early Stage Development UroGen plans to screen Agenus Antibody for incorporation into or admixture with UroGen’s proprietary sustained release gel formulation(s) known as RTGel™ or other proprietary or licensed technologies. Once a determination has been made by UroGen regarding whether Agenus Antibody is the lead candidate for use in development of the Licensed Product the next Development Plan update shall include the strategy for the initial Clinical Trials and the regulatory plan to support such Clinical Trials for such Licensed Product, as well as a rolling forecast of the quantity of Agenus Antibody that UroGen expects to need for preclinical studies and Clinical Trials (the “Forecast”) of the Licensed Product. The Forecast shall cover the remainder of the calendar year in which the Development Plan was approved and the […***…] years thereafter. The Forecast shall be attached as Exhibit E hereto) within sixty (60) days divided into […***…] and no later than ninety (90) days from shall include a delivery 36165924.6 schedule for the Effective Datefirst […***…] . Such Forecast shall become effective, which may be modified along with the associated delivery schedule, following written approval by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description Agenus of the studies Forecast or update thereto. Agenus shall have a […***…] to […***…] (or […***…] for) each Development Plan only in connection with (a) matters that present a […***…] of […***…] to the Agenus Antibody or (b) matters that have a […***…] on Agenus’ ability to […***…] the Agenus Antibody set forth in Section 3.4(b)(i) in a timely manner. TolerRx shall have the opportunity to provide input and suggestions with regard to the Development Plan[…***…] (collectively, Agenus’ “[…***…]”). The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The initial Development Plan shall be updated at least […***…] by Genentech for each calendar year UroGen and submitted to Agenus for review and […***…] not later than […***…] of each […***…] during the JSC Term. Each updated Development Plan shall include any proposed modifications to the previously approved Forecast, an overall plan for consideration and approval at least three months all major Development tasks remaining to be accomplished prior to Regulatory Approval to the beginning of the next calendar yearextent such tasks are known or can reasonably be ascertained, as well as a reasonably detailed clinical plan for each proposed Clinical Trial. The Development Plan will include specific tasks, milestones, Parties acknowledge and estimated timelines. As set forth in Section 3.4(b) and 3.4(f), it is anticipated anticipate that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan)will be […***…] and […***…] for near term activities, and not disclose to anyone any will initially be […***…] and all information arising […***…] for activities further out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof. For avoidance of doubt, the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by the JSC in the written minutes future. Notwithstanding any of the applicable JSC meeting; anything above with regard to […***…] and […***…], Agenus’ […***…] rights shall not approved by the JSC in such written minutes shall be deemed to be excluded from the Development Planunreasonably withheld or delayed.

Development Plan. Genentech (a) The Development of the Compounds and Collaboration Products under this Agreement (the “Development Program”) shall use Commercially Reasonable and Diligent Efforts be conducted pursuant to create 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: (which 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 agree that: (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 attached as Exhibit E hereto) within sixty (60) days and no later than ninety (90) days from subject to the Effective Date, which may be modified by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description of the studies approval process set forth in Section 3.4(b)(i6.2(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 timely mannerdetailed budget for such [ * ] Indication Development Work (the “[ * ] Indication Development Budget”). TolerRx Upon the other Party’s reasonable request, each Party shall have the opportunity to provide input and suggestions with regard to [ * ] Development activities under the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan [ * ] shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth included in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof[ * ] shall be subject to JDC approval. For avoidance of doubt[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. (b) The JDC shall update the Development Plan (including [ * ], as applicable) at least annually, with such annual update to be finally approved no later than [ * ] of the preceding Astellas’ fiscal year, provided that [ * ] Indication [ * ] subject to the [ * ] the JDC (and [ * ] Indication [ * ] after [ * ] for such Indication. By [ * ] of each calendar year, [ * ] Development activities are [ * ] the updated Development Plan, the JDC shall exclude marketing agree upon a proposed [ * ] for the following Astellas fiscal year. Astellas shall use good faith efforts to [ * ]. From time to time during the Term, the JDC shall prepare amendments, as appropriate, to the then-current Development Plan (including [ * ], as applicable), including adding additional Compounds and other commercialization activitiesCollaboration Products as well as additional Indications added to the Collaboration pursuant to Article 4. The JDC shall have the right to approve updates and amendments to the Development Plan (including [ * ], as applicable), provided that [ * ] subject to the [ * ] the JDC (and any modifications thereto shall be [ * ] for such Indication. Once approved by the JSC in JDC, such revised Development Plan shall replace the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes shall be deemed to be excluded from the prior Development Plan. (c) 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. Genentech (a) MONSANTO shall use Commercially Reasonable and Diligent Efforts to create a Development Plan cooperate with D&PL in the development activities outlined in the DEVELOPMENT PLAN. (which b) D&PL shall be attached not offer for COMMERCIAL SALE or make COMMERCIAL SALES of any LICENSED COMMERCIAL SEED of any particular DELTAPINE ROUNDUP READY(R) CULTIVAR unless D&PL shall have complied with the requirements as Exhibit E hereto) within sixty (60) days and no later than ninety (90) days from the Effective Date, which may be modified by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description of the studies set forth in Section 3.4(b)(i) in a timely manner. TolerRx shall have the opportunity to provide input Exhibits F, G and suggestions with regard to the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestonesH, and estimated timelinesMONSANTO has approved such sales in writing. As set forth in Subject to Section 3.4(b) and 3.4(f4.3(d), it MONSANTO's approval for COMMERCIAL SALE of particular D&PL ROUNDUP READY(R) CULTIVARS may be withheld if D&PL does not demonstrate that those requirements have been met, but shall not otherwise be withheld. MONSANTO shall notify D&PL in writing of its decision on approval of a particular DELTAPINE ROUNDUP READY(R) CULTIVAR within thirty (30) days after D&PL submits a written request for approval of that DELTAPINE ROUNDUP READY(R) CULTIVAR with the supporting data for which D&PL is anticipated that the Development Plan may assign specific tasks to TolerRxresponsible. TolerRx shall hold If MONSANTO does not notify D&PL in confidencewriting of its decision on approval within such thirty (30) period, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof. For avoidance of doubt, the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by the JSC in the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes MONSANTO shall be deemed to have approved the subject DELTAPINE ROUNDUP READY(R) CULTIVAR for COMERCIAL SALE. (c) If in MONSANTO's reasonable business judgment, COMMERCIAL SALES of a particular DELTAPINE ROUNDUP READY(R) CULTIVAR may result in product complaints which may cause MONSANTO to be excluded liable for significant compensation to growers due to an identifiable product quality or identifiable product performance issue, and MONSANTO gives such notice of same to D&PL not later than November 1 of any year and D&PL makes sales in THE TERRITORY of LICENSED COMMERCIAL SEED of such DELTAPINE ROUNDUP READY(R) CULTIVAR in subsequent years without prior notice (given by labels on the containers of LICENSED COMMERCIAL SEED or by other forms of notice selected by D&PL and approved by MONSANTO, whose approval will not be unreasonably withheld or delayed) to growers who subsequently purchase LICENSED COMMERCIAL SEED of such DELTAPINE ROUNDUP READY(R) CULTIVAR of the observation of the identifiable product quality or identifiable product performance issue set forth in MONSANTO's notice, then notwithstanding any other provision of this Agreement, MONSANTO shall have no liability to D&PL for any third party claims based on the identifiable product quality or identifiable product performance issue set forth in MONSANTO's notice with respect to LICENSED COMMERCIAL SEED of that DELTAPINE ROUNDUP READY(R) CULTIVAR so sold and D&PL shall indemnify and hold MONSANTO harmless from any third party claims based on the Development Planidentifiable product quality or identifiable product performance issue set forth in MONSANTO's notice with respect to LICENSED COMMERCIAL SEED of that DELTAPINE ROUNDUP READY(R) CULTIVAR so sold. MONSANTO shall apply this provision with respect to all notices to licensees of the subject GENE(S) in THE TERRITORY, regarding identifiable product quality or identifiable product performance issues in a substantially equal manner."

Development Plan. Genentech 2.1.1 If requested by PCYC, the Parties shall undertake a Manufacturing process development project for one or more of the Drug Products to be Manufactured by Contractor hereunder, consisting of the specific research and development activities agreed upon by the Parties and detailed in a Development Plan, subject to the terms of this Section 2. 1. The Parties shall use Commercially Reasonable good faith, commercially reasonable diligent efforts to complete successfully each such development project in accordance with the applicable Development Plan. The Parties shall conduct each such development project in accordance with a timetable that the Parties shall develop and Diligent Efforts to create a Development Plan (which shall be attached set forth in the applicable Development Plan. 2.1.2 The Parties shall undertake a Manufacturing process development project, as Exhibit E heretodescribed in Section 2.1.1, for the Initial Drug Product. Each Development Plan for the Initial Drug Product shall be developed in accordance with Section 2.1.3, and shall comply with outline of research and development activities set forth in the Drug Product Development Requirements in the Initial Drug Product Appendix. (a) within Contractor shall prepare and deliver two (2) copies of the first Development Plan for the Initial Drug Product to PCYC as soon as possible following the Effective Date, but in no event later than thirty (30) days following the Effective Date. (b) For each Drug Product for which PCYC requests Contractor to perform development services hereunder, other than the Initial Drug Product, Contractor shall prepare and deliver two (2) copies of each proposed Development Plan to PCYC as soon as possible following its receipt of PCYC's request for development services, but in any event, no later than sixty (60) days from the date that such request was received. (c) Following receipt of Contractor's proposed Development Plan under subsection (a) or (b) above, PCYC shall either sign such Development Plan and return one (1) copy to Contractor or shall return an amended Development Plan acceptable to PCYC, in each case within five (5) business days of receipt of such Development Plan from Contractor. If such amended Development Plan is not acceptable to Contractor, then Contractor shall so notify PCYC within five (5) business days of Contractor's receipt of such amended Development Plan, and the Parties shall promptly meet in order to resolve in good faith any outstanding disagreements with respect to such amended Development Plan. In no later than event shall Contractor be required to schedule any development activities under this Section 2.1 with respect to any Drug Product until a Development Plan for such Drug Product has been approved in writing by both PCYC and Contractor. Notwithstanding the foregoing, in the event that the Parties are unable to reach agreement using good-faith efforts with respect to a particular Development Plan within ninety (90) days from the date of request (or ninety (90) days from the Effective Date, which may be modified by Date in the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description case of the studies set forth in Section 3.4(b)(i) in a timely manner. TolerRx first Development Plan for the Initial Drug Product), then either Party shall have the opportunity right to provide input and suggestions terminate this Agreement with regard respect to the Development Plan. The Parties initially agree to develop a Licensed Drug Product related to immune tolerance. Only upon that is the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The subject of such Development Plan shall be updated by Genentech for each calendar year and submitted upon written notice to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof. For avoidance of doubt, the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by the JSC in the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes shall be deemed to be excluded from the Development PlanParty.

Development Plan. Genentech Subject to and in accordance with this Article 4 (Development), each Party shall be responsible for, and shall use Commercially Reasonable and Diligent Efforts to, complete the Development activities allocated to create a such Party in the Development Plan (which shall be in accordance with the timelines set forth therein. The initial Development Plan, attached hereto as Exhibit E hereto) within sixty B (60) days and no later than ninety (90) days from the Effective Date, which may be modified by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description of the studies set forth in Section 3.4(b)(i) in a timely manner. TolerRx shall have the opportunity to provide input and suggestions with regard to the “Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The ”), and each subsequent Development Plan shall include (i) a reasonably detailed and written plan for any Development activities and Clinical Trials to be updated conducted by Genentech 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 each calendar year the [***] as well as a plan for regulatory activities in such countries (it being agreed and submitted understood that (x) the Regulatory Approval timeline under such Plan shall not be adversely impacted as a result of [***] being included therein, (y) any separate [***] or otherwise outside of the Territory shall not be part of the [***] hereunder and shall be solely for [***] and (z) Partner shall be entitled to reference to the JSC resulting [***] and/or ex-Territory. data solely for consideration use in the Territory) (“Global Development Activities”), (ii) a reasonably detailed and approval at least three months prior written plan for any Development activities and Clinical Trials to be conducted in order to obtain Regulatory Approval to market the beginning of Licensed Products in the next calendar year. The Field in any country in the Territory that are not Global Development Plan will include specific tasks, milestones, Activities as well as a plan for regulatory activities with the EMA and estimated timelines. As set forth other Regulatory Authorities in Section 3.4(bthe Territory (the “Local Development Activities”) and 3.4(f), it is anticipated that (iii) a rolling five (5)-year budget for the Global Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use Activities and the Local Development Activities (except to perform its obligations under the “Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iiiBudget”). The foregoing confidentiality obligations During the Term, the JMC shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding review and prepare updates to the Development Plan and Development Budget on an annual basis, or more frequently as determined by the content thereof. For avoidance of doubtJMC ; provided, however, that any increases to the Development Plan shall exclude marketing and other commercialization activities. The Budget in excess of [***] of the most recent Development Plan and any modifications thereto shall be Budget approved by the JSC in JMC without Epirus’s use of its deciding vote pursuant to Section 3.2.3(c) (Matters Reserved for Epirus) shall require approval of Partner’s representative on the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes shall be deemed to be excluded from the Development PlanJMC.

Development Plan. Genentech (a) The Development of the Compounds and Collaboration Products under this Agreement (the “Development Program”) shall use Commercially Reasonable and Diligent Efforts be conducted pursuant to create 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: (which 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 agree that: (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 attached as Exhibit E hereto) within sixty (60) days and no later than ninety (90) days from subject to the Effective Date, which may be modified by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description of the studies approval process set forth in Section 3.4(b)(i6.2(d). 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 timely mannerdetailed budget for such [*] Indication Development Work (the “[*] Indication Development Budget”). TolerRx Upon the other Party’s reasonable request, each Party shall have the opportunity to provide input and suggestions with regard to [*] Development activities under the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan [*] shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth included in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof[*] shall be subject to JDC approval. For avoidance of doubtreference, the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be in effect as of the Amendment Effective Date is [*] which was approved by the JSC JDC and signed by the JDC co-chairs in the written minutes [*]. (b) The initial focus of the applicable JSC meeting; anything not Development Program was the conduct of Phase 1 Clinical Trials and Phase 2 readiness activities for the Lead Compound in 2013, with the [*] for the Lead Compound [*] (c) The Development Program in 2015 shall include the initial Phase 2 Clinical Trial of the Lead Compound in SMA. As of the Amendment Effective Date, the Parties have agreed on a [*] for such initial Phase 2 Clinical Trial within the document attached hereto as Exhibit M. Promptly after the Amendment Effective Date, the JDC shall update the Development Plan to include the conduct of such initial Phase 2 Clinical Trial in 2015, consistent with [*] set forth in such exhibit. (d) The JDC shall update the Development Plan (including [*] as applicable) at least annually, with such annual update to be finally approved no later than [*] of the preceding Astellas’ fiscal year, provided that [*] Indication [*] subject to the [*] the JDC (and [*] Indication [*]) after [*] for such Indication. By [*] of each calendar year starting on [*] Development activities are [*] the updated Development Plan, the JDC shall agree upon a proposed [*] for the following Astellas fiscal year beyond [*]. Astellas shall use good faith efforts to [*]. From time to time during the Term, the JDC shall prepare amendments, as appropriate, to the then-current Development Plan (including [*] as applicable), including adding additional Compounds and Collaboration Products as well as additional Indications [*] the Collaboration pursuant to Article [*] The JDC shall have the right to approve updates and amendments to the Development Plan (including [*] as applicable), provided that [*] subject to the [*] the JDC (and [* ]) after [*] for such Indication. Once approved by the JSC in JDC, such written minutes revised Development Plan shall be deemed to be excluded from replace the prior Development Plan. (e) 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. Genentech 5.1 In each Calendar Year that Development regarding the PIP is occurring, each Party shall at its own cost and expense (subject to Section 5.4) use Commercially Reasonable and Diligent Efforts to create a carry out the activities specified in the Development Plan in relation to the PIP as the responsibility of such Party so as to meet the timelines set out in them. 5.2 During the period of Development regarding the PIP by the Licensor, it shall update the Development Plan on or before November 1st in each year and shall submit the same to the JSC for review and approval. 5.3 The Licensor shall: (which a) be responsible for the conduct of the PIP, subject to and in accordance with the timelines set out in the Development Plan and subject to the direction of the JSC; (b) conduct all activities in relation to the PIP in compliance with all Legal Requirements, ethics committee, informed consent or similar approvals in relation thereto, and in compliance with GCP; (c) provide periodic updates regarding the PIP to the JSC as reasonably requested by the JSC; (d) permit Licensee (at its own cost) and upon reasonable notice to audit, during normal business hours, the trial master file and shall be attached cooperate with any such audit; and (e) promptly provide to the JSC the results of the PIP in the form of a copy of any Interim Report, a Formal Presentation and a copy of the Final Report as Exhibit E heretothese occur, even if between JSC scheduled meetings. 5.4 The Licensee shall reimburse the Licensor for seventy per cent (70%) within of the ongoing documented Development Costs reasonably incurred by the Licensor in accordance with the Development Plan and the PIP Budget. The Licensee shall reimburse its proportion of the Development Costs not later than sixty (60) days following receipt of the Licensor's invoices and no later than ninety (90) days from supporting evidence of such Development Costs having been incurred in connection with the Effective Dateconduct of the PIP, which may the Licensor shall submit as and when such Development Costs arise but no more frequently than on a quarterly basis, save where an invoice is for an amount equal to or greater than $100,000 whereupon the Licensor shall be modified permitted to invoice on a monthly basis. Payment shall be made by the JSC Licensee within thirty (30) Business Days of the date of receipt of the Licensor's invoice, into such bank account as provided above) the Licensor shall specify from time to time. TolerRx understands that Genentech's performance is dependent For the avoidance of doubt, the Licensor shall be responsible for the remaining thirty per cent (30%) of such Development Costs in part on connection with the TolerRx's actions, including but not limited to TolerRx providing the detailed description conduct of the studies set forth PIP. 5.5 During the period in Section 3.4(b)(i) in a timely manner. TolerRx shall have which the opportunity to provide input and suggestions with regard to the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall PIP is ongoing, the Parties perform any activities other than work related may, from time to immune tolerance. The Development Plan shall time, together agree in writing to update the PIP Budget and where this occurs the proposed changes will be updated by Genentech for each calendar year and submitted to the JSC for consideration review and approval discussion. Once agreed by the Parties in writing, the revised PIP Budget shall be the 'PIP Budget' for the purposes of this Agreement. 5.6 Upon a Bankruptcy Event of Licensor, Licensee shall have the right, but not the obligation, to assume full control of the PIP upon written notice to Licensor. Following any such notice, Licensor shall, to the extent permitted by Law, use its reasonable endeavors to promptly assign to Licensee or its designee all contracts associated with the PIP and shall cooperate with Licensee to ensure a smooth transition of control of the PIP to Licensee, including by executing such documents requested by Licensee as are necessary to enable such transition. Licensee shall thereafter carry out the PIP as set forth in the Development Plan on behalf of itself with respect to the Territory and on behalf of Licensor outside the Territory. Licensee shall pay Licensor's thirty percent (30%) share of the cost and expenses of the PIP as set forth in the PIP Budget and shall be entitled to deduct all such costs and expenses from any amounts of royalties or milestones owed to Licensor hereunder prior to making any payments to Licensor. 5.7 Except as expressly set forth above in relation to the PIP and subject to Section 5.7 below, each Party shall: (a) be responsible for the conduct and all associated costs and expenses of the Development activities for the Product in its own territory and for the avoidance of doubt 'territory' shall mean the USA and Canada for the Licensee and the rest of the world for the Licensor; (b) conduct all such Development activities in compliance with all Legal Requirements, ethics committee, informed consent or similar approvals in relation thereto, and in compliance with GCP; (c) provide the JSC with a summary and update in reasonable detail of such Development activities at each meeting of the JSC; and (d) provide the other Party with a copy of a near-final draft of each Clinical Trial protocol or update to a protocol for the Product at least three months forty-five (45) days prior to the beginning date on which such protocols or updates are provided to any Regulatory Authority or Clinical Trial site, in order to permit such other Party to comment on such protocol or update, and shall reasonably consider in good faith any comments thereon provided by such other Party within thirty (30) days following such other Party's receipt of such copy of such protocol or update. 5.8 The Parties agree that where any Development activity of the next calendar year. The Licensee is, in the Licensor's reasonable opinion, going to have a material adverse impact on the Development, Manufacture or Commercialization of the Product outside of the Territory for the Existing Indications, then the prior written consent of the of the Licensor will be required, such consent not to be unreasonably withheld, delayed or conditioned. 5.9 If Licensee wishes to Develop Product in the Territory for a New Indication, Licensee shall have the right to do so on the following conditions: (a) the Licensee shall be solely responsible for the costs and expenses of the Development Plan will include specific tasksactivities; (b) the Licensee shall supply the Licensor with all material Know How, milestonesDossiers and other Licensee IPR Package relating thereto, including a copy of each Final Report promptly following its preparation; (c) subject to paragraph 5.9(d), the Licensee hereby grants to the Licensor a perpetual, irrevocable, exclusive, sub-licensable, right and license to use the Licensee IPR Package for the Product for such New Indication to Develop, manufacture and Commercialize the Product outside the Territory; and (d) Licensor shall pay royalties to Licensee under such license on the same payment terms as, and estimated timelines. As set forth in Section 3.4(bat a rate equal to two percent (2%) less than the rate owed by, Licensee to Licensor for sales of Products hereunder, with all applicable definitions and 3.4(f)provisions having the Parties reversed, it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof. For avoidance of doubt, the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by the JSC in the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes shall be deemed to be excluded from the Development Planmutatis mutandis.

Development Plan. Genentech The development activities, including both preclinical and clinical development activities, that Cubist will conduct for Licensed Products shall be covered by a development plan that Cubist shall prepare and submit to the Development Subcommittee for review [ ]* after the Effective Date (such plan, the "Cubist Development Plan"). The Cubist Development Plan shall include at least the [ ]* in clauses (A), (B) and (C) above in Section 3.1 (a). The Cubist Development Plan shall [ ]*. Subject to its overall diligence obligations contained in this Section 3.1, Cubist reserves the right to change or modify the Cubist Development Plan (except with respect to the [ ]*) or any of the preclinical studies or clinical trials (other than the [ ]*) described in the Cubist Development Plan in response to (i) [ ]*, (ii) [ ]*, (iii) [ ]* or (iv) [ ]*. Cubist additionally reserves the right to change or modify any Core Trial (1) [ ]* such trial in accordance with the then-current protocol therefor as a result of [ ]*, or (2) in response to any [ ]*; PROVIDED, HOWEVER, that Cubist recognizes that Gilead's efforts to [ ]* will depend upon [ ]* and further provided that the foregoing ability to change or modify a Core Trial shall not contravene Cubist's obligations to provide [ ]*. Accordingly, if Cubist has the right to change or modify a Core Trial pursuant to the foregoing sentence, it shall so notify Gilead, the Parties shall discuss any proposed modification to the Core Trial at issue or other alternative arrangement to address the reason giving rise to Cubist's right to change or modify the Core Trial while providing for [ ]* from Cubist to [ ]*, and Cubist shall implement any such proposed modification or alternative arrangement to which the Parties *CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION. mutually agree. Cubist shall modify the Cubist Development Plan from time to time to reflect timing or protocol changes to the Core Trials or any other trials, and to reflect additional trials that Cubist conducts or trials Cubist terminates for any Licensed Product during the Term. Cubist shall also revise the Cubist Development Plan from time to time to reflect each new indication for or formulation of Licensed Products that Cubist is developing or plans to develop. Additionally, [ ]*, Cubist shall update the Cubist Development Plan no later [ ]* and submit such plan to the Development Subcommittee for review and comment. Cubist acknowledges that [ ]*. Accordingly, Cubist shall use Commercially Reasonable and Diligent Efforts to create a Development Plan (which shall be attached as Exhibit E hereto) within sixty (60) days and no later than ninety (90) days from the Effective Date, which may be modified by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description obtain Regulatory Approval of the studies set forth in Section 3.4(b)(i) in a timely manner. TolerRx shall have the opportunity to provide input and suggestions with regard to the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof. For avoidance of doubt, the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by the JSC Core IV Products in the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes shall be deemed to be excluded from the Development PlanUnited States.

Development Plan. Genentech The development activities, including both preclinical and clinical development activities, that Cubist will conduct for Licensed Products shall be covered by a development plan that Cubist shall prepare and submit to the Development Subcommittee for review [*] after the Effective Date (such plan, the "Cubist Development Plan"). The Cubist Development Plan shall include at least the [*] in clauses (A), (B) and (C) above in Section 3.1(a). The Cubist Development Plan shall [*]. Subject to its overall diligence obligations contained in this Section 3.1, Cubist reserves the right to change or modify the Cubist Development Plan (except with respect to the [*]) or any of the preclinical studies or clinical trials (other than the [*]) described in the Cubist Development Plan in response to (i) [*], (ii) [*], (iii) [*] or (iv) [*]. Cubist additionally reserves the right to change or modify any Core Trial (1) [*] such trial in accordance with the then-current protocol therefor as a result of [*], or (2) in response to any [*]; provided, however, that Cubist recognizes that Gilead's efforts to [*] will depend upon [*] and further provided that the foregoing ability to change or modify a Core Trial shall not contravene Cubist's obligations to provide [*]. Accordingly, if Cubist has the right to change or modify a Core Trial pursuant to the foregoing sentence, it shall so notify Gilead, the Parties shall discuss any proposed modification to the Core Trial at issue or other alternative arrangement to address the reason giving rise to Cubist's right to change or modify the Core Trial while providing for [*] from Cubist to [*], and Cubist shall implement any such proposed modification or alternative arrangement to which the Parties mutually agree. Cubist shall modify the Cubist Development Plan from time to time to reflect timing or protocol changes to the Core Trials or any other trials, and to reflect additional trials that Cubist conducts or trials Cubist terminates for any Licensed Product during the Term. Cubist shall also revise the Cubist Development Plan from time to time to reflect each new indication for or formulation of Licensed Products that Cubist is developing or plans to develop. Additionally, [*], Cubist shall update the Cubist Development Plan no later [*] and submit such plan to the Development Subcommittee for review and comment. Cubist acknowledges that [*]. Accordingly, Cubist shall use Commercially Reasonable and Diligent Efforts to create a Development Plan (which shall be attached as Exhibit E hereto) within sixty (60) days and no later than ninety (90) days from the Effective Date, which may be modified by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description obtain Regulatory Approval of the studies set forth in Section 3.4(b)(i) in a timely manner. TolerRx shall have the opportunity to provide input and suggestions with regard to the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof. For avoidance of doubt, the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by the JSC Core IV Products in the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes shall be deemed to be excluded from the Development PlanUnited States.

Development Plan. Genentech (a) The Development of the Compounds and Collaboration Products under this Agreement (the “Development Program”) shall use Commercially Reasonable and Diligent Efforts be conducted pursuant to create 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: (which shall 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 [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. 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. Except for the initial Development Plan attached as Exhibit E heretoH, (A) within sixty (60) days and no later than ninety (90) days from the Effective Date, which may be modified Development Plan will contain detailed plans for at least [*] covered by the JSC Development Plan, and summary plans for periods thereafter, and (as provided aboveB) from time the budget associated with such Development Plan shall be subject to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description of the studies approval process set forth in Section 3.4(b)(i) 5.2(b). The Development Plan shall include a coordinated development and regulatory strategy, including the Parties’ respective roles in a timely mannerthe development of each Collaboration Product and the countries in which Development of Collaboration Product will occur. TolerRx The Development Plan shall have also set forth the opportunity detailed budget of the Development activities to provide input and suggestions with regard to be [*]. Upon [*] Development activities under the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan [*] shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth included in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and shall be subject to JDC approval. The initial focus of the content thereofDevelopment Program shall be the conduct of Phase 1 Clinical Trials and Phase 2 readiness activities for the Lead Compound in 2013, with the [*] the Lead Compound [*]. For avoidance As of doubtthe Effective Date, the Parties have agreed upon an initial Development Plan and [*] for the Lead Compound for the period starting from the Effective Date and ending on [*], which are attached to this Agreement as Exhibit H, which will be deemed to have been approved by the JDC. (b) The JDC shall update the Development Plan (including [*]) at least annually, with such annual update to be finally approved no later than [*] of the preceding Astellas’ fiscal year. By [*] of each calendar year starting on [*] the updated Development Plan, the JDC shall exclude marketing agree upon a proposed [*] for the following Astellas fiscal year beyond [*]. Astellas shall use good faith efforts to [*]. From time to time during the Term, the JDC shall prepare amendments, as appropriate, to the then-current Development Plan (including [*]), including adding additional Compounds and other commercialization activitiesCollaboration Products. The JDC shall have the right to approve updates and amendments to the Development Plan and any modifications thereto shall be (including [*]). Once approved by the JSC in JDC, such revised Development Plan shall replace the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes shall be deemed to be excluded from the prior Development Plan. (c) 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. Genentech shall use Commercially Reasonable (a) Borrower will prepare and Diligent Efforts submit to create a Administrative Agent for Approval the initial Development Plan (which shall be attached as Exhibit E heretotogether with AFEs and all Supporting Documentation and Reimbursement Requests) within sixty (60) at least 30 days and no later than ninety (90) days from before requesting an Advance under the Effective Date, which may be modified by Term Loan to fund development activities in accordance with Section 1.3(b)(ii). Borrower can propose modifications to the JSC (as provided above) Development Plan from time to time. TolerRx understands , and those modifications will become effective when Approved (not to be unreasonably withheld or delayed) by Administrative Agent. (b) Administrative Agent’s Approval of a modification to the Development Plan proposed by Borrower shall be granted in Administrative Agent’s reasonable discretion. (c) In support of each Development Plan, Borrower will prepare and submit to Administrative Agent for Approval(not to be unreasonably withheld or delayed): (i) in the case of costs not yet expended, an AFE (including all Supporting Documentation) at least 15 days before Borrower incurs any costs that Genentech's performance is dependent it intends to fund out of an Advance or (ii) in part the case of costs already expended and to be reimbursed through an Advance, reasonable evidence of a request for payment by the applicable Operator and reasonable evidence of payment by Borrower (collectively, “Reimbursement Request”) at least 5 days before Borrower requests such an Advance. (d) Notwithstanding the Administrative Agent’s Approval of a Development Plan: (i) Borrower must nevertheless satisfy the conditions described in this Article I and Section 8.3 prior to the making of each Advance; and (ii) Lenders will have no obligation to make an Advance to fund projects included on the TolerRx's actions, including but not limited Development Plan: (A) unless the requested Advance relates to TolerRx providing an AFE or Reimbursement Request Approved by Administrative Agent; or (B) if the detailed description requested Advance (together with all amounts previously Advanced in respect of the studies applicable AFE or Reimbursement Request) exceeds (1) the cost set forth in Section 3.4(b)(i) in a timely manner. TolerRx shall have the opportunity to provide input and suggestions with regard to the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidencefor that project, not use or (except to perform its obligations 2) the Loan availability remaining under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof. For avoidance of doubt, the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by the JSC in the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes shall be deemed to be excluded from the Development PlanTerm Loan.