Common use of Development Plan Clause in Contracts

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, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have 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 following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the 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 LipimetiX shall require the prior written approval of LipimetiX, (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 (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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would 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, the Parties shall discuss such 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 Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharma.

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, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have 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 following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the 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 LipimetiX shall require the prior written approval of LipimetiX, (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 (c) the Development Plan shall always include (i) a program The Development 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 CD38 Product under this Agreement shall be deemed conducted pursuant to a development plan to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted implemented by or on behalf of LipimetiX I-Mab or its Affiliates outside or sublicensees to obtain Regulatory Approval of the Territory, CD38 Product in the Parties shall discuss such 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 Field in the Territory pursuant to (the “Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevailPlan”). The Development Plan shall be considered Confidential Information consistent with I-Mab’s obligation under the MorphoSys License with respect to the Development of Anji Pharmathe CD38 Product. The Development Plan shall also include a detailed budget (the “Development Budget”) for such Development activities. As of the Effective Date, the Parties have agreed on the initial Development Plan, attached hereto as Exhibit B. Pursuant to the initial Development Plan, the Development of CD38 Product shall be [completed] by December 31, 2024 (“Development Complete Date”) with a total budget of US$200,000,000 (the “Initial Development Budget”). Such Initial Development Budget shall be inclusive of all costs and expenses to be incurred by or on account of I-Mab and Everest under the initial Development Plan, but shall not include and shall be in addition to any payments (including upfront payments, development milestone payments, and any other payments) made by I-Mab under the License and Collaboration Agreement by and between I-Mab and MorphoSys AG (“Morphosys”), dated November 30, 2017 (the “Morphosys Agreement”). (ii) From time to time, I-Mab shall prepare amendments and updates to the then-current Development Plan and Development Budget and submit such amendments and updates to the JSC for review and approval. Once approved by the JSC, such revised Development Plan and Development Budget shall replace or supplement, as appropriate, the prior Development Plan and Development Budget. (iii) Upon the Listing of I-Mab, if I-Mab proposes to increase the Initial Development Budget or the then applicable Development Budget (as determined in accordance with this Article 3.2(a)(ii) and/or (iii)) (such amendment, “Material Development Plan Amendment” and such incremental increase of the Initial Development Budget, the “Increased Amount”), in addition to the approval by the JSC as required under Article 3.2(a)(ii), I-Mab shall comply with the applicable rules of the stock exchange on which its securities are listed (“Applicable Listing Rules”) and submit such Material Development Plan Amendment for the approval of its shareholders who are not otherwise connected with Everest (to be determined by the Applicable Listing Rules) (the “Unconnected Shareholders”). The Material Development Plan Amendment may only become effective after being approved by the JSC and the shareholders of I-Mab in accordance with the Applicable Listing Rules and such approved Material Development Plan Amendment shall replace or supplement, as appropriate, the prior Development Plan and Development Budget. In the event of a Material Development Plan Amendment, the JSC approves such Material Development Plan Amendment but the Unconnected Shareholders do not approve such Material Development Plan Amendment, then such Development Plan Amendment may only become effective, and the Parties shall carry out such Material Development Plan Amendment, if Everest agrees to bear one hundred percent (100%) of the Increased Amount without requiring I-Mab to share such Increased Amount under Section 4.1 (but for clarity I-Mab shall continue to share the then-current Development Budget before such proposed Material Development Amendment under Section 4.1) (the “Everest Sole Development Costs”).”

Development Plan. Within thirty (30a) days after All Development with respect to any Product hereunder shall be conducted pursuant to a Development Plan prepared and approved by the Effective DateJSC, Anji Pharma which shall prepare an initial Development plan, setting set forth the nonplan for the pre-clinical and clinical Development activities with respect to the Product pursuant to this AgreementDevelopment, and deliver Regulatory Approval of such Product in each of the European Territory, the North American Territory and the Co-Exclusive Territories and the activities to be carried out related thereto by LFB Biotech and GTC, together with a proposed budget for such activities (each, a “Development plan to LipimetiX. Plan”). The Parties shall promptly discuss and endeavor to finalize such initial will mutually agree upon a preliminary Development plan within thirty (30) days thereafter, which upon mutual acceptance by Plan for the Parties, shall be deemed effective Initial Product (the “Initial Development Plan”). During ) within ************ following the TermEffective Date, except a copy of which shall be attached hereto as may be expressly set forth in this Agreement and the Exhibit B. Each Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have 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 following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event shall include a projection 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 the plan of Development activities with respect to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiXrelevant product and timelines for performing such activities, (b) the proposed budget for such Development Plan shall summarize the activities, (c) expected Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunderfunding by each Party, and (cd) a non-binding forecast of clinical supply of Product to be supplied as provided under Article 7. The Development Plan for a Product shall also specify the jurisdictions (other than the US and EU) where Regulatory Approval will be sought for such Product and prospective indication extension after the First Major Regulatory Approval. Development Plans for subsequent Products shall also be attached to Exhibit B as such Development Plans are prepared, approved and amended by the JSC. For indicative purposes only a preliminary version of the business case prepared by the Parties for the Initial Product is attached hereto as Exhibit B-1. Such business case shall be reviewed and updated on a regular basis by the JSC. (b) For so long as necessary to complete Development of any Product, the Parties, through the JSC, shall update the Development Plan shall always include with respect to such Product on an annual basis prior to the commencement of the next calendar year, or more often as determined by the JSC. (ic) 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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to The JSC will review performance against the Development Plan would be reasonably expected for each Product on a quarterly basis, and will report any variations to have the Parties in writing. If, in any quarter, there is a material adverse effect on Development variation of ************ or Commercialization activities for greater from the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territorybudget, the Parties shall discuss such 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 Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between JSC will revise the Development Plan and budget for the applicable Product ************ prior to the commencement of the second quarter following the quarter in which the variation occurred. For example, if a ************ variation is reported in quarter one, a revised Development Plan and budget must be prepared at least ************ prior to the commencement of quarter three. (d) Until such time as a Development Plan is updated in accordance with this AgreementSection 5.1, the preceding Development Plan (including, without limitation, all budget projections and minimum expenditures therein) shall remain in effect. The JSC shall not update any Development Plan in a manner that is inconsistent with or contradicts the terms of this Agreement shall prevailAgreement. The Development Plan shall be considered Confidential Information of Anji Pharma.24

Development Plan. Within thirty (30) [*] days after of [*], the Effective DateParties shall, Anji Pharma shall prepare through the JSC, complete the preparation of an initial development plan for the Product that sets out the Development planactivities to be conducted by or under the authority of each Party for Developing, and obtaining Marketing Authorization(s) for, the Product in the U.S. and Europe (the “Development Plan”), as well as a reasonably detailed budget setting forth the non-clinical Development Costs for such activities related to Development of the Product for the U.S. and clinical Europe (the “Development Budget”). The allocation of activities between the Parties in the Development Plan shall be consistent with Section 5.1. In the event the Parties are unable to reach consensus with respect to the Development Plan and Development Budget within such [*]-day period, despite negotiating in good faith, Mylan shall not be obligated to make the FDA Advisory Milestone Payment and, if Mylan does not pay the FDA Advisory Milestone Payment, either Party may terminate this Agreement upon written notice to the other Party. At least once every calendar quarter until Marketing Authorization has been received in the U.S. and Europe, each Party shall submit to the JSC any updates to its proposed activities under the Development Plan, including any material modifications or additions thereto, for the JSC’s review and approval and coordination of the Parties’ 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, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have 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 following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the 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 LipimetiX shall require the prior written approval of LipimetiX, (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 (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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would 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, the Parties shall discuss such 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 Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall contain the following information with respect to the Product in the U.S. and Europe: (i) scope and timelines for the conduct of all Development activities and studies (including any studies for the applicable approvals of labeling, price and reimbursement) designed to support Marketing Authorization of the Product; (ii) estimated timing of meetings with Regulatory Authorities for the Product; and (iii) target schedules for achieving milestones in developing the Product. The Parties acknowledge and agree that Revance may conduct certain of its Development activities under the Development Plan, which are intended to support the MAA for the Product in the U.S., elsewhere in North America, and the associated Development Costs shall be considered Confidential Information of Anji Pharmashared in accordance with the Development Budget and Section 5.3(d).

Development Plan. Within thirty (30a) days after Attached hereto as Exhibit E is a multi-year development plan for Development Operations and Area-Wide Operations which the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development activities with respect Parties currently anticipate 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 be conducted by the PartiesParty Operators through calendar year 2020 (as hereafter amended, shall be deemed effective (modified or supplemented, the “Initial Development Plan”). During The Joint Development Committee shall have the Termsole right to amend, except as may modify and supplement the Development Plan. (b) Each Development Plan shall, to the extent possible, include: (i) a forecast of the number of active rigs, the drilling days from spud to rig release including the expected time from rig release to first production, including estimates for stimulation/completion days and a forecast of all relevant capital and operational costs related to the foregoing; (ii) the sequence of development of the applicable Operated Area, to the extent known; (iii) a forecast of future production in four categories: (A) ▇▇▇▇▇ already on stream, (B) ▇▇▇▇▇ stimulated but not on stream, (C) ▇▇▇▇▇ drilled but not stimulated, and (D) ▇▇▇▇▇ to be expressly set drilled (▇▇▇▇▇ on stream shall be forecasted on an individual performance basis (individual decline analysis) and all other ▇▇▇▇▇ shall be forecasted on an area basis based on expected performance for the relevant locations (pro-forma curves)). (c) Commencing in 2017 or earlier if the Parties mutually agree, on or before August 31 of each calendar year, each Party Operator shall, with respect to its Operated Area, prepare and submit to the Joint Development Committee an amendment to the portion of the then existing Development Plan covering such Operated Area, which amendment sets forth the Development Operations and Area-Wide Operations reasonably expected to be carried out during the following three calendar years in this Agreement and such Operated Area. Following distribution of all amendments to the Development Plan agreed to by from each of the PartiesParty Operators, the Anji Pharma Related Parties representatives of the Joint Development Committee shall have sole authority over, and control of30 days to furnish to the other members of the Joint Development Committee any proposed revisions they desire to make to the proposed amendments to the Development Plan. Promptly following the Joint Development Committee's 30-day review process, the Joint Development of Compounds and Products in Committee shall meet to consider the Territory, including amendments to 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 and any recommendations made with respect thereto by any member of the Joint Development Committee and approve or reject such amendments to the Development Plan and such recommendations. In addition, the Joint Development Committee shall annually review the Development Plan in connection with its annual review and approval of the Annual Plan and Budget for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise time amend or modify the Development Plan between annual updates; providedPlan. (d) For the avoidance of doubt, however, that Anji Pharma will provide to LipimetiX such revised Development Plan any reference 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 LipimetiX shall require the prior written approval of LipimetiX, (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 (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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would 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, the Parties shall discuss such 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 this Agreement to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between mean the Development Plan and this Agreementattached hereto as Exhibit E, as such Development Plan may be amended from time to time by the Joint Development Committee pursuant to the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmahereof.

Development Plan. Within thirty (30) days after the Effective Date, Anji Pharma shall prepare an initial All Development plan, setting forth the non-clinical and clinical Development activities with respect to the Product for a Pulmonary Indication will be conducted pursuant to this Agreementa Development Plan prepared by the Company and approved by the JSC in relation to the Product’s clinical Development and Regulatory Approval. Such Development Plans shall be prepared separately for each country in the Territory and will generally set forth, with reasonable specificity and detail, the anticipated budget, Development Costs as well as the development and operational plan, including without limitation, research objectives, priorities, milestones, and deliver personnel requirements, for the Product’s Development and Regulatory Approval in relation to the applicable Pulmonary Indication and corresponding country in the Territory. The Company shall submit its Development Plan, which shall include a report of the Development Costs incurred prior to the Effective Date, to the JSC within five (5) days from the Effective Date, and the JSC shall review and approve such Development plan Plan within five (5) days after receipt thereof. Development Plans established under this Agreement (including the initial Development Plan) may be amended or modified from time to LipimetiX. The Parties time by the Company in writing, subject to the review and approval of the JSC. Following JSC review and approval of the Development Plan, the JSC shall review the implementation and execution of the Development Plan on at least a quarterly basis; provided, that if the JSC identifies any unexpected circumstance or material deviations from the Development Plan, GCP and/or GLP, then the JSC shall promptly discuss convene a special meeting to review the causes for such variation and endeavor to finalize such establish a plan for remediation. By the June 30th following the date of the initial Development plan Plan and each June 30th thereafter, the Company will prepare and present to the JSC updated Development Plans on a country by country basis for the immediately following Calendar Year (e.g., the Company will prepare and present to the JSC the Calendar Year 2021 Development Plan by June 30, 2020). The JSC shall make a determination from time to time regarding the particular jurisdictions in which the Product will be Developed and then the Company shall prepare and present Development Plans (including annually updated Development Plans) for such jurisdiction within thirty (30) days thereafter, which upon mutual acceptance by the Parties, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have 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 following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the 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 LipimetiX shall require the prior written approval of LipimetiX, (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 (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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would 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, the Parties shall discuss such 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 Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmadetermination.

Development Plan. Within thirty (30a) days after Attached hereto as Exhibit E is a multi-year development plan for Development Operations and Area-Wide Operations which the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development activities with respect Parties currently anticipate 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 be conducted by the PartiesParty Operators through calendar year 2020 (as hereafter amended, shall be deemed effective (modified or supplemented, the “Initial Development Plan”). During The Joint Development Committee shall have the Termsole right to amend, except as may modify and supplement the Development Plan. (b) Each Development Plan shall, to the extent possible, include: (i) a forecast of the number of active rigs, the drilling days from spud to rig release including the expected time from rig release to first production, including estimates for stimulation/completion days and a forecast of all relevant capital and operational costs related to the foregoing; (ii) the sequence of development of the applicable Operated Area, to the extent known; (iii) a forecast of future production in four categories: (A) ▇▇▇▇▇ already on stream, (B) ▇▇▇▇▇ stimulated but not on stream, (C) ▇▇▇▇▇ drilled but not stimulated, and (D) ▇▇▇▇▇ to be expressly set drilled (▇▇▇▇▇ on stream shall be forecasted on an individual performance basis (individual decline analysis) and all other ▇▇▇▇▇ shall be forecasted on an area basis based on expected performance for the relevant locations (pro-forma curves)). (c) Commencing in 2017 or earlier if the Parties mutually agree, on or before August 31 of each calendar year, each Party Operator shall, with respect to its Operated Area, prepare and submit to the Joint Development Committee an amendment to the portion of the then existing Development Plan covering such Operated Area, which amendment sets forth the Development Operations and Area-Wide Operations reasonably expected to be carried out during the following three calendar years in this Agreement and such Operated Area. Following distribution of all amendments to the Development Plan agreed to by from each of the PartiesParty Operators, the Anji Pharma Related Parties representatives of the Joint Development Committee shall have sole authority over, and control of30 days to furnish to the other members of the Joint Development Committee any proposed revisions they desire to make to the proposed amendments to the Development Plan. Promptly following the Joint Development Committee’s 30-day review process, the Joint Development of Compounds and Products in Committee shall meet to consider the Territory, including amendments to 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 and any recommendations made with respect thereto by any member of the Joint Development Committee and approve or reject such amendments to the Development Plan and such recommendations. In addition, the Joint Development Committee shall annually review the Development Plan in connection with its annual review and approval of the Annual Plan and Budget for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise time amend or modify the Development Plan between annual updates; providedPlan. (d) For the avoidance of doubt, however, that Anji Pharma will provide to LipimetiX such revised Development Plan any reference 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 LipimetiX shall require the prior written approval of LipimetiX, (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 (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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would 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, the Parties shall discuss such 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 this Agreement to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between mean the Development Plan and this Agreementattached hereto as Exhibit E, as such Development Plan may be amended from time to time by the Joint Development Committee pursuant to the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmahereof.

Development Plan. Within thirty (30) days after The Initial Development Plan as attached hereto has been agreed upon by the Parties. With respect to annual updates to the Development Plan following the Effective Date, Anji Pharma Licensee shall prepare deliver to Licensor an initial annual updated Development planPlan in accordance with Section 5.4, setting which shall set forth in reasonable detail the non-clinical and clinical planned Development activities with respect to for at least the Product pursuant to this Agreementupcoming [***], as well as the anticipated timeline, [***], and deliver the budget for such activities. Such updated Development plan Plan shall be certified by Licensee and must be acceptable to LipimetiX. The Parties Licensor, and acceptance shall promptly discuss and endeavor to finalize such initial not be unreasonably conditioned, withheld, or delayed. Such updated Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties, Plan shall be deemed effective (acceptable if no written notice to the “Initial Development Plan”). During contrary is provided to Licensee by Licensor within [***] after Licensor’s receipt, and in each such instance the Term, except as may be expressly set forth in this Agreement and the proposed Development Plan agreed to by shall replace the Parties, the Anji Pharma Related Parties shall have sole authority over, prior Development Plan and control of, the Development become incorporated into and made part 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 Developmentthis Agreement. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an Should Licensor deem Licensee’s updated Development Plan for lacking sufficient detail to [***], then Licensor shall so notify Licensee in writing within such [***] after receipt of such updated Development Plan, specifically pointing to deficiencies and/or posing specific questions to Licensee that, if addressed or answered, would satisfy Licensor’s objection to the following calendar year updated Development Plan. Licensee shall, in good faith, address thoroughly and submit fully such revised matters and provide a response to Licensor within [***] after receipt of Licensor’s written notice. Provided the response from Licensee is a bona fide attempt to address every point or question raised by Licensor, then Licensee’s response shall automatically be deemed an acceptable updated Development Plan, shall replace the prior Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event shall become incorporated into and made a part of any material changes to the Development Plan along with an explanation of the reasons for any such material changesthis Agreement. Notwithstanding the foregoing, (a) any modification the mechanism of “automatic” acceptance through this process shall not be deemed as Licensor’s acceptance that [***], but solely that Licensee has fulfilled its obligation to the provide a Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (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 (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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would 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, the Parties shall discuss such 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 Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmaan annual basis.

Development Plan. Within thirty (30) days after 3DMed shall use commercially reasonable best efforts to Develop the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth Licensed Products in the non-clinical and clinical Field in the Territory pursuant to a development plan that will include a description of the Development activities with respect to be performed in support of obtaining Regulatory Approval for the Product pursuant to this AgreementLicensed Products in the Field in the Territory, including study designs and deliver projected timelines for the completion of 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, shall be deemed effective activities (the “Initial Development Plan”). During Without limiting the Termforegoing, except as may be expressly set forth the Development Plan will include projected timelines for the achievement of the following milestones: (a) submission by 3DMed of the first IND for a Licensed Product in this Agreement China; (b) Initiation of the first Phase 2 Clinical Trial in the Territory for a Licensed Product; (c) Initiation of the first Phase 3 Clinical Trial in the Territory for a Licensed Product; and (d) the submission of an MAA for a Licensed Product to the NMPA. The initial Development Plan agreed to by the Parties, Parties is attached hereto as Exhibit F. Not later than [***] after December 31 of each Calendar Year during the Anji Pharma Related Parties shall have sole authority over, and control of, the Term when Development of Compounds and the Licensed Products in the TerritoryField in the Territory is ongoing, including 3DMed shall submit to the Manufacture of Compounds JSC for its review 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 approval an updated Development Plan for the following calendar year and submit such revised pending Calendar Year. Such update shall take into account completion, commencement, changes in or cessation of Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise activities not contemplated by the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised then-current Development Plan in sufficient detail to reflect the event continued diligence of any 3DMed and its Sublicensees. Any material changes to the Development Plan along with an explanation made outside of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification annual process to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (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 (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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would 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, the Parties shall discuss such 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 update the Development Plan shall be performed in accordance with all Applicable Laws as well as drafted by 3DMed, including the ICH guidelinesaddition of any Clinical Trial protocols or any material changes thereto, and shall require the approval of the JSC. In the event of any inconsistency between proposed change to the Development Plan and this Agreementas a result of any interaction with any Regulatory Authority or Governmental Authority, the terms of this Agreement JSC shall prevailmeet as promptly as practicable to review and discuss any such proposed changes and determine an appropriate revision (if any) to the Development Plan. The SELLAS shall have the right to review and comment on any updates to the Development Plan proposed by 3DMed before such updates are submitted to the JSC for review and approval. In the event SELLAS reasonably disagrees with an update to the Development Plan, 3DMed shall be considered Confidential Information of Anji Pharmaconsider in good f▇▇▇▇ ▇▇▇▇▇▇’ comments relating thereto.

Development Plan. Within thirty (30) days after The Development of the Effective Date, Anji Pharma Licensed Compound and Licensed Products in the Field in the Territory shall prepare an initial Development plan, setting forth be conducted by Qilu pursuant to a development plan that will include a description of the non-clinical and clinical Development activities with respect to be performed in support of obtaining Regulatory Approval for a Licensed Product in the Product pursuant to this AgreementField in the Territory, and deliver including projected timelines for the completion of 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, shall be deemed effective activities (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the The initial high-level Development Plan agreed to by the PartiesParties is attached hereto as Exhibit D, which will be promptly updated by Qilu and submitted to the Anji Pharma Related Parties shall have sole authority over, JSC for review and control of, approval upon Qilu’s receipt of clarification from the applicable Regulatory Authorities as to the additional Development activities necessary to submit an MAA for a Licensed Product in the Field in China. Not later than [***] after December 31 of each Calendar Year during the Term when Development of Compounds the Licensed Compound and Licensed Products in the TerritoryField in the Territory is ongoing, including Qilu shall, if required, submit to the Manufacture of Compounds JSC for its review 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 approval an updated Development Plan for the following calendar year and submit such revised pending Calendar Year. Such update shall take into account completion, commencement, changes in or cessation of Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise activities not contemplated by the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised then-current Development Plan in sufficient detail to reflect the event continued diligence of any Qilu and its Sublicensees. Any material changes to the Development Plan along with an explanation made outside of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification annual process to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (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 (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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would 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, the Parties shall discuss such 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 update the Development Plan shall be performed in accordance drafted by Qilu, including the addition of any Clinical Trial protocols or any material changes thereto, and delivered to the JSC. Qilu shall make any and all proposed changes to the Development Plan as a result of any interaction with all Applicable Laws as well as any Regulatory Authority or Governmental Authority, and report such changes to the ICH guidelinesJSC. Sesen shall have the right to review and comment on any updates to the Development Plan. In the event of any inconsistency between Sesen reasonably disagrees with an update to the Development Plan and this AgreementPlan, Qilu shall consider in good faith Sesen’s comments relating thereto, provided, however, that subject to the terms last sentence of this Agreement shall prevail. The Development Plan Section 3.5 Qilu’s decision shall be considered Confidential Information of Anji Pharmafinal and binding upon the Parties.

Development Plan. Betta shall use Commercially Reasonable Efforts to develop the Licensed Products in the Field in the Territory pursuant to a development plan that will include a description of the development activities to be performed in support of obtaining Regulatory Approval for the Licensed Products in the Field in the Territory, including study designs and projected timelines for the completion of such activities (the “Development Plan”). Without limiting the foregoing, the Development Plan will include projected timelines for the achievement of material development milestones, including the following material development milestones: (a) submission by Betta of the first IND for a Licensed Product in China; (b) initiation of the first clinical trial in China for a Licensed Product; (c) initiation of the first Registrational Clinical Trial in China for a Licensed Product; and (d) the submission of an NDA for a Licensed Product to the NMPA. Within thirty (30) [***] days after the Effective Date, Anji Pharma Betta shall prepare an submit to the JSC the initial Development plan, setting forth Plan. Not later than [***] days prior to December 31 of each Calendar Year during the non-clinical and clinical Development activities with respect to Term when development of 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, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Licensed Products in the TerritoryField in the Territory is ongoing, including Betta shall submit to the Manufacture of Compounds and Products JSC 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 its review an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to timenext Calendar Year. Such update shall take into account completion, at its election and sole discretioncommencement, revise changes in or cessation of development activities not contemplated by the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised then-current Development Plan in sufficient detail to reflect the event continued diligence of any Betta and its Affiliates and Sublicensees. Any material changes to the Development Plan along with an explanation made outside of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification annual process to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (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 (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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would 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, the Parties shall discuss such 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 update the Development Plan shall be performed in accordance with all Applicable Laws as well as prepared by Betta, including the ICH guidelinesaddition of any clinical trial protocols or any material changes thereto, and shall be submitted to the JSC for review. In the event of any inconsistency between proposed change to the Development Plan and this Agreementas a result of any interaction with any Regulatory Authority or Governmental Authority, the terms of this Agreement JSC shall prevailmeet as promptly as practicable to review and discuss any such proposed changes and determine an appropriate revision (if any) to the Development Plan. The EyePoint shall have the right to review and comment on any updates to the Development Plan proposed by Betta before such updates are submitted to the JSC for review. In the event EyePoint reasonably disagrees with an update to the Development Plan, Betta shall be considered Confidential Information of Anji Pharmaconsider in good faith EyePoint’s comments relating thereto. For clarity, if Betta participates in the Global Trial, then the development plan for the Global Trial will replace the requirement for the Development Plan.

Development Plan. (a) Within thirty [***] days following the Exercise Date with respect to a given Collaboration Candidate, ONO will prepare and provide to the JSC an update to its proposed activities under the Joint Development Plan pursuant to which ONO will conduct Research and Development in the ONO Territory, and FATE will prepare and provide to the JSC (30i) days after an update to its proposed activities under the Effective DateJoint Development Plan pursuant to which FATE will conduct Research and Development in the FATE Territory, Anji Pharma shall prepare for such Collaboration Product on an initial Development planIndication-by-Indication basis, setting forth the as applicable and (ii) a process development and manufacturing plan for all non-clinical and clinical Development activities Materials of Collaboration Products for use both by ONO in the ONO Territory and by FATE in the FATE Territory. Each Party will prepare and provide a budget and estimated timeline with respect to its proposed activities under the 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, shall be deemed effective (the “Initial Joint Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have 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 following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the 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 LipimetiX shall require the prior written approval of LipimetiX, . (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, ONO and (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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would 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, the Parties shall FATE will discuss such concerns and Anji Pharma shall consider such concerns in good faith through the JSC, and use Commercially Reasonable Efforts to address any reach an agreement on, the Joint Development Plan, including but not limited to: (i) [***], (ii) and (iii) [***]. (c) During each Calendar Year, each Party shall provide its updates on the Joint Development Plan for the upcoming year covering activities [***] so that the Parties may agree on such concerns. All clinical trials conducted in the Territory pursuant update by [***] that year, and each Party shall continue to provide to the other Party, through the JSC, regular updates from time to time to its proposed activities under the Joint Development Plan Plan, as applicable. Each Party will consider in good faith the other Party's comments on such proposed activities and any updates thereto. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission. (d) If the JSC fails to agree, after the use of Commercially Reasonable Efforts in an attempt to reach an agreement between the Parties regarding the Joint Development Plan, notwithstanding the provisions of Article 12 (Dispute Resolution), the decision shall be performed made in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this AgreementSection 4.1.8 (Decision-Making; Limitations on JSC), the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmaprovided however, [***].

Development Plan. Within thirty (30a) days after All Development with respect to any Product hereunder shall be conducted pursuant to a Development Plan prepared and approved by the Effective DateJSC, Anji Pharma which shall prepare an initial Development plan, setting set forth the nonplan for the pre-clinical and clinical Development activities with respect to the Product pursuant to this AgreementDevelopment, and deliver Regulatory Approval of such Product in each of the European Territory, the North American Territory and the Co-Exclusive Territories and the activities to be carried out related thereto by LFB Biotech and GTC on behalf of LFB/GTC LLC, together with a proposed budget for such activities (each, a “Development plan to LipimetiX. Plan”). The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance by Plan for the Parties, shall be deemed effective Initial Product (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan ) has been agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, . Each Development Plan 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 following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event shall include a projection 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 the plan of Development activities with respect to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiXrelevant product and timelines for performing such activities, (b) the proposed budget for such Development Plan shall summarize the activities, (c) expected Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunderfunding by each Operating Party, and (cd) a non-binding forecast of clinical supply of Product to be supplied as provided under Article 7. The Development Plan for a Product shall also specify the jurisdictions (other than the US and EU) where Regulatory Approval will be sought for such Product and prospective indication extension after the First Major Regulatory Approval. Such business case shall be reviewed and updated on a regular basis by the JSC. (b) For so long as necessary to complete Development of any Product, the Operating Parties, through the JSC, shall update the Development Plan shall always include with respect to such Product on an annual basis prior to the commencement of the next calendar year, or more often as determined by the JSC. (ic) 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 LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to The JSC will review performance against the Development Plan would be reasonably expected for each Product on a quarterly basis, and will report any variations to have the Operating Parties in writing. If, in any quarter, there is a material adverse effect on Development variation of ************ or Commercialization activities for greater from the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territorybudget, the Parties shall discuss such 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 Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between JSC will revise the Development Plan and budget for the applicable Product ************ prior to the commencement of the second quarter following the quarter in which the variation occurred. For example, if a ************ variation is reported in quarter one, a revised Development Plan and budget must be prepared at least ************ prior to the commencement of quarter three. (d) Until such time as a Development Plan is updated in accordance with this AgreementSection 5.1, the preceding Development Plan (including, without limitation, all budget projections and minimum expenditures therein) shall remain in effect. The JSC shall not update any Development Plan in a manner that is inconsistent with or contradicts the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji PharmaAgreement.