Common use of Development Plan Clause in Contracts

Development Plan. (i) The Development of the CD38 Product under this Agreement shall be conducted pursuant to a development plan to be implemented by or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of the CD38 Product in the Field in the Territory (the “Development Plan”). The Development Plan shall be consistent with I-Mab’s obligation under the MorphoSys License with respect to the Development of the 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”).”

Appears in 2 contracts

Sources: Cd38 Product Collaboration Agreement (I-Mab), Supplemental Agreement (I-Mab)

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) The a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the CD38 Product under this Agreement Compounds and Products. Any revised Development Plan shall be conducted pursuant to a development plan deemed to be implemented 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 I-Mab LipimetiX or its Affiliates or sublicensees 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 obtain Regulatory Approval of the CD38 Product in the Field address any such concerns. All clinical trials conducted in the Territory (pursuant to the Development Plan”)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 consistent with I-Mab’s obligation under the MorphoSys License with respect to the Development considered Confidential Information of the 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”)Anji Pharma. (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”).”

Appears in 2 contracts

Sources: License Agreement, License Agreement (Capstone Therapeutics Corp.)

Development Plan. (ia) The Development of the CD38 Tirasemtiv and Product under this Agreement (the “Development Program”) shall be conducted pursuant to a development comprehensive written global Development plan to be implemented by or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of the CD38 Product in the Field in the Territory (the “Development Plan”), with Cytokinetics having final decision making authority pursuant to Section 2.11, subject to [*] described below. The Development Plan shall set forth the timeline and details of: (i) all preclinical and clinical Development activities to be consistent with I-Mab’s obligation under conducted by the MorphoSys License with respect Parties as necessary to generate data sufficient to meet the requirements for Regulatory Approval of the Product 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 Tirasemtiv and Product. The Parties agree that the Development Plan shall contain detailed plans for at least the initial [*] covered by the Development Plan. The Development Plan shall include a coordinated development and regulatory strategy, including the Parties’ respective roles in the development of each Product and the CD38 Productcountries in which Development of Product will occur. The Development Plan shall also include set forth a detailed budget of the Development activities to be [*] (the “Development Budget”). Within thirty (30) for such Development activities. As of days after the Effective Date, the Parties have agreed on Cytokinetics shall prepare the initial Development Plan, attached hereto as Exhibit B. Pursuant which shall include the development plan provided by Cytokinetics 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 Astellas under the initial Development Plan, but shall not include and shall be in addition 2014 Agreement at the time when the Early Data Package or Late Data Package (as applicable) for the Option exercise is provided by Cytokinetics to any payments (including upfront payments, development milestone payments, and any other payments) made by I-Mab Astellas under the License and Collaboration Agreement by and between I-Mab and MorphoSys AG (“Morphosys”), dated November 30, 2017 (the “Morphosys 2014 Agreement”). (iib) From time to timetime during the Term (but no less than annually), I-Mab the JDC shall prepare amendments and approve updates and amendments, as appropriate, to the then-current Development Plan and (including Development Budget and submit such amendments and Budget). By [*] of each calendar year starting on [*] or the Effective Date, whichever is later, the JDC shall agree upon a proposed [*] for the following Astellas fiscal year. Astellas shall use good faith efforts to [*]. Annual updates to shall be finally approved no later than [*] before the JSC for review and approvalbeginning of next calendar year. Once approved by the JSCJDC, such revised Development Plan and Development Budget shall replace or supplement, as appropriate, the prior Development Plan and Development BudgetPlan. (iiic) Upon Astellas shall not conduct any Development and/or Commercialization activities with respect to any Product in any Indication other than ALS without the Listing prior written consent of I-Mab, if I-Mab proposes Cytokinetics. Cytokinetics shall have the right to increase conduct Development and/or Commercialization activities under the Initial Development Budget Plan or the then applicable Development Budget Commercialization Plan as appropriate with respect to the Product in Indications other than ALS, provided that [*]. (as determined in accordance with this Article 3.2(a)(iid) and/or (iii)) (such amendment, “Material If the terms of the Development Plan Amendment” and such incremental increase of the Initial Development Budgetcontradict, or create inconsistencies or ambiguities with, 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 terms 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 Amendmentthis Agreement, then such Development Plan Amendment may only become effective, and the Parties terms of this Agreement 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”)govern.

Appears in 1 contract

Sources: License and Collaboration Agreement (Cytokinetics Inc)

Development Plan. (ia) The All Development of the CD38 with respect to any Product under this Agreement hereunder shall be conducted pursuant to a development Development Plan prepared and approved by the JSC, which shall set forth the plan to be implemented by or on behalf of Ifor the pre-Mab or its Affiliates or sublicensees to obtain clinical and clinical Development, and Regulatory Approval of the CD38 such Product in each of the Field in 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 (the each, a “Development Plan”). The Parties will mutually agree upon a preliminary Development Plan shall be consistent with I-Mab’s obligation under for the MorphoSys License with respect to the Development of the CD38 Product. The Development Plan shall also include a detailed budget Initial Product (the “Initial Development BudgetPlan”) for such Development activities. As of within ************ following the Effective Date, the Parties have agreed on the initial Development Plan, a copy of which shall be attached hereto as Exhibit B. Pursuant Each Development Plan and updated Development Plan shall include a projection of (a) the plan of Development activities with respect to the initial relevant product and timelines for performing such activities, (b) the proposed budget for such Development Planactivities, the (c) expected Development funding by each Party, and (d) a non-binding forecast of CD38 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 [completed] 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 December 31, 2024 (“Development Complete Date”) with the JSC. For indicative purposes only a total budget preliminary version of US$200,000,000 (the business case prepared by the Parties for the Initial Development Budget”)Product is attached hereto as Exhibit B-1. Such Initial Development Budget business case shall be inclusive of all costs reviewed and expenses to be incurred updated on a regular basis 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”)JSC. (iib) From time For so long as necessary to timecomplete Development of any Product, I-Mab the Parties, through the JSC, shall prepare amendments and updates update the Development Plan with respect to such Product on an annual basis prior to the then-current commencement of the next calendar year, or more often as determined by the JSC. (c) The JSC will review performance against the Development Plan for each Product on a quarterly basis, and will report any variations to the Parties in writing. If, in any quarter, there is a variation of ************ or greater from the budget, the JSC will revise the Development Plan and Development Budget and submit such amendments and updates budget for the applicable Product ************ prior to the JSC for review and approvalcommencement of the second quarter following the quarter in which the variation occurred. Once approved by the JSCFor example, such if a ************ variation is reported in quarter one, a revised Development Plan and Development Budget shall replace or supplement, as appropriate, budget must be prepared at least ************ prior to the prior Development Plan and Development Budgetcommencement of quarter three. (iiid) Upon the Listing of I-Mab, if I-Mab proposes to increase the Initial Until such time as a Development Budget or the then applicable Development Budget (as determined Plan is updated in accordance with this Article 3.2(a)(ii) and/or (iii)) (such amendmentSection 5.1, “Material the preceding Development Plan Amendment” (including, without limitation, all budget projections and such incremental increase of the Initial Development Budget, the “Increased Amount”), minimum expenditures therein) shall remain in addition to the approval by the effect. 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 not update any Development Plan Amendment for in a manner that is inconsistent with or contradicts the approval terms of its shareholders who are not otherwise connected with Everest (to be determined by the Applicable Listing Rules) (the “Unconnected Shareholders”)this Agreement. 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”).”24

Appears in 1 contract

Sources: Joint Development and Commercialization Agreement (GTC Biotherapeutics Inc)

Development Plan. (ia) The Development of the CD38 Tirasemtiv and Product under this Agreement (the “Development Program”) shall be conducted pursuant to a development comprehensive written global Development plan to be implemented by or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of the CD38 Product in the Field in the Territory (the “Development Plan”), with Cytokinetics having final decision making authority pursuant to Section 2.11, subject to [*] described below. The Development Plan shall set forth the timeline and details of: (i) all preclinical and clinical Development activities to be consistent with I-Mab’s obligation under conducted by the MorphoSys License with respect Parties as necessary to generate data sufficient to meet the requirements for Regulatory Approval of the Product 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 Tirasemtiv and Product. The Parties agree that the Development Plan shall contain detailed plans for at least the initial [*] covered by the Development Plan. The Development Plan shall include a coordinated development and regulatory strategy, including the Parties’ respective roles in the development of each Product and the CD38 Productcountries in which Development of Product will occur. The Development Plan shall also include set forth a detailed budget of the Development activities to be [*] (the “Development Budget”). Within thirty (30) for such Development activities. As of days after the Effective Date, the Parties have agreed on Cytokinetics shall prepare the initial Development Plan, attached hereto as Exhibit B. Pursuant which shall include the development plan provided by Cytokinetics 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 Astellas under the initial Development Plan, but shall not include and shall be in addition 2014 Agreement at the time when the Early Data Package or Late Data Package (as applicable) for the Option exercise is provided by Cytokinetics to any payments (including upfront payments, development milestone payments, and any other payments) made by I-Mab Astellas under the License and Collaboration Agreement by and between I-Mab and MorphoSys AG (“Morphosys”), dated November 30, 2017 (the “Morphosys 2014 Agreement”). (iib) From time to timetime during the Term (but no less than annually), I-Mab the JDC shall prepare amendments and approve updates and amendments, as appropriate, to the then-current Development Plan and (including Development Budget and submit such amendments and Budget). By [*] of each calendar year starting on [*] or the Effective Date, whichever is later, the JDC shall agree upon a proposed [*] for the following Astellas fiscal year. Astellas shall use good faith efforts to [*]. Annual updates to shall be finally approved no later than [*] before the JSC for review and approvalbeginning of next calendar year. Once approved by the JSCJDC, such revised Development Plan and Development Budget shall replace or supplement, as appropriate, the prior Development Plan and Development BudgetPlan. (iiic) Upon Astellas shall not conduct any Development and/or Commercialization activities with respect to any Product in any Indication other than ALS without the Listing prior written consent of I-Mab, if I-Mab proposes Cytokinetics. Cytokinetics shall have the right to increase conduct Development and/or Commercialization activities under the Initial Development Budget Plan or the then applicable Development Budget Commercialization Plan as appropriate with respect to the Product in Indications other than ALS, provided that [*]. (as determined in accordance with this Article 3.2(a)(iid) and/or (iii)) (such amendment, “Material If the terms of the Development Plan Amendment” contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and such incremental increase filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 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 Securities Exchange Act 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 supplement1934, 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”)amended.

Appears in 1 contract

Sources: License and Collaboration Agreement (Cytokinetics Inc)

Development Plan. (ia) The Attached hereto as Exhibit E is a multi-year development plan for Development of Operations and Area-Wide Operations which the CD38 Product under this Agreement shall Parties currently anticipate to be conducted pursuant to a development plan to be implemented by the Party Operators through calendar year 2020 (as hereafter amended, modified or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of the CD38 Product in the Field in the Territory (supplemented, the “Development Plan”). The Joint Development Committee shall have the sole right to amend, 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 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 such Operated Area. Following distribution of all amendments to the Development Plan from each of the Party Operators, the representatives of the Joint Development Committee shall have 30 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 Committee shall meet to consider the amendments to the 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 may from time to time amend or modify the Development Plan. (d) For the avoidance of doubt, any reference in this Agreement to the Development Plan shall be consistent with I-Mab’s obligation under the MorphoSys License with respect to mean the Development of the 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 supplementE, 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 be amended from time to time by the Parties shall carry out such Material Joint Development Plan Amendment, if Everest agrees Committee pursuant 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”)terms hereof.

Appears in 1 contract

Sources: Joint Development Agreement (CONSOL Energy Inc)

Development Plan. (i) The Within [*] days of [*], the Parties shall, through the JSC, complete the preparation of an initial development plan for the Product that sets out the Development of the CD38 Product under this Agreement shall activities to be conducted pursuant to a development plan to be implemented by or on behalf under the authority of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of each Party for Developing, and obtaining Marketing Authorization(s) for, the CD38 Product in the Field in the Territory U.S. and Europe (the “Development Plan”), as well as a reasonably detailed budget setting forth the Development Costs for such activities related to Development of the Product for the U.S. and Europe (the “Development Budget”). The allocation of activities between the Parties in the Development Plan shall be consistent with I-Mab’s obligation under Section 5.1. In the MorphoSys License 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 CD38 ProductParties’ activities with respect to the Product as set forth hereunder. The Development Plan shall also include a detailed budget 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 Budget”activities and studies (including any studies for the applicable approvals of labeling, price and reimbursement) for such Development activities. As designed to support Marketing Authorization of the Effective Date, 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 have agreed on acknowledge and agree that Revance may conduct certain of its Development activities under the initial Development Plan, attached hereto as Exhibit B. Pursuant which are intended to support the initial MAA for the Product in the U.S., elsewhere in North America, and the associated Development Plan, the Development of CD38 Product Costs 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 shared 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 and Section 4.1) (the “Everest Sole Development Costs”5.3(d).

Appears in 1 contract

Sources: Collaboration and License Agreement (Revance Therapeutics, Inc.)

Development Plan. (a) Borrower’s revised and current Development Plan covering the development activities of Borrower is attached to this Agreement as Schedule 1.5. Borrower can propose modifications to the Development Plan from time to time, 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) The Development in the case of costs not yet expended, an AFE (including all Supporting Documentation) at least 15 days before Borrower incurs any costs that it intends to fund out of an Advance or (ii) in the CD38 Product under this Agreement shall be conducted pursuant to a development plan case of costs already expended and to be implemented reimbursed through an Advance, reasonable evidence of a request for payment by or on behalf the applicable Operator and reasonable evidence of I-Mab or its Affiliates or sublicensees to obtain Regulatory payment by Borrower (collectively, “Reimbursement Request”) at least 5 days before Borrower requests such an Advance. (d) Notwithstanding the Administrative Agent’s Approval of the CD38 Product in the Field in the Territory (the “a Development Plan”). The Development Plan shall be consistent with I-Mab’s obligation under : (i) Borrower must nevertheless satisfy the MorphoSys License with respect conditions described in this Article I and Section 8.3 prior to the Development making of the 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”).each Advance; and (ii) From time Lenders will have no obligation to time, I-Mab shall prepare amendments and updates make an Advance to fund projects included on the then-current Development Plan: (A) unless the requested Advance relates to an AFE or Reimbursement Request Approved by Administrative Agent; or (B) if the requested Advance (together with all amounts previously Advanced in respect of the applicable AFE or Reimbursement Request) exceeds (1) the cost set forth in the Development Plan and Development Budget and submit such amendments and updates to for that project, or (2) the JSC for review and approval. Once approved by Loan availability remaining under the JSC, such revised Development Plan and Development Budget shall replace or supplement, as appropriate, the prior Development Plan and Development BudgetTerm Loan. (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”).”

Appears in 1 contract

Sources: Credit Agreement (Voyager Oil & Gas, Inc.)

Development Plan. 5.1 In each Calendar Year that Development regarding the PIP is occurring, each Party shall at its own cost and expense (isubject to Section 5.4) The Development of use Commercially Reasonable Efforts to carry out the CD38 Product under this Agreement shall be conducted pursuant to a development plan to be implemented by or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of the CD38 Product activities specified in the Field in the Territory (the “Development Plan”). The Development Plan shall be consistent with I-Mab’s obligation under the MorphoSys License with respect 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 of regarding the CD38 Product. The PIP by the Licensor, it shall update 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 before November 1st in each year and shall be in addition to any payments (including upfront payments, development milestone payments, and any other payments) made by I-Mab under submit 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 same 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. 5.3 The Licensor shall: (iiia) Upon be responsible for 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 conduct of the Initial Development BudgetPIP, the “Increased Amount”), in addition subject 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, timelines set out in the prior Development Plan and Development Budget. In subject to the event 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 cooperate with any such audit; and (e) promptly provide to the JSC the results of the PIP in the form of a Material Development Plan Amendmentcopy of any Interim Report, a Formal Presentation and a copy of the Final Report as these occur, even if between JSC approves such Material Development Plan Amendment but scheduled meetings. 5.4 The Licensee shall reimburse 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 Licensor for seventy per cent (10070%) of the Increased Amount without requiring Iongoing 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 supporting evidence of such Development Costs having been incurred in connection with the conduct of the PIP, which 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 permitted to invoice on a monthly basis. Payment shall be made by the Licensee within thirty (30) Business Days of the date of receipt of the Licensor's invoice, into such bank account as the Licensor shall specify from time to time. For the avoidance of doubt, the Licensor shall be responsible for the remaining thirty per cent (30%) of such Development Costs in connection with the conduct of the PIP. 5.5 During the period in which the PIP is ongoing, the Parties may, from time to time, together agree in writing to update the PIP Budget and where this occurs the proposed changes will be submitted to the JSC for review and 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-Mab final draft of each Clinical Trial protocol or update to share a protocol for the Product at least forty-five (45) days prior to the date on which such Increased Amount 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 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 activities; (b) the Licensee shall supply the Licensor with all material Know How, Dossiers 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 Section 4.1 such license on the same payment terms as, and at a rate equal to two percent (but 2%) less than the rate owed by, Licensee to Licensor for clarity I-Mab shall continue to share sales of Products hereunder, with all applicable definitions and provisions having the then-current Development Budget before such proposed Material Development Amendment under Section 4.1) (the “Everest Sole Development Costs”)Parties reversed, mutatis mutandis.

Appears in 1 contract

Sources: License Agreement (Aeterna Zentaris Inc.)

Development Plan. (i) The Development of the CD38 Product under this Agreement shall be conducted pursuant Prior to a development plan to be implemented by or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of the CD38 Product in the Field in the Territory (the “Development Plan”). The Development Plan shall be consistent with I-Mab’s obligation under the MorphoSys License with respect to the Development of the CD38 Product. The Development Plan shall also include a detailed budget (the “Development Budget”) for such Development activities. As of the Effective Date, the JDT adopted a Joint Development Plan and Joint Budget (each, as defined in the Collaboration Agreement) that govern the global Development, Manufacturing, and regulatory activities of the Parties have agreed on the initial Development Plan, attached hereto as Exhibit B. Pursuant with respect to the initial Development PlanProduct under the Collaboration Agreement. As promptly as practicable following the Effective Date, the JDC shall (a) update such Joint Development of CD38 Product shall be [completed] Plan and Joint Budget to the extent necessary to (i) align the contents thereof with this Agreement and the Approved Plans hereunder, including by December 31, 2024 (“incorporating the Global Regulatory Plan prepared pursuant to Section 8.1.1 and by revising the Joint Development Complete Date”) with a total budget of US$200,000,000 (Plan and Joint Budget to exclude Manufacturing and instead addressing Manufacturing activities in the “Initial Development Budget”). Such Initial Development Budget shall be inclusive of all costs and expenses separate Global Manufacturing Plan to be incurred by or on account of I-Mab drafted and Everest under the initial Development Plan, but shall not include and shall be in addition to any payments (including upfront payments, development milestone paymentsapproved hereunder, 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 otherwise reflect the global Development activities of the Parties with respect to the then-current Development Plan Product throughout the Territory, and Development Budget the corresponding budget therefor, and (b) submit such amendments updated plan and updates budget to the JSC for review and approval. Once approval (as approved by the JSC, such revised plan and budget, collectively, the “Global Development Plan”). Following its approval by the JSC, the Global Development Plan under this Agreement shall replace the Joint Development Plan and Development Joint Budget shall replace under the Collaboration Agreement for all purposes with respect to the Product under this Agreement and the Collaboration Agreement. On an annual basis, or supplement, more often as the Parties deem appropriate, the prior JDC shall prepare amendments to the then-current Global 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 for approval by the JSC. The JSC as required under Article 3.2(a)(ii), I-Mab shall comply with will endeavor to approve the applicable rules Global Development Plan or such amendments before the end 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 Budgetthen- applicable Year. In the event of a Material any inconsistency between the Global Development Plan Amendmentand this Agreement, the JSC approves such Material terms of this Agreement shall prevail. For clarity, and without limiting the treatment of CMC Development Costs as Development Costs, the portions of the existing Joint Development Plan Amendment but and Joint Budget relating to Manufacturing or CMC Development will not become part of the Unconnected Shareholders do not approve such Material Global Development Plan Amendmentpursuant to this Section ​ [*] = Certain information contained in this document, then such Development Plan Amendment may only become effectivemarked by brackets, has been omitted because it is both not material and is the Parties shall carry out such Material Development Plan Amendment, if Everest agrees to bear one hundred percent (100%) type 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”).”information that we treat as private or confidential. ​

Appears in 1 contract

Sources: Joint Commercialization Agreement (Genmab a/S)

Development Plan. (ia) The Attached hereto as Exhibit E is a multi-year development plan for Development of Operations and Area-Wide Operations which the CD38 Product under this Agreement shall Parties currently anticipate to be conducted pursuant to a development plan to be implemented by the Party Operators through calendar year 2020 (as hereafter amended, modified or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of the CD38 Product in the Field in the Territory (supplemented, the “Development Plan”). The Joint Development Committee shall have the sole right to amend, 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 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 such Operated Area. Following distribution of all amendments to the Development Plan from each of the Party Operators, the representatives of the Joint Development Committee shall have 30 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 Committee shall meet to consider the amendments to the 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 may from time to time amend or modify the Development Plan. (d) For the avoidance of doubt, any reference in this Agreement to the Development Plan shall be consistent with I-Mab’s obligation under the MorphoSys License with respect to mean the Development of the 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 supplementE, 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 be amended from time to time by the Parties shall carry out such Material Joint Development Plan Amendment, if Everest agrees Committee pursuant 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”)terms hereof.

Appears in 1 contract

Sources: Joint Development Agreement (Noble Energy Inc)

Development Plan. (iPromptly after the execution of this Agreement, on a Collaboration Product-by-Collaboration Product basis, Pfenex and Agila shall jointly prepare a mutually-agreed written work plan for any Collaboration Product(s) The Development that sets out in reasonable detail the development activities to be conducted by each Party and its designees for the Successful Completion of the CD38 Product under first Phase I Clinical Trial for any Collaboration Product(s), as well as the location, protocol, budget and timelines for completion of various tasks therefor [*] Certain information in this Agreement shall be conducted pursuant document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (each, a development plan to be implemented by or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of the CD38 Product in the Field in the Territory (the “Development Plan”). The Each Development Plan shall be consistent with I-Mabsubject to the JSC’s approval. Upon the JSC’s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, unless and until the Parties sign the Development Plan for any Collaboration Product, neither Party shall have any obligation under the MorphoSys License with respect to any product hereunder; provided, however, that unless and until the Development earlier of (a) the CD38 Product. The Parties sign a Development Plan shall also include therefor or (b) either Party provides sixty (60) days’ prior written notice to the other Party of its intent to exclude a detailed budget product described in Section 1.6(a) — (the “Development Budget”) for such Development activities. As of the Effective Datee), the Parties have agreed shall use good faith efforts to prepare and agree on the initial Development Plan, attached hereto as Exhibit B. Pursuant Plan therefor prior to the initial Development Plan, date specified in Exhibit 1 (as may be amended from time to time by 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”Parties). 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 Each Development Plan will be updated 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 Isemi-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 annually by the JSC and shall be consistent with the shareholders general allocation of I-Mab responsibilities described in Section 3.2 below. Without limiting the foregoing, any material modifications or additions to any Development Plan (including any proposed change(s) to any Third Party designee) shall be first approved by JSC prior to its implementation. Each Party shall perform its obligations allocated to it under each Development Plan in accordance with the Applicable Listing Rules terms and such approved Material Development Plan Amendment shall replace or supplement, as appropriateconditions of this Agreement (including the diligence requirement set forth in Article 8), the prior applicable 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”)all Applicable Laws.

Appears in 1 contract

Sources: Joint Development and License Agreement (Pfenex Inc.)