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. (ia) The Development plan for the development of Product as agreed to by the CD38 Product under Parties (including timelines therein) is set forth in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement shall be conducted pursuant to a development (such plan to be implemented by or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of the CD38 Product as set forth in the Field memorandum, the “Initial Development Plan” and together with any updates thereto in the Territory (accordance herewith, the “Development Plan,” and the conduct of the activities under the Development Plan, the “Development Program”). The Development Plan shall includes (i) each Party’s responsibilities for those activities to be consistent performed in regards to obtaining Regulatory Approval for Product, including timelines for initiation and completion of such activities, [***] Certain information in this document has been omitted and filed separately with I-Mab’s obligation under the MorphoSys License Securities and Exchange Commission. Confidential treatment has been requested 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”)omitted portions. (ii) From annual budgeted Program Related Costs for Product for each Annual Period and (iii) the target dates for the submission of an application and other Regulatory Materials for the Regulatory Approval of Product in each Major Market. Pfenex and Hospira shall cooperate with one another to update and/or amend the Development Plan and/or Product Data Sheet from time to time, I-Mab shall prepare amendments and updates time at the request of a Party by such Party’s submission of the proposed amendment to the then-Executive Steering Committee. Within ten (10) Business Days following the submission by a Party of any such proposed amendment to the Development Plan and/or Product Data Sheet, the Executive Steering Committee shall decide whether to approve such amendment, or a modified version thereof. Notwithstanding the above, Hospira shall have the right to make updates and/or amendments to the Initial Development Plan and any updated Development Plan without submitting such changes to the Executive Steering Committee so long as such updates and/or amendments do not result in a delay to any “Finish Date” to a Critical Task (as defined in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement). The Parties shall refer to the most current Development Plan when identifying the applicable Finish Date with respect to a Critical Task. In all events Hospira shall promptly notify the Project Lead for the Development Program at Pfenex of such updates and Development Budget and submit such amendments and updates amendments. Such notice may be provided by email to the JSC for review and approvalProject Lead. Once approved by Except as set forth in this Section 3.2(a), neither the JSC, such revised Development Plan and Development Budget shall replace or supplement, as appropriate, nor Product Data Sheet may be amended without the prior Development Plan and Development Budgetdocumented approval of the Executive Steering Committee (subject to the limitations on Hospira’s final decision making authority as set forth in Section 3.2(b) below). (iiib) Upon Hospira shall not have the Listing of Iright to exercise its final decision-Mab, if I-Mab proposes making authority within the Executive Steering Committee with respect to increase amendments to the Development Plan in a manner (x) that would cause a material delay in the timelines set forth in the Initial Development Budget Plan (for clarity, the timelines in the Initial Development Plan for a particular activity shall be subject to extension for matters beyond the reasonable control of the Party responsible for the particular activity (e.g., delays related to clinical hold by a Regulatory Agency); provided, that such Party uses Commercially Reasonable Efforts to mitigate any such delay and such extension shall be limited to the period necessary to accommodate such delay), (y) that is inconsistent terms of this Agreement, or (z) that would unilaterally impose any material obligation on Pfenex (including causing Pfenex to incur or share any cost that is not provided for in the then applicable Development Budget Plan or this Agreement as of the date hereof); provided, that Pfenex shall not unreasonably withhold, condition or delay the consent to perform activities requested by Hospira that are necessary or useful for the development of Product and Pfenex is in the unique position of being able to perform such activities and Hospira agrees to reimburse Pfenex’s internal and external costs incurred in connection with the performance of such activities (as which in the case of internal costs shall be 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”GAAP).”

Appears in 2 contracts

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

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 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. (i) The Development of 3DMed shall use commercially reasonable best efforts to Develop 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 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”). The Without limiting the foregoing, the Development Plan shall be consistent with I-Mab’s obligation under will include projected timelines for the MorphoSys License with respect achievement of the following milestones: (a) submission by 3DMed of the first IND for a Licensed Product in 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 Development of the CD38 ProductNMPA. The initial Development Plan shall also include a detailed budget (the “Development Budget”) for such Development activities. As of the Effective Date, agreed to by the Parties have agreed on the initial Development Plan, is attached hereto as Exhibit B. Pursuant F. Not later than [***] after December 31 of each Calendar Year during the Term when Development of the Licensed Products in the Field in the Territory is ongoing, 3DMed shall submit to the initial JSC for its review and approval an updated Development Plan, Plan for 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”)pending Calendar Year. Such Initial update shall take into account completion, commencement, changes in or cessation of Development Budget shall be inclusive of all costs and expenses to be incurred activities not contemplated 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 in sufficient detail to reflect the continued diligence of 3DMed and its Sublicensees. Any material changes to the Development Budget Plan made outside of the annual process to update the Development Plan shall be drafted by 3DMed, including the addition of any Clinical Trial protocols or any material changes thereto, and submit shall require the approval of the JSC. In the event of any proposed change to the Development Plan as a result of any interaction with any Regulatory Authority or Governmental Authority, the JSC shall meet as promptly as practicable to review and discuss any such amendments proposed changes and determine an appropriate revision (if any) to the Development Plan. 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. 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 SELLAS reasonably disagrees with an update to the Development Plan AmendmentPlan, 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 3DMed 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”)consider in good f▇▇▇▇ ▇▇▇▇▇▇’ comments relating thereto.”

Appears in 1 contract

Sources: Exclusive License Agreement (SELLAS Life Sciences Group, Inc.)

Development Plan. (i) The Development of Betta shall use Commercially Reasonable Efforts to develop 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 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”). The Without limiting the foregoing, the Development Plan shall be consistent with I-Mab’s obligation under will include projected timelines for the MorphoSys License with respect 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 Development of the CD38 ProductNMPA. The Development Plan shall also include a detailed budget (the “Development Budget”) for such Development activities. As of Within [***] days after the Effective Date, Betta shall submit to the Parties have agreed on JSC the initial Development Plan. Not later than [***] days prior to December 31 of each Calendar Year during the Term when development of the Licensed Products in the Field in the Territory is ongoing, attached hereto as Exhibit B. Pursuant Betta shall submit to the initial JSC for its review an updated Development Plan, Plan for 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”)next Calendar Year. Such Initial Development Budget update shall be inclusive take into account completion, commencement, changes in or cessation of all costs and expenses to be incurred development activities not contemplated 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 in sufficient detail to reflect the continued diligence of Betta and its Affiliates and Sublicensees. Any material changes to the Development Budget Plan made outside of the annual process to update the Development Plan shall be prepared by Betta, including the addition of any clinical trial protocols or any material changes thereto, and submit such amendments and updates shall be submitted 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 Budgetreview. In the event of a Material any proposed change to the Development Plan Amendmentas a result of any interaction with any Regulatory Authority or Governmental Authority, the JSC approves shall meet as promptly as practicable to review and discuss any such Material proposed changes and determine an appropriate revision (if any) to the Development Plan. EyePoint shall have the right to review and comment on any updates to the Development Plan Amendment but proposed by Betta before such updates are submitted to the Unconnected Shareholders do not approve such Material JSC for review. In the event EyePoint reasonably disagrees with an update to the Development Plan AmendmentPlan, Betta shall consider in good faith EyePoint’s comments relating thereto. For clarity, if Betta participates in the Global Trial, then such the development plan for the Global Trial will replace the requirement for the 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”)Plan.”

Appears in 1 contract

Sources: Exclusive License Agreement (EyePoint Pharmaceuticals, Inc.)

Development Plan. (i) The Initial Development of Plan as attached hereto has been agreed upon by the CD38 Product under this Agreement Parties. With respect to annual updates to the Development Plan following the Effective Date, Licensee shall be conducted pursuant deliver to a development plan to be implemented by or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of Licensor an annual updated Development Plan in accordance with Section 5.4, which shall set forth in reasonable detail the CD38 Product in planned Development activities for at least the Field in upcoming [***], as well as the Territory (anticipated timeline, [***], and the “Development Plan”)budget for such activities. The Such updated Development Plan shall be consistent with I-Mab’s obligation under the MorphoSys License with respect certified by Licensee and must be acceptable to the Development of the CD38 ProductLicensor, and acceptance shall not be unreasonably conditioned, withheld, or delayed. The Such updated 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 be deemed acceptable if no written notice to the initial Development Plan, the Development of CD38 Product shall be contrary is provided to Licensee by Licensor within [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 paymentsafter Licensor’s receipt, and any other payments) made by I-Mab under in each such instance 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 proposed 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 become incorporated into and made part of this Agreement. Should Licensor deem Licensee’s updated Development Budget. (iii) Upon the Listing Plan lacking sufficient detail to [***], then Licensor shall so notify Licensee in writing within such [***] after receipt of I-Mabsuch updated Development Plan, specifically pointing to deficiencies and/or posing specific questions to Licensee that, if I-Mab proposes addressed or answered, would satisfy Licensor’s objection to increase the Initial updated 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”)Plan. Licensee shall, in addition good faith, address thoroughly and fully such matters and provide a response to Licensor within [***] after receipt of Licensor’s written notice. Provided the approval response from Licensee is a bona fide attempt to address every point or question raised by the JSC as required under Article 3.2(a)(ii)Licensor, I-Mab then Licensee’s response shall comply with the applicable rules of the stock exchange on which its securities are listed (“Applicable Listing Rules”) and submit such Material automatically be deemed an acceptable updated 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 Plan, shall replace or supplement, as appropriate, the prior Development Plan and Development Budgetshall become incorporated into and made a part of this Agreement. In Notwithstanding the event foregoing, 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 provide 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”)on an annual basis.”

Appears in 1 contract

Sources: Exclusive License Agreement (Vir Biotechnology, 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” 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. (i) The Development of the CD38 Product under this Agreement Licensed Compound and Licensed Products in the Field in the Territory shall be conducted by Qilu pursuant to a development plan that will include a description of the Development activities to be implemented by or on behalf performed in support of I-Mab or its Affiliates or sublicensees to obtain obtaining Regulatory Approval of the CD38 for a Licensed Product in the Field in the Territory Territory, including projected timelines for the completion of such activities (the “Development Plan”). The initial high-level Development Plan shall be consistent with I-Mab’s obligation under the MorphoSys License with respect agreed 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, by the Parties have agreed on the initial Development Plan, is attached hereto as Exhibit B. Pursuant D, which will be promptly updated by Qilu and submitted to the initial JSC for review and approval upon Qilu’s receipt of clarification from the applicable Regulatory Authorities as to the additional Development Plan, 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 CD38 Product shall be [completed] by December 31the Licensed Compound and Licensed Products in the Field in the Territory is ongoing, 2024 (“Qilu shall, if required, submit to the JSC for its review and approval an updated Development Complete Date”) with a total budget of US$200,000,000 (Plan for the “Initial Development Budget”)pending Calendar Year. Such Initial update shall take into account completion, commencement, changes in or cessation of Development Budget shall be inclusive of all costs and expenses to be incurred activities not contemplated 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 in sufficient detail to reflect the continued diligence of Qilu and its Sublicensees. Any material changes to the Development Budget Plan made outside of the annual process to update the Development Plan shall be drafted by Qilu, including the addition of any Clinical Trial protocols or any material changes thereto, and submit delivered to the JSC. Qilu shall make any and all proposed changes to the Development Plan as a result of any interaction with any Regulatory Authority or Governmental Authority, and report such amendments changes to the JSC. Sesen shall have the right to review and comment on any 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 BudgetPlan. In the event Sesen reasonably disagrees with an update to the Development Plan, Qilu shall consider in good faith Sesen’s comments relating thereto, provided, however, that subject to the last sentence of a Material Development Plan Amendment, Section 3.5 Qilu’s decision shall be final and binding upon 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”)Parties.”

Appears in 1 contract

Sources: Exclusive License Agreement (Sesen Bio, Inc.)

Development Plan. (a) Within [***] days following the Exercise Date with respect to a given Collaboration Candidate, ONO will prepare and provide to the JSC an update to its proposed activities under the Joint Development Plan pursuant to which ONO will conduct Research and Development in the ONO Territory, and FATE will prepare and provide to the JSC (i) The an update to its proposed activities under the Joint Development of the CD38 Product under this Agreement shall be conducted Plan 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 which FATE will conduct Research and Development in the Field FATE Territory, for such Collaboration Product on an Indication-by-Indication basis, as applicable and (ii) a process development and manufacturing plan for all non-clinical and clinical Materials of Collaboration Products for use both by ONO in the ONO Territory (and by FATE in the “Development Plan”)FATE Territory. The Development Plan shall be consistent with I-Mab’s obligation under the MorphoSys License Each Party will prepare and provide a budget and estimated timeline with respect to its proposed activities under the Joint Development of Plan. (b) ONO and FATE will discuss in good faith through the CD38 Product. The Development Plan shall also include a detailed budget (the “Development Budget”) for such Development activities. As of the Effective DateJSC, and use Commercially Reasonable Efforts to reach an agreement on, the Parties have agreed on the initial Joint Development Plan, attached hereto as Exhibit B. Pursuant including but not limited to: (i) [***], (ii) and (iii) [***]. (c) During each Calendar Year, each Party shall provide its updates on the Joint Development Plan for the upcoming year covering activities [***] so that the Parties may agree on such update by [***] that year, and each Party shall continue to provide to the initial other Party, through the JSC, regular updates from time to time to its proposed activities under the Joint Development Plan, as applicable. Each Party will consider in good faith the Development 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 CD38 Product shall be [completed] by December 31, 2024 (“Development Complete Date”) with a total budget of US$200,000,000 (Commercially Reasonable Efforts in an attempt to reach an agreement between 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 Parties regarding the initial Joint Development Plan, but shall not include and notwithstanding the provisions of Article 12 (Dispute Resolution), the decision 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 Section 4.1.8 (iii)) (such amendment, “Material Development Plan Amendment” and such incremental increase of the Initial Development Budget, the “Increased Amount”Decision-Making; Limitations on JSC), in addition to the approval by the JSC as required under Article 3.2(a)(ii)provided however, 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: Collaboration and Option Agreement (Fate Therapeutics 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. (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 Development of the CD38 Product Compounds and Collaboration Products under this Agreement (the “Development Program”) shall be conducted pursuant to a development comprehensive written 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 for each Compound and corresponding Collaboration Products shall set forth the timeline and details of: (i) all preclinical and clinical Development activities to be conducted by the Parties as necessary to generate data sufficient to meet the requirements for Marketing Approval of such Compound and corresponding Collaboration Products for each of the Indications as agreed by the Parties and set forth in the Development Plan; (ii) the protocol synopsis for each clinical trial included in such Development Plan; (iii) a Manufacturing plan; and (iv) any other Development activities that the Parties agree to pursue in collaboration for such Compound and corresponding Collaboration Products. The Parties agree that: (A) the Development Plan will contain detailed plans for at least [*] covered by the Development Plan, and summary plans for periods thereafter, and (B) the budget associated with such Development Plan shall be consistent with I-Mab’s obligation under the MorphoSys License with respect subject to the approval process set forth in Section 6.2(d). The Development Plan shall include a coordinated development and regulatory strategy, including the Parties’ respective roles in the development of each Collaboration Product and the countries in which Development of the CD38 ProductCollaboration Product will occur. The Development Plan shall also include set forth: (1) a detailed budget of the Development activities to be [*]; (2) if Cytokinetics has exercised the Cytokinetics Co-Funding Option for a Collaboration Product and [*] for such Collaboration Product, a detailed budget for [*] of such Collaboration Product in the [*] Indications (the [*]); and (3) if [*] Indication [*] the Collaboration and [*] for such [*] Indication, a detailed budget for such [*] Indication Development Work (the “[*] Indication Development Budget”). Upon the other Party’s reasonable request, each Party shall [*] Development activities under the Development Plan. The [*] shall be included in the Development Plan and [*] shall be subject to JDC approval. For reference, the Development Plan in effect as of the Amendment Effective Date is [*] which was approved by the JDC and signed by the JDC co-chairs in [*]. (b) The initial focus of the Development Program was the conduct of Phase 1 Clinical Trials and Phase 2 readiness activities for such the Lead Compound in 2013, with the [*] for the Lead Compound [*] (c) The Development activitiesProgram in 2015 shall include the initial Phase 2 Clinical Trial of the Lead Compound in SMA. As of the Amendment Effective Date, the Parties have agreed on a [*] for such initial Phase 2 Clinical Trial within the initial Development Plan, document attached hereto as Exhibit B. Pursuant M. Promptly after the Amendment Effective Date, the JDC shall update the Development Plan to include the conduct of such initial Phase 2 Clinical Trial in 2015, consistent with [*] set forth in such exhibit. (d) The JDC shall update the Development Plan (including [*] as applicable) at least annually, with such annual update to be finally approved no later than [*] of the preceding Astellas’ fiscal year, provided that [*] Indication [*] subject to the initial [*] the JDC (and [*] Indication [*]) after [*] for such Indication. By [*] of each calendar year starting on [*] Development activities are [*] the updated Development Plan, the Development of CD38 Product JDC shall be agree upon a proposed [completed*] by December 31, 2024 (“Development Complete Date”) with a total budget of US$200,000,000 (for the “Initial Development Budget”)following Astellas fiscal year beyond [*]. Such Initial Development Budget Astellas shall be inclusive of all costs and expenses use good faith efforts 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 timetime during the Term, I-Mab the JDC shall prepare amendments and updates amendments, as appropriate, to the then-current Development Plan (including [*] as applicable), including adding additional Compounds and Development Budget Collaboration Products as well as additional Indications [*] the Collaboration pursuant to Article [*] The JDC shall have the right to approve updates and submit such amendments and updates to the JSC Development Plan (including [*] as applicable), provided that [*] subject to the [*] the JDC (and [* ]) after [*] for review and approvalsuch Indication. 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. (iiie) Upon If the Listing terms 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 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. (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.)