Development Plan. Within thirty (30) days after the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development activities with respect to the Product pursuant to this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharma.
Appears in 2 contracts
Sources: License Agreement, License Agreement (Capstone Therapeutics Corp.)
Development Plan. Within thirty (30) days after the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development activities with respect to the Product pursuant to this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program The Development of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan CD38 Product under this Agreement shall be deemed conducted pursuant to a development plan to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted implemented by or on behalf of LipimetiX I-Mab or its Affiliates outside or sublicensees to obtain Regulatory Approval of the Territory, CD38 Product in the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted Field in the Territory pursuant to (the “Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevailPlan”). The Development Plan shall be considered Confidential Information consistent with I-Mab’s obligation under the MorphoSys License with respect to the Development of Anji Pharmathe CD38 Product. The Development Plan shall also include a detailed budget (the “Development Budget”) for such Development activities. As of the Effective Date, the Parties have agreed on the initial Development Plan, attached hereto as Exhibit B. Pursuant to the initial Development Plan, the Development of CD38 Product shall be [completed] by December 31, 2024 (“Development Complete Date”) with a total budget of US$200,000,000 (the “Initial Development Budget”). Such Initial Development Budget shall be inclusive of all costs and expenses to be incurred by or on account of I-Mab and Everest under the initial Development Plan, but shall not include and shall be in addition to any payments (including upfront payments, development milestone payments, and any other payments) made by I-Mab under the License and Collaboration Agreement by and between I-Mab and MorphoSys AG (“Morphosys”), dated November 30, 2017 (the “Morphosys Agreement”).
(ii) From time to time, I-Mab shall prepare amendments and updates to the then-current Development Plan and Development Budget and submit such amendments and updates to the JSC for review and approval. Once approved by the JSC, such revised Development Plan and Development Budget shall replace or supplement, as appropriate, the prior Development Plan and Development Budget.
(iii) Upon the Listing of I-Mab, if I-Mab proposes to increase the Initial Development Budget or the then applicable Development Budget (as determined in accordance with this Article 3.2(a)(ii) and/or (iii)) (such amendment, “Material Development Plan Amendment” and such incremental increase of the Initial Development Budget, the “Increased Amount”), in addition to the approval by the JSC as required under Article 3.2(a)(ii), I-Mab shall comply with the applicable rules of the stock exchange on which its securities are listed (“Applicable Listing Rules”) and submit such Material Development Plan Amendment for the approval of its shareholders who are not otherwise connected with Everest (to be determined by the Applicable Listing Rules) (the “Unconnected Shareholders”). The Material Development Plan Amendment may only become effective after being approved by the JSC and the shareholders of I-Mab in accordance with the Applicable Listing Rules and such approved Material Development Plan Amendment shall replace or supplement, as appropriate, the prior Development Plan and Development Budget. In the event of a Material Development Plan Amendment, the JSC approves such Material Development Plan Amendment but the Unconnected Shareholders do not approve such Material Development Plan Amendment, then such Development Plan Amendment may only become effective, and the Parties shall carry out such Material Development Plan Amendment, if Everest agrees to bear one hundred percent (100%) of the Increased Amount without requiring I-Mab to share such Increased Amount under Section 4.1 (but for clarity I-Mab shall continue to share the then-current Development Budget before such proposed Material Development Amendment under Section 4.1) (the “Everest Sole Development Costs”).”
Appears in 2 contracts
Sources: Cd38 Product Collaboration Agreement (I-Mab), Supplemental Agreement (I-Mab)
Development Plan. Within thirty (30a) days after The Development of the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical Compounds and clinical Development activities with respect to the Product pursuant to Collaboration Products under 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 Agreement (the “Initial Development Program”) shall be conducted pursuant to a comprehensive written Development plan (the “Development Plan”). During The Development Plan for each Compound and corresponding Collaboration Products shall set forth the Term, except timeline and details of: (i) all preclinical and clinical Development activities to be conducted by the Parties as may be expressly necessary to generate data sufficient to meet the requirements for Marketing Approval of such Compound and corresponding Collaboration Products for each of the Indications as agreed by the Parties and set forth in this Agreement 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 agreed to will contain detailed plans for at least [ * ] covered by the Parties, the Anji Pharma Related Parties shall have sole authority overDevelopment Plan, and control ofsummary plans for periods thereafter, and (B) the budget associated with such Development of Compounds Plan shall be subject to the approval process set forth in Section 6.2(b). The Development Plan shall include a coordinated development and Products in the Territoryregulatory strategy, including the Manufacture Parties’ respective roles in the development of Compounds each Collaboration Product and Products the countries in which Development of Collaboration Product will occur. The Development Plan shall also set forth: (1) a detailed budget of the Development activities to be [ * ]; (2) if Cytokinetics has exercised the Cytokinetics Co-Funding Option for a Collaboration Product and [ * ] for such DevelopmentCollaboration Product, and shall bear all costs and expenses a detailed budget for [ * ] of such DevelopmentCollaboration 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”). Prior 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 January 1 JDC approval. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
(b) The JDC shall update the Development Plan (including [ * ], as applicable) at least annually, with such annual update to be finally approved no later than [ * ] of the preceding Astellas’ fiscal year, provided that [ * ] Indication [ * ] subject to the [ * ] the JDC (and [ * ] Indication [ * ] after [ * ] for such Indication. By [ * ] of each calendar year year, [ * ] Development activities are [ * ] the updated Development Plan, the JDC shall agree upon a proposed [ * ] for the following Astellas fiscal year. Astellas shall use good faith efforts to [ * ]. From time to time during the Term, an Anji Pharma Related Party the JDC shall prepare an updated amendments, as appropriate, to the then-current Development Plan (including [ * ], as applicable), including adding additional Compounds and Collaboration Products as well as additional Indications added to the Collaboration pursuant to Article 4. The JDC shall have the right to approve updates and amendments to the Development Plan (including [ * ], as applicable), provided that [ * ] subject to the [ * ] the JDC (and [ * ] for such Indication. Once approved by the following calendar year and submit JDC, such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise shall replace the prior Development Plan.
(c) If the terms of the Development Plan between annual updates; providedcontradict, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development create inconsistencies or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territoryambiguities with, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event terms of any inconsistency between the Development Plan and this Agreement, then the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmagovern.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Development Plan. Within thirty (30a) days after Attached hereto as Exhibit E is a multi-year development plan for Development Operations and Area-Wide Operations which the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development activities with respect Parties currently anticipate to the Product pursuant to this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance be conducted by the PartiesParty Operators through calendar year 2020 (as hereafter amended, shall be deemed effective (modified or supplemented, the “Initial Development Plan”). During The Joint Development Committee shall have the Termsole right to amend, except as may modify and supplement the Development Plan.
(b) Each Development Plan shall, to the extent possible, include:
(i) a forecast of the number of active rigs, the drilling days from spud to rig release including the expected time from rig release to first production, including estimates for stimulation/completion days and a forecast of all relevant capital and operational costs related to the foregoing;
(ii) the sequence of development of the applicable Operated Area, to the extent known;
(iii) a forecast of future production in four categories: (A) ▇▇▇▇▇ already on stream, (B) ▇▇▇▇▇ stimulated but not on stream, (C) ▇▇▇▇▇ drilled but not stimulated, and (D) ▇▇▇▇▇ to be expressly set drilled (▇▇▇▇▇ on stream shall be forecasted on an individual performance basis (individual decline analysis) and all other ▇▇▇▇▇ shall be forecasted on an area basis based on expected performance for the relevant locations (pro-forma curves)).
(c) Commencing in 2017 or earlier if the Parties mutually agree, on or before August 31 of each calendar year, each Party Operator shall, with respect to its Operated Area, prepare and submit to the Joint Development Committee an amendment to the portion of the then existing Development Plan covering such Operated Area, which amendment sets forth the Development Operations and Area-Wide Operations reasonably expected to be carried out during the following three calendar years in this Agreement and such Operated Area. Following distribution of all amendments to the Development Plan agreed to by from each of the PartiesParty Operators, the Anji Pharma Related Parties representatives of the Joint Development Committee shall have sole authority over, and control of30 days to furnish to the other members of the Joint Development Committee any proposed revisions they desire to make to the proposed amendments to the Development Plan. Promptly following the Joint Development Committee's 30-day review process, the Joint Development of Compounds and Products in Committee shall meet to consider the Territory, including amendments to the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan and any recommendations made with respect thereto by any member of the Joint Development Committee and approve or reject such amendments to the Development Plan and such recommendations. In addition, the Joint Development Committee shall annually review the Development Plan in connection with its annual review and approval of the Annual Plan and Budget for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise time amend or modify the Development Plan between annual updates; providedPlan.
(d) For the avoidance of doubt, however, that Anji Pharma will provide to LipimetiX such revised Development Plan any reference in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant this Agreement to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between mean the Development Plan and this Agreementattached hereto as Exhibit E, as such Development Plan may be amended from time to time by the Joint Development Committee pursuant to the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmahereof.
Appears in 1 contract
Development Plan. Within thirty (30a) days after The Development of the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical Compounds and clinical Development activities with respect to the Product pursuant to Collaboration Products under 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 Agreement (the “Initial Development Program”) shall be conducted pursuant to a comprehensive written Development plan (the “Development Plan”). During The Development Plan for each Compound and corresponding Collaboration Products shall set forth the Termtimeline 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 [ * ] = Certain confidential information contained in this document, except marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to rule 24b-2 of the Securities Exchange Act of 1934, as may amended. forth in the Development Plan; (ii) the protocol synopsis for each clinical trial included in such Development Plan; (iii) a Manufacturing plan; and (iv) any other Development activities that the Parties agree to pursue in collaboration for such Compound and corresponding Collaboration Products. Except for the initial Development Plan attached as Exhibit H, (A) the Development Plan will contain detailed plans for at least [*] covered by the Development Plan, and summary plans for periods thereafter, and (B) the budget associated with such Development Plan shall be expressly subject to the approval process set forth in this Agreement Section 5.2(b). The Development Plan shall include a coordinated development and regulatory strategy, including the Parties’ respective roles in the development of each Collaboration Product and the countries in which Development of Collaboration Product will occur. The Development Plan shall also set forth the detailed budget of the Development activities to be [*]. Upon [*] Development activities under the Development Plan. The [*] shall be included in the Development Plan and shall be subject to JDC approval. The initial focus of the Development Program shall be the conduct of Phase 1 Clinical Trials and Phase 2 readiness activities for the Lead Compound in 2013, with the [*] the Lead Compound [*]. As of the Effective Date, the Parties have agreed upon an initial Development Plan and [*] for the Lead Compound for the period starting from the Effective Date and ending on [*], which are attached to this Agreement as Exhibit H, which will be deemed to have been approved by the Parties, the Anji Pharma Related Parties JDC.
(b) The JDC shall have sole authority over, and control of, update the Development Plan (including [*]) at least annually, with such annual update to be finally approved no later than [*] 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 Developmentpreceding Astellas’ fiscal year. Prior to January 1 By [*] of each calendar year starting on [*] the updated Development Plan, the JDC shall agree upon a proposed [*] for the following Astellas fiscal year beyond [*]. Astellas shall use good faith efforts to [*]. From time to time during the Term, an Anji Pharma Related Party the JDC shall prepare an updated amendments, as appropriate, to the then-current Development Plan for (including [*]), including adding additional Compounds and Collaboration Products. The JDC shall have the following calendar year right to approve updates and submit amendments to the Development Plan (including [*]). Once approved by the JDC, such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise shall replace the prior Development Plan.
(c) If the terms of the Development Plan between annual updates; providedcontradict, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development create inconsistencies or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territoryambiguities with, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event terms of any inconsistency between the Development Plan and this Agreement, then the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmagovern.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Development Plan. Within thirty (30) days after Prior to the Effective Date, Anji Pharma shall prepare an initial the JDT adopted a Joint Development planPlan and Joint Budget (each, setting forth as defined in the non-clinical Collaboration Agreement) that govern the global Development, Manufacturing, and clinical Development regulatory activities of the Parties with respect to the Product under the Collaboration Agreement. As promptly as practicable following the Effective Date, the JDC shall (a) update such Joint Development Plan and Joint Budget to the extent necessary to (i) align the contents thereof with this Agreement and the Approved Plans hereunder, including by incorporating the Global Regulatory Plan prepared pursuant to this AgreementSection 8.1.1 and by revising the Joint Development Plan and Joint Budget to exclude Manufacturing and instead addressing Manufacturing activities in the separate Global Manufacturing Plan to be drafted and approved hereunder, and deliver (ii) otherwise reflect the global Development activities of the Parties with respect to the Product throughout the Territory, and the corresponding budget therefor, and (b) submit such Development updated plan and budget to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty the JSC for approval (30) days thereafter, which upon mutual acceptance as approved by the PartiesJSC, shall be deemed effective (such plan and budget, collectively, the “Initial Global Development Plan”). During Following its approval by the TermJSC, except as may be expressly set forth in the Global Development Plan under this Agreement shall replace the Joint Development Plan and Joint Budget under the Collaboration Agreement for all purposes with respect to the Product under this Agreement and the Development Plan agreed to by Collaboration Agreement. On an annual basis, or more often as the PartiesParties deem appropriate, 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 JDC shall prepare an updated amendments to the then-current Global Development Plan for approval by the following calendar year and submit such revised JSC. The JSC will endeavor to approve the Global Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise or such amendments before 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 end of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelinesthen- applicable Year. In the event of any inconsistency between the Global Development Plan and this Agreement, the terms of this Agreement shall prevail. The For clarity, and without limiting the treatment of CMC Development Costs as Development Costs, the portions of the existing Joint Development Plan shall be considered Confidential Information and Joint Budget relating to Manufacturing or CMC Development will not become part of Anji Pharma.the Global Development Plan pursuant to this Section [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential.
Appears in 1 contract
Development Plan. Within thirty (30) days after Without limiting the Effective Dategenerality of the other provisions in this Article 4, Anji Pharma shall prepare an initial initial, mutually agreed 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 Plan is attached hereto as Exhibit D (the “Initial Development Plan”). During Within [***] after the TermEffective Date, except as may be expressly set forth Terns (in this Agreement conjunction with assistance from Genfit) will prepare and submit to the Development Plan agreed to by JSC a detailed plan containing the Partiesstrategy, the Anji Pharma Related Parties shall have sole authority overactivities, study designs, timeline, study material needs (API and control of, the drug product) and budget for research and Development of Compounds the Licensed Compound and Licensed Products in the Territory, including Field in the Manufacture of Compounds Terns Territory (the “First Supplemental Development Plan,” and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during together with the Term, an Anji Pharma Related Party shall prepare an updated Initial Development Plan for and any subsequent updates pursuant to this Section 4.2, 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 changesPlan”). 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 The First Supplemental 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 hereunderinclude among other things, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of preall material non-clinical and clinical Development for studies, CMC Information collection activities and regulatory activities with respect to the Compounds Licensed Compound and Products. Any revised Development Plan shall be deemed Licensed Products to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX Terns or its Affiliates outside or their respective Sublicensees in the Terns Territory. From time to time during the Term (but at least [***] per [***]), Terns shall prepare amendments and updates, as appropriate, to the then-current Development Plan, and shall submit such amendments and updates to the JSC in accordance with Section 4.3. For clarity, if there are no amendments or updates to the then-current Development Plan that are applicable in a [***], Terns’ sole responsibility under this Section 4.2 during such [***] shall be to inform Genfit that the then-current Development Plan is up to date. Notwithstanding the above, following [***] in the Terns Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant no amendment or update to the Development Plan shall be performed required for Investigator Sponsored Clinical Studies for such Licensed Product in accordance the Terns Territory, provided that Terns shall provide to Genfit a reasonably detailed description of each such study [***], and shall consider in good faith any comments provided by Genfit with all Applicable Laws as well as the ICH guidelinesrespect to such study before such commencement. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan Terns shall be considered Confidential Information solely responsible for all decisions regarding the day-to-day conduct of Anji PharmaDevelopment within the Terns Territory.
Appears in 1 contract
Development Plan. (a) The Development of Tirasemtiv and Product under this Agreement (the “Development Program”) shall be conducted pursuant to a comprehensive written global Development plan (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 conducted by the 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 countries in which Development of Product will occur. The Development Plan shall also set forth a detailed budget of the Development activities to be [*] (the “Development Budget”). Within thirty (30) days after the Effective Date, Anji Pharma Cytokinetics shall prepare an the initial Development planPlan, setting forth which shall include the nondevelopment plan provided by Cytokinetics to Astellas under the 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 Astellas under the 2014 Agreement.
(b) From time to time during the Term (but no less than annually), the JDC shall prepare and approve updates and amendments, as appropriate, to the then-clinical and clinical current Development Plan (including Development 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 shall be finally approved no later than [*] before the beginning of next calendar year. Once approved by the JDC, such revised Development Plan shall replace the prior Development Plan.
(c) Astellas shall not conduct any Development and/or Commercialization activities with respect to any Product in any Indication other than ALS without the prior written consent of Cytokinetics. Cytokinetics shall have the right to conduct Development and/or Commercialization activities under the Development Plan or the Commercialization Plan as appropriate with respect to the Product pursuant to in Indications other than ALS, provided that [*].
(d) If the terms of the Development Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, then the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmagovern.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Development Plan. Within thirty During the Term, Licensee will conduct all Development activities in connection with each Licensed Compound and Licensed Product in accordance with this Article 4 (30Development, Manufacturing, and Commercialization) days after and the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical plan for Development activities with respect to the Product each Licensed Compound and Licensed Product, an initial version of which is attached hereto as Schedule 4.3 (as such plan may be amended from time-to-time pursuant to this AgreementSection 4.3 (Development Plan), 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 Licensee’s 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, include (a) any modification to a summary of [*] as of the date such Development Plan that materially increases the costs is drafted or obligations of LipimetiX shall require the prior written approval of LipimetiXamended, (b) all other material Development activities reasonably anticipated to be undertaken by Licensee, as of the date such Development Plan shall summarize is drafted or amended, to obtain Regulatory Approval of one or more Licensed Products throughout 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 hereunderTerritory, and (c) estimated dates on which Licensee expects to achieve material Development Milestone Events and other significant Development events (such as [*] and the [*]), to the extent such estimates are reasonably possible given the development stage of the applicable Licensed Compound or Licensed Product as of the date such [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Productsis drafted or amended. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change Licensee will prepare updates or amendments to the Development Plan would at least annually and in advance of [*], and may amend the Development Plan in its discretion at any time during the Term; provided that all annual updates and any material amendments must be reasonably expected to have a material adverse effect on consistent with the terms of this Section 4.3 (Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the TerritoryPlan). For clarity, the initial version of the Development Plan attached hereto as Schedule 4.3 is a preliminary version that does not necessarily satisfy the content requirements described above, and therefore the Parties shall discuss agree that such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in content requirements will only apply beginning with the Territory pursuant first update or amendment to the Development Plan shall be performed in accordance prepared by Licensee under this Section 4.3 (Development Plan). Licensee will provide Licensor with a copy of all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between updates or amendments to the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji PharmaPlan.
Appears in 1 contract
Development Plan. Within thirty (30) days Promptly after the Effective Dateexecution of this Agreement, Anji Pharma on a Collaboration Product-by-Collaboration Product basis, Pfenex and Agila shall jointly prepare an initial Development plana mutually-agreed written work plan for any Collaboration Product(s) that sets out in reasonable detail the development activities to be conducted by each Party and its designees for the Successful Completion of the first Phase I Clinical Trial for any Collaboration Product(s), setting forth as well as the non-clinical location, protocol, budget and clinical Development activities timelines for completion of various tasks therefor [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the Product pursuant to this Agreementomitted portions. (each, 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 a “Initial Development Plan”). During Each Development Plan shall be subject to the TermJSC’s approval. Upon the JSC’s approval of a Development Plan, except such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as may be expressly set forth in a part of this Agreement Agreement. For the avoidance of doubt, unless and until the Parties sign the Development Plan agreed to by the Partiesfor any Collaboration Product, the Anji Pharma Related Parties neither Party 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 any obligation with respect 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 updatesany product hereunder; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in unless and until the event earlier 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 Parties sign a Development Plan that materially increases the costs therefor 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 either Party provides sixty (c60) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon days’ prior written approval of LipimetiX. If LipimetiX believes that a change notice to the Development Plan would be reasonably expected other Party of its intent to have exclude a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territoryproduct described in Section 1.6(a) — (e), the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in use good faith efforts to prepare and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant agree on Development Plan therefor prior to the date specified in Exhibit 1 (as may be amended from time to time by the Parties). Each Development Plan will be updated and approved semi-annually by the JSC and shall be performed consistent with the general allocation of responsibilities described in Section 3.2 below. Without limiting the foregoing, any material modifications or additions to any Development 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 all Applicable Laws as well as the ICH guidelines. In terms and conditions of this Agreement (including the event of any inconsistency between diligence requirement set forth in Article 8), the applicable Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmaall Applicable Laws.
Appears in 1 contract
Sources: Joint Development and License Agreement (Pfenex Inc.)
Development Plan. Within thirty (30a) days after All Development with respect to any Product hereunder shall be conducted pursuant to a Development Plan prepared and approved by the Effective DateJSC, Anji Pharma which shall prepare an initial Development plan, setting set forth the nonplan for the pre-clinical and clinical Development activities with respect to the Product pursuant to this AgreementDevelopment, and deliver Regulatory Approval of such Product in each of the European Territory, the North American Territory and the Co-Exclusive Territories and the activities to be carried out related thereto by LFB Biotech and GTC, together with a proposed budget for such activities (each, a “Development plan to LipimetiX. Plan”). The Parties shall promptly discuss and endeavor to finalize such initial will mutually agree upon a preliminary Development plan within thirty (30) days thereafter, which upon mutual acceptance by Plan for the Parties, shall be deemed effective Initial Product (the “Initial Development Plan”). During ) within ************ following the TermEffective Date, except a copy of which shall be attached hereto as may be expressly set forth in this Agreement and the Exhibit B. Each Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event shall include a projection of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification the plan of Development activities with respect to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiXrelevant product and timelines for performing such activities, (b) the proposed budget for such Development Plan shall summarize the activities, (c) expected Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunderfunding by each Party, and (cd) a non-binding forecast of clinical supply of Product to be supplied as provided under Article 7. The Development Plan for a Product shall also specify the jurisdictions (other than the US and EU) where Regulatory Approval will be sought for such Product and prospective indication extension after the First Major Regulatory Approval. Development Plans for subsequent Products shall also be attached to Exhibit B as such Development Plans are prepared, approved and amended by the JSC. For indicative purposes only a preliminary version of the business case prepared by the Parties for the Initial Product is attached hereto as Exhibit B-1. Such business case shall be reviewed and updated on a regular basis by the JSC.
(b) For so long as necessary to complete Development of any Product, the Parties, through the JSC, shall update the Development Plan shall always include with respect to such Product on an annual basis prior to the commencement of the next calendar year, or more often as determined by the JSC.
(ic) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to The JSC will review performance against the Development Plan would be reasonably expected for each Product on a quarterly basis, and will report any variations to have the Parties in writing. If, in any quarter, there is a material adverse effect on Development variation of ************ or Commercialization activities for greater from the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territorybudget, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between JSC will revise the Development Plan and budget for the applicable Product ************ prior to the commencement of the second quarter following the quarter in which the variation occurred. For example, if a ************ variation is reported in quarter one, a revised Development Plan and budget must be prepared at least ************ prior to the commencement of quarter three.
(d) Until such time as a Development Plan is updated in accordance with this AgreementSection 5.1, the preceding Development Plan (including, without limitation, all budget projections and minimum expenditures therein) shall remain in effect. The JSC shall not update any Development Plan in a manner that is inconsistent with or contradicts the terms of this Agreement shall prevailAgreement. The Development Plan shall be considered Confidential Information of Anji Pharma.24
Appears in 1 contract
Sources: Joint Development and Commercialization Agreement (GTC Biotherapeutics Inc)
Development Plan. Within thirty (30a) days after Attached hereto as Exhibit E is a multi-year development plan for Development Operations and Area-Wide Operations which the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development activities with respect Parties currently anticipate to the Product pursuant to this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance be conducted by the PartiesParty Operators through calendar year 2020 (as hereafter amended, shall be deemed effective (modified or supplemented, the “Initial Development Plan”). During The Joint Development Committee shall have the Termsole right to amend, except as may modify and supplement the Development Plan.
(b) Each Development Plan shall, to the extent possible, include:
(i) a forecast of the number of active rigs, the drilling days from spud to rig release including the expected time from rig release to first production, including estimates for stimulation/completion days and a forecast of all relevant capital and operational costs related to the foregoing;
(ii) the sequence of development of the applicable Operated Area, to the extent known;
(iii) a forecast of future production in four categories: (A) ▇▇▇▇▇ already on stream, (B) ▇▇▇▇▇ stimulated but not on stream, (C) ▇▇▇▇▇ drilled but not stimulated, and (D) ▇▇▇▇▇ to be expressly set drilled (▇▇▇▇▇ on stream shall be forecasted on an individual performance basis (individual decline analysis) and all other ▇▇▇▇▇ shall be forecasted on an area basis based on expected performance for the relevant locations (pro-forma curves)).
(c) Commencing in 2017 or earlier if the Parties mutually agree, on or before August 31 of each calendar year, each Party Operator shall, with respect to its Operated Area, prepare and submit to the Joint Development Committee an amendment to the portion of the then existing Development Plan covering such Operated Area, which amendment sets forth the Development Operations and Area-Wide Operations reasonably expected to be carried out during the following three calendar years in this Agreement and such Operated Area. Following distribution of all amendments to the Development Plan agreed to by from each of the PartiesParty Operators, the Anji Pharma Related Parties representatives of the Joint Development Committee shall have sole authority over, and control of30 days to furnish to the other members of the Joint Development Committee any proposed revisions they desire to make to the proposed amendments to the Development Plan. Promptly following the Joint Development Committee’s 30-day review process, the Joint Development of Compounds and Products in Committee shall meet to consider the Territory, including amendments to the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan and any recommendations made with respect thereto by any member of the Joint Development Committee and approve or reject such amendments to the Development Plan and such recommendations. In addition, the Joint Development Committee shall annually review the Development Plan in connection with its annual review and approval of the Annual Plan and Budget for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise time amend or modify the Development Plan between annual updates; providedPlan.
(d) For the avoidance of doubt, however, that Anji Pharma will provide to LipimetiX such revised Development Plan any reference in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant this Agreement to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between mean the Development Plan and this Agreementattached hereto as Exhibit E, as such Development Plan may be amended from time to time by the Joint Development Committee pursuant to the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmahereof.
Appears in 1 contract
Development Plan. (a) The Development of Tirasemtiv and Product under this Agreement (the “Development Program”) shall be conducted pursuant to a comprehensive written global Development plan (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 conducted by the 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 countries in which Development of Product will occur. The Development Plan shall also set forth a detailed budget of the Development activities to be [*] (the “Development Budget”). Within thirty (30) days after the Effective Date, Anji Pharma Cytokinetics shall prepare an the initial Development planPlan, setting forth which shall include the nondevelopment plan provided by Cytokinetics to Astellas under the 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 Astellas under the 2014 Agreement.
(b) From time to time during the Term (but no less than annually), the JDC shall prepare and approve updates and amendments, as appropriate, to the then-clinical and clinical current Development Plan (including Development 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 shall be finally approved no later than [*] before the beginning of next calendar year. Once approved by the JDC, such revised Development Plan shall replace the prior Development Plan.
(c) Astellas shall not conduct any Development and/or Commercialization activities with respect to any Product in any Indication other than ALS without the prior written consent of Cytokinetics. Cytokinetics shall have the right to conduct Development and/or Commercialization activities under the Development Plan or the Commercialization Plan as appropriate with respect to the Product pursuant to in Indications other than ALS, provided that [*].
(d) If the terms of the Development Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, then the terms of this Agreement shall prevailgovern. The Development Plan shall be considered Confidential Information [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of Anji Pharmathe Securities Exchange Act of 1934, as amended.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Development Plan. Within thirty (30a) days after The Development of the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical Compounds and clinical Development activities with respect to the Product pursuant to Collaboration Products under 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 Agreement (the “Initial Development Program”) shall be conducted pursuant to a comprehensive written Development plan (the “Development Plan”). During The Development Plan for each Compound and corresponding Collaboration Products shall set forth the Term, except timeline and details of: (i) all preclinical and clinical Development activities to be conducted by the Parties as may be expressly necessary to generate data sufficient to meet the requirements for Marketing Approval of such Compound and corresponding Collaboration Products for each of the Indications as agreed by the Parties and set forth in this Agreement 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 agreed to will contain detailed plans for at least [*] covered by the Parties, the Anji Pharma Related Parties shall have sole authority overDevelopment Plan, and control ofsummary plans for periods thereafter, and (B) the budget associated with such Development Plan shall be 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 Collaboration Product will occur. The Development Plan shall also set forth: (1) a detailed budget of the Development activities to be [*]; (2) if Cytokinetics has exercised the Cytokinetics Co-Funding Option for a Collaboration Product and [*] for such Collaboration Product, a detailed budget for [*] of such Collaboration Product in the [*] Indications (the [*]); and (3) if [*] Indication [*] the Collaboration and [*] for such [*] Indication, a detailed budget for such [*] Indication Development Work (the “[*] Indication Development Budget”). Upon the other Party’s reasonable request, each Party shall [*] Development activities under the Development Plan. The [*] shall be included in the Development Plan and [*] shall be subject to JDC approval. For reference, the Development Plan in effect as of Compounds the Amendment Effective Date is [*] which was approved by the JDC and Products signed by the JDC co-chairs in [*].
(b) The initial focus of the TerritoryDevelopment Program was the conduct of Phase 1 Clinical Trials and Phase 2 readiness activities for the Lead Compound in 2013, including with the Manufacture [*] for the Lead Compound [*]
(c) The Development Program in 2015 shall include the initial Phase 2 Clinical Trial of Compounds and Products the Lead Compound in SMA. As of the Amendment Effective Date, the Parties have agreed on a [*] for such Developmentinitial Phase 2 Clinical Trial within the document attached hereto as Exhibit M. Promptly after the Amendment Effective Date, and the JDC shall bear all costs and expenses update the Development Plan to include the conduct of such Developmentinitial Phase 2 Clinical Trial in 2015, consistent with [*] set forth in such exhibit.
(d) The JDC shall update the Development Plan (including [*] as applicable) at least annually, with such annual update to be finally approved no later than [*] of the preceding Astellas’ fiscal year, provided that [*] Indication [*] subject to the [*] the JDC (and [*] Indication [*]) after [*] for such Indication. Prior to January 1 By [*] of each calendar year starting on [*] Development activities are [*] the updated Development Plan, the JDC shall agree upon a proposed [*] for the following Astellas fiscal year beyond [*]. Astellas shall use good faith efforts to [*]. From time to time during the Term, an Anji Pharma Related Party the JDC shall prepare an updated amendments, as appropriate, to the then-current Development Plan (including [*] as applicable), including adding additional Compounds and Collaboration Products as well as additional Indications [*] the Collaboration pursuant to Article [*] The JDC shall have the right to approve updates and amendments to the Development Plan (including [*] as applicable), provided that [*] subject to the [*] the JDC (and [* ]) after [*] for such Indication. Once approved by the following calendar year and submit JDC, such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise shall replace the prior Development Plan.
(e) If the terms of the Development Plan between annual updates; providedcontradict, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development create inconsistencies or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territoryambiguities with, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event terms of any inconsistency between the Development Plan and this Agreement, then the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmagovern.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cytokinetics Inc)
Development Plan. Within 5.1 In each Calendar Year that Development regarding the PIP is occurring, each Party shall at its own cost and expense (subject to Section 5.4) use Commercially Reasonable Efforts to carry out the activities specified in the Development Plan in relation to the PIP as the responsibility of such Party so as to meet the timelines set out in them.
5.2 During the period of Development regarding the PIP by the Licensor, it shall update the Development Plan on or before November 1st in each year and shall submit the same to the JSC for review and approval.
5.3 The Licensor shall:
(a) be responsible for the conduct of the PIP, subject to and in accordance with the timelines set out in the Development Plan and subject to the direction of the JSC;
(b) conduct all activities in relation to the PIP in compliance with all Legal Requirements, ethics committee, informed consent or similar approvals in relation thereto, and in compliance with GCP;
(c) provide periodic updates regarding the PIP to the JSC as reasonably requested by the JSC;
(d) permit Licensee (at its own cost) and upon reasonable notice to audit, during normal business hours, the trial master file and shall cooperate with any such audit; and
(e) promptly provide to the JSC the results of the PIP in the form of a copy of any Interim Report, a Formal Presentation and a copy of the Final Report as these occur, even if between JSC scheduled meetings.
5.4 The Licensee shall reimburse the Licensor for seventy per cent (70%) of the ongoing documented Development Costs reasonably incurred by the Licensor in accordance with the Development Plan and the PIP Budget. The Licensee shall reimburse its proportion of the Development Costs not later than sixty (60) days following receipt of the Licensor's invoices and 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) days after Business Days of the Effective Datedate of receipt of the Licensor's invoice, Anji Pharma into such bank account as the Licensor shall prepare an initial 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 planCosts in connection with the conduct of the PIP.
5.5 During the period in which the PIP is ongoing, setting 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 non-clinical and clinical Development activities 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 pursuant to this Agreementin 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 deliver in compliance with GCP;
(c) provide the JSC with a summary and update in reasonable detail of such Development plan activities at each meeting of the JSC; and
(d) provide the other Party with a copy of a near-final draft of each Clinical Trial protocol or update to LipimetiX. The Parties a protocol for the Product at least forty-five (45) days prior to the date on which such protocols or updates are provided to any Regulatory Authority or Clinical Trial site, in order to permit such other Party to comment on such protocol or update, and shall promptly discuss and endeavor to finalize reasonably consider in good faith any comments thereon provided by such initial Development plan other Party within thirty (30) days thereafterfollowing 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, 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 TerritoryLicensor's reasonable opinion, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected going to have a material adverse effect impact on Development the Development, Manufacture or Commercialization activities of the Product outside of the Territory for the Compound 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 conducted by or in the Territory for a New Indication, Licensee shall have the right to do so on behalf the following conditions:
(a) the Licensee shall be solely responsible for the costs and expenses of LipimetiX or 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 Affiliates preparation;
(c) subject to paragraph 5.9(d), the Licensee hereby grants to the Licensor a perpetual, irrevocable, exclusive, sub-licensable, right and license to use the Licensee IPR Package for the Product for such New Indication to Develop, manufacture and Commercialize the Product outside the Territory; and
(d) Licensor shall pay royalties to Licensee under such license on the same payment terms as, and at a rate equal to two percent (2%) less than the rate owed by, Licensee to Licensor for sales of Products hereunder, with all applicable definitions and provisions having the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreementreversed, the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharmamutatis mutandis.
Appears in 1 contract
Development Plan. Within thirty (30) [*] days after of [*], the Effective DateParties shall, Anji Pharma shall prepare through the JSC, complete the preparation of an initial development plan for the Product that sets out the Development planactivities to be conducted by or under the authority of each Party for Developing, and obtaining Marketing Authorization(s) for, the Product in the U.S. and Europe (the “Development Plan”), as well as a reasonably detailed budget setting forth the non-clinical Development Costs for such activities related to Development of the Product for the U.S. and clinical Europe (the “Development Budget”). The allocation of activities between the Parties in the Development Plan shall be consistent with Section 5.1. In the event the Parties are unable to reach consensus with respect to the Development Plan and Development Budget within such [*]-day period, despite negotiating in good faith, Mylan shall not be obligated to make the FDA Advisory Milestone Payment and, if Mylan does not pay the FDA Advisory Milestone Payment, either Party may terminate this Agreement upon written notice to the other Party. At least once every calendar quarter until Marketing Authorization has been received in the U.S. and Europe, each Party shall submit to the JSC any updates to its proposed activities under the Development Plan, including any material modifications or additions thereto, for the JSC’s review and approval and coordination of the Parties’ activities with respect to the Product pursuant to this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall contain the following information with respect to the Product in the U.S. and Europe: (i) scope and timelines for the conduct of all Development activities and studies (including any studies for the applicable approvals of labeling, price and reimbursement) designed to support Marketing Authorization of the Product; (ii) estimated timing of meetings with Regulatory Authorities for the Product; and (iii) target schedules for achieving milestones in developing the Product. The Parties acknowledge and agree that Revance may conduct certain of its Development activities under the Development Plan, which are intended to support the MAA for the Product in the U.S., elsewhere in North America, and the associated Development Costs shall be considered Confidential Information of Anji Pharmashared in accordance with the Development Budget and Section 5.3(d).
Appears in 1 contract
Sources: Collaboration and License Agreement (Revance Therapeutics, Inc.)