Common use of Development Plan Clause in Contracts

Development Plan. Within thirty (30) days after the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development activities with respect to the Product pursuant to this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharma.

Appears in 2 contracts

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

AutoNDA by SimpleDocs

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

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

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) xxxxx already on stream, (B) xxxxx stimulated but not on stream, (C) xxxxx drilled but not stimulated, and (D) xxxxx to be expressly set drilled (xxxxx on stream shall be forecasted on an individual performance basis (individual decline analysis) and all other xxxxx 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

Samples: Joint Development Agreement (Noble Energy Inc)

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

Samples: Joint Development and License Agreement (Pfenex 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

Samples: Joint Commercialization Agreement (Genmab a/S)

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

Samples: License and Collaboration Agreement (Cytokinetics Inc)

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

Samples: License and Collaboration Agreement (Cytokinetics Inc)

AutoNDA by SimpleDocs

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) xxxxx already on stream, (B) xxxxx stimulated but not on stream, (C) xxxxx drilled but not stimulated, and (D) xxxxx to be expressly set drilled (xxxxx on stream shall be forecasted on an individual performance basis (individual decline analysis) and all other xxxxx 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

Samples: Joint Development Agreement (CONSOL Energy 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

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

Development Plan. Within thirty (30a) days after Borrower’s revised and current Development Plan covering the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development development activities with respect to the Product pursuant of Borrower is attached to this Agreement, and deliver such Development plan Agreement as Schedule 1.5. Borrower can propose modifications 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 those modifications will provide become effective when Approved (not to LipimetiX such revised Development Plan in the event be unreasonably withheld or delayed) by Administrative Agent. (b) Administrative Agent’s Approval 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 a modification to the Development Plan proposed by Borrower shall be granted in Administrative Agent’s reasonable discretion. (c) In support of each Development Plan, Borrower will prepare and submit to Administrative Agent for Approval(not to be unreasonably withheld or delayed): (i) in the case of costs not yet expended, an AFE (including all Supporting Documentation) at least 15 days before Borrower incurs any costs that materially increases it intends to fund out of an Advance or (ii) in the case of costs already expended and to be reimbursed through an Advance, reasonable evidence of a request for payment by the applicable Operator and reasonable evidence of payment by Borrower (collectively, “Reimbursement Request”) at least 5 days before Borrower requests such an Advance. (d) Notwithstanding the Administrative Agent’s Approval of a Development Plan: (i) Borrower must nevertheless satisfy the conditions described in this Article I and Section 8.3 prior to the making of each Advance; and (ii) Lenders will have no obligation to make an Advance to fund projects included on the Development Plan: (A) unless the requested Advance relates to an AFE or obligations Reimbursement Request Approved by Administrative Agent; or (B) if the requested Advance (together with all amounts previously Advanced in respect of LipimetiX shall require the prior written approval of LipimetiX, applicable AFE or Reimbursement Request) exceeds (b1) the cost set forth in 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 hereunderfor that project, and or (c2) 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 Loan availability remaining under 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 PharmaTerm Loan.

Appears in 1 contract

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

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

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

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!