Joint Development Plan and Budget Sample Clauses

Joint Development Plan and Budget. (i) Initial Development Plan and Budget. Subject to Section 5.2.1(a) (Jointly Controlled Project – General), with respect to Developing, Manufacturing and seeking Regulatory Approval for (A) Compounds arising from the Jointly Controlled Project (“Joint Compounds”), (B) Products containing Joint Compounds (“Joint Products”) and (C) Diagnostic Products for the Joint Compound or Joint Product, the JSC shall allocate such responsibilities between the Parties pursuant to a [**] rolling Development plan and budget approved by the JSC (such plan and budget, together with all revisions and amendments thereto, the “Joint Development Plan and Budget”); provided that BII shall be solely responsible for pursuing Regulatory Approval for Joint Products and Diagnostic Products for Joint Compounds or Joint Products if such Regulatory Approvals relate solely to an ROW country or countries. Without limitation, the Joint Development Plan and Budget shall set forth, among other things, (1) the specific Clinical Trials to be Conducted, including those that are committed and those that are conditioned upon the results of ongoing Clinical Trials, (2) the anticipated timelines for such Clinical Trials and (3) the Clinical Trial activities to be assigned to each Party, with respect to (1)-(3), for the Joint Product in the Territory. The Parties shall not conduct any Development, Manufacturing or Regulatory Activities with respect to the Joint Compounds, Joint Products or Diagnostic Products for Joint Compounds or Joint Products that are inconsistent with the Joint Development Plan and Budget. In the event the JSC has been disbanded pursuant to Section 2.1.4 (Disbandment), the Joint Development Plan and Budget will terminate (except as provided for under any transition related plans), and BII will be responsible for preparing and providing Epizyme with [**] reports with respect to the Joint Product that correspond with the reporting provisions found in Section 5.1.1 (BII Products Report) of this Agreement, mutatis mutandis.
Sample 1
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Joint Development Plan and Budget. The Initial Joint Development Plan and Budget is attached hereto as Annex 4. The Joint Development Committee shall review the Joint Development Plan and Budget within forty-five (45) days after the results of the International Clinical Trial are made available to the Parties, and thereafter, at least annually, and shall recommend amendments thereto (on or before September 30th of each calendar year) to the JSC for its approval with respect to the Development of the Compound and Product for the upcoming calendar year, including the addition of new Clinical Trials for any Additional Indications for which the Parties have agreed to Develop and Commercialise the Product hereunder. Upon reaching such written agreement, each such agreed upon Additional Indication shall be an “Agreed Indication”. For avoidance of doubt, the Joint Development Plan and Budget shall not contain any Development of the Product with respect to Additional Indications, other than Agreed Indications, and Lundbeck shall have no right or obligation hereunder to Develop the Product for any Additional Indication, unless and until such Additional Indication becomes an Agreed Indication by agreement of the Parties in each such Party’s sole discretion. Notwithstanding anything to the contrary contained herein, except to the extent set forth in the Initial Joint Development Plan and Budget, in no event shall the Joint Development Plan and Budget be amended or updated to impose additional costs (including reimbursement obligations) or other obligations (including obligations to devote resources or personnel) on a Party without the prior written consent of such Party in its sole discretion. Notwithstanding the licenses granted by the Parties in this Agreement, including those granted in Articles 2.1 and 2.2, the disclosure and Data sharing rights and obligations of the Parties in this Agreement, including those specified Articles 2.3, Article IV and Article VIII hereunder, and any other provisions herein to the contrary notwithstanding, if one Party recommends a particular Clinical Trial for inclusion in the Joint Development Plan and Budget, and the other Party (through its representatives on the JDC, the JSC or otherwise) refuses to permit such Clinical Trial to be included within the Joint Development Plan and Budget, then, assuming the conduct of such Clinical Trial by the proposing Party is otherwise permitted hereunder, the proposing Party shall be permitted to conduct such Clinical Trial und...
Sample 1

Related to Joint Development Plan and Budget

  • Development Plan As defined in Section 3.2(a).

  • Business Plan and Budget To the extent requested by any Initial Lender, as soon as available, but in any event within thirty (30) days after the end of each fiscal year of the Borrower, an annual business plan and budget of the Borrower and its Subsidiaries on a Consolidated basis, including forecasts prepared by management of the Borrower, in form satisfactory to such Lender, of Consolidated balance sheets and statements of income or operations and cash flows of the Borrower and its Subsidiaries on a monthly basis for the immediately following fiscal year. As to any information contained in materials filed with the SEC or furnished pursuant to Section 6.2(f), the Borrower shall not be separately required to furnish such information under Section 6.1(a) or (b) above, but the foregoing shall not be in derogation of the obligation of the Borrower to furnish the information and materials described in Sections 6.1(a) and (b) above at the times specified therein.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

  • Annual Business Plan and Budget As soon as practicable and in any event not later than thirty (30) days after the end of each Fiscal Year, a business plan and operating and capital budget of the Borrower and its Subsidiaries for the ensuing four (4) fiscal quarters, such plan to be prepared in accordance with GAAP and to include, on a quarterly basis, the following: a quarterly operating and capital budget, a projected income statement, statement of cash flows and balance sheet, calculations demonstrating projected compliance with the financial covenants set forth in Section 9.15 and a report containing management’s discussion and analysis of such budget with a reasonable disclosure of the key assumptions and drivers with respect to such budget, accompanied by a certificate from a Responsible Officer of the Borrower to the effect that such budget contains good faith estimates (utilizing assumptions believed to be reasonable at the time of delivery of such budget) of the financial condition and operations of the Borrower and its Subsidiaries for such period.

  • Joint Development Committee The Parties shall form a joint development committee (the “Joint Development Committee” or “JDC”), made up of an equal number of representatives of Merck and BioLineRx, which shall have responsibility of coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of information between the Parties, with respect to the Study. Other JDC members will be agreed by both Parties. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearly, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the Study. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any such meeting, the BioLineRx Project Manager shall provide an update in writing to the Merck Project Manager, which update shall contain information about the overall progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study. In addition to a Project Manager, each Party shall designate an alliance manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information, and shall serve as the primary point of contact for any issues arising under this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed, and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, the issue shall be elevated to the Head of Clinical Oncology for Merck and the Vice President of Medical Affairs or Business Development for BioLineRx.

  • Annual Business Plan and Budgets As soon as available but in any event no later than 45 days following the end of each fiscal year of the Borrower, an annual business plan and budget of the Consolidated Parties containing, among other things, pro forma financial statements for the next four fiscal quarters and the next fiscal year.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

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