Joint Development Plans Sample Clauses

Joint Development Plans. (i) Within (x) [***] days after the Merck Participation Election Date for the PCV Program, or (y) subject to the last sentence of this Section 4.3(c)(i), [***] days after the date of the Merck Participation Election Notice for a given Joint SAV Program, the Parties shall agree on the Collaboration Activities of the Parties with respect to the applicable Joint Development Program and set forth such activities and a [***] year rolling budget therefor (such budget to be on a study-by-study or activity-by-activity basis) in a joint development plan (each, a “Joint Development Plan and Budget”), the initial draft of which shall be prepared by [***]. The purpose of the Joint Development Plan and Budget for the applicable Program is to set forth the specific Development activities to be performed by the Parties in support of such Joint Development Program, [***]. Each Joint Development Plan and Budget for the applicable Program shall set forth activities that are similar in nature to those contained in the applicable POC Plan. Notwithstanding anything herein to the contrary, if the Parties fail to mutually agree on a Joint Development Plan and Budget for a given Joint SAV Program within [***] days after the date of the Merck Participation Election Notice for such Joint SAV Program, then Moderna shall deliver written notice (together with an invoice) to Merck that the SAV Participation Election Payment for such Joint SAV Program is due and either (1) Merck may pay the SAV Participation Election Payment for such Joint SAV Program within [***] Business Days after receipt of such notice, and the Parties will continue to diligently work to mutually agree on a Joint Development Plan and Budget for such Joint SAV Program, or (2) if Merck does not make such payment under clause (1), then [***]. (ii) Either Party may propose at any meeting of the JDC amendments to the Joint Development Plan and Budget for the applicable Program; provided, however, if such amendments involve an Additional Study or series of related Additional Studies, the inclusion of such Additional Study(ies) shall be in accordance with Section 4.4. Notwithstanding the foregoing, at a minimum, no later than [***] days prior to the start of a Calendar Year, the Parties shall propose an updated budget for any ongoing studies or activities under the then-current Joint Development Plan and Budget for the applicable Joint Development Program for the upcoming Calendar Year for the JDC’s review and JSC’s approv...
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Joint Development Plans. The Joint Development Plans, when mutually agreed upon in writing and signed by the Parties, form part of this Agreement and shall have full force and effect as if expressly set out in the body of this Agreement, and reference to this Agreement shall include the attached Joint Development Plans. If any conflict arises between any term, condition or provision of a Joint Development Plan and any term, condition or provision of this Agreement, the applicable term, condition or provision of this Agreement shall prevail.
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Joint Development Plans. Pursuant to Section 4.4(a), the Working Group designated by JDRC shall in good faith discuss and prepare the Joint Development Plan covering Approved Clinical Study(ies) for review by JDRC. (i) Once Joint Development Plan prepared by the Working Group is approved at JDRC, the Parties shall initiate the Approved Clinical Study(ies) in accordance with the Joint Development Plan. (ii) In the event that the JDRC is unable to agree upon a Joint Development Plan for such Approved Clinical Study within sixty (60) days after the applicable Joint Study Proposal has been approved by the JDRC, each Party shall be free to carry out such Approved Clinical Study(ies) at its own expense independently upon notice to the other Party, and subject to the terms of Sections 2.1 and 4.4(c). (iii) The JDRC shall review the Joint Development Plan on an ongoing basis from time-to-time as needed. The JDRC may make adjustments to the then-current Joint Development Plan from time-to-time as it deems appropriate.
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Joint Development Plans. If a Joint Development Plan is approved by all members of the JDC, then each Party will use Commercially Reasonable Efforts to conduct those Development activities allocated to such Party under and in accordance with the Joint Development Plan and the applicable Joint Development Budget.
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Joint Development Plans. Each Joint Development Plan shall include a comprehensive overall plan, including Clinical Studies anticipated to be conducted to satisfy applicable regulatory requirements for obtaining Regulatory Approval for [***]. The Lead Party shall allocate responsibility for each Development activity in the Joint Development Plan, including Clinical Studies, to one of the Parties in good faith, taking into consideration each Party’s capabilities and available resources. The terms of, and activities set forth in, the Joint Development Plan shall at all times be designed to be in compliance with all applicable Laws and the Parties’ Applicable Internal Policies (as described in Section 3.11). The Parties expect that [***].
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Joint Development Plans. Promptly upon designation of a Jointly Funded Clinical Combination and or a Joint Development Radioconjugate, the Parties will meet (through the JDC) to prepare (or in the case of a Jointly Funded Clinical Combination, update as necessary the applicable Clinical Development Plan) and submit to the JSC for approval a detailed development plan setting forth all Development activities to be conducted with respect to such Jointly Funded Clinical Combination and or a Joint Development Radioconjugate (each a “Joint Development Plan”). In addition, each Joint Development Plan shall also include a reasonably detailed budget of the costs and expenses (including FTE Costs) for the activities to be conducted pursuant to such plan (the “Joint Development Budget”) on an activity-by-activity or study-by-study basis, as appropriate. (a) The Parties intend, and each Joint Development Plan will reflect that AstraZeneca will sponsor and operationally run all clinical trials conducted under each Joint Development Plan. (b) The JDC will periodically (or at the request of one of the Parties) review each then-current Joint Development Plan, and if the JDC determines an amendment is needed to a then-current Joint Development Plan, the JDC will collaborate to prepare an amendment to such then-current Joint Development Plan, for review, comment and approval by the JSC. Such amended Joint Development Plan will reflect any changes (including additions) to the applicable Joint Development Budget. Once approved by the JSC, such amended Joint Development Plan will become effective and supersede the previous Joint Development Plan as of the date of such approval.
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Joint Development Plans. Nycomed shall be responsible for implementing and overseeing any Joint Development Plans prepared by the Joint Development Committee relating to the [*] Process and the Parties shall each be responsible for fifty percent (50%) of the costs and expenses of implementing any such Joint Development Plans. If NPS does not agree to any such Joint Development Plans, then NPS may elect not to participate and shall not be obligated to pay any costs or expenses associated with such Joint Development Plan. In the event of such an election not to participate by NPS, each Party may pursue its own Development relating to the [*] Process and shall be responsible for its own costs and expenses incurred in connection therewith. Thereafter, if either Party desires to utilize any Improvements Developed solely by the other Party (the “Developing Party”) relating to the [*] Process, such Party shall be offered the rights to such Improvements by reimbursing the Developing Party an amount equal to [*] of the Developing Party’s costs incurred after the Effective Date to Develop such Improvements plus interest on such amount equal to an annual compound rate of [*] of such amount beginning on the date the Developing Party began incurring costs for such Developing such Improvements up to the date of payment.
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Joint Development Plans. If the Parties agree to jointly Develop any Indications on a global basis, the Parties shall consider the specific sales potential and regulatory requirements on an Indication-by-Indication and Country-by-Country basis in designing any studies and in selecting the primary investigators, the key opinion leader and the trial centers used to Develop such Indication in such Country; provided that any such Joint Development Plans may not adversely affect the commercial potential of Product outside the Territory. Each Party shall be responsible for fifty percent (50%) of all costs and expenses associated with such joint Development of any Indication. If Nycomed desires to change any Joint Development Plan previously agreed by the Parties and NPS does not agree to such change, then NPS may elect not to participate in such Joint Development Plan and shall not be obligated to pay any costs or expenses associated with such Joint Development Plan; provided, however, that any such changes to a Joint Development Plan may not adversely affect the commercial potential of Product outside the Territory. In the event of such an election not to participate by NPS, NPS may subsequently opt-in to such Development Plan in accordance with Section 4.2(g).
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Joint Development Plans 
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Related to Joint Development Plans

  • Development Plans Customer has provided Provider with a report attached hereto as Exhibit D (the “Current Development Plan”) describing in detail, as of January 1, 2017, the planned development, drilling, production, processing, treating, marketing and other activities to take place with respect to Dedicated Production and Customer Injected NGLs for the applicable Development Period. The information contained in the Current Development Plan is, with respect to the first three Years covered by the Current Development Plan, on a Quarter-by-Quarter basis, and with respect to the remaining Years covered by the Current Development Plan, on a Year-by-Year basis. The Current Development Plan attached hereto has been approved by the Parties. (a) From time to time during each Year of the Term, the Parties shall meet to discuss the planned development, drilling, production, processing, treating, marketing and other activities that Customer expects to take place with respect to Dedicated Production and Customer Injected NGLs for the then-applicable Development Period. Customer and Provider shall each make their respective representatives available to participate in such meetings and discussions. No later than August 1 of each such Year, Customer shall provide (or cause to be provided) to Provider a proposed update of the then-currently agreed Development Plan, prepared on the same basis as the Current Development Plan and describing in detail the planned development, drilling, production, processing, treating, marketing and other activities to take place with respect to Dedicated Production and Customer Injected NGLs for the then-applicable Development Period (any such update, an “Updated Development Plan” and, together with the Current Development Plan, each, a “Development Plan”). (b) Each proposed Development Plan shall include information as to the following, in each case, broken out, with respect to the first three Years covered by such Development Plan, on a Quarter-by-Quarter basis, and, with respect to the remaining Years covered by such Development Plan, on a Year-by-Year basis: (i) forward-looking production estimates for the applicable time period covered by such Development Plan for all Customer Gas and Customer Injected NGLs (A) that Customer reasonably and in good faith believes will become owned or Controlled by Customer during the time period covered by such Development Plan, and/or (B) that will be produced from (I) in the aggregate, all ▇▇▇▇▇ then-existing and (II) in the aggregate, all ▇▇▇▇▇ that are expected to be drilled during the time period covered by such Development Plan (each such Well reflected in such Development Plan, a “Planned Well” and, such collective estimates described in subsections (A) and (B), both with respect to a particular Quarter and an entire Year, the “Dedicated Production Estimates”); TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**). (ii) (A) each new receipt point (including the location thereof) proposed by Customer with respect to the Dedicated Production Estimate reflected in such Development Plan (each such receipt point, a “Planned Receipt Point”), (B) each Receipt Point at which Customer expects to Tender Customer Gas or Customer Injected NGLs reflected in such Development Plan into the TGP System, and (C) the estimated portion of the Dedicated Production Estimate contained in such Development Plan that Customer expects to Tender at each such Receipt Point and Planned Receipt Point; (iii) (A) each new delivery point (including the location thereof) proposed by Customer with respect to the Dedication Production Estimate reflected in such Development Plan (each such delivery point, a “Planned Delivery Point”), (B) each Delivery Point at which Customer expects to Nominate Customer Residue Gas or Customer NGLs produced from the Dedicated Production Estimate reflected in such Development Plan to be redelivered to Customer, and (C) the estimated volumes of Customer Residue Gas and Customer NGLs produced from the Dedication Production Estimate contained in such Development Plan that Customer expects to Nominate to each such Delivery Point; (iv) the earliest date on which each Planned Receipt Point and Planned Delivery Point included in the Development Plan is required by Customer to be placed into service, which date shall not be earlier than three Months after the January 1st that is immediately subsequent to the date that the Development Plan that initially reflected such Planned Receipt Point or Planned Delivery Point was delivered to Provider hereunder; (v) the anticipated characteristics of the production from the ▇▇▇▇▇ and Planned ▇▇▇▇▇ reflected in such Development Plan (including liquids content and gas and liquids composition) and the projected production volumes and production pressures applicable thereto; provided that Customer may utilize the existing and historical production information from similarly situated ▇▇▇▇▇; (vi) any (A) proposed revision to the then-existing Dedicated Area and/or any then-existing Dedicated Contract and/or (B) any new contract that Customer proposes to be a Dedicated Contract; and (vii) other information reasonably requested by Provider that is relevant to the design, construction, and operation of the TGP System, including (A) any applicable Plant Expansion or Facilities Modification proposed by Customer, (B) the relevant Receipt Point and Planned Receipt Point facilities applicable to such Development Plan, and (C) the relevant Delivery Point and Planned Delivery Point facilities applicable to such Development Plan. TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**).

  • Joint Development If joint development is involved, the Recipient agrees to follow the latest edition of FTA Circular 7050.1, “Federal Transit Administration Guidance on Joint Development.”

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • 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.

  • Joint Development Committee (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.