Additional Development. If either Party proposes to conduct additional Development of a Product in the Field beyond the Initial Indication Development performed pursuant to Section 4.1(a), including Development of Product for any Additional Indication or label expansion or modification (“Additional Development”) for (a) the purpose of seeking Regulatory Approval both in and outside the Territory (“Global Additional Development”) or (b) the purpose of seeking Regulatory Approval solely in the Territory (“Territory Additional Development”), then the proposing Party shall provide the other Party with a written proposal of such Additional Development (the “Additional Development Proposal”), including a synopsis of the Development activities related to such Additional Development, the potential role of the non-Proposing Party with respect to such Additional Development, the anticipated timeline for such Additional Development, the proposed clinical trial protocols or designs, if applicable, the estimated costs associated with such Additional Development, and, in the case of Global Additional Development, the proposed cost allocation between each Party’s territory taking into account the respective value of such Development to each Party’s territory (including, with respect to an Additional Indication, the anticipated market value of such Additional Indication using sales data provided by IQVIA or similar Third Party provider) (“Cost Allocation”). For clarity, Global Additional Development does not include any Additional Clinical Trial or other Development that is required solely by a Regulatory Authority or Applicable Laws for obtaining Regulatory Approval in one Party’s territory and is not required by Regulatory Authorities or Applicable Laws for obtaining Regulatory Approvals both within and outside the Territory. (i) Within thirty (30) days of receipt of an Additional Development Proposal, the JSC shall meet to review the Additional Development Proposal and to permit the non-proposing Party an opportunity to ask questions and request additional information from the proposing Party related to the Additional Development Proposal, including whether such Proposal is reasonably likely to have a material adverse effect on obtaining or maintaining Regulatory Approval of any Product or Commercializing any Product, in either case, in the non-proposing Party’s territory. The non-proposing Party shall be given the opportunity to (a) comment on the Additional Development Proposal to ensure th...
Additional Development. Any customized work beyond the scope of this Service Definition will be documented in a separate Statement of Work.
Additional Development. The Promoter undertakes that it has no right to make additions or to put up additional structure anywhere in the Project after the building plan, layout plans sanction plan and specifications, amenities and facilities has been approved by the competent authorities and disclosed, except for as provided in the Act.
Additional Development. If either Party (the “Proposing Party”) desires to conduct Other Global Development or any other additional Development of the Licensed Compound or a Licensed Product in its territory that is not included in any [***] Plan or the then-current Current Global Development Plan or the then-current Territory-Specific Development Plan (including for any New Indication, New Formulation, or any Other Global Development, but excluding any [***], “Additional Development”), then the Proposing Party will present a proposal to the JSC for its [***] pursuant to Section 3.1.5(k) (Specific Responsibilities of the JSC), including a synopsis of the Development activities related to such Additional Development, the potential role of the non-Proposing Party with respect to such Additional Development, the timeline for such Additional Development, and the estimated costs associated with such Additional Development. Notwithstanding the foregoing, if a Regulatory Authority in a country or jurisdiction in the Territory requires a New Formulation for a Licensed Product in order for such Regulatory Authority to grant Regulatory Approval for such Licensed Product in an Initial Indication in such country or jurisdiction, then all Development related to such New Formulation will not be Additional Development and instead will be conducted as Territory-Specific Development pursuant to Section 4.2 (Territory-Specific Development).
4.3.1 [***] Additional Development.
(a) JSC [***]; Agreement. If the JSC [***] any Additional Development as Other Global Development and both Parties agree to participate in such Additional Development, then the Parties will enter into a co-development agreement (or an amendment to this Agreement) regarding such Additional Development, including the allocation of costs and responsibilities related to such Additional Development and the reporting of information regarding such Additional Development, and each Party will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further Assurances) to the data generated from such Additional Development for the purposes of obtaining Regulatory Approval and Commercializing the Licensed Product in its territory. If the JSC [***] any Additional Development as new Territory-Specific Development and [***] agrees to conduct such Additional Development, then [***] will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further Assurances) to the data generated from such Additional ...
Additional Development. Company acknowledges that it will be solely responsible, after the completion of the Research Program, for further clinical development and, if commercially feasible, commercialization of the Product, including obtaining all regulatory approvals.
Additional Development. Except as set forth in Section 4.1, Section 4.2 and Section 4.3, Onconova shall not have any obligation to develop the Licensed Product in the Licensed Territory.
Additional Development. As part consideration for entering into and acquiring rights under the terms of this Agreement, with legal description Operator grants Participant the right, if then available and not otherwise taken, (on the same, or other negotiated terms that are not lesser than the terms of this Agreement), to participate in any additional xxxxx (“Subsequent Xxxxx”) which Operator may elect to drill or re-complete on the South 40 Leases described herewith as the X.X. XXXX "18-1", being the Wl/2 of the NW1/4 of Section 18, Xxxxx X-00, Xxxxxx Xxxxxx Xxxxx, Xxxx Xxxxxx, Texas, containing Forty (South 40) acres only more or less (see also Exhibit “A”, Section B, Description of Lands hereto for further reference). At any time after the Prospect Well or Xxxxx have been drilled and completed or plugged and abandoned, as the case may be, upon mutual election by Operator and Participants to drill an additional Subsequent Well or Xxxxx on the South 40 Leases described herein this section, any additional drilling/re-entry activity to take place on the Leases, as proposed by Operator, subsequent of xxxxx, shall not be subject to the payout provisions provided for in this Agreement, shall not be drilled under the terms of turnkey arrangements, unless the same shall be proposed by Operator to Participant. Operator, other than described herein section II. 1) shall not maintain a “carried interest” in Subsequent Xxxxx and each Participant shall pay and be responsible for their proportionate share of any and all costs, to the extent of their after payout interests, for the drilling of the Subsequent Xxxxx. For development selection regarding Subsequent Xxxxx, the following formations, not all inclusive, are available for consideration in the South 40 acreage. Glorietta, Upper Clearfork, Xxxxx, Lower Clearfork, Witchita Albany, Detrital Zone, Devonian, Fusselman.
Additional Development. If Allergan desires preclinical or clinical studies in addition to that set forth in this Section 3.2 and the Development Plan for expanded label indications for the Product within the Field, then Allergan shall notify Ista in writing and include a preliminary preclinical or clinical plan. Through the Joint Operating Committee, the parties will determine whether or not to proceed with such work and the allocation of such work and the expenses therefor. In the absence of a mutual agreement, either party may conduct such work at its expense, and the other party shall reasonably cooperate to the extent such cooperation does cause such party to incur any material additional expenses.
Additional Development. Upon Inrange's request, Ancor shall provide reasonable development services, in addition to those development services provided under Section 4.1, for development of additional boards incorporating the ASICs, subject to availability of appropriate engineering personnel and mutual agreement on the scope of such development services, at the rate of $* per staff month.
Additional Development. Upon completion of the seven-part Schoolcraft Customer Service Training Series, an employee will receive a stipend in the amount of $250.00.
