Current Global Development Program definition

Current Global Development Program means the Global Phase 3 NDD-CKD Program and the Global Phase 3 DD-CKD Program, the other clinical and non-clinical studies set forth on Schedule 1.44, and any other Development activity for the purpose of obtaining Regulatory Approval from [***] for the Licensed Products for each of the DD-CKD Indication and the NDD-CKD Indication in the [***] that is conducted pursuant the Current Global Development Plan, as the same may be amended in accordance with this Agreement. For clarity, [***] are not included in the Current Global Development Program.
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Current Global Development Program means the Global Phase 3 Program, [***], the other clinical and non-clinical studies set forth on Schedule 1.28, and any Approval Study.
Sample 1

Examples of Current Global Development Program in a sentence

  • In addition to the foregoing, on a quarterly basis, Akebia shall provide the JDC with a written summary of any Development, manufacturing, and regulatory activities related to the Licensed Compound and the Licensed Products outside of the Territory that materially impact the Current Global Development Program.

  • Until the [***], Akebia will have the sole right to publish any clinical data or other clinical or non-clinical results from such programs or any other results under the Current Global Development Program; provided that Akebia will [***].

  • Until the [***], Akebia will have the sole right to publish any clinical data or other clinical or nonclinical results from such programs or any other results under the Current Global Development Program; provided that Akebia shall [***].

  • Following receipt of Regulatory Approval from the EMA for the Licensed Product in each Initial Indication, Licensee will be responsible for preparing, filing, and submitting, directly or through its Affiliates and permitted sublicensees, all Regulatory Submissions in the E.U. relating to the Current Global Development Program.

  • Subject to Licensee’s performance of its obligations and fulfillment of its responsibilities, in each case, with respect to regulatory affairs in accordance with Article V (Regulatory Affairs), Akebia will use Commercially Reasonable Efforts to perform the Current Global Development Program, and Licensee will provide assistance reasonably requested by Akebia in connection with the activities under the Current Global Development Plan.

  • No later than [***], Akebia will provide Licensee with a Cost Share Notice that includes (i) the estimated budget for the Current Global Development Program for the next [***] following the date of such Cost Share Notice, (ii) an invoice for the estimated amount of the applicable Licensee R&D Cost Share for the [***], and (iii) a report of actual Current Global Development Costs incurred by or on behalf of Akebia during the [***].

  • If Akebia desires to create a new protocol (including any Approval Study), or to revise the protocol for any clinical study included in the Current Global Development Program, then Akebia will provide a draft of the applicable new or revised protocol to the JDC reasonably in advance of Akebia’s submission thereof for the JDC’s [***] as set forth in Section 3.3.3(a) (Specific Responsibilities of the JDC).

  • Akebia may prepare amendments or updates to the Current Global Development Plan, including any (a) new protocols proposed by Akebia for any additional clinical or non-clinical study that is not an [***] and is to be included in the Current Global Development Program, and (b) material revisions proposed by Akebia to the protocol of any clinical or non-clinical [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request.

Related to Current Global Development Program

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Development Program means the implementation of the development plan.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Economic development project means land and existing or planned improvements suitable for use by an industrial or commercial enterprise, or housing development, or the protection of the environment, including, but not limited to, groundwater or surface water. Economic development project includes necessary buildings, improvements, or structures suitable for and intended for or incidental to use as an industrial or commercial enterprise or housing development; and includes industrial park or industrial site improvements and port improvements or housing development incidental to an industrial or commercial enterprise; and includes the machinery, furnishings, and equipment necessary, suitable, intended for, or incidental to a commercial, industrial, or residential use in connection with the buildings or structures.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • spatial development framework means the Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • Development Plan has the meaning set forth in Section 3.2.

  • Economic development incentive means a financial incentive,

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Economic development means all powers expressly granted and reasonably inferred pursuant to SDCL § 9-54.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Joint Development Committee or “JDC” has the meaning set forth in Section 3.10.

  • Individual development account means a contract between an account holder and a fiduciary organization, for the deposit of funds into a financial institution by the account holder, and the deposit of matching funds into the financial institution by the fiduciary organization, to allow the account holder to accumulate assets for use toward achieving a specific purpose approved by the fiduciary organization.

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Existing development means development, other than that associated with agricultural or forest management activities, that meets one of the following criteria: