Palatin Development Plan definition

Palatin Development Plan means the Development activities, including ***, to be performed by Palatin *** and listed in Exhibit V, as the same may be amended in accordance with the provisions of this Agreement. For the avoidance of doubt, ***.
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Palatin Development Plan means the Development activities, including ***, to be performed by Palatin *** and listed in Exhibit V, as the same may be amended in accordance with the provisions of this Agreement. For the avoidance of doubt, ***. 1.36 “Palatin Know-How” means (a) any Information within the Control of Palatin as of the Effective Date relating to the Development of the Product in the Field, including but not limited to the information contained in the documentation listed in Exhibit II, (b) all Information generated or obtained by Palatin after the Effective Date during the performance of Palatin’s obligations under this Agreement, and (c) all other Information generated or obtained by Palatin after the Effective Date relating to the Development of the Product in the Field and Commercialization activities undertaken by or on behalf of Palatin. Notwithstanding anything herein to the contrary, Palatin Know-How shall exclude the Palatin Patents. 1.37 “Palatin Patent” means (i) each patent application and patent listed in Exhibit III, including (a) all reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, or divisions of or to any of the foregoing; and (b) all extensions, renewals or restorations of any of the foregoing by existing or future extension, renewal or restoration mechanisms, including supplementary protection certificates or the equivalent thereof and (ii) any patent application filed or to be filed, and any patent obtained or to be obtained, by Palatin in the Territory during the term of this Agreement relating to the Product in the Field. 1.38 “Phase III Study” means a Clinical Study designed to confirm the preliminary evidence that an investigational product is safe and effective for use in the intended indication and recipient population. 1.39 “Pivotal Study” means a Phase III Study intended to support Regulatory Approval by the Competent Authorities. 1.40 “Product” means any pharmaceutical product for humans formulated in any finished product form that contains bremelanotide (PT-141) as active pharmaceutical ingredient, including but not limited to any relevant device necessary for administration. 1.41 “Regulatory Approval” means any approvals, product and/or establishment licenses, registrations or authorizations of any Competent Authority or other governmental entity, necessary for the commercial manufacture, use, storage, import, export, tr...
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Examples of Palatin Development Plan in a sentence

  • Each Party shall keep the Joint Steering Committee appropriately informed of the status of its clinical development program and other activities conducted under the Xxxxxx Xxxxxxx Development Plan, the Palatin Development Plan and the other provisions of this Agreement, as applicable, and its other development activities with respect to the Product in the Field.

  • All Development and regulatory activities in connection with the clinical development programs conducted to obtain and maintain Regulatory Approval for the Product in the Territory shall be conducted by and on behalf of Xxxxxx Xxxxxxx in accordance with the Xxxxxx Xxxxxxx Development Plan and the other provisions of this Agreement, and by and on behalf of Palatin in accordance with the Palatin Development Plan and the other provisions of this Agreement.

  • Upon reasonable prior written notice, each Party shall have the right to inspect records and notebooks reflecting the work done and results achieved by or on behalf of the other Party in the performance of its development activities with respect to the Product in the Field pursuant to either the Xxxxxx Xxxxxxx Development Plan or the Palatin Development Plan and the other provisions of this Agreement, as applicable.

  • Palatin shall use Commercially Reasonable Efforts to conduct and complete the studies and activities assigned to it in the Palatin Development Plan and the other provisions of this Agreement in order to achieve the goals of the Palatin Development Plan in accordance with the timelines accepted by the Joint Committee.

  • The Parties, through the Joint Steering Committee, shall negotiate in good faith to amend the Xxxxxx Xxxxxxx Development Plan and the Palatin Development Plan from time to time for the conduct of additional development activities.

  • Without limiting the foregoing, each Party shall, on a *** basis (or, if sooner, promptly upon request by the Joint Steering Committee), provide the Joint Steering Committee with summaries of data and results and all supporting data and results generated or obtained in the course of such Party’s performance of studies and activities under the Xxxxxx Xxxxxxx Development Plan and the Palatin Development Plan, and the other provisions of this Agreement, as applicable.

  • Each Party shall conduct those activities for which it is the responsible Party under the Xxxxxx Xxxxxxx Development Plan or Palatin Development Plan and the other provisions of this Agreement, as applicable, in compliance in all material respects with all applicable laws and in accordance with GLP and GCP and GVP (when applicable) under the applicable laws of the country in which such activities are conducted.

Related to Palatin Development Plan

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

  • 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;

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

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

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

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

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

  • Development Program means the implementation of the development plan.

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

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

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

  • 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.

  • 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.

  • Development Phase means the period before a vehicle type is type approved.

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • 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.

  • Development Works means the external development works and internal development works on immovable property;

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

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

  • Planned development means a real property development other than a community apartment project, a condominium project, or a stock cooperative, having either or both of the following features:

  • 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;

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;