Process Development Activities definition

Process Development Activities means: the activities, if any, to be provided by SYNCO in the Process Development Phase in accordance with this Agreement, as described in the applicable Service Specific Addendum which may be amended from time to time in accordance with the provisions of this Agreement.
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Process Development Activities has the meaning set forth in Section 8.4(a).
Sample 1
Process Development Activities means: the activities, if any, to be conducted and/or provided by FCDI, independently or interdependently with Century’s conduct or provision of the Century Process Development Activities, in the Process Development Phase in accordance with this Agreement, in each case, as described in the applicable Work Order(s).
Sample 1

Examples of Process Development Activities in a sentence

  • The Project Team will provide ADVAXIS and SYNCO with weekly technical progress updates on the status, progress, deviations and corrective actions of the Technology Transfer Activities, Process Development Activities and/or Analytical Testing Development Activities performed or to be performed according to the applicable Service Specific Addendum.

  • In the event SYNCO executes the Process Development Activities and/or Analytical Testing Development Activities more expeditiously than indicated in the Time Schedule, no changes will be made to the Financial Terms as described in the applicable Service Specific Addendum and SYNCO remains entitled to the full amounts attributed as described in the applicable Service Specific Addendum concerning the Process Development Activities and/or Analytical Testing Development Activities.

  • Service” or “Services” means: the Technology Transfer Activities and/or Process Development Activities and/or Analytical Testing Development Activities and/or Manufacturing Activities to be provided and/or related activities to be performed by SYNCO for ADVAXIS as described in the applicable Service Specific Addendum.

  • SYNCO agrees to use its reasonable best efforts to execute the Process Development Activities and/or Analytical Testing Development Activities, if any, according to the Time Schedule as described in the applicable Service Specific Addendum.

  • The Parties will agree in writing on the Process Development Objectives and/or Analytical Testing Development Objectives ultimately within six (6) weeks prior to the start of the Process Development Activities and/or Analytical Testing Development Activities.

  • If at any time, SYNCO comes to the conclusion on the basis of the results of the Technology Transfer Activities, Process Development Activities and/or Analytical Testing Development Activities performed, that SYNCO shall not be able to verify or scale-up the manufacturing process for the Product, SYNCO will notify the Steering Committee immediately.

  • In the event there is a delay in the utilization of the Slot that is not related to the Process Development Activities and due to failure of SYNCO to meet its Time Schedule in accordance with the Service Specific Addendum, including any delay pursuant to Article 16.1, such Reservation Fee for any Slot will be held by SYNCO and utilized toward the reservation of a new Slot.

  • Draft GMP Specifications” means: the draft specifications to be agreed by SYNCO and ADVAXIS in writing after completion of the Process Development Activities prior to the performance of the Engineering Batch.

  • Upon completion of the Process Development Activities and/or Analytical Testing Development Activities, SYNCO shall provide ADVAXIS with a report (the “Process Development Report”), which sets forth in sufficient detail the results of the Process Development Activities and/or Analytical Testing Development Activities.

  • Upon termination of this Agreement in accordance with the provisions of this Agreement, SYNCO will return to ADVAXIS (at the cost of ADVAXIS) all data and unused materials related to the Process Development Activities and the Manufacturing Activities (including all Materials and Raw Materials), whilst retaining copies of any necessary documents and data required for archive and regulatory purposes, which copies and data will remain subject to the provisions of Article 13 hereof.

Related to Process Development Activities

  • 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;

  • 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.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • 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;

  • 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.

  • 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.

  • 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.

  • Development Program means the implementation of the development plan.

  • 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.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • 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;

  • 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.

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

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

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

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

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

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

  • 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;

  • Development Area means that area to which a development plan is applicable.

  • Research means a methodical investigation into a subject.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • 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.

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • Project Activities means the activities to be undertaken or Works to be delivered or Property to be contributed or provided by you, your approved Sub-Grantees or your approved sub- contractors as summarised in the Particulars and more particularly described in the Agreed Proposal for which Xxxxx is payable under this Agreement;