Moderna mRNA API definition

Moderna mRNA API means [***].

Examples of Moderna mRNA API in a sentence

  • Moderna will Manufacture (or have Manufactured) and supply to Merck, and Merck will purchase exclusively from Moderna, [***], quantities of non-cGMP Moderna mRNA API as Merck may reasonably require in connection with the performance of its Collaboration Activities.

  • Subject to Section 2.14(b) and any obligation of Moderna to supply Merck with Moderna mRNA API, Merck will be solely responsible for all Development activities during the Post-R&D Period.

  • Subject to Moderna’s obligation to supply Merck with Moderna mRNA API and/or Drug Product as set forth in Section 4, all Development work performed hereunder by Moderna will terminate upon the expiration of the R&D Term, unless Moderna will perform Development activities to support Merck’s Development of Product Candidates during the Post-R&D Period pursuant to Section 2.14(b).

  • Merck shall issue purchase orders in substantially the form set forth on Schedule 1 to Exhibit A to Moderna for the purchase of non-cGMP Moderna mRNA API (the “non-cGMP Order Form”).

  • Notwithstanding the foregoing described exclusivity, from and after the initiation of a Registrational Study with respect to a given Product Candidate or Elected Candidate, Merck and/or its Third Party Manufacturer can Manufacture, and Merck may purchase, cGMP Moderna mRNA API for each such Product Candidate or Elected Candidate, in accordance with Section 4.3; provided, that, [***].

  • Except (a) following a Triggering Event as described in Section 4.7, (b) on a Product-by-Product basis, at such time as [***], or (c) [***], neither AstraZeneca nor any Affiliate of AstraZeneca (nor any others on behalf of or under license or sublicense from AstraZeneca or any of its Affiliates) will Manufacture (i) any Moderna mRNA API or (ii) Product, except for the Manufacture of Product using Moderna mRNA API supplied by or on behalf of Moderna.

  • If not previously prepared and filed, Moderna will, at Merck’s request, prepare and file with all applicable Regulatory Authorities a DMF for the Moderna mRNA API and Moderna shall also provide such other information and assistance as Merck may reasonably request in connection with the completion of and submission of applications for Regulatory Approvals for Products and the maintenance thereof.

  • Notwithstanding the foregoing, the Parties acknowledge and agree that AstraZeneca will have no right to acquire from Moderna, and Moderna will have no obligation to Manufacture and supply to AstraZeneca, any Moderna mRNA API for use in connection with the Commercialization of any Product unless and until AstraZeneca has exercised its Option as set forth in Section 6.6 of the A&R Option Agreement and paid the applicable Initial Payment under the A&R Option Agreement with respect to such Product.

  • In accordance with Exhibit A-1, Moderna will Manufacture and supply AstraZeneca with non-cGMP Moderna mRNA API for use in support of the Services Program, Development Pool Services or Pre-Clinical Activities, as applicable, with respect to each applicable Collaboration mRNA Construct.

  • For clarity, the rights and obligations under this Section 4, Exhibit A-1 and Exhibit A-2 relate solely to unformulated Moderna mRNA API, unless otherwise agreed by the Parties.

Related to Moderna mRNA API

  • HEPA filter means a high efficiency particulate absolute air filter capable of trapping and retaining 99.97 percent of fibers greater than 0.3 micrometers in mass median aerodynamic diameter equivalent.

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

  • Cannabinoid extract means a substance obtained by separating cannabinoids from marijuana by:

  • Beam axis means a line from the source through the centers of the x-ray fields.

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • 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.

  • Automated drug dispensing system means a mechanical or electronic system that performs

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Antibody means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof.

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

  • DNA sample means any material that has come from a human body and consists of or includes human cells;

  • Cell Line means the cell line, particulars of which are set out in Schedule 1.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • DNA profile means a letter or number code which represents a set of identification characteristics of the non-coding part of an analysed human DNA sample, i.e. the particular molecular structure at the various DNA locations (loci);

  • Antigen means a substance recognized by the body as being foreign; it results in the production of specific antibodies directed against it.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Pump spray means a packaging system in which the product ingredients within the container are not under pressure and in which the product is expelled only while a pumping action is applied to a button, trigger or other actuator.

  • Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

  • Cannabis testing facility means an entity registered by