Development Tasks definition
Development Tasks has the meaning specified in Section 4.1.
Development Tasks means, with respect to each Designated Product:
1. those tasks or milestones, together with estimated completion dates or durations therefor, as shall be designated from time to time by Committee Action as being, within industry norms and standards, sufficient evidence of a potentially useful and marketable product that the next steps in the development of such product would be Certification Tasks, or (where no Certification Tasks have then been designated by Committee Action) large-scale clinical trials to determine the safety and efficacy of such Designated Product; and
2. the designation by Committee Action of an initial set of Certification Tasks and an initial Certification Budget for such Designated Product. In most instances, the Development Tasks will include (without limitation) formulation development, in vitro dissolution studies and/or animal studies and bioavailability studies, as well as small-scale clinical trials conducted under an Investigational New Drug Application ("IND") filed with the FDA, of the sort called "Phase I Clinical Trials" and "Phase II Clinical Trials" in order to demonstrate that, within the scope of such studies, the Designated Product is shown, when administered BID, to be a stable formulation having substantially equigesic effect in blood level studies to the targeted dosage strength of the relevant immediate release Oxymorphone product. In most cases, the large-scale trials to follow during the Certification Period would be of the sort called "Phase III Clinical Trials" in the FDA context. However, the applicable Development Tasks may be defined and altered in specific cases by Committee Action, whether or not in conformity with the above described usual case as now anticipated.
Development Tasks shall have the meaning set forth for such term in Section 3.4.
Examples of Development Tasks in a sentence
Seller shall provide Notice to Purchaser within five (5) Business Days when all of the Development Tasks have been satisfied or achieved by Seller (the “Development Completion Notice”), and Seller is ready to proceed with installation of the System.
If any of the Development Tasks have not been satisfied in their entirety (or otherwise waived in writing by Purchaser, in its sole discretion) within one hundred twenty five (125) Business Days (and such 125 Business Day period shall not include time for reviews or modifications pursuant to Section 4.1 and shall be extended on a day-for- day basis pursuant to Section 4.1), then either Party may terminate this Agreement upon thirty (30) Days Notice of such termination to the other Party.
More Definitions of Development Tasks
Development Tasks means those steps, phases, activities, and ----------------- responsibilities of each party and its Contractors that will be part of each Development Project, as more fully described in the applicable Project Plan and Budget. Subject to Section 4.3, the Development Tasks will include, but not be limited to the following:
(i) The "Biogen Development Tasks," which are defined as follows: -------------------------
(A) preclinical biology and animal studies;
(B) final formulation development, design and optimization;
(C) human clinical trials;
(D) preparation and submission of all regulatory filings other than BMFs [*]; and
(E) activities related to the Initial Ad Interferon-beta Project Plan and Budget.
(ii) The "Targeted Development Tasks," which are defined as follows: ---------------------------
(A) vector design and optimization;
(B) manufacturing process development, optimization, scale-up and validation;
(C) assay development, qualification, and validation;
(D) manufacture of Research Vectors and Clinical Vectors; and [*] Confidential Treatment Requested
(E) creation and management of BMFs, and filing of BMFs for regulatory purposes.
Development Tasks means the Development Tasks under the Original Agreement.
Development Tasks means those activities and responsibilities of ----------------- each party that will be part of the Development Project, as more fully described from time to time in the Development Plan and Budget. The Development Tasks shall include with respect to a particular Licensed Product, as more fully described in the Development Plan and Budget: [*] [*] designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission Unless the parties agree otherwise, [*]
Development Tasks has the meaning specified in Section 4.1. “Dispute” has the meaning specified in Section 14.5(a).
Development Tasks means those activities and responsibilities of ----------------- each party that will be part of the Development Project, as more fully described from time to time in the Development Plan and Budget. The Development Tasks shall include with respect to a particular Licensed Product, as more fully described in the Development Plan and Budget:
(a) preparation for [ * ];
(b) preclinical [ * ] performed in preparation for the [ * ] surveillance [ * ] all other applicable regulatory obligations [ * ] animal subjects;
(c) [ * ] of, and obtaining [ * ] including [ * ];
(d) [ * ] for activities under the [ * ];
(e) [ * ];
(f) preparation and [ * ];
(g) [ * ] as to specific indications, as required or agreed [ * ];
(h) [ * ] by one party hereunder to the other party [ * ] but not in any event less stringent than [ * ] and to the appropriate [ * ] with respect to [ * ] arising during the [ * ] for such [ * ] and associated with such [ * ] or any [ * ]; and
(i) such other activities, regardless of [ * ] that are [ * ] as determined by [ * ] in order to obtain [ * ]. Unless the parties agree otherwise, [ * ] shall have the primary responsibility for the [ * ] described in [ * ] provided, however, that the parties hereto shall [ * ] covered by any of the inventions or technologies [ * ] and shall give [ * ] to such [ * ] provided it is able and willing [ * ] under terms and conditions [ * ] to the parties hereto than the terms and conditions under which [ * ] is able and willing to [ * ].