Additional Clinical Studies Clause Samples
Additional Clinical Studies. Licensee is interested in participating in future clinicial studies which TXMD may wish to conduct in order to expand the Initial Indication of the Products. Licensee would commit to contribute both financially and using its technical expertise. The design and cost of any such studies would need to be mutually agreed between the Parties.
Additional Clinical Studies. Upon ▇▇▇▇▇▇'▇ initiation of any Investigational New Drug Application related to any new indication, dosage form or formulation of the Product, the parties shall meet to discuss such Investigational New Drug Application and the projected expenses involved in conducting a program for a Supplemental New Drug Application to the FDA, including required expenditures for new clinical development programs. If Cephalon is interested in pursuing a collaboration for such new indication, dosage form, or formulation, Cephalon shall notify ▇▇▇▇▇▇ within thirty (30) days of their meeting and the parties shall thereafter negotiate in good faith during the succeeding three (3) month period a sharing of the clinical development expenditures necessary to file a Supplemental New Drug Application, the allocation of marketing responsibilities, as well as a sharing of the revenues related to the sale of drug under such Supplemental New Drug Application. The sharing of such expenditures, responsibilities and revenues shall reflect the parties' good faith determination of the extent to which the percentage of the market for the new indication, dosage form or formulation is in the Field. If the parties are unable to agree on such sharing arrangements, the matter shall be referred to ▇▇▇▇▇▇'▇ Vice President, Pharmaceutical Commercial Operations, and Cephalon's Chief Operating Officer for resolution. If such dispute cannot be resolved as aforesaid, the matter shall be submitted to alternative dispute resolution in accordance with Section 18.7 hereof. If Cephalon is not interested in pursuing such a collaboration, or if the parties are unable to agree on the terms of such a collaboration within three (3) months following good faith negotiations and the dispute is not submitted to alternative dispute resolution in accordance with Section 18.7, then ▇▇▇▇▇▇ shall have the right to develop and market, either by itself or with other collaboration partners, the new indication, dosage form, or formulation that is the subject of the Supplemental New Drug Application. If ▇▇▇▇▇▇ markets such new indication, dosage form, or formulation in the Territory during the Collaboration Period, the parties further agree to examine in good faith an appropriate methodology, if necessary, to distinguish sales of the new indication, dosage form, or formulation from "Net Sales" of the Product so that neither party is prejudiced hereunder by the sale of such new indication, dosage form, or formulation in the Te...
Additional Clinical Studies. BMS will provide ASCENT from time to time with reasonable quantities, as determined by ASCENT in its sole discretion, of samples of the Product to be used in making detail calls to Pediatricians in the Territory. Product samples will in all cases be shipped to ASCENT on not less than thirty (30) days' advance written notice and subject to the same shipping schedules as that under which BMS distributes Product samples to its own sales representatives. Product samples will be shipped to an ASCENT central distribution point from which ASCENT will further distribute them to its sales representatives. All costs