Warner-LeukoSite Product. For each Warner-LeukoSite Product, pre-clinical and clinical Development thereof will be pursued jointly under the direction of the Development Committee to the extent necessary or desirable for regulatory approval in each Designated Co-Promotion Country. The preparation, filing and prosecution of Investigational New Drug Applications, New Drug Applications and other regulatory filings required to be filed with the FDA and its foreign equivalents in regard to any Warner-LeukoSite Product will be in the name of and at the responsibility of Warner, subject, in the case of Designated Co-Promotion Countries, to the advice of LeukoSite. The costs incurred by Warner or LeukoSite (and approved by the Development Committee) in the preparation, filing and submission of such regulatory filings in Designated Co-Promotion Countries and all costs of Development related to regulatory approvals in such countries (not including the costs of Pharmacoeconomic Studies incurred after initiation of the Term of Co-Promotion, Phase IV Studies, Phase V Studies or any other clinical studies not reasonably necessary for authorization by relevant regulatory authorities to sell such Product for its first approved 20 20 indication in each country), will be borne 70% by Warner and 30% by LeukoSite (whether incurred by Warner or LeukoSite), retroactive to the date the Warner-LeukoSite Product was designated a Development Candidate. LeukoSite within its sole discretion at the time of designation of a Development Candidate as a Warner-LeukoSite Product may elect to pay less than thirty percent (30%) of such costs of Development but in no event less than twenty percent (20%) thereof. LeukoSite may not thereafter change the percentage of Development costs borne by it without Warner's consent. Neither party warrants that any regulatory filings will actually be filed or, if filed, will be approved. All such costs shall be paid/reimbursed on a current basis. Cost of Development shall mean the following insofar as they are reasonably charged directly to Development of the Product: salaries, fringe benefits, overtime, chemicals, lab supplies, animals and other direct charges, all at actual cost plus an overhead allocation of 25% (cost X 1.25). In addition, costs of Development will also include actual costs for travel (other than costs relating to committee meetings referred to in Section 2.5), experimental products (experimental product cost is the actual, direct cost of manufactured drug for c...
Warner-LeukoSite Product. For each Warner-LeukoSite Product, Development thereof will be, pursued under the direction of the Development Committee to the extent necessary or desirable for regulatory approval. The preparation, filing and prosecution of Investigational New Drug Applications, New Drug Applications and other regulatory filings required to be filed with the FDA and its foreign equivalents in regard to any Warner-LeukoSite Product will be in the name of and at the responsibility of Warner, subject to the advice of LeukoSite. The costs incurred by Warner (and approved by the Development Committee) in the preparation, filing and submission of such regulatory filings in the Territory and all Development Costs related to regulatory approvals in such countries (not including the costs of clinical studies not reasonably necessary for authorization by relevant regulatory authorities to sell such Warner-LeukoSite Product for its first approved indication in each country), will be borne *** by Warner and *** by LeukoSite, retroactive to the date the Warner-LeukoSite Product was
