definiens: or means the written document with respect to a Licensed Product that:(a ) specifies the labeling concepts that are the ‘ base case ’ goals of the Development program, ( b ) documents the specificstudies intended to support the labeling concepts for such Licensed Product, and ( c ) forms the basis for a constructivedialogue with the FDA or EMA . The Target Product Profile sets forth the preferred version of what is requested to be claimedin labeling for such Licensed Product which then guide the design, conduct, and analysis of Clinical Trials to maximize theefficiency of the Development of such Licensed Product . The TPP shall be determined on an Indication - by - Indication basis bythe JDC . It is expected but not certain that the final version of the TPP would be similar in content to the annotated draftlabeling submitted with a new drug application or biologics license application ; provided, however, that there shall be noconsequences hereunder if the labeling meets at least the foregoing minimum acceptable labeling . The Parties acknowledgethat the TPP attached hereto as part of the Exhibit 1.54 does not contain the ‘ minimum acceptable labeling ’ for the LicensedProduct . The Parties shall, no later than March 31, 2015, agree on and document the minimum acceptable labeling which shallthen become a part of the TPP and shall be incorporated therein ; provided, however, that in developing such ‘ minimumacceptable labeling ’, Section 3.1.6.3(a ) shall not apply