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 specific studies intended to support the labeling concepts for such Licensed Product, and ( c ) forms the basis for a constructive dialogue with the FDA or EMA . The Target Product Profile sets forth the preferred version of what is requested to be claim ed in labeling for such Licensed Product which then guide the design, conduct, and analysis of Clinical Trials to maximize the efficiency of the Development of such Licensed Product . The TPP shall be determined on an Indication -by - Indication basis by the J DC . It is expected but not certain that the final version of the TPP would be similar in content to the annotated draft labeling submitted with a new drug application or biologics license application ; provided, however, that there shall be no consequences hereunder if the labeling meets at least the foregoing minimum acceptable labeling . The Parties acknowledge that the TPP attached hereto as part of the Exhibit 1.54 does not contain the ‘ minimum acceptable labeling ’ for the Licensed Product . The Parties sh all, no later than March 31, 2015, agree on and document the minimum acceptable labeling which shall then become a part of the TPP and shall be incorporated therein ; provided, however, that in developing such ‘ minimum acceptable labeling ’, Section 3.1.6.3 ( a ) shall not apply