definiens: means a pharmaceutical product ( in any specific dosage form or mode of administration ) thatcontains the Compound or a Related Compound as an active pharmaceutical agent and is added to the scope of thisAgreement by agreement of the Parties as provided in Section 3.3 for development for a particular Indication(s ) ( whichproduct may also include, if agreed, one or more other active pharmaceutical agents ) . For clarity, the Initial Formulation asindicated for any Indication other than the Indications that, as of the Amendment Effective Date, are the subject of the InitialProduct NDA ( as the label resulting from such Initial Product NDA may be expanded or amended based upon any clinical dataresulting from the BLOOM - DM Trial or any clinical data specific to the Initial Product existing as of the AmendmentEffective Date ), shall constitute an Additional Product, if the Parties agree under Section 3.3 to develop such InitialFormulation for such additional Indication(s )