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 EffectiveDate, are the subject of the Initial Product NDA ( as the label resulting from such Initial Product NDA may be expanded oramended based upon any clinical data resulting from the BLOOM - DM Trial or any clinical data specific to the Initial Productexisting as of the Effective Date ), shall constitute an Additional Product, if the Parties agree under Section 3.3 to develop suchInitial Formulation for such additional Indication(s )