definiens: means : ( a ) in the case where the Licensed Formulation that has beengranted MA Approval for an Indicated Disease is a fixed - dose combination, a proposed formulation of theCompound and sulindac as the active ingredients in a single fixed - dose combination wherein the dose ofthe Compound in the combination is [ * * * * * ] milligrams and the sulindac dose in the combination is [ * * * * * ] milligrams ( or whole multiples of both in the same proportion ) ; or ( b ) a pharmaceutical formulation in thetablet, capsule, granular or powder form of the Compound that, with respect to tablet or capsule forms, is inany dose less than [ * * * * * ] mg of the Compound or such form being a ½, a 1/3 or a whole number multiple ofthe dose of the Compound being used in a respective Licensed Product . For clarity, an oral liquid form ofthe Compound is not an Interchangeable Formulation