definiens: means one or more product(s ) that ( i ) is not itself a Product ; ( ii ) when combined with a Product, the market value of such combined product is materially higher than the market value for such Product ( if sold separately ) as a result of such combined product containing or using such Product Component, and ( iii ) is a separate functional device or active ingredient . For clarity, the term shall not include excipients, buffers or other similar substances that are typically formulated with the drug product contained in the Product to form the final Product for sale, nor standard, off - the - shelf components or delivery devices such as syringes, but may include specialized drug delivery devices, other active drug substances, or other proprietary materials intended to deliver the drug contained in the Product . For clarity, a Combination Product is deemed a Product in its entirety ( except as provided in Section S.l(f ) ) . For the sake of clarity, any Royalty Adjustment pursuant to Section S.l(d ) that results in a reduction of the applicable royalty rate shall not apply to a Product Component