definiens: means one or more product(s ) that : ( i ) is not itse lf a Collaboration Product ; ( ii ) when combined with a Co llaboration Product, the market value of such combined product is materially higher than the market value for such Collaboration Product ( if sold separately ) as a result of such co mbined product containing or using such Product Component, ( iii ) is a specialized separate functional device, active ingredient, or delivery mechanism, and ( iv ) is covered by a Party ’ s or a Third Party ’s patent rights . For clarity, the term shall not inc lude excipients, buffers or other similar substances that are typically formulated with the d rug product contained in the Collaboration Product to form the final Collaboration Product for sale, nor standard, off - the - shelf components or delivery devices such as syringes, bu t may include specialized drug delivery devices, other active drug substances, or other pro prietary materials intended to deliver the drug contained in the Combination Product . For clar ity, a Combination Product is deemed a Collaboration Product in its entirety