definiens: means with respect to a particular Product, a diagnostic product that ( a ) contains as active ingredient secretin ( orany derivative or variant or similar form of such agent ) ; ( b ) is approved for use in the United States pursuant to a regulatory approval process governingapproval of generic, interchangeable or biosimilar biologics based on the then - current standards for regulatory approval in the United States, whether ornot such regulatory approval was based in whole or part upon clinical data generated by either Innovate or Repligen pursuant to this Agreement or wasobtained using an abbreviated, expedited or other process ; and ( c ) is sold in the United States by any Third Party who has not obtained the right oraccess to such product ( through ( sub)license, subcontract or chain of distribution ) from Innovate or any of its Aﬃliates or licensees and did not purchasesuch product in a chain of distribution that included Innovate or any of its Affiliates or licensees . For clarity, [ * * * ] shall not constitute Generic Product