definiens: means any Licensed Product ( including a composition, fOlmuiatioll, devi¢(\ assay or other product, but excluding Microarrays ( as defined in Schedule V ofthe!PSMAIAgreement ) ) ( a ) for sale as an in vitro or ill vivo diagnostic for use in or in rdation toimmans, or ( b ) for sale separately from but in suppOtt of a therapeutic product for usc in or in relation to humans, 2, means any product, substance or fonnulation arising from the Target Program, and ( a ) the Development, manufacture, impoliation, use or sale of which would but for the provisions of this Agreement infringe one or morc Valid Claims under thc ~[edhnmun ~ Licenscd Patents, or ( b ) which uttlJ;7;es the .:1'redImmune- : Background Know - How . -3 . means the : United States of Americ;,i the [ Tnited Kingdol1l~7 -'Spairi ) and hpan, J -- ' - -- ' - '' -- ~,'-,, ~--4 . means the approval of an M.AA for a Licensed Product and any pricing and reimbursement approvals to the extent the applicable Regulatory Authorities in a country require a pricing or reimbursement approval prior to the marketing and sale of such Licensed Product in such country