definiens: means, with respect to the Licensed Territory, th e period of data exclusivity as provided under local Laws durin g which Third Parties do not have the right, in con nection with seeking or obtaining Marketing Approval of a pharma ceutical product that contains the same or substant ially similar active ingredient(s ) or the same active moi ety(ies ) as a Licensed Product, ( i ) to reference th e Licensed Product ’s clinical dossier without an express right of reference from the dossier holder, or ( ii ) to r ely on previous Regulatory Authority determinations of safety and e ffectiveness with respect to the Licensed Product t o support the submission, review or approval of a Drug Approv al Application or similar regulatory submission fil ed with the applicable Regulatory Authority for such pharma ceutical product, as well as any other exclusivity periods available under local Laws ( e.g. with respect to or phan drugs, new chemical entity exclusivity and ped iatric exclusivity ) during which Third Parties are prevent ed from filing or having accepted by Regulatory Aut horities a Drug Approval Application for, or obtaining Marketi ng Approval of, a pharmaceutical product that conta ins the same or substantially similar active ingredient(s ) or the same active moiety(ies ) as a Licensed Produc t in the Licensed Field in the Licensed Territory