definiens: means, with respect to a Licensed Product in a pa rticular country, any cell therapy product that : ( a ) ( i ) contains substan tially the same gene edits in the same cell type, i n each case, as such Licensed Product, and is approved by the Regul atory Authority in such country with the same or substantially the same labeling as such Licensed Pr oduct for at least one indication in the Therapeuti cs Field or ( ii ) is approved by the Regulatory Authority in suc h country or jurisdiction as a substitutable biosim ilar or bioequivalent for such Licensed Product for an indi cation in the Therapeutics Field or otherwise appro ved in a manner that relied on or incorporated data submitte d by Licensee, its Affiliates or Sublicensees, in c onnection with the regulatory filings for such Licensed Produ ct, including as a un der the Patient Protection and Affordable Care Act, as amen ded by the Health Care and Education Reconciliation Act of 2010, Title VII, Subtitle A Biologics Price Competi tion and Innovation Act of 2009, 42 U.S.C. 262, Sec tion 351 of the PHSA, or, outside the United States, in acco rdance with European Directive 2001/83 / EC on the Community Code for medicinal products ( Article 10(4 ) and Section 4, Part II of Annex I ) and European Regulation EEC/2309/93 establishing the Community p rocedures for the authorization and evaluation of medicinal products, each as amended, and together w ith all associated guidance, and any counterparts t hereof or equivalent process inside or outside of the United States or EU to the foregoing, or any similar 6 procedure provided for biosimilars or that may be a pplicable to gene therapy products in each case now or in the future ; and ( b ) is sold in such country or jurisdic tion by a third party that is not a Sublicensee or an Affiliate of Licensee or a Third Party Distributor of any of the m. Any product or component thereof ( including any Licensed Product or component thereof ) licensed, marketed, s old, manufactured or produced by Licensee or its Af filiates or Sublicensees will not constitute a Generic / Biosi milar Product