definiens: as that term is defined in 21 C.F.R. § 314.3(b ) ( or any successor rule or analogous law recognized outs ide of the U.S. ), with the right to grant further Rights of reference or use to its ( sub)lice nsees and Affiliates through multiple tiers to all such DMFs and MAFs owned or controlled by 3M. T he right granted in the previous sentence shall be for use with the Product, does no t include any rights except as relates to the Product, and is subject to the provisions of Sectio n 6.8 of this Agreement ; for avoidance of doubt, the right granted in the previous sentence s pecifically excludes any right in such DMFs or MAFs with respect to or for use with anything ot her than Product . Other than as provided above, 3 M specifically reserves all other rights in all DMFs and MAFs for all other purposes, including without limitation the for any product . 3 M will provide to RADIUS, its Affiliates or its ( sub)licensees and to any specified Regulatory Authority a letter of authorization, or other such executed ins trument as may be necessary under, or as RADIUS, its Affiliates or its ( sub)licensees may 18 [ * ] Certain information in this document has been omitted and filed separately with the Securities an d Exchange Commission . Confidential treatment has been requested with respect to the omitted portions