In Favor of Photocure Sample Clauses

In Favor of Photocure. Solely for purposes of filing XXXx and obtaining Regulatory Approvals for the Lumacan Products in the Photocure Territory, Salix hereby grants Photocure (i) rights to cross-reference, file or incorporate by reference, with the right to grant further rights of reference to sublicensees, any data or documentation used in support of regulatory filings for Lumacan Products by or on behalf Salix or its Sublicensees, including any technical documentation and other Regulatory Documentation, Clinical Data, Regulatory Approvals and Drug Master Files to the extent Controlled by Salix or its Sublicensees or otherwise prepared by or on behalf of Salix or its Sublicensees in accordance with Applicable Law, including Directive 93/42/EEC and Directive 2001/83/EC, as and to the extent necessary or useful to support any applications for Regulatory Approvals that Photocure or its licensees may make with respect to Lumacan Products in the Photocure Territory ; and (ii) a “right of reference or use” (as that term is defined in 21 C.F.R. §314.3(b), as amended from time to time), and any non-United States equivalents (including Article 10c of Directive 2001/83/EC, as amended), to any and all data contained or referenced in any Regulatory Approvals and other Regulatory Documentation relating to Lumacan Products, including all Clinical Data, reports, correspondence and conversation logs, to the extent Controlled by Salix, and Salix shall provide appropriate notification of the Photocure’s access and reference rights to the applicable Regulatory Authorities, including an informed consent letter under Article 10c of Directive 2001/83/EC as amended.
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