In Favor of Salix. Solely for purposes of filing Registrational Filings and obtaining Regulatory Marketing Approvals for Products in the Territory, Progenics hereby grants Salix (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 Products by Progenics or its licensees or their sublicensees or its or their Affiliates, including any technical documentation, CMC documentation, and other Regulatory Documentation, Clinical Data, Regulatory Approvals, drug master files, and any other data or information necessary to the conduct of clinical trials or the submission or approval of any Registrational Filing, in each case to the extent Controlled by Progenics or its Affiliates or otherwise prepared by or on behalf of Progenics, 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 Development activities and any applications for Regulatory Approvals that Salix or its Sublicensees may make with respect to Products in the Field in the 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 Products, including all Clinical Data, reports, correspondence and conversation logs, in each case to the extent Controlled by Progenics or its Affiliates, and Progenics shall provide appropriate notification of Salix’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.
In Favor of Salix. Alfa shall indemnify, defend and hold harmless Salix, its Affiliates, and their respective officers, directors, employees and agents, from and against any and all Losses, in connection with any and all suits, actions, investigations, claims or demands of Third Parties arising from or occurring as a result of:
In Favor of Salix. Solely for purposes of filing XXXx and obtaining Regulatory Approvals for the Lumacan Products in the Salix Territory, Photocure hereby grants Salix (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 Photocure or its licensees or their sublicensees or its or their Affiliates, including any technical documentation, CMC documentation, and other Regulatory Documentation, Clinical Data, Regulatory Approvals, Drug Master Files (to the extent applicable), and any other data or information necessary to the conduct of clinical trials or the submission or approval of any MAA, in each case to the extent Controlled by Photocure or its Affiliates or otherwise prepared by or on behalf of Photocure, 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 Development activities and any applications for Regulatory Approvals that Salix or its Sublicensees may make with respect to Lumacan Products in the Salix 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, in each case to the extent Controlled by Photocure or its Affiliates, and Photocure shall provide appropriate notification of Salix’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.
In Favor of Salix. Except as otherwise provided in ARTICLE 7.1, Alfa shall defend, indemnify and hold Salix and its Affiliates and their respective officers, directors and employees harmless from and against any and all claims, demands, losses, damages, liabilities (including without limitation, Product liability), settlement amounts, costs or expenses whatsoever (including reasonable legal fees and court costs) arising from or relating to any claim, action or proceeding made or brought against such person by a Third Party as a result of Alfa’s negligence, willful misconduct or breach of this Agreement (including, without limitation, Alfa’s failure to comply with the Specifications, any breach by Alfa of the warranties contained in ARTICLE 6.1 or otherwise any breach of the provisions of this Agreement by Alfa).
In Favor of Salix. AWH shall indemnify, defend and hold harmless Salix, its Affiliates, and their respective officers, directors, employees and agents, from and against any and all costs, claims, damages and expenses (including but not limited to reasonable attorneys’ fees and other expenses of legal proceedings) (collectively, “Losses”), in connection with any and all suits, actions, investigations, claims or demands of Third Parties arising from or occurring as a result of:
In Favor of Salix. Solely for purposes of filing XXXx and obtaining and maintaining Regulatory Approvals for the Covered Products in the applicable Salix Territory, Cosmo hereby grants to Salix and its Affiliates rights to use, reference, file or incorporate by reference, with the right to grant further rights of reference to sublicensees in accordance with Section 2.4, any data or documentation used in support of regulatory filings for Covered Products by Cosmo, its Affiliates and sublicensees, including any technical documentation, CMC documentation, Regulatory Documentation, Clinical Data, Regulatory Approvals, Drug Master Files (to the extent applicable), and any other data or information necessary to the conduct of clinical trials or the submission or approval of any MAA, in each case to the extent Controlled by Cosmo or its Affiliates or otherwise prepared by or on behalf of Cosmo or its Affiliates or sublicensees, as and to the extent necessary or useful to support Development activities and any applications for Regulatory Approvals that Salix, its Affiliates or its sublicensees may make with respect to Covered Products in the applicable Salix Territory, and Cosmo shall provide appropriate notification of Salix’s access and reference rights to the applicable Regulatory Authorities.
