Right to Reference. Each Party hereby has the right to cross reference, refer to, rely on, file, incorporate by reference, or otherwise use any regulatory submission or drug master file controlled by the other Party or its Affiliates (and any data contained therein) for the Combined Systems or any component thereof, made in any country in the Agreed Markets (including all Regulatory Approvals and, ***; provided, that (i) Tandem’s right to cross-reference, refer to, rely on, file, incorporate by reference or otherwise use shall be limited to doing so in order to support regulatory submissions that Tandem makes under this Agreement or any other Transaction Agreement for the Combined Systems in the Agreed Markets and to enable Tandem to fulfill its obligations, or exercise its rights, under this Agreement or any other Transaction Agreement to develop and/or to commercialize the Combined Systems in the Agreed Markets, including doing so in order to conduct, support or sponsor Clinical Studies utilizing such DexCom CGM-Enabled Tandem Display Device, and (ii) DexCom’s right to cross-reference, refer to, rely on, file, incorporate by reference or otherwise use shall be limited to doing so in order to support regulatory submissions that DexCom makes under this Agreement or any other Transaction Agreement for the DexCom System for use with the Combined Systems in the Agreed Markets. Each Party hereby agrees to promptly provide or have provided to the applicable Regulatory Authorities and/or the other Party or its designee a letter of consent to permit such referencing. In any case in which the Regulatory Authority for the applicable jurisdiction requires a Party to have copies of such filings in order to exercise its rights or perform its obligations hereunder, the other Party shall provide such copies to such requesting Party (provided that the requesting Party shall be responsible for any translation costs in connection therewith).
Appears in 1 contract
Samples: Commercialization Agreement (Tandem Diabetes Care Inc)
Right to Reference. Each Party hereby has the right to cross reference, refer to, rely on, file, incorporate by reference, or otherwise use any regulatory submission or drug master file controlled Controlled by the other Party or its Affiliates (and any data contained therein) for the Combined Systems System Implementations or any component thereof, made in any country in the Agreed Markets (including all Regulatory Approvals and, ***Approvals); provided, that (i) Tandem’s right to cross-reference, refer to, rely on, file, incorporate by reference or otherwise use shall be limited to doing so in order to support regulatory submissions that Tandem makes under this Agreement or any other Transaction Agreement for the Combined Systems System Implementations in the Agreed Markets and to enable Tandem to fulfill its obligations, or exercise its rights, under this Agreement or any other Transaction Agreement to develop and/or to commercialize the Combined Systems System Implementations in the Agreed Markets, including doing so in order to conduct, support or sponsor Clinical Studies utilizing such DexCom CGM-Enabled Tandem Display Device, and (ii) DexCom’s right to cross-reference, refer to, rely on, file, incorporate by reference or otherwise use shall be limited to doing so in order to support regulatory submissions that DexCom makes under this Agreement or any other Transaction Agreement for the DexCom System for use with the Combined Systems System Implementations in the Agreed Markets. Each Party hereby agrees to promptly provide or have provided to the applicable Regulatory Authorities and/or the other Party or its designee a letter of consent to permit such referencing. In any case in which the Regulatory Authority for the applicable jurisdiction requires a Party to have copies of such filings in order to exercise its rights or perform its obligations hereunder, the other Party shall provide such copies to such requesting Party (provided that the requesting Party shall be responsible for any translation costs in connection therewith).
Appears in 1 contract
Right to Reference. Each Party hereby has the right to cross reference, refer to, rely on, file, incorporate by reference, or otherwise use any regulatory submission or drug master file controlled Controlled by the other Party or its Affiliates (and any data contained therein) for the Combined Systems or any component thereof, made in any country in the Agreed Markets (including all Regulatory Approvals and, ***Approvals); provided, that (i) Tandem’s right to cross-reference, refer to, rely on, file, incorporate by reference or otherwise use shall be limited to doing so in order to support regulatory submissions that Tandem makes under this Agreement or any other Transaction Agreement for the Combined Systems in the Agreed Markets and to enable Tandem to fulfill its obligations, or exercise its rights, under this Agreement or any other Transaction Agreement to develop and/or to commercialize the Combined Systems in the Agreed Markets, including doing so in order to conduct, support or sponsor Clinical Studies utilizing such DexCom CGM-Enabled Tandem Display Device, and (ii) DexCom’s right to cross-reference, refer to, rely on, file, incorporate by reference or otherwise use shall be limited to doing so in order to support regulatory submissions that DexCom makes under this Agreement or any other Transaction Agreement for the DexCom System for use with the Combined Systems in the Agreed Markets. Each Party hereby agrees to promptly provide or have provided to the applicable Regulatory Authorities and/or the other Party or its designee a letter of consent to permit such referencing. In any case in which the Regulatory Authority for the applicable jurisdiction requires a Party to have copies of such filings in order to exercise its rights or perform its obligations hereunder, the other Party shall provide such copies to such requesting Party (provided that the requesting Party shall be responsible for any translation costs in connection therewith).
Appears in 1 contract
Samples: Commercialization Agreement (Tandem Diabetes Care Inc)
Right to Reference. Each Party hereby has the right to cross reference, refer to, rely on, file, incorporate by reference, or otherwise use any regulatory submission or drug master file controlled by the other Party or its Affiliates (and any data contained therein) for the Combined Systems System Implementations or any component thereof, made in any country in the Agreed Markets (including all Regulatory Approvals and, ***Approvals); provided, that (i) Tandem’s right to cross-reference, refer to, rely on, file, incorporate by reference or otherwise use shall be limited to doing so in order to support regulatory submissions that Tandem makes under this Agreement or any other Transaction Agreement for the Combined Systems System Implementations in the Agreed Markets and to enable Tandem to fulfill its obligations, or exercise its rights, under this Agreement or any other Transaction Agreement to develop and/or to commercialize the Combined Systems System Implementations in the Agreed Markets, including doing so in order to conduct, support or sponsor Clinical Studies utilizing such DexCom CGM-Enabled Tandem Display Device, and (ii) DexCom’s right to cross-reference, refer to, rely on, file, incorporate by reference or otherwise use shall be limited to doing so in order to support regulatory submissions that DexCom makes under this Agreement or any other Transaction Agreement for the DexCom System for use with the Combined Systems System Implementations in the Agreed Markets. Each Party hereby agrees to promptly provide or have provided to the applicable Regulatory Authorities and/or the other Party or its designee a letter of consent to permit such referencing. In any case in which the Regulatory Authority for the applicable jurisdiction requires a Party to have copies of such filings in order to exercise its rights or perform its obligations hereunder, the other Party shall provide such copies to such requesting Party (provided that the requesting Party shall be responsible for any translation costs in connection therewith).
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