Common use of Current Registration Status of Product; Acquisition by PRONOVA Clause in Contracts

Current Registration Status of Product; Acquisition by PRONOVA. PRONOVA hereby represents, warrants and covenants to RELIANT: (a) that the Registration for the Product has been filed in the name of, and is currently held by, Xxxxxx Laboratories or one of its subsidiaries or Affiliates (collectively, “Abbott”); (b) that the Registration for the Product being prosecuted by Abbott is the only Registration for the Product (regardless of indication) based on intellectual property rights owned, controlled or licensed by PRONOVA (and PRONOVA is not currently aware of any other Registrations in the Territory for the Product, any Additional Product or the API); (c) that PRONOVA has the unconditional (except for a fee payable by PRONOVA to Abbott), irrevocable and indefeasible right and option to acquire all right, title and interest to any and all Registrations for the Product from Abbott no later than the earlier to occur of (i) forty-five (45) days following FDA approval of the Registration for the Product for the HTG indication, or (ii) forty-five (45) days following June 30, 2005 in the event that the FDA has not approved the Registration for the Product by such date (it being acknowledged that the foregoing forty-five (45) day time periods include a thirty (30) day termination right plus an additional seven (7) to fourteen (14) day period during which Abbott shall assign, transfer and return to PRONOVA the actual Registration(s) and related data, information and correspondence); provided that the foregoing time periods set forth in this clause (c) do not include any delays resulting from any regulation or other requirement requiring approval or other action by the FDA in order that such transfer of a Registration be effective; (d) that PRONOVA has provided or caused to be provided, and will continue to provide or cause to be provided, to RELIANT a correct and complete copy of any and all Registration(s) for the Product, including, all data, clinical and CMC data, information and correspondence included in or related to the Registration or the file for application of the Registration for the Product (or, as applicable, the reasonable access thereto for RELIANT); (e) that, except for certain redacted portions, PRONOVA has provided to RELIANT a true, correct and complete copy of the Abbott Agreement (as defined in Section 15.1(d)), and such agreement is currently in full force and effect; (f) that PRONOVA shall not amend, waive or otherwise modify any provision of or rights or obligations under the Abbott Agreement without the prior written consent of RELIANT, which shall not be unreasonably withheld, delayed or conditioned; and (g) that PRONOVA shall fully pay, perform and discharge its obligations under the Abbott Agreement, when and as due, and shall fully enforce and protect its rights, benefits and privileges under the Abbott Agreement. PRONOVA shall acquire the Registration for the Product from Abbott and, subject to the terms of this Agreement, transfer unencumbered ownership to the Registration(s) (including, all data, clinical and CMC data, information and correspondence included in or related to the Registration(s) or the file for application of the Registration(s)) for the Product to RELIANT, without undue delay after the Actual Abbott Handover Date. In any event RELIANT must have received the Registration(s) for the Product no later than sixty (60) days following FDA approval of the Registration of the Product or September 15, 2005, whichever comes first (the “Abbott Outside Date”); provided that the Abbott Outside Date shall be postponed for any delays resulting from any regulation or other requirement requiring approval or other action by the FDA in order that such transfer of a Registration be effective. Prior to the date RELIANT receives the Registration, RELIANT shall have no obligations under this Section 3. In the event that PRONOVA shall not have transferred the Registration for the Product to RELIANT by the Abbott Outside Date, any and all amounts previously paid by RELIANT to PRONOVA shall be immediately refunded by PRONOVA to RELIANT.

Current Registration Status of Product; Acquisition by PRONOVA. PRONOVA hereby represents, warrants and covenants to RELIANT: (a) that the Registration for the Product has been filed in the name of, and is currently held by, Xxxxxx Laboratories or one of its subsidiaries or Affiliates (collectively, “AbbottXxxxxx”); (b) that the Registration for the Product being prosecuted by Abbott Xxxxxx is the only Registration for the Product (regardless of indication) based on intellectual property rights owned, controlled or licensed by PRONOVA (and PRONOVA is not currently aware of any other Registrations in the Territory for the Product, any Additional Product or the API); (c) that PRONOVA has the unconditional (except for a fee payable by PRONOVA to AbbottXxxxxx), irrevocable and indefeasible right and option to acquire all right, title and interest to any and all Registrations for the Product from Abbott Xxxxxx no later than the earlier to occur of (i) forty-five (45) days following FDA approval of the Registration for the Product for the HTG indication, or (ii) forty-five (45) days following June 30, 2005 in the event that the FDA has not approved the Registration for the Product by such date (it being acknowledged that the foregoing forty-five (45) day time periods include a thirty (30) day termination right plus an additional seven (7) to fourteen (14) day period during which Abbott Xxxxxx shall assign, transfer and return to PRONOVA the actual Registration(s) and related data, information and correspondence); provided that the foregoing time periods set forth in this clause (c) do not include any delays resulting from any regulation or other requirement requiring approval or other action by the FDA in order that such transfer of a Registration be effective; (d) that PRONOVA has provided or caused to be provided, and will continue to provide or cause to be provided, to RELIANT a correct and complete copy of any and all Registration(s) for the Product, including, all data, clinical and CMC data, information and correspondence included in or related to the Registration or the file for application of the Registration for the Product (or, as applicable, the reasonable access thereto for RELIANT); (e) that, except for certain redacted portions, PRONOVA has provided to RELIANT a true, correct and complete copy of the Abbott Xxxxxx Agreement (as defined in Section 15.1(d)), and such agreement is currently in full force and effect; (f) that PRONOVA shall not amend, waive or otherwise modify any provision of or rights or obligations under the Abbott Xxxxxx Agreement without the prior written consent of RELIANT, which shall not be unreasonably withheld, delayed or conditioned; and (g) that PRONOVA shall fully pay, perform and discharge its obligations under the Abbott Xxxxxx Agreement, when and as due, and shall fully enforce and protect its rights, benefits and privileges under the Abbott Xxxxxx Agreement. PRONOVA shall acquire the Registration for the Product from Abbott Xxxxxx and, subject to the terms of this Agreement, transfer unencumbered ownership to the Registration(s) (including, all data, clinical and CMC data, information and correspondence included in or related to the Registration(s) or the file for application of the Registration(s)) for the Product to RELIANT, without undue delay after the Actual Abbott Xxxxxx Handover Date. In any event RELIANT must have received the Registration(s) for the Product no later than sixty (60) days following FDA approval of the Registration of the Product or September 15, 2005, whichever comes first (the “Abbott Xxxxxx Outside Date”); provided that the Abbott Xxxxxx Outside Date shall be postponed for any delays resulting from any regulation or other requirement requiring approval or other action by the FDA in order that such transfer of a Registration be effective. Prior to the date RELIANT receives the Registration, RELIANT shall have no obligations under this Section 3. In the event that PRONOVA shall not have transferred the Registration for the Product to RELIANT by the Abbott Xxxxxx Outside Date, any and all amounts previously paid by RELIANT to PRONOVA shall be immediately refunded by PRONOVA to RELIANT.