Patent Certifications. (a) To the extent required or permitted by Applicable Laws, [* * *] shall use its Commercially Reasonable Efforts to maintain with the applicable Regulatory Authorities in the Territory during the Term of this Agreement correct and complete listings of applicable Patents covering the Product, including in the U.S., all so called “Orange Book” listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ Act. In the event either Party receives notice that a Third Party has filed a patent certification under the ▇▇▇▇▇-▇▇▇▇▇▇ Act or any successor statute (e.g., a Paragraph IV Certification under 21 C.F.R. §314.50(i) or 314.94(a)(12)) referencing a Patent licensed under Section 3.1, then such Party shall immediately notify the other Party in writing of such notice. (b) Alpharma shall have the first right, but not the duty, upon written notice to Durect to institute an action against such Third Party alleging infringement of any Product Patent Rights, and to the extent necessary, Durect shall assign to Alpharma its cause of action for infringement of any Product Patent Rights against such Third Party. Alpharma shall consider in good faith all comments provided by Durect within the [* * *] period following Durect’s receipt of such notice from Alpharma regarding Alpharma’s intention to initiate an action against such Third Party alleging infringement of any Product Patent Rights; provided that, subject to terms of Section 9.3(d), Alpharma shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action. If Alpharma determines not to institute an action against such Third Party alleging infringement of any Product Patent Rights, Alpharma shall so notify Durect at least [* * *] before the expiration of the period Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. within which a patent holder may bring an action for infringement against such Third Party. Durect shall then have the right, but not the duty, to institute such an action against such Third Party alleging infringement of any Product Patent Rights. (c) As between Durect and Alpharma, Durect shall have the first right, but not the duty, upon written notice to Alpharma to institute an action against a Third Party for infringement of the [* * *] in response to such Third Party’s filing of a Paragraph IV certification referencing such Patent rights. Durect shall consider in good faith all comments provided by Alpharma within the [* * *] period following Alpharma’s receipt of such notice from Durect regarding Durect’s intention to initiate an action against such Third Party alleging infringement of the [* * *]; provided that, subject to terms of Section 9.3(d), Durect shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action. If Durect determines not to institute an action against such Third Party alleging infringement of the [* * *], Durect shall so notify Alpharma at least [* * *] before the expiration of the period within which a patent holder may bring an action for infringement against such Third Party. Alpharma shall then have the right, but not the duty, to institute such an action against such Third Party alleging infringement of the [* * *]; provided, however, that Alpharma’s right to undertake any such action alleging infringement of the [* * *] shall be subject to the prior written consent of Durect, not to be unreasonably withheld, and also the applicable terms of any agreements relating to the [* * *] entered into by Durect prior to the Effective Date, and with respect any actions alleging infringement of the [* * *], subject to the applicable terms of the [* * *] Agreement. (d) The Costs of any such action under this Section 9.3 (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action, such Costs shall be borne by the Parties in such proportions as they may agree in writing. For any such action to terminate any such infringement, in the event that either Party is unable to initiate or prosecute such action solely in its own name or it is otherwise advisable to obtain an effective remedy, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the enforcing Party to initiate and maintain such action. Each Party shall at its own expense promptly give to the Party bringing such infringement Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. proceedings such reasonable assistance as the Party bringing the action may reasonably request. The Party instituting any such action may not enter into any settlement, consent judgment or other voluntary final disposition of such action that admits the invalidity or unenforceability of any Patent licensed hereunder, subjects the other Party to an injunction or requires the other Party to make any monetary payment without the prior written consent of the other Party, not to be unreasonably withheld by the other Party. The Party undertaking any proceedings shall keep the other reasonably informed of the progress of the action and shall consider the comments and observations of the other in prosecuting the proceedings. Any award paid by a Third Party as a result of such an infringement action (whether by way of settlement or otherwise) shall be allocated in the same manner as provided in Section 9.4.
Appears in 1 contract
Patent Certifications. (a) To Each Party will immediately give written notice to the extent required other of any certification of which it becomes aware that has been filed pursuant to 21 U.S.C. § 355(b)(2)(A)(iv), or permitted by Applicable Laws, [* * *] shall use its Commercially Reasonable Efforts to maintain with § 355(j)(2)(A)(vii)(IV) (or any amendment or successor statute thereto or Canadian equivalent statute) claiming that the applicable Regulatory Authorities in the Territory during the Term of this Agreement correct and complete listings of applicable BIAL Patents covering the Licensed Product are invalid, unenforceable, and/or that infringement will not arise from the manufacture, use, sale or offer for sale, of such Third Party product by a Third Party. If BIAL decides not to bring infringement proceedings against the Third Party making such a certification with respect to any Licensed Product, including BIAL will give notice to SEPRACOR of its decision not to bring suit within [**] after receipt of notice of such certification (or, if the time period permitted by law is less than [**], within half of the time period permitted by law for SEPRACOR to commence such action). SEPRACOR may then, but is not required to, bring suit against the Third Party that filed the certification. Any suit by either Party may be in the U.S.name of either or both Parties, all so called “Orange Book” listings as may be required under by law. For this purpose, the ▇▇▇▇▇-▇▇▇▇▇▇ Act. In Party not bringing suit will execute such legal papers necessary for the event either Party receives notice that a Third Party has filed a patent certification under the ▇▇▇▇▇-▇▇▇▇▇▇ Act or any successor statute (e.g., a Paragraph IV Certification under 21 C.F.R. §314.50(i) or 314.94(a)(12)) referencing a Patent licensed under Section 3.1, then prosecution of such Party shall immediately notify suit and will provide assistance at the other Party's expense as may be reasonably requested by the Party in writing of such noticebringing suit.
(b) Alpharma shall have If BIAL commences infringement proceedings against the first right, but not the duty, upon written notice to Durect to institute an action against such Third Party alleging infringement of any Product Patent Rights, and to the extent necessary, Durect shall assign to Alpharma its cause of action for infringement of any Product Patent Rights against such Third Party, [**], even if BIAL names SEPRACOR as a co-plaintiff or otherwise brings SEPRACOR into the lawsuit. Alpharma shall consider in good faith all comments provided by Durect within BIAL will seek the [* * *] period following Durect’s receipt advice of such notice from Alpharma and consult with SEPRACOR regarding Alpharma’s intention to initiate an action against such Third Party alleging infringement of any Product Patent Rights; provided that, subject to terms of Section 9.3(d), Alpharma shall have the sole discretion strategy and authority to exercise its first right to institute such a patent infringement action. If Alpharma determines not to institute an action against such Third Party alleging infringement of any Product Patent Rights, Alpharma shall so notify Durect at least [* * *] before the expiration prosecution of the period Confidential treatment has been requested for portions lawsuit. BIAL will seek SEPRACOR's approval of this exhibitcounsel selected to prosecute the lawsuit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * [*. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. within which a patent holder may bring an action for infringement against such Third Party. Durect shall then have the right, but not the duty, to institute such an action against such Third Party alleging infringement of any Product Patent Rights*].
(c) As between Durect and Alpharma, Durect shall have If SEPRACOR commences infringement proceedings against the first right, but not the duty, upon written notice to Alpharma to institute an action against a Third Party for infringement of the [* * *] in response to such Third Party’s filing of a Paragraph IV certification referencing such Patent rights. Durect shall consider in good faith all comments provided by Alpharma within the , [* * *] period following Alpharma’s receipt of such notice from Durect regarding Durect’s intention to initiate an action against such Third Party alleging infringement of the [* * *]; provided that, subject to terms of Section 9.3(d), Durect shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action. If Durect determines not to institute an action against such Third Party alleging infringement of the [* * *], Durect shall so notify Alpharma at least [* * *] before even if SEPRACOR names BIAL as a co-plaintiff or otherwise brings BIAL into the expiration lawsuit. SEPRACOR will seek the advice of and consult with BIAL regarding the strategy and prosecution of the period within which a patent holder may bring an action for infringement against such Third Partylawsuit. Alpharma shall then have SEPRACOR will seek BIAL's approval of counsel selected to prosecute the right, but not the duty, to institute such an action against such Third Party alleging infringement of the lawsuit. [* * **]; provided, however, that Alpharma’s right to undertake any such action alleging infringement of the [* * *] shall be subject to the prior written consent of Durect, not to be unreasonably withheld, and also the applicable terms of any agreements relating to the [* * *] entered into by Durect prior to the Effective Date, and with respect any actions alleging infringement of the [* * *], subject to the applicable terms of the [* * *] Agreement.
(d) The Costs of any such action under this Section 9.3 (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action, such Costs shall be borne by the Parties in such proportions as they may agree in writing. For any such action to terminate any such infringement, in the event that either Party is unable to initiate or prosecute such action solely in its own name or it is otherwise advisable to obtain an effective remedy, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the enforcing Party to initiate and maintain such action. Each Party shall at its own expense promptly give to the Party bringing such infringement Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. proceedings such reasonable assistance as the Party bringing the action may reasonably request. The Party instituting any such action may not enter into any settlement, consent judgment or other voluntary final disposition of such action that admits the invalidity or unenforceability of any Patent licensed hereunder, subjects the other Party to an injunction or requires the other Party to make any monetary payment without the prior written consent of the other Party, not to be unreasonably withheld by the other Party. The Party undertaking any proceedings shall keep the other reasonably informed of the progress of the action and shall consider the comments and observations of the other in prosecuting the proceedings. Any award paid by a Third Party as a result of such an infringement action (whether by way of settlement or otherwise) shall be allocated in the same manner as provided in Section 9.4.
Appears in 1 contract
Patent Certifications. (a) To the extent required or permitted by Applicable Lawslaw, [* * *] Endo shall use its Commercially Reasonable Efforts to maintain with the applicable Regulatory Authorities regulatory authorities in the Licensed Territory during the Term term of this *** Material has been omitted pursuant to a request for confidential treatment and such material has been filed separately with the SEC. Agreement correct and complete listings of applicable Patents covering patents relating to the Product, including in the U.S., all so called “Orange Book” listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ Act. .
(b) In the event either Party receives notice that a Third Party has filed a patent paragraph IV certification under relating to the ▇▇▇▇▇-▇▇▇▇▇▇ Product pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV) of the Hatch/Waxman Act (or any successor statute (e.g.statute), a Paragraph IV Certification under 21 C.F.R. §314.50(i) or 314.94(a)(12)) referencing a Patent licensed under Section 3.1, then such Party shall immediately notify the other Party in writing of such notice.
(b) Alpharma . Endo shall have the first right, but not the duty, upon written notice to Durect to institute an a patent infringement action against such Third Party alleging infringement of any Product Patent Rights, and to the extent necessary, Durect shall assign to Alpharma its cause of action for infringement of any Product Patent Rights against such Third Party. Alpharma In such instance, Endo may, if necessary, institute such an action in Durect’s name. Endo shall consider in good faith all comments provided by Durect within the [* * ***] day period following Durect’s receipt of such notice from Alpharma regarding Alpharma’s intention to initiate an action against such Third Party alleging infringement of any Product Patent RightsEndo; provided that, subject to terms of Section 9.3(d), Alpharma that Endo shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action; however, Endo may not enter into any settlement, consent judgment or other voluntary final disposition of such action that adversely affects any Durect Patent without the prior written consent of Durect. If Alpharma Endo determines not to institute an action infringement proceeding against such Third Party alleging infringement of any Product Patent RightsParty, Alpharma Endo shall so notify Durect at least [* * ***] before the expiration of the period Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. within which a patent holder may bring an action for infringement against such Third Party. Durect shall then have the right, but not the duty, to institute such an action against such Third Party alleging infringement of any Product Patent Rights.
(c) As between Durect and Alpharma, Durect shall have the first right, but not the duty, upon written notice to Alpharma to institute an action against a Third Party for infringement of the [* * *] in response to such Third Party’s filing of a Paragraph IV certification referencing such Patent rights. Durect shall consider in good faith all comments provided by Alpharma within the [* * *] period following Alpharma’s receipt of such notice from Durect regarding Durect’s intention to initiate an action against such Third Party alleging infringement of the [* * *]; provided that, subject to terms of Section 9.3(d), Durect shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action. If Durect determines not to institute an action against such Third Party alleging infringement of the [* * *], Durect shall so notify Alpharma at least [* * *] days before the expiration of the period within which a patent holder may bring an action for infringement against such Third Party, and give Durect a reasonable period of time to take action with respect to Durect’s right set forth in the following sentence. Alpharma Durect shall then have the right, but not the duty, to institute such an infringement action against such Third Party alleging Party, and to the extent necessary, Endo shall assign to Durect its cause of action for infringement of the [* * *]any Endo Patent against such Third Party; providedprovided that Durect may not enter into any settlement, however, that Alpharma’s right to undertake any consent judgment or other voluntary final disposition of such action alleging infringement of the [* * *] shall be subject to that adversely affects any Endo Patent without the prior written consent of Durect, not to be unreasonably withheld, Endo. The costs and also the applicable terms of any agreements relating to the [* * *] entered into by Durect prior to the Effective Date, and with respect any actions alleging infringement of the [* * *], subject to the applicable terms of the [* * *] Agreement.
(d) The Costs expenses of any such action under this Section 9.3 (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action, such Costs costs and expenses shall be borne by the Parties in such proportions as they may agree in writing. For any Each Party shall execute all necessary and proper documents, take such action actions as shall be appropriate to terminate any such infringement, in the event that either Party is unable to initiate or prosecute such action solely in its own name or it is otherwise advisable to obtain an effective remedy, allow the other Party will join to institute and prosecute such infringement action voluntarily and will execute shall otherwise cooperate in the institution and cause its Affiliates to execute all documents necessary for the enforcing Party to initiate and maintain prosecution of such action. Each Party shall at its own expense promptly give to the Party bringing prosecuting any such infringement Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. proceedings such reasonable assistance as the Party bringing the action may reasonably request. The Party instituting any such action may not enter into any settlement, consent judgment or other voluntary final disposition of such action that admits the invalidity or unenforceability of any Patent licensed hereunder, subjects the other Party to an injunction or requires the other Party to make any monetary payment without the prior written consent of the other Party, not to be unreasonably withheld by the other Party. The Party undertaking any proceedings shall keep the other Party reasonably informed as to the status of the progress of the action and shall consider the comments and observations of the other in prosecuting the proceedingssuch action. Any award paid by a Third Party as a result of such an infringement action (whether by way of settlement or otherwise) shall be allocated in the same manner as provided in Section 9.48.6(g).
Appears in 1 contract
Sources: License Agreement (Durect Corp)
Patent Certifications. (a) To Each Party will immediately give written notice to the extent required other of any certification of which it becomes aware that has been filed pursuant to 21 U.S.C. § 355(b)(2)(A)(iv), or permitted by Applicable Laws§ 355(j)(2)(A)(vii)(IV) (or any amendment or successor statute thereto or Canadian equivalent statute) claiming that the BIAL Patents, [* * *] shall use its Commercially Reasonable Efforts to maintain with the applicable Regulatory Authorities in the Territory during the Term of this Agreement correct and complete listings of applicable Joint Patents or NBIX Patents covering the ProductLicensed Product are invalid, including in unenforceable, and/or that infringement will not arise from the U.S.manufacture, all so called “Orange Book” listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ Act. In the event either use, offer for sale or sale, of such Third Party receives notice that product by a Third Party has filed a patent certification under the ▇▇▇▇▇-▇▇▇▇▇▇ Act or any successor statute (e.g., a Paragraph IV Certification under 21 C.F.R. §314.50(i) or 314.94(a)(12)) referencing a Patent licensed under Section 3.1, then such Party shall immediately notify the other Party in writing of such notice.
(b) Alpharma Party. BIAL shall have the first right, but shall not be obligated, to bring suit against the dutyThird Party that filed the certification. If BIAL decides not to bring infringement proceedings against the Third Party making such a certification with respect to any BIAL Patent or Joint Patent and a Licensed Product, upon written BIAL will give notice to Durect NBIX of its decision not to institute an action against such Third Party alleging infringement of any Product Patent Rights, and to the extent necessary, Durect shall assign to Alpharma its cause of action for infringement of any Product Patent Rights against such Third Party. Alpharma shall consider in good faith all comments provided by Durect bring suit within the [* * …***…] period following Durect’s after receipt of notice of such notice from Alpharma regarding Alpharma’s intention to initiate an action against such Third Party alleging infringement of any Product Patent Rights; provided thatcertification (or, subject to terms of Section 9.3(d)if the time period permitted by law is less than […***…], Alpharma shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action. If Alpharma determines not to institute an action against such Third Party alleging infringement of any Product Patent Rights, Alpharma shall so notify Durect at least [* * *] before the expiration within half of the time period Confidential treatment has been requested permitted by law for portions of this exhibitNBIX to commence such action). The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. within which a patent holder may bring an action for infringement against such Third Party. Durect NBIX shall then have the right, but shall not the dutybe obligated, to institute such an action bring suit against such the Third Party alleging that filed the certification. Any suit by either Party may be in the name of either or both Parties, as may be required by law. For this purpose, the Party not bringing suit will execute such legal papers necessary for the prosecution of such suit and will provide assistance at the other Party’s expense as may be reasonably requested by the Party bringing suit, including joining such action as a party. In any event, the Party bringing the suit shall (i) seek approval of the law firm selected to litigate such action from the other Party (such approval not to be unreasonably withheld or delayed) and (ii) provide regular updates from its counsel on the status of such action to the other Party. In addition, the Party not bringing suit has the right to be present, but not to actively participate, for all depositions, settlement negotiations, and other significant meetings or hearings.
(b) If BIAL commences infringement proceedings against the Third Party, BIAL will be solely responsible for the expenses and costs of any Product Patent Rightsprosecuting that lawsuit, even if BIAL names NBIX as a co-plaintiff or otherwise brings NBIX into the lawsuit. BIAL will seek the advice of and consult with NBIX regarding the strategy and prosecution of the lawsuit. In no event will BIAL dismiss or otherwise resolve such lawsuit without the participation of and express written consent of NBIX, which shall not be unreasonably withheld, conditioned or delayed.
(c) As between Durect If NBIX commences infringement proceedings against the Third Party, NBIX will be solely responsible for the expenses and Alpharmacosts of prosecuting that lawsuit, Durect shall have even if NBIX names BIAL as a co-plaintiff or otherwise brings BIAL into the first right, but not lawsuit. NBIX will seek the duty, upon written notice to Alpharma to institute an action against a Third Party for infringement advice of and consult with BIAL regarding the strategy and prosecution of the [lawsuit. In no event will NBIX dismiss or *** * *] in response to Confidential Treatment Requested otherwise resolve such Third Party’s filing lawsuit without the participation of a Paragraph IV certification referencing such Patent rights. Durect shall consider in good faith all comments provided by Alpharma within the [* * *] period following Alpharma’s receipt of such notice from Durect regarding Durect’s intention to initiate an action against such Third Party alleging infringement of the [* * *]; provided that, subject to terms of Section 9.3(d), Durect shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action. If Durect determines not to institute an action against such Third Party alleging infringement of the [* * *], Durect shall so notify Alpharma at least [* * *] before the expiration of the period within which a patent holder may bring an action for infringement against such Third Party. Alpharma shall then have the right, but not the duty, to institute such an action against such Third Party alleging infringement of the [* * *]; provided, however, that Alpharma’s right to undertake any such action alleging infringement of the [* * *] shall be subject to the prior express written consent of DurectBIAL, which shall not to be unreasonably withheld, and also the applicable terms of any agreements relating to the [* * *] entered into by Durect prior to the Effective Date, and with respect any actions alleging infringement of the [* * *], subject to the applicable terms of the [* * *] Agreementconditioned or delayed.
(d) The Costs of any such action under this Section 9.3 (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action, such Costs shall be borne by the Parties in such proportions as they may agree in writing. For any such action to terminate any such infringement, in the event that either Party is unable to initiate or prosecute such action solely in its own name or it is otherwise advisable to obtain an effective remedy, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the enforcing Party to initiate and maintain such action. Each Party shall at its own expense promptly give to the Party bringing such infringement Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. proceedings such reasonable assistance as the Party bringing the action may reasonably request. The Party instituting any such action may not enter into any settlement, consent judgment or other voluntary final disposition of such action that admits the invalidity or unenforceability of any Patent licensed hereunder, subjects the other Party to an injunction or requires the other Party to make any monetary payment without the prior written consent of the other Party, not to be unreasonably withheld by the other Party. The Party undertaking any proceedings shall keep the other reasonably informed of the progress of the action and shall consider the comments and observations of the other in prosecuting the proceedings. Any award paid by a Third Party as a result of such an infringement action (whether by way of settlement or otherwise) shall be allocated in the same manner as provided in Section 9.4.
Appears in 1 contract
Patent Certifications. (a) To the extent required or permitted by Applicable Laws, [* * **] shall use its Commercially Reasonable Efforts to maintain with the applicable Regulatory Authorities in the Territory during the Term of this Agreement correct and complete listings of applicable Patents covering the Product, including in the U.S., all so called “Orange Book” listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ Act. In the event either Party receives notice that a Third Party has filed a patent certification under the ▇▇▇▇▇-▇▇▇▇▇▇ Act or any successor statute (e.g., a Paragraph IV Certification under 21 C.F.R. §314.50(i) or 314.94(a)(12)) referencing a Patent licensed under Section 3.1, then such Party shall immediately notify the other Party in writing of such notice.
(b) Alpharma shall have the first right, but not the duty, upon written notice to Durect to institute an action against such Third Party alleging infringement of any Product Patent Rights, and to the extent necessary, Durect shall assign to Alpharma its cause of action for infringement of any Product Patent Rights against such Third Party. Alpharma shall consider in good faith all comments provided by Durect within the [* * **] period following Durect’s receipt of such notice from Alpharma regarding Alpharma’s intention to initiate an action against such Third Party alleging infringement of any Product Patent Rights; provided that, subject to terms of Section 9.3(d), Alpharma shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action. If Alpharma determines not to institute an action against such Third Party alleging infringement of any Product Patent Rights, Alpharma shall so notify Durect at least [* * **] before the expiration of the period Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. within which a patent holder may bring an action for infringement against such Third Party. Durect shall then have the right, but not the duty, to institute such an action against such Third Party alleging infringement of any Product Patent Rights.
(c) As between Durect and Alpharma, Durect shall have the first right, but not the duty, upon written notice to Alpharma to institute an action against a Third Party for infringement of the [* * **] in response to such Third Party’s filing of a Paragraph IV certification referencing such Patent rights. Durect shall consider in good faith all comments provided by Alpharma within the [* * **] period following Alpharma’s receipt of such notice from Durect regarding Durect’s intention to initiate an action against such Third Party alleging infringement of the [* * **]; provided that, subject to terms of Section 9.3(d), Durect shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action. If Durect determines not to institute an action against such Third Party alleging infringement of the [* * **], Durect shall so notify Alpharma at least [* * **] before the expiration of the period within which a patent holder may bring an action for infringement against such Third Party. Alpharma shall then have the right, but not the duty, to institute such an action against such Third Party alleging infringement of the [* * **]; provided, however, that Alpharma’s right to undertake any such action alleging infringement of the [* * **] shall be subject to the prior written consent of Durect, not to be unreasonably withheld, and also the applicable terms of any agreements relating to the [* * **] entered into by Durect prior to the Effective Date, and with respect any actions alleging infringement of the [* * **], subject to the applicable terms of the [* * **] Agreement.
(d) The Costs of any such action under this Section 9.3 (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action, such Costs shall be borne by the Parties in such proportions as they may agree in writing. For any such action to terminate any such infringement, in the event that either Party is unable to initiate or prosecute such action solely in its own name or it is otherwise advisable to obtain an effective remedy, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the enforcing Party to initiate and maintain such action. Each Party shall at its own expense promptly give to the Party bringing such infringement Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. proceedings such reasonable assistance as the Party bringing the action may reasonably request. The Party instituting any such action may not enter into any settlement, consent judgment or other voluntary final disposition of such action that admits the invalidity or unenforceability of any Patent licensed hereunder, subjects the other Party to an injunction or requires the other Party to make any monetary payment without the prior written consent of the other Party, not to be unreasonably withheld by the other Party. The Party undertaking any proceedings shall keep the other reasonably informed of the progress of the action and shall consider the comments and observations of the other in prosecuting the proceedings. Any award paid by a Third Party as a result of such an infringement action (whether by way of settlement or otherwise) shall be allocated in the same manner as provided in Section 9.4.
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Patent Certifications. (a) To Each Party will immediately give written notice to the extent required other of any certification of which it becomes aware that has been filed pursuant to 21 U.S.C. § 355(b)(2)(A)(iv), or permitted by Applicable Laws§ 355(j)(2)(A)(vii)(IV) (or any amendment or successor statute thereto or Canadian equivalent statute) claiming that the BIAL Patents, [* * *] shall use its Commercially Reasonable Efforts to maintain with the applicable Regulatory Authorities in the Territory during the Term of this Agreement correct and complete listings of applicable Joint Patents or NBIX Patents covering the ProductLicensed Product are invalid, including in unenforceable, and/or that infringement will not arise from the U.S.manufacture, all so called “Orange Book” listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ Act. In the event either use, offer for sale or sale, of such Third Party receives notice that product by a Third Party has filed a patent certification under the ▇▇▇▇▇-▇▇▇▇▇▇ Act or any successor statute (e.g., a Paragraph IV Certification under 21 C.F.R. §314.50(i) or 314.94(a)(12)) referencing a Patent licensed under Section 3.1, then such Party shall immediately notify the other Party in writing of such notice.
(b) Alpharma Party. BIAL shall have the first right, but shall not be obligated, to bring suit against the dutyThird Party that filed the certification. If BIAL decides not to bring infringement proceedings against the Third Party making such a certification with respect to any BIAL Patent or Joint Patent and a Licensed Product, upon written BIAL will give notice to Durect NBIX of its decision not to institute an action against such Third Party alleging infringement of any Product Patent Rights, and to the extent necessary, Durect shall assign to Alpharma its cause of action for infringement of any Product Patent Rights against such Third Party. Alpharma shall consider in good faith all comments provided by Durect bring suit within the [* * …***…] period following Durect’s after receipt of notice of such notice from Alpharma regarding Alpharma’s intention to initiate an action against such Third Party alleging infringement of any Product Patent Rights; provided thatcertification (or, subject to terms of Section 9.3(d)if the time period permitted by law is less than […***…], Alpharma shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action. If Alpharma determines not to institute an action against such Third Party alleging infringement of any Product Patent Rights, Alpharma shall so notify Durect at least [* * *] before the expiration within half of the time period Confidential treatment has been requested permitted by law for portions of this exhibitNBIX to commence such action). The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. within which a patent holder may bring an action for infringement against such Third Party. Durect NBIX shall then have the right, but shall not the dutybe obligated, to institute such an action bring suit against such the Third Party alleging that filed the certification. Any suit by either Party may be in the name of either or both Parties, as may be required by law. For this purpose, the Party not bringing suit will execute such legal papers necessary for the prosecution of such suit and will provide assistance at the other Party’s expense as may be reasonably requested by the Party bringing suit, including joining such action as a party. In any event, the Party bringing the suit shall (i) seek approval of the law firm selected to litigate such action from the other Party (such approval not to be unreasonably withheld or delayed) and (ii) provide regular updates from its counsel on the status of such action to the other Party. In addition, the Party not bringing suit has the right to be present, but not to actively participate, for all depositions, settlement negotiations, and other significant meetings or hearings.
(b) If BIAL commences infringement proceedings against the Third Party, BIAL will be solely responsible for the expenses and costs of any Product Patent Rightsprosecuting that lawsuit, even if BIAL names NBIX as a co-plaintiff or otherwise brings NBIX into the lawsuit. BIAL will seek the advice of and consult with NBIX regarding the strategy and prosecution of the lawsuit. In no event will BIAL dismiss or otherwise resolve such lawsuit without the participation of and express written consent of NBIX, which shall not be unreasonably withheld, conditioned or delayed.
(c) As between Durect If NBIX commences infringement proceedings against the Third Party, NBIX will be solely responsible for the expenses and Alpharmacosts of prosecuting that lawsuit, Durect shall have even if NBIX names BIAL as a co-plaintiff or otherwise brings BIAL into the first right, but not lawsuit. NBIX will seek the duty, upon written notice to Alpharma to institute an action against a Third Party for infringement advice of and consult with BIAL regarding the strategy and prosecution of the [* * *] in response to lawsuit. In no event will NBIX dismiss or otherwise resolve such Third Party’s filing lawsuit without the participation of a Paragraph IV certification referencing such Patent rights. Durect shall consider in good faith all comments provided by Alpharma within the [* * *] period following Alpharma’s receipt of such notice from Durect regarding Durect’s intention to initiate an action against such Third Party alleging infringement of the [* * *]; provided that, subject to terms of Section 9.3(d), Durect shall have the sole discretion and authority to exercise its first right to institute such a patent infringement action. If Durect determines not to institute an action against such Third Party alleging infringement of the [* * *], Durect shall so notify Alpharma at least [* * *] before the expiration of the period within which a patent holder may bring an action for infringement against such Third Party. Alpharma shall then have the right, but not the duty, to institute such an action against such Third Party alleging infringement of the [* * *]; provided, however, that Alpharma’s right to undertake any such action alleging infringement of the [* * *] shall be subject to the prior express written consent of DurectBIAL, which shall not to be unreasonably withheld, and also the applicable terms of any agreements relating to the [* * *] entered into by Durect prior to the Effective Date, and with respect any actions alleging infringement of the [* * *], subject to the applicable terms of the [* * *] Agreementconditioned or delayed.
(d) The Costs of any such action under this Section 9.3 (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action, such Costs shall be borne by the Parties in such proportions as they may agree in writing. For any such action to terminate any such infringement, in the event that either Party is unable to initiate or prosecute such action solely in its own name or it is otherwise advisable to obtain an effective remedy, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the enforcing Party to initiate and maintain such action. Each Party shall at its own expense promptly give to the Party bringing such infringement Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. proceedings such reasonable assistance as the Party bringing the action may reasonably request. The Party instituting any such action may not enter into any settlement, consent judgment or other voluntary final disposition of such action that admits the invalidity or unenforceability of any Patent licensed hereunder, subjects the other Party to an injunction or requires the other Party to make any monetary payment without the prior written consent of the other Party, not to be unreasonably withheld by the other Party. The Party undertaking any proceedings shall keep the other reasonably informed of the progress of the action and shall consider the comments and observations of the other in prosecuting the proceedings. Any award paid by a Third Party as a result of such an infringement action (whether by way of settlement or otherwise) shall be allocated in the same manner as provided in Section 9.4.
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