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8.3.2. Enforcement of Cugene Patents Prior to the License Option Effective Date. The following provisions shall apply with respect to enforcement of the Cugene Patents prior to the License Option Effective Date: |
(a) Other Cugene Patents. Cugene shall have the sole right (except with respect to Mixed Cugene Patents, in which case Cugene shall have the first right), but not the obligation, to prosecute any Product Infringement with respect to Other Cugene Patents in the Territory, including as a defense or counterclaim in connec... |
If Cugene prosecutes any such Product Infringement, AbbVie shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense to the extent such claim, suit, or proceeding relates to Mixed Cugene Patents; provided that Cugene shall retain ... |
To the extent such claim, suit, or proceeding relates to Mixed Cugene Patents, Cugene shall: (a) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantive... |
If such Product Infringement relates to Mixed Cugene Patents and Cugene does not take commercially reasonable steps to prosecute such Product Infringement (i) within 90 days following the first notice provided above with respect to such Product Infringement, or (ii) provided such date occurs after the first such notice... |
(b) Product Patents. Cugene shall have the first right, but not the obligation, to prosecute any Product Infringement with respect to Product Patents in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and Cugene shall retain control of th... |
If Cugene prosecutes any such Product Infringement, AbbVie shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense; provided that Cugene shall retain control of the prosecution of such claim, suit, or proceeding. |
Cugene shall: (a) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantively comment thereon, (b) reasonably consider taking action to incorporate AbbVie... |
If Cugene does not take commercially reasonable steps to prosecute such Product Infringement (i) within 90 days following the first notice provided above with respect to such Product Infringement, or (ii) provided such date occurs after the first such notice of such Product Infringement is provided, ten Business Days b... |
8.3.3. Enforcement of Cugene Patents After the License Option Effective Date. The following provisions shall apply with respect to enforcement of the Cugene Patents on or after the License Option Effective Date: |
(a) Other Cugene Patents. Cugene shall have the sole right (except with respect to Mixed Cugene Patents, in which case Cugene shall have the first right), but not the obligation, to prosecute any Product Infringement with respect to Other Cugene Patents in the Territory, including as a defense or counterclaim in connec... |
If Cugene prosecutes any such Product Infringement, AbbVie shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense to the extent such claim, suit, or proceeding relates to Mixed Cugene Patents; provided that Cugene shall retain ... |
To the extent such claim, suit, or proceeding relates to Mixed Cugene Patents, Cugene shall: (a) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantive... |
If such Product Infringement relates to Mixed Cugene Patents and Cugene does not take commercially reasonable steps to prosecute such Product Infringement (i) within 90 days following the first notice provided above with respect to such Product Infringement, or (ii) provided such date occurs after the first such notice... |
(b) Product Patents. AbbVie shall have the first right, but not the obligation, to prosecute any Product Infringement with respect to Product Patents in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense (except as may be otherwise agreed to ... |
If AbbVie prosecutes any such Product Infringement, Cugene shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense; provided that AbbVie shall retain control of the prosecution of such claim, suit, or proceeding. |
AbbVie shall: (a) keep Cugene reasonably informed regarding material developments in such claim, suit, or proceeding and (b) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. |
If AbbVie does not take commercially reasonable steps to prosecute a Product Infringement (i) within 90 days following the first notice provided above with respect to the Product Infringement, or (ii) provided such date occurs after the first such notice of the Product Infringement is provided, ten Business Days before... |
8.3.4. Enforcement of Joint Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Joint Patents by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement based on the development, commercialization, o... |
After the License Option Effective Date, AbbVie shall have the first right, but not the obligation, to prosecute any such infringement in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and AbbVie shall retain control of the prosecution o... |
If AbbVie prosecutes any such infringement, Cugene shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense; provided that AbbVie shall retain control of the prosecution of such claim, suit, or proceeding. |
AbbVie shall: (a) keep Cugene reasonably informed regarding material developments in such claim, suit, or proceeding and (b) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. |
If AbbVie does not take commercially reasonable steps to prosecute the alleged or threatened infringement in the Territory with respect to such Joint Patents (a) within 90 days following the first notice provided above with respect to such alleged infringement, or (b) provided such date occurs after the first such noti... |
8.3.5. Enforcement of AbbVie Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the AbbVie Patents by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement based on the development, commercialization,... |
AbbVie shall have the sole right, but not the obligation, to prosecute any such infringement in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and AbbVie shall retain control of the prosecution of the applicable claim, suit or proceeding... |
8.3.6. Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 8.3. If a Party brings such an action, the other Party shall, if necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action. |
Unless otherwise set forth herein, the Party entitled to bring any patent infringement litigation in accordance with this Section 8.3 shall have the right to settle such claim; provided that neither Party shall have the right to settle any patent infringement litigation under this Section 8.3 in a manner that imposes a... |
The Party commencing the litigation shall provide the other Party with copies of all pleadings and other documents filed with the court and shall consider reasonable input from the other Party during the course of the proceedings. |
8.3.7. Patent Exclusivity Listings. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA (a "Biosimilar Application") naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as i... |
If either Party receives any equivalent or similar certification or notice in any other jurisdiction in the Territory, such Party shall, within ten Business Days, notify and provide the other Party with copies of such communication. |
Regardless of the Party that is the "reference product sponsor" for purposes of such Biosimilar Application, after the License Option Effective Date (a) AbbVie shall have the sole right to designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who shall receive confidential ... |
If required pursuant to Applicable Law, Cugene shall prepare such lists and make such responses at AbbVie's direction. Cugene shall (i) provide to AbbVie, within 15 days of AbbVie's request, all Information in Cugene's control that is necessary or reasonably useful to enable AbbVie to make such lists and communications... |
AbbVie shall (A) reasonably consult with Cugene prior to identifying any Cugene Patents to a Third Party as contemplated by this Section 8.3.7 and shall consider in good faith Cugene's advice and suggestions with respect thereto, and (B) notify Cugene of any such lists or communications promptly after they are made. |
8.3.8. Conduct of Patent Litigation Under the Biologics Price Competition and Innovation Act. Notwithstanding anything to the contrary in Section 8.3, AbbVie shall have the first right to bring an action for infringement of the AbbVie Patents and Joint Patents and, after the License Option Effective Date, Cugene Patent... |
The Parties' rights and obligations with respect to the foregoing legal actions shall be as set forth in Section 8.3.2 through Section 8.3.5; provided that within 15 days of reaching agreement on a list of Patents for litigation under Section 351(l)(4) or exchange of Patent lists pursuant to Section 351(l)(5)(B), AbbVi... |
Either Party shall, within ten Business Days, notify and provide the other Party with copies of any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to Section 351(l)(8)(A) of the PHSA, or any equivalent or similar certification or notice in any other jurisdiction. |
Thereafter, the Party controlling any Patent infringement litigation pursuant to this Section 8.3.8 shall have the first right to seek an injunction against such commercial marketing as permitted pursuant to Section 351(l)(8)(B) of the PHSA. If no such litigation is ongoing at the time of such notice, then AbbVie shall... |
8.3.9. Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement and except with respect to costs incurred by a Party that joins and participates in such litigation at its sole cost and expense as set forth in this Section 8.3, any recovery realized as a result of such litigation... |
Any remainder after such reimbursement is made shall be retained by the Party that has exercised its right to bring the enforcement action; provided that to the extent that any award or settlement (whether by judgment or otherwise) is attributable to loss of sales or profits with respect to a Licensed Product, the Part... |
8.4. Infringement Claims by Third Parties. |
8.4.1. If the manufacture, sale, or use of a Licensed Therapeutic or Licensed Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging patent infringement by AbbVie (or its Affiliates or Sublicensees) (a "Third Party Infringement Claim"),... |
8.4.2. Notwithstanding Section 11.3.2, following the License Option Effective Date, AbbVie shall have the first right, but not the obligation, to defend and control the defense and settlement of any Third Party Infringement Claim at its own expense (but subject to deduction as provided below), using counsel of its own ... |
Cugene may participate in any such Third Party Infringement Claim with counsel of its choice at its own expense. Without limitation of the foregoing, if AbbVie finds it necessary or desirable to join Cugene as a party to any such Third Party Infringement Claim, Cugene shall execute all papers and perform such acts as s... |
8.4.3. AbbVie shall keep Cugene reasonably informed of all material developments in connection with any Third Party Infringement Claim. AbbVie shall have the right to settle any Third Party Infringement Claim in its reasonable discretion; provided that AbbVie shall not have the right to settle any Third Party Infringem... |
If Cugene is named as a party in a Third Party Infringement Claim, (a) AbbVie agrees to provide Cugene with copies of all pleadings filed in the applicable action and to allow Cugene reasonable opportunity to participate in the defense of the Third Party Infringement Claim and (b) if AbbVie elects (in a written communi... |
8.4.4. AbbVie shall be entitled to deduct 50% of the out-of-pocket costs borne by AbbVie in defending or settling such Third Party Infringement Claim (including pursuant to any adverse judgment in connection therewith) from any royalties payable under Section 7.5.1 in accordance with and subject to the limitations set ... |
Any recoveries by a Party of any sanctions awarded to such Party and against a party asserting a claim being defended under this Section 8.4 shall be applied as follows: such recovery shall be applied first to (a) reimburse AbbVie for its out-of-pocket costs of defending such Third Party Infringement Claim to the exten... |
The balance of any such recoveries shall be retained by or provided to AbbVie and, to the extent that such recoveries are attributable to loss of sales or profits with respect to a Licensed Product, included in calculation of Net Sales for the relevant Licensed Product. |
8.5. Invalidity or Unenforceability Defenses or Actions. |
8.5.1. Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the Cugene Patents, AbbVie Patents, or Joint Patents by a Third Party, in each case in the Territory and of which such Party becomes aware. |
8.5.2. Defense of Cugene Patents Prior to the License Option Effective Date. The following provisions shall apply with respect to defense of the Cugene Patents prior to the License Option Effective Date: |
(a) Other Cugene Patents. Cugene shall have the sole right (except with respect to Mixed Cugene Patents, in which case Cugene shall have the first right), but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Other Cugene Patents at its own expense... |
AbbVie may participate in any claim, suit, or proceeding arising under this Section 8.5.2(a) in the Territory relating to Mixed Cugene Patents with counsel of its choice at its own expense; provided that Cugene shall retain control of the defense in such claim, suit, or proceeding. |
To the extent such claim, suit, or proceeding relates to Mixed Cugene Patents, Cugene shall: (i) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantive... |
If Cugene elects not to defend or control the defense of the Mixed Cugene Patents in a claim, suit, or proceeding arising under this Section 8.5.2(a) brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, and, in either case, has not settled and is not ... |
(b) Product Patents. Cugene shall have the first right, but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Product Patents at its own expense in the Territory; provided that, this Section 8.5.2(b) shall not apply to Defense Proceedings, which sh... |
AbbVie may participate in any claim, suit, or proceeding arising under this Section 8.5.2(b) in the Territory with counsel of its choice at its own expense; provided that Cugene shall retain control of the defense in such claim, suit, or proceeding. |
Cugene shall: (i) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantively comment thereon, (ii) reasonably consider taking action to incorporate AbbVi... |
If Cugene elects not to defend or control the defense of the Product Patents in a claim, suit, or proceeding arising under this Section 8.5.2(b) brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, and, in either case, has not settled and is not activ... |
8.5.3. Defense of Cugene Patents After the License Option Effective Date. The following provisions shall apply with respect to defense of the Cugene Patents on or after the License Option Effective Date: |
(a) Other Cugene Patents. Cugene shall have the sole right (except with respect to Mixed Cugene Patents, in which case Cugene shall have the first right), but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Other Cugene Patents at its own expense... |
AbbVie may participate in any claim, suit, or proceeding arising under this Section 8.5.3(a) in the Territory relating to Mixed Cugene Patents with counsel of its choice at its own expense; provided that Cugene shall retain control of the defense in such claim, suit, or proceeding. |
To the extent such claim, suit, or proceeding relates to Mixed Cugene Patents, Cugene shall: (i) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantive... |
If Cugene elects not to defend or control the defense of the Mixed Cugene Patents in a claim, suit, or proceeding arising under this Section 8.5.3(a) brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, and, in either case, has not settled and is not ... |
(b) Product Patents. AbbVie shall have the first right, but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Product Patents at its own expense in the Territory; provided that, this Section 8.5.3(b) shall not apply to Defense Proceedings, which sh... |
Cugene may participate in any claim, suit, or proceeding arising under this Section 8.5.3(b) in the Territory with counsel of its choice at its own expense; provided that AbbVie shall retain control of the defense in such claim, suit, or proceeding. |
AbbVie shall: (i) keep Cugene reasonably informed regarding material developments in such claim, suit, or proceeding and (ii) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. |
If AbbVie elects not to defend or control the defense of the Product Patents in a claim, suit, or proceeding arising under this Section 8.5.3(b) brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, and, in either case, has not settled and is not activ... |
8.5.4. Joint Patents. AbbVie shall have the first right, but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the Joint Patents at its own expense in the Territory; provided that this Section 8.5.4 shall not apply to Defense Proceedings, which shall b... |
Cugene may participate in any claim, suit, or proceeding arising under this Section 8.5.4 in the Territory with counsel of its choice at its own expense; provided that AbbVie shall retain control of the defense in such claim, suit, or proceeding. |
AbbVie shall: (a) keep Cugene reasonably informed regarding material developments in such claim, suit, or proceeding and (b) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. |
If AbbVie elects not to defend or control the defense of the Joint Patents in a claim, suit, or proceeding arising under this Section 8.5.4 brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, and, in either case, has not settled and is not actively p... |
8.5.5. AbbVie Patents. AbbVie shall have the sole right, but not the obligation, to defend and control any claim, suit, or proceeding regarding the validity and enforceability of the AbbVie Patents at its own expense in the Territory. |
8.5.6. Cooperation. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in this Section 8.5, including by being joined as a party plaintiff in the applicable claim, suit or proceeding described in Section 8.5... |
In connection with any such claim, suit or proceeding, the controlling Party shall consider in good faith any comments from the other Party and shall keep the other Party reasonably informed of any steps taken, and shall provide copies of all documents filed, in connection with such claim, suit or proceeding. |
In connection with the activities set forth in this Section 8.5, each Party shall consult with the other as to the strategy for the defense of the Cugene Patents and Joint Patents. Unless otherwise set forth herein, the Party entitled to control such claim, suit, or proceeding in accordance with this Section 8.5 shall ... |
For clarity, AbbVie shall no longer be required to assist Cugene and Cugene shall no longer be obligated to consult with AbbVie, in each case as contemplated by this Section 8.5.6, if the License Option expires without exercise by AbbVie, from and after the expiration of the License Option Period with respect to any Cu... |
8.6. Third Party Licenses and Patents. |
8.6.1. Cugene. If, prior to the License Option Effective Date, Cugene or any of its Affiliates enters into a license agreement with a Third Party, pursuant to which Cugene or its Affiliate in-licenses any Patent or Information that is necessary or reasonably useful to Exploit a Licensed Therapeutic or Licensed Product ... |
If, after the License Option Effective Date, Cugene becomes aware of any Third Party's Patent or Information that is necessary or reasonably useful to Exploit a Licensed Therapeutic or Licensed Product in the Field in the Territory, Cugene shall notify AbbVie. AbbVie shall lead and have the sole right, but not the obli... |
If Cugene breaches such obligation, then the applicable Patents or Information that are the subject of such license shall automatically be deemed Controlled by Cugene and Cugene shall be solely responsible for any payments arising under such license agreement as a result of the license grants to AbbVie pursuant to Sect... |
For clarity, Cugene or its Affiliates or collaborators shall have the right, but not the obligation, to negotiate with any party, including such Third Party, for obtaining a license to Exploit Excluded Compounds and products thereof in any field and any territory as long as such license does not include the right to pr... |
8.6.2. AbbVie. If on or after the License Option Effective Date, AbbVie determines that any Patent, trade secret, or other intellectual property right of a Third Party in any country or other jurisdiction in the Territory is necessary or reasonably useful for the Development, Manufacture, or Commercialization of any Li... |
8.6.3. Third Party Patent Challenges. If in the reasonable opinion of AbbVie, a Third Party's Patent may relate to the Exploitation of any Licensed Therapeutic (if such Licensed Therapeutic is not used in any product that is Developed or Commercialized by Cugene outside the scope of this Agreement) or Licensed Product ... |
On and after the License Option Effective Date, Cugene shall not challenge the patentability, validity, or enforceability of such Patent in any court or governmental body without AbbVie's prior written consent (not to be unreasonably withheld, conditioned, or delayed). Cugene shall assist and cooperate with AbbVie as A... |
8.7. Product Trademarks. |
8.7.1. Ownership and Prosecution of Product Trademarks. AbbVie shall own all right, title, and interest to the Product Trademarks in the Territory, and shall be responsible for the registration, prosecution, and maintenance thereof. All costs and expenses of registering, prosecuting, and maintaining the Product Tradema... |
8.7.2. Enforcement of Product Trademarks. AbbVie shall have the sole right and responsibility for taking such action as AbbVie deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair trade practices or any other like of... |
8.7.3. Third Party Claims. AbbVie shall have the sole right and responsibility for defending against and settling any alleged, threatened, or actual claim by a Third Party that the use or registration of the Product Trademarks in the Territory infringes, dilutes, misappropriates, or otherwise violates any Trademark or ... |
AbbVie shall bear the costs and expenses relating to any defense commenced pursuant to this Section 8.7.3 and any settlements and judgments with respect thereto, and shall retain any damages or other amounts collected in connection therewith. |
8.7.4. Notice and Cooperation. Each Party shall provide to the other Party prompt written notice of any actual or threatened infringement of the Product Trademarks in the Territory and of any actual or threatened claim that the use of the Product Trademarks in the Territory violates the rights of any Third Party. Each ... |
8.8. Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Party's employees or agents that are inventors under any applicable inventor remuneration laws. |
8.9. Common Interest. All Information exchanged between the Parties regarding the prosecution, maintenance, enforcement and defense of Patents under this ARTICLE 8 will be deemed to be Confidential Information of each Party that Controls the applicable Patent. In addition, each Party acknowledges and agrees that, with ... |
Each Party agrees and acknowledges that it has not waived, and nothing in this Agreement constitutes a waiver of, any legal privilege concerning Patents under this ARTICLE 8, including privilege under the common interest doctrine and similar or related doctrines. Notwithstanding anything to the contrary in this Agreeme... |
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE |
9.1. Confidentiality Obligations. |
9.1.1. At all times during the Term and for a period of ten years following termination or expiration of this Agreement in its entirety, each Party shall and shall cause its officers, directors, employees, agents and contractors to, keep confidential and not publish or otherwise disclose to a Third Party and not use, d... |
9.1.2. Notwithstanding Section 9.1.1, the confidentiality and non-use obligations under this Section 9.1 with respect to any Confidential Information shall not apply to any information that: |
(a) has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault, or negligence by the Receiving Party; |
(b) can be demonstrated by documentation or other competent proof to have been in the Receiving Party's possession prior to disclosure by the Disclosing Party without any obligation of confidentiality with respect to such information; provided that the foregoing exception shall not apply with respect to Product Informa... |
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