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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... |
(c) is subsequently received by the Receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information; |
(d) has been published by a Third Party or otherwise enters the public domain through no fault of the Receiving Party in breach of this Agreement; or |
(e) can be demonstrated by documentation or other competent evidence to have been independently developed by or for the Receiving Party without reference to the Disclosing Party's Confidential Information; provided that the foregoing exception shall not apply with respect to Product Information. |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combin... |
9.2. Permitted Disclosures. The Receiving Party may use and disclose Confidential Information of the Disclosing Party to the extent that such disclosure is: |
9.2.1. made in response to a valid order of an arbitral tribunal, court of competent jurisdiction or other Governmental Authority of competent jurisdiction or, if in the reasonable opinion of the Receiving Party's legal counsel, such disclosure is otherwise required by Applicable Law or the rules of a stock exchange on... |
9.2.2. made by or on behalf of the Receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a Patent under this Agreement; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such prot... |
9.3. Additional Permitted Disclosures and Use by AbbVie. After the License Option Effective Date, AbbVie and its Affiliates and its and their Sublicensees may disclose and use Confidential Information of Cugene as may be necessary or reasonably useful in connection with the Exploitation of the Licensed Therapeutic and ... |
9.4. Additional Permitted Disclosures and Use by Cugene. Cugene and its Affiliates may disclose and use Confidential Information of AbbVie as may be necessary or reasonably useful for Cugene to exercise its rights or fulfill its obligations under this Agreement, including in connection with any filing or submission to ... |
9.5. Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo or other Trademarks of the other Party or any of its Affiliates or any of its or their (sub)licensees (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotiona... |
9.6. Public Announcements. The Parties have agreed upon the content of a press release that shall be issued by AbbVie substantially in the form attached hereto as Schedule 9.6, the release of which the Parties shall coordinate in order to accomplish such release promptly upon a date to be mutually agreed by the Parties... |
9.7. Publications. The Parties recognize the desirability of publishing and publicly disclosing the results of and information regarding the activities under this Agreement. |
9.7.1. Cugene Publications. During the Term of this Agreement, Cugene shall not, and shall cause each of its Affiliates and its and their licensees and (sub)licensees not to, make any publications or public disclosures regarding Product Information without AbbVie's prior written consent in its sole discretion. For clar... |
9.7.2. AbbVie Publications. From and after the License Option Effective Date until termination of this Agreement, AbbVie may publicly disclose the results of and information regarding activities under this Agreement with respect to any Licensed Therapeutic or any Licensed Products, subject to prior review and complianc... |
9.8. Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, at the written request of a Party, the non-requesting Party shall either, at the requesting Party's election: (a) promptly destroy all copies of the requesting Party's Confidential Information in the po... |
Notwithstanding the foregoing, the non-requesting Party shall be permitted to retain such Confidential Information (x) to the extent necessary or useful for purposes of performing any continuing obligations or exercising any ongoing rights hereunder and, in any event, a single copy of such Confidential Information for ... |
ARTICLE 10 REPRESENTATIONS AND WARRANTIES |
10.1. Mutual Representations and Warranties. Each Party represents and warrants to the other Party, as of the Effective Date: |
10.1.1. it is duly organized, validly existing and in good standing under the Applicable Law of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; |
10.1.2. the execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and do not violate: (a) such Party's charter documents, bylaws or other organizational documents; (b) in any material respect, any agreement,... |
10.1.3. this Agreement is a legal, valid and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availabi... |
10.2. Additional Representations, Warranties and Covenants of Cugene. |
10.2.1. Cugene additionally represents and warrants to AbbVie (a) as of the Effective Date that except as set forth in the disclosure schedules delivered by Cugene on the Effective Date (the "Initial Disclosure Schedules") and (b) as of each Bring Down Date, except as set forth in the Updated Disclosure Schedules, in e... |
(a) All Existing Patents (i) are listed on the Existing Patents Schedule, (ii) to Cugene's Knowledge, with respect to issued Existing Patents (if any), are subsisting and are not invalid or unenforceable, in whole or in part, (iii) are being diligently prosecuted in the respective patent offices in the Territory in acc... |
(b) There are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Cugene or any of its Affiliates relating to the Existing Regulatory Documentation, the Existing Patents, or the Cugene Know-How. No claim or litigation has been brought or, to Cugene's Knowledge, threatened by any Perso... |
(c) Cugene is (i) the sole and exclusive owner of the entire right, title, and interest in the Existing Patents listed on Schedule 10.2.1(c), Part A (the "Owned Patents") and the Existing Know-How and (ii) the sole and exclusive licensee of the Existing Patents listed on Schedule 10.2.1(c), Part B subject to valid and ... |
(d) The Existing Patents represent all Patents within Cugene's or its Affiliates' ownership or control that are necessary or reasonably useful for the Exploitation of the Licensed Therapeutics or the Licensed Products. To Cugene's Knowledge, there is no Information owned or otherwise controlled by Cugene or any of its ... |
(e) Each Person who has or has had any rights in or to any Owned Patents or Cugene Know-How has assigned and has executed an agreement assigning its entire right, title, and interest in and to such Owned Patents or Cugene Know-How to Cugene, and to the extent any of Cugene's or its Affiliates', (sub)licensees, employee... |
(f) Cugene has obtained the right (including under any Patents and other intellectual property rights) to use all Information that is necessary or reasonably useful for the Exploitation of the Licensed Therapeutics or the Licensed Products and all other materials that Cugene is required to transfer to AbbVie under this... |
(g) Cugene has made available to AbbVie: (i) examination reports for the Existing Patents for each country in the Territory where a Product Patent or Mixed Cugene Patent has been applied for; (ii) all Existing Regulatory Documentation (excluding any administrative or scheduling correspondence or documentation) and all ... |
(h) Cugene has no Knowledge of any scientific or technical facts or circumstances that would materially adversely affect the scientific, therapeutic, or commercial potential of the Licensed Therapeutics or Licensed Products. Neither Cugene nor any of its Affiliates is aware of anything that would materially adversely a... |
(i) The Processing of Personal Data conducted by or on behalf of Cugene (including any transfer of Personal Data across national borders) in connection with the Licensed Therapeutics and Licensed Products is and has been in material compliance with applicable Data Protection Laws, all privacy related consents and notic... |
(j) In the last five years, Cugene has not received written notice of any alleged material violation from a Regulatory Authority or other Third Party of any Privacy and Security Obligations and has no Knowledge of facts that would give rise to such a violation. Cugene is not under investigation by any Regulatory Author... |
(k) The execution, delivery, and performance of this Agreement and the other agreements and instruments contemplated hereby, and the consummation of the transactions contemplated hereunder, comply with the Privacy and Security Obligations. Cugene has the full right and authority to provide to AbbVie such Personal Data ... |
(l) All In-License Agreements are listed on the In-License Schedule, and (i) the licenses to Cugene in the In-License Agreements are in full force and effect and by their terms are sublicensable to AbbVie as contemplated by this Agreement, (ii) neither Cugene nor any of its Affiliates is in breach under any of the In-L... |
(m) Neither Cugene nor any of its Affiliates has previously entered into any agreement, whether written or oral, with respect to or otherwise assigned, transferred, licensed, conveyed or otherwise encumbered its right, title or interest in or to any Patent or other intellectual property or proprietary right or Informat... |
(n) Each of the Existing Patents properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Existing Patent is issued or such application is pending. |
(o) There are no pending or, to Cugene's Knowledge, alleged or threatened, (i) inter partes reviews, post-grant reviews, interferences, re-examinations or oppositions involving the Existing Patents that are in or before any patent authority (or other Governmental Authority performing similar functions) or (ii) inventor... |
(p) The inventions claimed by the Existing Patents (i) were not conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, (ii) are not a "subject invention" as that term is described in... |
(q) Cugene and its Affiliates have kept the Existing Know-How confidential and have disclosed the Existing Know-How to Third Parties only under terms of confidentiality. To the Knowledge of Cugene and its Affiliates, no breach of such confidentiality has been committed by any Third Party. |
(r) Cugene and its Affiliates have conducted, and, to Cugene's Knowledge, their respective contractors and consultants have conducted, all Development of the Licensed Therapeutics and Licensed Products (including the generation, preparation, maintenance and retention of all Regulatory Documentation) in all material res... |
(s) None of Cugene, its Affiliates or any Third Party manufacturer Manufacturing the Licensed Therapeutics and Licensed Products (or any intermediate thereof) under agreement with Cugene or its Affiliates, has included, incorporated, utilized or practiced any Information, Patent or other intellectual property or propri... |
(t) Neither Cugene nor any of its Affiliates, nor any of its or their respective officers, employees or, to Cugene's Knowledge, agents has made an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Development of the Licensed Therapeutics or the Li... |
(u) Cugene has not ever been, is not currently, nor is it the subject of a proceeding that could lead to it becoming a Debarred Entity, Excluded Entity, or Convicted Entity and it will not use in any capacity, in connection with the obligations to be performed under this Agreement, any person who is a Debarred Individu... |
(1) A "Debarred Individual" is an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) from providing services in any capacity to a person that has an approved or pending drug or biological product application. |
(2) A "Debarred Entity" is a corporation, partnership, or association that has been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of such a corporation, partnership, or association. |
(3) An "Excluded Individual" or "Excluded Entity" is (i) an individual or entity, as applicable, who has been excluded, debarred, suspended, or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of H... |
(4) A "Convicted Individual" or "Convicted Entity" is an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. § 335a (a) or 42 U.S.C. § 1320a - 7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible. |
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