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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. |
(5) "FDA's Disqualified/Restricted List" is the list of clinical investigators restricted from receiving investigational drugs, biologics, or devices if the FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false Informa... |
10.2.2. Bring Down of Representations and Warranties. |
(a) During the License Option Period, AbbVie shall have the right to request that Cugene bring down the representations and warranties in Section 10.2.1 by notifying Cugene of such request (such notice, a "Bring Down Request" and the date AbbVie delivers such Bring Down Request, the "Bring Down Request Date") as set fo... |
(b) AbbVie shall have the right to provide one Bring Down Request at any time during the License Option Period and an additional Bring Down Request within 90 days after each Early Exercise Request; it being understood that Cugene will only be required to bring down the representation and warranties in Section 10.2.1 fo... |
(c) With respect to each Bring Down Request, (i) Cugene makes the representations and warranties in Section 10.2.1 as of the date that is 30 days after such Bring Down Request Date (such date, the "Bring Down Date"), and (ii) subject to Section 10.2.2(d), Cugene shall have the right to provide AbbVie updated disclosure... |
(d) The disclosures set forth in any Updated Disclosure Schedule shall be limited to (i) updating the Existing Patent Schedule and the In-License Schedule and (ii) any matter (1) existing as of the Effective Date which, if known at the Effective Date, would have been required to be set forth or described in the Initial... |
10.3. Additional Covenants of Cugene. |
10.3.1. From and after the Effective Date, Cugene shall not, and shall cause its Affiliates not to, (a) misappropriate, infringe or use without authorization any intellectual property rights of a Third Party in connection with the performance of its activities under this Agreement, (b) enter into any agreement, whether... |
10.3.2. For all Personal Data Processed by or on behalf of Cugene or any of its Affiliates in performance of this Agreement, Cugene shall: |
(a) comply at all times with the applicable Data Protection Laws in all material respects; |
(b) to the extent permitted by Applicable Law, notify AbbVie, as soon as practicable and in any event prior to making the relevant disclosure, if it is obliged to make a disclosure of such Personal Data under Applicable Law; |
(c) make timely notification to, and obtain any necessary authorizations from, any applicable Regulatory Authority if required under applicable Data Protection Laws of its collection and other Processing of Personal Data in order to comply with its obligations under this Agreement; |
(d) implement and maintain reasonable administrative, technical, organizational and physical safeguards designed to (i) maintain the security and confidentiality of all Personal Data, (ii) protect against reasonably anticipated threats or hazards to the security or integrity of Personal Data and (iii) protect against u... |
(e) notify AbbVie promptly, and in any event within 48 hours, of receipt of (i) any correspondence from a data protection regulator in relation to the Processing of Personal Data related to this Agreement or (ii) a request or notice from a data subject exercising his rights under applicable Data Protection Laws includi... |
(f) refrain from taking actions related to the Processing of the Personal Data under this Agreement that would be reasonably likely to damage or impair AbbVie's reputation. |
10.3.3. At the reasonable request of AbbVie, the Parties shall cooperate to enter into any necessary joint controller agreements or controller-processor agreements with respect to such Personal Data as necessary to comply with Applicable Law. If Cugene or any of its Affiliates needs to transfer Personal Data originatin... |
10.3.4. Cugene shall notify AbbVie immediately upon learning of any actual or suspected misappropriation or unauthorized access to, or disclosure or use of, the Personal Data collected, Processed, hosted, or transmitted in performance by Cugene under this Agreement, including the conduct of the Initial Development Plan... |
10.4. Additional Representations, Warranties and Covenants of AbbVie. AbbVie additionally represents and warrants to Cugene, as of the Effective Date, and covenants that: |
10.4.1. there are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial, or legal, administrative, or other proceedings or governmental investigations pending or threatened against AbbVie which would reasonably be expected to adversely affect or restrict the ability of AbbVie t... |
10.4.2. AbbVie 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 Indi... |
10.4.3. for all Personal Data included in the Study Data Processed by or on behalf of AbbVie or any of its Affiliates in performance of this Agreement, AbbVie shall: |
(a) comply at all times with the applicable Data Protection Laws in all material respects; |
(b) to the extent permitted by Applicable Law, notify Cugene, as soon as practicable and in any event prior to making the relevant disclosure, if it is obliged to make a disclosure of such Personal Data included in the Study Data under Applicable Law; |
(c) make timely notification to, and obtain any necessary authorizations from, any applicable Regulatory Authority if required under applicable Data Protection Laws of its collection and other Processing of Personal Data included in the Study Data in order to comply with its obligations under this Agreement; |
(d) implement and maintain reasonable administrative, technical, organizational and physical safeguards designed to (i) maintain the security and confidentiality of all Personal Data included in the Study Data, (ii) protect against reasonably anticipated threats or hazards to the security or integrity of Personal Data ... |
(e) notify Cugene promptly, and in any event within 48 hours, of receipt of (i) any correspondence from a data protection regulator in relation to the Processing of Personal Data included in the Study Data related to this Agreement or (ii) a request or notice from a data subject exercising his rights under applicable D... |
(f) refrain from taking actions related to the Processing of the Personal Data included in the Study Data under this Agreement that would be reasonably likely to damage or impair Cugene's reputation. |
10.5. DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL OR ... |
10.6. Anti-Bribery and Anti-Corruption Compliance. Each Party represents, warrants, and covenants to the other Party in connection with this Agreement that such Party and its Affiliates (a) have complied and shall comply with all applicable laws, rules, regulations and industry codes governing bribery, money laundering... |
ARTICLE 11 INDEMNITY |
11.1. Indemnification of Cugene. AbbVie shall indemnify Cugene, its Affiliates and its and their respective directors, officers, employees and agents (collectively, "Cugene Indemnitees"), and defend and save each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including ... |
11.2. Indemnification of AbbVie. Cugene shall indemnify AbbVie, its Affiliates and its and their respective directors, officers, employees and agents (collectively, "AbbVie Indemnitees"), and defend and save each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims ari... |
11.3. Indemnification Procedures. |
11.3.1. Notice of Claim. All indemnification claims in respect of an AbbVie Indemnitee or a Cugene Indemnitee shall be made solely by Cugene or AbbVie, as applicable (each of Cugene or AbbVie in such capacity, the "Indemnified Party"). The Indemnified Party shall give the indemnifying Party (each of Cugene or AbbVie in... |
11.3.2. Control of Defense. Subject to Section 8.4, Section 8.5 and Section 8.7, at its option, the Indemnifying Party may assume the defense of any Third Party Claim by notifying the Indemnified Party in writing within 30 days after the Indemnifying Party's receipt of an Indemnification Claim Notice. The assumption of... |
11.3.3. Right to Participate in Defense. Any Indemnified Party shall be entitled to participate in, but not control (except as provided in Section 8.4, Section 8.5 and Section 8.7), the defense of a Third Party Claim and to employ counsel of its choice for such purpose; provided that such employment shall be at the Ind... |
11.3.4. Settlement. With respect to any Third Party Claim for which the Indemnifying Party has assumed the defense of such Third Party Claim in accordance with Section 11.3.2 that relates solely to the payment of money damages in connection with such Third Party Claim and that will not result in any AbbVie Indemnitee o... |
11.3.5. Cooperation. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each AbbVie Indemnitee or Cugene Indemnitee, as applicable, to cooperate in the defense or prosecution thereof and shall furnish such records, information ... |
11.3.6. Expenses. Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any claim shall be reimbursed on a Calendar Quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party's right to contest any Ab... |
11.4. Special, Indirect and Other Losses. EXCEPT (A) IN THE EVENT OF THE WILLFUL MISCONDUCT OR FRAUD OF A PARTY OR OF A PARTY'S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 9 OR SECTION 4.6, (B) AS PROVIDED UNDER SECTION 13.10, AND (C) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAI... |
11.5. Insurance. |
11.5.1. Cugene's Insurance Obligations. Cugene shall maintain, at its cost, its current insurance against liability and other risks associated with its activities conducted prior to the License Option Effective Date under this Agreement. Upon AbbVie's reasonable request, Cugene shall furnish to AbbVie certificates evid... |
11.5.2. AbbVie's Insurance Obligations. AbbVie hereby represents and warrants to Cugene that it is self-insured against liability and other risks associated with its and its Affiliates' and any Sublicensees' activities and obligations under this Agreement, including Clinical Studies (sponsored by AbbVie in any territor... |
ARTICLE 12 TERM AND TERMINATION |
12.1. Term and Expiration. This Agreement shall commence on the Effective Date and, unless earlier terminated pursuant to Section 12.2, shall continue in force and effect until either (a) expiration or termination of the License Option pursuant to Section 3.5, or (b) after the License Option Effective Date, the date of... |
12.2. Termination. |
12.2.1. Material Breach. |
(a) If either Party (the "Breaching Party") materially breaches any of its material obligations under this Agreement, in addition to any other right and remedy the other Party (the "Non-Breaching Party") may have, the Non-Breaching Party may terminate this Agreement by providing 90 days' (or, with respect to any paymen... |
(b) Notwithstanding Section 12.2.1(a), if after the License Option Effective Date (i) any uncured material breach of a material obligation by AbbVie of any of its obligations under Section 5.2 is with respect to one or more, but not all, of the countries or other jurisdictions in the Territory for which it has diligenc... |
12.2.2. Termination by AbbVie. |
(a) AbbVie may terminate this Agreement in its entirety at any time during the Term immediately upon written notice to Cugene that AbbVie in good faith determines, based on available data and information, the benefits to patients of any Licensed Product are outweighed by the risks to patient safety of such Licensed Pro... |
(b) Prior to the License Option Effective Date, AbbVie may terminate this Agreement in its entirety for any or no reason, upon 120 days' prior written notice to Cugene. After the License Option Effective Date, AbbVie may terminate this Agreement in its entirety or on a country-by-country basis (or jurisdiction-by-juris... |
12.2.3. Termination for Insolvency. If either Party (or, if applicable, any controlling Affiliate of such Party) (a) files for protection under bankruptcy or insolvency laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its ... |
12.2.4. Termination for HSR. AbbVie may terminate this Agreement in its entirety effective immediately upon written notice to Cugene if (a) either Party receives a second request for additional information under the HSR Act (a "Second Request") or (b) the License Option Effective Date has not occurred within 180 days a... |
12.2.5. Termination by Cugene. Except to the extent the following is unenforceable or prohibited under Applicable Law or is in violation of public policy in a particular jurisdiction, Cugene shall have the right to terminate this Agreement in its entirety upon 30 days' prior written notice to AbbVie if AbbVie or any of... |
12.3. Rights in Bankruptcy. |
12.3.1. The Parties intend to take advantage of the protections of Section 365(n) (or any successor provision) of the U.S. Bankruptcy Code or any analogous provisions in any other country or other jurisdiction to the maximum extent permitted by Applicable Law. All rights and licenses granted under or pursuant to this A... |
12.3.2. In the event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code or any analogous provisions in any other country or other jurisdiction, the Party that is not subject to such proceeding shall be entitled to a complete duplicate of (or complete access to, as a... |
12.3.3. Unless and until the subject Party rejects this Agreement, the subject Party shall perform this Agreement or provide the intellectual property (including all embodiments of such intellectual property) to the non-subject Party, and shall not interfere with the rights of the non-subject Party to such intellectual... |
12.4. Consequences of Termination. |
12.4.1. Termination prior to License Option Effective Date. If this Agreement is terminated in its entirety prior to the License Option Effective Date: |
(a) all rights and licenses granted by one Party to the other Party, including the License Option, shall immediately terminate; |
(b) AbbVie shall terminate all patent preparation, filing, prosecution, maintenance, enforcement and defense activities related to any Cugene Patents (if any) and take all such actions as Cugene deems necessary to transfer the control of such activities to Cugene; and |
(c) AbbVie shall, and hereby does, effective as of the effective date of termination, grant Cugene an exclusive, sublicensable, royalty-free, fully-paid, perpetual and irrevocable license under AbbVie's interest in any Joint IP to Exploit any Licensed Product or Licensed Therapeutic in the Territory. |
12.4.2. Termination in its Entirety after License Option Effective Date. If this Agreement is terminated in its entirety after the License Option Effective Date: |
(a) except to the extent required for AbbVie to exercise its rights and perform its obligations under the Transition Agreement, all rights and licenses granted by Cugene hereunder shall immediately terminate; |
(b) all rights and licenses granted by AbbVie hereunder shall immediately terminate; |
(c) AbbVie shall terminate all patent preparation, filing, prosecution, maintenance, enforcement and defense activities related to any Cugene Patents (if any) and take all such actions as Cugene deems necessary to transfer the control of such activities to Cugene; |
(d) except in the event of a termination by AbbVie pursuant to Section 12.2.1 or Section 12.2.3, subject to the Parties' execution of a Transition Agreement in accordance with Section 12.5 and subject to Section 12.6, AbbVie shall, and hereby does, effective as of the effective date of termination, grant Cugene a royal... |
(e) notwithstanding the termination of AbbVie's licenses and other rights under this Agreement, if, at the time of the termination of this Agreement, the First Commercial Sale of a Licensed Product has occurred in a country or jurisdiction, then AbbVie shall have the right for 12 months after the effective date of such... |
12.4.3. Termination in a Terminated Territory after License Option Effective Date. If this Agreement is terminated with respect to a Terminated Territory by AbbVie pursuant to Section 12.2.2(b) or by Cugene pursuant to Section 12.2.1 (but not in the case of any termination of this Agreement in its entirety) after the L... |
(a) except to the extent required for AbbVie to exercise its rights and perform its obligations under the Transition Agreement, all rights and licenses granted by Cugene hereunder (i) shall automatically be deemed to be amended to exclude, if applicable, the right to market, promote, detail, distribute, sell, offer for... |
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