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(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... |
(b) 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 royalty-bearing, sublicensable license under (i) the AbbVie Grantback Agreement Patents, the AbbVi... |
(c) AbbVie shall not, and shall not permit any of its Affiliates to, and shall use commercially reasonable efforts not to permit any of its and their Sublicensees or Distributors to, distribute, market, promote, offer for sale, or sell any Licensed Therapeutics or Licensed Products directly or indirectly (i) to any Per... |
(d) Cugene shall not, and shall not permit any of its Affiliates to, and shall use commercially reasonable efforts not to permit any of its and their (sub)licensees, or distributors to, distribute, market, promote, offer for sale, or sell any Reversion Product (or Licensed Therapeutic contained therein) directly or ind... |
(e) notwithstanding the amendment of AbbVie's licenses and other rights under this Agreement in the Terminated Territory, if, at the time of such termination, the First Commercial Sale of a Licensed Product has occurred in the Terminated Territory, then AbbVie shall have the right for 12 months after the effective date... |
12.5. Transition Agreement. |
12.5.1. In the event of any termination of this Agreement whether in its entirety or with respect to the Terminated Territory, except with respect to a termination by AbbVie pursuant to Section 12.2.1, Section 12.2.2(a) or Section 12.2.3, Cugene and AbbVie shall negotiate in good faith the terms and conditions of a wri... |
12.5.2. If this Agreement is terminated in its entirety, the Transition Agreement shall provide that AbbVie shall (and shall cause its Affiliates to): |
(a) where permitted by Applicable Law, transfer and assign, or cause to be transferred and assigned, to Cugene all of AbbVie's and its Affiliates' right, title, and interest in all Regulatory Documentation then Controlled by AbbVie or its Affiliates or Sublicensees applicable to the Reversion Products in the Territory ... |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; |
(c) unless expressly prohibited by any Regulatory Authority, transfer control to Cugene of all Clinical Studies being conducted by AbbVie or its Affiliates as of the effective date of termination and continue to conduct such Clinical Studies, at Cugene's cost, for up to six months to enable such transfer to be complete... |
(d) if requested by Cugene, assign (or cause its Affiliates to assign) to Cugene all agreements between AbbVie or any of its Affiliates, on the one hand, and any Third Party, on the other hand, that solely relate to the conduct of pre-clinical Development activities or Clinical Studies for the Reversion Products, inclu... |
(e) if requested by Cugene, shall supply to Cugene any or all of the inventory of the Reversion Products held by AbbVie or its Affiliates or Sublicensees as of the date of termination at a price equal to the direct costs of manufacturing without markup, provided that AbbVie shall only be obligated to supply Cugene such... |
(f) assign to Cugene all right, title, and interest of AbbVie in each Product Trademark; provided that Cugene shall pay to AbbVie an amount equal to the fair market value of such Product Trademarks. |
12.5.3. If this Agreement is terminated with respect to a country or other jurisdiction but not in its entirety, the Transition Agreement shall: (x) include provisions regarding the maintenance of the global safety database for products that contain or comprise a Licensed Therapeutic and a process for the exchange of a... |
(a) where permitted by Applicable Law, transfer and assign, or cause to be transferred and assigned, to Cugene all of AbbVie's and its Affiliates' right, title, and interest in all Regulatory Approvals Controlled by AbbVie or its Affiliates or Sublicensees applicable to the Terminated Territory and to the Reversion Pro... |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; |
(c) grant Cugene a right of reference to all Regulatory Documentation then owned by AbbVie or its Affiliates and in AbbVie's or its Affiliates' name that are not transferred to Cugene pursuant to clause (a) above that are necessary or reasonably useful for Cugene, any of its Affiliates or (sub)licensees to Develop or C... |
(d) if requested by Cugene, shall supply to Cugene any or all of the inventory of the Reversion Products intended for the Terminated Territory held by AbbVie or its Affiliates or Sublicensees as of the date of termination at a price equal to the direct costs of manufacturing without markup, provided that AbbVie shall o... |
(e) assign to Cugene all right, title, and interest of AbbVie or its Affiliates in each Product Trademark in such Terminated Territory; provided that Cugene shall pay to AbbVie an amount equal to the fair market value of such Product Trademarks. |
12.5.4. Except as expressly set forth above in this Section 12.5 or as otherwise agreed in the Transition Agreement, each Party shall be responsible for its own costs in connection with the Transition Agreement. |
12.6. Reverse Royalty. If this Agreement is terminated in its entirety or with respect to the Terminated Territory, and in connection therewith, AbbVie grants to Cugene a grantback royalty-bearing license pursuant to Section 12.4.2(d) or Section 12.4.3(b), then, on a Reversion Product-by-Reversion Product basis, Cugene... |
12.7. AbbVie Rights in Lieu of Termination. If it is determined pursuant to applicable dispute resolution procedure that AbbVie has the right to terminate this Agreement pursuant to Section 12.2.1, then in lieu of such termination, AbbVie may, by written notice to Cugene before the termination becomes effective, elect ... |
12.7.1. if Cugene's material breach of a material obligation by virtue of which AbbVie has the right to terminate this Agreement occurs on or prior to the License Option Effective Date, the amount of (a) the License Option Exercise Payment payable by AbbVie to Cugene pursuant to Section 7.2, (b) any Development Milesto... |
12.7.2. if Cugene's material breach of a material obligation by virtue of which AbbVie has the right to terminate this Agreement occurs after the License Option Effective Date, the amount of (a) any Development Milestone Payments payable by AbbVie to Cugene pursuant to Section 7.3 for any Development Milestone Event ac... |
12.7.3. AbbVie's diligence obligations under Section 5.2 shall terminate; |
12.7.4. the JGC shall disband and all activities of the Parties thereunder shall terminate; and |
12.7.5. all other provisions of this Agreement shall remain in full force and effect without change. |
12.8. Remedies. Except as otherwise expressly provided herein, termination of this Agreement (either in its entirety or with respect to one or more countries or other jurisdictions) in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
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