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12.4.3 Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in the Indemnified Party's becoming subject to injunctive or other relief, and as to which the indemnifying Party shall have acknowledged in writing the obligati... |
12.4.4 Cooperation. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and at... |
12.4.5 Expenses. Unless as otherwise provided in this Article 12 (Indemnity), the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any Third Party Claim shall be reimbursed on a Calendar Quarter basis in arrears by the indemn... |
12.5 Special, Indirect, and Other Losses. EXCEPT (A) FOR WILLFUL MISCONDUCT, (B) FOR A PARTY'S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 10 (CONFIDENTIALITY AND NON-DISCLOSURE) OR SECTION 6.7 (EXCLUSIVITY), AND (C) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PART... |
12.6 Insurance. Parvus shall obtain and carry in full force and effect the minimum insurance requirements set forth herein from an insurance company properly licensed to provide the required insurance. Such insurance shall (a) be primary insurance with respect to Parvus' own participation under this Agreement, (b) be i... |
12.6.1 Types and Minimum Limits. The types of insurance, and minimum limits shall be: |
(a) Worker's Compensation with statutory limits in compliance with the Worker's Compensation laws of the state or states in which the Party has employees in the United States (excluding Puerto Rico). |
(b) Employer's Liability coverage with a minimum limit of Five Hundred Thousand Dollars ($500,000) per occurrence; provided that a Party has employees in the United States (excluding Puerto Rico). |
(c) General Liability Insurance (i) with a minimum limit of Two Million Five Hundred Thousand Dollars ($2,500,000) per occurrence and Five Million Dollars ($5,000,000) in the aggregate, as of the Effective Date and (ii) with a minimum limit of Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($1... |
Parvus shall at all times maintain in force any insurance policy that is required by Applicable Law which may govern or have jurisdiction over any provision of this Agreement and at all times remain fully compliant with any such Applicable Law. |
12.6.2 Certificates of Insurance. Upon request by AbbVie, Parvus shall provide certificates of insurance evidencing compliance with the requirements of Section 12.6.1 (Insurance—Types and Minimum Limits). The insurance policies shall be under an occurrence form, but if only a claims-made form is available to Parvus, th... |
ARTICLE 13 TERM AND TERMINATION |
13.1 Term. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect until the earlier to occur of (a) termination of the Agreement in accordance with Section 4.4 (Termination of License Option), and (b) the date of expiration of the Ro... |
13.1.1 Effect of Expiration of the Term. Following the expiration of the Term pursuant to clause (b) (but not clause (a)) of Section 13.1 (Term), the grants in Section 6.2 (Grants to AbbVie on the License Option Effective Date) shall become unrestricted, fully-paid, royalty-free, perpetual, and irrevocable. |
13.2 Termination for Material Breach. |
13.2.1 Material Breach by Parvus. If AbbVie believes that Parvus has materially breached one (1) or more of its material obligations under this Agreement, then AbbVie may deliver notice of such material breach to Parvus (a "Parvus Default Notice"). If Parvus does not dispute that it has committed a material breach of o... |
13.2.2 Material Breach by AbbVie. If Parvus believes that AbbVie has materially breached (a) at any time, one (1) or more of its payment obligations under this Agreement, or (b) at any time before First Commercial Sale of a Licensed Product in the United States or any Major European Market, its obligations under Sectio... |
13.2.3 Invocation of Termination for Material Breach. Notwithstanding the foregoing, the Parties agree that termination pursuant to this Section 13.2 (Termination for Material Breach) is a remedy to be invoked only if the breach is not (a) cured in accordance with Section 13.2.1 (Material Breach by Parvus) or Section 1... |
13.3 Additional Termination Rights by AbbVie. |
13.3.1 For Cause or Safety. AbbVie may terminate this Agreement in its entirety effective immediately upon written notice to Parvus: |
(a) pursuant to Sections 11.4 (Debarment and Exclusion) or 11.5 (Anti-Bribery and Anti-Corruption Compliance) or |
(b) (i) if a Regulatory Authority or safety data review board for the Clinical Studies of such Licensed Product recommends or requires (x) termination of Clinical Studies of such Licensed Product in the United States, or any Major European Market or (y) the withdrawal of a Regulatory Approval of such Licensed Product i... |
13.3.2 For Convenience. AbbVie may terminate this Agreement (a) in its entirety, (b) solely with respect to a Major Market or (c) on a Licensed Product-by-Licensed Product basis, in each case for any or no reason, upon ninety (90) days' prior written notice to Parvus. |
13.3.3 For Failure or Delay to Obtain Antitrust Clearance. AbbVie may terminate this Agreement in its entirety effective immediately upon written notice to Parvus if AbbVie has exercised the License Option, and (a) either Party receives a request for additional information under the HSR Act or if the transaction contem... |
13.4 Termination for Insolvency. If either 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 property that is not discharged within ninety (90) days after su... |
13.5 Rights in Bankruptcy. |
13.5.1 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 jurisdiction ("Bankruptcy Code") to the maximum extent permitted by Applicable Law. All rights and licenses granted under or pursu... |
13.5.2 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 jurisdiction, the Party that is not subject to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropri... |
13.5.3 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 p... |
13.6 Effects of Termination of this Agreement in the Entirety. |
13.6.1 In the event of a termination of this Agreement in its entirety by either Party: |
(a) all rights and licenses granted by Parvus hereunder shall immediately terminate; |
(b) all rights and licenses granted by AbbVie hereunder shall immediately terminate; and |
(c) only if such termination is by AbbVie pursuant to Section 13.3.2(a) (Additional Termination Rights by AbbVie – For Convenience) or by Parvus pursuant to Section 13.2.2 (Termination for Material Breach – Material Breach by AbbVie) or 13.4 (Termination for Insolvency) and the License Option Effective Date has occurre... |
13.6.2 If AbbVie has the right to terminate this Agreement in its entirety pursuant to Section 13.2.1 (Material Breach by Parvus), 13.3.1(a) (Additional Termination Rights by AbbVie – For Cause), or 13.4 (Termination for Insolvency), AbbVie may, in lieu of termination, elect (in its sole discretion) by written notice t... |
(a) all rights and licenses granted by AbbVie hereunder shall immediately terminate; |
(b) all rights and licenses granted by Parvus hereunder shall become irrevocable, unrestricted, and perpetual rights and licenses, and (i) any royalties and milestone payments, after giving effect to any deductions allowable hereunder, that would have been due to Parvus by AbbVie with respect to Licensed Products befor... |
(c) AbbVie's obligations pursuant to Section 5.2 (Diligence) shall terminate. |
The remedies set forth in this Section 13.6.2 (Effects of Termination of this Agreement in the Entirety) shall be without limitation to any other rights or remedies that may be available to AbbVie under this Agreement or at law. |
13.7 Effects of Termination of a Major Market Terminated Territory. In the event of a termination of this Agreement with respect to a Terminated Territory by AbbVie pursuant to Section 13.3.2 (Additional Termination Rights by AbbVie – For Convenience) (but not in the case of any termination of this Agreement in its ent... |
13.7.1 all rights and licenses granted by Parvus hereunder (a) shall automatically be deemed to be amended to exclude, if applicable, the right to market, promote, detail, distribute, import, sell, offer for sale, submit any Drug Approval Application for, or seek any Regulatory Approval for, such terminated Licensed Co... |
13.7.2 only if the License Option Effective Date has occurred prior to the effective date of such termination then, subject to the Parties' execution of a Transition Agreement in accordance with Section 13.8 (Transition Agreement and Other Performance Obligations) and subject to Section 13.9 (Reverse Royalty), AbbVie s... |
13.7.3 Exploitation of the Grantback Products in the Terminated Territory by Parvus shall not breach Section 6.6 (Confirmatory Patent License); |
13.7.4 Parvus shall not, and shall not permit any of its Affiliates, 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 Grantback Product (or Licensed Compound contained therein) directly or indire... |
13.7.5 From and after the effective date of termination of this Agreement with respect to such Terminated Territory, neither Party (or its Affiliates) shall do any act or fail to do any act that is within such Party's (or its Affiliates') control in connection with any Grantback Product (or Licensed Compound contained ... |
13.8 Transition Agreement and Other Performance Obligations. |
13.8.1 Promptly after any termination of this Agreement by AbbVie pursuant to Section 13.3.2(a) (Additional Termination Rights by AbbVie – For Convenience) or by Parvus pursuant to Sections 13.2.2 (Termination for Material Breach – Material Breach by AbbVie) or 13.4 (Termination for Insolvency) and the License Option E... |
13.8.2 In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 13.3.2(a) (Additional Termination Rights by AbbVie – For Convenience) or by Parvus pursuant to Sections 13.2.2 (Termination for Material Breach – Material Breach by AbbVie) or 13.4 (Termination for Insolvency), the Tran... |
(a) Where permitted by Applicable Law, transfer to Parvus all of AbbVie's and its Affiliates' right, title, and interest in all Regulatory Documentation then owned by AbbVie or its Affiliates and in its or their name applicable solely to the Grantback Products in the Territory that are the subject of the license grant ... |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above, including transfer of global safety databases applicable to the Grantback Products; |
(c) at Parvus' request, either (i) subject to patient safety and other ethical considerations, wind-down any ongoing Clinical Studies being conducted by AbbVie or its Affiliates as of the effective date of termination in accordance with Applicable Law and at Parvus' expense or (ii) unless expressly prohibited by any Re... |
(d) at Parvus' request, transfer and assign to Parvus all assignable (including using Commercially Reasonable Efforts to obtain consent to assign) agreements with Third Parties that solely relate to the Development, use or Commercialization of Grantback Products other than manufacturing agreements, but including agreem... |
(e) at Parvus' request, AbbVie shall use Commercially Reasonable Efforts to Manufacture or cause to be Manufactured clinical or commercial supply (as applicable) of the applicable Grantback Product(s) to Parvus for a period of time to be mutually agreed by the Parties. |
13.8.3 In the event of a termination of this Agreement with respect to a Terminated Territory by AbbVie pursuant to Section 13.3.2 (Additional Termination Rights by AbbVie – For Convenience) (but not in the case of any termination of this Agreement in its entirety), the Transition Agreement shall (x) include provisions... |
(a) Where permitted by Applicable Law, transfer to Parvus all of AbbVie's and its Affiliates' right, title, and interest in all Regulatory Approvals then owned by AbbVie or its Affiliates and then in its or their name that is solely applicable to the Terminated Territory and to the Grantback Products that are the subje... |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; and |
(c) grant Parvus 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 Parvus pursuant to clause 13.6.2(a) above that are necessary or reasonably useful for Parvus, any of its Affiliates or sublicensees to Develop ... |
13.8.4 Notwithstanding any other provision of this Section 13.8 (Transition Agreement and Other Performance Obligations), AbbVie shall have no obligation to grant to Parvus any license or other right under Information, Regulatory Approvals or Regulatory Documentation Controlled by AbbVie related to the Manufacture of L... |
13.9 Reverse Royalty. If this Agreement is terminated in its entirety or with respect to one (1) or more Terminated Territories, and in connection therewith, AbbVie grants to Parvus a grantback license pursuant to Section 13.6.1(c) (Effects of Termination of this Agreement in the Entirety) or 13.7.2 (Effects of Termina... |
(a) if the effective date of termination occurs after the License Option Effective Date but prior to the completion of the first Phase III Study for such Grantback Product, three percent (3%) of Net Sales of such Grantback Product; |
(b) if the effective date of termination occurs after the completion of the first Phase III Study for such Grantback Product but prior to the first Regulatory Approval for such Grantback Product, four percent (4%) of Net Sales of such Grantback Product; or |
(c) if the effective date of termination occurs on or after the first Regulatory Approval for such Grantback Product, five percent (5%) of Net Sales of such Grantback Product; |
provided, however, that if this Agreement is terminated pursuant to Section 13.2.2 (Material Breach by AbbVie), then such royalty rates shall be reduced by fifty percent (50%). |
For purposes of this Section 13.9 (Reverse Royalty), the definition of "Net Sales," 7.6 (Royalty Payments and Reports), and Sections 7.8 (Mode of Payment; Offsets) through 7.14 (Audit Dispute) shall apply mutatis mutandis to the calculation, payment, recording, and auditing of Parvus' obligations to pay royalties under... |
13.10 Remedies. Except as otherwise expressly provided herein, termination of this Agreement (either in its entirety or with respect to one (1) or more country(ies) or other jurisdiction(s)) in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
13.11 Accrued Rights; Surviving Obligations. |
13.11.1 Termination or expiration of this Agreement (either in its entirety or with respect to one (1) or more country(ies) or other jurisdiction(s)) or one or more Licensed Product(s) for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or ... |
Notwithstanding the termination of AbbVie's licenses and other rights under this Agreement or with respect to a particular country or other jurisdiction, as the case may be, AbbVie shall have the right for one (1) year after the effective date of such termination with respect to the Terminated Territory to sell or othe... |
ARTICLE 14 MISCELLANEOUS |
14.1 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable contro... |
14.2 Change in Control of Parvus. |
14.2.1 Parvus (or its successor) shall provide AbbVie with written notice of any Change in Control of Parvus within two (2) Business Days following the closing date of such transaction. |
14.2.2 In the event of a Change in Control of Parvus where the acquiror is a Significant Biopharmaceutical Company and Parvus is the acquired Party, (a) Parvus shall comply with the terms of Section 6.6 (Confirmatory Patent License), and (b) AbbVie shall have the right, in its sole and absolute discretion, by written n... |
14.3 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information ... |
14.4 Assignment. |
14.4.1 Without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned, or delayed, neither Party shall sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its ri... |
14.4.2 The rights to Information, materials, and intellectual property: (a) controlled by a Third Party permitted assignee of a Party that were controlled by such assignee immediately prior to such assignment; or (b) controlled by an Affiliate of a Party who becomes an Affiliate through any Change in Control of such Pa... |
14.5 Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agree... |
14.6 Governing Law and Service. |
14.6.1 Governing Law. This Agreement and the performance, enforcement, breach and termination hereof shall be interpreted, governed by and construed in accordance with the laws of the State of New York, United States, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or ... |
14.6.2 Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 14.8.2 (Address for Notice) shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
14.7 Dispute Resolution. |
Except for disputes resolved by the procedures set forth in Sections 2.3.4 (General Provisions Applicable to the JGC—Dispute Resolution), 7.14 (Audit Dispute) or 14.11 (Equitable Relief), if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in ... |
14.7.1 General. Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resol... |
14.7.2 Intellectual Property Disputes. If a Dispute arises with respect to the validity, scope, enforceability, inventorship or ownership of any Patent, Trademark, or other intellectual property rights, and such Dispute cannot be resolved in accordance with Section 14.7.1 (Dispute Resolution—General), unless otherwise ... |
14.7.3 ADR. Any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth in Schedule 14.7.3 (ADR Procedures). |
14.7.4 Adverse Ruling. Any determination pursuant to this Section 14.7 (Miscellaneous— Dispute Resolution) that a Party is in material breach of its obligations hereunder shall specify a (non-exclusive) set of actions to be taken to cure such material breach, if feasible. |
14.7.5 Interim Relief. Notwithstanding anything herein to the contrary and without limiting Section 14.11 (Equitable Relief), nothing in this Section 14.7 (Miscellaneous—Dispute Resolution) shall preclude either Party from seeking interim or provisional relief from any court of competent jurisdiction, including a tempo... |
14.8 Notices. |
14.8.1 Notice Requirements. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand, (b) sent by facsimile transmission (with transmis... |
14.8.2 Address for Notice. |
If to AbbVie, to: AbbVie Group Investments Limited Thistle House 4 Burnaby Street Hamilton, HM11 Bermuda Attention: Executive Vice President, General Counsel and Corporate Secretary with a copy (which shall not constitute notice) to: 1 North Waukegan Road North Chicago, IL 60064 Attention: Vice Chairman, External Affai... |
If to Parvus, to: Parvus Therapeutics, Inc. 3655 36th St. NW Calgary, Alberta T2L 1Y8 Canada Attention: Chief Executive Officer Email: pstrumph@parvustx.com with a copy (which shall not constitute notice) to: Latham & Watkins, LLP 140 Scott Drive Menlo Park, CA 94025 U.S.A. Attention: Judith A. Hasko Email: judith.has... |
14.9 Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral... |
14.10 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between... |
14.11 Equitable Relief. Each Party acknowledges and agrees that the restrictions on Parvus set forth in Section 6.7 (Exclusivity) and Article 8 (Intellectual Property) and Article 10 (Confidentiality and Non-Disclosure) are reasonable and necessary to protect the legitimate interests of the other Party and that such ot... |
14.12 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. Th... |
14.13 No Benefit to Third Parties. Except as provided in Article 12 (Indemnity), covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons. |
14.14 Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party m... |
14.15 Relationship of the Parties. It is expressly agreed that Parvus, on the one hand, and AbbVie, on the other hand, shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture, or agency, including for all tax purposes. Neither Parvus, on the one h... |
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