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9.15 FTE Costs. |
9.15.1 FTE Records and Calculations. Each Party shall record and account for its FTE effort with respect to each ALS Product to the extent that such FTE efforts are included in Co-Development Costs, Regulatory Expenses, Allowable Expenses that are, or may in the future be, shared under this Agreement. Each Party shall ... |
9.15.2 Adjustment of FTE Rates. The FTE Rates applicable to activities undertaken by either Party pursuant to this Agreement are subject to annual adjustment (with the first of such adjustments to be made as of January 1, 2022 and each subsequent Calendar Year thereafter, but such adjustment determined no later than th... |
9.16 Other Invoiced Amounts. In the event that either Party (the "Invoicing Party") is owed amounts by the other Party (the "Invoiced Party") pursuant to this Agreement, other than pursuant to Section 9.6 or Section 9.14, including reimbursable amounts pursuant to Section 5.1.2 and Section 5.3.4(c) and amounts reimburs... |
9.17 Nonrefundability; Mode of Payment. All upfront payments, milestone payments (including Milestone Payments, Ophthalmology Milestone Payments and ALS Milestone Payments) and option payments made by either Party pursuant to Section 9.1, Section 9.3, Section 9.4, Section 9.5 and Section 9.10, as applicable, shall be n... |
9.18 Taxes. |
9.18.1 Withholding Taxes. Where any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, the Parties shall use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation... |
9.18.2 Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the "Indirect Taxes"). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments follow... |
9.19 Interest on Late Payments. If any payment due to either Party under this Agreement is not paid when due, then such paying Party shall pay interest thereon (before and after any judgment) at a rate per annum equal to the lesser of (a) the higher of (i) two percent (2%) per annum or (ii) one hundred (100) basis poin... |
9.20 Financial Records. AbbVie shall, and shall cause its Affiliates and its and their Sublicensees to, keep complete and accurate financial books and records pertaining to Development Costs, Regulatory Expenses, Allowable Expenses, and Net Sales, and Capsida shall, and shall cause its Affiliates and its and their Subl... |
9.21 Audit. |
9.21.1 Procedures. At the request of the other Party, each Party shall, and shall cause its Affiliates and its and their Sublicensees to, permit an independent auditor designated by the other Party and reasonably acceptable to the audited Party, at reasonable times and upon reasonable notice, to audit the books and rec... |
9.21.2 Audit Dispute. In the event of a dispute with respect to any audit under this Section 9.21, Capsida and AbbVie shall work in good faith to resolve the dispute. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be submitted for resol... |
9.21.3 Confidentiality. The receiving Party shall treat all information subject to review under this Article 9 in accordance with the confidentiality provisions of Article 11 and the Parties shall cause the Auditor to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such fi... |
9.22 Right to Offset. Each Party shall have the right to offset any amount owed by the other Party to such first Party under or in connection with this Agreement against any payments owed by such first Party to such other Party under this Agreement. Such offsets shall be in addition to any other rights or remedies avai... |
9.23 Diagnostic or Veterinary Products. The milestones and royalties in this Article 9 shall not apply to the Development and Commercialization of Licensed Products or Licensed Ophthalmology Products for diagnostic, veterinary or any other non-human use or for uses solely for screening patients who have been diagnosed ... |
ARTICLE 10<br>INTELLECTUAL PROPERTY |
10.1 Ownership of Intellectual Property. |
10.1.1 Ownership of IP. Subject to the license grants and other rights herein, including Capsida's assignment obligations under Section 3.4 and Section 10.1.2, as between the Parties, (a) all right, title and interest in and to all Know-How conceived, discovered, developed or otherwise made solely by or on behalf of Ca... |
10.1.2 Exceptions. |
(a) Capsida Platform IP. Notwithstanding Section 10.1.1, subject to the license grant in Section 8.1, as between the Parties, Capsida shall exclusively own all right, title and interest in and to any and all Capsida Platform IP, in each case regardless of which Party or any of its Affiliates or Sublicensees developed s... |
(b) Cargo IP. Notwithstanding Section 10.1.1, subject to the license grant in Section 8.2, as between the Parties, AbbVie shall exclusively own all right, title and interest in and to any and all Cargo IP, regardless of which Party or any of its Affiliates or Sublicensees developed such Cargo IP or whether such Cargo I... |
(c) Program IP. Notwithstanding Section 10.1.1, subject to the terms of this Agreement, including the license grants in Section 8.1 and Section 8.2, as applicable, the Parties each shall own an equal, undivided interest in any and all Program IP, regardless of which Party or its employees or agents developed such Progr... |
(d) Manufacturing IP. Notwithstanding Section 10.1.1, ownership of Manufacturing IP shall follow the inventorship of such Manufacturing IP. |
10.1.3 United States Law. The determination of inventorship and whether Know-How is conceived, discovered, developed or otherwise made by a Party for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property rights) therein, shall, for purposes of this Agreement, be made i... |
10.1.4 Assignment Obligation. Each Party shall cause its and its Affiliates' and its and their Sublicensees' employees and representatives, and shall use commercially reasonable efforts to cause any Third Party (other than a Sublicensee) who performs any activities for such Party under the Research Program or the POC P... |
10.1.5 Control of Intellectual Property. Neither Party shall enter into or amend any agreement with a Third Party, or include in any such agreement or amendment any restrictive provisions, with an intent to limit its Control of, or to not Control, any Know-How, Patent or other intellectual property right that would be ... |
10.2 Maintenance and Prosecution of Patents. |
10.2.1 Patent Prosecution and Maintenance of Capsida Background Patents, Capsida Platform Patents, Program Patents and Joint Patents. |
(a) Subject to Section 10.2.1(b), as between the Parties, (i) prior to the applicable Option Exercise Date, Capsida shall have the first right, but not the obligation, at its sole cost and expense, using counsel reasonably satisfactory to AbbVie, to Prosecute and Maintain the Program Patents, Joint Patents, and Manufac... |
(b) The Parties agree that it is to the benefit of both Parties and to the benefit of (i) the Licensed Product to have a Patent filed that solely claims a Selected Capsid without the AbbVie Cargo or (ii) the Licensed Ophthalmology Product to have a Patent filed that solely claims a Selected Ophthalmology Capsid without... |
(c) The Party with the first right to Prosecute and Maintain and conduct any Defense Proceedings with respect to any of the above Patents (the "First Party") shall timely notify the other Party as to any decision not to initiate or continue Prosecution and Maintenance of, or not to initiate or continue any Defense Proc... |
(d) Without limitation of the foregoing, the Party Prosecuting and Maintaining or conducting any Defense Proceeding with respect to, any of the above Patents (the "Prosecuting Party") shall (i) keep the non-Prosecuting Party reasonably informed of all material communications, actual and prospective filings or submissio... |
10.2.2 Patent Prosecution and Maintenance of Manufacturing Patents, AbbVie Background Patents, Cargo Patents, Capsida Background Patents and Capsida Platform Patents. As between the Parties, AbbVie shall have the sole right, but not the obligation, at its sole cost and expense (except to the extent any such cost or exp... |
10.2.3 UPC Opt-Out and Opt-In. The Parties shall coordinate in good faith and agree on any decision regarding whether or not to elect Opt-Out or Opt-In with respect to any Product-Specific Patent, Program Patent and Joint Patent; provided that after the applicable Option Exercise Date, AbbVie shall have the right to ma... |
10.2.4 Cooperation. With respect to the Capsida Background Patents, Capsida Platform Patents, AbbVie Background Patents, Cargo Patents, Program Patents, Manufacturing Patents and Joint Patents, the non-Prosecuting Party shall, and shall cause its Affiliates to, assist and cooperate with the Prosecuting Party, as the Pr... |
10.2.5 Patent Term Extension and Supplementary Protection Certificate. With respect to each Licensed Product and each Licensed Ophthalmology Product, AbbVie shall have the sole right to make decisions regarding, and AbbVie shall have the sole right, at its sole cost and expense (except to the extent any such cost or ex... |
10.2.6 Patent Listings. As between the Parties, with respect to each Licensed Capsid or Licensed Product and with respect to each Licensed Ophthalmology Capsid or Licensed Ophthalmology Product, AbbVie shall have the sole right to make all filings with Regulatory Authorities or other governmental authorities in the Ter... |
10.3 Enforcement of Patents. |
10.3.1 Notice. Each Party shall promptly notify the other Party in writing of any knowledge it acquires of any alleged or threatened infringement of the Capsida Background Patents, Capsida Platform Patents, Program Patents, Joint Patents or Product-Specific Patents based on the Exploitation of any product containing (a... |
10.3.2 Actions. |
(a) Capsida Background Patents, Capsida Platform Patents, Program Patents and Joint Patents. If any Capsida Background Patent, Capsida Platform Patent, Program Patent or Joint Patent is infringed by a Third Party in any country in the Territory, then, as between the Parties, (i) prior to the applicable Option Exercise ... |
(b) AbbVie Background Patents; Cargo Patents. If any AbbVie Background Patent or Cargo Patent is infringed by a Third Party in any country in the Territory, then, as between the Parties, AbbVie shall have the sole right, but not the obligation, to institute, prosecute, and control any suit, claim or proceeding against ... |
(c) Biosimilar Litigation. Notwithstanding anything to the contrary in this Agreement, AbbVie shall have the first right, but not the obligation, to prosecute, manage and settle any litigation with respect to Biosimilar Products or any product sought to be approved as Biosimilar Product, and any proceedings associated ... |
10.3.3 Cooperation. The Parties agree to cooperate fully in any action pursuant to Section 10.3.2 including, by making the inventors, applicable records and documents (including laboratory notebooks) of the relevant Patents available to the controlling Party upon such Party's request. Where a Party controls such an act... |
10.3.4 Recovery. Except as otherwise agreed by the Parties in writing, any recovery realized as a result of such litigation described above in this Section 10.3.4 (whether by way of settlement or otherwise) shall be first allocated to reimburse the Parties for their costs and expenses in making such recovery (which amo... |
10.4 Invalidity or Unenforceability Defense or Actions. With respect to any challenge (including via declaratory judgement actions) against the validity or enforceability of a Capsida Background Patent, Capsida Platform Patent, AbbVie Background Patent, Cargo Patent, Program Patent or Joint Patent, excluding any challe... |
10.5 Infringement Claimed by Third Parties. |
If a Third Party commences, or threatens to commence, any proceeding against a Party alleging infringement of such Third Party's intellectual property by the Exploitation by a Party, its Affiliates, subcontractors, Sublicensees, Distributors or customers of any Licensed Capsid or Licensed Product or any Licensed Ophtha... |
Without limiting the right of the Party against whom a Third Party Infringement Claim is filed to seek indemnification for such Third Party Infringement Claim covered pursuant to Article 13 as between the Parties, the alleged infringing Party shall have the right, but not the obligation, at its sole cost and expense, u... |
10.6 Third Party Licenses and Patents. If in the reasonable opinion of AbbVie, it is necessary or useful for the Exploitation of any Licensed Capsid, Licensed Product, Licensed Ophthalmology Capsid or Licensed Ophthalmology Product under this Agreement to obtain rights in any Patent, trade secret, or other intellectual... |
10.7 Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Party's inventors under any applicable inventor remuneration laws. |
10.8 International Nonproprietary Name. As between the Parties, AbbVie shall have the sole right and responsibility to select the International Nonproprietary Name or other name or identifier for any Licensed Product or any Licensed Ophthalmology Product or any component thereof. AbbVie shall have the sole right and re... |
10.9 Common Interest. All information exchanged between the Parties regarding the prosecution, maintenance, enforcement and defense of Patents under this Article 10 will be deemed to be Confidential Information of the disclosing Party. In addition, the Parties acknowledge and agree that, with regard to such prosecution... |
10.10 Product Trademarks. |
10.10.1 Ownership of Product Trademarks. As between the Parties, AbbVie shall have the sole right to determine and shall own all right, title and interest in and to the Trademarks that are used in connection with any Licensed Product or with any Licensed Ophthalmology Product (the "Product Trademarks") on a worldwide b... |
10.10.2 Enforcement of Product Trademarks. As between the Parties, AbbVie shall have the sole right to take such action as AbbVie, after consultation with Capsida with respect to the ALS Product in the U.S., deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misapp... |
10.10.3 Third Party Claims. As between the Parties, AbbVie shall have the sole right to defend against (including the right to settle) 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 viola... |
10.10.4 Notice and Cooperation. Capsida shall, and shall cause its Affiliates and its and their Sublicensees to, (a) provide 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 Terri... |
ARTICLE 11<br>CONFIDENTIALITY AND NON-DISCLOSURE |
11.1 Confidentiality Obligations. |
11.1.1 At all times during the Term, except as otherwise set forth in Section 14.5, and for a period of ten (10) years following termination or expiration of this Agreement in its entirety (and thereafter with respect to any Confidential Information that either Party specifically identifies to the other Party in writin... |
11.1.2 Notwithstanding Section 11.1.1, the confidentiality and non-use obligations under this Article 11 shall not apply to the extent that it can be established by the Receiving Party that such Confidential Information: |
(a) was in the lawful knowledge and possession of the Receiving Party prior to the time it was first disclosed to the Receiving Party by the Disclosing Party, or was otherwise developed independently by the Receiving Party without reference to any of the Disclosing Party's Confidential Information, in each case as evid... |
(b) was generally available to the public or otherwise part of the public domain at the time of its first disclosure to the Receiving Party by the Disclosing Party; |
(c) became generally available to the public or otherwise part of the public domain by public use, publication, general knowledge or the like after its disclosure to the Receiving Party by the Disclosing Party and other than through any act or omission of the Receiving Party in breach of this Agreement or the Existing ... |
(d) was disclosed to the Receiving Party by a Third Party who had no obligation to the Disclosing Party or to any Third Party not to disclose such information to others. |
Specific aspects or details of Confidential Information shall not be deemed to be generally available to the public or otherwise part of the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information that is generally available to the pu... |
For the avoidance of doubt, any information disclosed by a Party or any of its Affiliates to the other Party or any of its Affiliates prior to the Effective Date pursuant to the Bilateral Confidential Disclosure Agreement between Capsida and AbbVie dated as of June 17, 2020, or the Confidential Disclosure Agreement bet... |
11.2 Permitted Disclosures. A Receiving Party may use and disclose Confidential Information of the Disclosing Party to the extent that such disclosure is: |
11.2.1 made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the receiving Party's legal counsel and subject to Section 11.5, s... |
11.2.2 made by or on behalf of the receiving Party to a patent authority as may be (a) reasonably necessary for purposes of preparing, filing or obtaining a Patent or (b) reasonably necessary or useful for enforcing a Patent; provided, however, that reasonable measures shall be taken to assure confidential treatment of... |
11.3 Additional Permitted Disclosures. AbbVie and its Affiliates and its and their Sublicensees may disclose and use Confidential Information of Capsida to the extent necessary or reasonably useful to Exploit the Licensed Products or the Licensed Ophthalmology Products (including in connection with any filing, applicat... |
11.4 Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo or Trademark of the other Party or any of its Affiliates or any of its or their Sublicensees (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional materia... |
11.5 Public Announcements. Capsida issued a press release to announce the execution of the Original Agreement, substantially in the form attached hereto as Schedule 11.5A. In connection with the Ophthalmology Program, the Parties have agreed upon the content of one joint press release which shall be issued substantiall... |
11.6 Publications. Subject to the remainder of this Section 11.6, (a) neither a Party nor its Affiliates shall make any publication or public disclosure regarding a Reserved Capsid, Selected Capsid, Research Product, Licensed Capsid, Licensed Product, Reserved Ophthalmology Capsid, Selected Ophthalmology Capsid, Ophtha... |
ARTICLE 12<br>REPRESENTATIONS AND WARRANTIES |
12.1 Mutual Representations and Warranties. Capsida and AbbVie each represents and warrants to the other, as of the Original Agreement Effective Date and the Effective Date: |
12.1.1 such Party is duly organized, validly existing and in good standing under the Laws 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; |
12.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; |
12.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor ... |
12.1.4 the execution, delivery and performance of this Agreement by such Party do not conflict with and do not violate: (a) such Party's charter documents, bylaws or other organizational documents; (b) in any material respect, any agreement or any provision or obligation thereof, or any instrument or understanding, ora... |
12.1.5 it is not under any obligation, contractual or otherwise, to any Person that, to its Knowledge, would materially impede the diligent and complete fulfillment of its obligations hereunder; |
12.1.6 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable Laws currently in effect, is or will be necessary for, or in connection with, ... |
12.1.7 neither Party nor any of its Affiliates has been debarred or is subject to debarment pursuant to Section 306 of the FFDCA or who is the subject of a conviction described in such section. |
12.2 Representations, and Warranties of Capsida for the Neurology Program. Capsida hereby represents and warrants to AbbVie with respect to the Neurology Program as of the Effective Date: (a) except as set forth in Schedule 12.2 attached hereto (the "Neurology Initial Disclosure Schedule") as of the Effective Date; and... |
12.2.1 Capsida is entitled to grant the licenses specified herein. Except with respect to the Existing In-License Agreements as set forth on Schedule 12.2.1 and any Future Capsida In-License Agreements to the extent agreed by AbbVie pursuant to Section 8.4.2 under the Original Agreement or Section 8.4.2 of this Agreeme... |
12.2.2 Except with respect to the sequence of an AbbVie Cargo that may be encoded thereby (with respect to which Capsida is making no representation or warranty under this Section 12.2.2), (a) the conduct of the Research Program and the POC Plan and (b) to the Knowledge of Capsida, (i) the Exploitation of the Program C... |
12.2.3 The conduct of the Research Program and the Research, Development, Manufacture or Commercialization of the Program Capsids, Reserved Capsids, Selected Capsids, Licensed Capsids or Licensed Products as contemplated herein are not, and to its Knowledge will not be, subject to any license or agreement (other than t... |
12.2.4 All Capsida Background Patents and Capsida Platform Patents existing as of such date (collectively, the "Existing NP Patents") are listed on Schedule 12.2.4 (as such schedule may be supplemented in connection with any Updated Disclosure Schedule) and identified as Capsida Managed Patents or Third Party Managed P... |
12.2.5 all Existing In-License Agreements and any Future Capsida In-License Agreements that were entered into pursuant to Section 8.4.2 under the Original Agreement (and all modifications to, amendments of or waivers with respect to any of the foregoing agreements) and, as of the applicable Neurology Option Bringdown D... |
12.2.6 All of the Existing In-License Agreements, and, as of the applicable Neurology Option Bringdown Date, all Future Capsida In-License Agreements, are listed on Schedule 12.2.1 (as such schedule may be supplemented in connection with the delivery of any Updated Disclosure Schedule), and (a) to Capsida's Knowledge, ... |
12.2.7 Neither Capsida nor any of its Affiliates has entered into any agreement, whether written or oral, that (a) assigns, transfers, licenses, conveys or otherwise encumbers (including by granting a covenant not to sue with respect to) Capsida's right, title or interest in or to, or (b) grants any Third Party any rig... |
12.2.8 No claim or litigation has been brought or asserted by a Third Party in writing (and Capsida has no Knowledge of any claim, whether or not brought or asserted by a Third Party in writing) alleging that (a) the issued patents in the Existing NP Patents, the Capsida Background Patents or the Capsida Platform Paten... |
12.2.9 Except as described in the In-License Agreements previously provided to AbbVie, there are no amounts that will be required to be paid to a Third Party as a result of (a) the Exploitation of the Capsida Platform and Capsida Platform IP in Capsida's conduct of the Research Program or the POC Plan or (b) the Exploi... |
12.2.10 To Capsida's Knowledge, no Person is infringing or threatening to infringe, or misappropriating or threatening to misappropriate, the Existing NP Patents, the Capsida Background Know-How, the Capsida Platform IP or any Capsida NP Regulatory Filings, in each case in a manner that would affect AbbVie's rights und... |
12.2.11 Each of the Capsida Managed Patents and, to Capsida's Knowledge, each of the Third Party Managed Patents, properly identifies, or when issued will identify, each and every inventor of the claims thereof as determined in accordance with the Applicable Law of the jurisdiction in which such Existing NP Patent is i... |
12.2.12 (a) There are no pending, and to Capsida's Knowledge, there are no alleged or threatened, (i) inter partes reviews, post-grant reviews, interferences, re-examinations or oppositions involving the Capsida Managed Patents that are in or before any patent authority (or other governmental authority performing simil... |
12.2.13 With respect to the Patents licensed to AbbVie under Section 8.1, except to the extent any such Patent is in-licensed by Capsida or any of Capsida's Affiliates, all named inventors of such Patents have properly assigned to Capsida (or to an Affiliate or Third Party that assigned to Capsida) each such inventor's... |
12.2.14 To Capsida's Knowledge, other than inventions and intellectual property licensed under the CalTech License Agreement, the inventions covered by the Existing NP Patents (a) were not conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the f... |
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