Exhibit 10.5
[***] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and would be competitively harmful if publicly disclosed.
Execution Copy
DATED AS OF May 10, 2019
BY AND AMONG
THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA AND THE CHILDREN’S HOSPITAL OF PHILADELPHIA
AND
Eiger BioPharmaceuticals, INC.
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Article 1 |
| DEFINITIONS |
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Article 2 |
| LICENSES AND OTHER RIGHTS |
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Article 3 |
| DILIGENCE |
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Article 4 |
| FINANCIAL PROVISIONS |
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Article 5 |
| INTELLECTUAL PROPERTY |
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Article 6 |
| REPRESENTATIONS, WARRANTIES AND COVENANTS |
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Article 7 |
| INDEMNIFICATION; INSURANCE AND LIMITATION OF LIABILITY |
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Article 8 |
| TERM AND TERMINATION |
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Article 9 |
| ADDITIONAL PROVISIONS |
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EXHIBIT A |
| INSTITUTIONS PATENT RIGHTS |
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EXHIBIT B |
| LICENSED DATA |
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EXHIBIT C |
| CERTAIN FINANCIAL TERMS |
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APPENDIX I |
| FORM OF FINANCIAL REPORT |
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APPENDIX II |
| CLIENT AND BILLING AGREEMENT |
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Appendix III |
| Development plan |
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APPENDIX IV |
| FORM OF Sublicense Development Report |
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This License Agreement (this “Agreement”) is dated as of May 10, 2019 (the “Effective Date”) by and among The Trustees of the University of Pennsylvania, a Pennsylvania nonprofit corporation (“Penn”), The Children’s Hospital of Philadelphia (“CHOP”) (Penn and CHOP, collectively, “Institutions”), and Eiger BioPharmaceuticals, Inc., a Delaware corporation (“Licensee”). Institutions and Licensee may be referred to herein as a “Party” or, collectively, as “Parties”.
WHEREAS, Institutions own and control certain innovative technology for the therapeutic application of incretin antagonists in subjects with hypoglycemic disorders as further defined herein (Penn Reference [***], CHOP Reference [***]), that were developed by [***] (the “Inventor(s)”);
WHEREAS, Penn and CHOP each desire to license to Licensee, Institutions’ intellectual property rights in such technology, in a manner that will benefit the public and best facilitate the distribution of useful products and the utilization of new technology, consistent with Institutions’ educational and research missions and goals; and
WHEREAS, Licensee desires to license from Institutions, Institutions’ intellectual property rights in such technology, to develop, manufacture and commercialize such technology, all on the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the various promises and undertakings set forth herein, the Parties agree as follows:
Article 1
DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1.1 | “Achievement Date” means, with respect to a Diligence Event, the corresponding date such Diligence Event is to be achieved as provided in Exhibit C attached hereto subject to modification pursuant to Section 3.3 below. |
1.3 | “Clinical Trial” means any Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, Pivotal Clinical Trial or a variation or subset of such trials. |
1.5 | “Confidential Information” of a Party, means (i) information relating to the business, operations or products of a Party or any of its Affiliates, including any know-how, that such Party discloses to the other Party under this Agreement, or otherwise becomes known to the other Party by virtue of this Agreement, and (ii) the terms of this Agreement; provided that Confidential Information shall not include information that: |
| (a) | is or becomes generally available to the public other than as a result of disclosure by the recipient; |
| (b) | is already known by or in the possession of the recipient at the time of disclosure by the disclosing Party; |
| (c) | is independently developed by recipient without use of or reference to the disclosing Party’s Confidential Information; or |
| (d) | is obtained by recipient from a Third Party that has not breached any obligations of confidentiality. |
1.6 | “Controlled” means, with respect to intellectual property rights, that a Party or one of its Affiliates owns or has a license or sublicense to such intellectual property rights and has the ability to provide to, grant a license or sublicense to, or assign its right, title and interest in and to, such intellectual property rights as provided for in this Agreement without violating the terms of any agreement or other arrangement with any Third Party. |
1.7 | “Data Lock” means, with respect to a Clinical Trial being conducted by or on behalf of a Person, the locking (no additional data collected and no data is removed) by or on behalf of such Person of the database that contains the data collected from such Clinical Trial in a manner consistent with industry standards and Laws to enable data analysis and reporting of such Clinical Trial. |
1.8 | “Development Plan” means the development plan provided by Licensee to Penn that provides the activities, and the associated timelines of when such activities shall be conducted (including in detail the activities that shall be conducted in the calendar year following the submission of such Development Plan to Penn), in order to develop a Product for commercialization. The initial Development Plan is attached hereto as Appendix III. |
1.9 | “Diligence Event” means each of the events that Licensee is expected to accomplish in the development of a Product as provided in Exhibit C attached hereto. |
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1.11 | “First Commercial Sale” means, on a country-by-country basis, the first commercial transfer or disposition for value of Product in such country to a Third Party by Licensee, or any of its Affiliates or Sublicensees, in each case after all Governmental Approvals have been obtained for such country. |
1.12 | “GAAP” means United States generally accepted accounting principles applied on a consistent basis. |
1.13 | “Governmental Approval” means, with respect to a Product in a country or region, all approvals, clearances, licenses, registrations and authorizations of the relevant Governmental Body, if applicable, required for the commercialization of such Product in such country. |
1.14 | “Governmental Body” means any: (a) nation, principality, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, provincial, state, local, municipal, foreign or other government; (c) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or entity and any court or other tribunal); (d) multi-national or supranational organization or body; or (e) individual, entity, or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature. |
1.15 | “Indication” means a human disease or medical condition for which a separate Governmental Approval or a label expansion of a Governmental Approval can be obtained, provided that such separate Governmental Approval or label expansion (a) requires additional Clinical Trial(s), (b) is not solely to treat an expanded set of patients for the previously approved disease or medical condition, and (c) is not solely for use as a different line of therapy for the previously approved disease or medical condition. |
1.16 | “Initiation” means with respect to a Clinical Trial, first dosing of the first human subject in such Clinical Trial. |
1.18 | “Intellectual Property” means the Institutions Patent Rights. |
1.19 | “Law” or “Laws” means all applicable laws, statutes, rules, regulations, ordinances and other pronouncements having the binding effect of law of any Governmental Body. |
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1.21 | “[***]” means [***]. |
1.22 | “NDA” means a new drug application filed under Section 505 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), or similar application for Governmental Approval of a Product in the Field of Use submitted to a Governmental Body. |
1.23 | “Net Sales” means the gross consideration invoiced or received by Licensee or any of its Affiliates or Sublicensees for Sales of Product (including any cash amounts plus the fair market value of any other forms of consideration), less the following deductions [***] to the extent reasonable and customary and solely related to the sale of the Product(s): |
[***]
Even if there is overlap between any of deductions described above, each individual item shall only be deducted once in the overall Net Sales calculation. Each of the above deductions to Net Sales shall be calculated in accordance with US GAAP.
1.24 | “Patent Rights” means any of the following, whether existing now or in the future anywhere in the world: issued patent, including inventor's certificates, substitutions, extensions, confirmations, reissues, re-examination, renewal or any like governmental grant for protection of inventions, and any pending application for any of the foregoing. |
1.25 | “Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government or agency or political subdivision thereof. |
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1.30 | “Product” means any (a) process, service or method covered by a Valid Claim or whose use or practice would, absent the License, constitute an infringement, inducement of infringement or contributory infringement of any Valid Claim (“Method”), (b) article, composition, apparatus, substance, chemical or any other material covered by a Valid Claim or whose manufacture, import, use offer for sale or sale would, absent the License, constitute an infringement, inducement of infringement or contributory infringement of any Valid Claim; (c) service, article, composition, apparatus, chemical, substance or any other material imported, made, used or sold by or utilizing or practicing a Method; or (d) [***]. |
1.32 | “Sale” means any transaction for which consideration is received or expected by Licensee, its Affiliates or Sublicensees for sale, use, lease, transfer or other disposition of a Product to or for the benefit of a Third Party. For clarity, sale, use, lease, transfer or other disposition of a Product by Licensee or any of its Affiliates or Sublicensees to another of these entities for resale by such entity to a Third Party shall not be deemed a Sale. |
1.33 | “Sublicensee” means a Person (including any Affiliate) to which a Sublicense is granted pursuant to the terms of Section 2.4. |
1.34 | “Sublicense Documents” means any and all agreements, amendments or written understandings entered into with a Sublicensee (including any of its Affiliates) that [***]. For clarity, a [***] is a Sublicense Document. |
1.35 | “Sublicense Income” means income received by Licensee or its Affiliates in consideration for a Sublicense [***]. Sublicense Income includes income received from a Sublicensee in the form of license issue fees, milestone payments and similar payments but specifically excludes [***]. For clarity, a wholesaler or distributor that purchases Product in a bona fide arm’s length transaction from Licensee or its Affiliates or Sublicensees and with respect to which such Licensee, its Affiliates or Sublicensees do not receive additional consideration for such Sale from a wholesaler or distributor, such consideration for such purchase shall not be deemed to be a Sublicensing Income but shall be subject to a Royalty under Section 4.4; provided that, to the extent that any additional consideration is paid by any wholesaler or distributor to Licensee or its Affiliates or Sublicensees in connection with such Sale of Product, then any such additional consideration shall be deemed Sublicensing Income. In any event, any agreement entered into with a wholesaler or distributor for sales of Product shall be consistent with the following sections of this Agreement: Section 9.4 (Use of Names); and Article 7 (INDEMNIFICATION, INSURANCE AND LIMITATION OF LIABILITY). |
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1.37 | “Third Party” means any Person other than CHOP or Penn, Licensee or any of their respective Affiliates. |
1.38 | “United States” or “US” means the United States of America, its territories and possessions. |
1.39 | “USD” or “$” means the lawful currency of the United States of America. |
1.41 | Other Terms. The definition of each of the following terms is set forth in the section of the Agreement indicated below: |
Defined Term | Section |
Advance Payment | 5.2.3 |
Agreement | |
Bankruptcy Action | 8.3.5 |
Carve-Out Patent Rights | 5.1.2 |
Disclosure | |
Effective Date | |
Financial Report | 4.7 |
Historic Patent Cost | 5.2.1 |
Infringement Notice | 5.4.1 |
Inventor(s) | |
Issue Fee | 4.1 |
License | 2.1 |
7.1.1 | |
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Maintenance Fee | 4.2 |
Method | 1.30 |
Milestone | 4.3.1 |
Milestone Payment | 4.3.1 |
Minimum Annual Royalty | 4.4.6 |
Ongoing Patent Costs | 5.2.2 |
Parties | |
Party | |
Patent Costs | 5.2.1 |
Patent Counsel | 5.1.1 |
Patent Termination Notice | 5.3 |
Progress Reports | 3.4.1 |
Prosecution Request | 5.1.2 |
Royalty | 4.4.1 |
Sublicense | 2.4.1 |
Term | 8.1 |
Article 2
LICENSES AND OTHER RIGHTS
2.3 | U.S. Government Rights. The License is expressly subject to all applicable provisions of any license to the United States Government executed by either Penn, CHOP or Institutions and is subject to any overriding obligations to the United States Federal Government under 35 U.S.C. §§200-212, applicable governmental implementing regulations, and the U.S. Government sponsored research agreement or other guidelines, including that products that result from intellectual property funded by the United States Federal Government that are sold in the United States be substantially manufactured in the United States. In the event that Licensee believes in good faith that substantial manufacture of such product is not commercially feasible in the United States and makes a request to Penn in writing to assist in obtaining a waiver of such requirement from the United States Government, then Institutions shall, at the expense of Licensee, use reasonable efforts to assist in obtaining such waiver. In addition, Licensee acknowledges the obligations to the United States Federal Government under 37 Code of Federal Regulations, Part 401 and shall provide information to the extent necessary to satisfy any such applicable obligations to the United States Federal Government thereunder. |
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| (b) | Infringement and enforcement provisions with respect to the Institutions Patent Rights and Licensed Data that do not conflict with the restrictions and procedural requirements imposed on Licensee and do not provide greater rights to Sublicensee than those provided to Licensee as provided in Section 5.4. |
| (c) | Confidentiality provisions with respect to Confidential Information of Institutions consistent with the restrictions on Licensee in Section 5.6 of this Agreement. |
| (d) | Covenants by Sublicensee that are not less protective of the rights of Institutions than to those made by Licensee in Section 6.5. |
| (e) | A requirement of indemnification of Institutions by Sublicensee that is not less protective of the rights of Institutions to indemnification by Licensee under Section 7.1 of this Agreement. |
| (h) | A requirement of antidiscrimination by Sublicensee no less stringent than that provided in Section 9.5 of this Agreement. |
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Any Sublicense that does not include all of the terms and conditions set forth in this Section 2.4.2 or which is not issued in accordance with the terms and conditions set forth in this Section 2.4, shall be considered null and void with no further notice from Institutions.
| 2.4.4 | Licensee shall provide an [***] Sublicense Development Report on or before [***] during the Term (“SDR Report”) a form of which is attached hereto as Appendix IV. |
2.5 | No Implied License. Each Party acknowledges that the rights and licenses granted in this Agreement are limited to the scope expressly granted. Accordingly, except for the rights expressly granted under this Agreement, no right, title, or interest of any nature whatsoever is granted whether by implication, estoppel, reliance, or otherwise, by either Party to the other Party. All rights with respect to any know-how, patent or other intellectual property rights that are not specifically granted herein are reserved to the owner thereof. |
Article 3
DILIGENCE
3.1 | Development Plan. No later than [***] during the Term, Licensee shall submit to Penn an updated Development Plan, which shall include amendments and revisions to any long term development activities and detailed activities to be conducted in the following [***], provided that such updated Development Plan for a given Product shall not be due after the First Commercial Sale of that Product in the United States. |
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| 3.3.2 | Penn’s sole and exclusive remedy with respect to Licensee’s failure to achieve a Diligence Event by the corresponding Achievement Date shall be its right to terminate this Agreement. |
| 3.4.2 | Each Progress Report must include the following, to the extent applicable, for each annual period: |
| (a) | Summary of work completed, including against the Development Plan for such period; |
| (b) | Key scientific discoveries; |
| (c) | Summary of work in progress [***] on Product development; |
| (d) | Current schedule of anticipated events or milestones, including anticipated timeline for achievement of Diligence Events; |
| (e) | Market plans for introduction of Product; |
| (f) | An updated SDR that lists any and all Sublicenses granted by Licensee; |
| (g) | [***]; and |
| (h) | [***]. |
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4.3 | Milestone Payments. |
| 4.3.2 | Each time a Milestone is achieved, then any other applicable Milestone Payments with respect to earlier applicable Milestones that have not yet been paid will be due and payable together with the Milestone Payment for the Milestone that is actually achieved. |
If Licensee [***], Licensee shall deduct from the Royalties payable in a given calendar quarter [***] in such calendar quarter [***], provided that (a) [***].
| 4.4.2 | With respect to any Product whose manufacture, use, sale and import is [***], then the Royalty with respect to such Product shall be reduced by [***]. |
| 4.4.3 | Notwithstanding sections 4.4.2 and 4.4.3, the Royalty on Net Sales shall [***] on Net Sales of a Product during the Royalty Term for such Product. |
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| 4.4.4 | Licensee must pay Royalties owed to Penn on a calendar quarter basis on or before the following dates: |
| (a) | [***] for any Sales that took place on or before the last day of the calendar quarter ending [***], of the prior year; |
| (b) | [***] for any Sales that took place on or before the last day of the calendar quarter ending [***] of such calendar year; |
| (c) | [***] for any Sales that took place on or before the last day of the calendar quarter ending [***] of such calendar year; and |
| (d) | [***] for any Sales that took place on or before the last day of the calendar quarter ending [***] of such calendar year. |
| 4.5.1 | [***] for any Sublicense Income received by Licensee on or before the last day of the calendar quarter ending [***], of the prior year; |
| 4.5.2 | [***] for any Sublicense Income received by Licensee on or before the last day of the calendar quarter ending [***] of such calendar year; |
| 4.5.3 | [***] for any Sublicense Income received by Licensee on or before the last day of the calendar quarter ending [***] of such calendar year; and |
| 4.5.4 | [***] for any Sublicense Income received by Licensee on or before the last day of the calendar quarter ending [***] of such calendar year. |
4.6 | Mode of Payment and Currency. All payments to Penn hereunder shall be made by deposit of USD in the requisite amount to the “The Trustees of the University of Pennsylvania” and will be made by delivery to any one of the following: |
[***] | [***] |
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Payments under this Agreement shall be made in USD. All Royalties payable shall be calculated [***]. The exchange rate for such conversion shall be the average of the rate quoted in The Wall Street Journal for the last business day of each month in the calendar quarter for such Royalty payment made.
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| 4.7.1 | [***] |
Each Financial Report shall be in the form of the sample report attached hereto as Appendix I. Each Financial Report shall be the Confidential Information of Licensee.
4.8 | Late Payments. In addition to any other remedies available to Penn, including the right to terminate this Agreement, any failure by Licensee to make a payment within [***] after the date when due shall obligate Licensee to pay computed interest, the interest period commencing on the due date and ending on the actual payment date, to Penn at a rate per annum equal to [***] per month, or the highest rate allowed by Law, whichever is lower. |
4.9 | Default Payment. In the event of default in payment of any payment owing to Penn under the terms of this Agreement, and if it becomes necessary for Penn to undertake legal action to collect said payment, in the event that Licensee is found liable in a court of competent jurisdiction, then Licensee shall [***]. |
4.10 | Accounting. Each Party shall calculate all amounts, and perform other accounting procedures required, under this Agreement and applicable to it in accordance with GAAP. |
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underpayment; (b) shall reimburse Penn for the cost of the audit, [***]; and (c) provide such auditors with an audit right exercisable within [***] after Institutions receives the audit report. If the auditor finds overpayment by Licensee, then Licensee shall have the right to deduct the overpayment from any future Milestone Payments, Royalties, Minimum Annual Royalty or Institutions Sublicense Income due to Penn by Licensee or, if no such future Milestone Payments, Royalties, Minimum Annual Royalty or Institutions Sublicense Income are payable, then Penn shall refund the overpayment to Licensee within [***] after Penn receives the audit report. Licensee may designate competitively sensitive information which such auditor may see and review but which it may not disclose to Penn; provided, however, that such designation shall not restrict the auditor’s investigation or conclusions. |
4.13 | Taxes. All payments made by Licensee to Penn under the Agreement shall be made [***] Taxes on or with respect to such payments. |
Article 5
INTELLECTUAL PROPERTY
5.1 | Patent Filing Prosecution and Maintenance. |
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5.2 | Patent Costs. |
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If, with respect to an infringement or potential infringement described in an Infringement Notice, such infringement or potential infringement has not been abated within [***] (or within [***]) following the date of such Infringement Notice , then during the period in which, and in the jurisdiction where, [***] under the Institutions Patent Rights that are the subject of such infringement or potential infringement, Licensee shall have the first right, but not the obligation, to institute suit for patent infringement against the infringer after providing Penn [***]. For clarity, the information provided by Licensee to Institutions pursuant to the foregoing sentence shall be deemed the Confidential Information of Licensee and Institutions. Institutions may voluntarily join such suit at [***], but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of Licensee’s suit or any judgment rendered in such suit. Licensee may not join Institutions, unless Institutions are a necessary party, in a suit initiated by Licensee without Institutions’ prior written consent, such consent not to be unreasonably withheld, conditioned or delayed. If in a suit initiated by Licensee, Institutions are involuntarily joined other than by Licensee, then Licensee will [***], provided, however, that if [***]. Licensee shall be free to enter into a settlement, consent judgment or other voluntary disposition, provided that any settlement, consent judgment or other voluntary disposition that (i) limits the scope, validity or enforcement of Institutions Patent Rights or (ii) admits fault or wrongdoing on the part of Licensee or Institutions must be approved in advance by Institutions in writing. Licensee’s request for such approval shall include [***]. Institutions shall provide Licensee notice of its approval or denial within [***] of any request for such approval by Licensee, provided that [***].
| 5.4.3 | Notwithstanding Sections 5.4.1 and 5.4.2, in the event that any Institutions Patent Rights are infringed by a Third Party [***] regarding such infringement, the Parties |
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| shall discuss, and will mutually agree, in writing, as to how to handle such infringement by such Third Party. |
| 5.4.4 | The recovery or settlement paid in any infringement suit, if the patents subject to this Agreement are not the only patents enforced in such suit, will first be [***] the recovery or settlement amount received in connection with any suits herein, such determination to be made by an independent third party selected by mutual agreement of the Parties. |
| 5.4.5 | Any recovery or settlement received in connection with any suit involving the Institutions Patent Rights will first be [***] and next shall be [***]. Any remaining recoveries shall be allocated as follows: |
For any portion of the recovery or settlement attributed to the Institutions Patent Rights will, [***]:
| (a) | for any suit that is [***], Penn shall receive [***] of the recovery and the Licensee shall receive the remainder; and |
| (b) | for any suit that is [***]. The initiating party shall receive the remainder of any such recovery. |
For any portion of the recovery or settlement attributed to the Institutions Patent Rights will [***]:
| (c) | for any suit that is [***], Penn shall receive [***] and Licensee shall receive the remainder; and |
| (d) | for any suit that is [***], Penn shall receive [***] and Licensee shall receive the remainder. |
For any portion of the recovery or settlement received in connection with any suit that is [***], any recovery in excess of litigation costs will [***].
| 5.4.6 | Each Party will reasonably cooperate and assist with the other in litigation proceedings instituted hereunder but at the expense of the Party who initiated the suit (unless such suit is being jointly prosecuted by the Parties). For clarity, such requirement does not require a Party to join a suit unless otherwise specifically required under this Agreement. If Penn is subjected to third party discovery related to the Institutions Patent Rights or Products licensed to Licensee hereunder, Licensee will [***]. |
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| 5.6.2 | Notwithstanding Section 5.6.1, each Party may disclose the Confidential Information of the other Party to the extent such disclosure is reasonably necessary in the following instances: |
| (a) | preparing and submitting regulatory filings for Products that such Party has a license or right to develop and commercialize hereunder; |
| (c) | disclosure to its employees, agents, consultants, contractors, licensees, or Sublicensees, in each case on a need-to-know basis for the sole purpose of performing its obligations or exercising its rights under this Agreement, and in each case under written obligations of confidentiality and non-use consistent with those contained in this Agreement; |
| (d) | disclosure to potential and actual investors, acquirers, licensees, and other financial or commercial partners solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition, or collaboration, in each case under appropriate obligations of confidentiality and non-use consistent with those contained in this Agreement; or |
| (e) | required by Law or court order; provided, however, that the recipient promptly provides to the disclosing Party prior written notice of such disclosure and provides reasonable assistance in obtaining an order or other remedy protecting or limiting the Confidential Information from public disclosure. |
Article 6
REPRESENTATIONS, WARRANTIES AND COVENANTS
6.1 | Mutual Representations and Warranties. Each Party represents and warrants to the other Party that, as of the Effective Date: |
| 6.1.1 | such Party is duly organized and validly existing under the Laws of the jurisdiction of its incorporation or organization; |
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| 6.1.2 | such Party has taken all action necessary to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement; |
| 6.1.3 | this Agreement is a legal and valid obligation of such Party, binding upon such Party and enforceable against such Party in accordance with the terms of this Agreement, except as enforcement may be limited by applicable bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles; and |
| 6.1.4 | such Party has all right, power and authority to enter into this Agreement, to perform its obligations under this Agreement. |
Penn represents, through the Penn Center for Innovation to the Licensee that, to The Penn Center for Innovation’s knowledge, as of the time of signing this Agreement:
| 6.2.3 | Penn and CHOP have executed a written agreement granting Penn the right to administer Institutions Patent Rights and Licensed Data as provided herein; |
| 6.2.5 | Penn has not granted to any Third Party any license or other right with respect to the Penn’s Patent Rights that conflict with the License granted to the Licensee in this Agreement. |
6.3 | Additional CHOP Representations. |
CHOP represents, through its Office of Technology Transfer to the Licensee that, to its knowledge, at the time of signing this Agreement:
| 6.3.3 | CHOP has the lawful right to grant the license and other rights granted to the Licensee in this Agreement; and |
| 6.3.4 | CHOP has not granted to any Third Party any license or other right with respect to the Institutions Patent Rights or Licensed Data that conflict with the License or any other rights granted to the Licensee in this Agreement. |
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| 6.4.2 | Furthermore, nothing in this Agreement will be construed as: |
| (a) | A representation or warranty by Institutions as to the validity or scope of any Institutions Patent Right; |
| (b) | A representation or warranty that anything made, used, sold or otherwise disposed of under the License is or will be free from infringement of patents, copyrights, trademarks or any other forms of intellectual property rights or tangible property rights of Third Parties; |
| (c) | Obligating Institutions to bring or prosecute actions or suits against Third Parties for patent, copyright or trademark infringement; |
| (d) | Conferring by implication, estoppel or otherwise any license or rights under any Patent Rights of Institutions other than Institutions Patent Rights as defined herein, regardless of whether such Patent Rights are dominant or subordinate to Institutions Patent Rights; and |
| (e) | Obligating Institutions to furnish any know-how. |
| 6.5.1 | Licensee and its Affiliates will not, directly or indirectly (including where such is done by a Third Party on behalf of Licensee or its Affiliates, at the urging of Licensee or its Affiliates or with the assistance of the Licensee or its Affiliates) challenge the validity, scope, or enforceability of or otherwise oppose any Institutions Patent Right, provided that if any Institutions Patent Right is asserted against Licensee or its Affiliate for activities authorized under this Agreement, then such Licensee or its Affiliates is entitled to all and any defenses available to it including challenging the validity or enforceability of such Patent Right. |
| 6.5.3 | Licensee will not grant a security interest in any Institutions Patent Right licensed under this Agreement. |
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Article 7
INDEMNIFICATION; INSURANCE AND LIMITATION OF LIABILITY
| 7.1.3 | Notwithstanding Section 7.1.2 above, in the event that a reasonable and bona fide conflict exists between Licensee and Institutions or any other Institutions Indemnitee with respect to a claim or suit subject to indemnification hereunder, then Institutions or such other Institutions Indemnitee shall have the right to defend against any such claim or suit itself, including by selecting its own counsel, with any documented attorney’s fees and litigation expenses being paid for by Licensee. Licensee will pay such fees and expenses either directly or will reimburse Institutions within thirty (30) days of Licensee’s receipt of invoices for such fees and expenses. |
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| (a) | [***] |
Penn may review periodically the adequacy of the minimum amounts of insurance for each coverage required by this Section 7.2.1, and the Parties agree to discuss in good faith reasonable adjustments to such minimum amounts.
| 7.2.2 | If the above insurance is written on a claims-made form, it shall continue for [***] following termination or expiration of this Agreement. The insurance shall have a retroactive date of placement prior to or coinciding with the Effective Date of this Agreement. |
| 7.2.3 | Licensee expressly understands, however, that [***]. Licensee’s insurance will: |
| (a) | [***] |
| 7.2.4 | Licensee must furnish to Penn with (a) valid certificate of insurance evidencing compliance with all requirements of this Agreement and (b) additional insured endorsements for Licensee’s applicable policies naming “The Trustees of the University of Pennsylvania” as an additional insured. Licensee shall furnish both documents upon Penn’s reasonable request. |
7.3 | LIMITATION OF LIABILITY. |
IN NO EVENT SHALL EITHER PARTY OR ANY OF ITS AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, INCLUDING LOSS OF PROFITS, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE TRANSACTIONS CONTEMPLATED HEREIN OR ANY BREACH HEREOF. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS AGREEMENT SHALL LIMIT LICENSEE’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 7.1, OR SHALL LIMIT INSTITUTIONS REMEDIES OR ABILITY TO RECOVER DAMAGES, INCLUDING INCREASED DAMAGES, FOR WILLFUL INFRINGEMENT IN THE EVENT INSTITUTIONS ASSERT THEIR INTELLECTUAL PROPERTY RIGHTS.
Article 8
TERM AND TERMINATION
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8.3 | Termination For Cause. |
| 8.3.1 | If Licensee fails to fulfill its obligations under Section 3.2 (i.e. use Commercially Reasonable Efforts to develop and commercialize a Product), Penn may provide written notice to Licensee of such failure. If Licensee fails to address such failure to the reasonable satisfaction of Penn within three (3) months of receiving such written notice, Penn may terminate this Agreement upon written notice to Licensee; provided, however, that if the Parties mutually agree that such failure is incapable of being addressed to the reasonable satisfaction of Penn within three (3) months, then Licensee and Penn will confer and mutually agree on a reasonable extension to address such failure to the reasonable satisfaction of Penn. |
| 8.3.2 | In the event Licensee fails to achieve any Diligence Event by the corresponding Achievement Date subject to any delays or extensions in accordance with Section 3.3.1, Penn has the right and option to terminate this Agreement, upon written notice, with immediate effect. |
| 8.3.3 | If Licensee materially breaches any of its material obligations under this Agreement, Penn may give to Licensee a written notice specifying the nature of the default, requiring it to cure such breach, and stating its intention to terminate this Agreement. If such breach is not cured within sixty (60) days of such notice, such termination shall become effective upon a notice of termination by Institutions thereafter. For clarity, a breach of a material obligation includes: |
| (a) | [***] |
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| 8.4.1 | Notwithstanding the termination of this Agreement, the following provisions shall survive: Sections 4.7-4.12, inclusive, 5.6 and 8.4 and Articles 1, 6, 7 and 9. |
| 8.4.2 | Termination of this Agreement shall not relieve the Parties of any obligation or liability that, at the time of termination, has already accrued hereunder, or which is attributable to a period prior to the effective date of such termination. Termination of this Agreement shall not preclude either Party from pursuing all rights and remedies it may have hereunder or at Law or in equity with respect to any breach of this Agreement nor prejudice either Party’s right to obtain performance of any obligation. |
Article 9
ADDITIONAL PROVISIONS
9.1 | Relationship of the Parties. Nothing in this Agreement is intended or shall be deemed, for financial, tax, legal or other purposes, to constitute a partnership, agency, joint venture or employer-employee relationship between the Parties. The Parties are independent contractors and at no time will either Party make commitments or incur any charges or expenses for or on behalf of the other Party. |
9.3 | Third Party Beneficiary. The Parties agree that each Sublicensee is a third party beneficiary of this Agreement with respect to Section 8.4.3. |
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| 9.6.1 | The terms and provisions hereof shall inure to the benefit of, and be binding upon, the Parties and their respective successors and permitted assigns. |
| 9.6.3 | Any assignment not in accordance with this Section 9.6 shall be void. |
9.7 | Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments and to do all such other acts as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. |
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Any amendment that alters the rights or obligations of CHOP hereunder will also require the written consent of CHOP, as applicable.
9.9 | Governing Law. This Agreement shall be governed by and interpreted in accordance with the laws of the Commonwealth of Pennsylvania, excluding application of any conflict of laws principles that would require application of the law of a jurisdiction outside of the Commonwealth of Pennsylvania. |
9.10 | Dispute Resolution. If a dispute arises between the Parties concerning this Agreement, then the Parties will confer, as soon as practicable, in an attempt to resolve the dispute. If the Parties are unable to resolve such dispute amicably, then the Parties will submit to the exclusive jurisdiction of, and venue in, the state and Federal courts located in the Eastern District of Pennsylvania. |
9.11 | Notices and Deliveries. Any notice, request, approval or consent required or permitted to be given under this Agreement shall be in writing and directed to a Party at its address or facsimile number shown below or such other address or facsimile number as such Party shall have last given by notice to the other Party. A notice will be deemed received: if delivered personally, on the date of delivery; if mailed, five (5) days after deposit in the United States mail; if sent via courier, one (1) business day after deposit with the courier service; or if sent via facsimile, upon receipt of confirmation of transmission provided that a confirming copy of such notice is sent by certified mail, postage prepaid, return receipt requested. |
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9.12 | Waiver. A waiver by either Party of any of the terms and conditions of this Agreement in any instance shall not be deemed or construed to be a waiver of such term or condition for the future, or of any other term or condition hereof. All rights, remedies, undertakings, obligations and agreements contained in this Agreement shall be cumulative and none of them shall be in limitation of any other remedy, right, undertaking, obligation or agreement of either Party. |
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9.14 | Interpretation. The words “include,” “includes” and “including” shall be deemed to be followed by the phrase “without limitation.” All references herein to Articles, Sections, Schedules and Exhibits shall be deemed references to Articles and Sections of, Schedules and Exhibits to, this Agreement unless the context shall otherwise require. Except as otherwise expressly provided herein, all terms of an accounting or financial nature shall be construed in accordance with GAAP, as in effect from time to time. Unless the context otherwise requires, countries shall include territories. References to any specific Law or article, section or other division thereof, shall be deemed to include the then-current amendments or any replacement Law thereto. |
9.15 | Counterparts. This Agreement may be executed in counterparts, each of which will be deemed an original, and all of which together will be deemed to be one and the same instrument. A facsimile or a portable document format (PDF) copy of this Agreement, including the signature pages, will be deemed an original. |
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, duly authorized representatives of the Parties have executed this Agreement as of the Effective Date.
THE TRUSTEES OF THE UNIVERSITY |
| Eiger Biopharmaceuticals, Inc. | ||||
OF PENNSYLVANIA |
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By: |
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Name: |
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| Name: |
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Title: |
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| Eiger BioPharmaceuticals, Inc. |
THE CHILDREN’S HOSPITAL OF | ||
PHILADELPHIA | ||
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Name: |
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Title: |
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[Signature Page to License Agreement]
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Licensed Data
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Certain Financial Terms
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| Diligence Event | Achievement Date |
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Development & Commercialization |
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| • Licensee may extend any Achievement Date for a Diligence Event by [***] increments, but not more than [***] by making a [***] to Penn [***] of such Achievement Date for such Diligence Event. | |||
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| • Issue Fee. $1,000,000. | |||
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| • License Maintenance Fee. $[***]. | |||
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Certain Financial Terms |
| • Development Milestone Payments. Payable once per Product or if the same Product is developed for a second Indication once per Indication. | |||
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| • Sales Milestone Payments. Payable only once upon first achievement. | |||
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| • Royalty. [***] on all Net Sales of all Products. | |||
| • Minimum Annual Royalties. [***]. | ||||
| • Institutions Sublicense Income. | ||||
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Appendix I
Form of Financial Report
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Development Plan
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Form of Sublicense Development Report
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