Execution Version
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Exhibit 10.46
Revenue Interest Financing Agreement
This Revenue Interest Financing Agreement (this “Agreement”) is entered into as of November 4, 2022 (the “Effective Date”), between FibroGen, Inc., a Delaware corporation having an address of 409 Illinois Street, San Francisco, CA 94158 (“Company”) and NQ Project Phoebus, L.P., a Delaware limited partnership having an address of 4208 Six Forks Road, Suite 920 Raleigh, NC 27609 (“NovaQuest”). Company and NovaQuest are each referred to herein by name or, individually, as a “Party” or, collectively, as “Parties.”
Introduction
A. Company researches, develops, and commercializes products for the treatment of human diseases, disorders, and conditions.
B. Company has previously entered into certain agreements with Astellas (as defined below), pursuant to which, among other things, Company granted Astellas a license to commercialize the Product (as defined below) in the Territory (as defined below) and Company receives certain payments from Astellas in connection therewith.
C. In consideration of the Investment Amount (defined below), NovaQuest and Company desire for NovaQuest to be granted an undivided percentage interest in Company’s revenue received under the Astellas Agreements (defined below) and for Company to make certain payments to NovaQuest as set forth herein, all subject to the terms and conditions of this Agreement.
D. As a material inducement for NovaQuest’s entry into this Agreement, the Company has agreed to grant to NovaQuest a security interest in the Collateral, as set forth in this Agreement.
NOW, THEREFORE, in consideration of the premises and mutual covenants herein below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
DEFINITIONS
“2022 Royalty Dates” has the meaning set forth in Section 4.1.
“AAA” has the meaning set forth in Section 11.2(b).
“AAA Rules” has the meaning set forth in Section 11.2(b).
[*].
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
“Acquiring Party” means a Third Party that obtains control of Company in connection with a Change of Control of Company. For purposes of this definition, the term “control” shall have the meaning set forth in the definition of Affiliate.
“Act” means, collectively, the United States Federal Food, Drug, and Cosmetic Act of 1938, including any amendments thereto, and all regulations promulgated thereunder and any successor laws.
“Affiliate” means, with respect to an entity, any business entity controlling, controlled by, or under common control with, such entity, but only for so long as such control exists. For the purposes of this definition, “controlling,” “controlled,” and “control” mean the possession, directly (or indirectly through one or more intermediary entities), of the power to direct the management or policies of an entity, including through ownership of fifty percent (50%) or more of the voting securities of such entity (or, in the case of an entity that is not a corporation, ownership of fifty percent (50%) or more of the corresponding interest for the election of the entity’s managing authority). Notwithstanding the foregoing, for purposes of this Agreement, NovaQuest Capital Management, L.L.C. shall be deemed to have no control Persons.
“Agreement” has the meaning set forth in the preamble hereto.
“Applicable Law” means any applicable law, rule, or regulation of any Governmental Authority, or judgment, order, writ, decree, permit, or license of any Governmental Authority.
“Arbitration” has the meaning set forth in Section 11.2(b).
“Arbitrator” has the meaning set forth in Section 11.2(c).
“Astellas” means Astellas Pharma Inc., a Japanese corporation with a principal place of business at 3-11 Nihonbashi-Honcho, 2-Chome, Chuo-ku, Tokyo, 103-8411 Japan.
“Astellas Agreement” means each or any of the Astellas EMEA Agreement or the Astellas Japan Agreement. “Astellas Agreements” means both of the foregoing, collectively.
“Astellas EMEA Agreement” means (a) that certain Anemia License and Collaboration Agreement by and between Astellas Pharma Inc. and FibroGen, Inc. dated April 28, 2006, as amended and supplemented by that certain Amendment to Anemia License and Collaboration Agreement, dated August 31, 2006, that certain Amendment No. 2, dated December 1, 2006, and that certain Amendment No. 3, dated May 10, 2012, attached hereto as Exhibit B, and as may be further amended from time to time in accordance with this Agreement and (b) that certain Astellas EU Supply Agreement dated Jan 1, 2021, as amended (“Astellas EMEA Supply Agreement”).
“Astellas EMEA Revenue” means, [*].
“Astellas Japan Agreement” means that certain Collaboration Agreement by and between Astellas Pharma Inc. and FibroGen, Inc. dated June 1, 2005, as amended January 1, 2013, attached hereto as Exhibit C, and as may be further amended from time to time in accordance with this Agreement.
“Astellas Japan Revenue” means, [*].
“Astellas Other Revenue” means [*].
“Astellas Revenue” means, collectively, the Astellas EMEA Revenue, the Astellas Japan Revenue and the Astellas Other Revenue.
“Bankruptcy Event of Default” means any of: (a) the liquidation or dissolution of Company; (b) a Voluntary Bankruptcy; or (c) an Involuntary Bankruptcy
“Bankruptcy Laws” means, collectively, bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, fraudulent transfer, or other similar laws affecting the enforcement of creditors’ rights generally.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
“Business Day” means any day other than Saturday, Sunday, or any day on which banking institutions located in the State of New York are permitted or obligated by law to close.
“Change of Control” means, with respect to Company a transaction with one or more Third Parties that is: (a) a merger, share exchange, or other reorganization of Company; (b) the sale, by one or more stockholders or holders of equity securities, of stock or equity securities representing a majority of the voting power of Company; or (c) the sale or exclusive license of all or substantially all of the assets of the Company, or a sale of Company’s business and assets related to the Product; or (d) the acquisition of majority control of the board of directors or equivalent governing body of Company, for which, in each of cases of clauses (a) and (b) of this definition, the stockholders or holders of other equity securities of Company prior to such transaction do not own a majority of the voting power of the acquiring, surviving, or successor entity, as the case may be.
“Collateral” means the Revenue Interest Collateral and the Product IP Rights.
“Collateral Revenue Interests” means, in each case, as further described in Section 4.1(a) (i) twenty-two and one-half percent (22.5%) of each of the Astellas EMEA Revenue, Astellas Japan Revenue and Replacement Net Sales Revenue, (ii) from the Effective Date and through Fiscal Year 2027, ten percent (10%) of Astellas Other Revenue, (iii) for Fiscal Year 2028 and all Fiscal Years thereafter, twenty percent (20%) of Astellas Other Revenue , (iv) for Fiscal Years prior to 2028, ten percent (10%) of Replacement Other Revenue, and (v) for Fiscal Year 2028 and all Fiscal Years thereafter, twenty percent (20%) of Replacement Other Revenue.
“Commercially Reasonable Efforts” means, [*].
“Commercialize” or “Commercialization” means any and all activities directed to marketing, promoting, distributing, importing, exporting, offering to sell, or selling the Product, including commercial manufacturing activities.
“Company” has the meaning set forth in the preamble hereto.
“Company Competitor” means any Person that, in the Fiscal Year preceding the date of determination, derived more than [*]) of its revenue from its or its Affiliates’ direct sales of pharmaceutical products.
“Compound” means Roxadustat, as more particularly described in Exhibit D.
“Confidential Information” has the meaning set forth in Section 6.1.
“Cover” means that the use, manufacture, sale, offer for sale, development, commercialization, or importation of the subject matter in question by an unlicensed entity would infringe a claim of an issued Patent, or a claim, if issued, of a patent application that constitutes a Patent.
“Custodian” means any receiver, trustee, assignee, liquidator, custodian, or similar official under any Bankruptcy Law.
“Data Room” has the meaning set forth in Section 5.4.
“Default” means any event that, with the giving of notice or passage of time, or both, could result in an Event of Default.
“Defaulting Party” has the meaning set forth in Section 8.6(d)(iii).
“Diligence Expenses” means NovaQuest’s reasonable and documented out-of-pocket legal fees, due diligence expenses, and other reasonable and documented out-of-pocket expenses relating to the Transaction Documents that have been incurred up to and on the Effective Date, up to [*].
“Dispute” has the meaning set forth in Section 11.2(a).
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
“Dispute Notice” has the meaning set forth in Section 11.2(a).
“Dollars” or “$” means U.S. dollars.
“Effective Date” has the meaning set forth in the preamble hereto.
“Encumbrance” means any lien, charge, security interest, mortgage, option, privilege, pledge, right of first refusal, hypothecation, adverse ownership interest, charge, trust or deemed trust (whether contractual, statutory, or otherwise arising), or any other encumbrance, right, or claim of any other Person of any kind whatsoever whether choate or inchoate. “Encumber” means to restrict, impose, suffer, or otherwise create any Encumbrance.
“ESG Questionnaires” has the meaning set forth in Section 5.4.
“Event of Default” means each or any of: (a) any Bankruptcy Event of Default; (b) the breach by Company of any material payment obligations under Section 4.1 of this Agreement, which failure to pay continues for more than [*] after receipt by Company of written notice from NovaQuest; (c) except as set forth in clause (b) of this definition, the breach by Company of any of its obligations under this Agreement, where written notice of such breach has been provided by NovaQuest to Company and Company has not cured such breach within [*] following receipt of such notice and where such breach, if not cured, would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; (d) breach by Company of any of its respective obligations under any Astellas Agreement, and which breach, if curable, is not cured within [*] following receipt by Company of written notice of such breach and where such breach, if not cured, would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; and (e)(i) [*].
“Event of Default Fee” means [*].
“Event of Default Payment Date” has the meaning set forth in Section 8.3(a).
“FDA” means the United States Food and Drug Administration, or any successor agency thereto.
“Fiscal Quarter” means each of the following three (3)‑month periods during each Fiscal Year: January 1 through March 31; April 1 through June 30; July 1 through September 30; and October 1 through December 31.
“Fiscal Year” means the twelve (12)‑month period from January 1 through December 31.
“GAAP” means U.S. generally accepted accounting principles, as in effect on the date or for the period with respect to which such standards are applied.
“Governmental Authority” means any national, supra‑national (e.g., the European Commission or the Council of the European Union), federal, state, local, or foreign court or governmental agency, authority, instrumentality, regulatory body, department, bureau, political subdivision, or other governmental entity (including the FDA, the European Medicines Agency, the Japanese Ministry of Health, Labour and Welfare or Pharmaceuticals and Medical Devices Agency, and the Medicines and Health Products Regulatory Agency, as well as any similar regulatory body in any country in the Territory) or any arbitrational tribunal, in each case of a competent jurisdiction, including any such authority that is responsible for taxation or for issuing approvals, licenses, registrations, or authorizations necessary for the manufacture, import, sale, pricing, or use of the Product for human therapeutic use in any applicable regulatory jurisdiction.
“Gross‑Up Amount” has the meaning set forth in Section 4.3(a).
“GxP” means all relevant Governmental Authority requirements for: (a) current Good Clinical Practices for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials; (b) current Good Laboratory Practice for laboratory activities for pharmaceuticals; and (c) current Good Manufacturing Practices, including in each case, as set forth in Title 21 of the United States Code of Federal Regulations.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
“IFRS” means international accounting standards, as in effect on the date or for the period with respect to which such standards are applied, as established by the International Financial Reporting Standards.
“Indebtedness” means, with respect to a Person: (a) all obligations of such Person for borrowed money; (b) all obligations of such Person evidenced by a note, bond, debenture, or similar instrument; (c) all obligations of such Person upon which interest charges are customarily paid; (d) all obligations of such Person under conditional sale or other title retention agreements relating to property acquired by such Person; (e) all obligations of such Person in respect of the deferred purchase price of property or services (excluding deferred compensation and accounts payable incurred in the ordinary course of business and not overdue by more than [*]; (f) all Indebtedness as described in clauses (a) through (e) or clauses (h) through (l) of others secured by (or for which the holder of such indebtedness has an existing right, contingent or otherwise, to be secured by) any Lien on property owned or acquired by such Person if the Indebtedness secured thereby has been assumed; (g) all guarantees by such Person of Indebtedness as described in clauses (a) through (e) or clauses (h) through (l) of others; (h) all capital lease obligations of such Person; (i) all obligations, contingent or otherwise, of such Person as an account party in respect of letters of credit and letters of guaranty; (j) all net obligations of such Person under any interest rate exchange agreement, foreign currency exchange agreement, commodity price protection agreement, currency swap, forward, future or derivative transactions or other interest or currency exchange rate or commodity price hedging arrangement; (k) all obligations, contingent or otherwise, of such Person in respect of bankers’ acceptances; and (l) any disqualified equity interests of such Person.
“Indemnified Party” has the meaning set forth in Section 10.2(a).
“Investment Amount” has the meaning set forth in Section 3.1(a).
“Investor Return Payment” means each or any of the Revenue Interest Payments, True-Up Payments, or Event of Default Fee. “Investor Return Payments” means all of the foregoing, collectively.
“Investor Return Payment Satisfaction” has the meaning set forth in Section 4.1(e).
“Involuntary Bankruptcy” means a court of competent jurisdiction enters an order or decree under any Bankruptcy Law that: (a) is for relief against Company in an involuntary case; (b) appoints a Custodian of Company or for any substantial part of its property; or (c) orders the winding up or liquidation of Company; or any similar relief is granted under any non-U.S. laws, and in each case ((a)–(c)), such order or decree remains unstayed and in effect for [*].
“Knowledge of Company” or “Knowledge” means the actual knowledge, after making reasonable inquiry, of [*].
“Liabilities” means any and all indebtedness, liabilities, and obligations, whether accrued, fixed, or contingent, mature or inchoate, known or unknown, reflected on a balance sheet or otherwise, including those arising under any law or judgment of any court of any kind or any award of any arbitrator of any kind, and those arising under any contract, commitment, or undertaking.
“License” means a grant of any Product IP Rights or Regulatory Approvals for making, developing, Commercializing or otherwise exploiting the Product in the Territory. For the avoidance of doubt: (a) the Astellas EMEA Agreement is a License; (b) the Astellas Japan Agreement is a License; and (c) any Replacement Agreement shall be a License.
“Licensee” means a Third Party or an Affiliate of Company that is granted a License, by Company, an Affiliate of Company, or another Licensee. For the avoidance of doubt: (a) Astellas is a Licensee and (b) any Third Party that enters into a Replacement Agreement with Company or with any Affiliate of Company shall be a Licensee.
“Lien” means any mortgage, lien, pledge, participation interest, charge, adverse claim, security interest, encumbrance or restriction of any kind, whether voluntarily incurred and arising by operation by law or otherwise, including any restriction on use, transfer or exercise of any other attribute of ownership of any kind.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
“Loss” has the meaning set forth in Section 10.1.
“Material Adverse Effect” means any material adverse effect on: (a) the ability of the Company to make the Revenue Interest Payments required to be made by this Agreement; (b) the Commercialization of the Product in the Territory; (c) for the purpose of Section 7.1 only, any of the Product IP Rights, including Company’s rights in or to any Product IP Rights; (d) for the purpose of Section 7.1 only, any Regulatory Approval granted prior to the Effective Date for the Product in the Territory; (e) for the purpose of Section 7.1 only, the legality, validity, or enforceability of any Astellas Agreement or Transaction Document; (f) the ability of Company to perform any of its material obligations under any Astellas Agreement or Transaction Document, or to consummate the transactions contemplated hereby or thereby; or (g) the rights or remedies of NovaQuest under any Transaction Document.
“Material Contract” means: (a) any agreement to which Company or any Affiliate of Company is a party and is material to the Commercialization of the Product in the Territory; or (b) any other agreement to which Company or any Affiliate of Company is a party for which breach, non-performance, or failure to renew by a Responsible Party could reasonably be expected to result in a Material Adverse Effect; [*].
“NDA” means a new drug application (as defined in Title 21 of the U.S. Code of Federal Regulations, as amended from time to time) submitted to the FDA seeking approval to introduce, distribute, sell, or market a drug product for human therapeutic use in the U.S. (including a new drug application submitted under Section 505(b)(2) of the Act) and the foreign equivalent in any country in the Territory.
“NovaQuest Indemnitees” has the meaning set forth in Section 10.1.
“NovaQuest” has the meaning set forth in the preamble hereto.
“Parties” has the meaning set forth in the preamble hereto.
“Party” has the meaning set forth in the preamble hereto.
“Patents” means all patents (including all reissues, extensions, substitutions, confirmations, re‑registrations, re‑examinations, revalidations, supplementary protection certificates, and patents of addition) and patent applications (including all provisional applications, continuations, continuations‑in‑part, and divisions) and all counterparts and equivalents of any of the foregoing in any country or jurisdiction.
“Payment Cap” means: (a) with respect to a date of determination that is on or before December 31, 2028, One Hundred Million Dollars ($100,000,000); (b) with respect to a date of determination that is on or after January 1, 2029, but on or before December 31, 2029, One Hundred Twelve Million, Five Hundred Thousand Dollars ($112,500,000); or (c) with respect to a date of determination that is after January 1, 2030, One Hundred Twenty-Five Million Dollars ($125,000,000).
“Payment Report” has the meaning set forth in Section 4.1(f).
“Permitted Company” means [*].
“Permitted Encumbrance” means
(a) Encumbrances imposed by law, such as carriers’, warehousemen’s, landlords’, materialmen’s, repairman’s, construction contractors’, mechanics’, airports’, navigation authority’s or other like Encumbrances, in each case for sums not yet overdue by more than [*] or being contested in good faith by appropriate proceedings or other Encumbrances arising out of judgments or awards against such Person with respect to which such Person shall then be proceeding with an appeal or other proceedings for review (or which, if due and payable, are being contested in good faith by appropriate proceedings and for which adequate reserves are being maintained, to the extent required by IFRS);
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
(b) Encumbrances for taxes, assessments or other governmental charges or levies (i) which are not yet overdue for [*] or not yet due or payable, (ii) which are being contested in good faith by appropriate proceedings and (iii) for which adequate reserves are being maintained to the extent required by IFRS or GAAP;
(c) Encumbrances securing indebtedness (including, without limitation, capital lease obligations and purchase money obligations) incurred by the Company to finance all or any part of the purchase, lease, construction, installation, repair or improvement of property (real or personal), plant or equipment or other fixed or capital assets; provided such lien extends only to the assets the acquisition, lease, construction, repair, replacement or improvement of which is financed thereby and any replacements, additions and accessions thereto and any income or profits thereof;
(d) Encumbrances on specific items of inventory or other goods and proceeds of any Person securing such Person’s obligations in respect of bankers’ acceptances or letters of credit entered into in the ordinary course of business issued or created for the account of such Person to facilitate the purchase, shipment or storage of such inventory or other goods;
(e) grants of software, technology and other intellectual property licenses in the ordinary course of business;
(f) Encumbrances in favor of customs and revenue authorities arising as a matter of law to secure payment of customs duties in connection with the importation and exportation of goods in the ordinary course of business;
(g) [*];
(h) the Encumbrances or Liens granted in favor of NovaQuest pursuant to this Agreement; and
(i) Encumbrances arising solely by virtue of any statutory or common law provision or customary business provision relating to banker’s encumbrances, rights of set-off or similar rights.
“Person” means any natural person, corporation, trust, joint venture, association, unincorporated organization, cooperative, company, partnership, trust, limited liability company, government (domestic or foreign), and any agency or instrumentality thereof, or any other entity recognized by law.
“Prepayment” has the meaning set forth in Section 4.1(d).
“Prepayment Amount” means, as of the date of determination: (a) the amount that is in the column labeled “Prepayment Amount” and in the row with the then-current “Fiscal Year” in the table set forth below this definition; minus (b) the sum of any Revenue Interest Payments paid to NovaQuest prior to such date.
Fiscal Year During Which Prepayment Amount is Received by NovaQuest | Prepayment Amount |
[*] | $80,000,000 |
[*] | [*] |
[*] | [*] |
[*] | [*] |
2028 | $100,000,000 |
2029 | $112,500,000 |
2030 | $125,000,000 |
“Prime Rate” has the meaning set forth in Section 4.4.
“Product” means any prescription pharmaceutical product that contains the Compound.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
“Product IP Rights” means all of the following intellectual property owned or licensed by the Company, in each case, as they exist in the Territory and solely as necessary or useful to the manufacturing, development or Commercialization of the Product in the Territory: (a) the Product Know‑How; (b) the Product Patents; and (c) all trademarks, service marks, trade names, and works protectable under copyright laws.
“Product Know‑How” means, with respect to the Product in the Territory, all trade secrets, technology, processes, practices, formulae, instructions, procedures, assembly procedures, results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, preclinical, clinical, safety, manufacturing and quality control data, including study designs and protocols), know-how, methods, treatments, techniques, systems, designs, artwork, drawings, plans, specifications, data and information, in each case whether or not confidential, proprietary, patentable, copyrightable, or susceptible to any other form of legal protection, in written, electronic or any other form.
“Product Patents” has the meaning set forth in Section 7.1(e).
“Quarterly Report” means a report submitted by Company to NovaQuest in accordance with the provisions of Section 3.1(b), that contains (a) the information from quarterly reports in respect of the preceding Fiscal Quarter or other reports and material correspondence received from Astellas during the preceding Fiscal Quarter under its obligations under the Astellas Agreements relating to Commercialization of the Product in the Territory; (b) a statement setting forth Company’s good faith qualitative assessment of Astellas’s performance of its obligations under the Astellas Agreements relating to Commercialization of the Product in the Territory during the preceding Fiscal Quarter; and (c) at any time after the termination of either of the Astellas Agreements and Company’s entry into a Replacement Agreement, information similar to the information set forth in clauses (a) and (b) of this definition to the extent received from any Responsible Party or to the extent pertaining to such Responsible Party’s performance under the applicable Replacement Agreement. All amounts in each Quarterly Report shall be denominated in Dollars. Notwithstanding the foregoing, Company may, at its election, deliver the information contemplated herein and therein via disclosures made pursuant to Company’s public reporting requirements, by delivery of summaries, reports, or presentations to NovaQuest, or by providing excerpts of materials presented to the Company’s board of directors or executive leadership team.
“Recordkeeping Period” has the meaning set forth in Section 5.2(a).
“Register” has the meaning set forth in Section 11.6.
“Regulatory Approval” means, with respect to the Product, in any country or jurisdiction, any approval, registration, license, or authorization that is required by the applicable Governmental Authority to market and sell such Product in such country or jurisdiction.
“Regulatory Filing” means any application, filing, or submission required by or provided to a Governmental Authority relating to the development, manufacture, Commercialization, pricing, or other exploitation of the Product, including any supporting documentation, correspondence, meeting minutes, amendments, supplements, registrations, licenses, regulatory drug lists, advertising and promotion documents, adverse event files, complaint files, and manufacturing, shipping, or storage records with respect to any of the foregoing, including an NDA, drug master filing, clinical trial application, and any counterparts or equivalents of any of the foregoing.
“Replacement Agreement” means an agreement entered into between Company or any Affiliate of Company and a Third Party following the termination (in whole or in part) of any Astellas Agreement in which Company grants a License or otherwise transfers any of the Product IP Rights in the Territory or other rights that are relevant to making, using, selling, offering for sale, or importation of the Product in the Territory. Agreements expressly considered Replacement Agreements include: (x) exclusive licenses, option agreements, right of first refusal agreements, non-assertion agreements, distribution agreements that grant or otherwise transfer any Product IP Rights in the Territory, or similar agreements; and (y) agreements that grant or otherwise transfer rights in the Product IP Rights along with rights owned by Company or any Affiliate of Company or granted to Company or any Affiliate of Company by a Third Party. For the avoidance of doubt, Replacement Agreement excludes any or all of the Astellas Agreements.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
“Replacement Net Sales Revenue” means any payments based on sales of the Product in the Territory received by Company or any of its Affiliates under or pursuant to a Replacement Agreement. For the avoidance of doubt, Replacement Net Sales Revenue excludes Astellas EMEA Revenue, Astellas Japan Revenue, and Astellas Other Revenue.
“Replacement Other Revenue” means any revenue, other than Replacement Net Sales Revenue, recognized by Company or any of its Affiliates under or pursuant to a Replacement Agreement attributable to payments for the Product in the Territory. For the avoidance of doubt, Replacement Net Sales Revenue excludes Astellas EMEA Revenue, Astellas Japan Revenue, and Astellas Other Revenue.
“Responsible Party” means Company, Astellas, its and their respective Affiliates and Licensees, and any Acquiring Party.
“Revenue Interest Collateral” means the [*].
“Revenue Interests” means [*].
“Revenue Interest Payment” has the meaning set forth in Section 4.1(a). “Revenue Interest Payments” means the Revenue Interest Payment, collectively.
“Sales Forecast” has the meaning set forth in Section 5.1(b).
[*].
[*].
[*].
“Senior Officer” means: (a) in the case of NovaQuest, its chief investment officer; and (b) in the case of Company, its Chief Executive Officer.
[*].
“Tax” means any present or future tax, levy, impost, duty, assessment, charge, fee, deduction, or withholding in the nature of a tax and whatever called (including interest and penalties thereon) imposed, levied, collected, withheld, or assessed by any Governmental Authority.
“Term” has the meaning set forth in Section 9.1.
“Territory” means each or any of the following countries, individually or collectively: Albania, Andorra, Armenia, Austria, Azerbaijan, Belarus, Belgium, Bosnia & Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Kazakhstan, Kyrgyzstan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Moldova, Monaco, Netherlands, Norway, North Macedonia, Poland, Portugal, Romania, Russia, San Marino, Serbia and Montenegro (Yugoslavia), Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tajikistan, Turkey, Turkmenistan, Ukraine, United Kingdom, Uzbekistan, Vatican City, Bahrain, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syria, United Arab Emirates, Yemen, and any other country in which Astellas has rights to Commercialize the Product (an “Additional Country”) (provided that any such Additional Country shall be included in the Territory only if and to the extent Astellas is Commercializing the Product in such Additional Country).
“Third Party” means any Person, including a Governmental Authority, other than Company, NovaQuest, and each of their respective Affiliates. “Third-Party” has the corresponding meaning.
“Third‑Party Claim” has the meaning set forth in Section 10.1.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
“Transaction Documents” means this Agreement, [*], and any other documents, instruments, or financing statements required to be delivered hereunder or thereunder or in connection herewith or therewith.
“True-Up Payment” means each or any of True-Up Payment One or True-Up Payment Two. “True-Up Payments” means both of the foregoing, collectively.
“True-Up Payment One” has the meaning set forth in Section 4.1(c)(i).
“True-Up Payment Two” has the meaning set forth in Section 4.1(c)(ii).
“UCC” means the Uniform Commercial Code as in effect from time to time in the State of New York, provided that if, with respect to any financing statement or by reason of any provisions of applicable law, the perfection or the effect of perfection or non-perfection of the security interest or any portion thereof granted pursuant to Section 4.5 is governed by the Uniform Commercial Code as in effect in a jurisdiction of the United States other than the State of New York, then “UCC” means the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions of this Agreement and any financing statement relating to such perfection or effect of perfection or non-perfection.
“United States” or “U.S.” means the United States of America, including its territories and possessions.
“Voluntary Bankruptcy” means Company, pursuant to or within the meaning of any Bankruptcy Law: (a) commences a voluntary case; (b) consents to the entry of an order for relief against it in an involuntary case; (c) consents to the appointment of a Custodian of it or for any substantial part of its property; or (d) makes a general assignment for the benefit of its creditors or takes any comparable action under any non-U.S. laws relating to insolvency.
“Voluntary Transfer” means with respect to NovaQuest, or any of its Affiliates (to the extent relevant): (a) the sale or disposition of all or substantially all of the assets of such Party; (b) the sale or transfer of more than [*]) of the voting power of the outstanding voting securities of such Party or any Affiliate of such Party that directly or indirectly controls (as defined in the definition of Affiliate) such Party; (c) the merger or consolidation of such Party or any Affiliate of such Party that directly or indirectly controls (as defined in the definition of Affiliate) such Party, with or into another entity Person; or (d) the assignment by such Party of this Agreement or all or any portion of the rights and obligations hereunder.
“Withholding Payment” has the meaning set forth in Section 4.3(a).
SCOPE OF AGREEMENT
10
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
NOVAQUEST FUNDING; COMMERCIALIZATION
PAYMENTS TO NOVAQUEST
[*].
11
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Each Revenue Interest Payment shall be due and payable [*].
12
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
13
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
14
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
INFORMATION RIGHTS; RECORD KEEPING
Notwithstanding the foregoing, Company may, at its election, deliver the information contemplated herein and therein via disclosures made pursuant to Company’s public reporting requirements, by delivery of summaries, reports, or presentations to NovaQuest, or by providing excerpts of materials presented to the Company’s board of directors or executive leadership team, provided that upon NovaQuest’s reasonable request, Company promptly shall provide reasonable access to any material information and documents encompassing the information provided by Company pursuant to this Section 5.1(a).
15
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Company’s and the Responsible Parties’ recordkeeping obligations under this Section 5.2 shall survive the termination of this Agreement until the date that is [*] following the last day on which a payment is due under this Agreement (the “Recordkeeping Period”).
16
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Notwithstanding the foregoing, Company may, at its election, deliver the information contemplated herein and therein via disclosures made pursuant to Company’s public reporting requirements, by delivery of summaries, reports, or presentations to NovaQuest, or by providing excerpts of materials presented to Company’s board of directors or executive leadership team.
17
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
CONFIDENTIAL INFORMATION
Notwithstanding anything to the contrary in this Agreement, a Party is entitled to seek injunctive relief to restrain the breach or threatened breach by the other Party of this ARTICLE VI without having to prove actual damages or threatened irreparable harm or post any bond. Such injunctive relief will be in addition to any rights and remedies available to the aggrieved Party at law, in equity, and under this Agreement for such breach or threatened breach.
18
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
[*].
19
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
REPRESENTATIONS AND WARRANTIES; LIMITATION OF LIABILITY
20
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
21
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
22
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
23
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
COVENANTS
24
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
25
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
This Section 8.5 does not require Company to take any actions beyond which Company has the right to take under the Astellas Agreements in effect as of the Effective Date.
26
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
TERM AND TERMINATION
27
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
INDEMNIFICATION
28
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
29
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
MISCELLANEOUS
30
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
31
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
32
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
If to Company:
FibroGen, Inc.
409 Illinois Street
San Francisco, CA 94158
[*]
with a copy to:
Goodwin Procter LLP
100 Northern Avenue
Boston, MA 02210
[*]
If to NovaQuest:
NQ Project Phoebus, L.P.
4208 Six Forks Road, Suite 920
Raleigh, NC 27609
[*]
with a copy to:
Wyrick Robbins Yates & Ponton LLP
4101 Lake Boone Trail, Suite 300
Raleigh, North Carolina 27607
[*]
or to such other address or addresses as NovaQuest or Company may from time to time designate by notice as provided herein. Any such notice shall be deemed given: (a) when actually received when so delivered personally or by overnight courier; (b) if mailed, other than during a period of general discontinuance or disruption of postal service due to strike, lockout or otherwise, on the [*] after its postmarked date thereof; or (c) if sent by e-mail with acknowledgement of receipt, transmission on the date sent if such day is a Business Day or the next following Business Day if such day is not a Business Day.
33
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
34
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
[Signature page follows]
35
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
IN WITNESS WHEREOF, the Parties have executed this Funding Agreement by their duly authorized representatives as of the Effective Date.
FibroGen, Inc. | |
By: | /s/ [*] |
Name: | [*] |
Title: | [*] |
[Signature Page to NovaQuest – FibroGen Revenue Interest Financing Agreement]
IN WITNESS WHEREOF, the Parties have executed this Funding Agreement by their duly authorized representatives as of the Effective Date.
NQ PROJECT PHOEBUS, L.P. | |
By: | NQ POF V GP, Ltd, its general partner |
By: | /s/ [*] |
Name: | [*] |
Title: | [*] |
[Signature Page to NovaQuest – FibroGen Revenue Interest Financing Agreement]
Exhibit A
Reserved
[Exhibit A to NovaQuest – FibroGen Revenue Interest Financing Agreement] 1
Exhibit B
Astellas EMEA Agreement
[Attached]
[Exhibit B to NovaQuest – FibroGen Revenue Interest Financing Agreement] 1
Exhibit C
Astellas Japan Agreement
[Attached]
[Exhibit C to NovaQuest – FibroGen Revenue Interest Financing Agreement] 1
Exhibit D
Compound
The chemical compound or bulk active pharmaceutical compound, known as FG-4592, whose specific INN name is roxadustat with CAS number 808118-40-3
[Exhibit D to NovaQuest – FibroGen Revenue Interest Financing Agreement] 1
Exhibit E
Company Bank Account Information
[*]
[Exhibit E to NovaQuest – FibroGen Revenue Interest Financing Agreement] 1
Schedule 7.1(e)
Product Patents
[*].
[Schedule 7.1(e) to NovaQuest – FibroGen Revenue Interest Financing Agreement] 1
Schedule 7.1(f)
Litigation
[*].
[Schedule 7.1(f) to NovaQuest – FibroGen Revenue Interest Financing Agreement] 1
Schedule 7.1(h)
Material Contracts
[*].
[Schedule 7.1(h) to NovaQuest – FibroGen Revenue Interest Financing Agreement] 1
Schedule 7.1(i)
Certain Regulatory Matters
[Schedule 7.1(i) to NovaQuest – FibroGen Revenue Interest Financing Agreement] 1