Exhibit 10.3
PUBLIC HEALTH SERVICE
PATENT LICENSE AGREEMENT NONEXCLUSIVE – SUBLICENSABLE
ThisAgreement is based on the model Patent License Non-Exclusive Sublicensable Agreement adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy Board for use by components of the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are agencies of thePHS within the Department of Health and Human Services (“HHS”).
This Cover Page identifies the Parties to thisAgreement:
The U.S. Department of Health and Human Services, as represented by
National Human Genome Research Institute (NHGRI) an Institute
(hereinafter referred to as the “IC”) of the
NIH
and
LogicBio Therapeutics, Inc.,
hereinafter referred to as the “Licensee”, having offices at 610 Main Street, 3rd Floor, Cambridge, MA 02139,
created and operating under the laws of Delaware.
Tax ID No.:_47-1514975
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For theIC’s internal use only:
License Number:
License Application Number:
Serial Number(s) of Licensed Patent(s) or Patent Application(s):
Licensee:
Cooperative Research and Development Agreement (CRADA) Number (if a subject invention):
Additional Remarks:
Public Benefit(s):
This Patent License Agreement, hereinafter referred to as the “Agreement”, consists of this Cover Page, an attachedAgreement, a Signature Page, Appendix A (List of Patent(s) or Patent Application(s)), Appendix B (Fields of Use and Territory), Appendix C (Royalties), Appendix D (Benchmarks), Appendix E (Commercial Development Plan), Appendix F (Example Royalty Report), and Appendix G (Royalty Payment Options).
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TheIC and theLicensee agree as follows:
1. | BACKGROUND |
1.1 | In the course of conducting biomedical and behavioral research, theIC investigators made inventions that may have commercial applicability. |
1.2 | By assignment of rights from theIC employees and other inventors,HHS, on behalf of theGovernment, owns intellectual property rights claimed in any United States or foreign patent applications or patents corresponding to the assigned inventions.HHS also owns any tangible embodiments of these inventions actually reduced to practice by theIC. |
1.3 | The Secretary ofHHS has delegated to theIC the authority to enter into thisAgreement for the licensing of rights to these inventions under 35 U.S.C. §§200-212, the Federal Technology Transfer Act of 1986, 15 U.S.C. §3710(a), and the regulations governing the licensing ofGovernment-owned inventions, 37 CFR Part 404. |
1.4 | The IC desires to transfer these inventions to the private sector through commercialization licenses to facilitate the commercial development of products and processes for public use and benefit. |
1.5 | TheLicensee desires to acquire commercialization rights to certain of these inventions in order to develop processes, methods, or marketable products for public use and benefit. |
2. | DEFINITIONS |
2.1 | “Affiliate” of an entity means any corporation or other business entity controlled by, controlling, or under common control with such entity at any time during the term of the agreement. For this purpose, “control” means direct or indirect beneficial ownership of at least fifty percent (50%) of the voting stock or at least fifty percent (50%) interest in the income of the corporation or other business entity. |
2.2 | “Australian Orphan Drug Exclusivity” means exclusive marketing rights granted by the Australian Government’s Department of Health, Therapeutic Goods Administration (“TGA”), upon approval of an orphan drug in Australia. Orphan drug designation status granted by the TGA typically gives marketing exclusivity in Australia for 5 years after approval. |
2.3 | “Biologics License Application (BLA)” means a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). |
2.4 | “Combination Product” means a product that contains aLicensed Product and at least one other active therapeutic component or one other device other than aLicensed Product. For the avoidance of doubt, “Combination Products” include products in which a gene therapy product comprises multiple active therapeutic components, including a transgene, a cassette and a capsid. |
2.5 | “Effective Date” means the date set forth in Paragraph 13.1. |
2.6 | “European Orphan Drug Exclusivity” means exclusive marketing rights granted by European Medicines Agency (EMA) upon approval of an orphan drug in European Union. Orphan drug status granted by the EMA gives marketing exclusivity in European Union for 10 years after approval. |
2.7 | “FDA” means the United States Food and Drug Administration. |
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2.8 | “First Commercial Sale” means the initial transfer by or on behalf of theLicensee or itsSublicensees ofLicensed Productsor the initial practice of aLicensed Process by or on behalf of theLicenseeor itsSublicensees, in either case, pursuant to a valid marketing authorization from a competent regulatory authority body (for example, NDA approval by FDA in the United States) in exchange for cash or some equivalent to which value can be assigned for the purpose of determiningNet Sales. |
2.9 | “Government” means the Government of the United States of America. |
2.10 | “Japanese Orphan Drug Exclusivity” means exclusive marketing rights granted by the Japanese Ministry of Health, Labour and Welfare (MHLW) upon approval of an orphan drug in Japan. Orphan drug designation status granted by the MHLW gives marketing exclusivity in Japan for up to 10 years after approval. |
2.11 | “Licensed Fields of Use” means the fields of use identified in Appendix B. |
2.12 | “Licensed Patent Rights” shall mean: |
(a) | Patent applications (including provisional patent applications and PCT patent applications) or patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from these applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all these patents; |
(b) | to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.12(a): |
(i) | continuations-in-part of 2.12(a); |
(ii) | all divisions and continuations of thesecontinuations-in-part; |
(iii) | all patents issuing from thesecontinuations-in-part, divisions, and continuations; |
(iv) | priority patent application(s) of 2.12(a); and |
(v) | any reissues, reexaminations, and extensions of all these patents; |
(c) | to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.12(a): all counterpart foreign and U.S. patent applications and patents to 2.12(a) and 2.12(b), including those listed in Appendix A; and |
(d) | Licensed Patent Rights shallnot include 2.12(b) or 2.12(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in 2.12(a). |
2.13 | “Licensed Processes” means processes, which in the course of being practiced, would be within the scope of one or more claims of theLicensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction. |
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2.14 | “Licensed Product” means tangible materials, which in the course of development, manufacture, use, distribution, sale, or importation, would be within the scope of one or more claims of theLicensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction. For clarity, Licensee shall pay running royalties and benchmark royalties with respect to Licensed Products the development, manufacture, use, distribution, sale or importation of which are no longer within the scope of one or more claims of the Licensed Patents Rights in a country that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction if such products have validOrphan Drug Exclusivity in such country. |
2.15 | “Licensed Territory” means the geographical area identified in Appendix B. |
2.16 | “MMA” means Methylmalonic Acidemia, which is an inherited disorder in which the body is unable to process certain proteins and fats (lipids) properly. |
2.17 | “Net Sales” means the total gross receipts for sales of Licensed Products or practice of Licensed Processes by or on behalf of the Licensee or its Sublicensees, and from leasing, renting, or otherwise making Licensed Products available to others without sale or other dispositions, whether invoiced or not, less returns and allowances, packing costs, insurance costs, freight out, taxes or excise duties imposed on the transaction (if separately invoiced), and wholesaler and cash discounts in amounts customary in the trade to the extent actually granted. No deductions shall be made for commissions paid to individuals, whether they are with independent sales agencies or regularly employed by the Licensee or a Sublicensee and on its payroll, or for the cost of collections. |
If theLicensee,Affiliates or itsSublicensees sell aCombination Product, theNet Sales for suchCombination Product shall be the market price of theLicensed Product portion of theCombination Product when sold separately, and if theLicensed Product is not sold separately, then theNet Sales for suchCombination Productshall be the greater of (i) the market price at which theLicensed Product reasonably could be sold as a separate item, or (ii) Net Salesof theCombination Product multiplied by a factor 1/x, where x is the number of active components and/or devices contained in theCombination Product, wherein x cannot exceed a value of five (5).
2.18 | “Orphan Indication” means a disease that affects less than two hundred thousand (200,000) people in the United States as defined by theFDA or five (5) in ten thousand (10,000) people in the European Union as defined by the European Medicines Agency. |
2.19 | “Orphan Drug Designation” means the granting of special status by a country and/or government regulatory agency (such as the FDA, EMA, MHLW, or TGA) to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor under the U.S. Orphan Drug Act (ODA) or any foreign equivalent(s) to this law enacted by other countries including but not limited to Australia, member countries of European Union, and Japan. |
2.20 | “Orphan Drug Exclusivity” means exclusive marketing rights granted by a country and/or government regulatory agency (such as the FDA, EMA, MHLW, or TGA) to a drug or biological product (“drug”) to treat a rare and/or neglected disease or condition upon regulatory approval of said drug for a given period of time (which varies from country to country) and which can run concurrently with a patent or not. |
2.21 | “Phase 1 Clinical Study” means the initial introduction of an investigational new drug into humans, the principal purpose of which is to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness, in compliance with 21 C.F.R. §312(a) or foreign equivalent. |
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2.22 | “Phase 2 Clinical Study” means controlled human clinical studies conducted to evaluate the effectiveness of a drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug in compliance with 21 C.F.R. §312(b) or foreign equivalent, and shall include any clinical study that leads to a conditional regulatory approval, that is followed by a confirmatoryPhase 3 Clinical Study. |
2.23 | “Phase 3 Clinical Study” means expanded controlled and uncontrolled human clinical trials pursuant to a randomized study with endpoints agreed upon by regulatory bodies for regulatory approval performed afterPhase 2 Clinical Study evidence suggesting effectiveness of a drug has been obtained, and is intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of a drug and to provide an adequate basis for regulatory approval and physician labeling, as in compliance with 21 C.F.R. §312 or foreign equivalent, and shall include a confirmatory study that is conducted following conditional regulatory approval. |
2.24 | “Practical Application” means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and in each case, under these conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law orGovernment regulations available to the public on reasonable terms. |
2.25 | “Priority Review” means, with respect to a human drug application as defined in 21 USC § 379g(l), review and action by the Secretary ofHHS (“Secretary”) on such application as described in the Manual of Policies and Procedures of the Food and Drug Administration (FDA) and goals identified in the letters described in Section 101(b) of the Prescription Drug User Fee Amendments of 2012. |
2.26 | “Priority Review Voucher” means a voucher issued by theSecretary to the sponsor of aRare Pediatric Disease Product Application that entitles the holder of such voucher to priority review of a single human drug application submitted under 21 USC § 355(b)(1) or Section 351(a) of the Public Health Service Act [42 USC § 262(a)] after the date of approval of theRare Pediatric Disease Product Application. |
2.27 | “Rare Pediatric Disease” means a disease that meets each of the following criteria:(A) The disease is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents; (B) The disease is a rare disease or condition, within the meaning of 21 USC § 360bb. |
2.28 | “Rare Pediatric Disease Product Application” means a human drug application, as defined in 21 USC § 360ff (a)(4), for aRare Pediatric Disease. |
2.29 | “Sublicensee” means a legal entity, which is not an Affiliate of Licensee, which receives a sublicense of some or all of the rights granted to Licensee under this Agreement. |
2.30 | “Third Party” means an entity other than (i) Licenseeor any of itsAffiliates orSublicensees and (ii) IC. |
2.31 | “U.S. Orphan Drug Exclusivity” means exclusive marketing rights granted by the FDA upon approval of an orphan drug and can run concurrently with a patent or not. The right prevents the submission or effective approval of ANDAs or applications (ANDA, 505(b)(2) or “full” NDA or BLA) for the same drug for the same orphan disease or condition for seven years after FDA approval. |
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2.32 | “Valid Claim” means a claim of an issued and unexpired patent that is in force included within theLicensed Patent Rightswhich has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction (which decision is not appealable or has not been appealed within the time allowed for appeal), and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise. |
3. | GRANT OF RIGHTS |
3.1 | The IC hereby grants and theLicensee and itsAffiliates accepts, subject to the terms and conditions of thisAgreement, a nonexclusive license under, and to, theLicensed Patent Rights in theLicensed Territory to develop, make and have made, to develop and have developed, to register and have registered, to use and have used, to distribute and have distributed, to sell and have sold, to offer to sell, and to import and export anyLicensed Products in theLicensed Fields of Use and to practice and have practiced anyLicensed Processes in theLicensed Fields of Use. For clarity, LogicBio will pay royalties forLicensed Products that are no longer covered by theLicensed Patent Rights but enjoyOrphan Drug Exclusivity in a country (as defined in Paragraph 2.14 (“Licensed Product”)). |
3.2 | ThisAgreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of theIC other than theLicensed Patent Rights regardless of whether these patents are dominant or subordinate to theLicensed Patent Rights. |
4. | SUBLICENSING |
4.1 | Upon written approval, which shall include prior review of any sublicense agreement by theIC and which shall not be unreasonably withheld, theLicensee may enter into sublicensing agreements under theLicensed Patent Rights and the Orphan Drug Designation only when it concurrently licenses proprietary or in-licensed intellectual property rights. For the avoidance of doubt, theLicensee does not have the right to solely sublicense theLicensed Patent Rights orthe Orphan Drug Designation. |
4.2 | TheLicensee agrees that any sublicenses granted by it shall provide that the obligations to theIC of Paragraphs 5.1, 5.2, 8.1, 10.1, 10.3, 12.5, and 13.7-13.9 of thisAgreement shall be binding upon theSublicensee as if it were a party to thisAgreement. TheLicensee further agrees to include copies of these Paragraphs in all sublicense agreements. |
4.3 | Any sublicenses granted by theLicensee shall provide for the termination of the sublicense, or the conversion to a license directly between theSublicensee and theIC, at the option of theSublicensee, upon termination of thisAgreement under Article 13. This conversion is subject to theIC approval and contingent upon acceptance by theSublicensee of the remaining provisions of thisAgreement. |
4.4 | TheLicensee agrees to forward to theIC a complete copy of each fully executed sublicense agreement postmarked within [***] ([***]) days of the execution of the agreement. To the extent permitted by law, theIC agrees to maintain each sublicense agreement in confidence. |
5. | STATUTORY AND NIH REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS |
5.1 | Prior to theFirst Commercial Sale, and upon agreement of the parties, theLicensee shall provide theIC with reasonable quantities ofLicensed Products or materials made through theLicensed Processes for theIC’s research use. Such materials shall be considered the confidential information of the Licensee and will not be disclosed by the IC without the prior written consent of the Licensee. |
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5.2 | TheLicensee agrees that products used or sold in the United States embodyingLicensed Products or produced through use ofLicensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from theIC. |
6. | ROYALTIES AND REIMBURSEMENT |
6.1 | TheLicensee agrees to pay theIC a noncreditable, nonrefundable license issue royalty as set forth in Appendix C. |
6.2 | TheLicensee agrees to pay theIC a minimum annual royalty as set forth in Appendix C. |
6.3 | TheLicensee agrees to pay theIC earned royalties as set forth in Appendix C. |
6.4 | TheLicensee agrees to pay theIC benchmark royalties as set forth in Appendix C. |
6.5 | TheLicensee agrees to pay theIC sublicensing royalties as set forth in Appendix C. |
6.6 | The Licensee agrees to pay theIC the assignment royalty as set forth in Paragraph 14.7. |
6.7 | A patent or patent application licensed under thisAgreement shall cease to fall within theLicensed Patent Rights orthe Orphan Drug Exclusivityfor the purpose of computing earned royalty payments in any given country on the latest of the date(s) that: |
(a) | the application has been abandoned and not continued; |
(b) | the patent expires or irrevocably lapses; or |
(c) | the patent has been held to be invalid or unenforceable by an unappealed or unappealable decision of a court of competent jurisdiction or administrative agency; |
and anOrphan Drug Exclusivity terminates or expires in a particular country or region.
6.8 | No multiple royalties shall be payable because anyLicensed Products orLicensed Processes are covered by more than one of theLicensed Patent Rights. |
6.9 | On sales ofLicensed Products by theLicensee toSublicensees or on sales made in other than anarms-length transaction, the value of theNet Sales attributed under this Article 6 to this transaction shall be that which would have been received in anarms-length transaction, based on sales of like quantity and quality products on or about the time of this transaction. |
6.10 | With regard to unreimbursed expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within theLicensed Patent Rights and paid by theIC on or after theEffective Date of thisAgreement, theIC, at its sole option, may require theLicensee: |
(a) | to pay theIC on an annual basis, within [***] ([***]) days of theIC’s submission of a statement and request for payment, a royalty amount equivalent to [***] percent ([***]%) of these unreimbursed expenses paid during the previous calendar year(s); provided that ifIC grants one or more additional licenses to one or moreThird Parties, then theLicensee shall pay theIC [***] percent ([***]%) of a pro-rated portion of such unreimbursed expenses calculated by dividing the total patent costs paid during the previous calendar year(s) by two (2) times the number of additional licenses of record. |
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6.11 | The IC agrees, upon written request, to provide theLicensee with summaries of patent prosecution invoices for which theIC has requested payment from theLicensee under Paragraphs 6.9 and 6.10. TheLicensee agrees that all information provided by theIC related to patent prosecution costs shall be treated as confidential commercial information and shall not be released to aThird Party except as required by law or a court of competent jurisdiction. |
6.12 | TheLicensee may elect to surrender its rights in any country of theLicensed Territory under any of theLicensed Patent Rights upon [***] ([***]) days written notice to theIC and owe no payment obligation under Paragraph 6.10 for patent-related expenses paid in that country after the effective date of the written notice. |
7. | PATENT FILING, PROSECUTION, AND MAINTENANCE |
7.1 | The IC agrees to take responsibility for the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in theLicensed Patent Rights. |
8. | RECORD KEEPING |
8.1 | TheLicensee agrees to keep accurate and correct records ofLicensed Products made, used, sold, or imported andLicensed Processes practiced under thisAgreement appropriate to determine the amount of royalties due theIC. These records shall be retained for at least five (5) years following a given reporting period and shall be available during normal business hours for inspection, at the expense of theIC, by an accountant or other designated auditor selected by theIC for the sole purpose of verifying reports and royalty payments hereunder. The accountant or auditor shall only disclose to theIC information relating to the accuracy of reports and royalty payments made under thisAgreement. If an inspection shows an underreporting or underpayment in excess of [***]percent ([***]%) for any twelve (12) month period, then theLicensee shall reimburse theIC for the cost of the inspection at the time theLicensee pays the unreported royalties, including any additional royalties as required by Paragraph 9.7. All royalty payments required under this Paragraph shall be due within [***] ([***]) days of the date theIC provides theLicensee notice of the payment due. |
9. | REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS |
9.1 | Prior to signing thisAgreement, theLicensee has provided theIC with theCommercial Development Plan under which theLicensee intends to bring the subject matter of theLicensed Patent Rights to the point ofPractical Application. |
9.2 | TheLicensee shall report to theIC the dates for achievingBenchmarks specified in Appendix D and theFirst Commercial Sale in each country in theLicensed Territory within [***] ([***]) days of such occurrences. |
9.3 | TheLicensee shall submit to theIC, within [***] ([***]) days after each calendarhalf-year ending June 30 and December 31, a royalty report, as described in the example in Appendix F, setting forth for the precedinghalf-year period the amount of theLicensed Products sold orLicensed Processes practiced by or on behalf of theLicensee in each country within theLicensed Territory, theNet Sales, and the amount of royalty accordingly due. With each royalty report, theLicensee shall submit payment of earned royalties due. If no earned royalties are due to theIC for any reporting period, the written report shall so state. The royalty report shall be certified as correct by an authorized officer of theLicensee and shall include a detailed listing of all deductions made under Paragraph 2.17 to determineNet Sales made under Article 6 to determine royalties due. |
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9.4 | TheLicensee agrees to forwardsemi-annually to theIC a copy of these reports received by theLicensee from itsSublicensees during the precedinghalf-year period as shall be pertinent to a royalty accounting to theIC by theLicensee for activities under the sublicense. |
9.5 | Royalties due under Article 6 shall be paid in U.S. dollars and payment options are listed in Appendix G. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the New York foreign exchange rate quoted inThe Wall Street Journal on the day that the payment is due, and any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely by theLicensee. The royalty report required by Paragraph 9.4 shall be mailed to theIC at its address forAgreement Notices indicated on the Signature Page. |
9.6 | TheLicensee shall be solely responsible for determining if any tax on royalty income is owed outside the United States and shall pay this tax and be responsible for all filings with appropriate agencies of foreign governments. |
9.7 | Additional royalties may be assessed by theIC on any payment that is more than [***] ([***]) days overdue at the rate of [***] percent ([***]%) per month. This [***] percent ([***]%) per month rate may be applied retroactively from the original due date until the date of receipt by theIC of the overdue payment and additional royalties. The payment of any additional royalties shall not prevent theIC from exercising any other rights it may have as a consequence of the lateness of any payment. |
9.8 | All plans and reports required by this Article 9 and marked “confidential” by theLicensee shall, to the extent permitted by law, be treated by theIC as commercial and financial information obtained from a person and as privileged and confidential, and any proposed disclosure of these records by theIC under the Freedom of Information Act (FOIA), 5 U.S.C. §552 shall be subject to the predisclosure notification requirements of 45 CFR §5.65(d). |
10. | PERFORMANCE |
10.1 | TheLicensee shall use its reasonable commercial efforts to bring theLicensed Products andLicensed Processes toPractical Application. “Reasonable commercial efforts” for the purposes of this provision shall include commercially reasonable efforts to adhere to theCommercial Development Plan in Appendix E and performance of theBenchmarks in Appendix D. The efforts of a Sublicensee shall be considered the efforts of theLicensee. |
10.2 | Upon theFirst Commercial Sale, until the expiration or termination of thisAgreement, the Licensee shall use its reasonable commercial efforts to makeLicensed Products andLicensed Processes reasonably available in the United States. |
10.3 | TheLicensee agrees that, to the extent commercially reasonable, after itsFirst Commercial Sale,to make reasonable quantities ofLicensed Products or materials produced through the use ofLicensed Processesavailable to patient assistance programs. |
10.4 | TheLicenseeagrees, after itsFirst Commercial Saleand as part of its marketing and product promotion, to develop educational materials (e.g., brochures, website, etc.) directed to patients and physicians detailing theLicensed Products or medical aspects of the prophylactic and therapeutic uses of theLicensed Products. |
10.5 | TheLicensee agrees to supply, to the Mailing Address forAgreementNotices indicated on the Signature Page, the Office of Technology Transfer,NIH with inert samples of theLicensed Products orLicensed Processesor their packaging for educational and display purposes only. |
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11. | INFRINGEMENT AND PATENT ENFORCEMENT |
11.1 | The IC and theLicensee agree to notify each other promptly of each infringement or possible infringement of theLicensed Patent Rights, as well as, any facts which may affect the validity, scope, or enforceability of theLicensed Patent Rights of which either Party becomes aware. |
11.2 | In the event that a declaratory judgment action alleging invalidity of any of theLicensed Patent Rights shall be brought against theIC, the IC agrees to notify theLicensee that an action alleging invalidity has been brought. TheIC does not represent that it shall commence legal action to defend against a declaratory action alleging invalidity. The Licensee shall take no action to compel theGovernment either to initiate or to join in any declaratory judgment action. Should theGovernment be made a party to any suit by motion or any other action of theLicensee, theLicensee shall reimburse theGovernment for any costs, expenses, or fees, which theGovernment incurs as a result of the motion or other action. Upon theLicensee’s payment of all costs incurred by theGovernment as a result of theLicensee’s joinder motion or other action, these actions by theLicensee shall not be considered a default in the performance of any material obligation under thisAgreement. |
12. | NEGATION OF WARRANTIES AND INDEMNIFICATION |
12.1 | The IC offers no warranties other than those specified in Article 1. |
12.2 | The IC does not warrant the validity of theLicensed Patent Rights and makes no representations whatsoever with regard to the scope of theLicensed Patent Rights, or that theLicensed Patent Rights may be exploited without infringing other patents or other intellectual property rights ofThird Parties. |
12.3 | THE IC MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THELICENSED PATENT RIGHTS OR TANGIBLE MATERIALS RELATED THERETO. |
12.4 | The IC does not represent that it shall commence legal actions againstThird Parties infringing theLicensed Patent Rights. |
12.5 | TheLicensee shall indemnify and hold theIC, its employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage in connection with or arising out of: |
(a) | the use by or on behalf of theLicensee, itsSublicensees, itsAffiliates, or their respective directors, employees, orThird Parties (on behalf of theLicensees, itsSublicensees, orAffiliates) of anyLicensed Patent Rights; or |
(b) | the design, manufacture, distribution, or use of anyLicensed Products,Licensed Processes or materials, by theLicensee, or other products or processes developed in connection with or arising out of theLicensed Patent Rights. |
12.6 | TheLicensee agrees to maintain a liability insurance program consistent with sound business practice. |
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13. | TERM, TERMINATION, AND MODIFICATION OF RIGHTS |
13.1 | This Agreement is effective when signed by all parties, (the “Effective Date”), and shall extend to the expiration of the last to expire of (a) the Licensed Patent Rights and (b) the U.S. Orphan Drug Exclusivity, European Orphan Drug Exclusivity, Australian Orphan Drug Exclusivity, Japanese Orphan Drug Exclusivity or equivalent foreign Orphan Drug Exclusivity with respect to any Licensed Product, unless sooner terminated under Article 6 or 13. |
13.2 | In the event that theLicensee is in default in the performance of any material obligations under thisAgreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within [***] ([***]) days after the date of notice in writing of the default, theIC may terminate thisAgreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. |
13.3 | In the event that theLicensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of aThird Party’s intention to file an involuntary petition in bankruptcy, theLicensee shall immediately notify theIC in writing. |
13.4 | TheLicensee shall have a unilateral right to terminate thisAgreement in any country or territory by giving theIC sixty (60) days written notice to that effect. |
13.5 | The IC shall specifically have the right to terminate or modify, at its option, thisAgreement, if theIC determines that theLicensee: |
(a) | has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by thisAgreement; |
(b) | has committed a material breach of a covenant or agreement contained in thisAgreement; |
(c) | is not keepingLicensed Products orLicensed Processes reasonably available to the public afterFirst Commercial Sale; |
(d) | cannot reasonably satisfy unmet health and safety needs; or |
(e) | cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. |
13.6 | In making the determination referenced in Paragraph 13.5, theIC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by theLicensee under Paragraph 9.2. Prior to invoking termination or modification of thisAgreement under Paragraph 13.5, theIC shall give written notice to theLicensee providing theLicensee specific notice of, and a [***] ([***]) day opportunity to respond to, theIC’sconcerns as to the items referenced in 13.5(a)-13.5(g). If theLicensee fails to alleviate theIC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to theIC’s satisfaction, theIC may terminate thisAgreement. |
13.7 | TheIC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify thisAgreement if it is determined that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by theLicensee. |
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13.8 | Within [***] ([***]) days of receipt of written notice of theIC’s unilateral decision to modify or terminate thisAgreement, theLicensee may, consistent with the provisions of 37 CFR §404.11, appeal the decision by written submission to the designated theIC official. The decision of the designatedIC official shall be the final agency decision. TheLicensee may thereafter exercise any and all administrative or judicial remedies that may be available. |
13.9 | Within [***] ([***]) days of expiration or termination of thisAgreement under this Article 13, a final report shall be submitted by theLicensee. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to theIC shall become immediately due and payable upon termination or expiration. If terminated under this Article 13,Sublicensees may elect to convert their sublicenses to direct licenses with theIC pursuant to Paragraph 4.3. Unless otherwise specifically provided for under thisAgreement, upon termination or expiration of thisAgreement, theLicensee shall return allLicensed Products or other materials included within theLicensed Patent Rights to theIC or provide theIC with written certification of the destruction thereof. TheLicensee may not be granted additional theIC licenses if the final reporting requirement is not fulfilled. |
14. | GENERAL PROVISIONS |
14.1 | Neither party may waive or release any of its rights or interests in thisAgreement except in writing. The failure of theGovernment to assert a right hereunder or to insist upon compliance with any term or condition of thisAgreement shall not constitute a waiver of that right by theGovernment or excuse a similar subsequent failure to perform any of these terms or conditions by theLicensee. |
14.2 | ThisAgreement constitutes the entire agreement between the Parties relating to the subject matter of theLicensed Patent Rights,Licensed ProductsandLicensed Processes, and all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by thisAgreement. |
14.3 | The provisions of thisAgreement are severable, and in the event that any provision of thisAgreement shall be determined to be invalid or unenforceable under any controlling body of law, this determination shall not in any way affect the validity or enforceability of the remaining provisions of thisAgreement. |
14.4 | If either party desires a modification to thisAgreement, the parties shall, upon reasonable notice of the proposed modification by the party desiring the change, confer in good faith to determine the desirability of the modification. No modification shall be effective until a written amendment is signed by the signatories to thisAgreement or their designees. |
14.5 | The construction, validity, performance, and effect of thisAgreement shall be governed by Federal law as applied by the Federal courts in the District of Columbia. |
14.6 | AllAgreement notices required or permitted by thisAgreement shall be given by prepaid, first class, registered or certified mail or by an express/overnight delivery service provided by a commercial carrier, properly addressed to the other party at the address designated on the Signature Page, or to any other address as may be designated in writing by such other party.Agreement notices shall be considered timely if such notices are received on or before the established deadline date or sent on or before the deadline date as verifiable by U.S. Postal Service postmark or dated receipt from a commercial carrier. Parties should request a legibly dated U.S. Postal Service postmark or obtain a dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing. |
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14.7 | ThisAgreement shall not be assigned or otherwise transferred (including any transfer by legal process or by operation of law, and any transfer in bankruptcy or insolvency, or in any other compulsory procedure or order of court) except to a purchaser of all or substantially of theLicensee’s assets or to theLicensee’s Affiliate(s) without the prior written consent of theIC. The parties agree that the identity of the parties is material to the formation of thisAgreement and that the obligations under thisAgreement are nondelegable. In the event that theICapproves a proposed assignment, the Licensee shall pay theIC, as an additional royalty, [***] percent ([***]%) of the fair market value of any consideration received for any assignment of thisAgreement within [***] ([***]) days of the assignment. |
14.8 | TheLicensee agrees in its use of anyIC-supplied materials to comply with all applicable statutes, regulations, and guidelines, including theNIH and theHHS regulations and guidelines. TheLicensee agrees not to use the materials for research involving human subjects or clinical trials in the United States without complying with 21 CFR Part 50 and 45 CFR Part 46. TheLicensee agrees not to use the materials for research involving human subjects or clinical trials outside of the United States without notifying theIC, in writing, of the research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to theIC of research involving human subjects or clinical trials outside of the United States shall be given no later than [***] ([***]) days prior to commencement of the research or trials. |
14.9 | TheLicensee acknowledges that it is subject to and agrees to abide by the United States laws and regulations (including the Export Administration Act of 1979 and Arms Export Control Act) controlling the export of technical data, computer software, laboratory prototypes, biological materials, and other commodities. The transfer of these items may require a license from the appropriate agency of theGovernment or written assurances by theLicensee that it shall not export these items to certain foreign countries without prior approval of the agency. TheIC neither represents that a license is or is not required or that, if required, it shall be issued. |
14.10 | The Licensee agrees to mark theLicensed Products or their packaging sold in the United States with all applicable U.S. patent numbers and similarly to indicate “Patent Pending” status. AllLicensed Products manufactured in, shipped to, or sold in other countries shall be marked in a manner to preserve theIC patent rights in those countries. |
14.11 | By entering into thisAgreement, theIC does not directly or indirectly endorse any product or service provided, or to be provided, by theLicensee whether directly or indirectly related to thisAgreement. TheLicensee shall not state or imply that thisAgreement is an endorsement by theGovernment, theIC, any otherGovernment organizational unit, or anyGovernment employee. Additionally, theLicensee shall not use the names of theIC,NIH,FDAorHHS or theGovernment or their employees in any advertising, promotional, or sales literature without the prior written approval of theIC. |
14.12 | The Parties agree to attempt to settle amicably any controversy or claim arising under thisAgreement or a breach of thisAgreement, except for appeals of modifications or termination decisions provided for in Article 13. TheLicensee agrees first to appeal any unsettled claims or controversies to the designated theIC official, or designee, whose decision shall be considered the final agency decision. Thereafter, theLicensee may exercise any administrative or judicial remedies that may be available. |
14.13 | Nothing relating to the grant of a license, nor the grant itself, shall be construed to confer upon any person any immunity from or defenses under the antitrust laws or from a charge of patent misuse, and the acquisition and use of rights pursuant to 37 CFR Part 404 shall not be immunized from the operation of state or Federal law by reason of the source of the grant. |
14.14 | Paragraphs 8.1, 9.7, 9.8,12.1-12.5, 13.8, 13.9, 14.12 and 14.14 of thisAgreement shall survive termination of thisAgreement. |
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14.15 | The terms and conditions of thisAgreement shall, at theIC’s reasonable discretion, be considered by theIC to be withdrawn from theLicensee’s consideration and the terms and conditions of thisAgreement, and theAgreementitself to be null and void, unless thisAgreement is executed by theLicensee and a fully executed original is received by theIC within [***] ([***]) days from the date of theIC signature found at the Signature Page. |
SIGNATURES BEGIN ON NEXT PAGE
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NIH PATENT LICENSE AGREEMENT NONEXCLUSIVE – SUBLICENSABLE
SIGNATURE PAGE
For theIC:
[***] | December 14, 2018 | |||||||||||||
[***] | Date |
Director, Technology Transfer Office (TTO)
National Human Genome Research Institute (NHGRI)
National Institutes of Health Mailing Address or E-mail Address forAgreement notices and reports:
Mailing Address or E-mail Address forAgreement notices and reports:
License Compliance and Administration
Monitoring & Enforcement
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.
E-mail: LicenseNotices_Reports@mail.nih.gov
For theLicensee (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements of theLicensee made or referred to in this document are truthful and accurate.):
by:
/s/ Frederic Chereau | ||||||||||||||
Signature of Authorized Official Date | Date 12/10/2018 | |||||||||||||
Fred Chereau | ||||||||||||||
Printed Name | ||||||||||||||
Chief Executive Officer | ||||||||||||||
Title |
I. Official and Mailing Address forAgreement notices: |
Thomas Wilton | ||||||||||||||||||||
Name | ||||||||||||||||||||
Chief Business Officer | ||||||||||||||||||||
Title | ||||||||||||||||||||
Mailing Address |
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LogicBio, 610 Main Street, 3rd Floor, Cambridge, MA 02139 | ||||||||||||||||||||
Email Address: | twilton@logicbio.com | |||||||||||||||
Phone: | 215 316 9239 | |||||||||||||||
Fax: |
II. Official and Mailing Address for Financial notices (theLicensee’s contact person for royalty payments) |
Mathias Jaffe | ||||||||||||||||||||
Name | ||||||||||||||||||||
Chief Financial Officer | ||||||||||||||||||||
Title | ||||||||||||||||||||
Mailing Address: | ||||||||||||||||||||
LogicBio, 610 Main Street, 3rd Floor, Cambridge, MA 02139 | ||||||||||||||||||||
Email Address: | mjaffe@logicbio.com | |||||||||||||||
Phone: | 617 959 7425 | |||||||||||||||
Fax: |
Any false or misleading statements made, presented, or submitted to theGovernment, including any relevant omissions, under thisAgreement and during the course of negotiation of thisAgreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including fine(s) and/or imprisonment).
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APPENDIX A – PATENT(S) OR PATENT APPLICATION(S)
Patent(s) or Patent Application(s):
I. | US Provisional Patent Application No.: 61/792,081 |
HHS Ref. No.: E-243-2012/0-US-01
Filing Date: March 15, 2013
Current Status: Expired
II. | PCT Patent Application No.: PCT/2014/028045 |
HHS Ref. No.: E-243-2012/0-PCT-02
Filing Date: March 14, 2014
Current Status: Nationalized
III. | EP Patent Application 14729502.6 |
HHS Ref. No.: E-243-2012/0-EP-03
Filing Date: March 14, 2014
Current Status: Issued 2968602
IV. | US Patent Application No.: 14/773,885 |
HHS Ref. No.: E-243-2012/0-US-04
Filing Date: September 09, 2015
Current Status: Issued US 9,719,080
V. | US Patent Application No.: 15/070,787 (Continuation in Part) |
HHS Ref. No.: E-243-2012/1-US-01
Filing Date: March 15, 2016
Current Status: Issued US 9,944,918
VI. | US Patent Application No.: 15/633,964 (CON) |
HHS Ref. No.: E-243-2012/0-US-05
Filing Date: June 27, 2017
Current Status: Pending
VII. | BE Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-BE-06
Filing Date: March 14, 2014
Current Status: Issued
VIII. | CH Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-CH-07
Filing Date: March 14, 2014
Current Status: Issued
IX. | DE Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-DE-08
Filing Date: March 14, 2014
Current Status: Issued
X. | DK Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-DK-09
Filing Date: March 14, 2014
Current Status: Issued
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XI. | ES Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-ES-10
Filing Date: March 14, 2014
Current Status: Issued
XII. | FR Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-FR-11
Filing Date: March 14, 2014
Current Status: Issued
XIII. | GB Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-GB-12
Filing Date: March 14, 2014
Current Status: Issued
XIV. | IE Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-IE-13
Filing Date: March 14, 2014
Current Status: Issued
XV. | IT Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-IT-14
Filing Date: March 14, 2014
Current Status: Issued
XVI. | LU Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-LU-15
Filing Date: March 14, 2014
Current Status: Issued
XVII. | NL Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-NL-16
Filing Date: March 14, 2014
Current Status: Issued
XVIII. | SE Patent Application No.: 14729502.6 |
HHS Ref. No.: E-243-2012/0-SE-17
Filing Date: March 14, 2014
Current Status: Issued
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APPENDIX B – LICENSED FIELDS OF USE AND TERRITORY
I. | Licensed Fields of Use: |
(a) | Research, development, manufacture and commercialization of pharmaceutical products for the treatment and/or prevention of Methylmalonic Acidemia (MMA) using gene therapy constructs in humans that incorporate the Licensed Product(s). |
II. | Licensed Territory: Worldwide |
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APPENDIX C – ROYALTIES
Royalties:
TheLicensee agrees to pay to theIC a noncreditable, nonrefundable license issue royalty in the amount of Twenty Five Thousand Dollars ($25,000.00) within [***] ([***]) days from theEffective Date of thisAgreement.
TheLicensee agrees to pay to theIC a nonrefundable minimum annual royalty in the amount of [***] Dollars ($[***]) as follows:
The minimum annual royalty payments are due and payable on January 1 of each calendar year and may be credited against any earned royalties due for sales made in that year.
Sublicensing Royalties:
TheLicensee agrees to pay theIC additional sublicensing royalties of:
[***] percent ([***]%) of any upfront payment in cash or of the fair market value of any upfront non-cash consideration received by theLicensee for granting each sublicense, within [***] ([***]) days of the execution of each sublicense.
Running Royalties on Net Sales:
TheLicensee agrees to pay theIC earned royalties of [***] percent ([***]%) on U.S. basedNet Sales by or on behalf of theLicensee, on a Licensed Product-by-Licensed Product basis, until the last to expire of theLicensed Patent Rights or theU.S. Orphan Drug Exclusivityfor a Licensed Product.
TheLicensee agrees to pay theICearned royalties of [***] percent ([***]%) on EuropeanNet Sales by or on behalf of theLicensee, on a Licensed Product-by-Licensed Product basis, until the last to expire of theLicensed Patent Rights orEuropean Orphan Drug Exclusivity for a Licensed Product.
TheLicensee agrees to pay theIC earned royalties of [***] percent ([***]%) on “rest of the world” (ROW) country/ies (i.e., other than the US or Europe) basedNet Sales by or on behalf of theLicensee, on a Licensed Product-by-Licensed Product basis, until the last to expire of theLicensed Patent Rights or theOrphan Drug Exclusivityfor a Licensed Product in the corresponding ROW countries (if applicable).
For clarity, Licensee shall not pay running royalties on Net Sales of a Licensed Product in any country where (a) the development, manufacture, use, distribution, sale or importation of the Licensed Product are no longer within the scope of one or more claims of the Licensed Patents Rights in the country that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction, and (b) such Licensed Product does not have valid Orphan Drug Exclusivity.
Benchmark Royalties:
TheLicensee agrees to pay theIC Benchmark royalties within [***] ([***]) days of achieving eachBenchmark:
(a) | [***] dollars ($[***]) for initiation of theLicensee-sponsoredPhase 1 Clinical Study (trial) or foreign equivalent in theLicensed Field of Use. |
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(b) | [***] dollars ($[***]) for initiation of theLicensee-sponsoredPhase 2 Clinical Study (trial)or foreign equivalent in theLicensed Field of Use or, in the case of the absence ofPhase 2 Clinical Study (trial)for anOrphan Indication, a pivotal trial. |
(c) | [***] dollars ($[***]) for initiation of the firstLicensee-sponsoredPhase 3 Clinical Study (trial)or foreign equivalent in theLicensed Field of Use or, in the case of the absence ofPhase 3 Clinical Study (trial) for anOrphan Indication, a pivotal trial. |
(d) | [***] dollars ($[***]) for submission of the first new drug application (NDA) or foreign equivalent as defined by theFDA for aLicensed Product orLicensed Process for anOrphan Indication or in theLicensed Field of Use. |
(e) | [***] dollars ($[***]) for submission of the first new drug application (or European equivalent thereof) for EMA approval for aLicensed Product orLicensed Process for anOrphan Indication or in theLicensed Field of Use. |
(f) | [***] dollars ($[***]) for submission of the first new drug application (or Japanese equivalent thereof) for Japanese regulatory approval for aLicensed Product orLicensed Process for anOrphan Indication or in theLicensed Field of Use. |
(g) | [***] dollars ($[***]) upon theFirst Commercial Sale in theLicensed Field of Use forMMA, in the United States. |
(h) | [***] Dollars ($[***]) upon theFirst Commercial Sale in theLicensed Field of Use forMMA, in Europe. |
(i) | [***] Dollars ($[***]) upon theFirst Commercial Sale in theLicensed Field of Use forMMA, outside the US or Europe. |
Initiation of a clinical trial study is defined as the first patient dosed in said clinical trial study.
The first time the CumulativeNet Sales of allLicensed Products achieve the following thresholds, theLicensee pays the following one-timeBenchmark royalties:
a) | [***] dollars ($[***]) when the cumulativeNet Sales of allLicensed Products reaches [***] dollars ($[***]). |
b) | [***] dollars ($[***]) when the cumulativeNet Sales of allLicensed Products reaches [***] dollars ($[***]). |
c) | [***] dollars ($[***]) when the cumulativeNet Sales of allLicensed Products reaches [***] dollars ($[***]). |
d) | [***] dollars ($[***]) when the cumulativeNet Sales of allLicensed Products reaches [***] dollars ($[***]). |
e) | [***] dollars ($[***]) when the cumulativeNet Sales of allLicensed Products reaches [***] dollars ($[***]). |
Priority Review Voucher Royalties:
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If a Priority Review Voucher or a foreign equivalent is granted to theLicensee by the FDA or another regulatory agency (such as but not limited to the Australian TGA, the EMA or the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)) for a Licensed Product, the Licensee agrees to make one of the following Benchmark royalty payments for each Priority Review Voucher or foreign equivalent:
(1) [***] percent ([***]%) of the transfer or sale price paid or fair market value of any non-cash consideration by the Third Party to theLicensee orAffiliate for the sold or transferredPriority Review Voucher or a foreign equivalent shall be due and payable to the IC within [***] ([***]) days followingLicensee’sreceipt of funds from such third-party sale or transfer; or
(2) If theLicensee orAffiliate is grantedPriority Review or a foreign equivalent ofLicensee’s BLA, NDA, ANDAor other regulatory application by theFDA for a product under thePriority Review Voucher or a foreign equivalent, and theLicensee orAffiliateuses the Voucher to obtain approval of its own or its Affiliate’s therapeutic for anOrphan Indication or in the Licensed Field of Use, [***] percent ([***]%) of the fair market value shall be due and payable to the IC within [***] days ([***]) following the grant of thePriority Review by theFDA or its foreign equivalent.
For the sake of clarity,Licensee shall have no further obligation to payBenchmark Royalties after the expiration or termination of this Agreement, and on a per-country basis or per-region basis (e.g., European Union),Net Sales in a particular country or region where there is no validLicensed Patent Rights orOrphan Drug Exclusivity shall not contribute to the cumulativeNet Sales for purposes of calculatingBenchmark Royalties.
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APPENDIX D – BENCHMARKS
1. | [***] |
2. | [***] |
3. | [***] |
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APPENDIX E – COMMERCIAL DEVELOPMENT PLAN
LB-001 is our lead GeneRide product candidate, which we are developing for the treatment of MMA in patients with the MUT mutation.
LB-001 consists of a DNA construct including a gene encoding the humanMUTenzyme encapsulated in an AAV capsid. TheMUTenzyme coding sequence is coupled to the 2A peptide sequence and surrounded by homology guides that drive the integration of theMUTgene and the 2A peptide sequence into the chromosomal locus for the albumin gene. Based on the way our construct integrates into the albumin locus, theMUTgene is then expressed resulting in synthesis ofMUTenzyme as a separate protein from albumin. We chose LK03, the AAV capsid we use in LB-001, because it has been optimized to target human liver cells.
In collaboration with our partners at NHI, LogicBio has demonstrated the safety and efficacy of LB-001 in mouse models of MMA, and is planning to submit an IND for the LB-001 program by the end of 2019. We recently completed a $80M IPO which has provided sufficient funds to progress the LB-001 program to a first in human study in 2020. Assuming successful completion of this study LogicBio will progress the program to pivotal studies.
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APPENDIX F – EXAMPLE ROYALTY REPORT
Required royalty report information includes:
• | License reference number (L-XXX-200X/0) |
• | Reporting period |
• | Catalog number and units sold of each Licensed Product (domestic and foreign) |
• | Gross Sales per catalog number per country |
• | Total Gross Sales |
• | Itemized deductions from Gross Sales |
• | Total Net Sales |
• | Earned Royalty Rate and associated calculations |
• | Gross Earned Royalty |
• | Adjustments for Minimum Annual Royalty (MAR) and other creditable payments made |
• | Net Earned Royalty due |
Example
Catalog Number | Product Name | Country | Units Sold | Gross Sales (US$) | ||||
1 | A | US | 250 | 62,500 | ||||
1 | A | UK | 32 | 16,500 | ||||
1 | A | France | 25 | 15,625 | ||||
2 | B | US | 0 | 0 | ||||
3 | C | US | 57 | 57,125 | ||||
4 | D | US | 12 | 1,500 |
Total Gross Sales | 153,250 | |||||||
Less Deductions: | ||||||||
Freight | 3,000 | |||||||
Returns | 7,000 | |||||||
Total Net Sales | 143,250 | |||||||
Royalty Rate | 8% | |||||||
Royalty Due | 11,460 | |||||||
Less Creditable Payments | 10,000 | |||||||
Net Royalty Due | 1,460 |
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APPENDIX G – ROYALTY PAYMENT OPTIONS
[***]
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