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Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Double asterisks denote omissions. | | Exhibit 10.20 |
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EXCLUSIVE LICENSE AGREEMENT
THISLICENSE AGREEMENT(the“Agreement”)is entered into by and betweenTHE JOHNS HOPKINS UNIVERSITY,a Maryland corporation having an address at 3400 N. Charles Street, Baltimore, Maryland 21218-2695(“JHU”)andTOKAI PHARMACEUTICALS, INC.,a Delaware corporation having an address at One Broadway, 14th Floor, Cambridge, Massachusetts 02142(“LICENSEE”).
RECITALS
WHEREAS, a valuable invention or inventions listed and described inExhibit A(“INVENTION”)was/were developed during the course of research conducted by the inventors listed onExhibit A (all hereinafter,“INVENTORS”).JHUhas acquired through assignment all rights, title and interest of saidINVENTORSin said valuableINVENTIONand the related patent rights.JHUdesires that the invention be perfected and marketed as soon as possible so that resulting products may be available for public use and benefit.
WHEREAS,LICENSEEdesires to obtain certain rights in suchINVENTIONSand related patent rights and know-how as herein provided, and to commercially develop, manufacture, use and distribute products and processes based upon or embodying said valuable inventions and/or know-how, andJHUdesires to grant such rights toLICENSEEon the terms set forth herein.
NOW, THEREFORE, in consideration of the foregoing and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledge, the parties to this Agreement hereby agree as follows:
All references to particular Exhibits, Articles or Paragraphs shall mean the Exhibits to, and Paragraphs and Articles of, this Agreement, unless otherwise specified. Any reference herein to any defined term shall include both the singular and the plural, whether or not both forms are included in the reference. For the purposes of this Agreement and the Exhibits hereto, the following words and phrases shall have the following meanings:
1.1“AFFILIATED COMPANY”means any corporation, company, partnership, joint venture or other entity, which controls, is controlled by or is under common control withLICENSEE. For purposes of this Paragraph control shall mean the direct or indirect ownership of at least fifty percent (50%) of the voting stock or other ownership interest of such entity.
1.2“EFFECTIVE DATE”means the date that the last party hereto has executed this Agreement.
1.3“EXCLUSIVE LICENSE”means that, subject to specific limitations in this Agreement, and subject to rights retained by the United States Government, if any,JHUgrants toLICENSEEall ofJHU’srights under theLICENSED PATENT(S)in theFIELD OF USEin theLICENSED TERRITORY. Exclusive refers toLICENSED PATENTSonly.KNOW HOW,data and other materials licensed are provided on anon-exclusive basis only.
1.4“FIELD OF USE”has the meaning given it inExhibit A.
1.5“FIRST COMMERCIAL SALE”means the first transfer by aLICENSEE, AFFILIATED COMPANY or SUBLICENSEEof aLICENSED PRODUCT or LICENSED SERVICEfor value, but shall not include
a transfer of materials for the purpose of use in a clinical trial, where the consideration received is intended to cover the manufacturing costs of the materials.
1.6“IMPROVEMENT”means an invention( a) that is first conceived or reduced to practice on or after theEFFECTIVE DATE,(b) where anINVENTORis an inventor as determined under U.S. patent law, and (c) the use or practice of which in theFIELD OF USEwould be dominated by one or more claims of theLICENSED PATENTS.
1.7“JHU REF. NUMBER”means theJHUTechnology Transfer Office case number or numbers, shown on Exhibit A, to which theTECHNOLOGYlicensed pertains. It is used forJHUreference only. TheTECHNOLOGYlicensed herein is described in this Agreement, and may not include all the technology that may be a part of theJHUreference number.
1.8“JHU INDEMNITEES”meansJHU,The Johns Hopkins Hospital, The Johns Hopkins Health System Corporation, and their affiliated entities, their present and former trustees, officers,INVENTORS,agents, faculty, employees and students.
1.9“KNOW HOW”means non-public information, including but not limited to data, test results, research methodology or manufacturing techniques created byINVENTORSthat is necessary or useful for the effective practice of theLICENSED PATENTS.
1.10“LICENSED PATENT”means (a) [**] and the inventions disclosed and claimed therein, (b) any patent or patent application that claims priority to and is a divisional, continuation, reissue, renewal, reexamination, substitution or extension of any patent application identified in (a); (c) any patents issuing on any patent application identified in (a) or (b), including any reissues, renewals, reexaminations, substitutions or extensions thereof; (d) any claim of a continuation-in-part application or patent (including any reissues, renewals, reexaminations, substitutions or extensions thereof) that is entitled to the priority date of, and is directed specifically to subject matter specifically described in, at least one of the patents or patent applications identified in (a), (b), (c); (e) any foreign counterpart (including PCTs) of any patent or patent application identified in (a), (b), or (c) or of the claims identified in (d); and (f) any supplementary protection certificates, pediatric exclusivity periods, any other patent term extensions and exclusivity periods and the like of any patents and patent applications identified in (a) through (e).
1.11“LICENSED PRODUCT”shall mean any process or method, material, compositions, drug, or other product, created or developed usingTECHNOLOGY,or for which the development, manufacture, use or sale, if done by a third party without rights under theLICENSED PATENT(S),would constitute an infringement of aVALID CLAIM of LICENSED PATENTS.
1.12“LICENSED SERVICE”includes any service or services, including the manufacture of any product or the use of any product or composition, performed byLICENSEEfor any third party using or incorporating theTECHNOLOGY,or which, if done by a third party without rights under theLICENSED PATENT(S),would constitute an infringement of a claim ofLICENSED PATENTS.
1.13“LICENSED TERRITORY”means all of the countries in the world.
1.14“NET REVENUES”whether they beNET SALES REVENUES OR NET SERVICE REVENUESshall include everything of value actually received byLICENSEE, AFFILIATED COMPANIESand
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SUBLICENSEE(S)for the sale, license, lease or other transfer ofLICENSED PRODUCTS,or the performance ofLICENSED SERVICES. Consideration includes but is not limited to currency, equity of the purchaser, lessee or other transferee, intangible rights, services and other things of value provided or received as part of the transaction forLICENSED PRODUCTS or LICENSED SERVICES,the fair value of which must be included to determineNET REVENUES.NET REVENUESmay be calculated using the accrual or cash method, but such calculation must be consistent from month to month and year to year, and must be the same method used byLICENSEEfor all similar transactions, or if none, the same method used generally byLICENSEEin reporting its business activity for United States federal tax purposes.
NET REVENUESmay exclude the following items, but only to the extent that they are included in gross revenue, and are separately billed to purchaser, and paid or remitted byLICENSEEto third parties:
(i) import, export, excise and sales taxes, custom duties, and shipping charges;
(ii) costs of packing, insurance covering damage during shipping, and transportation from the place of manufacture to the customer’s premises or point of installation; and
(iii) amounts repaid or credited by reason of rejections, defects, errors, overbilling, recalls or returns.
In the event that aLICENSED PRODUCT or LICENSED SERVICEis sold in a country or other jurisdiction in the Territory in the form of a combination product/service,NET REVENUESshall be calculated by multiplyingNET REVENUESfor the combination product/service by the fraction A/(A+B), where A is the invoice price of theLICENSED PRODUCT or LICENSED SERVICEand B is the invoice price of the other service(s) in the combination product/service if both theLICENSED PRODUCT or LICENSED SERVICE(as applicable) and the other product(s) or service(s) are sold separately. If either theLICENSED PRODUCT or LICENSED SERVICE(as applicable) or the other product(s) or service(s) in the combination product/service are not sold separately,NET REVENUESshall be calculated by multiplyingNET REVENUESfor the combination product/service by the fraction C/(C+D), where C is the value of theLICENSED PRODUCT or LICENSED SERVICE(as applicable) and D is the reasonably estimated value (using accepted industry standards) of the other product(s) or service(s) in the combination product/service, based at least in part on the value of the other active component or components used in the combination product/service.
1.15“NET SALES REVENUES”shall meanNET REVENUESderived from the sale ofLICENSED PRODUCTS,where a sale includes any license of use, lease, sale or other transfer of rights to theLICENSED PRODUCT.
1.16“NET SERVICE REVENUES” SHALL meanNET REVENUES derived from the sale or performance ofLICENSED SERVICES.
1.17“PATENT COSTS”means all unreimbursed costs of prosecuting and maintaining anyLICENSED PATENT,including reasonable attorneys’ fees or costs paid or incurred, and expenses paid or incurred for filing, maintenance, annuities, translation, or other costs directly related to the PATENT prosecution and maintenance.
1.18“SUBLICENSEE”means any person or entity other than anAFFILIATED COMPANYto whichLICENSEEhas granted a sublicense of theTECHNOLOGYunder this Agreement, but shall not include any service provider ofLICENSEE, an AFFILIATED COMPANY or SUBLICENSEEobtaining an implied
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license under theTECHNOLOGYto perform the contracted services on behalf ofLICENSEE, an AFFILIATED COMPANY or SUBLICENSEE.
1.19“SUBLICENSING INCOME”means everything of value received byLICENSEEin consideration for any sublicense which includes rights to theTECHNOLOGYlicensed herein. For clarity, and subject in all cases to clause (v) below,SUBLICENSING INCOMEis the total amount received, regardless of whether or not theSUBLICENSEincludes intellectual property in addition to the licensedTECHNOLOGY,and includes the sublicense fee, milestone payments, stock or other forms of equity, and the fair value of any services or other compensation received. The following may be excluded from the gross amount received for the sublicense when calculatingSUBLICENSING INCOME:
(i) The reasonable cost of services to be performed thereafter byLICENSEEor anAFFILIATED COMPANYfor or on behalf of theSUBLICENSEEif, but only if, those services are specifically described and the cost itemized and stated separately in the sublicense. Payments on the achievement of results shall be deemed to be milestone payments and are included inSUBLICENSING INCOME.
(ii) Reimbursement of the amount paid for fees incurred byLICENSEE,such as patent costs, or fees paid to governmental agencies, which are incurred after the date of the sublicense and are actually paid to third parties byLICENSEE.
(iii) Royalty payments onSUBLICENSEE’S NET REVENUES,which will be paid toJHUon pursuant to and on the terms of this Agreement.
(iv) The amount of any milestone payment made toJHUunder this Agreement as a result of activity ofLICENSEE or SUBLICENSEE,which results in a milestone payment by the sublicense toLICENSEEunder theSUBLICENSE. The difference between the milestone payment to be paid toJHUand the milestone payment paid toLICENSEEby the sublicensee shall be consideredSUBLICENSING INCOME. For clarification, ifSUBLICENSEEmakes a payment toLICENSEEas a milestone, andLICENSEEis obligated to make a milestone payment toJHUunder this Agreement for that same milestone, that milestone payment amount paid toJHUshall be deducted from the milestone amount paid under theSUBLICENSE,and the remainder shall be theSUBLICENSING INCOME.
(v) The amount received for technology independently developed byLICENSEEor itsAFFILIATED COMPANIES,or technology of third parties licensed or acquired byLICENSEEor itsAFFILIATED COMPANIESand included in theSUBLICENSE,includingLICENSEE’Spatent rights claiming the composition of galeterone and related methods and formulations, if said amount is separately stated in the sublicense.
If theSUBLICENSE includes the right or obligation of theSUBLICENSEE to purchase equity inLICENSEE at a cost greater than the then current fair market value of the equity, the difference between the fair market value and the amount paid shall beSUBLICENSING INCOME.
1.20“TECHNOLOGY” means theLICENSED PATENT(S) andKNOW HOW.
1.21“VALID CLAIM”means those claims of an issued patent in any country that (i) has not expired; (ii) has not been disclaimed; (iii) has not been revoked, held invalid, or otherwise declared unenforceable or not allowable by a tribunal or patent authority of competent jurisdiction over such
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claim in such country from which no further appeal has or may be taken; and (iv) in the case of a pending application, was filed and is being prosecuted in good faith towards allowance.
2.1Grant. Subject to the terms and conditions of this Agreement,JHUgrantsLICENSEEand itsAFFILIATED COMPANIES an EXCLUSIVE LICENSEunder theLICENSED PATENTSand a non-exclusive license under theKNOW-HOWin theFIELD of USEto make, have made, use, sell, offer to sell and importLICENSED PRODUCTSand performLICENSED SERVICESin theLICENSED TERRITORY. If anyAFFILIATED COMPANYexercises rights under this Agreement, suchAFFILIATED COMPANYshall be bound by all terms and conditions of this Agreement, including but not limited to indemnity and insurance provisions and royalty payments. In addition,LICENSEEshall remain fully liable toJHUfor all acts and obligations ofAFFILIATED COMPANYsuch that acts of theAFFILIATED COMPANYshall be considered acts of theLICENSEE.
2.2Retained Rights.
2.2.1JHU Rights. JHU retains the right, on behalf of itself, theINVENTORS and all other non-profit academic or research institutions to whomJHU extends rights, to practice and useTECHNOLOGY in theFIELD OF USE for any research or non-profit purpose, including, but not limited to sponsored research and collaborations with commercial entities (including for clinical trials), and assessment of patients at JHHS/JHU institutions (such as via the JHU CUA laboratory).JHU also has the right to publish any information included in theTECHNOLOGY.
2.2.2Government Rights. This Agreement is subject to Title 35 Sections 200-204 of the United States Code as implemented in 37 CFR Part 401, as may be amended from time to time. Among other things, these provisions provide the United States Government with certain nonexclusive rights in aLICENSED PATENT if federal funds were used to develop theTECHNOLOGY. They also impose the obligation thatLICENSED PRODUCTS sold or produced in the United States be “manufactured substantially in the United States.LICENSEE will ensure all required obligations of these provisions are met.
2.2.3No Implied licenses. The practice of the foregoing retained rights byJHU shall under no circumstances be construed as a license or ownership interest in, or other right to, any patent rights, know-how or other intellectual property rights ofLICENSEE or itsAFFILIATED COMPANIES andSUBLICENSEES, including without limitation any intellectual property rights covering or claiming galeterone or methods of manufacture or use thereof.
2.3Option Grant.JHUwill informLICENSEEin writing ofIMPROVEMENTS.JHUgrants toLICENSEEan option to negotiate for an exclusive license in theFIELD OF USEto any and all ofJHU’sinterests in theIMPROVEMENTS. The parties agree to negotiate in good faith the commercially reasonable terms and conditions of such an exclusive license, that may arise out of this Agreement.LICENSEEshall exercise its option by notifyingJHUin writing ofIMPROVEMENTSwhichLICENSEEintends to license within [**] days ofLICENSEE’snotification byJHUof suchIMPROVEMENTS.LICENSEEshall also provideJHUwith a diligence plan providing reasonable assurance toJHU of LICENSEE’Splans and capabilities to developIMPROVEMENTSinto aLICENSED PRODUCT or LICENSED SERVICEin theFIELD OF USEfor public use or benefit. The option will be subject toLICENSEEreimbursingJHUfor all unreimbursed costs of preparation, filing, prosecution and maintenance of patent rights incurred during the option and negotiation periods with respect to anyIMPROVEMENTS.JHUandLICENSEEwill have [**] months to come to terms afterJHUreceives notice ofLICENSEE’sintent to license any
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IMPROVEMENTS,after which,JHUwill be free to license suchIMPROVEMENTSto third parties without restriction. Such option will be subject to (i) Section 2.2 above, and (ii) any third party rights.
2.4Specific Exclusions.JHU does not:
2.4.1 commit toLICENSEE to bring suit against third parties for infringement, except as described in Article 9;
2.4.2 agree to furnish toLICENSEE any technology or technological information other than theTECHNOLOGY; or
2.4.3 agree to provideLICENSEE with any know how, invention, data, results or other assistance in the future unless specifically and clearly identified in this Agreement.
2.5Transfer of Know-How. Promptly following theEFFECTIVE DATE, JHU,through theINVENTORS,shall provideLICENSEEwith tangible manifestations of theKNOW-HOWin existence as of theEFFECTIVE DATEthat may be reasonably requested byLICENSEE,and shall ensure that theINVENTORSwill be reasonably available toLICENSEEduring the [**] month period following theEFFECTIVE DATEto respond to questions thatLICENSEEmay have regarding the use or practice of theKNOW-HOWin theFIELD OF USE.
3.1Permitted Sublicensing.LICENSEE may grant sublicenses in theFIELD OF USE in theLICENSED TERRITORY. For clarity,LICENSEE shall be responsible to payJHU royalties dueJHU on sales ofLICENSED PRODUCTS andLICENSED SERVICES by aSUBLICENSEE, to the same extent as ifLICENSEE made those sales directly, and whether or notSUBLICENSEE remits required royalty payments toLICENSEE.
3.2Sublicense Requirements. Any sublicense agreement executed pursuant to Section 3.1:
(i) is subject to this Agreement;
(ii) will not permit aSUBLICENSEEto further sublicense withoutJHU’sconsent;
(iii) will, as a condition of validity, expressly include the provisions of Articles 7, 8, 10.3 and 12.2 for the benefit ofJHU;
(iv) will, if this Agreement is terminated, require the transfer toJHUof all obligations, including the payment of royalties specified in theSUBLICENSE,without setoff for debts or obligations ofLICENSEE to SUBLICENSEE;and
(v) will not be valid againstJHUas to terms, conditions, obligations or limitations that are inconsistent with this Agreement and these sublicensing requirements.
3.3Notice and Copy of Sublicense.LICENSEEwill notifyJHUand within [**] days of execution will submit toJHUan unredacted copy of each sublicense, the terms of which will not be considered confidential as toJHU,but which termsJHUwill treat asLICENSEE’sconfidential information.
3.4Sublicensing Income.LICENSEEwill share with and pay toJHUthat portion ofSUBLICENSING INCOMEas stated inExhibit A.
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| 4. | DILIGENCE REPORTING AND DEVELOPMENT |
4.1Federal Funding. It is the requirement of federal law, and the obligation ofJHUandLICENSEE,that inventions created with federal funding be diligently developed into useful products and services.
4.2Milestones.LICENSEEwill diligently develop markets for and develop, manufacture, and sellLICENSED PRODUCTSandLICENSED SERVICES. In addition,LICENSEEwill use commercially reasonable efforts to meet the milestones and target dates, if any, shown in Exhibit A, and notifyJHUin writing within [**] days after each milestone is met.
4.3Diligence Report.
4.3.1 By [**] of each year,LICENSEE will submit a written annual report toJHU covering the preceding calendar year. The report will follow the Diligence Report Guidelines stated on Exhibit C and shall include information reasonably sufficient to enableJHU to satisfy reporting requirements of the U.S. Government and forJHU to ascertain progress byLICENSEE toward meeting this Agreement’s diligence requirements. Each report will describe, where relevant:
(i) progress byLICENSEE,AFFILIATED COMPANIES orSUBLICENSEE(S) toward commercialization ofLICENSED PRODUCTS orLICENSED SERVICES;
(ii) any FDA or other governmental filings and/or approvals regarding anyLICENSED PRODUCTS or LICENSED SERVICE made or obtained byLICENSEE, AFFILIATED COMPANY or SUBLICENSEE, the patents or patent applications licensed under this Agreement upon which such product or service is based, and the commercial name of such product or service;
(iii) a certificate of insurance or other evidence of insurance, as required by this Agreement, or a statement of why such insurance is not currently required;
(iv) identification of allAFFILIATED COMPANIES andSUBLICENSEE(S) which have exercised rights to theTECHNOLOGY, or a statement that noAFFILIATED COMPANY orSUBLICENSEE has exercised such rights;
(v) description of any diligence milestones achieved during the prior, and identification of any milestones expected to be achieved in the next year;
(vi) description of any sublicenses under theTECHNOLOGY that were entered during the year, with a copy of the sublicense agreement if not previously provided.
(vii) notification of any change of control, name change or other significant change related to this Agreement orLICENSEE.
4.3.2 Reports may be submitted electronically to an email address provided on request byJHU. Such reports shall be the Confidential Information ofLICENSEE.
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| 5. | FEES, ROYALTIES AND OTHER PAYMENTS |
5.1License Fee.LICENSEEshall pay toJHUthe noncreditable, nonrefundable license fee as described inExhibit A within [**] days of theEFFECTIVE DATE.
5.2Patent Costs.Exhibit A includes a summary of unreimbursedPATENT COSTS,andLICENSEEwill reimburseJHUthe amount stated inExhibit A at such time or in such manner as stated inExhibit A.
5.3Minimum Annual Royalty.
5.3.1LICENSEE will payJHU a yearly Minimum Annual Royalty(“MAR”) as described in Exhibit A, which will be paid in advance on or before [**] of each calendar year and which will apply to that calendar year.
5.3.2 MAR payments are nonrefundable. Earned royalty payments due onNET REVENUES occurring in the year to which the MAR pertains may be offset against the Minimum Annual Royalty paid for that year, but only for that year, without carry forward or back.
5.4Milestone Payments.LICENSEEwill payJHUmilestone payments as stated onExhibit A. Within [**] days of achieving a milestone set forth on Exhibit A.LICENSEEwill report the achievement toJHU,and pay toJHUthe milestone payment required. Milestones achieved should be included in the diligence report described in Section 4.3, even if previously reported.
5.5Earned Royalty.LICENSEEwill payJHUearned royalties, as described in Exhibit A, which shall be paid quarterly unless a different payment schedule is specifically stated.LICENSEEmay deduct from the earned royalty the amount of any MAR paid for the year in which the quarter occurs, until all of the MAR has been deducted from payments due for that year, after which any earned royalty in excess of the MAR shall be paid toJHU.
5.6Duration of Royalty Payments. Royalties shall be paid as described in Exhibit A for eachLICENSED PRODUCTmanufactured or produced or eachLICENSED SERVICEperformed, on acountry-by- country basis, until the later to occur of: (a) ten (10) years from date ofFIRST COMMERCIAL SALEof that particularLICENSED PRODUCT or LICENSED SERVICEin that country and (b) the last to expire patent included within theLICENSED PATENTSin such country.
5.7Payment for All Activities Performed under this Agreement.If LICENSED PRODUCTSare made, used, imported, or offered for sale before the date this Agreement terminates, and thoseLICENSED PRODUCTSare sold after the effective date of termination,LICENSEEwill payJHUthe earned royalty based on theNET REVENUEof thoseLICENSED PRODUCTS. In addition, use of theTECHNOLOGYbyLICENSEEshall be deemed to be use which is licensed under this Agreement, regardless of where performed, whether or not specificLICENSED PATENTSexist in the location of the activity for which activity a royalty or other payment is due under this Agreement.
5.8Obligation to Pay Royalties and Other Payments. Payments required herein must be paid on the dates or upon the conditions stated, notwithstanding any claims by eitherLICENSEEor third party challenging the validity of theLICENSED PATENTS. Payments once made are not refundable even if theLICENSED PATENTSare later determined to be invalid or not applicable to the particular product or service.
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5.9Currency. ForNET REVENUESin currencies other than U.S. Dollars,LICENSEEwill calculated the royalty in U.S. Dollars quarterly, using the appropriate foreign exchange rate for the currency as quoted by the United States Federal Reserve Bank, for the last business day of each calendar quarter, to apply to payments earned by activities during that quarter.
5.10Non-U.S. Taxes. If non-U.S. taxes are due on royalty or other payments, such taxes shall be deemed to be in addition to the payment, andLICENSEEwill pay all non-U.S. taxes related to royalty and any other payments under this Agreement. These tax payments are not deductible from any payments due toJHU.JHUwill cooperate withLICENSEEto receive a refund of such taxes to the extent available, and such refund shall be retained byLICENSEE.
5.11No requirement of invoice. All payments are due on the due date without invoice or demand for payment by or from JHU.
5.12Interest. Payments are considered due on the dates and at the times described in this agreement, and if not so stated, within [**] days of the date of the event requiring the payment. Payment is made when received byJHU. Payments not received within [**] days of the due date shall, beginning on the due date, bear interest at the rate of [**]% per annum, whether or notJHUhas made a demand for such payment or interest. Acceptance of late payments without interest will not act as a waiver of this provision.
5.13Payments and Obligations. All payments and obligations which come due shall be and remain due, and the existence of a dispute shall not suspend any duties under this License Agreement.
5.14Invoicing by JHU.JHUmay submit all invoices for any payments due in electronic form via e-mail sent to the e-mail address supplied byLICENSEEfrom time to time. An invoice directed to the last email address provided byLICENSEE to JHUshall be deemed received byLICENSEEwhen sent byJHU.
5.15Method of Payment. All payments under this Agreement shall be made in U.S. Dollars by either check or wire transfer.
5.16Payment Information. Payments shall be made as follows, or as further notified from time to time byJHU:
All check payments fromLICENSEE to JHUshall be sent to:
| | | | |
| Attention: | | Executive Director |
| | Johns Hopkins Technology Transfer |
| | The Johns Hopkins University |
| | 100 N. Charles Street |
| | 5th Floor |
| | Baltimore, MD 21201 |
| | Attn: | | A26360 |
or such other addresses which JHU may designate in writing from time to time. Checks are to be made payable to the “Johns Hopkins University”. Wire transfers may be made through:
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| | |
| |
| FED WIRE: | | [**] |
| |
| FED WIRE: | | [**] |
Company shall be responsible for any and all costs associated with wire transfers.
| 6. | ROYALTY REPORTS AND ACCOUNTING |
6.1Quarterly Earned Royalty Payment and Report. Beginning with theFIRST COMMERCIAL SALEof aLICENSED PRODUCT or LICENSED SERVICE, LICENSEEwill thereafter submit toJHUa written report [**] days after the end of each calendar quarter (even if there are noNET REVENUESduring that quarter), along with payment of any earned royalty due. This report will be in the form ofExhibit B and will state the number, description, and aggregateNET REVENUES of LICENSED PRODUCTSandLICENSED SERVICESfor the completed calendar quarter. Such reports must be filed and payments made during any claim against or challenge to the scope or validity of theLICENSED PATENTS.
6.2No Refund. In the event that a validity or non-infringement challenge of aLICENSED PATENTis successful,LICENSEEwill have no right to recoup any royalties paid before or during the challenge period.
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6.3Termination or Expiration Report.LICENSEEwill pay toJHUall applicable royalties and submit toJHUa written report within [**] days after the license expires or terminates.LICENSEEwill continue to submit required earned royalty payments and reports toJHUafter the license terminates, until allLICENSED PRODUCTSmade or imported under the license have been sold, and thereafter until the time for paying earned royalties has expired.
6.4Accounting.LICENSEEwill maintain records showing manufacture, importation, sale, and use ofLICENSED PRODUCTSor performance ofLICENSED SERVICESand the revenue received for [**] years from the date of sale of thatLICENSED PRODUCT or LICENSED SERVICE. Records will include general ledger records showing cash receipts and expenses, and records that include production records, customers, invoices, serial numbers and related information in sufficient detail to enableJHUto determine the royalties payable under this Agreement.
6.5Audit by JHU.LICENSEEwill allow an independent accounting firm designated byJHUto examineLICENSEE’srecords during regular business hours upon [**] days’ prior written notice to LICENSEE for the sole purpose of verifying payments made byLICENSEEunder this Agreement. Such inspection may not be made more than [**]. The costs of such inspection shall be paid by JHU; provided, however, that if the audit reveals an underreporting of earned royalties dueJHUof more than [**] percent ([**]%) for the period being audited,LICENSEEwill pay the additional royalties due, and reimburseJHUthe reasonable audit costs incurred.
| 7. | WARRANTIES, EXCLUSIONS AND NEGATION |
7.1JHU Warranty.JHUwarrants and represents that the Inventors listed have provided an invention disclosure to the JHU Office of Technology Transfer(“JHTT”),that the Inventors have assigned such rights as they have in the Inventions toJHU,and thatJHU,as assignee of the Inventions, has filed the patent applications referred to in this Agreement.JHUfurther warrants and represents that it has the complete right and authority to grant the licenses toLICENSEEhereunder, and that this Agreement and the exercise byLICENSEEof its rights hereunder does not violate or conflict with an contractual or other right thatJHUor its affiliated entities has with a third party. To the best ofJHU’sknowledge, information and belief, theLICENSED PATENT(S)accurately list the inventors of that Patent andJHUhas received no claims of a third party to rights in theLICENSED PATENTSother than as may be specifically stated in this Agreement.JHUdoes not warrant against presently unknown claims of third parties that may arise after this Agreement.
7.2Negation of Warranties. Except as set forth in Section 7.1, JHU providesLICENSEEthe rights granted in this Agreement AS IS and WITH ALL FAULTS.JHUmakes no other representations and extends no warranties of any kind, either express or implied. Among other things,JHUdisclaims any express or implied warranties of merchantability or fitness for a particular purpose.
7.3No Representation of LICENSED PATENT.LICENSEEalso acknowledges thatJHUdoes not represent or warrant:
(i) the validity or scope of anyLICENSED PATENT,or
(ii) that the exploitation ofLICENSED PATENT or TECHNOLOGY will be successful, or
(iii) except as set forth in Section 7.1,that there are no third party claims or prior filed patents that would affect ownership of theTECHNOLOGYor freedom to operate.
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7.4No other Promises or Warranties. Other than the obligations specifically stated in this Agreement,JHUmakes no promises, express or implied, regarding theTECHNOLOGY.LICENSEEagrees that no representation or statement by anyJHUemployee shall be deemed to be a statement or representation byJHU,and thatLICENSEEwas not induced to enter this Agreement based upon any statement or representation ofJHU,or any employee ofJHU.JHUis not responsible for any publications, experiments or results reported by anyJHUemployee, now or in the future, including any of theINVENTORSand it is the sole responsibility ofLICENSEEto evaluate theTECHNOLOGYand the accuracy of any data or results.
| 8. | INDEMNITY AND INSURANCE |
8.1Application.LICENSEEshall have exclusive control over theLICENSED PRODUCTSandLICENSED SERVICESprovided byLICENSEE,and the risks and costs associated therewith. Therefore, LICENSEE will protect JHU INDEMNITEES from exposure to damages which arise from the actions of LICENSEE.
8.2Indemnification.LICENSEE, AFFILIATED COMPANYand/orSUBLICENSEEagree that each shall be responsible for injuries or losses to third parties arising from or related to their own acts or omissions, or caused by or arising fromLICENSED PRODUCTS or LICENSED SERVICES,or allegedly arising as a consequence of the exercise byLICENSEE, AFFILIATED COMPANY or SUBLICENSEEof any rights granted in this Agreement. To that end,LICENSEE, AFFILIATED COMPANYandSUBLICENSEEshall protectJHU INDEMNITEESfrom any third party claims arising therefrom, including defending any action brought againstJHU INDEMNITEES,with counsel reasonably acceptable toJHU,and indemnifyingJHU INDEMNITEESas against any judgments, fees, expenses, or other costs arising from or incidental to any such lawsuit, claim, demand or other action, whether or not anyJHU INDEMNITEE,is named as a party defendant in any such lawsuit and whether or not theJHU INDEMNITEESare alleged to be negligent or otherwise responsible for any injuries to persons or property. Exercise of the rights granted in this Agreement, by anAFFILIATED COMPANYor an agent or aSUBLICENSEEor a third party on behalf of or for the account ofLICENSEE,shall be consideredLICENSEE’spractice of said inventions for purposes of this Paragraph.
8.3Exclusions.
8.3.1 No indemnification will be provided for claims arising from the practice by aJHU INDEMNITEE of theLICENSED PATENTS, or exercise of rights retained byJHU under this Agreement, or the practice of theLICENSED PATENTS outside theFIELD OF USE by a third party licensee ofJHU.
8.3.2 No indemnification will be provided for a claim against aJHU INDEMNITEE for injuries allegedly caused solely and directly by negligent use or administration by aJHU INDEMNITEE of aLICENSED PRODUCT or LICENSED SERVICE, but any products liability or similar claim based upon aLICENSED PRODUCT or LICENSED SERVICE, made by or provided byLICENSEE or anyAFFILIATED COMPANY or SUBLICENSEE will be covered by this indemnification requirement.
8.4Survival after Termination. The obligation ofLICENSEEto defend and indemnify as set out in this Paragraph shall survive the termination of this Agreement, shall continue even after assignment of rights and responsibilities to anAFFILIATED COMPANY or SUBLICENSEE,and shall not be limited by any other limitation of liability elsewhere in this Agreement.
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8.5Rights and Obligations of JHU.JHUshall provideLICENSEEwith prompt notice of any claims covered byLICENSEE’sobligation to indemnify, and will provide reasonable cooperation toLICENSEE in LICENSEE’sinvestigation and defense of suchclaims.JHUshall have the right to participate in such defense with counsel of its choice and atJHU’sown expense.JHUshall have the right to approve the settlement of any claim hereunder that imposes any liability or obligation onJHU,or affects theLICENSED PATENTS,other than the payment of money damages paid by theLICENSEE.
8.6Insurance. Prior to initial human testing orFIRST COMMERCIAL SALEof anyLICENSED PRODUCT or LICENSED SERVICE, LICENSEEwill establish and maintain Comprehensive General Liability Insurance, including Product Liability Insurance, with a reputable and financially secure insurance carrier acceptable toJHUto cover any liability ofLICENSEEandJHUto third parties related to anyLICENSED PRODUCT or LICENSED SERVICE,or otherwise arising from the activities ofLICENSEE,anyAFFILIATED COMPANY or SUBLICENSEE. TheLICENSEEor the acquired insurance will provide minimum limits of liability of $[**] per claim and $[**] in aggregate and will include allJHU INDEMNITEESas additional insureds.LICENSEEwill furnish a Certificate of Insurance or other evidence of compliance upon reasonable request. All insurance ofLICENSEEwill be primary coverage; other insurance ofJHUandJHU INDEMNITEESwill be excess and noncontributory.
| 9. | PATENT PROSECUTION, MAINTENANCE, & INFRINGEMENT |
9.1Prosecution & Maintenance.
9.1.1Filing and Prosecution.JHU, at LICENSEE’s expense, shall file, prosecute and maintain all patents and patent applications specified underLICENSED PATENTS. Title to all such patents and patent applications shall reside inJHU.JHU shall have final decision authority over all patent matter.JHU shall (a) request its patent counsel to timely copyLICENSEE on all official actions and written correspondence with any patent office, and (b) allowLICENSEE an opportunity to comment and adviseJHU on all matters relating to the prosecution and maintenance of theLICENSED PATENTS.JHU will consider any ofLICENSEE’s comments and advice in good faith.
9.1.2Responsibility of Licensee.LICENSEE shall be responsible for assuring thatLICENSED PATENTS desired byLICENSEE are protected to the extent and in the areas desired byLICENSEE, including assuring timely review of patents drafted or filed, timely filing as necessary and payment of required costs.
9.1.3Election Not to File in Certain Jurisdictions. By concurrent written notification toJHU and its patent counsel at least [**] days in advance (or later atJHU’s discretion) of any filing or response deadline, or fee due date,LICENSEE may elect not to have a patent application filed in any particular country or not to pay expenses associated with prosecuting or maintaining any patent application or patent, provided thatLICENSEE pays for all costs incurred up toJHU’s receipt of such notification. Failure to provide such notification will be considered byJHU to beLICENSEE’s authorization to proceed atLICENSEE’s expense. Upon such notification,JHU may file, prosecute, and/or maintain such patent applications or patent at its own expense and for its own benefit, and any rights or license granted hereunder held byLICENSEE, AFFILIATED COMPANIES or SUBLICENSEE(S) relating to theLICENSED PATENTS which comprise the subject of such patent applications or patent and/or apply to the particular country, shall terminate, and thereafter reside solely inJHU.
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9.2Notification of Infringement by Third Party. Each party will notify the other promptly in writing when any infringement by another is uncovered or suspected.
9.3Suit for Infringement.
9.3.1LICENSEE shall have the first right to enforce theLICENSED PATENTS in theFIELD OF USE against any infringement or alleged infringement thereof, and shall at all times keepJHU informed as to the status thereof. This right to sue for infringement shall not be used in an arbitrary or capricious manner. BeforeLICENSEE commences an action with respect to any infringement of such patents,LICENSEE shall give careful consideration to the views ofJHU and to potential effects on the public interest in making its decision whether or not to sue. Thereafter,LICENSEE may, at its own expense, institute suit against any such infringer or alleged infringer and control and defend such suit in a manner consistent with the terms and provisions hereof.
9.3.2 No settlement, consent judgment or other voluntary final disposition of the suit may be concluded without the prior written consent ofJHU, which consent shall not be unreasonably withheld or delayed.JHU shall reasonably cooperate in any such litigation atLICENSEE’s expense, including being named as a party plaintiff in such action to the extent required.
9.3.3 IfLICENSEE elects not to enforce any patent within theLICENSED PATENTS, it shall so notifyJHU promptly in writing andJHU may, in its sole judgment and at its own expense, take steps to enforce any patent and control, settle, and defend such suit in a manner consistent with the terms and provisions hereof, and recover, for its own account, any damages, awards or settlements resulting therefrom.
9.4Patent Invalidity Suit.LICENSEE shall defend atLICENSEE’s expense a declaratory judgment or other action brought by a third party namingLICENSEE or JHU as a defendant and alleging invalidity of any of theLICENSED PATENTS. JHU in its discretion may elect to take over the sole defense of the action at its own expense, in which caseLICENSEE shall cooperate fully withJHU in connection with any such action.
9.5Recovery. LICENSEE shall pay toJHU [**] percent ([**]%) of any monetary award, settlement or recovery, net of all reasonable attorneys’ fees and out-of-pocket costs and expenses incurred byLICENSEE in connection with each suit or settlement. If the cost and expenses exceed the recovery no additional amount shall be paid toJHU.
| 10. | HANDLING AND RESOLUTION OF DISPUTES. |
10.1Governing Law. This Agreement shall be construed, and legal relations between the parties hereto shall be determined, in accordance with the laws of the State of Maryland applicable to contracts executed and wholly to be performed within the State of Maryland without giving effect to the principles of conflicts of laws. Any disputes between the parties to the Agreement including the applicability or validity of anyLICENSED PATENTS may be brought in the state or federal courts located in Baltimore, Maryland. Both parties agree to waive their right to a jury trial and to consent to jurisdiction in such courts.
10.2Resolution. The parties shall attempt to resolve all disputes through informal means. This may include mediation, arbitration, or any other procedures upon which the parties agree. Each
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party agrees that, prior to resorting to litigation, it will confer with other party to determine whether other procedures that are less expensive or less time consuming can be adopted to resolve the dispute.
10.3Challenges to LICENSED PATENTS, Scope and Applicability – Requirements During and After Challenge of LICENSED PATENTS by LICENSEE. The provisions of this Paragraph 10.3 shall be included in anySUBLICENSE and pertain also to actions by aSUBLICENSEE. IfLICENSEE, Affiliate orSUBLICENSEEbrings an action againstJHU challenging the validity or scope of theLICENSED PATENTS, or applicability of theLICENSED PATENTS to aLICENSED PRODUCT orLICENSED SERVICE the following shall apply.
10.3.1 Actions by aSUBLICENSEE shall be attributed toLICENSEE unlessLICENSEE demonstrates that the action was taken independent of any influence byLICENSEE, andLICENSEE fully cooperates in defending the action, including affirming the validity of theLICENSED PATENTS challenged.
10.3.2 If such action determines that at least one claim of a patent challenged byLICENSEE, AFFILIATED COMPANY or SUBLICENSEE is valid and, if applicable, but for this Agreement, infringed by aLICENSED PRODUCT or LICENSED SERVICE, the party challenging will thereafter, except as toPATENT COSTS, [**]. For clarity, this shall apply to [**], except incurredPATENT COSTS which will be paid as otherwise agreed.
10.3.3 If such action determines that at least one claim of a patent challenged byLICENSEE, AFFILIATED COMPANY or SUBLICENSEE is valid and, if applicable, but for this Agreement, infringed by aLICENSED PRODUCT or LICENSED SERVICE, theLICENSEE, AFFILIATED COMPANY or SUBLICENSEE challenging will [**].
10.3.4 During the course of such challenge, all payments otherwise required by this Agreement shall be paid as and when due, to the same extent as if there were no challenge to theLICENSED PATENTS, andLICENSEE, AFFILIATED COMPANY or SUBLICENSEE will have no right to recoup any payments, including royalties, which become due before or during the challenge.
10.3.5LICENSEE, AFFILIATED COMPANY or SUBLICENSEE shall not pay royalties into any escrow or other similar account, but shall make all payments toJHU as due and when due, unlessLICENSEE or SUBLICENSEE has prior to the payment becoming due, voluntarily and completely terminated this Agreement. Timely and complete payment and full compliance byLICENSEE,Affiliate andSUBLICENSEE with all terms of this Agreement shall be a condition precedent to bringing and maintaining the legal action challenging theLICENSED PATENTS.
10.3.6 No less than [**] months prior to bringing an action seeking to invalidate or limit a LICENSED PATENT, LICENSEE or AFFILIATED COMPANY will provide written notice of the expected challenge to JHU which shall include a clear statement of the factual and legal basis for the challenge, and an identification of all prior art and other matter believed to invalidate any claim on the LICENSED PATENTS or which supports the claim that the LICENSED PATENT does not apply to the LICENSED PRODUCT or LICENSED SERVICE.
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11.1Term. The term of this Agreement shall commence on theEFFECTIVE DATE and shall continue, in each country, until the date of expiration of the last to expire patent included withinLICENSED PATENTS in that country or if no patents issue then for a term of ten (10) years from theFIRST COMMERCIAL SALE in such country.
11.2Termination by Licensee. LICENSEE may terminate this Agreement by givingJHU written notice at least 90 days in advance of the proposed effective date of termination selected byLICENSEE.LICENSEE shall pay all sums due under this Agreement, including MARs, earned royalties, milestone payments orPATENT COSTS which are incurred or are or become due prior to the effective date of termination. In addition,LICENSEE shall also be obligated to pay anyPATENT COSTS which are required to be incurred to preserve the patent prior to the effective date of termination. Termination will not preclude JHU from enforcing its right to collect from LICENSEE amounts accrued and payable prior to the effective date of termination.
11.3Termination by JHU.
11.3.1JHU may terminate this Agreement ifLICENSEE fails to perform or otherwise materially breaches any of its material obligations hereunder, or of any related agreement including a sponsored research agreement if, following the giving of notice by JHU of its intent to terminate and stating the grounds therefor, LICENSEE has not cured the failure or breach within [**] days. IfLICENSEE is diligently and in good faith attempting to cure the default,LICENSEE may request, andJHU shall grant an additional [**] days to cure the default. JHU may also terminate this Agreement if LICENSEE voluntarily or involuntarily enters bankruptcy or receivership proceedings.
11.3.2Failure to Meet a Required Diligence Milestone. If this Agreement provides for diligence milestones which must be accomplished by specified dates or within specified periods of time,LICENSEE may cure any default for failure to meet a required diligence milestone in accordance with this subsection.
(i)LICENSEE must be diligently pursuing the milestone and providesJHU a reasonable explanation of the reasons for such failure and (b) a reasonable, detailed, written plan for promptly achieving a reasonable extended and/or amended milestone. IfLICENSEE so notifiesJHU and providesJHU with the foregoing explanation and plan, both of which are acceptable toJHU in its reasonable discretion, then the applicable diligence milestone will be amended in writing to incorporate the extended and/or amended milestone set forth in the plan presented byLICENSEE.
(ii)JHU may not withhold its approval to any extended and/or amended milestone if the explanation provided byLICENSEE demonstrates to JHU’s reasonable satisfaction that (A) the existence of technical difficulties or delays in preclinical or clinical studies( e.g.,negative toxicological or pharmacological test results or an adverse clinical event) or regulatory processes thatLICENSEE, itsAFFILIATED COMPANIES and/orSUBLICENSEES could not have reasonably avoided; (B) the issuance of an injunction or the grant of other equitable relief by a court of competent jurisdiction preventingLICENSEE, itsAFFILIATED COMPANIES and/or SUBLICENSEES from practicing an invention under theLICENSED PATENTS; or (C) a failure to achieve, or a material delay in achieving, marketing approval for galeterone, aLICENSED PRODUCT or LICENSED SERVICE.
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(iii) If the explanation and plan provided by LICENSEE are not reasonably acceptable toJHU, thenLICENSEE may extend the milestone for up to an additional [**] months by paying [**] of the milestone payment associated with the milestone.
11.4Survival of Sublicenses. Upon termination of this Agreement for any reason, anySUBLICENSEE shall become a direct licensee ofJHU under the terms of this Agreement, provided thatJHU’s obligations toSUBLICENSEE(S) are no greater thanJHU’sobligations toLICENSEE hereunder.
| 12. | MISCELLANEOUS PROVISIONS. |
12.1Confidentiality.
12.1.1 As used in this Agreement, the term“Confidential Information” means any technical or business information furnished byLICENSEE to JHTI in connection with this Agreement which is (a) disclosed in writing or other tangible form and is labeled or identified as “CONFIDENTIAL” at the time of disclosure or, by written notice toJHU, within [**] days following disclosure; (b) disclosed verbally and reduced to writing or other tangible form and similarly labeled, within [**] days of verbal disclosure. It is understood and agreed that reports provided toJHU pursuant to paragraphs 4.3 and 6.1are Confidential Information hereunder.
12.1.2JHUshall and shall cause its employees, faculty, staff, students, trustees and advisors engaged in the performance of this Agreement to: (a) employ all reasonable and diligent efforts to maintain all Confidential Information in strict confidence, except thatJHUmay disclose or permit the disclosure of any Confidential Information to its employees who are obligated to maintain the confidential nature of such Confidential Information and who need to know such Confidential Information to perform this Agreement; (b) use all Confidential Information solely for purposes of performing this Agreement; and (c) reproduce the Confidential Information only to the extent necessary to perform this Agreement, with all such reproductions being considered Confidential Information.
12.1.3 The obligations ofJHUunder Paragraph 12.1.2 shall not apply to Confidential Information to the extent thatJHUcan demonstrate that such applicable Confidential Information: (a) was in the public domain prior to the time of its disclosure under this Agreement; (b) entered the public domain after the time of its disclosure under this Agreement through means other than an unauthorized disclosure resulting from an act or omission byJHU; (c) is or was disclosed toJHU at any time, whether prior to or after the time of its disclosure under this Agreement, by a third party having no fiduciary obligation of confidentiality with respect to such Confidential Information; (d) is or was developed by or forJHU without reference to information provided byLICENSEE or (e) is required to be disclosed to comply with applicable laws or regulations, or with a court or administrative order, provided thatLICENSEE receives prior written notice of such disclosure and the opportunity to assess the need to disclose and/or limit the scope of disclosure, and thatJHU takes all reasonable and lawful actions atLICENSEE’s request and expense to obtain confidential treatment for such disclosure and, if possible, to minimize the extent of such disclosure.
12.2Patent Marking. LICENSEE agrees that allLICENSED PRODUCT(S) sold byLICENSEE, AFFILIATED COMPANIES andSUBLICENSEE(S) will be marked with the number of the applicable patent(s) licensed hereunder in accordance with, and to the extent required by, each country’s patent laws.
12.3Use of Name.LICENSEE, AFFILIATED COMPANIESandSUBLICENSEE(S)shall not use the name of The Johns Hopkins University or The Johns Hopkins Health System or any of its constituent parts, such as the Johns Hopkins Hospital, Johns Hopkins Medicine or any contraction thereof or the name of
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Inventors in any advertising, promotional literature, web sites, electronic media applications, sales literature, fundraising documents, or press releases and other print or electronic communications without prior written consent from an authorized representative ofJHU.LICENSEE, AFFILIATED COMPANIESandSUBLICENSEE(S)shall allow at least [**] business days’ notice of any proposed public disclosure forJHU’sreview and comment or to provide written consent, unless a shorter period is required in order forLICENSEEto comply with its disclosure obligations under federal and state securities laws. Such request shall be made through JHTI.
12.4No Partnership. Nothing in this Agreement shall be construed to create any agency, employment, partnership, joint venture or similar relationship between the parties other than that of a licensor/licensee. Neither party shall have any right or authority whatsoever to incur any liability or obligation (express or implied) or otherwise act in any manner in the name or on the behalf of the other, or to make any promise, warranty or representation binding on the other.
12.5Notice of Claim. Each party shall give the other or its representative immediate notice of any suit or action filed, or prompt notice of any claim made, against them arising out of the performance of this Agreement or arising out of the practice of the inventions licensed hereunder.
12.6Assignment.
12.6.1Permitted Assignment by Licensee. LICENSEE may assign this Agreement as part of a sale or merger, regardless of whether such a sale occurs through an asset sale, stock sale, merger or other combination, if the sale or merger is ofLICENSEE’s entire business.
12.6.2Any Other Assignment by Licensee. Any other attempt to assign this Agreement byLICENSEE is null and void in the absence ofJHU’s written permission.
12.6.3Conditions of Assignment. For any assignment, the following conditions must be met:
(i)LICENSEE must giveJHU written notice of the assignment once complete, including the new assignee’s contact information; and
(ii) the new assignee must agree in writing toJHUto be bound by this Agreement.
12.6.4Assignment Payment to JHU. Where the assignment is the result of complete sale or merger of LICENSEE, thenLICENSEE (or its assignee) shall pay toJHU an assignment fee set forth inExhibit A. For all other assignments, the assignment shall be treated in the same manner as a sublicense, such that assignment income shall be treated asSUBLICENSING INCOME.
12.6.5After the Assignment. Upon a permitted complete assignment of this Agreement,LICENSEE will be released from further obligations under this Agreement, except for those sections that survive termination, and the term“LICENSEE” in this Agreement will thereafter mean the assignee.
12.7Notice. Except for those communications which specifically under this Agreement may be sent via e-mail or other electronic communication (such as notification ofPATENT COSTS incurred and due, and other routine communications), all notices, requests or communication required or permitted to be given by either party hereunder shall be given by registered mail or certified mail, return receipt
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requested, or sent by overnight courier, such as Federal Express, to the other party at its respective address set forth below or to such other address as one party shall give notice of to the other from time to time hereunder. Notices shall be deemed effective when received.
| | | | |
| If to LICENSEE: | | One Broadway, 14th Floor |
| | Cambridge, MA 02142 |
| | Attn: | | Chief Operating Officer |
| | jmcbride@tokaipharma.com |
| |
| If toJHU: | | Executive Director |
| | Johns Hopkins Technology Transfer |
| | 100 N. Charles Street, 5th Floor |
| | Baltimore, MD 21201 |
| | RE: | | Agreement No. A26360 |
Communications requiring a prompt response should also be sent via email to [**]
12.8Compliance with All Laws. In all activities undertaken pursuant to this Agreement, bothJHU andLICENSEE covenant and agree that each will in all material respects comply with such Federal, state and local laws and statutes, as may be in effect at the time of performance and all valid rules, regulations and orders thereof regulating such activities.
12.9Successors and Assigns. Other than as specifically stated herein, neither this Agreement nor any of the rights or obligations created herein, except for the right to receive any remuneration hereunder, may be assigned by either party, in whole or in part, without the prior written consent of the other party. This Agreement shall bind and inure to the benefit of the successors and permitted assigns of the parties hereto.
12.10No Waivers; Severability. No waiver of any breach of this Agreement shall constitute a waiver of any other breach of the same or other provision of this Agreement, and no waiver shall be effective unless made in writing and signed by the party waiving. Any provision hereof prohibited by or unenforceable under any applicable law of any jurisdiction shall as to such jurisdiction be deemed ineffective and deleted herefrom without affecting any other provision of this Agreement. It is the desire of the parties hereto that this Agreement be enforced to the maximum extent permitted by law, and should any provision contained herein be held by any governmental agency or court of competent jurisdiction to be void, illegal and unenforceable, the parties shall negotiate in good faith for a substitute term or provision which carries out the original intent of the parties.
12.11Entire Agreement; Amendment. LICENSEE andJHU acknowledge that they have read this entire Agreement and that this Agreement, including the attached Exhibits constitutes the entire understanding and contract between the parties hereto and supersedes any and all prior or contemporaneous oral or written communications with respect to the subject matter hereof, all of which communications are merged herein. It is expressly understood and agreed that: (i) there being no expectations to the contrary between the parties hereto, no usage of trade, verbal agreement or another regular practice or method dealing within any industry or between the parties hereto shall be used to modify, interpret, supplement or alter in any manner the express terms of this Agreement; and (ii) this Agreement shall not be modified, amended or in any way altered except by an instrument in writing signed by both of the parties hereto.
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12.12Binding Agreement. Exchange of this Agreement in draft or final form between the parties shall not be considered a binding offer, and this Agreement shall not be deemed final or binding on either party until the final Agreement has been signed by both parties.
12.13Delays or Omissions. Except as expressly provided herein, no delay or omission to exercise any right, power or remedy accruing to any party hereto, shall impair any such right, power or remedy to such party nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, or in any similar breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character on the part of any party of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies either under this Agreement or by law or otherwise afforded to any party, shall be cumulative and not alternative.
12.14Survival. All representations, warranties, covenants and agreements made herein and which by their express terms or by implication are to be performed or continue to apply after the execution and/or termination hereof, or are prospective in nature, shall survive such execution and/or termination, as the case may be. In addition, the following shall explicitly and specifically survive any termination or expiration:
(i)LICENSEE’sobligation to make payments toJHU,accrued or accruable during the License, including earned royalties, sublicensing payments, reimbursement ofPATENT COSTS,late payments and interest;
(ii) any claim ofLICENSEE or JHU,accrued or to accrue, because of any breach or default by the other party; and
(iii) the provisions of Articles 7, 8 and Paragraphs 11.4, 12.1 and 12.13.
12.15No Third Party Beneficiaries. Nothing in this Agreement shall be construed as giving any person, firm, corporation or other entity, other than the parties hereto and their successors and permitted assigns, any right, remedy or claim under or in respect of this Agreement or any provision hereof.
12.16Headings. Article headings are for convenient reference and not a part of this Agreement. All Exhibits are incorporated herein by this reference.
12.17Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which when taken together shall be deemed but one instrument.
[signature page follows]
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IN WITNESS WHEREOF, this Agreement shall take effect as of theEFFECTIVE DATE when it has been executed below by the duly authorized representatives of the parties.
| | | | | | | | | | |
| THE JOHNS HOPKINS UNIVERSITY | | | | TOKAI PHARMACEUTICALS, INC. |
| | |
/s/ Jill E. Uhl | | | | /s/ John McBride |
| Name: | | Jill E. Uhl | | | | Name: | | John McBride |
| Title: | | Interim Executive Director | | | | Title: | | COO |
| Date: | | 9 Jan 2015 | | | | Date: | | December 23, 2014 |
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EXHIBIT A
LICENSE DEAL SHEET
PATENTS, FEES, ROYALTIES, SUBLICENSING PAYMENTS AND OTHER TERMS
SPECIFIC TO THE LICENSE
| 1. | INVENTIONS and INVENTORS: |
[**].
| 2. | Unreimbursed Patent Costs: Estimated to be $[**]. Exact amount will be calculated and billed after execution of this Agreement. |
LICENSEE will reimburse half of the unreimbursedPATENT COSTS within [**] days of theEFFECTIVE DATE. The remainder of unreimbursedPATENT COSTS shall be paid in [**] equal quarterly installments until fully paid.
IfJHU grants additional commercial licenses under theLICENSED PATENTS outside theFIELD OF USE for consideration after theEFFECTIVE DATE,JHU shall notifyLICENSEE thereof in writing and, from and after the effective date of any such license,LICENSEE’s obligation to reimburseJHU for anyPATENT COSTS shall be reduced on apro ratabasis based on the number of additional commercial licensees ofJHU. AnyPATENT COSTS paid toJHU prior to the effective date of any such commercial license will be credited against future payments toJHU, if any such future payments toJHU are pending, on a pro rata basis.
| 3. | Field of Use: companion diagnostic for Galeterone (excluding commercial sale as research reagent). |
| 4. | Major Market: U.S., France, Germany, Italy, Spain, U.K., Japan, Canada |
| 5. | License Fee: The license fee due under Paragraph 5.1 is seventy-five thousand dollars ($75,000). |
| 6. | Minimum Annual Royalties: The MARs described under Paragraph 5.3 are: |
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| 7. | Royalties: The earned royalty rate payable under Paragraph 5.5 is [**] percent ([**]%) ofNET REVENUE. |
ShouldLICENSEE, anyAFFILIATED COMPANY or SUBLICENSEE be required to pay running royalties to a third party in order to make, have made, use, sell, offer for sale or import a particularLICENSED PRODUCT or LICENSED SERVICE (an“Other Royalty”), thenLICENSEE shall be entitled to credit [**] percent ([**]%) of such Other Royalties against the running royalty due toJHU, provided that the running royalties shall not be reduced below [**] percent ([**]%) of those that would otherwise be dueJHU for thatLICENSED PRODUCT or LICENSED SERVICE.
Notwithstanding the foregoing, the earned royalty rate under Paragraph 5.5 shall be [**] percent ([**]%) ofNET REVENUE in any country for anyLICENSED PRODUCT and LICENSED SERVICE not covered by an issued patent withinLICENSED PATENTS in the country of sale.
| 8. | Milestone Payments. The milestone payments under Paragraph 5.4 are as follows: |
[**]
| 9. | Diligence Milestones. The following milestones shall be achieved no later than the date shown. |
[**]
| 10. | Sublicensing Income. LICENSEE shall pay to JHU twenty percent (20%) of all SUBLICENSING INCOME. |
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Where multiple technologies or licenses are included on oneSUBLICENSE,where the amount attributed to each is not specifically stated in theSUBLICENSE,the amount attributable to each shall be deemed to apply equally to each technology or license that is included in theSUBLICENSE. Where reasonable to do so,LICENSEEmay request another application of theSUBLICENSING INCOME,by providing a written request and analysis to JHTI of the basis forLICENSEE’srequest, but in no circumstance shall less than [**]% of theSUBLICENSING INCOMEbe applied to theTECHNOLOGYlicensed by this Agreement.
| 11. | Assignment Payment to JHU. If an assignment of this Agreement under Section 12.6.4 is the result of complete sale or merger ofLICENSEE, thenLICENSEE(or its assignee) shall pay to JHU an assignment fee equal to the greater of: |
[**].
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EXHIBIT B
QUARTERLY SALES & ROYALTY REPORT
FOR LICENSE AGREEMENT BETWEEN
AND
THE JOHNS HOPKINS UNIVERSITY
DATED
| | | | | | | | | | |
| JHU Reference Number(s) | | | | | | |
| | | | |
| PERIOD: From | | | | | | To | | |
| | | |
| TOTAL ROYALTIES DUE FOR THIS PERIOD $ | | | | | | |
| | | | | | | | | | | | |
PRODUCT
ID | | PRODUCT
NAME | | *JHU
REFERENCE | | 1st
COMMERCIAL
SALE
DATE | | TOTAL
NET
SALES/
SERVICES | | ROYALTY
RATE | | AMOUNT
DUE |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| * | Please provide the JHU Reference Number or Patent Reference |
This report format is to be used to report quarterly royalty statements toJHU. It should be placed onLICENSEE letterhead and accompany any royalty payments due for the reporting period. After the first sale on which royalties accrue, this report shall be submitted even if no sales are reported.
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EXHIBIT C
DILIGENCE AND ANNUAL
REPORT GUIDELINES
FOR LICENSE AGREEMENT BETWEEN
AND
THE JOHNS HOPKINS UNIVERSITY
DATED
| | | | | | | | | | |
| JHU Reference Number(s) | | | | | | |
| | | | |
| PERIOD: From | | | | | | To | | |
A. Progress byLICENSEE, AFFILIATED COMPANIES orSUBLICENSEE(S) toward commercialization ofLICENSEDPRODUCTS orLICENSED SERVICES:
B. Notice of all FDA or other governmental filings and/or approvals regarding anyLICENSED PRODUCT orLICENSED SERVICE made or obtained byLICENSEE, AFFILIATED COMPANY or SUBLICENSEE, the patents or patent applications licensed under this Agreement upon which such product or service is based, and the commercial name of such product or service:
C. A Certificate of Insurance or other evidence of insurance
is required and is attached.
is not required. Reason:
D.AFFILIATED COMPANIES andSUBLICENSEES which have exercised rights to theTECHNOLOGY:
NONE
List attached with description of rights exercised.
E. Diligence and other milestones achieved:
F. Diligence and other milestones expected to be achieved this year:
G. Sublicense(s) entered during the year:
NONE
Identification ofSUBLICENSEE’s (copy of theSUBLICENSE attached, if not previously provided)
H. Change of control, name change or other significant change related to this Agreement orLICENSEE:
NONE
Details:
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