/Docs//S/Index/DataSharing/IP-Licenses.md
  Source views: Source JSON(ish) on GitHub (VSCode)   Doc views: Document (&k=NVCA.r00t): Visual Print Technical: OpenParameters Xray
Term Sheet for University Life Science Startup License
  1. Date
    The date of this Term Sheet is {EffectiveDate.YMD}. The "Effective Date" is the date on which the parties execute the definitive license agreement (the "License Agreement") and close the financing round (the "Closing Date"), anticipated to be {ClosingDate.YMD}.
  2. Licensor
    {Licensor.N,E,A}
  3. Licensee
    {Company.US.N,E,A} and/or its Affiliate(s). The term “Licensee” will only include Affiliate(s) to the extent that the License is assigned to such Affiliate or an Affiliate is granted a Sublicense.
  4. Territory
    Territory” means worldwide.
  5. Field of Use
    [any and all uses [in humans]]
  6. Term
    The License Agreement will begin on the Effective Date and will expire upon expiration of the last remaining Royalty Term, unless earlier terminated in accordance with the termination provisions. On a Licensed Product-by-Licensed Product and country-by-country basis, upon expiration of the applicable Royalty Term, Licensee will have a fully paid-up perpetual license to Licensed Know-How for such Licensed Product in such country (“country” shall also be deemed to refer to territories).
  7. Patent Rights
    means Licensor’s rights under the following:
    1. the patents and patent applications listed in Exhibit A;
    2. any non-provisional patent applications that claim priority to any provisional patent applications listed in Exhibit A;
    3. any foreign patent applications, foreign patents or related foreign patent documents that claim priority to a patent or patent application included in (a) or (b) above;
    4. any divisionals and continuations of patents or patent applications included in (a), (b), or (c) above (but not continuations-in-part, except as provided in (f) below);
    5. any patents, reissues, re-examinations, renewals, substitutions, and extensions issuing from the patent specification of any of the preceding; and
    6. any claims of continuation-in-part applications that claim priority to the U.S. patent applications listed in Exhibit A, but only to the extent such claims are directed specifically to subject matter described in at least one of the patents or patent applications identified in (a)-(e) above that meet the written description requirements of the first paragraph of 35 U.S.C. Section 112.
    Patent Rights do not include any inventions conceived (as determined under U.S. patent law) after the Effective Date, provided that to the extent a Patent Right is an Improvement, such Improvement will be added to Exhibit A by way of amendment.
  8. License to Improvements
    • Licensor shall disclose to Licensee all Improvements made in the laboratory of {PrincipalInvestigator.Name.Full} within [1-3] years of the Effective Date and disclosed to Licensor by the [Principal Investigator].
    • Patentable Improvements shall be added by amendment to the list of Patent Rights in Exhibit A of the License Agreement and Improvements that are not patentable will be considered Licensed Know-How and shall be added to Exhibit B of the License Agreement [in both cases by mutual agreement of the parties] and shall be licensed on the same terms of the License, with the option of minor additional economic terms (e.g., an upfront fee).
    • In addition, any Improvements that are developed under the SRA in the laboratory of {PrincipalInvestigator.Name.Full} shall be included in the License as Patent Rights.
    • Improvement” means any invention, patentable or otherwise, conceived under the direction of the [Principal Investigator] where the invention is (a) not encumbered by any third party rights, (b) has been disclosed to Licensor’s technology licensing office, and (c) for patentable Improvements, would necessarily infringe at least one Valid Claim in the Field of Use.
  9. License
    Licensor grants to Licensee an exclusive license to the Patent Rights, and a non-exclusive license to use Licensed Know-How, to research, discover, develop, manufacture/make, have made, use, market, sell, offer to sell, have sold, import, export, distribute, rent, license to end-users or lease Licensed Products in the Field of Use and the Territory.
  10. Sublicensing Rights / Requirements
  11. Survival of Sublicenses
  12. Subcontracts
    Licensee may engage a subcontractor to perform, on behalf of Licensee, research, development, and manufacturing services under the License, provided that (i) any subcontract will not relieve Licensee from any of its obligations under the License; (ii) any act or omission by a subcontractor shall be deemed an act or omission of Licensee; (iii) any subcontract provides for the automatic assignment to Licensee of any and all intellectual property generated by the subcontractor, its employees, and consultants in the course of performing the subcontracted services to Licensee (other than with respect to intellectual property generated that relates to such subcontractor’s platform or background intellectual property, ownership of which may remain with such subcontractor); and (iv) Licensee shall be responsible for each of its subcontractors complying with all applicable obligations of Licensee under the License. A subcontractor that Licensee has engaged through an agreement complying with the terms above shall not be deemed to be a Sublicensee under the License, regardless of whether such subcontract includes a grant of a sublicense under any Patent Rights or Licensed Know-How.
  13. License Issue Fee
    Licensee shall pay an up-front fee of $___ within [x] days of the Effective Date.
  14. Equity
    Licensee shall issue to Licensor shares of its common stock representing [x]% on a Fully Diluted Basis [[at the Effective Date] or [at the closing of Licensee’s next round of equity financing]].
    • Fully-Diluted Basis” means the total number of shares of Licensee’s issued and outstanding common stock, assuming (a) the conversion of all issued and outstanding securities convertible into common stock; (b) the exercise of all issued and outstanding warrants or options, regardless of whether then exercisable; and (c) the issuance, grant, and exercise of all securities reserved for issuance pursuant to any Licensee stock or stock option plan then in effect.
    • Anti-Dilution: Licensee will issue Licensor, without further consideration, additional shares of common stock as is necessary to ensure that the number of shares issued to Licensor do not represent less than x% of the shares issued and outstanding on a Fully-Diluted Basis. This anti-dilution protection will continue until an amount of at least $X,000,000, when aggregated with prior closings, has been raised by Licensee in bona fide financings through the sale of securities or by conversion of instruments convertible into equity (“Dilution Cap”). If the Dilution Cap is reached or exceeded during a specific round of funding, anti-dilution protection [will] [will not] extend to the total amount of funding raised through the closing of that specific round of funding.
    • Preemptive Rights: If Licensee proposes to sell any equity securities or securities that are convertible into equity securities, Licensor and/or its Assignee may purchase up to [[their pro rata] or [x%]] of the securities issued in each financing on the same terms and conditions as are offered to the other purchasers in each such financing. Licensee will provide [x] days advance written notice of each such financing, including reasonable detail regarding the terms and purchasers in the financing.
    • Assignee” means (a) [insert name of entity to which Licensor’s preemptive rights may be assigned] or (b) any entity that is controlled by Licensor.
  15. Development Milestone Payments
    Each of the following payments (each a “Development Milestone Payment”) will be due upon achieving the indicated milestone (each such milestone, a “Development Milestone” for [each Licensed Product] [the first Licensed Product] [the first [2][3] Licensed Products]. Licensee shall make each such payment irrespective of whether the associated Development Milestone was reached by Licensee itself, by a Sublicensee and/or by a third party acting on behalf of Licensee or a Sublicensee.
    1. [First/third/fifth] subject dosed in Phase [1/2/3] clinical trial: [$____]
    2. Submission of the first IND for a Licensed Product: [$____]
    3. FDA approval of a Licensed Product: [$____]
    4. First Commercial Sale of a Licensed Product: [$____]
  16. Royalty Rate
  17. Net Sales
    • means, with respect to a Licensed Product, for any period, the total amount billed or invoiced on sales of such Licensed Product during such period by the Selling Party in the Territory to third parties (including third party wholesalers and Third Party Distributors), in bona fide arm’s length transactions, less the following documented deductions , and in each case related specifically (or reasonably allocated by such Selling Party in accordance with its standard policies and procedures consistently applied across its products) to the Licensed Product, and not otherwise recovered by or reimbursed to the Selling Party:
      1. trade, cash and quantity discounts, charge-back payments, and rebates actually granted to trade customers, managed health care organizations, pharmaceutical benefit managers, group purchasing organizations, and national, state, or local governments;
      2. credits, rebates, or allowances actually allowed upon prompt payment or on account of claims, damaged goods, rejections, or returns of such Licensed Product, including in connection with recalls and retroactive price reductions;
      3. taxes to the extent included in the gross amount invoiced (excluding income or franchise taxes of any kind), duties, tariffs, mandated contribution, or other governmental charges levied on the sale of such Licensed Product, including VAT (net of reimbursement of any value added taxes actually received), excise taxes and sales taxes, that the Selling Party allocates to sales of such Licensed Product in accordance with its standard policies and procedures consistently applied across its products, as applicable;
      4. the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans relating to such Licensed Product;
      5. any invoiced amounts from a prior period which are not collected and are written off by the Selling Party, including bad debts (provided that if the debt is thereafter paid, the corresponding amount shall be added to the Net Sales for the period during which it is paid);
      6. that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) to the extent (a) reasonably allocable to sales of such Licensed Product and (b) the Selling Party actually includes such fee as a deduction from gross revenue in its publicly filed financial reports;
      7. packaging, freight, postage, shipping, transportation, warehousing, handling, export/import and insurance charges, in each case, actually allowed or paid for delivery of such Licensed Product, and any customary payments with respect to such Licensed Product actually made to wholesalers or other Distributors, in each case, actually allowed or paid for distribution and delivery of such Licensed Product, to the extent billed on actual invoices;
      8. any sales, credits, or allowances given or made with respect to such Licensed Product for wastage replacement; and
      9. any other similar and customary deductions that are consistent with GAAP as consistently applied by Selling Party to all of its products, but which may not be duplicative of the above deductions.
    • For Combination Products, Net Sales will be calculated as follows:
      1. If the Licensed Product and all Other Components of the Combination Product were sold separately during the same or immediately preceding calendar quarter, the proration factor will be determined by the formula [A / (A+B)], where A is the weighted average invoice price of all Licensed Product components during such period when sold separately from the Other Component(s), and B is the weighted average gross invoice price of the Other Components during such period when sold separately from the Licensed Product (as applicable);
      2. If the Licensed Product components containing only the Licensed Compound as its Active Ingredient are sold separately from the Other Components, but the Other Components in such Combination Product are not sold separately, then the proration factor will be determined by the formula [A / C], where A is the average gross sales price of all Licensed Product components containing only the Licensed Compound as its Active Ingredient during such period when sold separately from the Other Components, and C is the average gross sales price of the Combination Product during such period;
      3. If the Licensed Product components containing only the Licensed Compound as its Active Ingredient are not sold separately from the Other Components, but the Other Components in such Combination Product are sold separately, then the proration factor will be determined by the formula [(C- B) / C], where B is the average gross sales price of the Other Components included in such Combination Product if sold separately from the Other Component(s), and C is the average gross sales price of the Combination Product during such period; or
      4. If neither the Licensed Compound nor the Other Components included in the Combination Product were sold or provided separately during the relevant period, then the proration factor will be mutually agreed upon by the parties in good faith based on the relative value contributed by each component and, to the extent the parties are unable to establish such proration factor, then such proration factor will be established by Standard Dispute Resolution.
      5. In the event that such separate sales were not made or performed during the immediately preceding calendar year (“CY”), then the invoiced amounts for the Combination Product for purposes of calculating Net Sales will be multiplied by the fraction C/(C + D), where C is the average fully burdened cost of manufacture of the Licensed Products during the immediately preceding CY and D is the average fully burdened cost of manufacture of the additional items during the immediately preceding CY, in each case calculated in accordance with GAAP.
    • Any allocation of revenue from the sale or other disposition of Combination Products, or any allocation of the costs of manufacture, shall be done in good faith, and will take into consideration revenue recognition guidance under GAAP which is applicable to multiple-deliverable revenue arrangements.
    • All allocations of discounts, allowance, credits, rebates and other deductions must be reasonable. Any amounts received or invoiced by a Selling Party will be accounted for only once. For purposes of determining Net Sales, a Licensed Product will be deemed to be sold when recorded as a sale by Selling Party in accordance with GAAP.
    • Amounts received or invoiced by Licensee or a Sublicensee for the sale of a Licensed Product among Licensee or a Sublicensee will not be included in the computation of Net Sales, unless the purchasing entity is the end-user of such Licensed Product.
    • Net Sales will exclude any Licensed Product transferred or disposed of as samples or for clinical trials or at or below costs of goods therefor for any so-called treatment investigational new drug sales, named patient sales, expanded access program, compassionate or emergency use sales or pre-license sales made for non-commercial, compassionate purpose, or any indigent program or promotional or educational purposes; in each case with respect to such Licensed Product and are reported on the royalty report for such period when such Licensed Products are so transferred or disposed of.
    • Net Sales will be calculated in accordance with the standard internal policies and procedures of the Selling Party.
    • For purposes of calculating Net Sales, all Net Sales shall be converted into U.S. dollars.
  18. Royalty Term
    means, on a Licensed Product-by-Licensed Product and country-by-country basis, the royalty term will commence on the First Commercial Sale of a Licensed Product in any country and continue until the latest of (a) the date on which such Licensed Product is no longer Covered by a Valid Claim in the country in which the manufacture or sale occurs; (b) the expiration of Regulatory Exclusivity for such Licensed Product in the country in which the sale occurs; and (c) the [x] year anniversary of the First Commercial Sale of such Licensed Product in the country in which the sale occurs.
  19. Minimum Annual Royalty
    Licensee shall pay Licensor Minimum Annual Royalties as set forth below. Earned royalties paid during a given CY may be used as credit against the Minimum Annual Royalty due for that same CY, but cannot be used as credit against a Minimum Annual Royalty obligation owed for any other CY.
  20. Royalty Stacking
    Licensee will be entitled to deduct, from the cumulative royalties otherwise due Licensor in respect of Net Sales of Licensed Products, [X%] of all such royalties paid or payable by Selling Party(ies) to one or more third parties in respect of such Licensed Products if, in the absence of a license, sublicense, acquisition or access to a third party’s intellectual property rights, the researching, discovering, developing, manufacturing/making, having made, using, marketing, selling, offering to sell, having sold, importing, exporting, distributing, renting, licensing to end-users or leasing of a Licensed Product would or is likely to infringe or misappropriate such intellectual property rights. In no event will such deduction reduce any royalty payments to be made by Licensee by more than [X%] for any calendar quarter; and provided, further, that any reduction, or portion thereof, may be carried forward for use in a future calendar quarter. With respect to any third party exclusive licensors, the foregoing royalty stacking provisions will only apply in the event such third party exclusive licensors receiving royalties of [x]%] are also subject to similar royalty stacking provisions.
  21. Sublicensing Consideration
  22. Diligence Milestones
    Licensee shall use Commercially Reasonable Efforts to develop at least one Licensed Product in the Territory and commercialize such Licensed Product following regulatory approval.
    In addition, Licensee (either itself or through the acts of a Sublicensee) is required to achieve the following due diligence milestones (the “Diligence Milestone”) by the dates set forth below (the “Achievement Date”):
    1. Obtaining financing in an amount of at least [$] by [DATE]
    2. Nomination of a development candidate by [DATE]
    3. Initiation of GLP toxicity studies by [DATE]
    4. Submission of the first IND for a Licensed Product by [DATE]
    5. First subject dosed in Phase 1 clinical trial by [DATE]
  23. Deferral of Diligence Milestones
    Licensor acknowledges that due to long development times, scientific, potential safety and development hurdles and challenges and regulatory requirements and processes associated with Licensee’s industry, Licensee may be unable to achieve a particular Diligence Milestone by a relevant Achievement Date. Licensee will notify Licensor in writing in advance of any such anticipated delay, and as long as Licensee is fulfilling its obligations of Commercially Reasonable Efforts, the parties will negotiate in good faith an extension of the relevant Achievement Date upon the payment of a fee (the “Extension Fee”) equal to [$x/x% of the relevant Development Milestone Payment], which extension Licensee must exercise no later than [x days] before the relevant Achievement Date. [Licensee may extend each Diligence Milestone as set forth above only [once/twice]].
  24. Patent Prosecution
    • Licensor will have the right to control the preparation, filing, prosecution and maintenance of the Patent Rights, reexaminations, interferences, oppositions, and any other ex parte or inter partes matters (e.g., inter partes reviews) originating or conducted in a patent office (“{DefT.Patent_Actions}”), using outside counsel reasonably satisfactory to Licensee. Licensor will (a) instruct Licensor’s patent counsel to furnish to Licensee copies of material documents relevant to such Patent Actions before any deadlines; (b) allow Licensee a reasonable opportunity to comment on material documents filed with respect to such Patent Actions; and (c) take into reasonable consideration such comments from Licensee. Licensee will, to the fullest extent permitted by law, apply for and prosecute, or support in any reasonable way Licensor’s application for, any reasonable patent term extension for patents included in the Patent Rights.
    • So long as Licensee reimburses Licensor for Patent Costs, Licensor will continue to prosecute and maintain the Patent Rights in the countries selected by Licensee.
    • Subject to the terms of this section, with the consent of Licensor (such consent not to be unreasonably withheld), Licensee has the right, on a country-by-country basis, to elect to not reimburse Licensor for Patent Costs related to a particular Patent Action. If Licensee makes such an election, Licensee will provide reasonable advance notice to Licensor in writing, such notice to be at least 90 days prior to any such Patent Action. Upon such notice, such patent application(s) and patent(s) thereafter are and will be excluded from the definition of Patent Rights without further notice. Under such circumstances, Licensor may elect to abandon or continue the prosecution and/or maintenance of such application(s) or patent(s) at its sole or subsequent partner’s expense. If Licensee fails to provide such notice and Licensor incurs Patent Costs in respect of such Patent Action, then Licensee shall be responsible for such Patent Costs.
  25. Patent Expense Reimbursement
    Licensee will bear all out-of-pocket costs incurred by Licensor for Patent Actions (“Patent Costs”). Licensee will reimburse Licensor [within 30 days after Licensee’s receipt of an invoice from Licensor] for Patent Costs incurred by Licensor before the Effective Date and during the term of the License Agreement. Alternatively, if Licensor requests, Licensee will pay ongoing Patent Costs in advance or under a reasonable direct billing arrangement with Licensor’s patent counsel. Licensor will provide Licensee with documentation of the Patent Costs.
  26. Disclaimer of Warranties and Limitation of Liabilities
    • Licensed Technology is provided by Licensor without warranty of merchantability or fitness for a particular purpose or any other warranty of any kind, express or implied. Licensor makes no express or implied representation or warranty that use or commercialization of the patent rights or Licensed Products or non-patent technology will not infringe any patent, copyright, trademark or other rights.
    • Except as otherwise provided in the License Agreement, the License Agreement does not imply (a) a warranty or representation as to the validity, enforceability, or scope of any Patent Rights; (b) by implication, estoppel or otherwise, any grant of any license under any patents other than the Patent Rights or under any other rights other than the Licensed Know-How of Licensor, regardless of whether such patents or other rights are dominant or subordinate to Patent Rights.
    • In no event will either party be responsible or liable for any indirect, special, incidental, or consequential damages or lost profits or other economic loss or damage regardless of legal or equitable theory. The above limitations on liability apply even if the other party may have been advised of the possibility of such damage.
  27. Indemnification and Insurance
    1. {Secs}
  28. Patent Challenges
    Licensee will provide written notice to Licensor at least 90 days before Licensee, or Sublicensee initiates or participates directly or indirectly in a Patent Challenge. Licensee or such Sublicensee will identify all prior art and other evidence material to the Patent Challenge in such written notice. If Licensee or a Sublicensee participates directly or indirectly in a Patent Challenge, the following applies:
    1. {AltPrompt}: (copy)- "PatentChallenges.1..sec={PatentChallenges.1..AltX.sec}" where X is 1-2:
      1. Licensor has the right to terminate the License Agreement at any time (including after the termination of such Patent Challenge) upon written notice delivered to Licensee, and the License Agreement cure provisions for non-monetary breach will not apply; provided that if a Patent Challenge is initiated by a Sublicensee, Licensor will only be permitted to terminate the License Agreement if, within 30 days following receipt of notice that Sublicensee has initiated a Patent Challenge, Licensee has failed to terminate the Sublicense or Sublicensee has not vacated the Patent Challenge.
      2. Licensor will meet with Licensee and any designee of Licensee within three months after such notice from Licensee and at least semi-annually at the request of Licensee, in a good faith effort to resolve any Patent Challenge;
    2. during the pendency of such action or proceeding (including any appeals), the applicable royalty rate(s) will increase to double the applicable royalty rate(s);
    3. should the outcome of such action or proceeding determine that any such claim challenged by Licensee or a Sublicensee is valid, enforceable, and/or infringed by a Licensed Product, the royalty rate(s) will increase to triple the applicable royalty rate(s);
    4. Licensee and any Sublicensee(s) will have no right to recoup any royalties paid before such action or proceeding or during the period in which such action or proceeding is pending (including on appeal), no matter the outcome of such action or proceeding; and
    5. Licensee shall pay all reasonable costs and expenses incurred by Licensor (including, but not limited to, Licensor’s actual attorneys’ fees) in connection with such action or proceeding. Licensor may bill Licensee as frequently as monthly concerning such costs and expenses, and Licensee shall make payment no later than 30 days after receiving an invoice from Licensor. Notwithstanding any other provision of the Agreement, with respect to any such Patent Challenge, Licensor will have full control and authority to defend the Patent Rights in the action or proceeding and will not be required to share any work product concerning such action or proceeding with Licensee or the Sublicensee(s).
  29. Third Party Claim
    In the event of a third-party challenge (including inter partes reviews and declaratory judgements) to any of the Licensed Technology, Licensor will have the first right to assume and control the defense of the claim at Licensor’s expense. If Licensor fails to assume such defense within 60 days of becoming aware of such challenge, Licensee may assume and control such defense at Licensee’s expense. The party controlling the defense may join the other party in any such action if a court of competent jurisdiction determines the other party is an indispensable party to such proceeding and the controlling party shall pay the expenses of the joined party. The party controlling the defense of such legal action will keep the other party reasonably informed of the proceedings and will not settle such action without the prior written consent of the other party, such consent not to be unreasonably withheld.
  30. Patent Enforcement
    In the event that either party believes that a third party is infringing or misappropriating any of the Licensed Technology, [Licensee/Licensor] will have the first right to enforce the claim at {PatentEnforcement.Initiator.Licensee/Licensor}’s expense. If {PatentEnforcement.Initiator.Licensee/Licensor} fails to initiate such action within 90 days of becoming aware of such infringement or misappropriation, the other party may assume and control such action at the other party’s expense. The party controlling the action may require the other party to join in any such action if a court of competent jurisdiction determines the other party is an indispensable party to such proceeding and the controlling party will pay the expenses of the joined party. The party controlling such legal action will keep the other party reasonably informed of the proceedings and will not settle such action without the prior written consent of the other party, such consent not to be unreasonably withheld.
  31. Award Sharing
    Any recovery, whether by way of settlement or judgment, from a third party pursuant to a legal proceeding shall first be used to reimburse the initiating party and the non-initiating party for their actual fees, costs and expenses incurred in connection with such proceeding. The initiating party shall divide any remaining amounts from any such settlement or judgment as follows: (i) any recovery reflecting lost profits damages and/or reasonable royalty damages, Licensee retains or receives such recovery, and Licensor retains or receives the amount of royalties due to Licensor had those activities been performed by Licensee, and (ii) all other remaining amounts (including any punitive or exemplary damages) are divided [75%] to the party who initiated or carried on the proceedings and [25%] to the other party.
  32. Unmet Needs
    Licensor would like Licensee to address unmet needs, such as those of neglected patient populations or geographic areas, giving particular attention to improved therapeutics, diagnostics and agricultural technologies for low and middle income countries. If (a) Licensee is unable or unwilling to serve an unmet need for which there is an adequately-resourced company willing to be a Sublicensee, and (b) such potential Sublicensee has provided Licensee with a bona fide, detailed proposal to serve such unmet needs (which Licensee will provide to Licensor), then, unless Licensee can demonstrate to Licensor’s reasonable satisfaction that Licensee will serve such unmet need itself or through another third party, Licensee will, at Licensor’s request, negotiate in good faith a Sublicense with said potential Sublicensee on reasonable commercial terms. If the Sublicense is not executed within [12] months, then Licensor has the right to grant a license to serve such unmet need exclusively or non-exclusively, on reasonable commercial terms that, in the judgement of Licensee, will not impair its business, and Licensor will notify Licensee of such a license. Notwithstanding the foregoing, in no event will Licensee be compelled to negotiate a Sublicense [within the field of X/for X indications], it being understood and agreed that any such Sublicense would be competitive with or otherwise materially impair Licensee's business as proposed to be conducted.
  33. Institution Reservation of Rights
    Without limiting any other rights it may have, Licensor retains, on behalf of itself, the right to practice or have practiced the Patent Rights, and to use or have used the Licensed Know-How for any research, public service, internal (excluding any studies that are required to be reported to the FDA under 21 CFR Parts 58 and/or 312) and/or educational purposes with non-profit research institutions, including sponsored research and collaborations with such non-profit research institutions, and to publish their respective results, and the right to grant the same limited rights to other non-profit research institutions; provided that Licensor will, and will include in any grant of rights to such non-profit research institutions the obligation to, use its best efforts to provide a draft of any planned disclosure from the laboratory of [Principal Investigator] based upon the foregoing to Licensee 45 days in advance, and if Licensee determines new patent applications need to be filed in order to protect the Patent Rights, Licensed Know-How or Improvements, then Licensor agrees to delay such disclosure by an additional delay of 45 days during which the Licensee will prepare and file patent applications with respect to the foregoing at its own cost. The grant of rights to the Licensed Technology is subject to any existing right of the U.S. Government under Title 35, United States Code, Section 200 et seq. and under 37 Code of Federal Regulations, Section 401 et seq., (the (“Bayh Dole Act”) including but not limited to the grant to the U.S. Government of a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced any invention conceived or first actually reduced to practice in the performance of work for or on behalf of the U.S. Government throughout the world. Licensed Products shall be substantially manufactured in the United States to the extent (if at all) required by 35 U.S.C. Section 204.
  34. Audit
    No more than once per calendar year, Licensor may appoint a qualified audit firm to audit Licensee’s books and records relating to Licensee’s payments under the License Agreement. Such audit shall be conducted during normal business hours without unreasonable disruption to Licensee’s business, upon 30 days’ advance written notice to Licensee. In the event that the audit discloses an underpayment greater than [5-10%] of the amount due, Licensee shall bear the costs of the audit.
  35. Board Observer
    Up until the Licensee completes its first round of institutional investment [and thereafter by mutual agreement] Licensor may have a Board observer seat.
  36. Assignment
    Neither party may assign the License to a third party without the prior consent of the other party; provided that Licensee may assign the License without the prior consent of Licensor (i) to any Affiliate and (ii) in connection with a Change of Control.
  37. Dispute Resolution
    A senior representative of each party shall first engage in good faith efforts to resolve the dispute, for a period of 30 days from the date that one party notifies the other of its desire to commence Standard Dispute Resolution. If the dispute is not resolved within such time period, the parties shall submit the matter to arbitration under the AAA Commercial Arbitration Rules (with the option to use AAA Expedited Procedures by mutual agreement). The parties must agree to a single arbitrator, and if they cannot agree, one shall be appointed by the President of the City Bar Association of the city in which one of the parties is located (the choice of such city to be determined by a coin toss), provided that sole arbitrator must be experienced in the structuring and negotiation of licenses and commercial agreements in the life sciences industry and be impartial and independent. The arbitration will be conducted over a mutually agreed upon video conferencing platform, unless the parties agree to conduct it live in a mutually agreeable location. Except for the appointment of the arbitrator, which shall follow the timeline set forth in the AAA Road Map (www.adr.org/sites/default/files/document_repository/AAA197_Arbitration_Road_Map.pdf), all the other time periods specified therein shall be cut in half. The parties waive any rights to punitive damages. The parties shall evenly share all costs of such arbitration. This process is referred to as “Standard Dispute Resolution”.
  38. Governing Law
    1. {Secs}

Exhibit A


{LicensedRights.sec}

Defined Terms


  1. Affiliate” means any entity which, directly or indirectly, Controls Licensee, is Controlled by Licensee, or is under common Control with Licensee.
  2. Control” means having the actual present capacity to elect a majority of the directors, or the power to direct greater than 50% of the voting rights entitled to elect directors of such entity; provided, however, that with respect to any entity in a country where the local law will not permit majority foreign equity participation, control means the ownership or control (directly or indirectly) of the maximum percentage of such outstanding stock or voting rights permitted by local law. An entity will be deemed an Affiliate of Licensee solely for the term during which it satisfies the foregoing definition. [VC and its affiliated funds and their respective portfolio companies will not be deemed Affiliates.]
  3. Active Ingredient” means an active ingredient as defined in 21 CFR 210.3(b)(7).
  4. Change of Control” means (i) a consolidation or merger of the Licensee with or into any other corporation or other entity or person, or any other corporate reorganization, other than any such consolidation, merger or reorganization in which the shares of capital stock of the Licensee immediately prior to such consolidation, merger or reorganization continue to represent a majority of the voting power of the surviving entity immediately after such consolidation, merger or reorganization; (ii) any transaction or series of related transactions to which the Licensee is a party in which in excess of 50% of the Licensee’s voting power is transferred; or (iii) the sale or transfer of all or substantially all of the Licensee’s assets, or the exclusive license of all or substantially all of the Licensee’s material intellectual property; provided that a Change of Control shall not include any transaction or series of transactions principally for bona fide equity financing purposes in which cash is received by the Licensee or any successor, indebtedness of the Licensee is cancelled or converted, or a combination thereof.
  5. Combination Product” means a combination of (a) a Licensed Product and (b) Other Components, where such combinations of (a) and (b) are co-formulated, co-packaged or sold under one pricing scheme (whether payment of such price is paid to the same or to more than one seller).
  6. Commercially Reasonable Efforts” means, with respect to Licensee’s obligations as to a Licensed Product, the carrying out of such obligations with a level of efforts and resources consistent with those typically expended by a similarly situated company in the applicable industry for the research, development and/or commercialization of a similarly situated therapeutic [or diagnostic product] at a similar stage of development and/or commercialization as such Licensed Product, taking into account the anticipated value of the commercial opportunity, the prevailing regulatory environment (including the likelihood of receiving regulatory approval, and regulatory or data exclusivity), the proprietary position of the Licensed Product, the expected and actual competitiveness of alternative third party products in the marketplace, and other relevant scientific, technical, and commercial factors.
  7. Cover” or “Covered by
    • (For a Patent-only license:)
      • means the manufacture/making, use, marketing, sale, offer to sell, import, export, distribution, rent, end-use license or lease of a product, method or service, which absent the licenses to be granted in accordance with this term sheet, would infringe, or induce or contribute to infringement of, a Valid Claim.
    • (For a Patent and Know-How License):
      • means the manufacture/making, use, marketing, sale, offer to sell, import, export, distribution, rent, end-use license or lease of a product, method or service (a) which absent the licenses to be granted in accordance with this term sheet, would infringe, or induce or contribute to infringement of, a Valid Claim; and/or (b) that uses, incorporates, or is discovered, developed or produced through the use of any Licensed Know-How.
  8. Distributor” means any person appointed by a Selling Party to distribute, market and sell Licensed Product, with or without packaging rights, in one or more countries in the Territory, in circumstances where such Person purchases its requirements of Licensed Product from the Selling Party, but does not otherwise make any royalty or other payment to the Selling Party in consideration of intellectual property rights with respect to such Licensed Product.
  9. Effective Date” means the date of the License Agreement.
  10. First Commercial Sale” means the first sale, rental, or lease, in all cases through a bona fide arm’s-length transaction, or commercial use, of any Licensed Product by a Selling Party, excluding the sale of a Licensed Product for use in trials.
  11. Know-How Product” means (a) any product, method, or service that is Covered by Licensed Know-How, but excludes Patent Products and (b) which has been nominated as a development candidate within [5] years of the Effective Date.
  12. Licensed Compound” means any molecule or compound that constitutes a Patent Product or Know-How Product that is included within a Combination Product.
  13. Licensed Know-How” means any know-how, technical information, tangible materials and/or data, that (a) is expressly identified in Exhibit B or (b) was developed by or under the direction of [Principal Investigator] prior to the Effective Date.
  14. Licensed Products” means Patent Products and Know-How Products.
  15. Licensed Technology” means Patent Rights and Licensed Know-How.
  16. Other Components” means any delivery system(s), devices(s), companion diagnostics and/or one or more additional Active Ingredients.
  17. Patent Challenge” means any direct dispute or challenge of the validity, patentability, scope, priority, construction, non-infringement, inventorship, ownership or enforceability of any Patent Right or any claim thereof, or opposition or assistance in the opposition of the grant of any letters patent within the Patent Rights, in any legal or administrative proceedings, including in a court of law, before the USPTO or other agency or tribunal in any jurisdiction, or in arbitration including, without limitation, by reexamination, inter partes review, opposition, interference, post-grant review, nullity proceeding, pre-issuance submission, third party submission, derivation proceeding or declaratory judgment action. The term Patent Challenge will not include (i) Licensee being an essential party in any patent interference proceeding before the USPTO, which interference Licensee acts in good faith to try to settle, or (ii) Licensee, due to its status as an exclusive licensee of patent rights other than the Patent Rights, being named by the licensor of such patent rights as a real party in interest in such an interference, so long as Licensee either abstains from participation in, or acts in good faith to settle, the interference. A Patent Challenge will not include arguments made by Licensee that (a) distinguish the inventions claimed in patents or patent applications owned or controlled by Licensee (“Licensee Patents”) from those claimed in the Patent Rights but (b) do not disparage the Patent Rights or raise any issue of Patent Rights’ compliance with or sufficiency under applicable patent laws, regulations or administrative rules, in each case (x) in the ordinary course of ex parte prosecution of the Licensee Patents or (y) in inter partes proceedings before the USPTO or other agency or tribunal in any jurisdiction (excluding interferences or derivation proceedings), or in arbitration, wherein the Licensee Patents have been challenged.
  18. Patent Products” means any product, method, or service that is Covered by a Valid Claim.
  19. Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any regulatory authority with respect to a pharmaceutical product other than Patents, including orphan drug exclusivity, new chemical entity exclusivity data exclusivity, or pediatric exclusivity.
  20. Selling Party” means either Licensee or Sublicensee, as the case may be.
  21. Sublicense” means any agreement under which Licensee grants any of the rights to Licensed Technology or Licensed Products granted to Licensee under the License Agreement, including, without limitation, any option for such rights.
  22. Sublicensee” means any person or entity that is granted a Sublicense.
  23. Sublicensing Income” means any cash or equity consideration received by Licensee from a Sublicensee in consideration of the grant of a Sublicense under the Licensed Technology, including any license fee, license maintenance fee, option fee, milestone payments, and annual fees in excess of earned royalties, but excluding (a) royalties paid by a Sublicensee, (b) equity or debt investments in, or loan proceeds to, Licensee, (c) payments by Sublicensees for payment or reimbursement of patent prosecution, defense, enforcement and maintenance and other related expenses, (d) payments by Sublicensees for bona fide research, development, manufacturing or commercialization activities (including, without limitation, payments for FTEs) , (e) Development Milestone Payments, (f) any profit share for any product, and (g) payment received in a transaction that constitutes a Change of Control of Licensee.
  24. Valid Claim” means, with respect to a particular country, (a) any claim of an issued and unexpired Patent Right in such country that (i) has not been held revoked, unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal and (ii) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise in such country, or (b) a claim of a pending Patent Right application that has not been finally abandoned or finally rejected or expired and which has been pending [5-7] years from the date of filing of the earliest priority Patent Right application to which such pending Patent Right application is entitled to claim benefit. Any claim in a pending Patent application that is filed after [5-7] years from its earliest priority date will not be considered a Valid Claim until such claim is granted and meets the requirement of subsection (a).