Exhibit 10.14
Confidential Treatment Requested by ITUS Corporation,
IRS Employer Identification No. 11-2622630
***CONFIDENTIAL TREATMENT REQUESTED***
Note: Confidential treatment requested with respect to certain portions hereof denoted with [***]
LICENSE AGREEMENT
This LICENSE AGREEMENT (the Agreement) Is made as of the 13th day of November, 2017 (the Effective Date), by and between THE WISTAR INSTITUTE OF ANATOMY AND BIOLOGY, a nonprofit corporation organized and existing under the laws of the Commonwealth of Pennsylvania located at 3601 Spruce Street, Philadelphia, PA 19104 (Wistar), and Certainty Therapeutics, Inc., a corporation organized and existing under the laws of the State of Delaware with principal offices located at 3150 Almaden Expressway, Suite 250, San Jose, California 95118 (Company).
BACKGROUND
WHEREAS, Wistar owns or controls certain intellectual property as specifically described in Schedule I attached hereto and incorporated herein by reference (as further defined hereinafter, the Licensed Patents);
WHEREAS, Company is a majority owned corporation of ITUS Corporation, a corporation organized and existing under the laws of the State of Delaware with a principal place of business located at 3150 Almaden Expressway, Suite 250, San Jose, California 95118 (ITUS);
WHEREAS, Wistar and ITUS entered into an exclusive option agreement on May 18, 2017 granting ITUS a period of time in which to (i) evaluate the Licensed Patents, potential products arising therefrom and markets therefor and (ii) elect to negotiate a license with Wistar for the use of the Licensed Patents (the Option);
WHEREAS, in accordance with the terms and conditions set forth in the Option, Company wishes to enter into an exclusive license agreement granting to Company certain rights in and to the Licensed Patents;
WHEREAS, Company is capable of and committed to developing and commercializing products utilizing such rights;
WHEREAS, concurrent with the execution of this Agreement, Wistar will be receiving an equity interest in the Company; and
1
WHEREAS, Wistar is willing to grant such a license to Company, in consideration of Companys satisfaction of its obligations hereunder, and for other good and valuable consideration as set forth herein.
NOW, THEREFORE, in consideration of the premises and mutual covenants contained herein, and intending to be legally bound hereby, the parties hereto agree as follows:
The following terms, as used herein, shall have the following meanings:
1.1. Affiliate means, when used with reference to a Person, any Person directly or indirectly controlling, controlled by or under common control with, such Person. For the purposes of this definition, control means the direct or indirect ownership of over fifty percent (50%) of the outstanding voting securities of a Person, or the right to receive over fifty percent (50%) of the profits or earnings of a Person, or the ability to control the decisions of a Person.
1.2. Agreement has the meaning set forth in the Preamble.
1.3. Anti-Corruption Laws shall mean any anti-bribery and anti-corruption laws, rules, regulations applicable to a party under this Agreement (each as amended from time to time) including the Prevention of Corruption Act (cap.241) of Singapore, the U.S. Anti-Kickback Law, U.S. Foreign Corrupt Practices Act, the UK Bribery Act 2010 and the OECD Convention Against the Bribery of Foreign Government Officials in International Business Transactions, together with any applicable implementing legislation, including any applicable local law addressing bribery or corruption.
1.4. Bankruptcy Event means, with respect to any Person, any of the following:
(i) such Person shall commence a voluntary case or other proceeding seeking liquidation, reorganization or other relief with respect to itself or its debts under any bankruptcy, insolvency or other similar law now or hereafter in effect or seeking the appointment of a trustee, receiver, liquidator, custodian or other similar official of it or any substantial part of its property, or shall consent to any such relief or to the appointment of or taking possession by any such official in an involuntary case or other proceeding commenced against it, or shall make a general assignment for the benefit of creditors, or shall fail generally to pay its debts as they become due, or shall take any corporate action to authorize any of the foregoing;
(ii) an involuntary case or other proceeding shall be commenced against such Person seeking liquidation, reorganization or other relief with respect to it or its debts under any bankruptcy, insolvency or other similar law now or hereafter in effect or seeking the appointment of a trustee, receiver, liquidator, custodian or other similar official of it or any substantial part of its property, and such involuntary case or other proceeding shall remain undismissed and unstayed for a period of sixty (60) days; or an order for relief shall be entered against such Person under the federal bankruptcy laws as now or hereafter in effect; or
2
(iii) a receiver or trustee shall be appointed with respect to such Person or all or substantially all of the assets of such Person.
1.5. Bar Date has the meaning set forth in Section 7.1.1.
1.6. Calendar Quarter means each three (3) month period, or any portion thereof, beginning on January 1, April 1, July 1 and October 1 of each year.
1.7. Clinical Trials means any administration of Licensed Products to humans for the purpose of demonstrating the safety or efficacy of the Licensed Product.
1.8. Commercialization Plan has the meaning set forth in Section 4.2.1.
1.9. Company has the meaning set forth in the Preamble.
1.10. Company Confidential Information has the meaning set forth in Section 8.1.1.
1.11. Company IP has the meaning set forth in Section 9.6(iii).
1.12. Confidential Information has the meaning set forth in Section 8.1.1.
1.13. Control or Controlled means, with respect to the Licensed Technical Information, possession of the ability (whether by sole, joint or other ownership interest, license or otherwise, other than pursuant to this Agreement) to, without violating the terms of any agreement with a third party, grant a license or sublicense or provide access or other rights in, to or under such Licensed Technical Information.
1.14. Dilution Protection Cap has the meaning set forth in Section 3.1.2(ii).
1.15. Documentation and Approvals has the meaning set forth in Section 9.6(i).
1.16. EAR or Export Administration Regulations has the meaning set forth in Section 4.5.2.
1.17. Effective Date has the meaning set forth in the Preamble.
1.18. Equity Securities has the meaning set forth in Section 1.1.3.1.2(v)
1.19. First Commercial Sale means the first sale, transfer, disposition, performance, or practice for value of a Licensed Product.
3
1.20. Fully Diluted Capitalization has the meaning set forth in Section 3.1.2(i).
1.21. Funding Agency Interest has the meaning set forth in Section 2.2.2.
1.22. IND Filing means the preparation and filing of a Notice of Claimed Investigational Exemption for a New Drug with the U.S. Food and Drug Administration (FDA), or any comparable filing in a foreign jurisdiction.
1.23. Indemnified Party and Indemnified Parties have the meaning set forth in Section 6.3.
1.24. ITAR or International Traffic in Arms Regulations has the meaning set forth in Section 4.5.2.
1.25. Liability and Liabilities have the meaning set forth in Section 6.2.
1.26. Licensed Field means chimeric endocrine receptor targeted therapy for any human therapeutic and diagnostic use.
1.27. Licensed Patents means (i) the patent applications set forth on Schedule I hereto, (ii) all patents issuing from such applications, (iii) all continuations, continuations-in-part, additions, divisions, renewals, extensions, reexaminations and reissues of any of the foregoing, that claim the benefit of priority to the applications or patents referenced in (i) or (ii) hereof, and (iv)any patents in the Territory issuing from any applications filed after the Effective Date from which any of the patents or patent applications identified in (i), (ii), or (iii) claim priority.
1.28. Licensed Products means:
(i) any product, the making, using, selling, offering for sale, or importing of which product would (without the license granted under this Agreement) infringe at least one pending Valid Claim (were it to have issued) or issued Valid Claim of the Licensed Patents in any country;
(ii) any service, process or method, the performing or providing of which process or method would (without the license granted under this Agreement) infringe at least one pending Valid Claim (were it to have issued) or issued Valid Claim of the Licensed Patents in any country; and
(iii) any product or process that is not covered by the foregoing clauses (i) or (ii), but that uses, incorporates or is made, identified, developed, optimized, characterized, selected, derived or determined to have utility, in whole or in part, by the use or modification of (a) any Licensed Patent or any technology or invention covered thereby, (b) any Licensed Technical Information, or (c) any Licensed Product covered by the foregoing clauses (i) or (ii) or (iii).
4
1.29. Licensed Technical Information means technical information, know-how, protocols, data, techniques and other information that are not generally known laboratory techniques that pertain to the Licensed Patents and are necessary in the manufacture, sale, or use of the Licensed Products (i) made or developed by Dr. Jose Conejo-Garcia or laboratory personnel working directly under his supervision at Wistar, (ii) owned and Controlled by Wistar, and (iii) in Wistars possession as of the Effective Date. Licensed Technical Information shall exclude any of the foregoing information that is included in the written description of any of the Licensed Patents or any other patents or patent applications and shall also exclude (i) information that the Company can demonstrate by documentation: (a) was already known without restriction on use or disclosure prior to receipt of such information directly or indirectly from or on behalf of Wistar; (b) was or is independently developed without reference to or use of any of the Licensed Technical Information; (c) was or becomes generally known by the public other than by breach of this Agreement by Company, or other wrongful act of, Company; or (d) was received by Company from a third party who was not, at the time of receipt, under any obligation to Wistar or any other person to maintain the confidentiality of such information.
1.30. Minimum Annual Royalties has the meaning set forth in Section 3.4.
1.31. Net Sales means for each Licensed Product for any period, the gross amount actually collected by Company, its Affiliates and Sublicensees from third parties or end users for such Licensed Product including consideration in addition to cash less the following deductions: (i) customary trade, quantity and cash discounts actually allowed for Licensed Products, (ii) taxes levied on sale or transportation of Licensed Products and paid by or on behalf of Company, its Affiliates, or Sublicensees, and (iii) freight allowances, insurance and custom duties for Licensed Products. In the case of a sale or other transfer of a Licensed Product for which Company or a Sublicensee does not bill, Net Sales shall mean the amount received by Company and Sublicensees for the sale of such Licensed Product. If a Licensed Product is sold or otherwise transferred for consideration other than solely cash (whether or not at a discount), or if Licensed Product is billed or otherwise sold at a discounted price that is substantially lower than the customary prices charged by Company or Sublicensee, Net Sales shall mean what is actually received by the Company or Sublicensee in cash or other non-cash consideration, such non-cash consideration shall be calculated based on the fair market value of the consideration received.
5
1.32. Non-Royalty Sublicensing Income means the fair market value of any and all consideration received by Company and its Affiliates from Sublicensees (or which Company is entitled to receive, whether or not offset against amounts payable to Sublicensee under the Sublicense) under or otherwise in connection with its Sublicenses, including license issue fees, lump sum payments and other licensing fees, option fees, milestone payments, minimum annual royalties, distribution fees, joint marketing fees, equity or other payments of any kind whatsoever, irrespective of whether such consideration is received in the form of cash, barter, credit, stock, warrants, release from debt, goods or services, licenses back, a premium on the sale of equity (i.e., payments for equity that exceed the pre-Sublicense fair market value of the equity), equity exchanges, or any other form whatsoever. Notwithstanding the foregoing, Non-Royalty Sublicensing Income specifically excludes: (i) royalties on Net Sales pursuant to Section 3.2; and (ii) payments made by Sublicensee as consideration for the issuance of equity or debt securities of Company at the pre-Sublicense fair market value, provided that if a Sublicensee pays more than such fair market value for equity or debt securities then the portion in excess of fair market value shall be considered Non-Royalty Sublicensing Income and (iii) payments to Company for the purposes of funding the costs of future bona fide documented research of a Licensed Product to be conducted by the Company and (iv) payments received directly for Patenting Costs. For the purposes of Non-Royalty Sublicensing Income, the term fair market value means the cash consideration which Company, its Affiliates or any Sublicensees would realize from an unaffiliated, unrelated buyer in an arms length sale of an identical item sold in the same quantity and at the same time and place of the transaction. Non-Royalty Sublicensing Income that is a percentage of milestone payments received by Company from a Sublicensee shall be available for credit against miles tone payments payable to Wistar by Company under Section 3.7.
1.33. OFAC or Office of Foreign Assets Control has the meaning set forth in Section 4.5.2.
1.34. Option has the meaning set forth in the Background.
1.35. Past Patenting Costs has the meaning set forth in Section 7.1.1.
1.36. Patent Challenge means any direct or indirect dispute, challenge, or assistance in the challenge of the validity, patentability, scope, construction, enforceability, non-infringement or Wistars ownership of any issued patent comprising the Licensed Patents or any claims thereof, or opposition or assistance in the opposition of the grant of any letters patent comprising the Licensed Patents, in any legal or, administrative proceedings, including in a court of law, before the United States Patent and Trademark Office or other agency or tribunal in any jurisdiction, or in arbitration.
1.37. Patent Term Extension has the meaning set forth in Section 0.
1.38. Patenting Costs means any past or ongoing costs incurred or to be incurred, including government fees and attorneys fees, in the course of Prosecuting the Licensed Patents.
6
1.39. Performance Milestone(s) has the meaning set forth in Section 4.2.
1.40. Performance Milestone Dates has the meaning set forth in Section 4.2.
1.41. Performance Milestone Extension Fee has the meaning set forth in Section 4.3.
1.42. Person or Persons means any corporation, partnership, joint venture or any other entity or any natural person.
1.43. Proposed Product means an actual or potential Licensed Product that is for an application, product, sub-field or indication in the Licensed Field, but for which a Licensed Product is not being actively developed or commercialized by Company, its Affiliates or Sublicensees.
1.44. Proposed Product Election Notice has the meaning set forth in Section 2.5.2.
1.45. Proposed Product Notice has the meaning set forth in Section 2.5.1.
1.46. Proposed Product Sublicense has the meaning set forth in Section 2.5.4.
1.47. Proposing Third Party has the meaning set forth in Section 2.5.1.
1.48. Prosecution or Prosecuting means preparation, filing, prosecution, issuance and maintenance of the Licensed Patents, including continuations, continuations-in-part, divisionals, extensions, re-examinations, reissues, supplemental examination, appeals, interferences, derivation proceedings, oppositions, all other proceedings before the United States Patent and Trademark Office (including the Patent Trial and Appeal Board) and foreign patent offices, and any judicial or other appeals of the foregoing.
1.49. Qualified Sublicensee means a Sublicensee with (a) specific experience in the Licensed Field and (b) sufficient human and financial resources to develop and commercialize Licensed Products in the Licensed Field.
1.50. Regulatory Approval means, with respect to any jurisdiction, any and all approvals (including appropriate pricing and reimbursement approvals), product and/or establishment licenses, registrations or authorizations of any appropriate regulatory agency, department, bureau or other governmental entity, necessary for marketing a Licensed Product in such jurisdiction, as applicable.
1.51. Royalty Term has the meaning set forth in Section 3.3.
1.52. Shares has the meaning set forth in Section 3.1.2(i).
7
1.53. Sublicense means an agreement in which Company (i) grants or otherwise transfers any of the rights licensed to Company hereunder or other rights that are relevant to designing, developing, testing, making, using, selling, importation, exporting or distribution of Licensed Products in the Territory, (ii) agrees not to assert such rights or to sue, prevent or seek a legal remedy for the practice of same, or (iii) is under an obligation to grant, assign or transfer any such rights or non-assertion, or to forebear from granting or transferring such rights to any other entity, including by means of an option. Agreements expressly considered Sublicenses include licenses, option agreements, lock up agreements, right of first refusal agreements, non-assertion agreements, covenants not to sue, distribution agreements research and development agreements or similar agreements. For the avoidance of doubt, any Proposed Product Sublicense shall be a Sublicense as such term is used hereunder.
1.54. Sublicensee means any non-Affiliate third party to which Company has granted a Sublicense.
1.55. Term means the term of this Agreement, which shall commence on the Effective Date and shall remain in effect until the expiration of the Royalty Term in all countries in the Territory with respect to all Licensed Products, unless earlier terminated in accordance with the provisions of this Agreement.
1.56. Territory means the world.
1.57. Third Party Payment(s) has the meaning set forth in Section 3.2.2.
1.58. Third Party Proposed Product has the meaning set forth in Section 2.5.1.
1.59. Valid Claim means a claim of (i) a patent application included in the Licensed Patents that has been neither abandoned nor pending for more than ten (10) years or (ii) an issued Licensed Patent that has not been withdrawn, canceled or disclaimed or held invalid by a court or governmental authority of competent jurisdiction in an unappealed or unappealable decision no longer subject to discretionary review (for example, by way of writ of certiorari) or other review.
1.60. Wistar has the meaning set forth in the Preamble.
1.61. Wistar Confidential Information has the meaning set forth in Section 8.1.1.
1.62. Wistar Proposed Product has the meaning set forth in Section 2.5.1.
1.63. Withholding Taxes has the meaning set forth in Section 3.9.3.
8
9
10
(i) *** U.S. dollars ($*** USD) shall be paid upon execution of this Agreement;
(ii) *** U.S. dollars ($*** USD) shall be paid upon the one (1) year anniversary of the Effective Date of this Agreement; and
(iii) *** U.S. dollars ($*** USD) upon the earliest to occur of (a) issuance of the first Valid Claim of a Licensed Patent, or (b) the third (3rd) anniversary of the Effective Date of this Agreement.
11
(ii) Dilution Protection. In partial consideration of the licenses granted hereunder, from the Effective Date through the date by which Company has cumulatively raised or expended at least *** U.S. dollars ($*** USD) (the Dilution Protection Cap), Company will issue to Wistar, from time to time and at no additional consideration, such additional number of shares of Company as will cause Wistar to continue to hold in the aggregate five percent (5%) of the total shares of Company on a fully diluted basis, assuming the exercise, conversion and exchange of all outstanding securities of Company for or into shares. For the avoidance of doubt, the Dilution Protection Cap specifically excludes non-cash charges incurred by Company. Within forty-five (45) days of the end of each Fiscal Quarter of the Companys October 31 year end Fiscal Year, Company shall provide Wistar with a report that shows total financial proceeds or direct expenditures that are to be counted toward the Dilution Protection Cap for the previous Fiscal Quarter.
(iii) Restrictions on Transferability. The Shares shall not be transferable in the absence of a registration under the Securities Act of 1933, as amended, or an exemption therefrom. Company shall be entitled to give stop transfer instructions to the transfer agent with respect to the Shares in order to enforce the foregoing restrictions. The Shares shall also be subject to the restrictions on transfer set forth in the Equity Documents only so long as all other holders of common stock of the Company are subject to similar restrictions.
(iv) Restrictive Legend. Each certificate representing the Shares shall bear substantially the following legends (in addition to any legends required under applicable securities laws):
(v) Preemptive Rights. If the Company has raised or expended the Dilution Protection Cap limit and the Company proposes to sell any equity securities or securities that are convertible into equity securities of the Company (collectively, Equity Securities) in a financing, then Wistar and/or its Assignee (as defined below) will have the right to purchase up to that portion of the Equity Securities that equals Wistars then current, fully diluted percentage ownership of the Company on the same terms and conditions as are offered with respect to such Equity Securities sold in such financing, provided that upon notification to Wistar that financing is conducted with general terms, Wistar or its Assignee will have five (5) business days to determine whether it will participate in purchasing Equity Securities as permitted under this Section. For the purposes of this clause 3.1.2(v) 1.1, the term Assignee means (1) any entity to which Wistars preemptive rights have been assigned either by Wistar or another entity, or (2) any entity that is controlled by Wistar.
12
(vi) Right of Participation. From the date hereof until the date on which the Dilution Protection Cap has been exceeded, upon the sale by the Company of common stock or securities convertible or exercisable into common stock for cash consideration (other than for an acquisition or strategic transaction, a Subsequent Financing), Wistar shall have the right to participate in up to an amount of the Subsequent Financing equal to five percent (5%) of the Subsequent Financing (the Participation Maximum) on the same terms, conditions and price provided for in the Subsequent Financing. The Company shall provide at least ten (10) business days prior notice to Wistar of a Subsequent Financing. Such notice shall include a description of the proposed terms of the Subsequent Financing and the amount of proceeds intended to be raised thereunder. If Wistar desires to participate in the Subsequent Financing, Wistar shall provide written notice to the Company by not later than 5:30 p.m. (New York City time) on the fifth (5th) business day after notice was received. Such notice shall include the amount of such Wistars participation, and shall represent and warrant that Wistar has such funds ready, willing, and available for investment on the terms set forth in the Subsequent Financing notice. If the Company receives no such notice from Wistar as of such fifth (5th) business day, Wistar shall be deemed to have notified the Company that it does not elect to participate If Wistar elects to not participate in a Subsequent Financing, such election shall not waive Wistars Dilution Protection rights under Section 3.1.2(ii).
Royalty Percentage | for that portion of aggregate Net Sales of Licensed Products: |
*** | *** |
*** | *** |
*** | *** |
13
(c) any Third Party Payments that are not offset during the royalty reporting period when such payments are actually made shall not be creditable against payments arising in subsequent royalty reporting periods. As used in this Section 3.2.2¸ a Licensed Patent is dominated if it cannot be practiced without infringing a valid claim of an issued patent. If Company determines that Third Party Payments are necessary, Company will notify Wistar of said determination in writing within thirty (30) calendar days of reaching said determination.
(i) *** U.S. dollars ($*** USD) upon the third and fourth anniversaries of the Effective Date;
(ii) *** U.S. dollars ($*** USD) upon the fifth and sixth anniversaries of the Effective Date; and
(iii) *** U.S. dollars ($*** USD) upon the seventh anniversary of the Effective Date and on each anniversary of the Effective Date thereafter.
14
(i) *** U.S. dollars ($*** USD) upon the enrollment of the first patient in a Phase I or a Phase I/II Clinical Trial by Company, its Affiliates or any Sublicensee for *** Licensed Products;
(ii) *** U.S. dollars ($*** USD) upon the enrollment of the first patient in a Phase II Clinical Trial by Company, its Affiliates or any Sublicensee for *** Licensed Products (for the avoidance of doubt, Phase II Clinical Trials include Phase IIa and Phase IIb Clinical Trials);
(iii) *** U.S. dollars ($*** USD) upon the enrollment of the first patient in a Phase III Clinical Trial or other pivotal Clinical Trial by Company, its Affiliates or any Sublicensee for *** Licensed Products;
(iv) *** U.S. dollars ($*** USD) upon initial receipt by Company, its Affiliates or any Sublicensee of Regulatory Approval for *** Licensed Products;
(v) *** U.S. dollars ($*** USD) upon the First Commercial Sale of each Licensed Product by Company, its Affiliates or any Sublicensee; and
(vi) *** U.S. dollars ($*** USD) upon Company, its Affiliates and any Sublicensee achieving aggregate Net Sales of *** U.S. dollars ($*** USD) for Licensed Products.
15
For Payment By ACH/Wire: |
| For Payment By Check (Mail To): |
*** |
| *** |
(i) the spot rate or the mean of the buy and sell spot rates, if no single rate is published, as published by The Wall Street Journal; or
(ii) at the currency conversion rate published or issued at the close of business by a third party selected by Company, provided that Company has obtained Wistars prior written consent to use such third party rate for calculation of royalties due to Wistar.
16
17
18
19
20
(d) there is no settled, pending, or threatened litigation alleging the unpatentability, invalidity, misuse, unregisterability, unenforceability, or noninfringement of, or error in any Licensed Patent challenging Wistar's ownership of, or right to practice or license, any Licensed Patent, or alleging any adverse right, title, or interest with respect thereto; and (e)it has no knowledge of any factual, legal, or other reasonable basis for any litigation described in this Section and has not received any written, oral, or other notice of any litigation described in this Section. This paragraph expressly does not make any representations and warranties regarding any allegations as to patentability made in unrebutted communications from any patent office as of the Effective Date of this Agreement. Wistar has not brought or threatened any claim against any third party alleging infringement of any Licensed Patent, nor, to its knowledge, is any third party infringing or, to its knowledge, preparing or threatening to infringe any patent, or practicing any claim of any patent application, included as a Licensed Patent.
21
22
23
24
25
Company shall keep Wistar informed of the status and progress of any action brought under this Section 7.3 and Company shall not settle or compromise any such suit in a manner that imposes any obligations or restrictions on Wistar or grants any rights to the Licensed Patents, Wistar Confidential Information or Licensed Technical Information without Wistars prior written consent. Prior to commencing any such infringement action, Company shall consult with Wistar and shall consider the views of Wistar regarding the advisability of the proposed action and its effect on the public interest. If Company exercises its right to bring an infringement action against the alleged infringer, Company shall be obligated to defend any cross claim or counterclaim or action for declaratory judgment related to the Licensed Patents or Licensed Product.
26
At Wistars request, Company shall, in a timely manner, assist Wistar in preparing an application for Patent Term Extension in compliance with 35 U.S.C. §156 et seq., and, as appropriate, any applicable foreign patent laws. Company and its Sublicensees shall cooperate fully with Wistar in preparing the applications for Patent Term Extension. Company agrees to join in such applications at Wistars request. Company shall fully support such applications and shall provide such information as may be requested in support of such applications by Wistar or by the government.
27
(i) information that is known to the receiving party or independently developed by the receiving party prior to the time of disclosure without use of or reference to the other partys Confidential Information, in each case, to the extent evidenced by written records promptly disclosed to the furnishing party upon receipt of such Confidential Information;
(ii) information disclosed to the receiving party by a third party that has a right to make such disclosure;
(iii) information that becomes patented, published or otherwise part of the public domain as a result of acts by the furnishing party or a third party obtaining such information as a matter of right; or
(iv) information that is required to be disclosed by order of the FDA or similar authority or a court of competent jurisdiction or other government authority or agency; provided that the parties shall use their best efforts to obtain confidential treatment of such information by the agency, authority, or court.
28
(i) Company fails to pay any amount payable to Wistar within sixty (60) days after such amount becomes due;
(ii) Company fails to pay the Patenting Costs as required by Section 7.1.1 within sixty (60) days after such amount becomes due;
(iii) material breach by Company of any covenant or agreement (other than a breach referred to in clause (i) above) or any representation or warranty contained in this Agreement that is continuing sixty (60) days after Wistar gives Company written notice of such breach; notwithstanding the foregoing, if Company violates the laws, regulations or other legal authority in any jurisdiction relating to the development, use, storage, or marketing of the Licensed Products in a way that Wistar deems in its reasonable judgment to constitute a public safety or health hazard, Wistar may immediately terminate the license hereunder;
29
(iv) Company becomes subject to a Bankruptcy Event;
(v) the dissolution or cessation of operations by Company;
(vi) Company or any of its Affiliates or Sublicensees bring a Patent Challenge against Wistar, or assists others in bringing a Patent Challenge against Wistar (except as required under a court order or subpoena); or
(vii) Company fails to perform or fulfill its diligence obligations or any Performance Milestone in accordance with the requirements of Sections 4.1 or 4.2 and that failure is continuing ninety (90) days after Wistar gives Company written notice of such breach; and
(viii) Wistars right of termination in this Section 9.2 shall be in addition and without prejudice to, and shall not constitute a waiver of, any right of Wistar for recovery of any monies then due to it hereunder or any other right or remedy Wistar may have at law, in equity or under this Agreement.
30
(i) all rights and licenses granted to Company under the terms of this Agreement shall terminate and nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such termination or expiration;
(ii) all Confidential Information of the furnishing party shall be promptly returned or destroyed, at the furnishing partys election;
(iii) Company shall cease all production and sale of Licensed Products;
(iv) final reports in accordance with Section 3.8 shall be submitted to Wistar; and
(v) all royalties and other payments, including any unreimbursed Patent Costs, accrued or due to Wistar as of the termination or expiration date shall become immediately payable. Notwithstanding the foregoing, after the effective date of termination of this Agreement, unless for breach by Company, Company and its Sublicensees may, for a period of six (6) months, sell all Licensed Products existing at the time of such termination or expiration, and complete Licensed Products in the process of manufacture at the time of such termination or expiration and sell the same, provided that Company shall comply with, and cause its Sublicensees to comply with, all of the terms of this Agreement, including, (a) Company shall pay to Wistar the running royalties and other payments as required hereinabove in Article 3, (b) insurance requirements as described in Section 6.5, and (c) Company shall submit the reports required by Section 3.8 hereof.
(ii) permit Wistar and its licensees and sublicensees to utilize, reference, cross reference, incorporate in applications and filings, and otherwise have the benefit of all Documentation and Approvals.; and
31
9.8 Right to Payment Accrues During Term of Agreement. Whenever a payment to Wistar with respect to sales of any Licensed Product is provided for in this Agreement, the right of Wistar to such payment shall accrue at the time such product is manufactured or produced during the Term of this Agreement. Therefore any inventory or stocks of such products existing prior to the expiration or earlier termination of this Agreement but sold thereafter shall generate payment to Wistar in accordance with the applicable percentage or other method for determining the amount of such payment provided in this Agreement. In such cases, Company shall promptly remit payment to Wistar after the receipt of consideration from sale of such products.
32
If to Wistar:
The Wistar Institute
3601 Spruce Street
Philadelphia, PA 19104
Attn: Office of Business Development
With a copy to: Attn: Vice President, General Counsel, Secretary and Government Relations
If to Company:
Certainty Therapeutics, Inc.
3150 Almaden Expressway,
Suite 250, San Jose, California 95118
Attn: Amit Kumar, Chief Executive Officer
33
34
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement as of the Effective Date.
THE WISTAR INSTITUTE OF ANATOMY AND BIOLOGY
|
| CERTAINTY THERAPEUTICS, INC. | |||
By: | /s/ Heather A. Steinman |
| By: | /s/ Amit Kumar | |
| Heather A. Steinman, Ph.D., M.B.A. |
| Name: Amit Kumar Title: Chief Executive Officer | ||
| Vice President, Business Development and Executive Director, Technology Transfer |
|
|
| |
Date: | November 9, 2017 |
| Date: | November 13, 2017 | |
LICENSE AGREEMENT
BETWEEN
THE WISTAR INSTITUTE OF ANATOMY AND BIOLOGY
AND
CERTAINTY THERAPEUTICS, INC.
Schedule I Licensed Patents
Schedule II Quarterly Report
37
Schedule I
Licensed Patents
Inventors | Serial No. | App. Type | File Date | Title |
Alfredo Perales-Puchalt, Jose Conejo-Garcia | 62/059,068 | PPA1 | 10/02/2014 | Methods and Compositions for Treating Cancer |
Alfredo Perales-Puchalt, Jose Conejo-Garcia | 62/202,824 | PPA2 | 8/08/2015 | Methods and Compositions for Treating Cancer |
Alfredo Perales-Puchalt, Jose Conejo-Garcia | PCT/US2015/053128 Pub No. WO 2016/054153 | PCT | 9/30/2015 Pub Date: 4/07/2016 | Methods and Compositions for Treating Cancer |
Alfredo Perales-Puchalt, Jose Conejo-Garcia | US15/515,442 Pub No. US 2017/0226176 A1 | US National Phase | 9/30/2015 (5/29/2017) Pub Date: 8/10/2017 | Methods and Compositions for Treating Cancer |
Alfredo Perales-Puchalt, Jose Conejo-Garcia | 15847792.7 Pub No. EP2300815A | Europe National Phase | 9/30/2015 (4/29/2017) Pub Date: 8/09/2017 | Methods and Compositions for Treating Cancer |
Alfredo Perales-Puchalt, Jose Conejo-Garcia | 201580065382.9 Pub No. CN 106999552 | China National Phase | 9/30/2015 (6/01/2017) Pub Date: 8/01/2017 | Methods and Compositions for Treating Cancer |
Quarterly Report
Per Section 3.8 of this Agreement, reports shall include at least the following, on a Licensed Product-by-Licensed Product and country-by-country basis:
A. the numbers or quantity of each Licensed Product sold by Company, its Affiliates and each Sublicensee during the Calendar Quarter;
B. the gross amount billed and actually collected by Company, its Affiliates and Sublicensees for Licensed Products, and an accounting of any non-monetary consideration for each Licensed Product sold by Company, its Affiliates and each Sublicensee during the Calendar Quarter;
C. deductions applicable to the sale of each Licensed Product during the Calendar Quarter, as provided in the definition of Net Sales;
D. average sale price during the Calendar Quarter;
E. exchange rates used for currency conversion under Section 3.9.2 for the Calendar Quarter and the basis and methodology used;
F. total royalties due to Wistar under Section 3.2.1 for the Calendar Quarter, as well as a detailed accounting of how such payments were calculated;
G. milestone payments due to Wistar;
H. Minimum Annual Royalties and maintenance fees due to Wistar;
I. names and addresses of all Sublicensees of Company during the Calendar Quarter;
J. Non-Royalty Sublicensing Income received during the Calendar Quarter from each Sublicensee, identifying the types of payment as further described in the definition of Non-Royalty Sublicensing Income;
K. description and product codes, or other Company identifier, of each Licensed Product sold during the Calendar Quarter; and
L. a list of countries in which a First Commercial Sale occurred in the Calendar Quarter.