Document:

Exhibit 10.1

 

RESEARCH AND LICENSE AGREEMENT

 

This RESEARCH AND LICENSE AGREEMENT (this “Agreement”), dated as of June 15, 2006 (the “Effective Date”), is made by and between Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation for itself and for its Affiliate, Scott & White Clinic (collectively, “S&W”), Texas non-profit corporations, located at 2401 S 31st Street, Temple, Texas 76508; Arthur E. Frankel, M.D.; and Stemline Therapeutics, Inc., a Delaware corporation having a principal place of business located at ***, New York, New York 10128 (“Stemline”).

 

WHEREAS, Stemline is a company involved in the development of biopharmaceutical products;

 

WHEREAS, S&W is a non-profit, tax-exempt Texas corporation that, through its own resources and those of its Affiliates, performs clinical research, drug development, discovery, process development, manufacturing, preclinical, clinical trials, bioanalytical analysis, statistics, pharmacokinetics and other services;

 

WHEREAS, S&W is currently conducting research involving the Compound (as defined below), including a clinical trial(s), and owns certain intellectual property, including know-how, and materials related to the Compound;

 

WHEREAS, Stemline wishes to provide financial support for such research and to obtain an exclusive license to such intellectual property, know-how, and materials;

 

WHEREAS, S&W wishes to continue such research and grant such license;

 

WHEREAS, Arthur E. Frankel, M.D., is a researcher involved in the development of biopharmaceutical products;

 

WHEREAS, Arthur E. Frankel, M.D., wishes to continue research and development of compounds *** and ***;

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the parties hereby agree as follows:

 

ARTICLE I.

 

DEFINITIONS

 

Section 1.01                             Definitions.  Whenever used in this Agreement, whether in the singular or plural, the following capitalized terms shall have the following meanings:

 

(a)                                 “Affiliate” of a party means a person or legal entity that controls, is controlled by, or is under common control with, such party.  For purposes of this definition, “control” means the possession, direct or indirect, of the power or other where-with-all to direct or cause the direction of the management and policies of a person or entity, whether through the ownership of voting securities, by contract or otherwise.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

 

(b)                                 “Compound” shall mean Interleukin-3/Diphtheria Toxin recombinant peptide-toxin conjugate *** and any improvements thereof.

 

(c)                                  “Confidential Information” shall mean any and all information and materials disclosed or provided by either party or its Affiliates (in each case, the “Disclosing Party”) to the other party or its Affiliates (in each case, the “Receiving Party”) in connection with or relating to this Agreement; provided, however, that the term “Confidential Information” shall not include, or shall cease to include (as the case may be), information or materials that:

 

(i)                                   was already known to the Receiving Party or its Affiliates;

 

(ii)                                was or becomes generally available to the public, or part of the public domain, through no fault of or disclosure by the Receiving Party or its Affiliates;

 

(iii)                             was or becomes available to the Receiving Party of its Affiliates from a source other than the Disclosing Party or its Affiliates, provided that such source is not bound by a duty of confidentiality to the Disclosing Party; or

 

(iv)                              is independently developed by the Receiving Party or its Affiliates.

 

Confidential Information included within S&W Technology shall constitute Confidential Information of Stemline, and the foregoing clauses (i) and (iv) shall not apply to such Confidential Information.

 

(d)                                 “Confidentiality Agreement” shall mean the mutual confidentiality agreement between the parties, dated as of September 7, 2005.

 

(e)                                  “Control” shall mean possession of the legal right and authority to grant the licenses or sublicenses as provided herein without violating the terms of any agreement or other arrangements with any third party.

 

(f)                                   “Field” shall mean all fields of use, including the diagnosis, prophylaxis, and/or treatment of any disease or condition in humans or animals.

 

(g)                                  “Know-How” shall mean technical and other information, including discoveries, data, designs, formulae, drug formulations, dosing regimens, methods of treatment, methods of use, ideas, inventions, methods, models, assays, reagents, research plans, procedures, designs for experiments and tests and results of experimentation and testing (including data and results of research or development), processes (including manufacturing processes, specifications and techniques), laboratory records, chemical, pharmacological, toxicological, clinical, analytical and quality control data, clinical and non-clinical trial data, case report forms, data analyses, reports, manufacturing data or summaries and information contained in submissions to and information from ethical committees and regulatory authorities.  Notwithstanding the foregoing, “Know-How” excludes Patent Rights.

 

(h)                                 “Licensed Product” means any product containing or comprising the Compound, in finished dosage pharmaceutical form.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

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(i)                                     “Materials” shall mean any chemical or biological substances including any:  organic or inorganic material; nucleotide or nucleotide sequence including DNA and RNA sequences; gene; vector or construct including plasmids, phages or viruses; host organism including bacteria, fungi, algae, protozoa and hybridomas; cell line or expression system or any development strain or product of that cell line or expression system; protein including any peptide or amino acid sequence, enzyme, antibody or protein conferring targeting properties and any fragment of a protein or a peptide, enzyme or antibody; drug; assay or reagent; any other genetic or biological material or micro-organism; NMR spectra, X-Ray diffraction patterns and other primary experimental information, assignments and other calculations required for determination of the structure, and co-ordinates of the derived molecular structure; and transgenic animals.

 

(j)                                    “Adjusted Gross Sales” means the gross revenue received by Stemline, its Affiliates or sublicensee from the Sale of Licensed Products less sales and/or use taxes actually paid, import and/or export duties actually paid, outbound transportation prepaid or allowed, rebates, chargebacks, cash discounts, amounts allowed or credited due to returns (not to exceed the original billing or invoice amount), and all other reasonable and customary allowances and deductions actually granted to customers, in accordance with U. S. generally accepted accounting principles.  In the event that Stemline sublicenses the licensed rights hereunder to any person with respect to any country in the Territory, which sublicense provides for the payment of royalties on net sales, revenues or similar item, the definition of net sales, net revenues or similar term set forth in such sublicense will be substituted herein for purposes of determining Adjusted Gross Sales hereunder in such country.

 

(k)                                 “Patent Rights” shall mean patent applications and patents, utility certificates, improvement patents and models and certificates of addition and all foreign counterparts of them in all countries, including any divisional applications and patents, refilings, renewals, re-examinations, continuations, continuations-in-part, patents of addition, extensions (including patent term extensions), reissues, substitutions, confirmations, registrations, revalidations, and any equivalents of the foregoing in any and all countries of or to any of them, as well as any supplementary protection certificates and equivalent protection rights.

 

(l)                                     “Regulatory Filings” shall mean, with respect to Compound or Licensed Product, any submission to a governmental regulatory authority of any appropriate regulatory application, and shall include, without limitation, any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.  For the avoidance of doubt, Regulatory Filings shall include any Investigational New Drug Application, including Investigational New Drug Application ***, and any New Drug Application, in each case, in the United States, or the corresponding application in any other country or group of countries.

 

(m)                             “Research Program” shall mean experimental research involving Compounds including all clinical trials involving *** being conducted by or on behalf of S&W (which, for the avoidance of doubt, shall include the clinical trial relating to Investigational New Drug application ***) and production of *** for additional Clinical Studies.

 

(n)                                 “Clinical Research Term” shall mean the term of the Clinical Research Program hereunder, consisting of a period of *** months from the Effective Date and extensions thereof

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

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in writing amending this Agreement, except that Stemline shall also have the sole option to extend the original Clinical Research Term for an additional period of *** months (i.e. total of *** months) by providing written notice to S&W.

 

(o)                                 “Compound Development Research Term” shall mean the term of the Compound Development Research Program hereunder, consisting of a period of 36 months from the Effective Date and extensions thereof in writing amending this Agreement.

 

(p)                                 “Research Term” shall refer to both Clinical Research Term and the Compound Research Term.

 

(q)                                 “Sale”, “Sell” or “Sold” means the transfer or disposition of a Licensed Product for value to a person or entity other than Stemline, its Affiliates or sublicensees.

 

(r)                                    “S&W Know-How” shall mean all Know-How owned or Controlled by S&W or its Affiliates or the date hereof or at any time during the Research Term (including information disclosed to Stemline prior to the date hereof pursuant to the Confidentiality Agreement), related to or necessary or useful for the research, development, manufacture, registration, use or marketing of the Compound and/or Licensed Product.  S&W Know-How shall include all clinical and regulatory data.

 

(s)                                   “S&W Materials” shall mean all Materials owned or Controlled by S&W or its Affiliates on the date hereof or at any time during the Research Term related to or necessary or useful for the research, development, manufacture, registration, use or marketing of the Compound and/or the Licensed Product.  For avoidance of doubt, S&W Materials shall include master cell lines that produce Compound, working cell lines that produce Compound, as well as all materials necessary for the isolation and manufacturing of Compound, and the Compound itself.

 

(t)                                    “S&W Patent Rights” shall mean all Patent Rights owned or Controlled by S&W or its Affiliates on the date hereof or at any time during the Research Term related to or necessary or useful for the research, development, manufacture, registration, use or marketing of the Compound and/or Licensed Product.

 

(u)                                 “S&W Technology” shall mean, collectively, S&W Know-How, S&W Materials and S&W Patent Rights.

 

(v)                                 “Territory” shall mean the world.

 

ARTICLE II.

 

RESEARCH PROGRAM

 

Section 2.01                             General.

 

(a)                                 Conduct of the Research Program.  The Research Program shall be conducted by, and under the direction of, Arthur E. Frankel, M.D. (the “Principal Investigator”).  S&W shall be the sponsor of all clinical trials conducted as part of the Research Program (the “Clinical

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

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Study(ies)”), including any clinical trials conducted under Investigational New Drug Application ***.  It is mutually understood and agreed that there is no guarantee that the Research Program as conducted will be able to either develop a licensed product or guarantee a market for any Licensed Product of the Research Program.

 

(b)                                 Disclosure of S&W Technology.  Immediately after the Effective Date, S&W will provide Stemline with, or access to (including the right to make copies of), S&W Know-How, S&W Materials and Regulatory Filings relating to the Compound and/or Licensed Product (and any other information and documents known to S&W relating to the Compound and/or Licensed Product).  S&W will also provide Stemline with access to any and all personnel involved in the Research Program upon reasonable notification during regular business hours in accordance with the limitations delineated in Article II. of this Agreement.  Stemline shall have the sole right to file and prosecute patent applications relating to information provided as part of this disclosure, pursuant to Section 2.07.

 

(c)                                  Consultation with Stemline.  Stemline may, but shall not be obligated to, provide advice from time to time and consult with S&W and the Principal Investigator regarding the conduct of the Research Program, which advice will be reasonably considered by S&W; provided, that S&W shall make all final decisions regarding the conduct of the Research Program.

 

(d)                                 Compliance with Laws.  S&W covenants that the activities conducted by or on behalf of S&W under the Research Program shall be conducted in a professional and competent manner, in compliance with all applicable laws and regulations and in accordance with ICH Guidelines, FDA Good Laboratory Practice and Good Manufacturing Practice, as applicable.

 

(e)                                  Quality Controls.  S&W shall practice appropriate quality controls in order to insure compliance with the protocol and study plan for the Clinical Study. S&W shall comply with the Standard Operating Procedures as set forth in such documents, as appropriate.  S&W shall provide appropriate training for those personnel working on the Research Program.

 

(f)                                   Audits and Facilities Examination. Subject to reasonable and customary applicable Federal, State and institutional confidentiality and security compliance standards and procedures, during the Research Term and for a period of *** (***) years thereafter, S&W will permit Stemline’s representatives to examine or audit the work performed hereunder, and the facilities at which the Clinical Study will be conducted.  During such examination, Stemline’s representatives may verify documents, facilities and records, as well as methodology, procedures and any other relevant item relating to the research performed.  Stemline’s representatives may also visit S&W’s premises and examine or audit the services provided and related to this Agreement at reasonable times and frequency, during normal business hours, to observe the progress of activities under the Research Program.  S&W will also provide Stemline with access to any and all personnel involved in the Research Program upon reasonable notification during regular business hours.  However, Stemline’s access shall not interfere with S&W’s ability to conduct the work of the Research Program.

 

(g)                                  Debarment Certification and Notification of Inspections.  S&W certifies that it has not been debarred, and has not been convicted of a crime that could lead to debarment, under

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

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the Federal Food, Drug and Cosmetic Act and that it will use its best efforts not to employ any person or entity that has been so debarred or convicted to perform any activities under this Agreement.  S&W shall notify Stemline within *** (***) business days in writing of any FDA or other government inspection or inquiry concerning any activities conducted hereunder.

 

Section 2.02                             Compensation for Clinical Research.

 

(a)                                 Funding.  In order to fund the activities to be conducted under the Research Program and as consideration for the Patent Rights, if any, arising from the activities under this Agreement, Stemline shall pay to S&W by automatic remittance and on direct deposit (i.e. wire transfer) to an account designated by S&W:

 

(i)                                     *** dollars ($***) for *** of the Clinical Research Term plus ***% of such amount constituting deemed indirect costs incurred by S&W directly in connection with the conduct of the Research Program; and

 

(ii)                                  If the Research Term is extended for a second *** period, pursuant to Section 1.01(n), *** dollars ($***) for the second *** months of the Research Term plus ***% of such amount constituting deemed indirect costs incurred by S&W directly in connection with the conduct of the Research Program.

 

(b)                                 Payment.  Pursuant to Section 2.02(a)(i), for *** of the Research Term, payment of the $*** shall be made by Stemline to S&W in *** by automatic remittance and direct deposit (i.e. wire transfer) to an account designated by S&W with the first payment due not later than *** (***) days after the Effective Date and each subsequent payment due not more than *** (***) days after the due date for the prior payment; payment of said indirect costs shall be made by Stemline to S&W in *** at the conclusion of ***.  In the event the Research Program shall be terminated for any reason during ***, the indirect costs will be prorated on a per diem basis from the effective date of this Agreement to the date of Termination.  Pursuant to Section 2.02(a)(ii), if the Research Term is extended for ***, payment of the $*** plus said indirect costs shall be made by Stemline to S&W by automatic remittance on direct deposit (i.e. wire transfer) to an account designated by S&W in *** installments with the first payment due within *** (***) days following initiation of this extended term and each subsequent payment due *** (***) days after the due date for the prior payment.  If this Agreement is terminated during the second year or any subsequent quarterly period of the Research Term by Stemline, without cause, neither party shall incur any further liability or obligation to the other party, except that Stemline shall pay the agreed *** payment, prorated per diem to the effective date of termination, as outlined in this 2.02(b).  In the event that the Research Term expires or is terminated, any amounts paid pursuant to this Section 2.02 in respect of periods after the effective date of expiration or termination shall be promptly refunded to Stemline.  All payments shall be made to:

 

Scott and White Memorial Hospital

c/o Dick Dixon

2401 S. 31st Street

Temple, Texas 76508

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

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(c)                                  Escrow, Delinquency and Nonpayment.  Stemline shall maintain a $*** dollar balance in an agreed upon United States Financial Institution.  This $*** balance will be funded by Stemline to the Financial Institution in equal $*** installments with the first payment due upon execution of the agreement or effective date (whichever is later) and the subsequent installment due not more than *** (***) days after the due date for the first installment.  This money shall be available to S& W should Stemline be in arrears for payments owed to S&W (Exhibit B).

 

In the event that Stemline shall fail to make any payment when due, S&W may, in its sole discretion, charge interest upon the amount then due and owing at *** as published by the Wall Street Journal in effect on the due date of payment, until payment is received in full.

 

All interest or other earnings on the escrowed balance is the property of Stemline.

 

Section 2.03                             Compensation for Compound Development Research.

 

(a)                                 Funding.  In order to fund the activities to be conducted under the Compound Development Research Program and as consideration for the Patent Rights, if any, arising from the activities under this Agreement, Stemline shall pay to S&W by automatic remittance and on direct deposit (i.e. wire transfer) to an account designated by S&W the sum of *** Dollars ($***) for the Compound Research Term of *** (***) months.  Of said amount, *** Dollars ($***) will be used ***; *** Dollars ($***) will be used ***; *** Dollars ($***) will be used for ***; and, *** Dollars ($***) will be used for ***.

 

(b)                                 Payments.  Pursuant to Section 2.03(a), for the term of the Compound Research Term, payment of the $*** shall be made by Stemline to S&W in *** installments by automatic remittance and direct deposit (i.e. wire transfer) to an account designated by S&W with the first payment due not later than *** (***) days after the Effective Date and each subsequent payment due not more than *** (***) days after the due date for the prior payment.  All payments shall be made to:

 

Scott and White Memorial Hospital 
 c/o Dick Dixon
 2401 S. 31st Street
 Temple, Texas 76508

 

(c)                                  Escrow, Delinquency and Nonpayment.  Stemline shall establish a $*** dollar balance in an agreed upon United States Financial Institution.  This $*** balance will be funded by Stemline to the Financial Institution with the first installment for $*** due *** days after the execution date of the agreement or effective date (whichever is later) and the subsequent installment for $*** due *** days (***) after the first installment.  Stemline shall receive any interest earned on said escrow account.  This money shall be used to pay S& W in accordance with this section (Exhibit C).

 

In the event that Stemline shall fail to make any payment when due, S&W may, in its sole discretion, charge interest upon the amount then due and owing at *** as published by the Wall Street Journal in effect on the due date of payment, until payment is received in full.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

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All interest or other earnings on the escrowed balance is the property of Stemline.

 

Section 2.04                             Research Records; Disclosure of Data.

 

(a)                                 S&W shall maintain appropriate and accurate records, in accordance with U.S. generally accepted accounting principles, good scientific practices and appropriate detail for patent purposes, fully and properly reflecting all Research Program activities performed by it, costs and expenses incurred in connection therewith and the results thereof, including, without limitation, such data and materials as are required to be maintained pursuant to applicable laws and regulations.

 

(b)                                 S&W shall communicate in full detail and disclose all data, information, reports, results and other S&W Know-How or S&W Materials to Stemline as soon as such becomes available, but in any event within *** days.

 

(c)                                  Stemline acknowledges and agrees that S&W claims that it may not be legally authorized to disclose certain data, such as patient-specific data, under Texas or Federal law or if such disclosure would jeopardize the physician/patient confidentiality privilege.  Notwithstanding the foregoing, S&W and Stemline shall devise a mutually acceptable technique so that S&W shall provide Stemline with appropriate and necessary data to effect the necessary disclosure.

 

(d)                                 If S&W becomes aware that certain data related to or resulting from the Research Program cannot be provided to Stemline because of United States or Texas law, or the physician/patient confidentiality privilege, S&W will as soon as is reasonably possible notify Stemline.  S&W and Stemline shall make reasonable efforts to legally overcome said legal restrictions related to the data referenced above; provided, that if Stemline determines, in its reasonable discretion, that such legal restrictions will adversely affect its ability to research, develop or commercialize the Compound or Licensed Product or otherwise adversely affect the use or value of the license granted under Section 3.01, it shall be entitled to terminate the Research Program.

 

Section 2.05                             Progress Reports.  S&W shall provide oral updates, e.g. via teleconference, to Stemline from time to time, on a mutually agreeable basis but at least twice per month, regarding the conduct of the Research Program.  In addition, on at least an annual basis at the request of Stemline, S&W shall prepare and provide to Stemline a written summary describing, in reasonable detail, the status of the Research Program, including all discoveries and technical developments, and provide such other information as may be reasonably requested by Stemline relating to the Research Program.

 

Section 2.06                             Access to and Transfer of Regulatory Filings.  S&W hereby consents to and authorizes Stemline to use and rely upon or refer to Investigational New Drug Applications for purposes of conducting (or having conducted) one or more clinical trial(s) with respect to the Compound and/or Licensed Product.  In its role as the sponsor of all clinical trials pursuant to Section 2.01(a), S&W shall take such actions, including providing supporting documentation and data and executing such documents, as may be requested by Stemline from time to time in order

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

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to permit Stemline to facilitate such clinical trial(s) at such site or sites as the parties shall mutually agree upon, and such agreement shall not be unreasonably withheld.

 

Section 2.07                             Intellectual Property.

 

(a)                                 Ownership of Inventions.  All inventions arising from a party’s activities under this Agreement, including patent applications and patents covering such inventions (collectively, “Inventions”), made solely by employees or consultants of a party shall be owned by such party.  All Inventions made jointly by employees or consultants of both parties shall be owned jointly by the parties in equal shares.  Determination of inventorship shall be made in accordance with US patent laws.  S&W’s rights in any Inventions made under this Agreement and its interest in any Inventions owned jointly by the parties shall be included in the S&W Technology for purposes of this Agreement.

 

(b)                                 Disclosure; Patent Prosecution.  S&W will disclose to Stemline any Inventions resulting from the Research Program as soon as possible after creation and/or reduction to practice.  Stemline shall have the sole right to file patent applications claiming or covering any S&W Know-How, S&W Materials or other information disclosed by S&W to Stemline hereunder (including under Section 2.01(b) and/or this Section 2.07(b)) or arising under the Research Program, using patent counsel of its choice.  Stemline shall provide S&W with a draft of any said application(s) a reasonable period prior to filing.  In this case, S&W shall have *** (***) days, extendable for an additional *** (***) days upon reasonable request by S&W, to provide Stemline with comments on any such patent application(s), such comments to be reasonably considered and not unreasonably denied by Stemline.

 

ARTICLE III.

 

LICENSE

 

Section 3.01                             License to Stemline; Research License to S&W.  S&W hereby grants to Stemline an exclusive (even as to S&W) royalty-bearing sublicensable license under S&W Technology to make, have made, manufacture, have manufactured, formulate, use, have used, sell, offer for sale, have sold, import, export, research, develop, have developed, register, transport, distribute, promote, market or otherwise dispose or offer to dispose of Compounds and/or Licensed Products or in the Field in the Territory.  Stemline hereby grants S&W a nonexclusive, non-sublicensable, royalty-free sublicense under the license granted to S&W pursuant to the preceding sentence during the Research Term solely to the extent necessary to conduct the Research Program in accordance with this Agreement.

 

Section 3.02                             Extension to Affiliates.  Licensee may extend the license granted herein to any Affiliate if the Affiliate consents to comply with this Agreement to the same extent as Licensee.

 

Section 3.03                             Sublicenses.  Licensee may grant sublicenses of the licenses granted under this Agreement; provided, that Stemline will be responsible for the operations of its sublicensees relevant to this Agreement as if the operations were carried out by Stemline, including the payment of royalties whether or not paid to Stemline by a sublicensee.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

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Section 3.04                             S&W Rights. Notwithstanding Section 3.01, S&W retains the non-transferable, non-sublicensable right to use the S&W Technology for research, teaching and other education-related non-commercial purposes.

 

ARTICLE IV.

 

ROYALTIES

 

Section 4.01                             Royalties.  In consideration of rights granted by S&W to Stemline under this Agreement, Stemline will pay S&W a royalty on the Adjusted Gross Sales of Licensed Products in the Territory.  Such royalty shall be paid on a country-by-country Licensed Product-byLicensed Product basis for a period of 10 years following first commercial Sale of such Licensed Product in such country (the “Royalty Term”) at the following rates:

 

(a)                                 *** Percent (***%) of annual Adjusted Gross Sales in the Territory of such Licensed Product up to *** Dollars ($***); and

 

(b)                                 *** Percent (***%) of annual Adjusted Gross Sales in the Territory of such Licensed Product in excess of *** Dollars ($***) up to *** Dollars ($***); and

 

(c)                                  *** Percent (***%) of annual Adjusted Gross Sales in the Territory of such Licensed Product in excess of *** Dollars ($***) up to *** Dollars ($***); and

 

(d)                                 *** Percent (***%) of annual Adjusted Gross Sales in the Territory of such Licensed Product in excess of *** ($***) up to *** Dollars ($***); and

 

(e)                                  *** Percent (***%) of annual Adjusted Gross Sales in the Territory of such Licensed Product in excess of *** Dollars ($***) up to *** Dollars ($***); and

 

(f)                                   *** Percent (***%) of annual Adjusted Gross Sales in the Territory of such Licensed Product in excess of *** Dollars ($***) up to *** Dollars ($***); and

 

(g)                                  *** Percent (***%) of annual Adjusted Gross Sales in the Territory of such Licensed Product in excess of *** Dollars ($***) up to *** Dollars ($***); and

 

(h)                                 *** Percent (***%) of annual Adjusted Gross Sales in the Territory of such Licensed Product in excess of *** Dollars ($***).

 

Section 4.02                             Sublicense Fee.  In consideration of rights granted by S&W to Stemline under this Agreement, Stemline further agrees to pay S&W as additional consideration a sublicense fee consisting of:

 

(i)                                     *** percent (***%) of any Up-front Payment made to Stemline under a sublicense entered into ***;

 

(ii)                                  *** percent (***%) of any Upfront Payment made to Stemline under a sublicense entered into ***;

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

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(iii)                               *** percent (***%) of any Upfront Payment made to Stemline under a sublicense entered into ***; and

 

(iv)                              *** percent (***%) of any Upfront Payment made to Stemline ***.

 

For purposes hereof, an “Upfront Payment” shall mean any cash payment made by a third party to Stemline or its Affiliates up-front in consideration for the granting of a sublicense to such third party of S&W Technology licensed hereunder, excluding funds paid to Stemline or its Affiliates for research and development purposes or as bona fide debt or equity financing.

 

Section 4.03                             Audits.  During the Royalty Term of this Agreement, Stemline agrees to keep records of its Sales and applicable expenses of the Licensed Products under the license granted in this Agreement in sufficient detail to enable the royalties payable hereunder to be determined.  Stemline agrees to permit an independent public accountant selected by S&W and reasonably acceptable to Stemline, at S&W’s expense, to periodically (but no more frequently than once per year during the Research Tenn and once every two (2) years thereafter to audit and examine its records during regular business hours for the purpose of and to the extent necessary to verify royalties payable under this Agreement.  If the amounts due S&W are determined to have been underpaid by more than *** percent (***%), Stemline will pay the cost of the examination.

 

Section 4.04                             Royalty Reports.  Within *** (***) days after March 31 and September 30 of each year, beginning immediately after the first commercial Sale of a Licensed Product in the Territory, Stemline shall deliver to S&W a written report setting forth:

 

(a)                                 the quantities of Licensed Products that it has sold during the preceding six-month period;

 

(b)                                 the calculation of Adjusted Gross Sales thereon; and

 

(c)                                  the royalties computed and due S&W with respect to such period.

 

Simultaneously with the delivery of each report, Stemline shall pay to S&W the amount of royalties, if any, due for the period of each report.

 

Section 4.05                             Taxes.  All amounts payable here by Stemline must be paid in United States funds without deductions for taxes, assessments, fees, or charges of any kind.  Checks must be payable to “Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation.” In the event amounts payable may be subject to applicable tax withholding requirements, the amounts payable will be net of this amount.

 

ARTICLE V.

 

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

Section 5.01                             Representations, Warranties and Covenants of S&W.  S&W represents, warrants and covenants to Stemline that:

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

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(a)                                 S&W owns or possesses all right, title and interest in and to the S&W Technology free and clear of all known encumbrances, and has the right to convey to Stemline the license and other rights provided hereunder free and clear of all encumbrances.  Without limiting the generality of the foregoing, none of the S&W Technology has been pledged, assigned or otherwise conveyed, in whole or in part, to any person or entity.

 

(b)                                 S&W has not knowingly entered into a government funding relationship that would result in rights to any of the Licensed Products or the Compound residing in the Federal Government, National Institutes of Health or other governmental authority, and that the licenses granted hereunder are not subject to overriding obligations to the Federal Government as set forth in Public Law 96-517 (35 U.S.C. 200-204), as amended, or any similar obligations under the laws of any other country.

 

(c)                                  S&W and its Affiliates, subcontractors and collaborators, if any, have fully complied with all applicable laws, rules and regulations in the conduct and evaluation of its studies of the Licensed Products and/or the Compound and with regard to all applications and submissions for regulatory authorities in the Territory.

 

(d)                                 There are no claims, judgments or settlements against or amounts with respect thereto owed by S&W, and no pending or, to its knowledge after reasonable inquiry, threatened claims or litigation against S&W or its Affiliates, subcontractors or collaborators relating to the Compound, Licensed Products or S&W Technology.

 

(e)                                  There are no agreements or arrangements to which S&W or any of its Affiliates are a party relating to the Licensed Products, Compound or S&W Technology that would limit the rights granted to Stemline under this Agreement or that restrict or will result in a restriction on Stemline’s, its Affiliates’ or sublicensees’ ability to research, develop, manufacture, register, use or market the Compound and/or the Licensed Products.

 

(f)                                   All existing S&W Patent Rights as of the Effective Date are disclosed in Exhibit A.

 

ARTICLE VI.

 

INDEMNIFICATION AND INSURANCE

 

Section 6.01                             Indemnification by S&W.  S&W shall indemnify and hold Stemline and its Affiliates, and their respective officers, directors, employees, contractors, sublicensees, agents and assigns (each, a “Stemline Indemnified Party”), harmless from and against losses, damages and liabilities, including reasonable attorneys’ fees (collectively, “Losses”), incurred by any Stemline Indemnified Party as a result of any third party demands, claims or actions (“Claims”) against any Stemline Indemnified Party arising or resulting from: (a) activities undertaken in connection with the research or development of the Compound and/or Licensed Product by S&W or its Affiliates or agents (including product liability claims); (b) the negligence or willful misconduct of S&W, its Affiliates or agents in connection with performance of activities hereunder; or (c) the breach of any of the covenants, agreements, warranties and representations made by S&W to Stemline under this Agreement.  S&W shall only be obliged to so indemnify

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

12

 

and hold Stemline harmless to the extent that such Losses do not arise from the breach, negligence or willful misconduct of Stemline.

 

Section 6.02                             Indemnification by Stemline.  Stemline shall indemnify and hold S&W and its Affiliates, and their respective officers, directors, employees, contractors, agents and assigns (each, a “S&W Indemnified Party”), harmless from and against Losses incurred by any S&W Indemnified Party as a result of any Claims against any S&W Indemnified Party arising or resulting from:  (a) activities undertaken in connection with the research, development or commercialization of the Compound and/or Licensed Products by Stemline or its Affiliates, licensees or sublicensees (including product liability claims); (b) the negligence or willful misconduct of Stemline, its Affiliates or agents in connection with performance of activities hereunder; or (c) the breach of any of the covenants, agreements, warranties and representations made by Stemline to S&W under this Agreement.  Stemline shall only be obliged to so indemnify and hold S&W harmless to the extent that such Claims do not arise from the breach, negligence or willful misconduct of S&W.

 

Section 6.03                             Indemnification Procedure — Third Party Claims.

 

(a)                                 Any Stemline Indemnified Party or S&W Indemnified Party seeking indemnification hereunder (“Indemnified Party”) shall notify the Party from whom indemnification is sought (“Indemnifying Party”) in writing reasonably promptly after the assertion against the Indemnified Party of any Claim in respect of which the Indemnified Party intends to base a claim for indemnification hereunder, but the failure or delay so to notify the Indemnifying Party shall not relieve the Indemnifying Party of any obligation or liability that it may have to the Indemnified Party except to the extent that the Indemnifying Party demonstrates that its ability to defend or resolve such Claim is adversely affected thereby.

 

(b)                                 Subject to the provisions of sub-Sections (c) and (d) below, the Indemnifying Party shall have the right, upon written notice given to the Indemnified Party within thirty (30) days after receipt of the notice from the Indemnified Party of any Claim to assume the defense and handling of such Claim, at the Indemnifying Party’s sole expense, in which case the provisions of sub-Section (c) below shall govern.

 

(c)                                  The Indemnifying Party shall select counsel reasonably acceptable to the Indemnified Party in connection with conducting the defense and handling of such Claim, and the Indemnifying Party shall defend or handle the same in consultation with the Indemnified Party, and shall keep the Indemnified Party timely apprised of the status of such Claim.  The Indemnifying Party shall not, without the prior written consent of the Indemnified Party, agree to a settlement of any Claim which could lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder, or would involve any admission of wrongdoing on the part of the Indemnified Party.  The Indemnified Party shall cooperate with the Indemnifying Party, at the request and expense of the Indemnifying Party, and shall be entitled to participate in the defense and handling of such Claim with its own counsel and at its own expense.

 

(d)                                 Notwithstanding the foregoing, in the event the Indemnifying Party fails to conduct the defense and handling of any Claim in good faith after having assumed such or the

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

13

 

Indemnifying Party does not give written notice to the Indemnified Party, within thirty (30) days after receipt of the notice from the Indemnified Party of any Claim, of the Indemnifying Party’s election to assume the defense and handling of such Third Party Claim, the Indemnified Party may, at the Indemnifying Party’s expense, select counsel reasonably acceptable to the Indemnifying Party in connection with conducting the defense and handling of such Claim and defend or handle such Claim in such manner as it may deem appropriate, provided, however, that the Indemnified Party shall keep the Indemnifying Party timely apprised of the status of such Claim and shall not settle such Claim without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld.  If the Indemnified Party defends or handles such Claim, the Indemnifying Party shall cooperate with the Indemnified Party, at the Indemnified Party’s request but at no expense to the Indemnified Party, and shall be entitled to participate in the defense and handling of such Claim with its own counsel and at its own expense.

 

Section 6.04                             Certain Damages.  In no event shall either party be liable for any indirect, special, consequential or punitive damages (including, without imitation, damages for loss of profits) arising out of or in connection with this Agreement or its subject matter, regardless of whether such party knows or should know of the possibility of such damages.

 

Section 6.05                             Insurance.  Beginning at the time when any Licensed Product is being distributed or sold by Stemline or its sublicensee, Stemline shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts which are reasonable and customary for similarly situated companies in the biopharmaceutical industry.  Stemline shall provide Scott & White with written evidence of such insurance upon S&W’s reasonable request.

 

ARTICLE VII.

 

TERM AND TERMINATION OF AGREEMENT

 

Section 7.01                             Termination by Stemline.  Stemline may terminate the Clinical Research part of this Agreement in its sole discretion at any time after expiration or termination of *** (***) months of the Research Term on not less than *** (***) days’ prior written notice to S&W, in whole or on a country-by-country Licensed Product-by-Licensed Product basis.

 

Section 7.02                             Termination by Either Party for Cause.

 

(a)                                 In the event either party shall be in breach of any material obligation hereunder, the non-breaching party may give written notice to the breaching party specifying the claimed particulars of such breach, and in the event such material breach is not cured, or effective steps to cure such material breach have not been initiated or are not thereafter diligently pursued within *** (***) days following the date of such written notification, in addition to any other damages or remedies available to the non-breaching party, the non-breaching party shall have the right thereafter to terminate this Agreement by giving not less than *** (***) days’ prior written notice to the breaching party to such effect.  Any termination by any party under this Section 7.02 shall be without prejudice to any damages or remedies to which it may be entitled from the other party.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

14

 

(b)                                 Either party may terminate this Agreement upon written notice if the other party becomes insolvent, makes or has made an assignment for the benefit of creditors, is the subject of proceedings in voluntary or involuntary bankruptcy instituted on behalf of or against such party (except for involuntary bankruptcies which are dismissed within *** (***) days), or has a receiver or trustee appointed for substantially all of its property.

 

Section 7.03                             Effect of Termination on License; Certain Reversion Rights.

 

(a)                                 Upon termination of this Agreement by Stemline pursuant to Section 7.01 or upon termination of this Agreement by S&W pursuant to 7.02, all rights and obligations under this Agreement shall terminate (except as provided in Section 7.04) and all terminated licensed rights shall revert to S&W and except that in regard to termination of this Agreement pursuant to Section 7.01 with respect to a particular country or particular Licensed Product, only the rights and obligations under this Agreement with respect to such country or Licensed Product shall terminate (except as provided in Section 7.04) and the licensed rights with respect to such country or Licensed Product shall revert to S&W.

 

(b)                                 In the case of termination by Stemline pursuant to Section 7.02, all rights of Stemline shall survive, and all rights of S&W shall terminate.

 

Section 7.04                             Effect of Termination.

 

(a)                                 Upon expiration or termination of this Agreement, neither party shall have any rights or obligations under this Agreement, provided, that their respective rights and obligations pursuant to Article II. and Sections 6.01-6.04, 7.03 and 7.04, and pursuant to Article VIII., shall survive the expiration or termination of this Agreement.

 

(b)                                 Expiration or termination of this Agreement for any reason shall not release any party from any liability, obligation or agreement which has already accrued prior to such expiration or termination nor affect the survival of any provision hereof which is expressly stated to survive such expiration or termination.  Expiration or termination of this Agreement for any reason shall not constitute a waiver or release of, or otherwise be deemed to prejudice or adversely affect, any rights, remedies or claims, whether for damages or otherwise, which a party may have hereunder or which may arise out of or in connection with such termination.

 

ARTICLE VIII.

 

MISCELLANEOUS

 

Section 8.01                             Confidentiality.

 

(a)                                 All Confidential Information disclosed by the Disclosing Party to the Receiving Party hereunder shall be maintained in confidence and shall not be disclosed to any third party or used for any purpose except as expressly permitted by this Agreement without the prior written consent of the Disclosing Party.  Without limiting the generality of the foregoing:

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

15

 

(i)                                     The Receiving Party shall inform its Representatives and others who need to know the Confidential Information in order to assist the Receiving Party in exercising its rights and fulfilling its obligations under this Agreement of the confidential nature of the Confidential Information received from the Disclosing Party and shall direct such Representatives to treat such information confidentially and cause each such Representative to agree in writing to be bound by the confidentiality and non-use provisions of this Agreement.

 

(ii)                                  If, notwithstanding this Agreement, any Confidential Information is required to be disclosed by applicable law or legal process, the Receiving Party will give the Disclosing Party prompt written notice of such requirement and, if requested, will assist the Disclosing Party in seeking a protective order or other measures to preserve the confidentiality of such Confidential Information insofar as possible.

 

(b)                                 Notwithstanding the foregoing, each party may disclose Confidential Information belonging to the other party to the extent such disclosure is necessary in the following instances: (i) filing or prosecuting Patent Rights as permitted by this Agreement; (ii) in Regulatory Filings for Licensed Products such party has a license or right to develop hereunder; (iii) prosecuting or defending litigation as permitted by this Agreement; (iv) complying with applicable court orders or governmental regulations; and (v) disclosure to consultants, investors, bankers, lawyers, accountants, agents or other third parties in connection with due diligence or similar investigations by such third parties.

 

Section 8.02                             Publications.  S&W has the right to publish or otherwise publicly disclose information gained in the course of the Research Program, subject to Section 8.01.  In order to avoid loss of Patent Rights as a result of premature public disclosure of patentable information, S&W will submit any materials (or written summaries of proposed oral publications or disclosures) to Stemline at least *** (***) days prior to planned submission for review and comment and to permit the filing of appropriate patent applications.  S&W shall reasonably consider all Stemline comments in any proposed publication.  S&W shall cite Stemline as a funding source in the appropriate section of such publication.  Upon Stemline’s request, publication will be delayed up to *** (***) additional days to enable Stemline to secure adequate intellectual property protection for any intellectual property that would be affected by the publication.

 

Section 8.03                             Publicity. Neither party may make any public announcement or other disclosure of the terms or existence of this Agreement, except as may be required by law or upon the prior written approval of the other party or except under circumstances described in Section 8.01(b).

 

Section 8.04                             Integration.  This Agreement, including any Exhibits and Schedules attached hereto, constitutes the entire understanding between the parties with respect to the subject matter hereof, and supersedes and replaces all prior agreements, including the Confidentiality Agreement, implications, understandings, writings, and discussions between the parties relating to said subject matter.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

16

 

Section 8.05           Amendments.  This Agreement may be amended only by a written instrument executed by both parties.

 

Section 8.06           Waiver.  The failure of either party at any time or times to require performance by the other party of any provision hereof shall in no manner affect the first party’s rights at a later time to enforce the same.  No waiver by either party of any condition or term in any one or more instances shall be construed as a further or continuing waiver of such condition or term or any other condition or term.

 

Section 8.07           Assignability. This Agreement may not be assigned by either party without the prior written consent of the other party, except that either party may assign this Agreement to any of its Affiliates; provided that such successor agrees in writing to be bound by this Agreement and the assignor shall continue to be liable thereafter for all its obligations hereunder.  In addition, Stemline shall be entitled to assign this Agreement to any successor by merger or sale of stock or any purchaser of all or substantially all of its assets to which this Agreement relates.  Any attempt to assign this Agreement in violation of this Section shall be void.

 

Section 8.08           Notices.  Any notice required or permitted to be given hereunder shall be in writing and shall be deemed to have been duly given (a) upon actual receipt if sent by telecopier (with receipt confirmed) or (b) on the fifth business day after mailing if sent by nationally-recognized courier service, in each case to the appropriate address or telecopier number set forth below:

 

If to Stemline, to:

 

Stemline Therapeutics, Inc. 

c/o Ivan Bergstein

Chief Executive Officer

***

New York, New York 10128

Telephone:  ***

Telecopier:  212-244-0161

 

If to S&W, to:

 

Scott & White Memorial Hospital

c/o Dick Dixon

2401 South 31st Street 

Temple, Texas 76508 

Telephone:  254-724-2111 

Telecopier:  254-724-4483

 

Scott & White Memorial Hospital

Office of General Counsel 

2401 S. 31st Street

Temple, Texas 76508 

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

17

 

Telephone:  254-724-3001

Telecopier:  254-724-4501

 

Section 8.09           Titles.  All headings and titles used in this Agreement are for purposes of illustration or organization and are not legally binding on the parties.

 

Section 8.10           Relationship of the Parties.  Nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee, or joint venture relationship between the parties, and neither party is authorized or empowered to act as agent for the other for any purpose, or to make any statement, contract, warranty, representation or commitment on behalf of the other.

 

Section 8.11           Further Acts and Instruments.  Each party hereto agrees to execute, acknowledge, and deliver such further instruments and to do all such other acts as may be necessary or appropriate to effect the purpose and intent of this Agreement.

 

Section 8.12           Governing Law; Venue.  This Agreement shall be governed by and construed and interpreted in accordance with the laws of the State of Texas, without regard to its conflicts of laws principles.  Any controversy, dispute or claim which may arise out of or in connection with this Agreement, or the breach, termination or validity thereof, shall be settled by final and binding arbitration in accordance with the Rules of Conciliation and Arbitration of the International Chamber of Commerce or Arbitration Rules and Procedures of JAMS (Judicial Arbitration and Mediation Services).  The place of arbitration shall be a mutually acceptable location other than Texas or New York.  The decision of the arbitration tribunal must be in writing and must specify the basis on which the decision was made, and the award of the arbitration tribunal shall be final and judgment upon such an award may be entered in any competent court or application may be made to any competent court for judicial acceptance of such an award and order of enforcement.

 

Section 8.13           Representation by Legal Counsel.  Each party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof.  In interpreting and applying the terms and provisions of this Agreement, the parties agree that no presumption shall exist or be implied against the party which drafted such terms and provisions.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

18

 

IN WITNESS WHEREOF, the parties have caused their duly authorized representatives to execute this Agreement as of the date first above written.

 

	
STEMLINE   THERAPEUTICS, INC.
    	
 
    	
SCOTT   AND WHITE MEMORIAL
   HOSPITAL AND SCOTT, SHERWOOD
   AND BRINDLEY FOUNDATION
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Ivan Bergstein
    	
 
    	
By:
    	
/s/ Alfred B. Knight
    
	
 
    	
Name:   Ivan Bergstein
    	
 
    	
 
    	
Name:   Alfred B. Knight, M.D.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
Title:   CEO
    	
 
    	
 
    	
Title:   President and C.E.O.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
Date:
    	
6/29/06
    	
 
    	
 
    	
Date:
    	
6/23/06
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
By:
    	
/s/ Arthur E. Frankel
    
	
 
    	
 
    	
 
    	
Name:   Arthur E. Frankel, M.D.
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Title:   Principal Investigator
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Date:
    	
6/23/06
    
							

 

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

19

 

Exhibit A

 

Existing S&W Patent Rights

 

***

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

20

 

Exhibit B

Escrow, Delinquency and Nonpayment

Clinical Research

 

	
Clinical Research Escrow
    	
 
    	
Days from
   Effective Date
    	
 
    	
Clinical Research Payment Timing:
    	
 
    	
Days from
   Effective
   Date
    	
 
    	
Years
   from
   Effective
   Date
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
To CRI 
    	
 
    	
To Escrow
    	
 
    	
 
    	
 
    	
 
    
	
***
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

 

Exhibit C

Escrow, Delinquency and Nonpayment

Compound Development Research

 

	
Clinical Research Escrow
    	
 
    	
Days from
   Effective Date
    	
 
    	
Compound Development Escrow:
    	
 
    	
Days from
   Effective
   Date
    	
 
    	
Years
   from
   Effective
   Date
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
To CRI
    	
 
    	
To Escrow
    	
 
    	
 
    	
 
    	
 
    
	
***
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

 

First Amendment

 

This First Amendment (“First Amendment”), dated as of December 9, 2008 (“First Amendment Effective Date”) is made by and between Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation for itself and for its Affiliate, Scott and White Clinic (collectively, “S&W”), Texas non-profit corporations, located at 2401 S 31st Street, Temple, Texas 76508; Arthur E. Frankel, M.D.; and Stemline Therapeutics, Inc., a Delaware corporation having a principal place of business located at ***, New York, New York 10128 (“Stemline”).

 

WHEREAS, S&W, Arthur E. Frankel, M.D. and Stemline are parties to the Research and License Agreement dated as of June 15, 2006 (the “Agreement”) and desire to amend the terms of such Agreement.

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

 

1.                                      Capitalized terms used, but not defined, herein shall have the meaning ascribed to them in the Agreement.

 

2.                                      S&W and Stemline agree that Article III of the Agreement shall hereby be amended by adding the following as a new Section 3.05:

 

Section 3.05                             Diligence Obligation.  Stemline, itself or through its Affiliates or sublicensees, shall use commercially reasonable efforts to develop and commercialize a Licensed Product in the Field.  In furtherance of such objective, Stemline shall use commercially reasonable efforts to:

 

(a)                                 *** within *** (***) years after the First Amendment Effective Date; and/or

 

(b)                                 *** within *** (***) years after the First Amendment Effective Date.

 

Notwithstanding the foregoing, in the event of unforeseen technical, scientific, intellectual property or regulatory issues with respect to any Licensed Product, and provided that Stemline is using commercially reasonable efforts in the research and development of such Licensed Product, Stemline may request an extension of the time periods for the achievement of the foregoing milestones and provide a detailed list of the actions to be taken to resolve any such issues and S&W shall reasonably grant such extension in good faith.  For the avoidance of doubt, Stemline’s failure to meet one of the goals set forth above in and of itself shall not automatically establish Stemline’s failure to use commercially reasonable efforts for a Licensed Product, but Stemline shall be automatically deemed to have used commercially reasonable efforts for any time period set forth above if any milestone set forth above is achieved in the applicable time period.

 

S&W shall notify Stemline in writing if S&W determines that Stemline has failed to perform in accordance with this Section for at least one Licensed Product.  In the event

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

1

 

Stemline disagrees with S&W’s determination as to Stemline’s compliance with this Section 3.05, Stemline shall have *** (***) days to submit information in order to demonstrate Stemline’s efforts and the parties shall attempt to resolve such disagreement for a period of not more than *** (***) days.  If, at the end of such *** (***) day period, the parties have not reached agreement, the matter shall be submitted to dispute resolution in accordance with Section 8.12.  In the event the parties agree or the dispute resolution procedure determines that Stemline has failed to diligently perform (and such failure is not cured within the *** (***) day period under Section 7.02(a)) with respect to at least one Licensed Product, S&W shall have the right to convert the license granted hereunder to a non-exclusive license.

 

3.                                      Except as amended by this First Amendment, the Agreement shall remain in full force and effect.  After the date set forth above, every reference in the Agreement to the “Agreement” shall mean the Agreement as amended by this First Amendment.  This First Amendment shall be governed by and construed and interpreted in accordance with the laws of the State of Texas, without regard to its conflicts of laws principles.

 

IN WITNESS WHEREOF, the parties have duly executed this First Amendment as of the date first written above.

 

	
STEMLINE   THERAPEUTICS, INC.
    	
 
    	
SCOTT   AND WHITE MEMORIAL HOSPITAL AND SCOTT, SHERWOOD AND BRINDLEY FOUNDATION
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Ivan Bergstein
    	
 
    	
By:
    	
/s/   Richard Beswick
    
	
Name:
    	
Ivan   Bergstein
    	
 
    	
Name:
    	
Richard   Beswick, Ph.D., MBA
    
	
Title:
    	
President   and CEO
    	
 
    	
Title:
    	
 
    
	
 
    	
 
    	
 
    
	
Date:
    	
12/9/08
    	
 
    	
Date:
    	
12/9/08
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Arthur   E. Frankel, M.D.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
/s/ Arthur Frankel
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Date:
    	
12/9/08
    

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

2

 

Second Amendment

 

This Second Amendment (“Second Amendment”), dated as of March 11, 2010 (“Second Amendment Effective Date”) is made by and between Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation for itself and for its Affiliate, Scott and White Clinic (collectively, “S&W”), Texas non-profit corporations, located at 2401 S 31st Street, Temple, Texas 76508; Arthur E. Frankel, M.D.; and Stemline Therapeutics, Inc., a Delaware corporation having a principal place of business located at ***, New York, New York 10128 (“Stemline”).

 

WHEREAS, S&W, Arthur E. Frankel, M.D. and Stemline are parties to the Research and License Agreement dated as of June 15, 2006 and amended by the First Amendment dated December 9, 2008 (the “Agreement”) and desire to amend the terms of such Agreement.

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

 

1.                                      Capitalized terms used, but not defined, herein shall have the meaning ascribed to them in the Agreement.

 

2.                                      The parties acknowledge and agree that:

 

(a)                                 as of the Second Amendment Effective Date, Stemline has fully complied with its payment obligations and no payments shall be due pursuant to Sections 2.01 and 2.03;

 

(b)                                 the Clinical Research Term (as defined in the Agreement as of the Effective Date) was extended for the additional 12 month period pursuant to Sections 1.01(n) and 2.02(a)(ii) and therefore expired on June 15, 2008;

 

(c)                                  other than surviving obligations in agreements between S&W and The Leukemia and Lymphoma Society, as of the Second Amendment Effective Date, there are no agreements between S&W and any third party pertaining to the Compound; and

 

(d)                                 the license granted to Stemline under Section 3.01 is in full force and effect for the Term as set forth in Section 7.01 (as amended herein).

 

3.                                      The parties agree that Section 1.01(m) of the Agreement shall hereby be deleted in its entirety and replaced with the following:

 

“Research Program” shall mean all experimental research involving Compounds conducted by or on behalf of S&W during the Research Term in accordance with the terms of this Agreement, including (i) clinical trials involving *** (also referred to as “***”)(which, for the avoidance of doubt, shall include clinical trials relating to Investigational New Drug application ***) and (ii) production, preclinical research and clinical trials of *** (also  referred to as “***”); provided that, notwithstanding the terms of Sections 2.01 and 3.04, (a) commencing with the Second Amendment Effective Date and continuing during the Term, unless otherwise agreed in writing by the parties, S&W shall not conduct and the Research Program shall not include any production, preclinical

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

1

 

research and clinical trials of ***, and (b) commencing with the Transfer Date and continuing during the Term, except as set forth in Exhibit D hereto or as otherwise agreed in writing by the parties, S&W shall not conduct or sponsor and the Research Program shall not include any clinical trials of *** nor shall S&W produce or disseminate *** unless S&W is designated by Stemline as a vendor, provided that S&W may continue as a clinical site, as directed by Stemline, for *** supplied by or on behalf of Stemline.

 

4.                                      The parties agree that Section 1.01(p) of the Agreement shall hereby be deleted in its entirety and replaced with the following:

 

“Research Term” shall mean the period commencing with the Effective Date and continuing until the expiration of the Extended Research Term.

 

5.                                      The parties agree that Section 1.01(t) of the Agreement shall hereby be amended by adding the following text to the end of such Section:

 

The S&W Patent Rights shall include, without limitation, the Patent Rights listed on  Exhibit A, which shall be periodically updated during the term of this Agreement.

 

A copy of Exhibit A, as updated as of the Second Amendment Effective Date, is attached to this Second Amendment and is hereby appended to the Agreement.

 

6.                                      The parties agree that a new Section 1.01(w) shall hereby be added to the Agreement as follows:

 

“Extended Research Term” shall mean the period consisting of 44 months from the end of the Clinical Research Term (i.e., the period ending March 15, 2012) and extensions thereof in writing, executed by both parties, amending this Agreement.

 

7.                                      The parties agree that Section 2.01(a) of the Agreement shall hereby be amended by adding the following text to the end of such Section:

 

Notwithstanding any other provision of this Agreement, the parties hereby acknowledge and agree that, commencing with the Second Amendment Effective Date, unless otherwise agreed in writing by the parties, Stemline shall control and conduct, at Stemline’s discretion, all production, preclinical research and clinical trials of *** and Stemline shall make all final decisions regarding such activities and, commencing with the Transfer Date, unless otherwise agreed in writing by the parties, Stemline shall control and conduct, at Stemline’s discretion all production, preclinical research and clinical trials of ***, provided that S&W may continue as a clinical site, as directed by Stemline, for *** supplied by or on behalf of Stemline.

 

In the event the Principal Investigator is unable or unwilling to continue the Research Program for any reason, the parties shall cooperate to identify a replacement principal investigator.  Stemline shall have the right to select a replacement principal investigator at S&W, subject to such replacement principal investigator agreeing in writing to the terms of this Agreement and agreeing to participate in any ongoing clinical trials of the

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

2

 

Compound, including continuing to supply Compound for use in any ongoing clinical trials.  In the event a replacement principal investigator is not identified or has not agreed in writing to the foregoing within *** days (or such longer period as Stemline may select), the Research Program shall terminate, provided that S&W shall ensure the continued participation of S&W in any clinical trials that are ongoing at the time of such termination and the continued supply of Compound for use in any such clinical trials. The licenses granted to Stemline under Section 3.01 shall not be effected by a termination of the Research Program under this Section 2.01(a).

 

8.                                      The parties agree that the following shall hereby be added to the end of Section 2.06 of the Agreement:

 

Notwithstanding the foregoing, at any time during the Extended Research Term if requested by Stemline in writing at its sole discretion, upon a date specified by Stemline (the “Transfer Date”), as permitted by applicable laws and regulations, S&W and Dr. Frankel shall (a) execute and deliver such documents and instruments to Stemline for filing with the FDA in order to assign and/or transfer to Stemline S&W’s IND (***) and all documents related thereto and shall take all such actions reasonably requested by Stemline in order to effect such transfer and/or assignment, or (b) grant Stemline the exclusive right to reference S&W’s IND (***) in the event that Stemline files its own IND(s) for the Compounds, or (c) amend IND *** (e.g. CMC and/or protocol sections) to enable Stemline or its designee to become the sole drug distributor for any clinical trial using the Compounds, or (d) take such other reasonable steps with regulatory authorities requested by Stemline to facilitate Stemline’s development of the Compounds.  In addition, S&W and Dr. Frankel shall provide ongoing reasonable cooperation to ensure the completion of (a), (b), (c) and/or (d). Unless agreed in writing by the Parties, S&W shall not submit a new IND for the Compounds to any regulatory authority during the Term.

 

9.                                      The parties agree that the following new Section 2.07(c) shall hereby be added to the Agreement:

 

Any patent application filed by Stemline under Section 2.01(b) and 2.07(b) shall not be abandoned by Stemline without Stemline first providing written notice to S&W of its intention to abandon such patent application in sufficient time for S&W to undertake the prosecution of such patent application and thereafter S&W shall have the right, but not the obligation, to prosecute such patent application at S&W’s sole cost and such patent application shall no longer be licensed to Stemline hereunder.

 

10.                               The parties agree that the following new Section 2.08 shall hereby be added to the Agreement:

 

Compensation for Extended Research Term.  As consideration for the Patent Rights, if any, arising from the activities under this Agreement during the Extended Research Term, for the provision of the deliverables (or “Deliverables”) set forth on Exhibit D, and for continuing as a clinical site ***, Stemline shall pay to S&W by automatic remittance and on direct deposit (i.e., wire transfer) to an account designated by S&W the sum of up

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

3

 

to *** Dollars ($***) for the Extended Research Term.  Such amount shall become due and payable to S&W in accordance with Exhibit D.  Each payment shall be due to S&W not later than *** (***) days after the due date set forth in Exhibit D.  All payments shall be made to:

 

Scott and White Memorial Hospital

c/o Dick Dixon

2401 S. 31st Street

Temple, Texas 76508

 

A copy of Exhibit D is attached to this Second Amendment and is hereby appended to the Agreement.

 

11.                               The parties agree that the first sentence of Section 4.01 shall hereby be deleted in its entirety and replaced with the following:

 

In consideration of the rights granted by S&W to Stemline under this Agreement, Stemline will pay S&W a royalty on the Adjusted Gross Sales of Licensed Product in the Territory, whether such sales are effected by Stemline, a Stemline Affiliate, or a sublicensee of Stemline.  Further, any successor or assignee of Stemline under this Agreement shall have the same royalty payment obligations to S&W.

 

12.                               The parties agree that Section 4.02(iii) and Section 4.02(iv) shall hereby be deleted in their entirety and replaced with the following:

 

(iii)                               *** percent (***%) of any Upfront Payment made to Stemline under a sublicense entered into ***; and

 

(iv)                              *** percent (***%) of any Upfront Payment made to Stemline under a sublicense entered into ***.

 

13.                               The parties agree that the following new Section 7.00 shall hereby be added to the Agreement:

 

Term.  The term of this Agreement shall commence on the Effective Date and, unless terminated earlier pursuant to the terms of this Article VII, the rights and licenses granted hereunder shall expire on a country-by-country basis upon the later of (a) the date upon which Stemline is no longer obligated to provide royalty payments to S&W under Section 4.01 or (b) the expiration of the last-to-expire S&W Patent Right hereunder (the “Term”).  Upon expiration of this Agreement, the licenses granted to Stemline under Section 3.01 hereof shall become fully paid up, irrevocable, perpetual, non-exclusive, and royalty-free licenses.

 

14.                               The parties agree that Section 7.01 of the Agreement shall hereby be deleted in its entirety and replaced with the following:

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

4

 

Termination by Stemline.  Stemline may terminate the Research Program during the Extended Research Term in its sole discretion at any time on not less than *** (***) days prior written notice to S&W and Stemline’s obligation to make payments to S&W shall terminate upon the effective date of termination, except that S&W shall be reimbursed, within *** (***) days of invoice, for any non-cancellable obligations of S&W relating to the Research Program that are incurred prior to the effective date of termination.  Notwithstanding Section 7.03, the licenses granted to Stemline under Section 3.01 shall not be effected by a termination of the Research Program under this Section 7.01.  Stemline may terminate the licenses granted to Stemline under Section 3.01 on not less than *** (***) days prior written notice to S&W in whole or on a country-by-country Licensed Product-by-Licensed Product basis.

 

15.                               The parties agree that Section 7.03 of the Agreement shall hereby be deleted in its entirety and replaced with the following:

 

Upon termination of the license rights granted to Stemline under Section 3.01 by Stemline pursuant to Section 7.01 or upon termination of this Agreement by S&W pursuant to Section 7.02, then (a) all rights and obligations under this Agreement shall terminate (except as provided in Section 7.04), (b) all terminated licensed rights shall revert to S&W (including the right to prosecute and maintain the S&W Patent Rights) and (c) within *** (***) days of the termination, Stemline shall return to S&W, to the extent in Stemline’s possession, (i) a copy of any remaining S&W Know-How, S&W Materials and Deliverables provided by S&W to Stemline and (ii) in the event S&W’s IND (***) was assigned and/or transferred to Stemline pursuant to Section 2.06, Stemline shall assign and/or transfer such IND *** back to S&W.

 

16.                               The parties agree that contact information for Stemline set forth in Section 8.08 of the Agreement shall hereby be changed to the following:

 

Stemline Therapeutics, Inc.

c/o Ivan Bergstein, M.D.

Chief Executive Officer

***

New York, New York 10128

Telephone:                                   ***

Telecopier:                                    212-244-0161

 

17.                               Except as amended by this Second Amendment, the Agreement shall remain in full force and effect.  After the date set forth above, every reference in the Agreement to the “Agreement” shall mean the Agreement as amended by this Second Amendment.  This Second Amendment shall be governed by and construed and interpreted in accordance with the laws of the State of Texas, without regard to its conflicts of laws principles.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

5

 

IN WITNESS WHEREOF, the parties have duly executed this Second Amendment as of the date first written above.

 

	
STEMLINE   THERAPEUTICS, INC.
    	
 
    	
SCOTT   AND WHITE MEMORIAL HOSPITAL AND SCOTT, SHERWOOD AND BRINDLEY FOUNDATION
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Ivan Bergstein
    	
 
    	
By:
    	
/s/   Richard Beswick
    
	
Name:
    	
Ivan   Bergstein
    	
 
    	
Name:
    	
Richard   Beswick, Ph.D., M.B.A.
    
	
Title:
    	
President   and CEO
    	
 
    	
Title:
    	
Director   of Research
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
3/26/2010
    	
 
    	
Date:
    	
3/17/2010
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Arthur   E. Frankel, M.D.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
/s/   Arthur E. Frankel
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Date:
    	
3/22/2010
    

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

6

 

Exhibit A

S&W Patent Rights

 

***

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

7

 

Exhibit D

Extended Research Term

 

I.             Payment.

 

Stemline shall pay to S&W the sum of up to *** for the Extended Research Term (which includes up to *** for the *** associated with the Extended Research Term), as follows:

 

1.             For the first year following the Second Amendment Effective Date, up to *** shall be paid in equal quarterly payments of *** commencing within *** days of the Second Amendment Effective Date; provided that the first payment and each subsequent quarterly payment shall only be due and payable upon receipt by Stemline from S&W of the *** requested by Stemline for such quarterly period from the ***.

 

2.             For the second year following the Second Amendment Effective Date, up to *** shall be paid in quarterly payments of *** commencing within *** days of the anniversary of the Second Amendment Effective Date; provided that each such quarterly payment shall only be due and payable upon receipt by Stemline from S&W of the *** requested by Stemline for such quarterly period from the ***.

 

II.            Deliverables.

 

1.             General.

 

S&W and Stemline agree that it is in the best interest and the goal of both parties for *** and *** to advance through development.  As such, S&W and Dr. Frankel agree to provide all *** as requested by Stemline. This will include all ***.  Exhibit D may be reasonably amended by Stemline from time to time as additional resources are required at Stemline’s discretion for the development of *** and ***.

 

2.             Clinical.

 

In a format in full compliance with HIPAA, all patient information including ***.

 

All current and past contracts, relating to the ***, between S&W and any institution involved in any ***.  In addition, all related ***, and other related information and communications.

 

The final ***, including all amendments and the date the amendments were approved by the IRB at each site.

 

Implementation of Stemline’s *** at a time and manner to be designated by Stemline.

 

Any data or spreadsheets relating to ***.

 

8

 

3.             Regulatory.

 

All regulatory communications and FDA correspondences, including *** with the FDA, with all attachments, and any documentation and/or submissions to ***, including *** and annual updates or amendments.

 

Upon request from Stemline, a letter to the FDA from Dr. Frankel and S&W granting Stemline (1) a transfer and/or assignment of *** to Stemline, or (2) the sole right to reference *** pursuant to Section 2.06 of the Agreement.

 

Upon request from Stemline, a letter to the FDA from Dr. Frankel and S&W that amends the appropriate sections of *** to fully enable any necessary changes in *** development plan ***.  S&W and Dr. Frankel shall take such other reasonable steps with regulatory authorities requested by Stemline to facilitate Stemline’s development of the Compounds.

 

Upon request from Stemline, Dr. Frankel and S&W will amend any existing agreement between S&W and the various universities and academic centers participating in the *** to fully enable any necessary changes in the *** development plan, including ***.

 

All Standard Operating Procedures (SOPs) and protocols for *** including those relating to ***.

 

All SOPs and protocols for *** including those relating to ***.

 

4.             Preclinical.

 

Access to *** and copies upon request.

 

All final, signed reports (including primary data) for *** studies of ***.

 

5.             Drug Product and CMC.

 

Current inventory of ***.

 

Current inventory of ***.

 

*** records and *** records for the production of *** and ***, including records for the individual ***.

 

Regular updates of the inventory for ***.

 

All data and records related to the ***.

 

Access to ***, including ***, and the right to transfer and have transferred all *** from S&W to Stemline and its designee ***. Accordingly, and upon request from Stemline, a letter to the FDA from Dr. Frankel and S&W that amends the appropriate sections of *** to fully enable this.

 

9

 

Access to *** and the right to transfer and have transferred all *** from S&W to Stemline or its designee ***. Accordingly, and upon request from Stemline, a letter to the FDA from Dr. Frankel and S&W that amends the appropriate sections of *** to fully enable this.

 

***.

 

All *** materials needed for the characterization and release testing of ***, including ***.

 

6.             Coordination.

 

Reasonable and regular cooperation with clinical trial sites for the conduct and completion of the current ***.

 

Reasonable advance notice, and copies for review, of proposed submissions for publication and/or presentations relating to the Compounds in accordance with Section 8.02 of the Agreement.

 

Regularly scheduled calls with Dr. Frankel, clinical data coordinators, and other research staff involved in *** (at least once every ***).

 

Reasonable availability to answer questions verbally, in writing and/or in person relating to the Research Program with Stemline and/or its designees.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

10

 

Third Amendment

 

This Third Amendment (“Third Amendment”), dated as of July 12, 2011 (“Third Amendment Effective Date”) is made by and between Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation for itself and for its Affiliate, Scott and White Clinic (collectively, “S&W”), Texas non-profit corporations, located at 2401 S 31st Street, Temple, Texas 76508; Arthur E. Frankel, M.D.; and Stemline Therapeutics, Inc., a Delaware corporation having a principal place of business located at ***, New York, New York 10128 (“Stemline”).

 

WHEREAS, S&W, Arthur E. Frankel, M.D. and Stemline are parties to the Research and License Agreement dated as of June 15, 2006 and amended by the First Amendment dated December 9, 2008 and the Second Amendment dated March 17, 2010 (collectively, the “Agreement”) and desire to amend the terms of such Agreement; and

 

WHEREAS, Stemline sent S&W a letter dated June 17, 2011 terminating the Research Program (the “Termination Letter”), which termination would have become effective *** (***) days following the date of the Termination Letter; and

 

WHEREAS, Stemline and S&W have mutually agreed to continue the Research Program, as amended hereby, and Stemline has consequently agreed to revoke the Termination Letter in connection herewith;

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

 

1.                                      Capitalized terms used, but not defined, herein shall have the meaning ascribed to them in the Agreement.

 

2.                                      The parties acknowledge and agree that as of the Third Amendment Effective Date Stemline has fully complied with its payment obligations under the Agreement, and no payments are outstanding under the Agreement as of the Third Amendment Effective Date, including with respect to the Extended Research Term under Section 2.08 and Exhibit D of the Agreement.

 

3.                                      The parties agree that the Extended Research term will expire as of the Third Amendment Effective Date, that no further payments will be due under Section 2.08 or Exhibit D of the Agreement, and that a new Section 1.01(x) of the Agreement shall hereby be added to the Agreement as follows:

 

“Additional Extended Research Term” shall mean the period consisting of 24 months commencing on the Third Amendment Effective Date, and any extensions thereof in writing, executed by both parties, amending this Agreement.

 

4.                                      The parties agree that the following new Section 2.09 shall hereby be added to the Agreement:

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

1

 

Compensation for Additional Extended Research Term.  As consideration for the Patent Rights, if any, arising from the activities under this Agreement during the Additional Extended Research Term, for the provision of the deliverables set forth on Exhibit D that were not already provided during the Extended Research Term (the “Deliverables”), and for continuing ***, Stemline shall pay to S&W by automatic remittance and on direct deposit (i.e., wire transfer) to an account designated by S&W the sum of up to *** Dollars ($***) for the Additional Extended Research Term (which includes $*** for the indirect costs associated with the Extended Research Term).  Such amount shall be *** Dollars ($***) commencing within *** (***) days after the Third Amendment Effective Date; provided that the first payment and each subsequent *** payment shall only be due and payable upon receipt by Stemline from S&W of the deliverables reasonably requested by Stemline for such quarterly period.  Within *** (***) days following the termination or expiration of the Extended Research Term, S&W shall deliver to Stemline all of the Deliverables not already provided on or before the date of such expiration or termination.

 

Each payment shall be due to S&W not later than *** (***) days after the due date set forth above, and shall be made to:

 

Scott and White Memorial Hospital

Becky Jones, MS-AR-M116

2401 S. 31st Street

Temple, Texas 76508

 

5.                                      Upon execution of this Third Amendment, the Termination Letter shall be revoked and deemed of no further force or effect.

 

6.                                      Except as amended by this Third Amendment, the Agreement shall remain in full force and effect.  After the date set forth above, every reference in the Agreement to the “Agreement” shall mean the Agreement as amended by this Third Amendment.  This Third Amendment shall be governed by and construed and interpreted in accordance with the laws of the State of Texas, without regard to its conflicts of laws principles.

 

[the remainder of this page is intentionally left blank; signature page follows]

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

2

 

IN WITNESS WHEREOF, the parties have duly executed this Third Amendment as of the date first written above.

 

	
STEMLINE THERAPEUTICS, INC.
    	
 
    	
SCOTT   AND WHITE MEMORIAL HOSPITAL AND SCOTT, SHERWOOD AND BRINDLEY FOUNDATION
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By: 
    	
/s/ Tom Cirrito
    	
 
    	
By:
    	
/s/   Richard Beswick
    
	
 
    	
Name:
    	
Tom Cirrito
    	
 
    	
Name:
    	
Richard   Beswick, Ph.D., M.B.A.
    
	
 
    	
Title:
    	
Director of Operations
    	
 
    	
Title:
    	
Senior   Vice President of Research
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date: 
    	
8/3/2011
    	
 
    	
Date:
    	
7/22/2011
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
Arthur   E. Frankel, M.D.
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
/s/   Arthur E. Frankel
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
Date:
    	
7/20/2011
    

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

3Exhibit 10.2

 

EXCLUSIVE LICENSE AGREEMENT

 

This Agreement is made and entered into as of the 30th day of September, 2009 (“Effective Date”), by and between the University of Pittsburgh — Of the Commonwealth System of Higher Education, a non-profit corporation organized and existing under the laws of the Commonwealth of Pennsylvania, with an office at 200 Gardner Steel Conference Center, Thackeray and O’Hara Streets, Pittsburgh, Pennsylvania  15260 (“University”), and Stemline Therapeutics, Inc., with its principal business at ***, New York, New York 10128 (“Licensee”).

 

WHEREAS, University is the owner by assignment from the inventors of certain Patent Rights, entitled “***,” (University Case Number ***) developed by Dr. *** et al. of University faculty, and University has the right to grant licenses under such Patent Rights;

 

WHEREAS, University desires to have the Patent Rights utilized in the public interest;

 

WHEREAS, Licensee has represented to University, to induce University to enter into this Agreement, that Licensee is experienced in the development, production, manufacture, marketing and sale of products similar to or complimentary to the Licensed Products, as defined herein, and that Licensee shall commit itself to a thorough, vigorous and diligent program of exploiting the Patent Rights so that public utilization results therefrom; and

 

WHEREAS, Licensee desires to obtain a license under the Patent Rights upon the terms and conditions hereinafter set forth.

 

NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein, the parties hereto, intending to be legally bound, agree as follows:

 

ARTICLE 1 — DEFINITIONS

 

For purposes of this Agreement, the following words and phrases shall have the following meanings:

 

1.1                               “Affiliate” shall mean, with respect to University, any clinical or research entity that is operated or managed as a facility under the UPMC Health System, whether or not owned by University.  With respect to Stemline, “Affiliate” shall mean any corporation or other entity

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

 

which controls, is controlled by or is under common control with Stemline.  A corporation or other entity shall be regarded as in control of another corporation or entity if it owns or directly or indirectly controls more than fifty percent (50%) of the voting stock or other ownership interest of the other corporation or entity, or if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity or the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the corporation or other entity.

 

1.2                               “Field” shall mean ***.

 

1.3                               “Licensee” shall mean Stemline Therapeutics, Inc. and its Affiliates.

 

1.4                               “Licensed Product” shall mean any product or part thereof or service which is:

 

(a)                                 covered in whole or in part by an issued, unexpired or pending claim contained in the Patent Rights in the country in which any such product or part thereof is made, used or sold or in which any such service is used or sold; or

 

(b)                                 manufactured by using a process or is employed to practice a process which is covered in whole or in part by an issued, unexpired claim or a pending claim contained in the Patent Rights in the country in which any such process that is included in Licensed Product is used or in which such product or part thereof or service is used or sold.

 

1.5                               “Net Sales” shall mean the gross invoiced price for Licensed Product products and/or services sold by Licensee and its sublicensees less the sum of the following:

 

(a)                                 actual cost of freight charges or freight absorption, to include shipping and insurance charges, which must be separately stated in such invoice;

 

(b)                                 actual trade, quantity or cash discounts allowed, if any;

 

(c)                                  taxes, tariff duties, value-added taxes, governmental charges directly incurred for export or import of Licensed Product, and/or use taxes separately stated on each invoice;

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

2

 

(d)                                 actual credits or refunds for recalled, defective, damaged or returned Licensed Product, including actual expenses related to disposal; but with respect to Combination Products (as defined below), such credit or refund shall be prorated in a manner similar to the formula set forth below; and

 

(e)                                  rebates paid or credited to governmental agencies with respect to Medicaid, Medicare or similar state or foreign governmental programs.

 

In the event a Licensed Product is sold in the form of a combination product containing one or more active components which are not Licensed Products, or sold in combination with one or more separate products which are not Licensed Products (“Combination Product(s)”), the Net Sales for such Combination Product shall be calculated by multiplying the actual Net Sales of such Combination Product by the fraction A/(A+B), where A is the average Net Sales received for the Licensed Product in a country, if sold separately in finished form in such country, and B is the average Net sales received for all other components or products in the Combination Product in such country, if sold separately in finished form in such country.  If, on a country-by-country basis, the Licensed Product and/or the other components or products are not sold separately in finished form in such country, Net Sales for the Combination Product shall be determined by the parties in good faith and such agreement shall be reduced in writing by both parties.

 

1.6                               “Non-Commercial Education and Research Purposes” shall mean use of Patent Rights (including distribution of biological materials covered by the Patent Rights) for academic research or other not-for-profit scholarly purposes which are undertaken at a nonprofit or governmental institution that does not use the Patent Rights in the production or manufacture of products for sale or the performance of services for a fee.

 

1.7                               “Non-Royalty Sublicense Income” shall mean execution fees, maintenance fees, milestone fees and all other non-royalty payments received by Licensee from its sublicensees pursuant to any sublicense granted pursuant to Article 2.3 hereunder but excluding: (a) payments made by a sublicensee to Licensee in consideration for the issuance of securities of Licensee, but only to extent such payments reflect the fair market value of the securities; and (b) payments made as reimbursement for research and development or specifically committed to the research

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

3

 

and/or development of the Patent Rights or Licensed Products.  For the avoidance of doubt, equity investments made by sublicensees in Licensee in excess of fair market value shall be deemed Non-Royalty Sublicense Income to the extent of such excess or discounted amount.

 

1.8                               “Patent Rights” shall mean University intellectual property described below and assigned to University:

 

(a)                                 The United States and foreign patents and/or patent applications listed in Exhibit A;

 

(b)                                 United States and foreign patents issued from the applications listed in Exhibit A and from divisionals, substitutions, continuations and continuation-in-parts of these applications;

 

(c)                                  United States and foreign patents issued from any of the foregoing, including all reissues, registrations, renewals, reexaminations and extensions thereof; and

 

(d)                                 Claims of U.S. and foreign continuation and divisional applications, and of the resulting patents, which are directed to subject matter specifically described in the U.S. and foreign applications listed in Exhibit A.

 

The parties shall update Exhibit A from time to time as additional filings are made during the Term of this Agreement.

 

1.9                               “Phase I Clinical Trial” shall mean a clinical trial as defined in 21 C.R.F 312.21(a), as may be amended from time to time, and any foreign equivalent thereto.

 

1.10                        “Phase II Clinical Trial” shall mean a clinical trial as defined in 21 C.R.F 312.21(b), as may be amended from time to time, or any foreign equivalent thereto.

 

1.11                        “Phase III Clinical Trial” shall mean a clinical trial as defined in 21 C.R.F 312.21(c), as may be amended from time to time, or any foreign equivalent thereto.

 

1.12                        “Regulatory Approval” shall mean the receipt of all approvals, licenses, registrations or authorizations of any federal, state or local regulatory authority, agency or other governmental entity, necessary for the sale of Licensed Product in a country or region.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

4

 

1.13                        “Territory” shall mean Worldwide.

 

1.14                        “Term” shall have the meaning set forth in Article 10.1 hereof.

 

ARTICLE 2- GRANT

 

2.1                               Exclusive License.  Subject to the terms and conditions of this Agreement, University hereby grants to Licensee, subject to Article 2.2 below, the exclusive right and license, with the right to sublicense subject to Article 2.3 below, in the Territory to make, have made, use, sell, and import the Licensed Product in the Field and to practice under the Patent Rights in the Field until the expiration of the last to expire valid claim of the Patent Rights, unless this Agreement is terminated sooner as provided herein.  University reserves the royalty-free, nonexclusive right to practice under the Patent Rights and to use Licensed Product for Non-Commercial Education and Research Purposes.

 

2.2                               U.S. Government Rights.  The license granted hereby is subject to the rights of the United States government, if any, as set forth in 35 U.S.C. §200, et seq, including the United States government’s nonexclusive, nontransferable, paid up license to practice or have practiced for or on behalf of the United States the inventions described in the Patent Rights throughout the world and the requirement that Licensed Product produced for sale in the United States shall be substantially manufactured in the United States (unless a waiver under 35 U.S.C. §204 is granted by the appropriate United States government agencies).

 

2.3                               Licensee shall have the right to enter into sublicensing arrangements for the rights, privileges and licenses granted hereunder upon prior written approval of each sublicensee by University, which approval shall not be unreasonably withheld or delayed.  Any approved sublicensee shall not have rights to sublicense.  ***.  Upon the termination of this Agreement and upon the request of any sublicensee, any sublicenses granted prior to either party’s receipt of any termination notice under this Agreement shall survive such termination provided that such sublicensee:  (a) is not at such time in breach of this Agreement; and (b) agrees in writing prior to the effective date of termination to assume all of Licensee’s obligations under this Agreement.

 

Licensee agrees that any sublicense granted by it shall be consistent with the terms of this Agreement and shall require the sublicensee to agree to comply with terms no less stringent than

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

5

 

the terms of Articles *** and *** and Articles ***, *** and *** of this Agreement. Each sublicense granted by Licensee pursuant to this Agreement shall include ***.

 

Licensee agrees to forward to University a copy of any and all sublicense agreements promptly upon execution thereof, but in no event later than *** (***) days after each such sublicense agreement has been executed by both parties thereto.

 

2.4                               The license granted hereunder shall not be construed to confer any rights upon Licensee by implication, estoppel or otherwise as to any technology not specifically set forth in Exhibit A hereof.

 

ARTICLE 3 — DUE DILIGENCE

 

3.1                               Licensee, itself, or through its sublicensees, shall use its Commercially Reasonable Best Efforts to develop or commercialize a Licensed Product as soon as practicable, consistent with sound and reasonable business practice and judgment, and to continue active, diligent marketing efforts for the Licensed Product throughout the Term of this Agreement.  “Commercially Reasonable Best Efforts” shall mean best efforts consistent with the commercially reasonable and usual practice followed by Licensee in pursuing the commercialization and marketing of similar products to Licensed Products, taking into account safety and efficacy, regulatory requirements and structure, and other relevant market factors.

 

3.2                               In addition, Licensee shall adhere to each of the following milestones:

 

(a)                                 ***.  For the avoidance of doubt, *** shall not constitute achievement of this milestone.

 

(b)                                 ***;

 

(c)                                  ***; and

 

(d)                                 ***.

 

3.3                               For a single time for each milestone in Article 3.2, if any such milestone has not been completed within the timeframe allotted, through no fault of Licensee, and following

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

6

 

Commercially Reasonable Best Efforts of Licensee to meet such milestone, Licensee shall not be deemed to be in breach of the terms of this Agreement by failure to achieve the milestone date if Licensee makes a penalty payment of ***Dollars ($***).  In such case, in addition to the penalty payment required, Licensee and University shall negotiate in good faith a new time for attainment of such missed milestone and subsequent timeframes relying upon the meeting of a previous milestone may also be adjusted.  If Licensee fails to meet the revised milestone date, University may terminate this Agreement under Section 10.2(a) and upon termination all rights and interest to the Patent Rights and any other rights granted herein shall revert to University.  For the avoidance of doubt, this section shall not relieve the Licensee of any milestone payment required under Section 4.1(f).

 

3.4                               Except as specifically set forth in Article 3.3 above, Licensee’s failure to perform in accordance with Article 3.1 or to fulfill on a timely basis any one of the milestones set forth in Article 3.2 hereof shall be grounds for University to terminate this Agreement under Article 10.2(a) and upon termination all rights and interest to the Patent Rights and any other rights granted herein shall revert to University.

 

ARTICLE 4— LICENSE CONSIDERATION

 

4.1                               In consideration of the rights, privileges and license granted by University hereunder, Licensee shall pay royalties and other monetary consideration as follows:

 

(a)                                 Initial license fee, nonrefundable and noncreditable against royalties, of *** Dollars ($***), to be paid in two installments as follows:

 

(i)                                     *** Dollars ($***) due within *** (***) days after the Effective Date; and

 

(ii)                                  *** Dollars ($***) due within *** (***) days after the Effective Date.

 

(b)                                 Annual maintenance fees, non-refundable and non-creditable against royalties, as follows:

 

(i)                                     *** Dollars ($***) due on the *** (***) anniversary of the Effective Date;

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

7

 

(ii)                                  *** Dollars ($***) due on the *** (***) anniversary of the Effective Date; and

 

(iii)                               *** Dollars ($***) due on the *** (***)  anniversary of the Effective Date and each anniversary of the Effective Date thereafter until the first commercial sale of Licensed Product .

 

(c)                                  Royalties in an amount equal to ***percent (***%) of Net Sales of the Licensed Product per *** during the Term and during the period Licensee is authorized to sell Licensed Product under Section 10.4 below.

 

In the event Licensee is required to obtain a license from a non-Affiliate third party under any patent or other intellectual property rights and is obligated to pay a royalty to such non-Affiliate third party or parties with respect to any Licensed Product, then Licensee shall have the right to reduce the applicable royalty rate payable to the University by subtracting (a) the royalty rate which Licensee pays to such unaffiliated third party or parties for such patent or other intellectual property rights from (b) the royalty rate which would otherwise have been applicable had no such license(s) from such unaffiliated third party or parties been required; provided, however, that in no event shall the effective royalty rate payable to University hereunder be less than *** Percent (***%) of the Net Sales of Licensed Product.

 

(d)                                 Minimum annual royalty in the amount of *** Dollars ($***) per calendar year (which amount shall be prorated only for the first calendar year) commencing with the the first commercial sale of Licensed Product, but only to the extent such minimum annual royalty is greater than the aggregate annual royalty computed in accordance with Article 4.1(c) above; and

 

(e)                                  A share of Non-Royalty Sublicense Income:

 

(i)                                     *** percent (***%) for any sublicense agreement executed prior to ***; and

 

(ii)                                  *** percent (***%) for any sublicense agreement executed after ***.

 

(f)                                   One time Milestone Payments as follows:

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

8

 

(i)                                     *** Dollars ($***) upon ***;

 

(ii)                                  *** Dollars ($***) upon ***;

 

(iii)                               *** Dollars ($***) upon ***; and

 

(iv)                              *** Dollars ($***) upon ***.

 

4.2                               All payments pursuant to this Agreement may be made by check or by wire transfer (along with applicable wire transfer fees) in United States dollars without deduction or exchange, collection or other charges and directed to the address or , in the case of wire transfer, to the bank, set forth in Article 11.  Annual maintenance payments pursuant to Article 4.1(b) hereof shall be paid on *** in which they are due.  Royalty payments pursuant to Article 4.1(c) hereof shall be due within *** (***) days after each ***.  Minimum annual royalties pursuant to Article 4.1(d) shall be paid by *** of the calendar year in which they are due.  Non-Royalty Sublicense Income payments pursuant to Article 4.1(e) hereof shall by paid within *** (***) days after ***.  Finally, milestone payments pursuant to Article 4.1(f) shall be paid within *** (***) days of milestone event date.

 

4.3                               Taxes imposed by any governmental agency on any payments to be made to University by Licensee hereunder shall be paid by Licensee without deduction from any payment due to University hereunder.

 

4.4                               Payments pursuant to this Agreement, including those specified in Article 6.2, which are overdue shall bear interest calculated from the due date until payment is received at the rate of *** percent (***%) per annum, or the prime rate (as quoted by The Wall Street Journal) plus *** percent (***%), whichever is higher.  Payment of such interest by Licensee shall not negate or waive the right of University to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment, including, but not limited to, termination of this Agreement as set forth in Article 10.

 

4.5                               Licensee shall sell products and/or services resulting from Licensed Product to University and its Affiliates upon request at such price(s) and on such terms and conditions as

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

9

 

such products and/or processes are made available to Licensee’s similarly situated most favored customer purchasing similar quantities and on similar terms and conditions.

 

ARTICLE 5 — REPORTS

 

5.1                               Within *** (***) days after each March 31, June 30, September 30 and December 31 of each year during the term of this Agreement beginning in the year of the first commercial sale of Licensed Product, Licensee shall deliver to University true, accurate and detailed reports of the following information in a form acceptable to University:

 

(a)                                 Number of Licensed Product manufactured and sold by Licensee and all sublicensees;

 

(b)                                 Total billings for all such Licensed Products and Combination Products, and deductions taken to arrive at Net Sales;

 

(c)                                  Accounting for all Licensed Product and Combination Products services used or sold by Licensee and all sublicensees;

 

(d)                                 Deductions set forth in Article 1.5;

 

(e)                                  Total royalties due;

 

(f)                                   Name and addresses of sublicensees; and

 

(g)                                  Total Non-Royalty Sublicense Income received during such calendar quarter and total amount of payment due pursuant to Article 4.1(e).

 

All information and reports submitted by Licensee pursuant to this Article 5.1 shall constitute Confidential Information under Article 13.

 

5.2                               Licensee shall keep, and cause its sublicensees to keep, full, true and accurate books of account, in accordance with generally accepted accounting principles, containing all information that may be necessary for the purpose of showing the amounts payable to University hereunder.  Such books of account shall be kept at Licensee’s principal place of business.  Such books and the supporting data related thereto shall be open at all reasonable times during the

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

10

 

term of this agreement and for *** (***) years following the term of this agreement, to the University and its agents for the purpose of verifying Licensee’s royalty statement or compliance in other respects with this Agreement, but in no case shall such inspection of records occur more than one time per calendar year.  The fees and expenses of University’s representatives shall be borne by University; however, if an error of more than *** percent (***%) of the total payments due or owing for any year is discovered, then Licensee shall bear the fees and expenses of University’s representatives.

 

5.3                               No later than *** (***) days after December 31 of each calendar year during the term of this Agreement, Licensee shall provide to University a written annual progress report, describing Licensee’s progress on research and development, regulatory approvals, manufacturing, sublicensing, marketing and sales during the preceding twelve-month period ending December 31.

 

ARTICLE 6 - PATENT PROSECUTION

 

6.1                               University has or shall apply for, seek prompt issuance of and maintain during the Term of this Agreement the Patent Rights in the United States and in such foreign countries as may be designated by Licensee in a written notice to University within a reasonable time in advance of the required foreign filing dates and University shall not abandon the Patent Rights during the Term of this Agreement without Licensee’s prior written notice to abandon.  Licensee shall have the opportunity to provide input and advise the University in the prosecution, filing and maintenance of such Patent Rights.  University shall provide Licensee with copies of all patent filings and other related material submissions and material correspondence in advance to allow for review and comment by Licensee.  University shall reasonably consider all comments provided by Licensee in sufficient time.  Licensee shall notify University immediately if, at any time during the Term of this Agreement, Licensee or any of its sublicensees does not qualify as a “small entity” as provided by the United States Patent and Trademark Office.

 

6.2                               All fees and costs, including attorneys’ fees, relating to the filing, prosecution and maintenance of the Patent Rights (“Patent Costs”) shall be the responsibility of Licensee, whether incurred prior to or after the Effective Date.  Such Patent Costs incurred by and billed to University prior to the Effective Date in the amount of *** Dollars ($***) shall be paid by

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

11

 

Licensee to University as follows: *** Dollars ($***) within *** days of the Effective Date; ***Dollars ($***) on the *** of the Effective Date, *** Dollars ($***) on the *** of the Effective Date; *** Dollars ($***) on the *** of the Effective Date; and *** ($***) on the *** of the Effective Date.  Additionally, Licensee shall be liable to University for *** of University’s Patent Costs, for *** patent prosecution and maintenance actions that will be taken by patent counsel after the term of this Agreement but in response to any instructions that were sent during the term of this Agreement from University to patent counsel relating to the Patent Rights.  Patent Costs incurred after the Effective Date, or Patent Costs incurred before, but billed to University after the Effective Date, shall be paid by Licensee within *** (***) days after receipt of University’s invoice therefor.  Payments pursuant to this Article 6.2 are not creditable against royalties.

 

ARTICLE 7 — INFRINGEMENT ACTIONS

 

7.1                               Each party shall inform the other party promptly in writing of any alleged infringement of the Patent Rights by a third party and of any available evidence thereof.

 

7.2                               During the Term of this Agreement, Licensee shall have the right, but shall not be obligated, to prosecute at its own expense all infringements of the Patent Rights in the Field if Licensee provides University advance written notice of its intent to prosecute; provided, however, that such right to bring such an infringement action shall remain in effect only for so long as the license granted herein remains exclusive.  ***, University hereby agrees that Licensee may include University as a party plaintiff in any such suit, without expense to University.  ***.  Licensee shall indemnify University against any order for costs that may be made against University in such proceedings.

 

7.3                               If within *** (***) months after having been notified of any alleged infringement, Licensee shall have been unsuccessful in persuading the alleged infringer to desist and shall not have brought and shall not be diligently prosecuting an infringement action, or if Licensee shall notify University at any time prior thereto of its intention not to bring suit against any alleged infringer, then, and in those events only, University shall have the right, but shall not be obligated, to prosecute at its own expense any infringement of the Patent Rights, and University

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

12

 

may, for such purposes, use the name of Licensee as party plaintiff.  University shall bear all costs and expenses of any such suit.  ***.

 

7.4                               In the event that a declaratory judgment action alleging invalidity or infringement of any of the Patent Rights shall be brought against University, Licensee, at its option, shall have the right, within *** (***) days after commencement of such action, to intervene and take over the sole defense of the action at its own expense.

 

7.5                               In any infringement suit either party may institute to enforce the Patent Rights pursuant to this Agreement, the other party shall, at the request and expense of the party initiating such suit, cooperate in all respects and, to the extent possible, have its employees testify when requested and make available relevant records, papers, information, samples, specimens, and the like.

 

ARTICLE 8 — INDEMNIFICATION/INSURANCE/LIMITATION OF LIABILITY

 

8.1                               Licensee shall at all times during the term of this Agreement and thereafter indemnify, defend and hold University, its trustees, officers, employees and Affiliates (“Indemnified Parties”) harmless against all third party claims, proceedings, demands, and expenses, including legal expenses and reasonable attorneys’ fees, arising out of the death of or injury to any person or persons or out of any damage to property or the environment, and against any other third party claim, proceeding, demand, expense and liability of any kind whatsoever resulting from:  (a) the production, manufacture, sale, use, lease, consumption or advertisement of the Licensed Product, (bi) the practice by Licensee or any Affiliate or sublicensee of the Patent Rights; or (c) arising from any obligation of Licensee hereunder (“Claim(s)”).  Licensee shall provide this defense and indemnity whether or not any Indemnified Party, either jointly or severally, is named as a party defendant in a Claim and whether or not any Indemnified Party is alleged to be negligent or otherwise responsible for any injuries to person or property.  The obligation of Licensee to defend and indemnify as set forth herein shall not apply to the extent that such Claim is directly attributable to the gross negligence or intentional misconduct of the Indemnified Parties.  This obligation of the Licensee hereunder shall survive termination of this Agreement and shall not be limited by any other limitation of liability elsewhere in this Agreement.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

13

 

University shall immediately notify in writing, and provide a copy to, Licensee of any complaint, summons or other written notice that University receives of any Claim that may be subject to such obligations.  University shall allow Licensee the control of the defense and settlement thereof, and shall reasonably cooperate in such defense and settlement upon Licensee’s reasonable request but at Licensee’s sole cost and expense; provided, that University shall have the right to participate in any such proceeding with counsel of its choosing at its own expense.  University may not settle a Claim or action covered by this Article without the prior written consent of Licensee (and any payment made by University in violation of this sentence shall be at its own cost and expense).

 

8.2                               Licensee shall obtain and carry in full force and effect liability insurance which shall protect Licensee and University in regard to events covered by Article 8.1 above, as provided below:

 

	
COVERAGE
    	
 
    	
LIMITS
    
	
(a)
    	
 
    	
Commercial   General Liability, including, but not limited to, Products, Contractual,   Fire, Legal and Personal Injury
    	
 
    	
$***Combined   Single Limits for Bodily Injury and Property Damage
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
(b)
    	
 
    	
Products   Liability
    	
 
    	
$***   *
    

 

*Evidence of Products Liability coverage of $***is not required until *** and evidence thereof shall be submitted within *** (***) days of such ***.

 

The University of Pittsburgh is to be named as an additional insured with respect to insurance policies identified in Articles 8.2(a) and 8.2(b) above.  Certificates of insurance evidencing the coverage required above shall be filed with University’s Office of Risk Management, 1817 Cathedral of Learning, Pittsburgh, PA  15260, no later than *** (***) days after execution of this Agreement and annually thereafter.  Such certificates shall provide that the insurer will give University not less than *** (***) days advance written notice of any material changes in or cancellation of coverage.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

14

 

8.3                               University represents and warrants to Licensee that it owns all right, title and interest in the Patent Rights and has the full right and legal capacity to grant the license to Licensee hereunder and to execute this Agreement.  The University represents that it has not granted and covenants that it shall not grant any license to the Patent Rights inconsistent with the terms of this Agreement during the Term.

 

8.4                               EXCEPT AS SPECIFICALLY SET FORTH IN ARTICLE 8.3 ABOVE, UNIVERSITY MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING.  NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY GIVEN BY UNIVERSITY THAT THE PRACTICE BY LICENSEE OF THE LICENSE GRANTED HEREUNDER SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY.  UNIVERSITY ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF UNIVERSITY FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF UNIVERSITY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE OR SALE BY LICENSEE OR SUBLICENSEES OF THE LICENSED PRODUCT(S) LICENSED UNDER THIS AGREEMENT.  LICENSEE ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT THAT IS MANUFACTURED, USED OR SOLD BY LICENSEE (INCLUDING SUBLICENSEE SALES) WHICH IS LICENSED PRODUCT HEREUNDER.

 

ARTICLE 9  — ASSIGNMENT

 

9.1                               This Agreement is not assignable without the prior written consent of University (which consent shall not be unreasonably withheld or delayed) and any attempt to do so shall be null and void; provided that (a) Licensee may assign this Agreement to any Affiliate of Licensee or to any third party who purchases or otherwise succeeds by operation of law (whether by purchase of stock or assets, merger or otherwise) to all or substantially all of the line of business

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

15

 

of Licensee of which this Agreement is a part; and (b) the assignee agrees in writing to be bound by the terms of this Agreement to the same extent as Licensee.

 

ARTICLE 10 — TERM AND TERMINATION

 

10.1                        Term.  This Agreement shall commence on the Effective Date and, unless sooner terminated under this Article 10, shall continue until the last to expire valid claim of the Patent Rights (“Term”).

 

10.2                        University shall have the right to terminate this Agreement, upon written notice, if:

 

(a)                                 Licensee defaults in the performance of any of the obligations herein contained and such default has not been cured within *** (***) days after receiving a written notice thereof from University specifying University’s intent to terminate for breach;

 

(b)                                 Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors that is not dismissed within *** (***) days of commencement; or

 

(c)                                  ***.

 

10.3                        Licensee may terminate this Agreement upon *** (***) days prior written notice to University and upon payment of all amounts due University through the effective date of termination, including Patent Cost reimbursement pursuant to Article 6.2 hereof.

 

10.4                        Upon termination of this Agreement, neither party shall be released from any obligation that matured prior to the effective date of such termination.  Licensee and any sublicensee may, however, after the effective date of such termination, sell all products under the Licensed Product which Licensee produced prior to the effective date of such termination, provided that Licensee shall pay to University the royalties thereon as required by Article 4 hereof and submit the reports required by Article 5 hereof.  The following provisions shall survive the expiration or termination of this Agreement:  Articles 2.3 (with respect to the survival of sublicense agreements), 8, 10.4, and 13.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

16

 

ARTICLE 11  — NOTICES

 

11.1                        Any notice or communication pursuant to this Agreement shall be sufficiently made or given if sent by certified or registered mail, postage prepaid, or by overnight courier, with proof of delivery by receipt, addressed to the address below or as either party shall designate by written notice to the other party.

 

In the case of University:

 

Associate Vice Chancellor for Technology Management and Commercialization

Office of Technology Management

University of Pittsburgh

200 Gardner Steel Conference Center

Thackeray & O’Hara Streets

Pittsburgh, PA  15260

 

In the case of Licensee:

Ivan Bergstein, M.D., CEO

Stemline Therapeutics, Inc.

***

New York, New York  10128

 

Any payments to University hereunder by wire transfer shall be directed as follows:

 

Bank: Mellon Bank, NA, Pittsburgh, PA

ABA Routing No.: ***

Account No.: ***

Mellon SWIFT Code: *** (international transfers)

Reference Code: Office of Technology Management

 

ARTICLE 12 — AMENDMENT, MODIFICATION

 

12.1                        This Agreement may not be amended or modified except by the execution of a written instrument signed by the parties hereto.

 

ARTICLE 13 — CONFIDENTIALITY

 

13.1                        University shall maintain in confidence all Confidential Information (as defined below) of Licensee and shall not use or disclose such Confidential Information, except as expressly authorized by this Agreement.  “Confidential Information” shall mean the terms of this Agreement and all information and reports due to University under Article 5 and any terms of

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

17

 

sublicense agreements disclosed pursuant to Article 2.5, in each case which are disclosed in writing and marked “Confidential”, or disclosed orally and identified as confidential in a written summary provided to the University within *** (***) days after oral disclosure.  For the avoidance of doubt, Licensee may disclose the terms of this Agreement to the extent necessary to accountants, banks, investors and financing sources and their respective advisors and to any third party (and its affiliates, accountants, bankers, investors and advisors) in connection with a proposed merger, acquisition, licensing, collaboration or similar transaction.

 

13.2                        The non-disclosure and non-use obligations set forth above shall not apply to any information to the extent that (a) the University can show by written record that it possessed the information prior to its receipt from the other party; (b) the information was, at the time of disclosure, available to the public or became so through no fault of the University; or (c) the information is subsequently disclosed to the University free of any obligations of confidentiality by a third party that has the right to disclose it.  Notwithstanding any other provisions of this Article 13, the University may disclose Confidential Information of Licensee (i) on a need-to-know basis and in connection with University’s performance or its obligations and/or exercise of its rights under this Agreement to its Affiliates, employees, consultants, or agents provided that such individuals or entities are bound by non-disclosure and non-use obligations at least equivalent in scope to those set forth in this Article 13.2; (ii) in confidence to its trustees, directors and professional advisors; and (iii) to the extent that such disclosure is required by a court order, or in order to comply with applicable laws or regulations, but provided that University will, except where impracticable, give reasonable advance notice to Licensee of such required disclosure and use efforts to secure, or to assist the other party in securing, a protective order relating to, or confidential treatment of, such information.

 

13.3                        Nothing contained in this Article 13 is intended to replace, amend, or otherwise supercede the confidentiality obligations of the parties found in the Confidentiality Agreement dated May 9, 2008 in connection with Licensee’s proposed sponsored research with the University.

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

18

 

ARTICLE 14 - MISCELLANEOUS

 

14.1                        This Agreement shall be construed and interpreted in accordance with the laws of the Commonwealth of Pennsylvania.  The forum for any action relating to this Agreement, including those brought against foreseeable third parties such as University employees, shall be ***.

 

(a)                                 Notwithstanding the above, the parties agree to first attempt to amicably resolve any dispute arising out of or in any way connected with this Agreement or any term or condition hereof, or the performance by either party of its obligations hereunder within *** (***) days of written notice of the dispute, except that each party may apply to a court of competent jurisdiction for a temporary restraining order, a preliminary injunction or other equitable relief to preserve the status quo or prevent irreparable harm.

 

(b)                                 If the dispute cannot be resolved by the parties within *** (***) days, the Executive Vice Chancellor of University, or his designee, and the CEO of Licensee shall meet in person at a mutually acceptable time and location or by means of telephone or videoconference within *** (***) days to attempt to resolve the dispute.

 

14.2                        The parties acknowledge that this Agreement sets forth the entire understanding and intentions of the parties hereto as to the subject matter hereof and supersedes all previous understandings between the parties, written or oral, regarding such subject matter.

 

14.3                        Nothing contained in this Agreement shall be construed as conferring upon either party any right to use in advertising, publicity or other promotional activities any name, trade name, trademark, or other designation of the other party, including any contraction, abbreviation, or simulation of any of the foregoing.  Without the express written approval of the other party, neither party shall use any designation of the other party in any promotional activity associated with this Agreement or the Licensed Product.  Neither party shall issue any press release or make any public statement in regard to this Agreement without the prior written approval of the other party.

 

14.4                        If one or more of the provisions of this Agreement shall be held invalid, illegal or unenforceable, the remaining provisions shall not in any way be affected or impaired thereby.  In the event any provision is held illegal or unenforceable, the parties shall use reasonable efforts to

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

19

 

substitute a valid, legal and enforceable provision which, insofar as is practical, implements purposes of the provision held invalid, illegal or unenforceable.

 

14.5                        Failure at any time to require performance of any of the provisions herein shall not waive or diminish a party’s right thereafter to demand compliance therewith or with any other provision.  Waiver of any default shall not waive any other default.  A party shall not be deemed to have waived any rights hereunder unless such waiver is in writing and signed by a duly authorized officer of the party making such waiver.

 

14.6                        Licensee acknowledges that University is free to publish the results of the research activities of its faculty, staff and students, even though such publication may involve the Patent Rights or Licensed Product.  University agrees to submit to Licensee any proposed publication or presentation regarding the subject matter specifically described in the Patent Rights for prior review by Licensee at least *** (***) days before its submittal for publication or its presentation.  Licensee may, within *** (***) days after receipt of such proposed publication, request that such proposed publication be delayed not more than *** (***)days in order to allow for protection of intellectual property rights.

 

[remainder of page intentionally left blank]

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

20

 

IN WITNESS WHEREOF, the parties have set their hands and seals as of the date set forth on the first page hereof.

 

	
 
    	
UNIVERSITY   OF PITTSBURGH — OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By   
    	
/s/   Jerome Cochran
    
	
 
    	
 
    	
Jerome   Cochran
    
	
 
    	
 
    	
Executive   Vice Chancellor
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
STEMLINE THERAPEUTICS, INC.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By
    	
/s/   Ivan Bergstein
    
	
 
    	
Name:
    	
Ivan   Bergstein, M.D.
    
	
 
    	
Title:
    	
Chief   Executive Officer
    

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

 

21

 

EXHIBIT A

 

PATENT RIGHTS

 

	
Univ.
   Case
   No.
    	
 
    	
Application
   No.
    	
 
    	
Application
   Filing Date
    	
 
    	
Patent No.
    	
 
    	
Patent
   Issuance
   Date
    	
 
    	
Title
    	
 
    	
Country
    	
 
    
	
***
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

*** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00205-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00205-of-00352.parquet"}]]