Document:

Exhibit 10.3

 

CAMBRIDGE UNIVERSITY (1)
 TECHNICAL SERVICES LIMITED
 (“CUTS”)

 

and

 

STEMLINE THERAPEUTICS, INC. (2)
 (“Licensee”)

 

 

EXCLUSIVE PATENT AND
 NON-EXCLUSIVE KNOW-HOW
 LICENCE 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.

 

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1        Definitions

 

1.1          In this Agreement, the following words shall have the following meanings:

 

1.2          In this Agreement (except where the context otherwise requires):

 

1.3          The schedules form part of this Agreement.  If a provision of a schedule is inconsistent with a provision of this Agreement, the latter prevails.

 

2        Grant of rights

 

2.1          Licences

 

2.2          Formal licences

 

2.3          Sub-licensing

 

2.4          Reservation of rights

 

2.5          No other licence

 

3        Know-how and confidentiality

 

3.1          Provision of Know-how and Materials

 

3.2          Licensee to treat Know-how as confidential

 

3.3          Confidentiality

 

3.4          Use of Confidential Information

 

3.5          Disclosing Information

 

3.6          Exceptions to confidentiality obligations

 

3.7          Return of information and survival of confidentiality obligations

 

4        Payments

 

4.1          Initial payment and reimbursement of patent costs

 

4.2          Non-monetary consideration

 

4.3          Royalties and Sub-Licence Income (other than Royalties)

 

4.4          Milestone payments

 

4.5          Payment terms and price index

 

4.6          Financial reports

 

4.7          Records

 

5        Commercialisation obligations and reports

 

5.1          The Licensee shall diligently proceed to develop and commercially exploit the Licensed Technology.

 

5.2          Without prejudice to the generality of the Licensee’s obligations under clause 5.1, the Licensee shall send CUTS within *** days of each Anniversary after the *** Anniversary of this agreement an updated, written development plan, covering as a minimum the 12 months preceding the Anniversary and the 12 months following it.  The report shall show:

 

5.3          If CUTS considers at any time during the Term that the Licensee has without legitimate reason failed to proceed diligently to develop and commercially exploit the Licensed Technology, CUTS shall be entitled to request a meeting with the Licensee to discuss the failures.  The Licensee shall have *** days to rectify such failures to the satisfaction of CUTS.  If CUTS reasonably considers that such measures have not been installed to rectify the failures, then CUTS shall be entitled to refer to an independent expert the following questions:

 

5.4          The independent expert shall be appointed in accordance with the provisions of Schedule 2 and his decision shall be final and binding on the Parties.

 

5.5          If the expert determines that the Licensee has failed to comply with its obligations under this clause 5, and if the Licensee fails to take the Specific Action within *** months of the expert giving his decision in accordance with Schedule 2, CUTS shall be entitled, by giving, at any time within *** months after the end of that *** month period, not less than *** days’ notice to terminate this Agreement and the licences granted to the Licensee under clause 2.

 

6        Intellectual property

 

6.1          Patent protection

 

6.2          Infringement of the Patents

 

6.3          Infringement of third party rights

 

6.4          Improvements

 

7        Warranties and liability

 

7.1          Status of Licensed Technology and responsibility for development of Licensed Products

 

7.2          No representations or warranties

 

7.3          Liability and indemnity

 

8        Duration and termination

 

8.1          Commencement and termination by expiry

 

8.2          Early termination by the Licensee

 

*** = 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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8.3          Early termination by CUTS

 

8.4          Early termination by either party

 

8.5          Consequences of termination

 

9        Dispute resolution

 

9.1          The Parties agree that should any dispute arise between them in relation to this Agreement (other than under clause 5), they shall meet as soon as practicable and negotiate in good faith with a view to resolving the dispute.

 

9.2          If the Parties are unable to settle any dispute by negotiation within *** days the Parties will attempt to settle it by mediation in accordance with the Centre for Effective Dispute Resolution (CEDR) Model Mediation Procedure.

 

9.3          To initiate a mediation a party must give notice in writing to the other party, requesting a mediation in accordance with clause 9.2.

 

10      General

 

10.1        Force majeure.

 

10.2        Assignment.

 

10.3        Waiver

 

10.4        Invalid clauses

 

10.5        No agency

 

10.6        Notices

 

10.7        Law and jurisdiction

 

10.8        Further action

 

10.9        Announcements

 

10.10      Entire agreement

 

10.11      Third party rights

 

10.12      Export Control Regulations

 

10.13      Non-use of names and marking of Licensed Products

 

10.14      Insurance

 

Schedule 1

 

Part D Materials

 

Description of Materials to be recorded as set out in Clause 3.1Schedule 2

 

Schedule 2

 

Schedule 3

 

*** = 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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(1)                                 THIS AGREEMENT dated September 16, 2004 is between:

 

CAMBRIDGE UNIVERSITY TECHNICAL SERVICES LIMITED (“CUTS”), a company incorporated in England and Wales (registered number 1069886) whose registered address is at The Old Schools, Trinity Lane, Cambridge CB2 1TS, UK;

 

and

 

(2)                                 STEMLINE THERAPEUTICS, INC. (the “Licensee”) a company whose registered office is at ***, New York, NY 10128, USA.

 

RECITALS:

 

A.                                    CUTS is a company wholly owned by The Chancellor, Masters and Scholars of the University of Cambridge.

 

B.                                    Dr *** while working at *** and University has developed technology relating to purification and culturing of cancer stem cells, including the Patents and the Know-how. *** claims no ownership over the technology developed while Dr *** was at ***, and Dr ***, *** and the University have assigned to CUTS all their intellectual property rights in the Patents and the Know-how.

 

C.                                    The Licensee wishes to acquire rights under the Patents and to use the Know-how for the development and commercialisation of Licensed Products in the Field and in the Territory, in accordance with the provisions of this Agreement.

 

IT IS AGREED as follows:

 

1                                         Definitions

 

1.1                               In this Agreement, the following words shall have the following meanings:

 

	
Affiliate
    	
 
    	
Shall mean any company or entity, the voting   control of which is at least fifty percent (50%), directly or indirectly,   owned or controlled by Licensee, or any company, entity or person, which owns   or controls at least fifty percent (50%), directly or indirectly, of the   voting control of Licensee.
    
	
 
    	
 
    	
 
    
	
Anniversary
    	
 
    	
An anniversary of the Commencement Date.
    
	
 
    	
 
    	
 
    
	
Commencement Date
    	
 
    	
September 16, 2004
    
	
 
    	
 
    	
 
    
	
Confidential Information
    	
 
    	
Any information marked confidential obtained   directly or indirectly by one Party from the other Party.
    
	
 
    	
 
    	
 
    
	
Field
    	
 
    	
All human or animal use.
    
	
 
    	
 
    	
 
    
	
FDA
    	
 
    	
United States Food and Drug Administration
    
	
 
    	
 
    	
 
    
	
IND
    	
 
    	
An investigational new drug application submitted to   the FDA,
    

 

*** = 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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which requests authorization from the FDA to   administer an investigational drug or biological product to humans in the   United States.
    
	
 
    	
 
    	
 
    
	
Insolvency Event
    	
 
    	
Shall mean any event whereby a Party:   (i) becomes insolvent or bankrupt; (ii) makes an assignment for the   benefit of its creditors; (iii) has a trustee or receiver for all or a   substantial part of its property appointed; (iv) has any case or   proceeding or other action commenced or taken against or by it in bankruptcy   or otherwise seeking reorganization, liquidation, dissolution, winding-up,   arrangement, composition or readjustment of its debts or any relief under any   bankruptcy, insolvency, reorganization or other similar act or law of any   jurisdiction now or hereinafter in effect.
    
	
 
    	
 
    	
 
    
	
Know-how
    	
 
    	
Technical information in the Field developed   in the Laboratory under the supervision of the Principal Investigator and   relating directly to the inventions claimed in the Patents.
    
	
 
    	
 
    	
 
    
	
***
    	
 
    	
*** University, ***.
    
	
 
    	
 
    	
 
    
	
Improvements
    	
 
    	
Technical information that is required to   reduce the invention described in the Patents to practice, developed in the   Laboratory, under the supervision of the Principal Investigator, in the 18   months following the Commencement Date, owned and freely available for licence   by CUTS.
    
	
 
    	
 
    	
 
    
	
Inventor(s)
    	
 
    	
The inventors named in Schedule 1.
    
	
 
    	
 
    	
 
    
	
Laboratory
    	
 
    	
The laboratory of the Principal Investigator   within the University of Cambridge, Cambridge Centre for Brain Repair.
    
	
 
    	
 
    	
 
    
	
Licensed Product(s)
    	
 
    	
Any product, process or use which incorporates   or its development makes use of any of the Licensed Technology.
    
	
 
    	
 
    	
 
    
	
Licensed Technology
    	
 
    	
The Patents, the Improvements and the   Know-how.
    
	
 
    	
 
    	
 
    
	
Materials
    	
 
    	
The materials referred to in Schedule 1
    
	
 
    	
 
    	
 
    
	
Net Sales Value
    	
 
    	
Either;
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
(a)
    	
the price of Licensed Products invoiced in arm’s length transactions   to independent third parties exclusively for money or;
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
(b)
    	
the price that would have been invoiced if there had been such a   transaction
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
and in both cases without deduction of any commission   paid to a third party but less the following permitted deductions:
    

 

*** = 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)
    	
arm’s length trade   discounts or credits given; and
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
(ii)
    	
provided the amounts are   separately charged on the relevant invoice, any costs of packaging,   insurance, carriage and freight, any value added tax or other sales tax, and   any import duties or similar applicable government levies.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
(iii)
    	
any allowances actually made and taken for   returns; shipping and insurance costs actually paid; cash discounts and   promotional allowances actually allowed.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
(c)
    	
Additionally, if an Insolvency Event occurs   to a sub-licensee or a customer of Licensee or a customer of an Affiliate and   monies are owed to Licensee by such sub-licensee or an Affiliate by such   sub-licensee or customer suffering said Insolvency Event, then such monies   shall be deemed uncollectible, and Licensee shall not therefore owe royalties   on account of the Net Sales Value price of such debts unless actually   collected, and a proportionate deduction for prospective royalties shall be   made on account of any royalties already paid on such uncollectible Net Sales   Values.
    
	
 
    	
 
    	
 
    
	
Parties
    	
 
    	
CUTS and the Licensee, and “Party” shall mean   either of them.
    
	
 
    	
 
    	
 
    
	
Patents
    	
 
    	
Any and all of the patents and patent   applications based on the draft patent application described in Schedule 1   together with any patents granted pursuant to the applications and any   continuations, continuations in part, extensions, reissues, re-registrations,   reexaminations, divisions and supplementary protection certificates that   derive priority from the foregoing.
    
	
 
    	
 
    	
 
    
	
Payment Period
    	
 
    	
The payment periods specified in Schedule 3.
    
	
 
    	
 
    	
 
    
	
Phase III Clinical Trial
    	
 
    	
A clinical trial on sufficient numbers of subjects   that is designed to establish that a pharmaceutical product is safe and   efficacious for its intended use, and to define warnings, precautions, and   adverse reactions that are associated with such pharmaceutical product in the   dosage range to be prescribed, and the clinical trial will directly support   Regulatory Approval of such pharmaceutical product or label expansion of such   pharmaceutical product.
    
	
 
    	
 
    	
 
    
	
Principal Investigator
    	
 
    	
Dr ***
    
	
 
    	
 
    	
 
    
	
Regulatory Approval
    	
 
    	
The approvals, registrations or   authorizations of the FDA, or the equivalent regulatory agency in a foreign   country or jurisdiction necessary for the manufacture, distribution,   marketing and sale of a pharmaceutical or diagnostic product in the United   States, or such foreign country or jurisdiction, as applicable.
    

 

*** = 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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Royalty                                                                                                                                                   The royalty specified in clause 4.3.

 

Sub-Licence Income                                                                              Any payment due from a sub-licensee of the Licensed Technology to the Licensee or an Affiliate excluding royalties on Licensed Products.

 

Term                                                                                                                                                                The period specified in clause 8.1.

 

Territory                                                                                                                                         Worldwide.

 

University                                                                                                                                     The Chancellor, Masters and Scholars of the University of Cambridge.

 

1.2                               In this Agreement (except where the context otherwise requires):

 

(a)                                 any reference to a clause or schedule is to the relevant clause or schedule of or to this Agreement and any reference to a sub-clause or paragraph is to the relevant sub-clause or paragraph of the clause or schedule in which it appears;

 

(b)                                 the clause headings are included for convenience only and shall not affect the interpretation of this Agreement;

 

(c)                                  any reference to “person” or “persons”  includes natural persons, firms, partnerships, companies, corporations, associations, organisations, governments, states, foundations and trusts (in each case whether or not having separate legal personality); and

 

(d)                                 the singular includes the plural and vice versa;

 

(e)                                  words preceding “include”, “includes”, “including” and “included” shall be construed without limitation by the words which follow those words.

 

1.3                               The schedules form part of this Agreement.  If a provision of a schedule is inconsistent with a provision of this Agreement, the latter prevails.

 

2                                         Grant of rights

 

2.1                               Licences

 

CUTS hereby grants to the Licensee subject to the provisions of this Agreement:

 

(a)                                 an exclusive licence under the Patents and the Improvements, with the right to sub-license, subject to clause 2.3 below, to develop, manufacture, have manufactured, use, sell, offer to sell, market, have marketed, import, have imported, export and have exported Licensed Products only in the Field in the Territory; and

 

(b)                                 a non-exclusive licence to use the Know-how, with the right to sub-license, subject to clause 2.3 below, to develop, manufacture, have manufactured, use, sell, offer to sell, market, have marketed, import, have imported, export and have

 

*** = 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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exported Licensed Products only in the Field in the Territory.

 

2.2                               Formal licences

 

The Parties shall execute such formal licences as may be necessary or appropriate for registration with Patent Offices and other relevant authorities in particular territories.  In the event of any conflict in meaning between any such licence and the provisions of this Agreement, the provisions of this Agreement shall prevail.  Prior to the execution of the formal licence(s) (if any) referred to in this clause, the Parties shall so far as possible have the same rights and obligations towards one another as if such licence(s) had been granted.  The Parties shall use reasonable endeavours to ensure that, to the extent permitted by relevant authorities, this Agreement shall not form part of any public record.

 

2.3                               Sub-licensing

 

The Licensee shall be entitled to grant sub-licences of its rights under this Agreement to any person, provided that:

 

(a)                                 the sub-licence shall include terms which are equivalent to the obligations and limitations (including limitations of liability) which apply to the Licensee under this Agreement;

 

(b)                                 the sub-licence shall terminate automatically on the termination of this Agreement for any reason provided that sub-licensee shall have the right to assume the Agreement;

 

(c)                                  within *** days of the grant of any sub-licence the Licensee shall provide to CUTS a true copy of it; and

 

(d)                                 the Licensee shall be responsible for any breach of the sub-licence by the sub-licensee, as if the breach had been that of Licensee under this Agreement, and the Licensee shall indemnify CUTS against any loss, damages, costs, claims or expenses which are awarded against or suffered by CUTS as a result of any such breach by the sub-licensee.

 

2.4                               Reservation of rights

 

CUTS reserves for itself (and also grants to the University, any wholly owned subsidiary of the University, and ***) an irrevocable, world-wide, royalty-free non-exclusive right to use and to license other academic institutions to use the Patents in the Field for the purposes of academic research or teaching or both.  CUTS shall send written notice of any such license to Licensee within *** days of execution.

 

2.5                               No other licence

 

No licence is granted by CUTS to the Licensee other than any licence expressly granted by the provisions of this clause 2.

 

3                                         Know-how and confidentiality

 

3.1                               Provision of Know-how and Materials

 

*** = 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

 

Upon the Licensee’s reasonable request, CUTS shall arrange for the Principal Investigator to supply the Licensee with all Know-how and Materials in his possession that CUTS is at liberty to disclose or transfer and that has not previously been disclosed or transferred and which is reasonably necessary or desirable to enable the Licensee to undertake the further development of the Patents. Such Know-how and Materials to be recorded in Schedule 1.  The method of such supply shall be agreed between the Principal Investigator and the Licensee.  If it is agreed that the Principal Investigator shall travel to the Licensee’s premises in connection with such supply, the Licensee shall reimburse all travel accommodation and subsistence costs incurred provided such costs are approved by the Licensee prior to being incurred.

 

3.2                               Licensee to treat Know-how as confidential

 

The Licensee receives the Know-how as Confidential Information.  The Licensee undertakes that for a period of *** years from the Commencement Date or for so long as any substantial part of the Know-how remains subject to the obligations of confidence (in accordance with clauses 3.3 to 3.7 inclusive), whichever is the shorter, it shall protect the Know-how as Confidential Information and shall not use the Know-how for any purpose except as expressly licensed hereby and in accordance with the provisions of this Agreement.

 

3.3                               Confidentiality

 

No Confidential Information disclosed by one party (“Disclosing Party”) to the other party (“Recipient Party”) under this Agreement may be disclosed by the Recipient Party to any person except:

 

(a)                                 employees, officers, directors, auditors, consultants, or subcontractors of the Recipient Party or the University requiring the Confidential Information for the purposes of this Agreement;

 

(b)                                 with the prior written consent of the Disclosing Party which consent may be given or withheld in its absolute discretion;

 

(c)                                  to actual or potential customers or sub-licensees for Licensed Products in so far as such disclosure is necessary to promote the sale or use of Licensed Products;

 

(d)                                 if the Recipient Party is required to do so by law or stock exchange; or

 

(e)                                  if the Recipient Party is required to do so in connection with legal proceedings relating to this Agreement.

 

3.4                               Use of Confidential Information

 

No Confidential Information of the Disclosing Party may be used by the Recipient Party for any purpose other than the performance of the Recipient Party’s obligations or the exercise of the Recipient Party’s rights under this Agreement.

 

3.5                               Disclosing Information

 

Any Party disclosing information under clause 3.3 (a), (b) or (c) must use all reasonable endeavours to ensure that persons receiving Confidential Information from it

 

*** = 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)                                 do not disclose or use the information except in the circumstances permitted in clauses 3.3 and 3.4 and

 

(b)                                 sign a written confidentiality undertaking in terms as least as restrictive as that binding the Recipient Party.

 

3.6                               Exceptions to confidentiality obligations

 

Clauses 3.3, 3.4 and 3.5 do not apply to Confidential Information which:

 

(a)                                 is in or becomes part of the public domain other than through breach of this Agreement or an obligation of confidence owed to the Disclosing Party;

 

(b)                                 the Recipient Party can prove by contemporaneous written documentation was already known to it at the time of disclosure by the Disclosing Party (unless that knowledge arose from disclosure of information in breach of an obligation of confidence);

 

3.7                               Return of information and survival of confidentiality obligations

 

(a)                                 Upon Termination of this Agreement, The Recipient Party, upon Disclosing Party’s request, must return to the Disclosing Party all documents or other materials containing or referring to Confidential Information (other than the Know-how) which are in its possession, power or control or in the possession, power or control of persons who have received Confidential Information from it under clause 3.3(a), (b) or (c) at any time if requested to do so by the Disclosing Party.  Notwithstanding the foregoing, Recipient may retain one copy for legal records.

 

(b)                                 The provisions of clauses 3.3 to 3.7 inclusive will survive the expiry or earlier termination (for whatever reason) of this Agreement for a period of three years.

 

4                                         Payments

 

4.1                               Initial payment and reimbursement of patent costs

 

The Licensee shall pay to CUTS all external receipted costs in connection with obtaining patent protection for the Patents prior to the Commencement Date.

 

4.2                               Non-monetary consideration

 

The Licensee shall not accept and shall ensure that its sub-licensees do not accept, without the prior written consent of CUTS, which shall not be unreasonably withheld, any non-monetary consideration for any Licensed Product.

 

4.3                               Royalties and Sub-Licence Income (other than Royalties)

 

(a)                                 The Licensee shall pay CUTS a royalty for the *** Licensed Products to obtain Regulatory Approval of ***% (*** percent) of the Net Sales Value, and a royalty of ***% (*** percent) for the *** Licensed Product to obtain Regulatory Approval. For the avoidance of doubt once a Licensed Product has obtained Regulatory Approval then royalties shall be due for all sales of that product for all 

 

*** = 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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purposes and obtaining Regulatory Approval for additional indications for the same Licensed Product shall not be considered an additional Licensed Product.

 

(b)                                 The Licensee shall pay CUTS ***% (*** percent) of all Sub-Licence Income obtained ***, and ***% (*** percent) of all Sub-Licence Income obtained *** from the Commencement Date.

 

4.4                               Milestone payments

 

The Licensee shall pay CUTS the milestone payment(s) set out in the table below. Such payments shall be made on the each occasion that each of the Milestones are reached as indicated in the table below.

 

	
Milestone
    	
 
    	
Payment
    	
 
    
	
***
    	
 
    	
$
    	
***
    	
 
    
	
***
    	
 
    	
$
    	
***
    	
 
    
	
***
    	
 
    	
$
    	
***
    	
 
    

 

4.5                               Payment terms and price index

 

(a)                                 Payments shall be made in accordance with Schedule 3 Part C.

 

(b)                                 All consideration due under this Agreement is exclusive of Value Added Tax which where applicable shall be paid by the Licensee to CUTS.  Payments shall:

 

(i)                                     be paid within *** days of the end of each calendar quarter with respect to royalty-bearing sales or use occurring in that quarter. Royalties shall be paid by Licensee in U.S. dollars by telegraphic transfer to the account of Cambridge University Technical Services Ltd at Barclays Bank of Bene’t Street, Business Centre, PO Box No 2, Cambridge CB2 3PZ, sort code: ***, account number ***;

 

(ii)                                  be made ***, failing which CUTS may charge interest on any outstanding amount on a daily basis at ***% above Barclays Bank plc base lending rate then in force or under the Late Payment of Commercial Debts (Interest) Act 1998, whichever shall be the more favourable to CUTS; and

 

(iii)                               be made without deduction of income tax or other taxes charges or duties.

 

4.6                               Financial reports

 

(a)                                 Each payment shall be accompanied by a payment slip in the form set out in Schedule 3 Part B.  The Licensee shall also submit royalty reports summarising Royalties due to CUTS at the frequency and in the form set out in Schedule 3.

 

(b)                                 The Licensee shall report to CUTS the date of first sale of a Licensed Product within *** days of occurrence.

 

*** = 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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4.7                               Records

 

(a)                                 The Licensee shall keep at its normal place of business all information used to calculate payments due to CUTS under this Agreement including detailed and up to date records and accounts showing the quantity, description and value of Licensed Products sold by it and its sub-licensees, and the amount of sub-licensing revenues other than Royalties received by it in respect of Licensed Products, on a country by country basis.  The Licensee shall keep these records separate or otherwise make them extractable easily from its other business records and shall not dispose of them until after the *** anniversary of their creation.

 

(b)                                 The Licensee shall make such information available, on reasonable notice, but no more than once per year per Licensed Product,  for audit during business hours by a CUTS’ duly authorised representative for the purpose of verifying the accuracy of any report given by the Licensee to CUTS under this clause 4.  The representative shall be required to keep confidential all information learnt during any such inspection, and to disclose to CUTS only such details as may be necessary to report on the accuracy of the Licensee’s financial reports.  CUTS shall be responsible for the representative’s professional charges unless the representative certifies that there is an inaccuracy of more than ***% (*** per cent) in any financial statement, in which case the Licensee shall pay his charges in respect of that inspection.  The Licensee shall pay any underpayment reported by the representative within *** days of receipt of a CUTS’ invoice requiring payment for the same.

 

(c)                                  The Licensee shall ensure that CUTS has the same rights as those set out in this clause 4.7 in respect of any sub-licensee of the Licensee which is sub-licensed under the Patents or Know-how pursuant to this Agreement.

 

5                                         Commercialisation obligations and reports

 

5.1                               The Licensee shall diligently proceed to develop and commercially exploit the Licensed Technology.

 

5.2                               Without prejudice to the generality of the Licensee’s obligations under clause 5.1, the Licensee shall send CUTS within *** days of each Anniversary after the *** Anniversary of this agreement an updated, written development plan, covering as a minimum the 12 months preceding the Anniversary and the 12 months following it.  The report shall show:

 

(a)                                 all past, current and projected activities taken or to be taken by the Licensee to bring Licensed Products to market and maximise the sale of Licensed Products in the Territory

 

(b)                                 any Sub-Licence Income invoiced or received.

 

CUTS’ receipt or approval of any such plan shall not be taken to waive or qualify the Licensee’s obligations under clause 5.1.

 

5.3                               If CUTS considers at any time during the Term that the Licensee has without legitimate reason failed to proceed diligently to develop and commercially exploit the Licensed Technology, CUTS shall be entitled to request a meeting with the Licensee to discuss the failures.  The Licensee shall have *** days to rectify such failures to the satisfaction 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.

 

12

 

CUTS.  If CUTS reasonably considers that such measures have not been installed to rectify the failures, then CUTS shall be entitled to refer to an independent expert the following questions:

 

(a)                                 whether the Licensee has acted diligently; and if not

 

(b)                                 what specific action the Licensee should have taken (“Specific Action”) in order to have acted diligently.

 

5.4                               The independent expert shall be appointed in accordance with the provisions of Schedule 2 and his decision shall be final and binding on the Parties.

 

5.5                               If the expert determines that the Licensee has failed to comply with its obligations under this clause 5, and if the Licensee fails to take the Specific Action within *** months of the expert giving his decision in accordance with Schedule 2, CUTS shall be entitled, by giving, at any time within *** months after the end of that *** month period, not less than *** days’ notice to terminate this Agreement and the licences granted to the Licensee under clause 2.

 

6                                         Intellectual property

 

6.1                               Patent protection

 

The Licensee shall at its own cost and expense:

 

(a)                                 *** reasonably available, including the filing of divisional applications where appropriate; and

 

(b)                                 pay *** when due; and

 

(c)                                  ensure that CUTS receives copies of all correspondence concerning the patent application(s) listed in Schedule 1.

 

(d)                                 provided that if the Licensee wishes to abandon any such application or not to maintain any such Patent in the whole of or any part of the Territory (or to cease funding such application or Patent) it shall give reasonable prior written notice to CUTS and the Licensee shall cease to be licensed for those parts of the Territory under the patent application or patent identified in the notice.

 

6.2                               Infringement of the Patents

 

(a)                                 Each Party shall inform the other Party promptly if it becomes aware of any infringement or potential infringement of any of the Patents in the Field.

 

(b)                                 Subject to clause 6.2(c), the Licensee shall be entitled to take legal or other action against any third party to enforce the Patents at its sole expense.  If the alleged infringement is both within and outside the Field, the Parties shall also co-operate with CUTS’ other licensees (if any) in relation to any such action.

 

CUTS shall agree to be joined in any such legal action subject to being indemnified and secured in a reasonable manner as to any costs, damages, expenses or other liability ***.

 

*** = 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

 

(c)                                  Before starting legal action in accordance with sub-clause (b) or agreeing to any settlement, the Licensee shall consult CUTS and take its views into account about the advisability of the action or settlement, its effect on the University and CUTS’ good name, the public interest and how the action should be conducted. Any ***, shall be deemed to be Net Sales Value, upon which the Licensee shall pay CUTS a Royalty in accordance with clause 4.3, or Sub-Licence Income, depending on the nature of the payment.  Clause 2.3 specifies the extent to which the Licensee may grant a sub-licence to an infringer.

 

(d)                                 In the event that the Licensee fails to have initiated an infringement action within *** months of the Licensee first becoming aware of the basis for such action, CUTS shall have the right, at its sole discretion, to prosecute such infringement under its sole control and its sole expense, and any recovery obtained shall belong ***% to CUTS and ***% to Licensee, net of all expenses expended in pursuing such action.

 

6.3                               Infringement of third party rights

 

(a)                                 If any warning letter or other notice of infringement is received by a Party, or legal action is brought against a Party, alleging infringement of third party rights in the manufacture, use or sale of any Licensed Product or use of any Patents, that Party shall promptly provide full details to the other Party, and the Parties shall discuss the best way to respond.

 

(b)                                 The Licensee shall have the right but not the obligation to defend such action and shall have the right to settle with such third party, provided that if any action or proposed settlement involves the making of any statement, express or implied, concerning the validity of any Patent, the consent of CUTS must be obtained before taking such action or making such settlement.

 

6.4                               Improvements

 

CUTS shall inform the Licensee of any Improvements within *** days of the notification of such Improvements by the Inventor, which shall be recorded in Schedule 1. The Licensee shall then have *** days to decide whether to seek patent protection for such Improvements, and if so shall seek such protection as set out in this Clause 6.

 

7                                         Warranties and liability

 

7.1                               Status of Licensed Technology and responsibility for development of Licensed Products

 

The Licensee acknowledges that the Licensed Technology is at an early stage of development, that it is provided “as is” and specific results cannot be guaranteed.  The Licensee shall be exclusively responsible for the technical and commercial development and manufacture of Licensed Products and for incorporating any modifications or developments thereto that may be necessary or desirable and for all Licensed Products sold or supplied.

 

7.2                               No representations or warranties

 

(a)                                 The Licensee acknowledges that CUTS has not performed any searches or 

 

*** = 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

 

investigations into the existence of any third party rights, which may affect any of the Licensed Technology and that in entering into this Agreement it does not do so in reliance on any representation, warranty or other provision except as expressly provided in this Clause.

 

(b)                                 CUTS warrants that the University, and the Inventors have assigned to CUTS all their intellectual property rights in the Patents and that, so far as CUTS is aware, it owns the Patents.

 

CUTS shall have no liability under this warranty except for claims made against the Licensee by a third party and then only if the Licensee serves a notice in writing setting out particulars of such claim promptly and prior to the third Anniversary.

 

(c)                                  Except as provided by Clause 7.2(b) CUTS makes no representations or warranties of any kind, express or implied, concerning the Licensed Technology including (i) as to the satisfactory quality or fitness for a particular purpose (ii) as to the absence of latent or other defects, whether or not discoverable (iii) as to the validity or scope of the Patents or (iv) that the exploitation of the Licensed Technology or any Licensed Product will not infringe any patents or other intellectual property rights of a third party and all conditions, warranties or other terms implied by statute or common law are excluded from this Agreement to the fullest extent permitted by law.

 

7.3                               Liability and indemnity

 

(a)                                 The limitations in this Agreement shall not apply in respect of claims for personal injury or death caused by negligence to the extent that it is not lawful to limit liability or obtain an indemnity or in respect of fraud or fraudulent misrepresentation.

 

(b)                                 The aggregate liability of CUTS, the University, the University’s employees and students, the Inventors and the Principal Investigator for any damages or expenses of whatsoever nature and howsoever arising (including in contract, tort, negligence or for breach of statutory duty or misrepresentation) in connection with any use of the Licensed Technology or the manufacture, use or sale of the Licensed Products or otherwise in connection with this Agreement or any relationships established by it shall be limited to the income (less any expenses CUTS has incurred in obtaining, maintaining or defending the Patents) which CUTS has received under this Agreement or £***, whichever shall be the higher.

 

(c)                                  Except as provided by Clause 7.3(a), in no circumstances will CUTS, the University, the University’s employees or students, the Inventors or the Principal Investigator be liable for any economic loss (including loss of profits, revenue or business opportunity) any loss of goodwill or any indirect, incidental, consequential or special damages.

 

(d)                                 The Licensee shall indemnify CUTS, the University, the University’s employees and students and the Inventors and Principal Investigator in full against all direct, indirect incidental consequential or special liability, loss, damages, expenses, (including legal and other professional fees and expenses) claim or threatened 

 

*** = 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

 

claim arising from the use by the Licensee or any of its sub-licensees of the Licensed Technology or otherwise in connection with the manufacture, use or sale of or any other dealing in any of the Licensed Products by Licensee or any of its sub-licensees.

 

(e)                                  The Parties agree the allocation of liability set out in this clause. The Licensee acknowledges that without its agreement to the limitations of liability and indemnity set out in this clause, the Royalties and other fees charged under this Agreement would be higher.

 

8                                         Duration and termination

 

8.1                               Commencement and termination by expiry

 

This Agreement, and the licences granted hereunder, shall come into effect on the Commencement Date and, unless terminated earlier in accordance with this clause 8, shall continue in force on a country by country basis until the date on which the last-to-expire of the Patents has expired or has been revoked without a right of further appeal.

 

8.2                               Early termination by the Licensee

 

The Licensee may terminate this Agreement at any time on *** days’ notice in writing to CUTS.

 

8.3                               Early termination by CUTS

 

CUTS may terminate this Agreement

 

(a)                                 forthwith by giving written notice to the Licensee if the Licensee or its sub-licensee commence(s) legal proceedings, or assist(s) any third party to commence legal proceedings, to challenge the validity or ownership of any of the Patents; and

 

(b)                                 as provided in clause 5.

 

8.4                               Early termination by either party

 

Without prejudice to any other right or remedy, either Party may by written notice to the other Party terminate this Agreement at any time by notice in writing to the other Party, if

 

(a)                                 the other Party has materially breached this Agreement (and for the avoidance of doubt non-payment by the Licensee under clause 4 shall be deemed a material breach) and, in case of a remediable breach other than a persistent breach, has failed to remedy that breach within *** days of the date of service of a written notice from the other Party specifying the breach and requiring that it be remedied; or

 

(b)                                 the other Party ceases to carry on business, is unable to pay its debts when they fall due, is declared bankrupt, or an order is made or a resolution passed for the winding up of that other Party or the appointment of an administrator, receiver, liquidator or manager of that 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.

 

16

 

8.5                               Consequences of termination

 

(a)                                 Upon termination of this Agreement by expiry under clause 8.1 above, the licence of the Patents in clause 2.1(a) shall terminate but the Licensee shall have the non-exclusive right to use the Know-how in clause 2.1(b) without charge or other obligation to CUTS.

 

(b)                                 Upon termination of this Agreement for any reason otherwise than in accordance with clause 8.1:

 

(i)            the Licensee and its sub-licensees shall be entitled to sell, use or otherwise dispose of (subject to payment of royalties under clause 4.3) any unsold or unused stocks of the Licensed Products;

 

(ii)           subject to paragraph (i) above, the Licensee shall no longer be licensed to use or otherwise exploit in any way, either directly or indirectly, the Patents, in so far and for as long as any of the Patents remains in force, or the Know-how;

 

(iii)          subject to paragraph (i) above, the Licensee shall consent to the cancellation of any formal licence granted to it, or of any registration of it in any register, in relation to any of the Patents;

 

(iv)          each Party shall return to the other (or destroy at the other’s request) all Confidential Information disclosed to it by the other and all materials containing any Confidential Information in its possession or control (including, in the case of the Licensee, in the possession or control of its sub-licensees) notwithstanding the foregoing, each Party may retain one copy for its legal records; and

 

(v)           upon CUTS’s request, the Parties shall negotiate in good faith the terms of an agreement between them on reasonable commercial terms to enable CUTS to arrange for the further exploitation of the Licensed Technology and Licensed Products as they exist at the date of termination.

 

(c)                                  If the Parties are unable to agree to the terms of an agreement as described in clause 8.5(b)(v), they may initiate the procedure in clause 9.2.

 

(d)                                 The expiry or termination of this Agreement does not affect any rights or obligations of either Party which have arisen or accrued up to and including the date of expiry or termination including the right to payment under this Agreement.

 

(e)                                  Clauses 2.3(d), 2.4, 3, 4, 7, 8.5 and 9 survive expiry or termination (for whatever reason).

 

9                                         Dispute resolution

 

9.1                               The Parties agree that should any dispute arise between them in relation to this Agreement (other than under clause 5), they shall meet as soon as practicable and 

 

*** = 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

 

negotiate in good faith with a view to resolving the dispute.

 

9.2                               If the Parties are unable to settle any dispute by negotiation within *** days the Parties will attempt to settle it by mediation in accordance with the Centre for Effective Dispute Resolution (CEDR) Model Mediation Procedure.

 

9.3                               To initiate a mediation a party must give notice in writing to the other party, requesting a mediation in accordance with clause 9.2.

 

10                                  General

 

10.1                        Force majeure.

 

(a)                                 Notwithstanding any other provision of this Agreement, no Party need act if it is impossible to act due to force majeure, meaning any cause beyond its control (including war, riot, natural disaster, labour dispute, or law taking effect after the date of this Agreement).  A Party affected by force majeure agrees to notify the other Party promptly after it determines that it is unable to act.

 

(b)                                 A Party has no responsibility or liability for any loss or expense suffered or incurred by the other Party as a result of its not acting for so long as the force majeure under clause 10.1 continues.  However, the non-performing Party agrees to make reasonable efforts to avoid or remove the circumstances giving rise to the force majeure and agrees to continue performance under this Agreement promptly when they are removed.

 

10.2                        Assignment.

 

(a)                                 Save as provided by clause 10.3(b) and (c), neither party may assign, transfer, charge or deal in any other manner with this Agreement, nor purport to do so without the prior written consent of the other party.

 

(b)                                 CUTS may assign any of its rights under this Agreement provided that CUTS’ assignee shall undertake to be bound by and perform CUTS’ obligations under this Agreement. CUTS shall notify the Licensee of any assignment under this Agreement.

 

(c)                                  The Licensee may assign its rights under this Agreement where the assignment is connected with the transfer of all or substantially all of the Licensee’s assets to a purchaser and provided such purchaser undertakes to CUTS to be bound by and perform the obligations of the Licensee under this Agreement and is capable of performing such obligations.  The Licensee shall notify CUTS of any such assignment.

 

10.3                        Waiver

 

A provision of this Agreement or any right created under it cannot be waived or varied except in writing signed by the Parties.

 

10.4                        Invalid clauses

 

If the whole or any part of a provision of this Agreement is void, unenforceable or illegal 

 

*** = 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 a jurisdiction it is severed for that jurisdiction.  The remainder of this Agreement has full force and effect and the validity or enforceability of that provision in any other jurisdiction is not affected.  This clause has no effect if the severance alters the basic nature of this Agreement or is contrary to public policy.

 

10.5                        No agency

 

Nothing contained or implied in this Agreement constitutes a Party the partner, agent, or legal representative of another Party or of the other Party for any purpose or creates any partnership, agency or trust, and no Party has any authority to bind the other Party in any way.

 

10.6                        Notices

 

Any notice to be given under this Agreement shall be in writing and delivered by hand, prepaid registered post or facsimile to the other Party at the address or fax number set out below or to such other address or fax number as either Party may specify in writing to the other.

 

	
Notices to CUTS
    	
 
    	
c/o Research Services Division,
    
	
 
    	
 
    	
University of Cambridge,
    
	
 
    	
 
    	
16 Mill Lane,
    
	
 
    	
 
    	
Cambridge  
    
	
 
    	
 
    	
CB2 1SB
    
	
 
    	
 
    	
UK  
    
	
 
    	
 
    	
Fax number: +44 1223 332988.
    
	
 
    	
 
    	
 
    
	
Notices to the Licensee
    	
 
    	
Attn: Ivan Bergstein, MD
    
	
 
    	
 
    	
Stemline Therapeutics, Inc.,  
    
	
 
    	
 
    	
***,  
    
	
 
    	
 
    	
***,  
    
	
 
    	
 
    	
New York,
    
	
 
    	
 
    	
NY 10128,  
    
	
 
    	
 
    	
USA
    
	
 
    	
 
    	
Fax: +1-212-244-0161
    

 

Notices are deemed to have been given:

 

*** = 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

 

(a)                                 if delivered by hand or overnight courier, at the time of the delivery unless delivered after 5pm in the place of receipt or on a non-business day, in which case the notice is deemed to have been given at 9am the next business day;

 

(b)                                 if sent by registered post from the United Kingdom or by registered mail from the United States, seven  business days after posting; and

 

(c)                                  if sent by facsimile, at the time the facsimile is received shown in the transmission report as the time that the whole facsimile was sent unless received after 5pm in the place of receipt or on a non-business day, in which case the notice is deemed to have been given at 9am the next business day.

 

10.7                        Law and jurisdiction

 

This Agreement and any documents to be entered into pursuant to it shall be governed by and construed in accordance with English law and each Party irrevocably submits to the exclusive jurisdiction of the courts of England over any claim or matter arising under or in connection with this Agreement and the documents entered into pursuant to it except that a Party may seek an interim injunction in any court of competent jurisdiction.

 

10.8                        Further action

 

Each Party agrees to execute, acknowledge and deliver such further instruments, and do all further similar acts, as may be necessary or appropriate to carry out the purposes and intent of this Agreement.

 

10.9                        Announcements

 

A Party may not make press or other announcements or releases relating to this Agreement or the transactions the subject of this Agreement without the approval of the other Party to the form and manner of the announcement or release unless and to the extent that the announcement or release is required to be made by the Party, by law or by a stock exchange.

 

10.10                 Entire agreement

 

This Agreement constitutes the entire agreement and understanding of the Parties and supersedes all negotiations, understandings or previous agreement between the Parties relating to the subject matter of this Agreement.

 

10.11                 Third party rights

 

The University, any University wholly owned subsidiary, the Inventors and the Principal Investigator may enforce those terms of this Agreement which expressly confer rights on them, subject to and in accordance with the Contracts (Rights of Third Parties) Act 1999.  Save as aforesaid no term of this Agreement shall be enforceable under that Act by a person who is not a party to this Agreement, but this shall not affect any right or remedy of any third party which exists or is available other than under that Act.  Notwithstanding that any term of this Agreement may be or become enforceable under that Act by a person which is not a party to it, this Agreement may be amended in any respect, or suspended, cancelled or terminated by agreement in writing between the Parties, in each

 

*** = 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

 

case without the consent of such third party.

 

10.12                 Export Control Regulations

 

(a)                                 “Export Control Regulations” mean any United Nations trade sanctions or EU or UK legislation or regulation, from time to time in force, which impose arms embargoes or control the export of goods, technology or software, including weapons of mass destruction and arms, military, paramilitary and security equipment and dual-use items (items designed for civil use but which can be used for military purposes) and certain drugs and chemicals.

 

(b)                                 The Licensee shall ensure that, in using the Licensed Technology and in selling Licensed Products, it shall not and nor shall its employees or sub-contractors or sub-licensees breach or compromise, directly or indirectly, compliance with any Export Control Regulations.

 

10.13                 Non-use of names and marking of Licensed Products

 

The Licensee shall not use and shall ensure that its sub-licensees do not use the name, any adaptation of the name, any logo, trademark or other device of the “University of Cambridge”, “Cambridge University Technical Services Limited” nor of the Inventors or Principal Investigator in any advertising, promotional or sales materials without prior written consent obtained from CUTS in each case, except that Licensee may state that it is licensed by CUTS to use the Licensed Technology and to make a supply the Licensed Products.

 

10.14                 Insurance

 

Without limiting its liability under clause 7.3(d) the Licensee shall take out with a reputable insurance company and maintain at all times during the Term public and product liability insurance including against all loss of and damage to property (whether real personal or intellectual) and injury to persons including death arising out of or in connection with this Agreement and the Licensee’s and its sub-licensees use of the Licensed Technology and use, sale of or any other dealing in any of the Licensed Products.  Such insurances may be limited in respect of one claim and in aggregate (but shall not be limited to any other respect) provided that such limit must be at least £***.

 

*** = 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

 

AGREED by the parties through their authorised signatories:-

 

	
For and on behalf of
    	
 
    	
For and on behalf of
    
	
 
    	
 
    	
 
    
	
CAMBRIDGE UNIVERSITY TECHNICAL SERVICES   LIMITED
    	
 
    	
STEMLINE THERAPEUTICS, INC.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
/s/ R.C. Jennings
    	
 
    	
/s/ Ivan Bergstein
    
	
signed
    	
 
    	
signed
    
	
 
    	
 
    	
 
    
	
R.C. Jennings
    	
 
    	
Ivan Bergstein
    
	
print name
    	
 
    	
print name
    
	
 
    	
 
    	
 
    
	
Director
    	
 
    	
President and CEO
    
	
title
    	
 
    	
title
    
	
 
    	
 
    	
 
    
	
17/9/04
    	
 
    	
9/22/04
    
	
date
    	
 
    	
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.

 

22

 

Schedule 1

 

Part A The Patents

 

***

 

Part B Improvements

 

Description of Improvements to be recorded as set out in Clause 6.4

 

Part C Know-how

 

Description of Know-how to be recorded as set out in Clause 3.1

 

Part D Materials

 

Description of Materials to be recorded as set out in Clause 3.1

 

*** = 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.

 

23

 

Schedule 2

 

Appointment of Expert

 

1                                         Pursuant to clause         , CUTS may serve notice on the Licensee (“Referral Notice”) that it wishes to refer to an expert (the “Expert”) the questions set out in clause           .

 

2                                         The parties shall agree the identity of a single independent, impartial expert to determine such questions.  In the absence of such agreement within *** days of the Referral Notice, the questions shall be referred to an expert appointed by the President of Law Society of England and Wales.

 

3                                         *** days after the giving of a Referral Notice, both parties shall exchange simultaneously statements of case in no more than *** words, in total, and each side shall simultaneously send a copy of its statement of case to the Expert.

 

4                                         Each party may, within *** days of the date of exchange of statement of case pursuant to paragraph 3 above, serve a reply to the other side’s statement of case of not more than *** words.  A copy of any such reply shall be simultaneously sent to the Expert.

 

5                                         The Expert shall make his decision on the said questions on the basis of written statements and supporting documentation only and there shall be no oral hearing.  The Expert shall issue his decision in writing within *** days of the date of service of the last reply pursuant to paragraph 4 above or, in the absence of receipt of any replies, within *** days of the date of exchange pursuant to paragraph 3 above.

 

6                                         The Expert’s decision shall be final and binding on the parties.

 

7                                         The Expert’s charges shall be borne equally by the parties.

 

*** = 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.

 

24

 

Schedule 3

 

Financial Reports

Part A:  Royalty Report Format

 

	
Licensee Name:
    	
 
    	
Case Number:
    
	
Licensee Invoice
   Address:
    	
 
    	
Date of Agreement:
    
	
Licensed Technology
   known as:
    	
 
    	
Commencement Date:
    
	
Payment Periods: [*** month periods ending on [31st March and 30th
   September]
    	
Expiry of Agreement:
    
	
Financial Report for the [***]   month period [        ] to [       ]
    	
Term: From the Commencement   Date until
   expiry
    

 

ROYALTY REPORT

Licensee Royalties

 

	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
*Net Sales Value
    	
 
    	
 
    	
 
    
	
Products
    	
 
    	
Royalty
   Rate
    	
 
    	
Territory
    	
 
    	
No of
   products
    	
 
    	
Local
   currency
    	
 
    	
Conversion rate
    	
 
    	
UK
   currency
    	
 
    	
Total/£
    	
 
    
	
Pharma
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Diagnostic
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Other
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

Sub-Licensee Royalties

 

	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
*Net Sales Value
    	
 
    	
 
    
	
Products
    	
 
    	
Royalty
   Rate
    	
 
    	
Territory
    	
 
    	
No of
   products
    	
 
    	
Local
   currency
    	
 
    	
Conversion rate
    	
 
    	
UK
   currency
    	
 
    	
Total/£
    
	
Pharma
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Diagnostic
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Other
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Grand Total
    	
 
    	
 
    	
 
    	
 
    

 

(All Royalties due with this Royalty Report)

 

* If deductions are made to arrive at Net Sales Value, please provide copy customer invoices showing that these sums were charged separately

 

SUB-LICENCE INCOME (Other than Royalties)

 

Sub-licence Income arising during the Payment Period (Clause 4.3(b))

 

	
Date of Invoice
    	
 
    	
Date of Receipt
    	
 
    	
Payment Rate
    	
 
    	
Local Currency
    	
 
    	
Conversion Rate
    	
 
    	
UK
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

Part B:   Payment Slip

 

	
Licensee Name:
    	
 
    	
Case Number:
    
	
Licensee Invoice
   Address:
    	
 
    	
Date of Agreement:
    
	
Licensed Technology
   known as:
    	
 
    	
Commencement Date:
    
	
Nature of the Payment: [ie   annual fee/milestone payment etc:
    This payment is [not]   subject to RPI [under clause 4.6(c)]
    	
 
    	
Expiry of Agreement:
   Term: From the Commencement Date until
   expiry
    
				

 

*** = 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.

 

25

 

Schedule 3

 

Part C:  Payment and Report  Schedule

 

	
Licensee Name:
    	
 
    	
Case Number:
    
	
Licensee Invoice Address:
    	
 
    	
Date of Agreement:
    
	
Licensed Technology known
   as:
    	
 
    	
Commencement
   Date:
    
	
 
    	
 
    	
Expiry of
    Agreement:
    
	
Payment Periods: [***] month periods   ending on [31st March and 30th
   September]
    	
Term: From the Commencement   Date
   until expiry
    
	
 
    	
 
    
	
Due date for payment: within *** days of the payment date specified in the   right hand column below  (Interest is payable if this   period is exceeded.) Payments   due between the end of the final Payment Period and termination or expiry of   this Agreement shall be paid within *** days of termination or expiry.
    
	
 
    
	
Each payment shall be   accompanied by a payment slip (as in Part B above) identifying the   nature of the payment. Other types of reports are also required (see the   right hand column below)
    

 

	
Event 
    	
 
    	
Payment and reports dates
    	
 
    
	
***
    	
 
    	
Payment date - ***
    	
 
    
	
***
    	
 
    	
 
    	
 
    
	
***
    	
 
    	
Payment date - ***
    	
 
    
	
***
    	
 
    	
Payment date - ***
    	
 
    
	
***
    	
 
    	
Payment date - ***
    	
 
    
	
***
    	
 
    	
Payment date - ***
    	
 
    
	
***
    	
 
    	
Payment 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.

 

26Exhibit 10.4

 

NON-EXCLUSIVE LICENSE AGREEMENT

 

This Agreement is made and entered into as of the 30th  day of March, 2012 (“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, having an office at 200 Gardner Steel Conference Center, Thackeray and O’Hara Street, Pittsburgh, Pennsylvania 15260 (“University”), and Stemline Therapeutics, Inc., having its principal office at ***, New York, New York 10128 (“Licensee”).

 

WHEREAS, University is the owner by assignment from the inventors of certain Patent Rights, entitled “***,” developed by ***, 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 the Licensed Product 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 non-exclusive 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 Licensee, “Affiliate” shall mean any corporation or other entity which controls, is controlled by or is under common control with Licensee. A corporation or other entity shall be regarded as in control of another corporation or 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.

 

 

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

 

1.3                                 “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 Technology is used or in which such product or part thereof or service is used or sold.

 

1.4                                 “Net Sales” shall mean the gross invoice price for Licensed Product sold by Licensee or its sublicensee(s) less the sum of the following:

 

(a)                                  Actual cost of freight charges or freight absorption, to include shipping and insurance charges, 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;

 

(d)                                 actual credits or refunds for recalled, defective, damaged or returned Licensed Product, including actual expenses related to disposal; and

 

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

 

*** = 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

 

1.5                                 “Patent Rights” shall mean University intellectual property described below:

 

(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 of these applications;

 

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

 

(d)                                 Claims of all 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;

 

(e)                                  Claims of all foreign patent applications, and of the resulting patents, which are directed to subject matter specifically described in the United States patents and/or patent applications described in (a), (b), (c) or (d) above.

 

1.6                                 “Field” shall mean use of Licensed Product or Patent Rights in or packaged with Licensee’s Proprietary Vaccine for administration to humans for the diagnosis, prevention and treatment of ***. For the avoidance of doubt: the Field specifically excludes use of Licensed Products and/or Patent Rights in the development of therapeutic vaccines or diagnostic tests for *** cancers.

 

1.7                                 “Non-Commercial Research and Education 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 non-profit 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.

 

1.8                                 “Exclusive Patent License Agreement” shall mean the patent and intellectual property license agreement relating to *** executed between University and Licensee on September 30, 2009.

 

*** = 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

 

1.9                                 “Combination Products” shall mean a product or service containing Licensed Product in combination with at least one additional antigen which is not covered by the Patent Rights and which is not Licensed Product hereunder.

 

1.10                           “Proprietary Vaccine” shall mean a vaccine which is developed or being developed for a therapeutic indication based on biological activity that is solely-owned or in-licensed by Licensee from third parties and which is not covered by the Patent Rights and which is not Licensed Product hereunder. For the avoidance of doubt, the *** licensed under the Exclusive Patent License Agreement shall constitute a Proprietary Vaccine.

 

ARTICLE 2 - GRANT

 

2.1                                 University hereby grants to Licensee the worldwide non-exclusive right and license in the Field, with the right to sublicense subject to Article 2.3 below, to make, have made, use, sell, offer for sale and import Licensed Products and to practice under the Patent Rights until the expiration of the last to expire claim of the Patent Rights, unless this Agreement is terminated sooner as provided herein. 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. For the avoidance of doubt, this Agreement does not grant ***.

 

2.2                                 University reserves the royalty-free, non-exclusive right to practice under the Patent Rights and to use the Licensed Technology for its own Non-Commercial Research and Education Purposes.

 

2.3                                 Licensee shall have the right to sublicense the rights, privileges and licenses granted hereunder, in whole or in part, and with respect to the entire world or a particular geographic territory, to any entity that is a permitted sublicensee under the Exclusive Patent License Agreement only in conjunction with a sublicense under the Exclusive Patent License Agreement, provided that any applicable agreement with such sublicensee is consistent with the terms and conditions hereof. For the avoidance of doubt, termination of the Exclusive Patent License Agreement shall terminate all rights to sublicense under this Section 2.3. 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

 

*** = 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

 

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.

 

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 as Patent Rights herein.

 

ARTICLE 3 - DUE DILIGENCE

 

3.1                                 Licensee, itself or through its sublicensees, shall use Commercially Reasonable Best Efforts to develop or commercialize Licensed Products as soon as practicable, consistent with sound and reasonable business practice and judgment, and to continue active, diligent marketing efforts for such product or service 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)                                  *** within *** (***) days of ***;

 

(b)                                 *** within *** (***) days of ***;

 

(c)                                  *** within ***  (***) days of ***; and

 

(d)                                 *** within *** (***) days of ***.

 

3.3                                 Licensee shall notify University of the achievement of each milestone within *** (***) days upon the achievement of the respective milestone.

 

3.4                                 Licensee’s failure to perform in accordance with Section 3.1 or to fulfill on a timely basis any one of the milestones set forth in Section 3.2 hereof shall be grounds for University to terminate this Agreement under Article 9.2(a) and upon termination all rights and interest to the Licensed Product and Patent Rights shall revert to 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.

 

5

 

ARTICLE 4 - ROYALTIES AND OTHER 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 ($***), payable in two installments, with the first installment of *** Dollars ($***) due within *** (***) business days from the Effective Date of this Agreement; and the second installment of *** Dollars ($***) payable on or before ***;

 

(b)                                 Annual maintenance fees, non-refundable and non-creditable against royalties, until the first Net Sales occur of *** Dollars ($***), to be paid within *** (***) days after each anniversary of the Effective Date;

 

(c)                                  Royalties in an amount equal to *** Percent (***%) of Net Sales per calendar quarter;. If a third party license is required in order for Licensee to exercise its rights hereunder to make, use or sell Licensed Product in such country, then Licensee shall have the right to credit *** percent (***%) of such third party royalty payments against the earned royalties owing to University under this Section 4.1(c) with respect to sales of Licensed Product in such country; provided that in no event shall the effective royalty rate on Net Sales payable to University in any quarterly period be lower than *** percent (***%) as a result of this subsection 4.1(c);

 

(d)                                 Following ***, a minimum annual royalty of *** Dollars ($***) payable in cash, but only to the extent such minimum annual royalty is greater than the aggregate annual royalty computed in accordance with Section 4.1(b) above.

 

4.2                                 Royalty payments pursuant to Section 4.1(c) above shall be paid to University in United States dollars and directed to the address set forth in Section 10.2 hereof within *** (***) days after each March 31, June 30, September 30 and December 31. The minimum royalty, pursuant to Section 4.1(d) above, if any, shall be paid to University by *** following the calendar year in which they are due.

 

*** = 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

 

4.3                                 Payments pursuant to this Agreement which are overdue shall bear interest calculated from the due date until payment is received at the higher of: (a) the rate of *** percent (***%) per annum; or (b) “prime” plus *** percent (***%). The “prime” rate used to calculate interest shall be the rate published in the “Wall Street Journal” on the first business day of each year for which such payments are due.

 

4.4                                 Licensee shall sell Licensed Products to University and its Affiliates upon request at such price(s) and on such terms and conditions as 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 AND AUDIT

 

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 ***, Licensee shall deliver to University true, accurate and detailed reports of the following information in a form as illustrated in Exhibit B:

 

(a)                                  Number of Licensed Products manufactured and sold by Licensee and all sublicensee(s);

 

(b)                                 Total billings for all such products;

 

(c)                                  Accounting for all Licensed Product services used or sold by Licensee;

 

(d)                                 Deductions set forth in Section 1.4;

 

(e)                                  Name and addresses of sublicensees; and

 

(f)                                    Total royalties due.

 

5.2                                 If, for any calendar quarter following the first commercial sale of a Licensed Product, no royalties shall be due hereunder, Licensee shall so advise University in writing within *** (***) days after the end of any such calendar quarter.

 

5.3                                 Licensee shall keep full, and shall cause all of its sublicensees to keep, 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

 

*** = 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

 

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 for *** (***) years following the end of the calendar year to which they pertain to the inspection of University or 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 *** 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.

 

5.4                                 Notwithstanding the above, commencing on ***, University shall have the right, on an annual basis, to inspect relevant technical information and other relevant information from Licensee sufficient to establish whether and to what extent Licensee is: (a) practicing the Patent Rights licensed hereunder; and (b) meeting its diligence obligations under Article 3, above.

 

5.5                                 All information provided by Licensee to University under Articles 5.1 and 5.4 shall be treated by the University as Licensee’s Confidential Information only if marked Confidential Information by Licensee. However, the University may disclose Licensee’s Confidential Information to the extent necessary to comply with applicable laws and court orders (including securities laws, regulations and guidance). 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 5.5, 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-

 

*** = 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

 

disclosure and non-use obligations at least equivalent in scope to those set forth in this Article 5.5; (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 effort to secure, or to assist the other party in securing, a protective order relating to, or confidential treatment of, such information. Nothing contained in this Article 5.5 is intended to replace, amend, or otherwise supersede the confidentiality obligations of the parties found in the Exclusive Patent License Agreement.

 

ARTICLE 6 - PATENT PROSECUTION AND INFRINGEMENT ACTIONS

 

6.1                                 University has or may apply for, seek prompt issuance of and shall use reasonable efforts to maintain during the term of this Agreement, the Patent Rights in such countries as University determines upon consultation with Licensee. In the event University desires to cease paying maintenance fees for any of the Patent Rights in any country, University shall provide Licensee with written notice thereof, which notice shall be provided to Licensee at least *** (***) days before the maintenance fees in question are due. In such event, Licensee shall have the right, but not the obligation, to pay any such maintenance fees on behalf of University.

 

6.2                                 Each party shall inform the other promptly in writing if such party becomes aware of any alleged infringement of the Patent Rights by a third party and of any available evidence thereof.

 

6.3                                 In any infringement lawsuit the University institutes to enforce the Patent Rights pursuant to this Agreement, Licensee shall, at the request of University 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.

 

6.4                                 Licensee shall be responsible for *** of all fees and costs, including attorneys’ fees, relating to the filing, prosecution and maintenance of the Patent Rights, whether incurred prior to or after the Effective Date. As used herein, Licensee’s *** of fees and costs shall equal ***. Licensee shall be required to pay ***% of fees and costs incurred 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.

 

9

 

University prior to the Effective Date in an amount of *** Dollars and *** Cents ($***) (“Pre-agreement Expenses”) which is *** of fees and costs as of the Effective Date of this Agreement. Such “Pre-agreement Expenses” shall be paid to University within *** (***) business days after the execution of this Agreement by Licensee. Fees and costs incurred by University after the Effective Date, or fees and costs incurred before the Effective Date, but not included in the Pre-agreement Expenses stated above, shall be paid by Licensee in accordance with its *** thereof within *** (***) days after receipt of University’s invoice therefor. Additionally, Licensee shall reimburse University for Licensee’s *** of University’s out-of-pocket filing, prosecution, and maintenance costs (including all attorneys’ fees and costs), for any and all 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. Payments pursuant to this Section 6.4 are not creditable against royalties.

 

ARTICLE 7 - INDEMNIFICATION/INSURANCE/LIMITATION OF LIABILITY

 

7.1                                 Licensee shall at all times during the term of this Agreement and thereafter indemnify, defend and hold University, its trustees, officers, faculty members, employees and Affiliates (“Indemnified Parties”) harmless against all third party claims 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 the production, manufacture, sale, use, lease, consumption or advertisement of the Licensed Technology or arising from or relating to this License Agreement or any obligation of Licensee hereunder (“Claims”). 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

 

*** = 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

 

hereunder shall survive termination of this Agreement and shall not be limited by any other limitation of liability elsewhere in this Agreement.

 

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).

 

7.2                                 Licensee shall obtain and carry in full force and effect liability insurance which shall protect Licensee and University in regard to events covered by Section 7.1 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
    	
 
    	
$***
    

 

The University of Pittsburgh is to be named as an additional insured with respect to insurance policies identified in Sections 7.2(a) and 7.2(b) above.

 

Certificates of insurance evidencing the coverage required above shall be filed with University’s Office of Technology Management, 200 Gardner Steel Conference Center, Thackeray & O’Hara Streets, Pittsburgh, PA 15260, no later than *** (***) days after execution of this Agreement and on or before *** of each subsequent year during the pendency of this Agreement. 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.

 

11

 

7.3                                 University represents and warrants that University owns the Patent Rights and has the right to grant the rights set forth in this License Agreement.

 

7.4                                 EXCEPT AS SPECIFICALLY SET FORTH IN ARTICLE 7.3 ABOVE, UNIVERSITY, AND ITS AGENTS AND/OR EMPLOYEES, MAKE NO REPRESENTATION AND EXTEND 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 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, ITS AGENTS AND/OR EMPLOYEES, 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 THIS AGREEMENT, INCLUDING THE MANUFACTURE, USE OR SALE OF THE PRODUCT(S) AND SERVICE(S) LICENSED UNDER THIS AGREEMENT BY LICENSEE. LICENSEE ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT THAT IS MANUFACTURED, USED OR SOLD BY LICENSEE WHICH IS A LICENSED PRODUCT(S) HEREUNDER.

 

ARTICLE 8 - ASSIGNMENT

 

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

 

12

 

terms of this Agreement to the same extent as Licensee; and (c) the assumption agreement is promptly delivered to University.

 

ARTICLE 9 - TERMINATION

 

9.1                                 This Agreement shall commence on the Effective Date and, unless sooner terminated under this Article 9, shall continue until the last to expire claim of the Patent Rights (“Term”).

 

9.2                                 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; or

 

(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.

 

9.3                                 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.

 

9.4                                 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 Licensed Products 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 provisions of this Section 9.4 shall survive the expiration or termination of this Agreement.

 

ARTICLE 10 - NOTICES

 

10.1                           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 carrier, with

 

*** = 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

 

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

 

10.2                           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 11 - MISCELLANEOUS

 

11.1                           This Agreement may not be amended or modified except by the execution of a written instrument signed by the University’s Executive Vice Chancellor, or its successor and/or designated University employee having signatory authority, and an authorized officer of the Licensee.

 

11.2                           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 individuals such as University employees or agents, shall be ***.

 

11.3                           The parties acknowledge that this Agreement and the Exhibits hereto set forth the entire understanding and intentions of the parties hereto as to the subject matter hereof and

 

*** = 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

 

supersedes all previous representations, negotiations, or understandings between the parties and/or its employees or agents, whether written or oral, regarding the subject matter of this Agreement.

 

11.4                           The parties acknowledge that they consulted, or had the opportunity to investigate and/or consult, with their legal counsel and/or other advisors with respect to the Patent Rights, Licensed Technology, and the terms of this Agreement.

 

11.5                           The parties agree that this Agreement constitutes an arm’s length business transaction and does not create a fiduciary relationship.

 

11.6                           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 Technology. 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.

 

11.7                           Licensee agrees that with respect to the performance of this Agreement or the practice of the rights granted by the University hereunder, it shall comply with any and all applicable United States export control laws and regulations, as well as any and all embargoes and/or other restrictions imposed by the Treasury Department’s Office of Foreign Asset Controls.

 

11.8                           If Licensee challenges the validity or enforceability of University’s Patent Rights or University’s ownership of the Patent Rights anywhere in the world, the Licensee shall continue to pay to University all royalties and other financial obligations required under this Agreement, to include patent costs and fees until the date of the first court order declaring all claims of the Patent Rights as invalid. If any such challenge is unsuccessful by Licensee, the royalty rates set forth in Article 4.1 above shall automatically double in value, to include all royalty minimums and floors; and Licensee shall reimburse the University for all fees and costs associated with defending such action, to include

 

*** = 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

 

attorneys’ and expert fees. The effective date of such increase in royalty rates shall be the date of the first court order or date of issuance of a re-examination certificate (or foreign equivalents thereof) declaring any claim of the Patent Rights as valid or enforceable.

 

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

 

11.10                     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.

 

[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.

 

16

 

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.

 

17

 

EXHIBIT A
 PATENT RIGHTS FOR NON-EXCLUSIVE LICENSE AGREEMENT BETWEEN
 THE UNIVERSITY OF PITTSBURGH AND STEMLINE

 

***

 

*** = 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 B
 SAMPLE ROYALTY REPORT

 

Licensee name:
 Reporting period: Date of report:

 

Royalty Reporting Form

 

	
Product
    	
 
    	
No. units sold
    	
 
    	
Invoiced price
   per unit
    	
 
    	
Gross sales
    	
 
    	
Allowable
   deductions
    	
 
    	
Net sales
    
	
Product   name
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Product   name
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Product   name
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Product   name
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Total
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

	
Total net sales
    	
$
    	
 
    
	
Royalty rate
    	
 
    
	
Royalty due
    	
$
    	
 
    

 

Total royalty due: $                                                 

 

Report prepared by:

 

Title:
 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.

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