Exhibit 10.7
LICENSE AGREEMENT
-----------------
This License Agreement (hereinafter referred to as the "Agreement"),
effective as of the 20th day of March, 1996 is by and between The
Charlotte-Mecklenburg Hospital Authority, a public authority having an address
at X.X. Xxx 00000, Xxxxxxxxx, Xxxxx Xxxxxxxx 00000-0000 (the "Licensor") and
Triad Pharmaceuticals, Inc., a corporation duly organized and existing under the
laws of the State of Delaware and having an address at 000 Xxxx Xxxxxx, Xxxxx
0000, Xxx Xxxx, Xxx Xxxx 00000 (the "Licensee").
WHEREAS, Licensor is the joint owner of U.S. Patent No. 5,474,760 and
[***] respectively (the "Patents"); and
WHEREAS, pursuant to the Interinstitutional Agreement dated September 18,
1995, between Licensor and Duke University, a copy of which is annexed hereto as
Appendix I, Licensor has the authority to grant licenses under the Patents; and
WHEREAS, Licensee now desires to obtain a license, under the Patents, upon
the terms and conditions hereinafter set forth; and
WHEREAS, Licensee has represented to Licensor, to induce Licensor to enter
into this Agreement, that it shall commit itself to a thorough, vigorous and
diligent program of developing and exploiting the inventions described in the
Patents, so that public utilization shall result therefrom; and
NOW, THEREFORE, it is agreed as follows:
[***] Confidential treatment requested.
ARTICLE 1 - DEFINITIONS
-----------------------
For the purposes of this Agreement, the following words and phrases, if
appearing in this Agreement in capitalized form, shall have the following
meanings:
1.1 "Licensee" shall mean Triad Pharmaceuticals, Inc., a Delaware
corporation.
1.2 "Affiliate" shall mean
(i) any company or entity, the voting control of which is at least
fifty percent (50%), directly or indirectly, owned or controlled by
Licensee, or
(ii) any company or entity that owns or controls at least fifty
percent (50%), directly or indirectly, of Licensee (a "Parent"), or
(iii) any company or entity, the voting control of which is at least
fifty percent (50%), directly or indirectly, owned or controlled by a
Parent of Licensee.
1.3 "Patent Rights" shall mean:
1.3.1 U.S. Patent No. 5,474,760 and U.S. Patent Applications Serial
Nos. [***] respectively, as set forth in Appendix II;
1.3.2 Any later-filed United States and/or foreign patent applications
based on the patent applications and/or patents listed in Appendix II, or
corresponding thereto, including any continuations, continuations-in-part,
divisional, reissues, reexaminations, or extensions thereof; and
1.3.3 Any United States and/or foreign patents issuing from any of the
foregoing.
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1.4 "Licensed Product(s)" shall mean:
1.4.1 Any product which is covered in whole or in part by a valid and
unexpired claim contained in the Patent Rights in the country in which the
product is made, used, leased or sold;
1.4.2 Any product which is manufactured by using a process which is
covered in whole or in part by a valid and unexpired claim contained in the
Patent Rights in the country in which the process is used;
1.4.3 Any product which is used according to a method which is covered
in whole or in part by a valid and unexpired claim contained in the Patent
Rights in the country in which the method is used.
1.5 "Licensed Process(es)" shall mean any process or method, which is
covered, in whole, or in part, by a valid and unexpired claim contained in the
Patent Rights in the country in which the process or method is used.
1.6 "Net Sales" shall mean Licensee's, a Sublicensee's, or an Affiliate's
xxxxxxxx for Licensed Products and Licensed Processes less the sum of the
following:
(a) discounts allowed and credited in amounts customary in the trade;
(b) sales, tariff duties and/or use taxes directly imposed and with
reference to particular sales;
(c) outbound transportation prepaid or allowed;
(d) amounts allowed or credited on returns; and
(e) bad debt deductions actually written off during the period.
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No deductions shall be made for commissions paid to individuals whether
they be independent sales agencies or regularly employed by Licensee, the
Sublicensee or the Affiliate, as the case may be. Licensed Products and Licensed
Processes shall be considered "sold" when billed out or invoiced.
1.7 "Sublicensee" shall mean any company or entity directly or indirectly
obtaining a sublicense under this Agreement to practice under the Patent Rights,
or to make, have made, use, lease and/or sell the Licensed Products or tO
practice the Licensed Processes. For purposes of calculating royalties due to
Licensor under Article 4 of this Agreement, the term "Sublicensee" shall include
a buyer of Licensed Products or Licensed Processes sold by Licensee, an
Affiliate or a Sublicensee that is, on the information and belief of the
Licensee, a reseller of such products or processes, other than, resellers
involved in the distribution of Licensed Products or Licensed Processes to
persons that appear to be, on the information and belief of Licensee, the
intended users of such products or processes. The exemption for retailers from
the definition of "Sublicensees" under this Section 1.7 shall only apply to the
extent that a royalty has been paid to make, have made, use, lease, and/or sell
the Licensed Products or to practice the Licensed Processes. For example,
pharmacies, pharmacists, hospitals or doctors that purchase Licensed Products or
Licensed Processes from Licensee, Sublicensee or an Affiliate that, on the
information and belief of Licensee, intend to supply and/or dispense such
products or processes to patients will not be considered Sublicensees for
purposes of calculating royalties due to Licensor under Article 4 of this
Agreement.
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ARTICLE 2 - GRANT
-----------------
2.1 Licensor hereby grants to Licensee a worldwide royalty bearing license
to practice under the Patent Rights, and to make, have made, use, lease and/or
sell the Licensed Products and to practice the Licensed Processes, to the full
end of the term for which the Patent Rights are granted, unless sooner
terminated as hereinafter provided, said license to include the right to
sublicense and to be exclusive to Licensee.
ARTICLE 3 - DUE DILIGENCE
-------------------------
3.1 Licensee shall use its reasonable best efforts to bring Licensed
Products or Licensed Processes to market through a thorough, vigorous and
diligent program for exploitation of the Patent Rights and continue active,
diligent marketing efforts for Licensed Products or Licensed Processes
throughout the life of this Agreement.
3.2 Licensee will begin human clinical trials of tyloxapol in the
indication of cystic fibrosis pursuant to the general protocol described in the
Investigational New Drug application number 48,478 within six months of the date
of this Agreement with an aggregate contracted cost in excess of $[***];
provided, however, that such six month period shall be extended for any period
in which initiation of the clinical trials is either not technically or legally
possible due to events outside the control of the Licensee.
3.3 Licensee's failure to perform the due diligence obligations described
in Paragraphs 3.1, and 3.2. shall constitute a material breach or default for
purposes of the termination provisions of Paragraph 7.3.
3.4 [***]
[***] Confidential treatment requested.
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[***]
3.5 [***]
ARTICLE 4 - ROYALTIES
---------------------
4.1 For the rights, privileges and license granted hereunder, Licensee
shall pay to Licensor, as set forth below, to the end of the term of the Patent
Rights or until this Agreement shall be terminated as hereinafter provided:
4.1.1 In each calendar year, a royalty in an amount equal to
[***] of Net Sales of the Licensed Products or Licensed Processes
sold by
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[***]
4.1.2 In each calendar year, a royalty in an amount equal to [***]
of the license fees or other lump sum payments received by
Licensee and its Affiliates from Sublicensees for the manufacture, use,
lease or sale of Licensed Products and Licensed Processes; [***]
4.1.3 Upon execution of this Agreement, Licensee shall pay Licensor a
nonrefundable, one time, license issue fee in the amount of eighty six
thousand four hundred dollars ($86,400).
4.1.4 [***]
4.1.5 [***]
[***] Confidential treatment requested.
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4.2 No multiple royalties shall be payable because the use, lease or sale
of any Licensed Product or Licensed Process is, or shall be, covered by more
than one valid and unexpired claim contained in the Patent Rights.
4.3 Royalty payments shall be paid in United States dollars in New York or
at such other place as Licensor may reasonably designate consistent with the
laws and regulations controlling in any foreign country. If any currency
conversion shall be required in connection with the payment of royalties
hereunder, such conversion shall be made by using the exchange rate prevailing
at Citibank, N.A. in New York, on the last business day of the calendar
quarterly reporting period to which such royalty payments relate.
ARTICLE 5 - REPORTS AND RECORDS
-------------------------------
5.1 Licensee shall keep full, true and accurate books of account containing
all particulars that may be necessary for the purpose of showing the amount
payable by Licensee, Affiliates and Sublicensees to Licensor by way of royalty
as aforesaid. Said books of account shall be kept at Licensee's principal place
of business in the United States. Said books and the supporting data shall be
open upon reasonable notice to Licensee no more than twice per calendar year,
for five (5) years following the end of the calendar year to which they pertain,
for inspection and copying by the Licensor's internal audit division or
corporate officer and/or by an independent certified public accountant employed
by Licensor for the purpose of verifying Licensee's royalty statement or
compliance in other respects with this Agreement.
5.2 Following the first commercial sale of Licensed Products or Licensed
Processes, Licensee, within sixty (60) days after the end of each semi-annual
period of
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each calendar year, shall deliver to Licensor true and accurate reports, giving
such particulars of the business conducted by Licensee during the preceding
half-year under this Agreement as shall be pertinent to a royalty accounting
hereunder. These shall include at least the following:
(a) All Licensed Products and Licensed Processes made, used, leased or
sold, by or for Licensee, its Affiliates and Sublicensees.
(b) Total amounts invoiced for Licensed Products and Licensed Processes
made, used, leased or sold, by or for Licensee, its Affiliates or its
Sublicensees.
(c) Deductions applicable in computed "Net Sales" as defined in Paragraph
1.6.
(e) Total royalties due based on Net Sales by or for Licensee, its
Affiliates or its Sublicensees.
(f) Names and addresses of all Sublicensees and Affiliates of Licensee.
(h) On an annual basis, Licensee's Annual Report.
5.3 With each such report submitted, Licensee shall pay to Licensor the
royalties due and payable under this Agreement. If no royalties shall be due,
Licensee shall so report.
ARTICLE 6 - PATENT PROSECUTION
------------------------------
Licensee, at its own expense and utilizing patent counsel that is mutually
agreeable to Licensee and Licensor, shall have the sole right and responsibility
for the filing, prosecution, and maintenance of any patent applications and
patents contained in the Patent Rights. Licensee, or its patent counsel, shall
provide Licensor with copies of all correspondence and documents filed with, or
received from, the United States Patent
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and Trademark Office or any foreign patent office or patent agent. In addition,
Licensee agrees that any and all official or "ribbon" copies of issued patents
shall be forwarded to, and retained by, Licensor. The parties agree that the law
firm of Xxxx Xxxxxxx Park & Xxxxxx located in Charlotte, North Carolina, will be
considered to be mutually agreeable patent counsel for purposes of this Article
6.
ARTICLE 7 - TERMINATION
-----------------------
7.1 If Licensee shall become bankrupt or insolvent, or shall file a
petition in bankruptcy, or if the business of Licensee shall be placed in the
hands of a receiver, assignee or trustee for the benefit of creditors, whether
by the voluntary act of Licensee or otherwise, this Agreement shall
automatically terminate.
7.2 Time is of the essence for all payments due. Should Licensee fail in
its payment to Licensor of royalties or license fees due in accordance with the
terms of this Agreement which are not the subject of a bona fide dispute between
Licensor and Licensee, Licensor shall have the right to serve notice upon
Licensee, by certified mail to the address designated in Article 14 hereof, of
its intention to terminate this Agreement within sixty (60) days after receipt
of said notice of termination unless Licensee shall pay to Licensor, within the
sixty (60) day period, all such royalties or license fees due and payable. Upon
the expiration of the sixty (60) day period, if Licensee shall not have paid all
such royalties or license fees due and payable, the rights, privileges and
license granted hereunder shall thereupon immediately terminate. Payments shall
not be delayed, escrowed or otherwise withheld absent a court order prohibiting
such payments.
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7.3 Upon any material breach or default of this Agreement by Licensee,
other than those occurrences set out in Paragraphs 7.1 and 7.2 hereinabove,
which shall always take precedence in that order over any material breach or
default referred to in this Paragraph 7.3, Licensor shall have the right to
terminate this Agreement and the rights, privileges and license granted
hereunder by ninety (90) days' notice to Licensee by certified mail to the
address designated in Article 14 hereof. Such termination shall become effective
unless Licensee shall have cured any such breach or default prior to the
expiration of the ninety (90) day period from receipt of the notice of
termination.
7.4 Licensee shall have the right to terminate this Agreement at any time
on sixty (60) days' notice to Licensor by certified mail to the address
designated in Article 14 hereof.
7.5 Upon termination of this Agreement for any reason, nothing herein shall
be construed to release either party from any obligation that matured prior to
the effective date of such termination. Licensee and/or any Sublicensee thereof
may, however, after the effective date of such termination, sell all Licensed
Products, and complete Licensed Products in the process of manufacture at the
time of such termination, and sell the same, provided that Licensee shall pay to
Licensor the royalties thereon as required by Article 5 of this Agreement and
shall submit the reports required by Article 5 hereof on the sales of Licensed
Products.
7.6 Except as provided in Paragraph 7.5, upon termination, Licensee will
return all technology and rights to the Licensed Products and Licensed
Processes, and both Licensor and Licensee will cooperate in executing the
necessary documentation.
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ARTICLE 8 - ARBITRATION
-----------------------
8.1 Except as to issues relating to the validity, enforceability, or
infringement of any patent contained in the Patent Rights licensed hereunder,
any and all claims, disputes or controversies arising under, out of, or in
connection with this Agreement, which have not been resolved by good faith
negotiations between the parties, shall be resolved by final and binding
arbitration in any United States court or tribunal having jurisdiction thereof
under the rules of the American Arbitration Association then in effect. The
arbitrators shall have no power to add to, subtract from, or modify any of the
terms or conditions of this Agreement. Any award rendered in such arbitration
may be enforced by either party in either the state or federal courts to whose
jurisdiction for such purposes Licensor and Licensee each hereby irrevocably
consents and submits.
8.1.1 The arbitration tribunal shall consist of three arbitrators.
Each party shall nominate in the request for arbitration and the answer
thereto one arbitrator, and these two arbitrators will then jointly appoint
a third arbitrator as chairman of the arbitration tribunal.
8.2 Any claim, dispute, or controversy concerning the validity,
enforceability, or infringement of any patent contained in the Patent Rights
licensed hereunder shall be resolved in any court having jurisdiction thereof.
8.3 In the event that, in any arbitration proceeding, any issue shall arise
concerning the validity, enforceability, or infringement of any patent contained
in the Patent Rights licensed hereunder, the arbitrators shall, to the extent
possible, resolve all issues other than validity, enforceability, and
infringement; in any event, the arbitrators
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shall not delay the arbitration proceeding for the purpose of obtaining or
permitting either party to obtain judicial resolution of such issues, unless an
order staying the arbitration proceeding shall be entered by a court of
competent jurisdiction. Neither party shall raise any issue concerning the
validity, enforceability, or infringement of any patent contained in the Patent
Rights licensed hereunder, in any proceeding to enforce any arbitration award
hereunder, or in any proceeding otherwise arising out of any such arbitration
award.
ARTICLE 9 - INFRINGEMENT AND OTHER ACTIONS
------------------------------------------
9.1 Licensee and Licensor shall promptly provide written notice, to the
other party, of any alleged infringement by a third party of the Patent Rights
and provide such other party with any available evidence of such infringement.
9.2 During the term of this Agreement, Licensee shall have the right, but
not the obligation, to prosecute and/or defend, at its own expense and utilizing
counsel of its choice, any infringement of, and/or challenge to, the Patent
Rights. In furtherance of such right, Licensor hereby agrees that Licensee may
join Licensor as a party in any such suit. [***] No settlement, consent
judgment or other voluntary final disposition of any such suit may be
entered into without the consent of Licensor, which consent shall not
unreasonably be withheld.
9.3 [***]
[***] Confidential treatment requested.
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[***]
9.4 If within six (6) months after receiving notice of any alleged
infringement, Licensee shall have been unsuccessful in persuading the alleged
infringer to desist, or shall not have brought and shall not be diligently
prosecuting an infringement action, or if Licensee shall notify Licensor, at any
time prior thereto, of its intention not to bring suit against the alleged
infringer, then, and in those events only, Licensor shall have the right, but
not the obligation, to prosecute, at its own expense and utilizing counsel of
its choice, any infringement of the Patent Rights, and Licensor may, for such
purposes, join the Licensee as a party plaintiff. [***]
9.5 In any suit to enforce and/or defend the Patent Rights pursuant to this
Agreement, the party not in control of such suit shall, at the request and
expense of the controlling party, cooperate in all respects and, to the extent
possible, have its employees testify when requested and make available relevant
records, papers, information, samples, specimens, and the like.
ARTICLE 10 - REPRESENTATIONS AND INDEMNIFICATION
------------------------------------------------
10.1 Licensor, by this Agreement, represents and warrants that it has the
sole and exclusive, unencumbered, right, title and interest to the Patent Rights
other than as set forth in the Interinstitutional Agreement between Licensor and
Duke University, a
[***] Confidential treatment requested.
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true and complete copy of which is annexed hereto as Appendix I. Licensor, by
this Agreement, makes no representation as to the patentability and/or breadth
of the inventions contained in the Patent Rights. Licensor, by this Agreement,
makes no representation as to patents now held or which will be held by others
in the field of the Licensed Products and Licensed Processes for a particular
purpose. Licensor, by this Agreement, disclaims all warranties and
representations not expressly set forth.
10.2 Licensee agrees to indemnify, hold harmless, and defend Licensor, its
trustees, officers, employees, and agents, against any and all claims, suits,
losses, damages, costs, fees, and expenses, including attorneys fees, resulting
or arising out of the exercise of this license. Licensee shall not be
responsible for the negligence or intentional wrongdoing of Licensor.
10.3 Licensee shall maintain in force at its sole cost and expense with
reputable insurance companies, products liability insurance coverage in an
amount reasonably sufficient to protect against liability under Article 10.2
above. Licensor shall have the right to ascertain from time to time that such
coverage exists, such right to be exercised in a reasonable manner.
10.4 Nothing in this agreement shall be deemed to be a representation or
warranty by Licensor of the validity of any of the patents or the accuracy,
safety, efficacy, or usefulness for any purpose, of any Subject Technology.
Licensor shall have no obligation, express or implied, to supervise, monitor,
review, or otherwise assume responsibility for production, manufacture, testing,
marketing, or sale of any Licensed Product, and Licensor shall have no liability
whatsoever to Licensee or any third parties
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for or on account of any injury, loss, or damage, of any kind or nature,
sustained by, or any damage assessed or asserted against, or any other liability
incurred by or imposed upon licensee or any other person or entity, arising out
of or in connection with or resulting from:
10.4.1 the production, use, or sale of any Licensed Product;
10.4.2 the use of any Subject Technology; or
10.4.3 advertising or other promotional activities with respect to any
of the foregoing.
10.5 Neither party hereto is an agent of the other party for any
purpose whatsoever.
ARTICLE 11 - ASSIGNMENT
-----------------------
Licensee may assign or otherwise transfer this Agreement and the license
granted hereunder and the rights acquired by it hereunder so long as such
assignment or transfer shall be accompanied by a sale or other transfer of
Licensee's entire business or of that part of Licensee's business to which the
license granted hereunder relates; provided further that such assignment or
transfer has the consent of Licensor, which consent shall not be withheld
unreasonably. Upon such assignment or transfer and agreement by such assignee or
transferee, the term Licensee as used herein shall include such assignee or
transferee.
ARTICLE 12 - NON-USE OF NAMES
-----------------------------
Licensee shall not use the name of Licensor or any adaptation thereof in
any advertising, promotional or sales literature without prior written consent
obtained from
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Licensor, in each case, except that Licensee may state that it is licensed by
Licensor, under one or more of the patents and/or applications comprising the
Patent Rights.
ARTICLE 13 - PAYMENTS NOTICES
------------------------------
AND OTHER COMMUNICATIONS
------------------------
Any payment, notice or other communication pursuant to this Agreement shall
be sufficiently made or given on the date of mailing if sent to such party by
certified first class mail, postage prepaid, addressed to it at its address
below or as it shall designate by written notice given to the other party:
In the case of Licensor:
The Charlotte-Mecklenburg Hospital Authority
X.X. Xxx 00000
Xxxxxxxxx, Xxxxx Xxxxxxxx 00000-0000
Attn: Xxxxx X. Xxxxxx, Ph.D.
In the case of Licensee:
Triad Pharmaceuticals, Inc.
000 Xxxx Xxxxxx, Xxxxx 0000
Xxx Xxxx, Xxx Xxxx 00000
Attn: Xxxxx X. Xxxxxx, Esq.
ARTICLE 14 - MISCELLANEOUS PROVISIONS
-------------------------------------
14.1 This Agreement shall be construed, governed, interpreted and applied
in accordance with the laws of the State of North Carolina, except that
questions affecting the validity, enforceability, or infringement of any patent
contained in the Patent Rights shall be determined by the law of the country in
which the patent was granted.
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14.2 The parties hereto acknowledge that this Agreement sets forth the
entire agreement and understanding of the parties hereto as to the subject
matter hereof, and shall not be subject to any change or modification except by
the execution of a written instrument subscribed to by the parties hereto.
14.3 The provisions of this Agreement are severable, and in the event that
any provision of this Agreement shall be determined to be invalid or
unenforceable under any controlling body of law, such invalidity or
unenforceability shall not in any way affect the validity or enforceability of
the remaining provisions hereof.
14.4 Licensee agrees to xxxx the Licensed Products sold in the United
States with all applicable United States patent numbers. All Licensed Products
shipped to, or sold in, other countries shall be marked in such a manner as to
conform with the patent laws and practice of the country of manufacture or sale.
14.5 The failure of either party to assert a right hereunder or to insist
upon compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other party.
ARTICLE 15 - GOVERNMENT CLEARANCE, PUBLICATION, OTHER USE, EXPORT
-----------------------------------------------------------------
15.1 Licensee agrees to use its best efforts to have the Subject Technology
cleared for marketing in those countries in which Licensee intends to sell
Licensed Products by the responsible government agencies requiring such
clearance. To accomplish such clearances at the earliest possible date, Licensee
agrees to file,
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according to the usual practice of Licensee, any necessary data with such
government agencies. Should Licensee cancel this Agreement, Licensee agrees to
assign its full interest and title in such market clearance application,
including all data relating thereto, to Licensor at no cost to Licensor.
15.2 Licensee further agrees that the right of publication of the invention
and such Subject Technology shall reside in the inventor and other staff of
Licensor. Licensor shall use its best efforts to provide a copy of such
publications forty-five (45) days in advance of such submission for review by
Licensee, but such review will be in no way construed as a right to restrict
such publication. Licensee shall also have the right to publish and/or co-author
any publication regarding the application of the Subject Technology.
15.3 It is agreed that, notwithstanding any provisions herein, Licensor is
free to use the Subject Technology and Patent Rights for its own educational,
teaching, research, and clinical purposes without restriction and without
payment of royalties or other fees.
15.4 This Agreement is subject to all of the United States laws and
regulations controlling the export of technical data, computer software,
laboratory prototypes, and other commodities and technology.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement, in
duplicate, by proper persons thereunto duly authorized.
THE XXXXXXXXX XXXXXXXXXXX HOSPITAL AUTHORITY
By: /s/ Xxxxx X. Xxxxxx
------------------------------------
Xxxxx X. Xxxxxx, Ph.D.
Vice President of Research
March 5, 1996
TRIAD PHARMACEUTICALS, INC.
By: /s/ Xxxxx Xxxxxx
------------------------------------
President
------------------------------------
March 20, 1996
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APPENDIX I
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Interinstitutional Agreement
APPENDIX II
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1. U.S. Patent No. 5,474,760;
[***]
[***] Confidential treatment requested.
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