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Search IP Intellectual Property License Assignment Agreement by:
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Exhibit 10.15
NATIONAL INSTITUTES OF HEALTH
CENTERS FOR DISEASE CONTROL
PATENT LICENSE AGREEMENT -- EXCLUSIVE
COVER PAGE
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For Office of Technology Transfer/NIH internal use only:
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Patent License Number: L-135-94
Serial Numbers of Licensed Patents: USPA SN 07/861,249
SN 08/065,618
Licensee: MediChem Research, Inc.
CRADA Number (if applicable):
Additional Remarks:
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This Patent License Agreement, hereinafter referred to as the "Agreement,"
consists of this Cover Page, an attached Agreement, a Signature Page, Appendix A
(Patent or Patent Application), Appendix B (Fields of Use and Territory),
Appendix C (Royalties), Appendix D (Modifications), and Appendix E (Benchmarks).
This Cover Page serves to identify the Parties to this Agreement:
1) The National Institutes of Health ("NIB") or the Centers for
Disease Control ("CDC"), hereinafter singly or collectively
referred to as "PES," agencies of the United States Public Health
Service within the Department of Health and Human Services
("DHHS"); and
2) The person, corporation, or institution identified above and/or on
the Signature Page, having offices at the address indicated on the
Signature Page, hereinafter referred to as "Licensee."
NIH Office of Technology Transfer
PHS PATENT LICENSE AGREEMENT - EXCLUSIVE
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PHS PATENT LICENSE AGREEMENT-EXCLUSIVE
PHS and Licensee agree as follows:
1. BACKGROUND
1.01 In the course of conducting biomedical and behavioral research,
PHS investigators made inventions that may have commercial
applicability.
1.02 By assignment of rights from PHS employees and other inventors,
DHHS, on behalf of the United States Government, owns intellectual
property rights claimed in any United States and foreign patent
applications or patents corresponding to the assigned inventions.
DHHS also owns any tangible embodiments of these inventions
actually reduced to practice by PHS.
1.03 The Assistant Secretary for Health of DHHS has delegated to PHS
the authority to enter into this Agreement for the licensing of
rights to these inventions under 35 U.S.C. Sections 200-212, the
Federal Technology Transfer Act of 1986, 15 U.S.C. Section 3710a,
and/or the regulations governing the licensing of Government-owned
inventions, 37 CFR Part 404.
1.04 PHS desires to transfer these inventions to the private sector
through commercialization licenses to facilitate the commercial
development of products and processes for public use and benefit.
1.05 Licensee desires to acquire commercialization rights to certain of
these inventions in order to develop processes, methods, or
marketable products for public use and benefit.
2. DEFINITIONS
2.01 "Licensed Patent Rights" shall mean:
a) U.S. patent applications and patents listed in Appendix A,
all divisions and continuations of these applications, all
patents issuing from such applications, divisions, and
continuations, and any reissues, reexaminations, and
extensions of all such patents;
b) to the extent that the following contain one or more claims
directed to the invention or inventions claimed in a)
above: i) continuations-in-part of a) above; ii) all
divisions and continuations of these continuations-in-part;
iii) all patents issuing from such continuations-in-part,
divisions, and continuations; and iv) any reissues,
reexaminations, and extensions of all such patents;
c) to the extent that the following contain one or more claims
directed to the invention or inventions claimed in a)
above:
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all counterpart foreign applications and patents to a) and
b) above, including those listed in Appendix A.
Licensed Patent Rights shall not include b) or c) above to
the extent that they contain one or more claims directed to
new matter which is not the subject matter of a claim in a)
above.
2.02 "Licensed Product(s)" means tangible materials which, in the
course of manufacture, use, or sale would, in the absence of this
Agreement, infringe one or more claims of the Licensed Patent
Rights that have not been held invalid or unenforceable by an
unappealed or unappealable judgement of a court of competent
jurisdiction.
2.03 "Licensed Process(es)" means processes which, in the course of
being practiced would, in the absence of this Agreement, infringe
one or more claims of the Licensed Patent Rights that have not
been held invalid or unenforceable by an unappealed or
unappealable judgment of a court of competent jurisdiction.
2.04 "Licensed Territory" means the geographical area identified in
Appendix B.
2.05 "Net Sales" means the total gross receipts for sales of Licensed
Products or practice of Licensed Processes by or on behalf of
Licensee or its sublicensees, and from leasing, renting, or
otherwise making Licensed Products available to others without
sale or other dispositions, whether invoiced or not, less returns
and allowances actually granted, packing costs, insurance costs,
freight out, taxes or excise duties imposed on the transaction (if
separately invoiced), and wholesaler and cash discounts in amounts
customary in the trade. No deductions shall be made for
commissions paid to individuals, whether they be with independent
sales agencies or regularly employed by Licensee, or sublicensees,
and on its payroll, or for the cost of collections.
2.06 "First Commercial Sale" means the initial transfer by or on behalf
of Licensee or its sublicensees of Licensed Products or the
initial practice of a Licensed Process by or on behalf of Licensee
or its sublicensees in exchange for cash or some equivalent to
which value can be assigned for the purpose of determining Net
Sales.
2.07 "Government" means the government of the United States of America.
2.08 "Licensed Fields of Use" means the fields of use identified in
Appendix B.
3. GRANT OF RIGHTS
3.01 PHS hereby grants and Licensee accepts, subject to the terms and
conditions of this Agreement, an exclusive license to Licensee
under the Licensed Patent Rights in the Licensed Territory to make
and have made, to use and have used, and to sell and have sold any
NIH Office of Technology Transfer
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Licensed Products in the Licensed Fields of Use and to practice
and have practiced any Licensed Processes in the Licensed Fields
of Use.
3.02 This Agreement confers no license or rights by implication,
estoppel, or otherwise under any patent applications or patents of
PHS other than Licensed Patent Rights regardless of whether such
patents are dominant or subordinate to Licensed Patent Rights.
4. SUBLICENSING
4.01 Upon written approval by PHS, which approval will not be
unreasonably withheld, Licensee may enter into sublicensing
agreements under the Licensed Patent Rights.
4.02 Licensee agrees that any sublicensee granted by it shall provide
that the obligations to PHS of Paragraphs 5.01-5.05, 8.01, 10.01,
10.02, 12.05, and 13.08-13.11 of this Agreement shall be binding
upon the sublicensee as if it were a party to this Agreement.
Licensee further agrees to attach copies of these Paragraphs to
all sublicense agreements.
4.03 Any sublicensee granted by Licensee shall provide for the
termination of the sublicense, or the conversion to a license
directly between such sublicensees and PHS, at the option of the
sublicensee, upon termination of this Agreement under Article 13.
Such conversion is subject to PHS approval and contingent upon
acceptance by the sublicensee of the remaining provisions of this
Agreement.
4.04 Licensee agrees to forward to PHS a copy of each fully executed
sublicense agreement postmarked within sixty (60) days of the
execution of such agreement.
5. STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
5.01 PHS reserves on behalf of the Government an irrevocable,
nonexclusive, nontransferable, royalty-free license for the
practice of all inventions licensed under the Licensed Patent
Rights throughout the world by or on behalf of the Government and
on behalf of any foreign government or international organization
pursuant to any existing or future treaty or agreement to which
the Government is a signatory.
5.02 Licensee agrees that products used or sold in the United States
embodying Licensed Products or produced through use of Licensed
Processes shall be manufactured substantially in the United
States, unless a written waiver is obtained in advance from PHS.
5.03 Licensee acknowledges that PHS may enter into future Cooperative
Research and Development Agreements (CRADAs) under the Federal
Technology Transfer Act of 1986 that relate to the subject matter
of
NIH Office of Technology Transfer
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this Agreement. Licensee agrees not to unreasonably deny requests
for sublicense or cross-license rights from such future
collaborators with PHS when acquiring such derivative rights is
necessary in order to make a CRADA project feasible. Licensee may
request an opportunity to join as a party to the proposed CRADA.
5.04 DHHS has responsibility for funding basic biomedical research, for
funding medical treatment through programs such as Medicare and
Medicaid, for providing direct medical care and, more generally,
for protecting the health and safety of the public. Because of
these responsibilities, and the public investment in the research
that culminated in the Licensed Patent Rights, PHS may require
Licensee to submit documentation in confidence showing a
reasonable relationship between the pricing of a Licensed Product,
the public investment in that product, and the health and safety
needs of the public. This paragraph shall not restrict the right
of Licensee to price a Licensed Product or Licensed Process so as
to obtain a reasonable profit for its sale or use. This Paragraph
5.04 does not permit PHS to set or dictate prices for Licensed
Products or Licensed Processes.
5.05 In addition to the reserved license of Paragraph 5.01 above, PHS
reserves the right to grant nonexclusive licenses to make and to
use the inventions defined by the Licensed Patent Rights for
purposes of research involving the inventions themselves, and not
for purposes of commercial manufacture or in lieu of purchase if
the inventions are available as commercial products for research
purposes. The purpose of this research license is to encourage
basic research, whether conducted at an academic or corporate
facility. In order to safeguard the Licensed Patent Rights,
however, PHS shall consult with Licensee before granting to
commercial entities a research license or providing to them
research samples of the materials claimed in the Licensed Patent
Rights.
6. ROYALTIES AND REIMBURSEMENT
6.01 Licensee agrees to pay to PHS a noncreditable, nonrefundable
license issue royalty as set forth in Appendix C within thirty
(30) days from the date that this Agreement becomes effective.
NIH Office of Technology Transfer
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6.02 Licensee agrees to pay to PHS a nonrefundable minimum annual
royalty as set forth in Appendix C. The minimum annual royalty is
due and payable on January 1 of each calendar year and may be
credited against any earned royalties due for sales made in that
year. The minimum annual royalty due for the first calendar year
of this Agreement may be prorated according to the fraction of the
calendar year remaining between the Effective Date of this
Agreement and the next subsequent January 1.
6.03 Licensee agrees to pay PHS earned royalties as set forth in
Appendix C.
6.04 Licensee agrees to pay PHS benchmark royalties as set forth in
Appendix C.
6.05 A claim of a patent or patent application licensed under this
Agreement shall cease to fall within the Licensed Patent Rights
for the purpose of computing the minimum annual royalty and earned
royalty payments in any given country on the earliest of the dates
that a) the claim has been abandoned but not continued, b) the
patent expires, c) the patent is no longer maintained by the
Government, or d) all claims of the Licensed Patent Rights have
been held to be invalid or unenforceable by an unappealed or
unappealable decision of a court of competent jurisdiction or
administrative agency.
6.06 No multiple royalties shall be payable because any Licensed
Products or Licenced Processes are covered by more than one of the
Licensed Patent Rights.
6.07 On sales of Licensed Products by Licensee to sublicensees or
affiliated parties or on sales made in other than an arm's-length
transaction, the value of the Net Sales attributed under this
Article 6 to such a transaction shall be that which would have
been received in an arm's-length transaction, based on sales of
like quantity and quality products on or about the time of such
transaction.
6.08 As an additional royalty, Licensee agrees to pay PHS, within sixty
(60) days of PHS's submission of a statement and request for
payment, an amount equivalent to all reasonable expenses
previously incurred by PHS in the preparation, filing,
prosecution, and maintenance of Licensed Patent Rights. Licensee
further agrees to pay PHS annually, within sixty (60) days of
PHS's submission of a statement and request for payment, a royalty
amount equivalent to all such future patent expenses incurred
during the previous calendar year, as of the date the statement
and request for payment is sent by PHS to Licensee. Fifty percent
(50%) of the cumulative amount of such payments may be credited
against royalties due under Paragraph 6.03; however, the net
royalty payment in any calendar year may not be lower than the
minimum annual royalty specified in Appendix B. Licensee may elect
to surrender its rights in any country of the Licensed Territory
under any Licensed Patent Rights
NIH Office of Technology Transfer
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upon sixty (60) days' written notice to PHS and owe no payment
obligation under this paragraph for subsequent patent-related
expenses incurred in that country.
7. DOMESTIC AND FOREIGN PATENT FILING, PROSECUTION, AND MAINTENANCE
7.01 PHS agrees to take responsibility for, but to consult with the
Licensee in, the preparation, filing, prosecution, and maintenance
of any and all patent applications or patents included in the
Licensed Patent Rights and shall furnish copies of relevant
patent-related documents to Licensee.
7.02 Each party shall promptly inform the other as to all matters that
come to its attention that may affect the preparation, filing,
prosecution, or maintenance of the Licensed Patent Rights and
permit each other to provide comments and suggestions with respect
to the preparation, filing, and prosecution of Licensed Patent
Rights, which comments and suggestions shall be considered by the
other party.
8. RECORD KEEPING
8.01 Licensee agrees to keep accurate and correct records of Licensed
Products made, used, or sold and Licensed Processes practiced
under this Agreement appropriate to determine the amount of
royalties due PHS. Such records shall be retained for at least
five (5) years following a given reporting period. They shall be
available during normal business hours for inspection at the
expense of PHS by an accountant or other designated auditor
selected by PHS for the sole purpose of verifying reports and
payments hereunder. The accountant or auditor shall only disclose
to PHS information relating to the accuracy of reports and
payments made under this Agreement. If an inspection shows an
underreporting or underpayment in excess of five percent (5%) for
any twelve (12) month period, then Licensee shall reimburse PHS
for the cost of the inspection at the time Licensee pays the
unreported royalties, including any late charges as required by
Paragraph 7.06 of this Agreement. All payments required under this
Paragraph shall be due within thirty (30) days of the date PHS
provides Licensee notice of the payment due.
9. REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
9.01 Prior to signing this Agreement, Licensee has provided to PHS a
written commercialization plan ("Commercial Development Plan")
under which Licenses intends to bring the subject matter of the
Licensed Patent Rights into commercial use. The Commercial
Development Plan is hereby incorporated by reference into this
Agreement. Based on this plan, performance benchmarks are
determined as specified in Appendix E ("Benchmarks").
NIH Office of Technology Transfer
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9.02 Licensee shall provide written annual reports on its product
development progress or efforts to commercialize under the
Commercial Development Plan for each of the Licensed Fields of Use
within sixty (60) days after December 31 of each calendar year.
These progress reports shall include, but not be limited to:
progress on research and development, status of applications for
regulatory approvals, manufacturing, sublicensing, marketing, and
sales during the preceding calendar year, as well as plans for the
present calendar year. If reported progress differs from that
projected in the Commercial Development Plan and Benchmarks,
Licensee shall explain the reasons for such differences. Licensee
may propose amendments in any such annual report to the Commercial
Development Plan, acceptance of which by PHS may not unreasonably
be denied. Licensee agrees to provide any additional data
reasonably required by PHS to evaluate Licensee's performance.
Licensee may amend the Benchmarks at any time upon written consent
by PHS. PHS shall not unreasonably withhold approval of any
request of Licensee to extend the time periods of this schedule if
such request is supported by a reasonable showing by Licensee of
diligence in its performance under the Commercial Development Plan
and toward bringing the Licensed Products to the point of
practical application as defined in 37 CFR 404.3(d). Licensee
shall amend the Commercial Development Plan and Benchmarks at the
request of PHS to address any Licensed Fields of Use not
specifically addressed in the plan originally submitted.
9.03 Licensee shall report to PHS the date of the First Commercial Sale
in each country in the Licensed Territory within thirty (30) days
of such occurrence.
9.04 Licensee shall submit to PHS within sixty (60) days after each
calendar half-year ending June 30 and December 31 a royalty report
setting forth for the preceding half-year period the amount of the
Licensed Products sold or Licensed Processes practiced by or on
behalf of Licensee in each country within the Licensed Territory,
the Net Sales, and the amount of royalty accordingly due. With
each such royalty report, Licensee shall submit payment of the
earned royalties due. If no earned royalties are due to PHS for
any reporting period, the written report shall so state. The
royalty report shall be certified as correct by an authorized
officer of Licensee and shall include a detailed listing of all
deductions made under Paragraph 2.05 to determine Net Sales made
under Article 6 to determine royalties due.
9.05 Licensee agrees to forward semi-annually to PHS a copy of such
reports received by Licensee from its sublicensees during the
preceding half-year period as shall be pertinent to a royalty
accounting to PHS by Licensee for activities under the sublicense.
9.06 Royalties due under Article 6 shall be paid in D.S. dollars. For
conversion of foreign currency to U.S. dollars, the conversion
rate shall be the rate quoted in The Wall Street Journal on the
day that the payment is due. All checks and bank drafts shall be
drawn on
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United States banks and shall be payable to NIH/Patent Licensing
at the address shown on the Signature Page below. Any loss of
exchange, value, taxes, or other expenses incurred in the transfer
or conversion to U.S. dollars shall be paid entirely by Licensee.
All royalty payments due under this Agreement shall be mailed to
the following address: NIH, P.O. Box 360120, Pittsburgh,
Pennsylvania 15251-6120. The royalty report required by paragraph
9.04 of this Agreement shall accompany each such payment and a
copy of such report shall also be mailed to PHS at its address for
notices indicated on the Signature Page of this Agreement.
9.07 Late charges will be applied to any overdue payments as required
by the U.S. Department of Treasury in the Treasury Fiscal
Requirements Manual, Section 8025.40. The payment of such late
charges shall not prevent PHS from exercising any other rights it
may have as a consequence of the lateness of any payment.
9.08 All plans and reports required by this Article 9 and marked
"confidential" by Licensee shall be treated by PHS as commercial
and financial information obtained from a person and as privileged
and confidential and, to the extent permitted by law, shall not be
subject to disclosure under the Freedom of Information Act, 5
U.S.C. Section 552.
10. PERFORMANCE
10.01 Licensee shall use its reasonable best eff






