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."
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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
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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
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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.
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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
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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").
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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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Xxxxxx Xxxxxx 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, X.X. Xxx 000000, Xxxxxxxxxx,
Xxxxxxxxxxxx 00000-0000. 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 efforts to introduce the
Licensed Products into the commercial market or apply the
Licensed Processes to commercial use as soon as practicable.
"Reasonable best efforts" for the purpose of this provision shall
include, but not be limited to, adherence to the Commercial
Development Plan and performance of the Benchmarks. The efforts of
a sublicensee shall be considered the efforts of Licensee.
10.02 Upon the First Commercial Sale, until the expiration of this
Agreement, Licensee shall use its reasonable best efforts to keep
Licensed Products and Licensed Processes reasonably accessible to
the public.
11. INFRINGEMENT AND PATENT ENFORCEMENT
11.01 PHS and Licensee agree to notify each other promptly of each
infringement or possible infringement, as well as any facts which
may affect the validity, scope, or enforceability of the Licensed
Patent Rights of which either Party becomes aware.
11.02 Pursuant to this Agreement and the provisions of Chapter 29 of
Title 35, United States Code, Licensee may a) bring suit in its
own name, at its own expense, and on its own behalf for
infringement of presumably valid claims in the Licensed Patent
Rights; b) in any such suit, enjoin infringement and collect for
its use, damages,
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profits, and awards of whatever nature recoverable for such
infringement; and c) settle any claim or suit for infringement of
the Licensed Patent Rights-provided, however, that PHS and
appropriate Government authorities shall have the first right to
take such actions and shall have a continuing right to intervene
in such suit. Licensee shall take no action to compel the
Government either to initiate or to join in any such suit for
patent infringement. Licensee may request the Government to
initiate or join any such suit if necessary to avoid dismissal of
the suit. Should the Government be made a party to any such suit,
Licensee shall reimburse the Government for any costs, expenses,
or fees which the Government incurs as a result of such motion or
other action, including any and all costs incurred by the
Government in opposing any such motion or other action. Upon
Licensee's payment of all costs incurred by the Government as a
result of Licensee's joinder motion or other action, these actions
by Licensee will not be considered a default in the performance of
any material obligation under this Agreement. In all cases,
Licensee agrees to keep PHS reasonably apprised of the status and
progress of any litigation. Before Licensee commences an
infringement action, Licensee shall notify PHS and give careful
consideration to the views of PHS and to any potential effects of
the litigation on the public health in deciding whether to bring
suit.
11.03 In any infringement action commenced under Paragraph 11.02, the
expenses including costs, fees, attorney fees, and disbursements,
shall be paid by Licensee. Up to fifty percent (50%) of such
expenses may be credited against the royalties payable to PHS
under Paragraph 6.03 under the Licensed Patent Rights in the
country in which such a suit is filed. In the event that fifty
percent (50%) of such expenses exceed the amount of royalties
payable by Licensee in any calendar year, the expenses in excess
may be carried over as a credit on the same basis into succeeding
calendar years. A credit against litigation expenses, however, may
not reduce the royalties due in any calendar year to less than the
minimum annual royalty. Any recovery made by Licensee, through
court judgment or settlement, first shall be applied to reimburse
PHS for royalties withheld as a credit against litigation expenses
and then to reimburse Licensee for its litigation expense. Any
remaining recoveries shall be shared equally by Licensee and PHS.
11.04 PHS shall cooperate fully with Licensee in connection with an
infringement action initiated under Paragraph 11.02. PHS agrees
promptly to provide access to all necessary documents and to
render reasonable assistance in response to a request by Licensee.
11.05 In the event that a declaratory judgment action alleging
invalidity or non-infringement of any of the Licensed Patent
Rights shall be brought against Licensee or raised by way of
counterclaim or affirmative defense in an infringement suit
brought by Licensee under Paragraph 11.02, pursuant to this
Agreement and the provisions of Chapter 29 of Xxxxx 00, Xxxxxx
Xxxxxx Code or other statutes, Licensee may a) defend the suit in
its own name, at its own expense,
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and on its own behalf for presumably valid claims in the Licensed
Patent Rights; b) in any such suit, ultimately to enjoin
infringement and to collect for its use, damages, profits, and
awards of whatever nature recoverable for such infringement; and
c) settle any claim or suit for declaratory judgment involving the
Licensed Patent Rights-provided, however, that PHS and appropriate
Government authorities shall have the first right to take such
actions and shall have a continuing right to intervene in such
suit. Licensee shall take no action to compel the Government
either to initiate or to join in any such declaratory judgment
action. Licensee may request the Government to initiate or join
any such suit if necessary to avoid dismissal of the suit. Should
the Government be made a party to any such suit by motion or any
other action of Licensee, Licensee shall reimburse the Government
for any costs, expenses, or fees which the Government incurs as a
result of such motion or other action. Upon Licensee's payment of
all costs incurred by the Government as a result of Licensee's
joinder motion or other action, these actions by Licensee will not
be considered a default in the performance of any material
obligation under this Agreement. If Licensee elects not to defend
against such declaratory judgment action, PHS, at its option, may
do so at its own expense. In all cases, Licensee agrees to keep
PHS reasonably apprised of the status and progress of any
litigation. Before Licensee commences an infringement action,
Licensee shall notify PHS and give careful consideration to the
views of PHS and to any potential effects of the litigation on the
public health in deciding whether to bring suit.
12. NEGATION OF WARRANTIES AND INDEMNIFICATION
12.01 PHS offers no warranties other than those specified in Article 1.
12.02 PHS does not warrant the validity of the Licensed Patent Rights
and makes no representations whatsoever with regard to the scope
of the Licensed Patent Rights, or that the Licensed Patent Rights
may be exploited without infringing other patents or other
intellectual property rights of third parties.
12.03 PHS MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED
BY THE CLAIMS OF THE LICENSED PATENT RIGHTS.
12.04 PHS does not represent that it will commence legal actions against
third parties infringing the Licensed Patent Rights.
12.05 Licensee shall indemnify and hold PHS, its employees, students,
fellows, agents, and consultants harmless from and against all
liability, demands, damages, expenses, and losses, including but
not limited to death, personal injury, illness, or property damage
in connection with or arising out of a) the use by or on behalf of
Licensee, its sublicensees, directors, employees, or third parties
of any Licensed Patent Rights, or b) the design, manufacture,
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distribution, or use of any Licensed Products, Licensed Processes
or materials, or other products or processes developed in
connection with or arising out of the Licensed Patent Rights.
Licensee agrees to maintain a liability insurance program
consistent with sound business practice.
13. TERM, TERMINATION, AND MODIFICATION OF RIGHTS
13.01 This Agreement is effective when signed by all parties and shall
extend to the expiration of the last to expire of the Licensed
Patent Rights unless sooner terminated as provided in this Article
13.
13.02 In the event that Licensee is in default in the performance of any
material obligations under this Agreement, and if the default has
not been remedied within ninety (90) days after the date of notice
in writing of such default, PHS may terminate this Agreement by
written notice.
13.03 At least thirty (30) days prior to filing a petition in
bankruptcy, Licensee must inform PHS in writing of its intention
to file the petition in bankruptcy or of a third party's intention
to file an involuntary petition in bankruptcy.
13.04 In the event that Licensee becomes insolvent, files a petition in
bankruptcy, has such a petition filed against it, determines to
file a petition in bankruptcy, or receives notice of a third
party's intention to file an involuntary petition in bankruptcy,
Licensee shall immediately notify PHS in writing. Furthermore, PHS
shall have the right to terminate this Agreement by giving
Licensee written notice. Termination of this Agreement is
effective upon Licensee's receipt of the written notice.
13.05 Licensee shall have a unilateral right to terminate this Agreement
and/or any licenses in any country by giving PHS sixty (60) days'
written notice to that effect.
13.06 PHS shall specifically have the right to terminate or modify, at
its option, this Agreement, if PHS determines that the Licensee:
1) is not executing the Commercial Development Plan submitted with
its request for a license and the Licensee cannot otherwise
demonstrate to PHS's satisfaction that the Licensee has taken, or
can be expected to take within a reasonable time, effective steps
to achieve practical application of the Licensed Products or
Licensed Processes; 2} has not achieved the Benchmarks as may be
modified under Paragraph 9.02; 3) has willfully made a false
statement of, or willfully omitted, a material fact in the license
application or in any report required by the license agreement; 4)
has committed a substantial breach of a covenant or agreement
contained in the license; 5) is not keeping Licensed Products or
Licensed Processes reasonably available to the public after
commercial use commences; 6) cannot reasonably satisfy unmet
health and safety needs; or
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7) cannot reasonably justify a failure to comply with the domestic
production requirement of Paragraph 5.01 unless waived. In making
this determination, PHS will take into account the normal course
of such commercial development programs conducted with sound and
reasonable business practices and judgment and the annual reports
submitted by Licensee under Paragraph 9.02. Prior to invoking this
right, PHS shall give written notice to Licensee providing
Licensee specific notice of, and a ninety (90) day opportunity to
respond to, PHS's concerns as to the previous items 1) to 7). If
Licensee fails to alleviate PHS's concerns as to the previous
items 1) to 7) or fails to initiate corrective action to PHS's
satisfaction, PHS may terminate this Agreement.
13.07 When the public health and safety so require, and after written
notice to Licensee providing Licensee a sixty (60) day opportunity
to respond, PHS shall have the right to require Licensee to grant
sublicensee to responsible applicants, on reasonable terms, in any
Licensed Fields of Use under the Licensed Patent Rights, unless
Licensee can reasonably demonstrate that the granting of the
sublicense would not materially increase the availability to the
public of the subject matter of the Licensed Patent Rights. PHS
will not require the granting of a sublicense unless the
responsible applicant has first negotiated in good faith with
Licensee.
13.08 PHS reserves the right according to 35 U.S.C. Section 209(f)(4) to
terminate or modify this Agreement if it is determined that such
action is necessary to meet requirements for public use specified
by Federal regulations issued after the date of the license and
such requirements are not reasonably satisfied by Licensee.
13.09 Within thirty (30) days of receipt of written notice of PHS's
unilateral decision to modify or terminate this Agreement,
Licensee may, consistent with the provisions of 37 CFR. Section
404.11, appeal the decision by written submission to the Director
of NIH or designee. The decision of the NIH Director or designee
shall be the final agency decision. Licensee may thereafter
exercise any and all administrative or judicial remedies that may
be available.
13.10 Within ninety (90) days of termination of this Agreement under
this Article 13 or expiration under Paragraph 3.02, a final report
shall be submitted by Licensee. Any royalty payments, including
those related to patent expense, due to PHS shall become
immediately due and payable upon termination or expiration. If
terminated under this Article 13, sublicensees may elect to
convert their sublicenses to direct licenses with PHS pursuant to
Paragraph 4.03.
14. GENERAL PROVISIONS
14.01 Neither Party may waive or release any of its rights or interests
in this Agreement except in writing. The failure of the Government
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
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right by the Government or excuse a similar subsequent failure to
perform any such term or condition by Licensee.
14.02 This Agreement constitutes the entire agreement between the
Parties relating to the subject matter of the Licensed Patent
Rights, and all prior negotiations, representations, agreements,
and understandings are merged into, extinguished by, and
completely expressed by this Agreement.
14.03 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
determination shall not in any way affect the validity or
enforceability of the remaining provisions of this Agreement.
14.04 If either Party desires a modification to this Agreement, the
Parties shall, upon reasonable notice of the proposed modification
by the Party desiring the change, confer in good faith to
determine the desirability of such modification. No modification
will be effective until a written amendment is signed by the
signatories to this Agreement or their designees.
14.05 The construction, validity, performance, and effect of this
Agreement shall be governed by Federal law as applied by the
Federal courts in the District of Columbia.
14.06 All notices required or permitted by this Agreement shall be given
by prepaid, first class, registered or certified mail properly
addressed to the other Party at the address designated on the
following Signature Page, or to such other address as may be
designated in writing by such other Party, and shall be effective
as of the date of the postmark of such notice.
14.07 This Agreement shall not be assigned by Licensee except a) with
the prior written consent of PHS, such consent to be reasonably
given; or b) as part of a sale or transfer of substantially the
entire business of Licensee relating to operations which concern
this Agreement. Licensee shall notify PHS within ten (10) days of
any assignment of this Agreement by Licensee.
14.08 Licensee agrees in its use of any PHS-supplied materials to comply
with all applicable statutes, regulations, and guidelines,
including Public Health Service and National Institutes of Health
regulations and guidelines. Licensee agrees not to use the
materials for research involving human subjects or clinical trials
in the United States without complying with 21 CFR Part 50 and 45
CFR Part 46. Licensee agrees not to use the materials for
research involving human subjects or clinical trials outside of
the United States without notifying PHS, in writing, of such
research or trials and complying with the applicable regulations
of the appropriate national control authorities. Written
notification to PHS of research involving human subjects or
clinical trials outside of the
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Xxxxxx Xxxxxx shall be given no later than sixty (60) days prior
to commencement of such research or trials.
14.09 Licensee acknowledges that it is subject to and agrees to abide by
the United States laws and regulations (including the Export
Administration Act of 1979 and Arms Export Control Act)
controlling the export of technical data, computer software,
laboratory prototypes, biological material, and other commodities.
The transfer of such items may require a license from the
cognizant agency of the U.S. Government or written assurances by
Licensee that it shall not export such items to certain foreign
countries without prior approval of such agency. PHS neither
represents that a license is or is not required or that, if
required, it shall be issued.
14.10 Licensee agrees to xxxx the Licensed Products or their packaging
sold in the United States with all applicable U.S. patent numbers
and similarly to indicate "Patent Pending" status. All Licensed
Products manufactured in, shipped to, or sold in other countries
shall be marked in such a manner as to preserve PHS patent rights
in such countries.
14.11 By entering into this Agreement, PHS does not directly or
indirectly endorse any product or service provided, or to be
provided, by Licensee whether directly or indirectly related to
this Agreement. Licensee shall not state or imply that this
Agreement is an endorsement by the Government, PHS, any other
Government organizational unit, or any Government employee.
Additionally, Licensee shall not use the names of NIH, CDC, or PHS
or their employees in any advertising, promotional, or sales
literature without the prior written consent of PHS.
14.12 The Parties agree to attempt to settle amicably any controversy or
claim arising under this Agreement or a breach of this Agreement,
except for appeals of modification or termination decisions
provided for in Article 13. Licensee agrees first to appeal any
such unsettled claims or controversies to the Director of NIH, or
designee, whose decision shall be considered the final agency
decision. Thereafter, Licensee may exercise any administrative or
judicial remedies that may be available.
14.13 Nothing relating to the grant of a license, nor the grant itself,
shall be construed to confer upon any person any immunity from or
defenses under the antitrust laws or from a charge of patent
misuse, and the acquisition and use of rights pursuant to 37 CFR
Part 404 shall not be immunized from the operation of state or
Federal law by reason of the source of the grant.
14.14 Paragraphs 4.03, 8.01, 9.06, 9.07, 12.01-12.05, 13.09, 13.10, and
14.12 of this Agreement shall survive termination of this
Agreement.
SIGNATURES BEGIN ON NEXT PAGE
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PHS PATENT LICENSE AGREEMENT-EXCLUSIVE
SIGNATURE PAGE
FOR PHS:
by: /s/ Xxxxxxx XxXxxxx 5/18/95
-------------------------------------------- ---------------
Xxxxxxx XxXxxxx, X.X. Date
Deputy Director, Office of Technology Transfer
National Institutes of Health
Mailing Address for Notices:
Office of Technology Transfer
National Institutes of Health
0000 Xxxxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxxxxx, Xxxxxxxx 00000
Fax: (000) 000-0000
FOR Licensee:
by: /s/ Xxxxxxx X. Xxxxxx 5/8/95
-------------------------------------------- ---------------
Xxxxxxx X. Xxxxxx, Ph.D. Date
President
MediChem Research, Inc.
Mailing Address for Notices:
MediChem Research, Inc.
00000 Xxxxx Xxx Xxxxxx
Xxxxxx, Xxxxxxxx 00000
Fax: (000) 000-0000
NIH Office of Technology Transfer
PHS PATENT LICENSE AGREEMENT - EXCLUSIVE
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APPENDIX A -- PATENT OR PATENT APPLICATION
Patent or Patent Application:
USPA SN 07/861,249 "Calanolides, Novel Antiviral Compounds, Compositions
and Uses Thereof"
USPA SN 08/065,618 (CIP of SN 07/861,249) "Calanolides, Novel Antiviral
Compounds, Compositions and Uses Thereof"
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XXXXXXXX X -- LICENSED FIELDS OF USE AND TERRITORY
Licensed Territory: World-wide, including all countries, states, provinces and
territories.
Licensed Fields of Use: Treatment of viral infection, viral-related infection or
viral-related disease in humans.
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PHS PATENT LICENSE AGREEMENT - EXCLUSIVE
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APPENDIX C -- ROYALTIES
Royalties:
Licensee agrees to pay to PHS a noncreditable, nonrefundable license issue
royalty in the amount of FIFTY THOUSAND DOLLARS ($50,000.00) according to the
following payment schedule:
A. FIFTEEN THOUSAND DOLLARS ($15,000.00) within thirty (30) days from the
Effective Date; and
B. THIRTY-FIVE THOUSAND DOLLARS ($35,000.00) within one (1) year from the
Effective Date less a credit of up to Twenty-Five Thousand Dollars
($25,000.00) for license issue royalties paid by Licensee to government
of Sarawak for the manufacture and sale of Licensed Products.
Licensee agrees to pay to PHS a nonrefundable minimum annual royalty according
to the following schedule:
A. FIVE THOUSAND DOLLARS ($5,000.00) beginning in 1996 less an annual
credit of up to Two Thousand Five Hundred Dollars ($2,500.00) for minimum
annual royalties paid by Licensee to government of Sarawak for the
manufacture and sale of Licensed Products; and
B. TEN THOUSAND DOLLARS ($10,000.00) for 1998 and subsequent years less
an annual credit of up to Five Thousand Dollars ($5,000.00) for minimum
annual royalties paid by Licensee to government of Sarawak for the
manufacture and sale of Licensed Products.
Licensee agrees to pay PHS earned royalties on Net Sales as follows:
A. FOUR PERCENT (4.0%) of Net Sales by Licensee or an Affiliate of
Licensee of all Licensed Products manufactured or sold in the Licensed
Territory; and;
B. Licensee shall be entitled to a One Hundred percent (100%) credit
against PHS earned royalty payments for earned royalty payments Licensee
must pay to the government of Sarawak for the manufacture and sale of
Licensed Products. Said reduction, however, shall not reduce the earned
royalty payments to PHS below half of the rate provided for under
Paragraph A above.
Licensee agrees to pay PHS Sublicensing Royalties as follows:
A. FOUR PERCENT (4.0%) of Net Sales by Sublicensee, or an Affiliate of
Sublicensee of all Licensed Products manufactured and sold in the
Licensed Territory plus Twenty per cent (20%) of the value of any
consideration received in granting the sublicense.
B. Licensee shall be entitled to a One Hundred percent (100%) credit
against PHS Sublicensing Royalties for sublicensing royalty payments
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Licensee must pay to the government of Sarawak. Said reduction, however,
shall not reduce the sublicensing royalty payments to PHS below half of
the rates' provided for under Paragraph A above.
Licensee agrees to pay PHS benchmark royalties as follows:
A. TWENTY-FIVE THOUSAND DOLLARS ($25,000.00) upon filing of an IND
application in the United States; and
B. FIFTY THOUSAND DOLLARS ($50,000.00) upon completion of Phase I and
initiation of Phase II clinical trials; and
C. ONE HUNDRED THOUSAND DOLLARS ($100,000.00) upon completion of Phase II
and initiation of Phase III clinical trials; and
D. TWO HUNDRED THOUSAND DOLLARS ($200,000.00) upon filing of a NDA
application or equivalent in the United States, Europe or Japan; and
E. Licensee shall be entitled to a One Hundred percent (100%) credit
against PHS benchmark royalties for benchmark royalty payments Licensee
must pay to the government of Sarawak. Said reduction, however, shall not
reduce the benchmark royalty payments to PHS below half of the rates
individually provided for under Paragraphs A through D above. One hundred
percent (100%) of such benchmark royalty payments actually made to PHS
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 C although uncredited
benchmark royalty payments may be carried forward into subsequent years.
NIH Office of Technology Transfer
PHS PATENT LICENSE AGREEMENT - EXCLUSIVE
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APPENDIX D -- MODIFICATIONS
PHS and Licensee agree to the following modifications to the Articles and
Paragraphs of this Agreement:
Article Two
2.09 (new) "Effective Date" shall mean the date when the last party to
sign has executed this Agreement.
Article Five
5.03 (revised) 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 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,
such request not to be unreasonably denied by PHS.
5.04 (revised) 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,
Licensee agrees, upon regulatory approval for marketing, to set up a special
patient access program in the United States so that Licensed Products may be
provided to individuals who are unable to afford them.
5.05 (revised) In addition to the reserved license of Paragraph 5.01
above, PHS reserves the right to grant nonexclusive licenses to make and to use,
but not to sell or have sold, 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. In the event that Licensee can
provide convincing written evidence to PHS that a commercial entity that has
been granted a research license to Licensed Patent Rights is developing the
inventions for commercial manufacture or in lieu of purchase if the inventions
are available as commercial products, then Licensee can request that PHS
terminate its research license with such commercial entities, such request not
to be unreasonably denied.
Article Six
6.01 (revised) Licensee agrees to pay to PHS a noncreditable,
nonrefundable license issue royalty as set forth in Appendix C within thirty
(30) days from the Effective Date of this Agreement.
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6.02 (revised) 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.
6.08 (revised) As an additional royalty, Licensee agrees to pay PHS upon
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 according to the
following schedule: one-third within sixty (60) days; one-third within one (1)
year of the Effective Date of this Agreement; and one-third within two (2) years
of the Effective Date of this Agreement. 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. Licensee may elect to surrender
its rights in any country of the Licensed Territory under any Licensed Patent
Rights 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.
Article Seven
7.01 (revised) Upon Effective Date of this Agreement, Licensee agrees to
take the responsibility for, as well as pay for, but to consult with PHS 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 PHS, who shall retain its
principle power of attorney. Licensee may elect to surrender its rights in any
country of the Licensed Territory under any Licensed Patent Rights 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.
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XXXXXXXX X -- BENCHMARKS
Licensee agrees to the following Benchmarks for its performance under this
Agreement and, within ten (10) days of achieving a Benchmark, shall notify PHS
that the Benchmark has been achieved:
A. DEVELOPMENT OF CALANOLIDE AS A THERAPEUTIC FOR TREATMENT OF HIV INFECTION
1. Begin negotiations for an agreement with Sarawak as to the extent of
return to Sarawak from eventual marketing of synthetic licensed product
within one (1) month of the Effective Date of the Agreement. Complete
agreement with Sarawak within nine (9) months of the Effective Date of
the Agreement.
2. Develop and validate a plasma assay (using mouse, rat and dog plasma)
for (+)Calanolide A. Compare behavior of (-)Dihydrocalanolide B (to be
supplied by the National Cancer Institute (NCI)) in same. To be completed
by February 28, 1996.
3. Determine pharmacology of (+)Calanolide A in the mouse, rate and dog
following single dose IV administration. Provide results in the mouse to
NCI to allow scheduling of efficacy and combination studies in hollow
fiber and PBL-SCID models. To be completed by March 31, 1996.
4. Develop and validate with respect to shelf stability of product a
formulation of (+)Calanolide suitable for use in further toxicologic and
eventual clinical evaluation. To be completed by March 31, 1996.
5. Using the results in (3) to select dose and schedule, conduct initial
dose-ranging studies in the rate and the dog with a frequency of
administration IV that would support a two-week duration clinical trial.
To be completed by June 30, 1996.
6. Formulate a quantity of GMP-prepared Calanolide A sufficient to
complete IND-directed toxicology studies and two Phase I studies. To be
completed by June 30, 1996.
7. Conduct IND-directed toxicology studies in the rat and the dog
according to protocols reviewed by NCI's Toxicology and Pharmacology
Branch to support a two-week IV infusion study. To be completed by
September 30, 1996.
8. Complete reports and quality control to support IND-filing. To be
completed by November 30, 1996.
9. File IND. To be completed by December 31, 1996.
10. Commence two-week infusion Phase I clinical trial. To be completed by
March 31, 1997.
11. Commence Phase II clinical trials by July 31, 1997.
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12. Commence Phase III clinical trials (if necessary) by September 30,
1998.
13. Submit NDA by December 31, 1999.
B. DEVELOPMENT OF CALANOLIDE A AS A THERAPEUTIC FOR TREATMENT OF NON-HIV
VIRAL INFECTIONS
1. Begin assessment of activity of Calanolide A in primary screens
against a panel of non-HIV viral strains which include but are not
limited to: Herpes Simplex Virus-2, Herpes Simplex Virus-2, Cytomegalo
Virus, Variella Zoster Virus, Xxxxxxx-Xxxx Virus, Adenovirus Type 5,
Parainfluenza Type 3 Virus, Respiratory Syncytial Virus, Hepatitis B
Virus, Measles Virus, Influenza A (H1N1), Influenza A (H3N2) by December
31, 1995.
2. Conclude analysis of activity of Calanolide A in primary screens
against non-HIV viral strains by March 31, 1996.
3. Election of non-HIV anti-viral therapeutic areas demonstrating
potential for development and submission of development plan for those
indications by June 30, 1996.
C. DEVELOPMENT OF CALANOLIDE-RELATED COMPOUNDS, INCLUDING COSTATOLIDE, AS
THERAPEUTICS FOR TREATMENT OF VIRAL INFECTIONS
1. Synthesize and submit to NCI for further testing at least one backup
compound to Calanolide A per calendar year from 1995 through 1997.
2. Election of Calanolide-related compounds demonstrating potential for
development and submission of development plan for those compounds by
December 31, 1997.
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