Exhibit 10.25
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933.
PUBLIC HEALTH SERVICE
PATENT LICENSE AGREEMENT--NONEXCLUSIVE
COVER PAGE
For PHS internal use only:
License Number:
Application Number:
A-294-2003
Serial Number(s) of Licensed Patent(s) and/or Patent Application(s):
United States Patent Serial Number 07/702,217 (PHS reference number
E-163-1991/0-US-01) filed May 17, 1991;
United States Patent Serial Number 08/109,187 (PHS reference number
E-163-1991/1-US-01) filed August 19, 1993;
United States Patent Serial Number 08/609,218 (PHS reference number
E-163-1991/1-US-03) filed March 1, 1996;
United States Patent Serial Number 08/905,280 (PHS reference number
E-163-1991/2-US-01) filed August 1, 1997; and
United States Patent Serial Number 09/810,502 (PHS reference number
E-163-1991/2-US-02) filed March 16, 2001, all entitled, "A Method for
reducing the immunogenicity of antibody variable domains," and all
continuations, reissues, divisionals and corresponding foreign
patent(s) or patent application(s)
Licensee:
Inhibitex
0000 Xxxxxxxxx Xxxxxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000
Cooperative Research and Development Agreement (CRADA) Number (if
applicable):
N/A
Public Benefit(s):
Development of antibodies for the prevention and treatment of bacterial
and fungal infections. Availability of these therapeutic agents to
qualified indigent patients.
This Patent License Agreement, hereinafter referred to as the "AGREEMENT",
consists of this Cover Page, an attached AGREEMENT, a Signature Page, Appendix A
(List of Patent(s) and/or Patent Application(s)), Appendix B (Fields of Use and
Territory), Appendix C (Royalties), Appendix D (Modifications), Appendix E
(Benchmarks), and Appendix F (Commercial Development Plan). The Parties to this
AGREEMENT are:
1) The National Institutes of Health ("NIH"), the Centers for
Disease Control and Prevention ("CDC"), or the Food and Drug
Administration ("FDA"), hereinafter singly or
collectively referred to as "PHS", 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".
Page 2 of 24
PHS PATENT LICENSE AGREEMENT--NONEXCLUSIVE
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/or 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 Secretary of DHHS has delegated to PHS the authority to
enter into this AGREEMENT for the licensing of rights to these
inventions.
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, and/or marketable products for public use and
benefit.
2. DEFINITIONS
2.01 "BENCHMARKS" mean the performance milestones that are set forth in
Appendix E.
2.02 "COMMERCIAL DEVELOPMENT PLAN" means the written
commercialization plan attached as Appendix F.
2.03 "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.
2.04 "GOVERNMENT" means the Government of the United States of
America.
2.05 "LICENSED FIELDS OF USE" means the fields of use identified in
Appendix B.
2.06 "LICENSED PATENT RIGHTS" shall mean:
a) Patent applications (including provisional patent
applications and PCT patent applications) and/or
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
disclosed 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; iv) priority patent application(s) of
a) above; and v) any reissues, reexaminations, AND
EXTENSIONS OF ALL SUCH PATENTS;
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c) to the extent that the following contain one or more
claims directed to the invention or inventions
disclosed in a) above: all counterpart foreign and
U.S. patent 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 disclosed in a) above.
2.07 "LICENSED PROCESS(ES)" means processes which, in the course of
being practiced would be within the scope of one or more
claims of the LICENSED PATENT RIGHTS that have not been held
unpatentable, invalid or unenforceable by an unappealed or
unappealable judgment of a court of competent jurisdiction.
2.08 "LICENSED PRODUCT(S)" means tangible materials which, in the
course of manufacture, use, sale, or importation would be
within the scope of one or more claims of the LICENSED PATENT
RIGHTS that have not been held unpatentable, invalid or
unenforceable by an unappealed or unappealable judgment of a
court of competent jurisdiction.
2.09 "LICENSED TERRITORY" means the geographical area identified in
Appendix B.
2.10 "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, 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 to the extent
actually granted. 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. LICENSED
PRODUCTS given customers free of charge, and not for re-sale,
as promotional samples are specifically excluded from NET
SALES. Donations of LICENSED PRODUCT(S) under the indigent
patient access program specified in Paragraph 10.03 are
excluded from NET SALES.
2.11 "PRACTICAL APPLICATION" means to manufacture in the case of a
composition or product, to practice in the case of a process
or method, or to operate in the case of a machine or system;
and in each case, under such conditions as to establish that
the invention is being utilized and that its benefits are to
the extent permitted by law or GOVERNMENT regulations
available to the public on reasonable terms.
3. GRANT OF RIGHTS
3.01 PHS hereby grants and LICENSEE accepts, subject to the terms
and conditions of this AGREEMENT, a nonexclusive license under
the LICENSED PATENT RIGHTS in the LICENSED TERRITORY to make
and have made, to use and have used, to sell and have sold, to
offer to sell, and to import any 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 LICENSEE has no right to sublicense.
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5. STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
5.01 Upon written request, and prior to the FIRST COMMERCIAL SALE,
LICENSEE agrees to provide PHS reasonable quantities of
LICENSED PRODUCTS or materials made through the LICENSED
PROCESSES for PHS research use.
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.
6. ROYALTIES AND REIMBURSEMENT
6.01 LICENSEE agrees to pay to PHS a, noncreditable, nonrefundable
license issue royalty as set forth in Appendix C.
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. Benchmark royalties are payable within thirty (30)
days from the date of completion of a Benchmark set forth in
Appendix C.
6.05 A patent or patent application licensed under this AGREEMENT
shall cease to fall within the LICENSED PATENT RIGHTS for the
purpose of computing earned royalty payments in any given
country on the earliest of the dates that a) the application
has been abandoned and not continued, b) the patent expires or
irrevocably lapses, or c) the claim has 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 LICENSED PROCESSES are covered by more than one of
the LICENSED PATENT RIGHTS.
6.07 On sales of LICENSED PRODUCTS by LICENSEE to sublicensees 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 With regard to expenses associated with the preparation,
filing, prosecution, and maintenance of all patent
applications and patents included within the LICENSED PATENT
RIGHTS incurred by PHS prior to the effective date of this
AGREEMENT, LICENSEE shall pay to PHS, as an additional
royalty, within sixty (60) days of PHS's submission of a
statement and request for payment to LICENSEE, an amount
equivalent to such patent expenses previously incurred by PHS.
LICENSEE's obligation is only related to unreimbursed payments
actually made by PHS and is a pro rata share of such expenses.
The pro rata share shall be based on the number of commercial
licensees granted rights under any of the LICENSED PATENT
RIGHTS and shall exclude any license(s) which are for internal
research use and/or for research reagents sales.
Page 5 of 24
6.09 With regard to expenses associated with the preparation,
filing, prosecution, and maintenance of all patent
applications and patents included within the LICENSED PATENT
RIGHTS incurred by PHS on or after the effective date of this
AGREEMENT, PHS, at its sole option, may require LICENSEE:
(a) to pay PHS on an annual basis, within sixty (60) days of
PHS's submission of a statement and request for payment, a
royalty amount equivalent to a pro rata share of all such
patent expenses incurred during the previous calendar year(s);
or
(b) to pay such expenses directly to the law firm employed by
PHS to handle such functions. However, in such event, PHS and
not LICENSEE shall be the client of such law firm.
The pro rata share shall be based on the number of commercial
licensees granted rights under any of the LICENSED PATENT
RIGHTS and shall exclude any license(s) which are for internal
research use and/or for research reagents sales.
Under exceptional circumstances, LICENSEE may be given the
right but not the obligation to assume responsibility for the
preparation, filing, prosecution, or maintenance of any patent
application or patent included with the LICENSED PATENT
RIGHTS. In that event, LICENSEE shall directly pay the
attorneys or agents engaged to prepare, file, prosecute, or
maintain such patent applications or patents and shall provide
to PHS copies of each invoice associated with such services as
well as documentation that such invoices have been paid.
6.10 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 Article 6.09 for patent-related expenses
incurred in that country after the effective date of such
written notice.
7. PATENT FILING, PROSECUTION, AND MAINTENANCE
7.01 PHS agrees to take responsibility for the preparation, filing,
prosecution, and maintenance of any and all patent
applications or patents included in the LICENSED PATENT
RIGHTS.
8. RECORD KEEPING
8.01 LICENSEE agrees to keep accurate and correct records of
LICENSED PRODUCTS made, used, sold, or imported 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 and 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 9.07 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.
8.02 LICENSEE agrees to have an audit of sales and royalties
conducted by an independent auditor at least every two (2)
years if annual sales of the LICENSED PRODUCT or LICENSED
PROCESSES are over thirty (30) million dollars. The audit
shall address, at a minimum, the amount of gross sales by or
on behalf of LICENSEE during the audit period, terms of the
license as to percentage or fixed royalty to be remitted to
the GOVERNMENT, the amount of royalty funds owed to the
GOVERNMENT under this AGREEMENT, and whether the royalty
amount owed has been paid to the GOVERNMENT and is
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reflected in the records of the LICENSEE. The audit shall also
indicate the PHS license number, product, and the time period
being audited. A report certified by the auditor shall be
submitted promptly by the auditor directly to PHS on
completion. LICENSEE shall pay for the entire cost of the
audit provided that it be in line with normal and customary
fees for such work throughout the industry.
9. REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
9.01 Prior to signing this AGREEMENT, LICENSEE has provided to PHS
the COMMERCIAL DEVELOPMENT PLAN at Appendix F, under which
LICENSEE intends to bring the subject matter of the LICENSED
PATENT RIGHTS to the point of PRACTICAL APPLICATION. This
COMMERCIAL DEVELOPMENT PLAN is hereby incorporated by
reference into this AGREEMENT Based on this plan, performance
BENCHMARKS are determined as specified in Appendix E.
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,
marketing, importing, and sales during the preceding calendar
year, as well as plans for the present calendar year. PHS also
encourages these reports to include information on any of
LICENSEE's public service activities that relate to the
LICENSED PATENT RIGHTS. If reported progress differs from that
projected in the COMMERCIAL DEVELOPMENT PLAN and BENCHMARKS,
LICENSEE shall explain the reasons for such differences. In
any such annual report, LICENSEE may propose amendments to the
COMMERCIAL DEVELOPMENT PLAN, acceptance of which by PHS may
not be denied unreasonably. LICENSEE agrees to provide any
additional information reasonably required by PHS to evaluate
LICENSEE's performance under this AGREEMENT. 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.
9.03 LICENSEE shall report to PHS the dates for achieving
BENCHMARKS specified in Appendix E and the FIRST COMMERCIAL
SALE in each country in the LICENSED TERRITORY within thirty
(30) days of such occurrences.
9.04 Beginning after the first commercial sale, 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 2.10 to determine NET SALES made under Article 6 to
determine royalties due.
9.05 Royalties due under Article 6 shall be paid in U.S. dollars.
For conversion of foreign currency to U.S. dollars, the
conversion rate shall be the New York foreign exchange rate
quoted in The Wall Street Journal on the day that the payment
is due. All checks and bank drafts shall be drawn on United
States banks and shall be payable, as appropriate, to
"NIH/Patent Licensing." All such payments shall be sent to the
following address: NIH, X.X. Xxx 000000, Xxxxxxxxxx, XX
00000-0000. 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. 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.
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9.06 LICENSEE shall be solely responsible for determining if any
tax on royalty income is owed by LICENSEE outside the United
States and shall pay any such tax and be responsible for all
filings with appropriate agencies of foreign governments. Any
foreign tax credits received relative to such payments are for
the account of LICENSEE.
9.07 Interest and penalties may be assessed by PHS on any overdue
payments in accordance with the Federal Debt Collection Act.
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, to the extent permitted by
law, be treated by PHS as commercial and financial information
obtained from a person and as privileged and confidential, and
any proposed disclosure of such records by the PHS under the
Freedom of Information Act (FOIA), 5 U.S.C. Section 552 shall
be subject to the predisclosure notification requirements of
45 CFR Section 5.65(d).
10. PERFORMANCE
10.01 LICENSEE shall use its reasonable best efforts to bring the
LICENSED PRODUCTS and LICENSED PROCESSES to PRACTICAL
APPLICATION. "Reasonable best efforts" for the purposes of
this provision shall include adherence to the COMMERCIAL
DEVELOPMENT PLAN at Appendix F and performance of the
BENCHMARKS at Appendix E.
10.02 Upon the FIRST COMMERCIAL SALE, until the expiration of this
AGREEMENT, LICENSEE shall use its reasonable best efforts to
make LICENSED PRODUCTS and LICENSED PROCESSES reasonably
accessible to the United States public.
10.03 Within one year following regulatory approval for marketing
LICENSED PRODUCTS in the United States, and subject to the
availability of sufficient supplies of Licensed Product to
meet the current demands of the market place, LICENSEE agrees
to establish an indigent patient access program for LICENSED
PRODUCTS, or to include LICENSED PRODUCTS in an existing
indigent patient access program, such that LICENSED PRODUCTS
may be provided to qualified indigent citizens of the United
States who are not covered under any public or private health
plan. "Sufficient supplies" means that there is enough product
in the trade or in inventory to fill orders as they are
received and that no back-order situation exists. LICENSEE
further agrees, one year following regulatory approval for
marketing LICENSED PRODUCTS in the United States, and as part
of its marketing and product promotion, to develop written
educational materials (including, for example, brochures and
advertisements) directed to patients and physicians detailing
the LICENSED PRODUCTS and therapeutic uses thereof. At no time
will the value of LICENSED PRODUCT donated to indigent patient
access programs surpass 5% of the total of LICENSED PRODUCT
sold or donated by LICENSEE.
11. INFRINGEMENT AND PATENT ENFORCEMENT
11.01 PHS and LICENSEE agree to notify each other promptly of each
infringement or possible infringement of the LICENSED PATENT
RIGHTS, 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 In the event that a declaratory judgment action alleging
invalidity of any of the LICENSED PATENT RIGHTS shall be
brought against PHS, PHS agrees to notify LICENSEE that an
action alleging invalidity has been brought. PHS does not
represent that it will commence legal action to defend against
a declaratory action alleging invalidity. LICENSEE shall take
no action to compel the GOVERNMENT either to initiate or to
join in any such declaratory judgment action. Should the
GOVERNMENT be made a party to any such suit by motion or any
other action of LICENSEE,
Page 8 of 24
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.
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 OR TANGIBLE MATERIALS RELATED THERETO.
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 directors, employees,
or third parties of any LICENSED PATENT RIGHTS; or b) the
design, manufacture, distribution, or use of any LICENSED
PRODUCTS, LICENSED PROCESSES or materials by LICENSEE, 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 The terms and conditions of this AGREEMENT shall be considered
by PHS to be withdrawn from LICENSEE's consideration and the
terms and conditions of this AGREEMENT and the AGREEMENT
itself to be null and void, unless this AGREEMENT is executed
within sixty (60) days from the date of printing indicated at
the bottom of each page.
13.03 In the event that LICENSEE is in default in the performance of
any material obligations under this AGREEMENT, including but
not limited to the obligations listed in Paragraph 13.06, 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 and pursue
outstanding amounts owed through procedures provided by the
Federal Debt Collection Act.
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 immediately upon LICENSEE's receipt of written
notice.
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13.05 LICENSEE shall have a unilateral right to terminate this
AGREEMENT in any country or territory 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
attached in Appendix E 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 material
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 7) cannot reasonably justify a failure to
comply with the domestic production requirement of Paragraph
5.02 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 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.
13.08 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 404.11,
appeal the decision by written submission to the designated
PHS official. The decision of the designated PHS official
shall be the final agency decision. LICENSEE may thereafter
exercise any and all administrative or judicial remedies that
may be available.
13.09 Within ninety (90) days of expiration or termination of this
AGREEMENT under this Article 13, a final report shall be
submitted by LICENSEE. Any royalty payments, including those
incurred but not yet paid (such as the full minimum annual
royalty), and those related to patent expense, due to PHS
shall become immediately due and payable upon termination or
expiration. Unless otherwise specifically provided for under
this AGREEMENT, upon termination or expiration of this
AGREEMENT, LICENSEE shall return all LICENSED PRODUCTS or
other materials included within the LICENSED PATENT RIGHTS to
PHS or provide PHS with certification of the destruction
thereof.
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 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.
Page 10 of 24
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 shall 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 or
by an express/overnight delivery service provided by a
commercial carrier, 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. Notices shall be considered timely if such
notices are received on or before the established deadline
date or sent on or before the deadline date as verifiable by
U.S. Postal Service postmark or dated receipt from a
commercial carrier. Parties should request a legibly dated
U.S. Postal Service postmark or obtain a dated receipt from a
commercial carrier or the U.S. Postal Service. Private metered
postmarks shall not be acceptable as proof of timely mailing.
14.07 This AGREEMENT shall not be assigned by LICENSEE except: a)
with the prior written consent of PHS, such consent not to be
withheld unreasonably; 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, and LICENSEE shall pay PHS, as an additional
royalty, one percent (1%) of the fair market value of any
consideration received for any assignment of this AGREEMENT
within thirty (30) days of such assignment.
14.08 LICENSEE agrees in its use of any PHS-supplied materials to
comply with all applicable statutes, regulations, and
guidelines, including PHS and DHHS 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 United States 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.
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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,
PHS, or DHHS or the GOVERNMENT 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 modifications or
termination decisions provided for in Article 13. LICENSEE
agrees first to appeal any such unsettled claims or
controversies to the designated PHS official, 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 8.01, 9.06-9.08, 12.01-12.05, 13.07, 13.08, 13.09,
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--NONEXCLUSIVE
SIGNATURE PAGE
For PHS:
/s/ Xxxxxx X. Xxxxxxxx 3/2/04
------------------------- ---------
Xxxxxx X. Xxxxxxxx Date
Director, Division of Technology Development and Transfer
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 00000-0000 X.X.X.
For LICENSEE (Upon, information and belief, the undersigned expressly certifies
or affirms that the contents of any statements of LICENSEE made or referred to
in this document are truthful and accurate.):
by:
/s/ Xxxxxxx X. Xxxxxxxx 3/2/04
________________________________________ _______________
Signature of Authorized Official Date
Xxxxxxx X. Xxxxxxxx
________________________________________
Printed Name
President and CEO
________________________________________
Title
Official and Mailing Address for Notices:
0000 Xxxxxxxxx Xxxxxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000
Any false or misleading statements made, presented, or submitted to the
GOVERNMENT, including any relevant omissions, under this AGREEMENT and during
the course of negotiation of this AGREEMENT are subject to all applicable civil
and criminal statutes including Federal statutes 31 U.S.C. Sections 3801-3812
(civil liability) and 18 U.S.C. Section 1001 (criminal liability including
fine(s) and/or imprisonment).
Page 13 of 24
APPENDIX A--PATENT(S) OR PATENT APPLICATION(S)
PATENT(S) OR PATENT APPLICATION(S):
United States Patent Serial Number 07/702,217 (PHS reference number
E-163-1991/0-US-01) filed May 17, 1991;
United States Patent Serial Number 08/109,187 (PHS reference number
E-163-1991/1-US-01) filed August 19, 1993;
United States Patent Serial Number 08/609,218 (PHS reference number
E-163-1991/1-US-03) filed March 1, 1996;
United States Patent Serial Number 08/905,280 (PHS reference number
E-163-1991/2-US-01) filed August 1, 1997; and
United States Patent Serial Number 09/810,502 (PHS reference number
E-163-1991/2-US-02) filed March 16, 2001, all entitled, "A Method for reducing
the immunogenicity of antibody variable domains," and all continuations,
reissues, divisionals and corresponding foreign patent(s) or patent
application(s).
Page 14 of 24
APPENDIX B--LICENSED FIELDS OF USE AND TERRITORY
LICENSED FIELDS OF USE:
For use in monoclonal antibodies for the prophylactic and therapeutic
treatment of bacterial and fungal infections.
LICENSED TERRITORY:
Worldwide
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XXXXXXXX X--XXXXXXXXX
[ *** ]
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APPENDIX D--MODIFICATIONS
PHS and LICENSEE agree to the following modifications to the Articles and
Paragraphs of this AGREEMENT:
All modifications are incorporated into the body and other appendices of this
AGREEMENT.
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APPENDIX E--BENCHMARKS AND PERFORMANCE
LICENSEE agrees to the following Commercial Development BENCHMARKS for its
performance under this AGREEMENT and, within thirty (30) days of achieving a
BENCHMARK, shall notify PHS that the BENCHMARK has been achieved.
First patient enrolled in Aurexis Phase II Clinical Trial [ *** ]
First patient enrolled in Aurexis Phase III Clinical Trial [ *** ]
BLA submission for Aurexis [ *** ]
First Commercial Sale [ *** ]
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APPENDIX F--COMMERCIAL DEVELOPMENT PLAN
COMMERCIAL PLAN FOR AUREXIS
[ *** ]
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[ *** ]
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[ *** ]
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[ *** ]
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[ *** ]
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[ *** ]
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