EXHIBIT 10.11
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS
DENOTE OMISSIONS.
PUBLIC HEALTH SERVICE
PATENT LICENSE AGREEMENT--EXCLUSIVE
COVER PAGE
For PHS internal use only:
Patent License Number: [**]
Serial Number(s) of Licensed Patent(s) and/or Patent Application(s):
1) U.S. Utility Patent Application No. [**].
2) U.S. Utility Patent Application No. [**].
Licensee: Millennium Pharmaceuticals, Inc.
▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Cooperative Research and Development AGREEMENT (CRADA) Number (if
applicable): CRADA No. 0676
Additional Remarks: None
Public Benefit(s): LICENSEE agrees, after its FIRST COMMERCIAL SALE, to
make reasonable quantities of LICENSED PRODUCT(S) or
materials produced through the use of LICENSED
PROCESS(ES) available on a compassionate use basis to
patients, either through the patient's physician(s)
and/or the medical center treating the patient; and
LICENSEE further agrees, after its FIRST COMMERCIAL SALE
and as part of its marketing and product promotion, to
develop written educational materials (e.g., brochures,
advertisements, etc.) directed to patients and
physicians detailing the LICENSED PRODUCT(S) and/or
medical aspects of using the LICENSED PRODUCT(S).
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:
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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".
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PHS PATENT LICENSE AGREEMENT -- EXCLUSIVE
PREAMBLE
Whereas PHS and LICENSEE were parties to a Cooperative Research and Development
Agreement (CRADA) (CACR 0676) entered into in December 1998; and
Whereas in the course of performing biomedical research under the CRADA, PHS
investigators and employees of LICENSEE made certain inventions that resulted in
the filing of certain patent applications set forth in Appendix A; and
Whereas LICENSEE filed the patent application designated by Roman numeral I
listed in Appendix A; and
Whereas PHS filed the patent application designated by Roman numeral II listed
in Appendix A; and
Whereas PHS and LICENSEE intend to prosecute any claims under such patent
applications in accordance with the laws governing, and rules and regulations
of, the United States Patent and Trademark Office and to enter into this
agreement to promote the commercialization of said inventions.
Now, therefore, 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.
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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 sublicenses of LICENSED PRODUCTS or the initial
practice of a LICENSED PROCESS by or on behalf of LICENSEE or its
sublicenses in exchange for cash or some equivalent to which value
can be assigned for the purpose of determining NET SALES. Transfer
of LICENSED PRODUCTS or practice of a LICENSED PROCESS for test
marketing, sampling and promotional uses, clinical trial purposes
or compassionate or similar use shall not be considered to
constitute a FIRST COMMERCIAL SALE.
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 FIELDS OF USE I" means the field of use identified in
Appendix B with the Roman numeral I.
2.07 "LICENSED FIELDS OF USE II" means the field of use identified in
Appendix B with the Roman numeral II.
2.08 "LICENSED PATENT RIGHTS" shall means DHHS' ownership interest in:
(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, renewals and extensions (including
any Supplemental Patent Certificate) of all such patents,
and any confirmation patent, registration patent or patent
of addition 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 renewals and extensions (including any
Supplemental Patent Certificate) of all such patents and any
confirmation patent, registration patent or patent of
addition 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.
2.09 "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.
2.10 "LICENSED PRODUCT(S)" means tangible materials which, in the
course of manufacture, use, sale, offer for 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.
2.11 "LICENSED TERRITORY" means the geographical area identified in
Appendix B.
2.12 "NET SALES" means the total gross receipts for sales or other
disposition of LICENSED PRODUCTS or practice of LICENSED PROCESSES
by or on behalf of LICENSEE or its sublicenses, 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), wholesaler and cash
discounts in amounts customary in the trade to the extent actually
granted, and credits or allowances given or made for wastage
replacement, indigent patient and any other sales programs. No
deductions shall be made for commissions paid to individuals,
whether they be with independent sales agencies or regularly
employed by LICENSEE, or sublicenses, and on its payroll, or for
the cost of collections.
2.13 "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.
2.14 "Research License" means a nontransferable, nonexclusive license
to practice the LICENSED PATENT RIGHTS for purposes of research
and not for purposes of commercial manufacture or distribution or
in lieu of purchase.
3. GRANT OF RIGHTS
3.01 PHS hereby grants and LICENSEE accepts, subject to the terms and
conditions of this AGREEMENT, an exclusive license including the
right to grant sublicenses,
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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 and have imported any LICENSED
PRODUCTS in the LICENSED FIELDS OF USE I and to practice and have
practiced any LICENSED PROCESSES in the LICENSED FIELDS OF USE I.
3.02 PHS hereby grants and LICENSEE accepts, subject to the terms and
conditions of this AGREEMENT, a nonexclusive license including the
right to grant sublicenses, 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 and
have imported any Licensed Products in the LICENSED FIELDS OF USE
II and to practice and have practiced any Licensed Processes in
the LICENSED FIELDS OF USE II.
3.03 Except as expressly provided herein, this AGREEMENT confers no
license or rights by implication, estoppel, or otherwise under any
patent applications or patents of PHS or under any patent
applications or patents of LICENSEE, other than the 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 or delayed, LICENSEE may enter into
sublicensing agreements under the LICENSED PATENT RIGHTS, provided
that if LICENSEE has not received any written response from PHS
within twenty (20) days of PHS's receipt of LICENSEE's written
submission of a sublicense for approval, such approval shall be
deemed to have been given.
4.02 LICENSEE agrees that any sublicenses granted by it will provide
that the obligations to PHS of Paragraphs 5.01-5.04, 8.01, 10.01,
12.05, and 13.06-13.07 of this AGREEMENT shall be binding upon the
sublicense 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 sublicenses granted by LICENSEE shall provide for the
termination of the sublicense, or the conversion to a license
directly between such sublicenses and PHS, at the option of the
sublicense, upon termination of this AGREEMENT under Article 13.
Such conversion is subject to PHS approval, such approval not to
be unreasonably withheld or delayed, and contingent upon
acceptance by the sublicense of the remaining provisions of this
AGREEMENT.
4.04 LICENSEE agrees to forward to PHS a copy of each fully executed
sublicense agreements postmarked within thirty (30) days of the
execution of such agreements. To the extent permitted by law, PHS
agrees to maintain each such sublicense agreements in confidence.
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5. STATUTORY AND PHS REQUIREMENTS AND RESERVE GOVERNMENT RIGHTS
5.01 (a) PHS reserves on behalf of the GOVERNMENT an irrevocable,
nonexclusive, nontransferable, royalty-free license to
practice 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.
(b) In the event that LICENSED PATENT RIGHTS are Subject
Inventions made under a Cooperative Research and Development
AGREEMENT (CRADA), LICENSEE grants to the GOVERNMENT, pursuant
to 15 U.S.C. Section 3710a(b)(1)(A), a nonexclusive,
nontransferable, irrevocable, paid-up license to practice
LICENSED PATENT RIGHTS or have LICENSED PATENT RIGHTS
practiced throughout the world by or on behalf of the
GOVERNMENT. In the exercise of such license, the GOVERNMENT
shall not publicly disclose trade secrets or commercial or
financial information that is privileged or confidential
within the meaning of 5 U.S.C. Section 552(b)(4) or which
would be considered as such if it had been obtained from a
non-Federal party.
5.02 LICENSEE agrees that products used or sold in the United States
embodying the LICENSED PATENT RIGHTS or produced through use of
processes set forth in the LICENSED PATENT RIGHTS, but only to the
extent LICENSEE does not otherwise have the right to manufacture
such products in the absence of the licenses granted under this
AGREEMENT, 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 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 a RESEARCH LICENSE from such future
collaborators with PHS when acquiring such 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 (a) In addition to the reserved license of Paragraph 5.01 above,
PHS reserves the right to grant nonexclusive RESEARCH LICENSES
directly or to require LICENSEE to grant nonexclusive RESEARCH
LICENSES on reasonable terms. 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 materials
made through the LICENSED PROCESSES.
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(b) In exceptional circumstances, and in the event that LICENSED
PATENT RIGHTS are Subject Inventions made under a CRADA, the
GOVERNMENT, pursuant to 15 U.S.C. Section 3710a(b)(1)(B),
retains the right to require the LICENSEE to grant to a
responsible applicant a nonexclusive, partially exclusive, or
exclusive sublicense to use LICENSED PATENT RIGHTS in the
LICENSED FIELD of Use I on terms that are reasonable under the
circumstances; or if LICENSEE fails to grant such a license,
the GOVERNMENT retains the right to grant the license itself.
The exercise of such rights by the GOVERNMENT' shall only be
in exceptional circumstances and only if the GOVERNMENT
determines (i) the action is necessary to meet health or
safety needs that are not reasonably satisfied by LICENSEE;
(ii) the action is necessary to meet requirements for public
use specified by Federal regulations, and such requirements
are not reasonably satisfied by the LICENSEE; or (iii) the
LICENSEE has failed to comply with an agreement containing
provisions described in 15 U.S.C. Section 3710a(c)(4)(B). The
determination made by the GOVERNMENT under this Article is
subject to administrative appeal and judicial review under 35
U.S.C. Section 203(2).
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, if any. 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 LICENSEE agrees to pay PHS sublicensing royalties as set forth in
Appendix C.
6.06 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, 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, or (d) the claim has been
pending, in prosecution by PHS, for more then eight (8) years,
except that such eight (8) year period shall be extended by any
period during which examination of the claim is interrupted by (a)
an interference
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proceeding under 35 U.S.C. Section 135 or (b) the claim is under
appeal by PHS from the decision of an examiner pursuant to 37
C.F.R. 1.; provided that if the claim subsequently issues, it
shall be deemed to fall within and shall be a claim under the
LICENSED PATENT RIGHTS, on which royalties are due.
6.07 No multiple royalties shall be payable because any LICENSED
PRODUCTS or LICENSED PROCESSES are covered by more than one of the
LICENSED PATENT RIGHTS.
6.08 On sales of LICENSED PRODUCTS by LICENSEE to sublicenses 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.
6.09 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
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.
6.10 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 LICENSEE agrees:
(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 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.
6.11 LICENSEE may elect to surrender its license to PHS's interest in
the LICENSED PATENT RIGHTS in any country of the LICENSED
TERRITORY upon ninety (90) days written notice to PHS. In such
case, PHS shall have the right, but not the obligation, to
continue the prosecution and maintenance of such patent
applications or patents in such country included within the
LICENSED PATENT RIGHTS, at its sole expense.
7. PATENT FILING, PROSECUTION, AND MAINTENANCE
7.01 (a) Prior to the date this AGREEMENT becomes effective, PHS has
been responsible for the prosecution of the Patent Application
No. II in
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Appendix A and LICENSEE has been responsible for the preparation,
filing and prosecution of Patent Application No. I in Appendix A,
each at its sole expense. After the effective date of this
AGREEMENT, PHS shall be responsible for the preparation, filing,
prosecution and maintenance of any and all patent applications or
patents included in the LICENSED PATENT RIGHTS at LICENSEE's sole
expense and shall on an ongoing basis promptly furnish copies of
all patent-related documents to LICENSEE. Notwithstanding the
foregoing, on a country-by-country basis, LICENSEE shall have the
right to elect not to be responsible for expenses pursuant to this
Section 7.01(a) with respect to any patent applications or patents
included in the LICENSED PATENT RIGHTS, with the understanding
that if LICENSEE makes such an election, the worldwide license
granted in Paragraphs 3.01 and 3.02 shall exclude the specific
patent applications or patents for which LICENSEE has made such
election in such country. PHS shall select registered patent
attorneys or patent agents to provide patent-related services
related to the LICENSED PATENT RIGHTS, reasonably acceptable to
LICENSEE. LICENSEE shall provide appropriate powers of attorney
and other documents necessary to undertake such actions to the
patent attorneys or patent agents providing such services. PHS and
its attorneys or agents shall provide LICENSEE sufficient
opportunity to comment on any document that PHS intends to file or
to cause to be filed with the relevant intellectual property or
patent office.
(b) PHS shall have the right and responsibility to prosecute and
maintain patent prosecution for all LICENSED PATENT RIGHTS.
LICENSEE shall make available to PHS or its authorized attorneys,
agents or representatives, such of its employees whom PHS in its
reasonable judgment deems necessary in order to assist it in
obtaining patent protection for such LICENSED PATENT RIGHTS.
LICENSEE shall provide appropriate powers of attorney and other
documents necessary to undertake such actions to the patent
attorneys or patent agents providing such services. PHS and its
attorneys or agents shall provide LICENSEE sufficient opportunity
to comment on any document that PHS intends to file or to cause to
be filed with the relevant intellectual property or patent office.
(c) In the event PHS elects not to file or continue to seek or
maintain patent protection on any LICENSED PATENT RIGHTS. LICENSEE
shall have the right, at its sole expense, to prosecute and
maintain in any country patent protection on such LICENSED PATENT
RIGHTS in PHS's name. In any such case, PHS shall make available
to LICENSEE or its authorized attorneys, agents or
representatives, such of its employees whom LICENSEE in its
reasonable judgment deems necessary in order to assist it in
obtaining patent protection for such LICENSED PATENT RIGHTS.
LICENSEE and its attorneys or agents shall provide PHS sufficient
opportunity to comment on any document that LICENSEE intends to
file or to cause to be filed with the relevant intellectual
property or patent office.
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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 suggestion with respect
to the preparation, filing, prosecution and maintenance 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, 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, not to exceed once during each calendar year, during
the term of this agreement, 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. Any such accountant or
auditor shall be reasonably acceptable to LICENSEE and shall
execute a standard form of confidentiality agreement with
LICENSEE. 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 9.08 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
fifteen (15) 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 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.
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
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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 LICENSED PRODUCTS
under the COMMERCIAL DEVELOPMENT PLAN within sixty (60) days after
December 31 of each calendar year. These progress reports shall
include progress on research and development, status of
applications for regulatory approvals, manufacturing,
sublicensing, 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 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 PATENT RIGHTS to
the point of PRACTICAL APPLICATION as defined in 37 C.F.R.
404.3(d). LICENSEE shall amend the COMMERCIAL DEVELOPMENT PLAN and
BENCHMARKS at the reasonable request of PHS to address any
LICENSED PRODUCTS not specifically addressed in the plan
originally submitted.
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 Commencing with the calendar half year in which the FIRST
COMMERCIAL SALE of a LICENSED PRODUCT occurs, 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 representative, officer, the
Vice President of Finance or the controller of LICENSEE, and shall
include a detailed listing of all deductions made under Paragraph
2.10 and such other information relevant to the calculation of NET
SALES made under Article 6 to determine royalties due.
9.05 LICENSEE agrees to forward, upon request, semi-annually to PHS a
copy of such reports received by LICENSEE from its sublicenses
during the preceding half-year
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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 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, ▇.▇. ▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇. 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.
9.07 LICENSEE shall be solely responsible for determining if any tax on
royalty income is owed outside the United States and shall pay any
such tax and be responsible for all filings with appropriate
agencies of foreign Governments.
9.08 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.
9.09 All plans, reports, and information required by Articles 7 or 8 or
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 C.F.R. Section 5.65(d).
10. PERFORMANCE
10.01 LICENSEE shall use commercially reasonable efforts to bring the
LICENSED PRODUCTS and LICENSED PROCESSES to PRACTICAL APPLICATION.
"Commercially reasonable 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. The efforts of a sublicense shall be considered the efforts of
LICENSEE.
10.02 Upon the FIRST COMMERCIAL SALE, until the expiration of this
AGREEMENT, LICENSEE shall use commercially reasonable efforts to
make LICENSED PRODUCTS and LICENSED PROCESSES reasonably
accessible to the United States public.
10.03 LICENSEE agrees, after its FIRST COMMERCIAL SALE, to make
reasonable quantities of LICENSED PRODUCT(S) or materials produced
through the use of LICENSED
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PROCESS(ES) available on a compassionate use basis to patients,
either through the patient's physician(s) and/or the medical
center treating the patient.
10.04 LICENSEE further agrees, after its FIRST COMMERCIAL SALE and as
part of its marketing and product promotion, to develop written
educational materials (e.g., brochures, advertisements, etc.)
directed to patients and physicians detailing the LICENSED
PRODUCT(S) and/or medical aspects of using the LICENSED
PRODUCT(S).
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 Pursuant to this AGREEMENT and the provisions of Chapter 29 of
title 35, United States Code, LICENSEE shall have: a) the first
right to bring suit in its own name, at its own expense, and on
its own behalf for infringement of the LICENSED PATENT RIGHTS; b)
the right in any such suit to enjoin infringement and collect for
its use, damages, profits, and awards of whatever nature
recoverable for such infringement; and c) the right to settle any
claim or suit for infringement of the LICENSED PATENT RIGHTS,
subject to approval by the U.S. Government. If LICENSEE desires to
initiate a suit for patent infringement, LICENSEE shall notify PHS
in writing. If LICENSEE fails to initiate such suit or action
within ninety (90) days of a written notice by PHS requesting that
LICENSEE initiate infringement proceedings, PHS shall have the
right to initiate such action. LICENSEE shall have a continuing
right to intervene or join 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 in 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. In all cases, LICENSEE agrees to keep PHS reasonably
apprised of the status and progress of any litigation brought by
LICENSEE and PHS agrees to keep LICENSEE reasonably apprised of
the status and progress of any litigation brought by PHS. 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 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 ▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇
▇▇▇▇▇▇ Code or other statutes, LICENSEE may: a) defend the suit in
its own name, at its own
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expense, and on its own behalf; 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 a continuing right
to join in such suit. Except where the Government is a legally
necessary party, 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 to 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 reasonable costs, expenses, or fees which
the GOVERNMENT incurs as a result of such motion or other action.
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.
11.04 In any action under Paragraphs 11.02 or 11.03, the expenses
including costs, fees, attorney fees, and disbursements, shall be
paid by LICENSEE. The value of any recovery made by LICENSEE
through court judgment or settlement shall be treated as NET SALES
and subject to earned royalties.
11.05 PHS shall cooperate fully with LICENSEE in connection with any
action under Paragraphs 11.02 or 11.03. PHS agrees promptly to
provide access to all necessary documents and relevant existing
employees, pursuant to 45 C.F.R. Part 2 and to render reasonable
assistance in response to a request by LICENSEE.
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.
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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 sublicenses, directors, or employees, of any
LICENSED PATENT RIGHTS; or b) the design, manufacture,
distribution, or use of any LICENSED PRODUCTS, LICENSED PROCESSES
or materials by LICENSEE or its sublicenses, or other products or
processes developed through the practice of the LICENSED PATENT
RIGHTS, unless such liability, demands, damages, expenses or
losses are due to the gross negligence or willful misconduct of
PHS, its employees, students, fellows, agents or consultants.
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 (the
"effective date") 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 Except as otherwise provided in Section 13.05, in the event that
LICENSEE is in default in performance of any material obligation
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
and pursue outstanding amounts owed through procedures provided by
the Federal Debt Collection Act.
13.04 LICENSEE shall have a unilateral right to terminate this
AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or
any licenses in any country or territory by giving PHS sixty (60)
days written notice to that effect. Upon any such termination by
LICENSEE, LICENSEE and PHS shall each have, in the relevant
country or territory, the right to practice the subject matter
covered by the LICENSED PATENT RIGHTS determined under United
States Patent Law to be jointly owned by the Parties and to
license their respective ownership rights to others in all fields,
countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section
404.5(b)(9), 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
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achieve PRACTICAL APPLICATION of the LICENSED PRODUCTS or LICENSED
PROCESSES; 2) has not performed its obligations under Section
10.01 to achieve 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 the commercial use
commences; or 6) cannot reasonably justify a failure to comply
with the domestic production requirement of Paragraph 5.04 unless
waived. In making this determination, PHS shall take into account
the normal course of similar commercial development programs
conducted with sound and commercially reasonable business
practices and judgment and the annual reports submitted by
LICENSEE under Paragraph 9.02, and shall not impose more stringent
performance obligations on LICENSEE than PHS customarily imposes
on other PHS licensees in respect of patent licenses pertaining to
human therapeutic products. 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 6). If LICENSEE fails to
alleviate PHS's concerns as to the previous items 1) to 6) or
fails to initiate commercially reasonable corrective action to
PHS's reasonable satisfaction, PHS may terminate or modify, at its
option, this AGREEMENT.
13.06 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
sublicenses to responsible applicants, on reasonable terms, in
LICENSED FIELDS OF USE I 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.
13.07 PHS reserves the right according to 37 C.F.R. Section 404.5(b)(9)
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 C.F.R. 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, and those related to patent expense, due
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to PHS shall become immediately due and payable upon termination
or expiration. If terminated under this Article 13, sublicenses
may elect to convert their sublicenses to direct licenses with PHS
pursuant to Paragraph 4.03. Unless otherwise specifically provided
for under this AGREEMENT, upon termination or expiration of this
AGREEMENT, LICENSEE shall have the right to sell or otherwise
transfer all LICENSED PRODUCTS or other materials included within
the LICENSED PATENT RIGHTS in its possession subject to the
royalty obligations of Appendix C.
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
or LICENSEE 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 LICENSEE,
as the case may be, or excuse a similar subsequent failure to
perform any such term or condition by LICENSEE or the GOVERNMENT,
as the case may be.
14.02 This AGREEMENT, together with CRADA CACR-0676, constitutes the
entire agreement between the Parties relating to 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 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
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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.
14.08 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.
14.09 Except where written notice pursuant to 35 U.S.C. Section 287(a)
is customarily used for enforcement of patent rights in the
pharmaceutical industry, LICENSEE agrees to: (a) ▇▇▇▇ LICENSED
PRODUCTS or their packaging sold in the United States with all
U.S. patent numbers corresponding to the LICENSED PATENT RIGHTS
and similarly to indicate "Patent Pending" status, and (b) ▇▇▇▇
all LICENSED PRODUCTS manufactured in, shipped to, or sold in
other countries in such a manner as to preserve PHS patent rights
in such countries.
14.10 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. PHS shall not use the name, logo, trademark or any
identification of LICENSEE for purposes of advertising or
promotion without the prior written consent of LICENSEE.
14.11 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 or determinations made by the
GOVERNMENT under Paragraph 5.04. 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.
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14.12 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
C.F.R. Part 404 shall not be immunized from the operation of state
or Federal law by reason of the source of the grant.
14.13 Paragraphs 4.04, 8.01, 9.05-9.07, 9.09, 12.01-12.05, 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 - EXCLUSIVE
SIGNATURE PAGE
For PHS:
/s/ ▇▇▇▇ ▇▇▇▇▇▇▇ 11/25/2002
---------------------- ------------
▇▇▇▇ ▇▇▇▇▇▇▇, Ph.D. 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
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ ▇.▇.▇.
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/▇▇▇▇▇ ▇▇▇▇▇ 12/2/02
---------------------- ---------
Signature of Authorized Official Date
/s/▇▇▇▇▇ ▇▇▇▇▇
--------------------------------------
▇▇▇▇▇ ▇▇▇▇▇
CHIEF OPERATING OFFICER
Title
Official and Mailing Address for Notices:
Millennium Pharmaceuticals, Inc.
▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: General Counsel
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. 3801-3812 (civil
liability) and 18 U.S.C. 1001 (criminal liability including fine(s) and/or
imprisonment).
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APPENDIX A--PATENT(S) OR PATENT APPLICATION(S)
PATENT(S) OR PATENT APPLICATION(S):
I. U.S. Utility Patent Application U.S.S.N. [**].
II. U.S. Utility Patent Application U.S.S.N. [**].
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APPENDIX B--LICENSED FIELDS OF USE AND TERRITORY
LICENSED FIELDS OF USE I: Research, development and manufacture of MLN341 for
distribution, sale and use in oncology disease states within the LICENSED
TERRITORY.
LICENSED FIELDS OF USE II: Research, development and manufacture of dipeptidic
boronic acid compounds and derivatives thereof for distribution, sale and use in
oncology and inflammatory disease states within the LICENSED TERRITORY.
LICENSED TERRITORY: Worldwide
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APPENDIX C--ROYALTIES
ROYALTIES:
I. UP-FRONT ROYALTY:
LICENSEE agrees to pay to PHS a noncreditable, nonrefundable license issue
royalty in the amount of [**] Dollars ($[**]) according to the following payment
schedule:
a) [**] Dollars ($[**]) due within thirty (30) days from the
effective date of this AGREEMENT; and
b) [**] Dollars ($[**]) due within three hundred and sixty-five (365)
days from the effective date of this = AGREEMENT.
II. MILESTONE ROYALTY:
LICENSEE agrees to pay PHS, within thirty days (30) days of achieving the
benchmark, benchmark royalties as follows:
a) [**]: $[**]
b) [**]: i) $[**]; or
ii) $[**]
c) [**]: $[**]
d) [**]: $[**]
For the avoidance of doubt, only one payment will be due in respect of the [**]
and this payment will be either $[**] or $[**], depending on which of the above
criteria is met.
III. RUNNING ROYALTIES:
LICENSEE agrees to pay PHS earned royalties of [**] percent ([**]%) on NET SALES
of Licensed Products by or on behalf of LICENSEE or its sublicenses in the
LICENSED TERRITORY.
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In the event that a LICENSED PRODUCT(S) are sold in any country in the form of a
combination product containing one or more therapeutically active ingredients in
addition to such LICENSED PRODUCT(S), NET SALES of such combination product will
be adjusted by multiplying actual NET SALES of such combination product in such
country by the fraction A/(A+B), where A is the average invoice price of the
LICENSED PRODUCT(S) in such country, if sold separately in such country, and B
is the average invoice price of any other therapeutically active ingredients in
the combination in such country, if sold separately in such country. If, in a
specific country, the other therapeutically active ingredients in the
combination product are not sold separately in such country, NET SALES shall be
calculated by multiplying actual NET SALES of such combination product by the
fraction A/C, where A is the average invoice price of the LICENSED PRODUCT(S) in
such country and C is the invoice price of the combination product in such
country. If, in a specific country, the LICENSED PRODUCT(S) are not sold
separately in such country, NET SALES shall be calculated by multiplying actual
NET SALES of such combination product by the fraction C-B/C, where B is the
average invoice price of the other therapeutically active ingredients in the
combination product in such country and C is the invoice price of the
combination product in such country. The invoice price for the LICENSED
PRODUCT(S) and for each other therapeutically active ingredient or process shall
be for a quantity comparable to that used in the combination product and of the
same class, purity and potency. If, in a specific country, both the LICENSED
PRODUCT(S) and the other therapeutically active ingredients in the combination
product are not sold separately in such country, a market price for the LICENSED
PRODUCT(S) and the other therapeutically active ingredients in the combination
product shall be negotiated in good faith by the Parties. In no event shall the
royalty on NET SALES of LICENSED PRODUCT(S) be reduced to less than .25% of NET
SALES of LICENSED PRODUCT(S) as a result of the application of the combination
products provisions of this paragraph.
IV. SUBLICENSING ROYALTIES:
LICENSEE agrees to pay PHS a sublicensing royalty of [**] percent ([**]%) of (i)
up-front sublicense fees, payments or the equivalent and (ii) milestone payments
attributable to LICENSED PATENT RIGHTS subject to:
(a) Payments not exceeding an aggregate lifetime maximum amount of
$[**];
(b) Subject to (a) above, a minimum payment to PHS of $[**] for
each sublicense granted by LICENSEE;
(c) This sublicensing royalty shall be computed after excluding
the amount of any milestone payments earned and received by
LICENSEE from its sublicenses that corresponds to a direct
milestone, in Section II of this Appendix C, related royalty
paid by LICENSEE to PHS, but shall apply to a) any portion of
a milestone payment earned by LICENSEE from a sublicense in
excess of these excluded amounts and b) any other milestone
payment earned by LICENSEE from a sublicense from a milestone
event not provided for under the "Milestone Royalty" as set
forth on the prior page of this Appendix C.
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For the avoidance of doubt, LICENSEE shall not pay to PHS any proportion of (i)
equity or (ii) future research and development funding.
V. MINIMUM ANNUAL ROYALTY: [**]
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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 have been incorporated into the body of the AGREEMENT.
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APPENDIX E--BENCHMARKS AND PERFORMANCE
LICENSEE agrees to the following BENCHMARKS in LICENSED FIELDS OF USE I for its
performance under this AGREEMENT and, within thirty (30) days of achieving a
BENCHMARK, shall notify PHS that the BENCHMARK has been achieved. If the NDA
filing Benchmark is met prior to reaching the Phase III U.S. Clinical Trial
BENCHMARK, then neither the Phase III U.S. Clinical Trial BENCHMARK nor the
Pre-NDA Meeting with the U.S. Food and Drug Administration BENCHMARK shall be
required. Notwithstanding the above, LICENSEE agrees that if the NDA filing
BENCHMARK results in anything other than an NDA approval, LICENSEE shall notify
PHS pursuant to paragraph 9.02 and this Appendix E shall be modified.
BENCHMARK ESTIMATED COMPLETION DATE
--------- -------------------------
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
LICENSED FIELDS OF USE II BENCHMARKS
LICENSEE is currently conducting preclinical evaluation in the area of
dipeptidic boronic acid (or boronate ester) compounds and derivatives in
LICENSED FIELDS OF USE II. Provided the license under Paragraph 3.02 is in
effect, LICENSEE will provide to PHS, on or before [**], a commercial
development plan for research and development of compounds under LICENSED FIELDS
OF USE II.
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APPENDIX F--COMMERCIAL DEVELOPMENT PLAN
NOTE: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY TRADE SECRET
INFORMATION OF MILLENNIUM PHARMACEUTICALS, INC. AND IS EXEMPT FROM MANDATORY
DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT, 5 USC 552 AND ITS IMPLEMENTING
REGULATIONS.
COMMERCIAL DEVELOPMENT PLAN FOR MLN341
Background
The licensed patent rights are being used for formulation of MLN341 (also known
as LDP-341 and PS-341), a novel, first in class, highly selective, small
molecule proteasome inhibitor. The proteasome is the multicatalytic enzyme
responsible for protein turnover in eukaryotic cells. Tumor cells are
differentially sensitive compared with normal cells, and blockade of the
proteasome arrests tumor growth by blocking the cell cycle, and inducing
apoptosis.
Millennium Pharmaceuticals, Inc. ("MLNM") is engaged in the development of
MLN341 and is seeking to develop, register and market MLN341 at the earliest
practical date in order to bring lifesaving therapies to cancer patients. MLNM
is utilizing the licensed patent rights under this Agreement to aid in this
effort. As a result of substantial investments to date, MLN341 is in an advanced
stage of development and many commercialization milestones have already been
achieved. A clear indication of MLNM's commitment is that between Q1 2000 and Q1
2002 it invested over $[**] in direct research and development expenses for
preclinical and clinical studies, and in 2002 alone it is estimated that direct
research and development costs, largely driven by the costs of advanced stage
clinical trials, will exceed $[**]. This level of investment demonstrates MLNM's
commitment to completing the commercialization of MLN341.
Evaluation of MLNM in [**]
The primary indication for which MLN341 is being developed is [**], an
indication for which there is clear and present medical need. Millennium expects
to announce the initiation of a Phase III clinical trial for patients [**]. MLNM
has already achieved, and plans to achieve, the clinical and regulatory
milestones set forth below.
MLN34I CLINICAL AND REGULATORY COMPLETION DATE OR ESTIMATED
----------------------------------------------------------------------
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
*Note: Because of the unmet medical need for effective therapies for [**], MLNM
is not satisfied with the customary development timeline applicable to products
subject to the normal
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approval route before the United States Food and Drug Administration ("FDA").
Accordingly, while MLNM is planning to conduct clinical trials based on
traditional development timelines, MLNM is also in discussions with the FDA
regarding the potential for accelerated approval of MLN341 based on current
▇▇▇▇▇ ▇▇ data. It would not be appropriate for MLNM to make any public
disclosure of these discussions [**]. However, should the FDA concur with MLNM's
perspective on the promising response rates in this patient population,
accelerated approval for MLN341 [**] could accelerate approval and launch of MLN
341 in this indication by up to [**]. While the outcome of this effort is
dependent on the data and agreement with FDA, it is further evidence of the
substantial effort MLNM is making to expeditiously develop and register the
product.
Development of MLNM for Additional Indications
[**]is only the beginning, and while a very significant step on its own, MLNM is
also evaluating MLN341 for the following additional indications, many of which
are the subject of active clinical trials:
- [**];
- [**];
- [**];
- [**];
- [**]; and
- [**].
Depending on the sufficiency of data obtained in Phase II and Phase III trials
and their acceptability to the FDA, it is anticipated that MLN341 could reach
the market for one or more of these secondary indications in [**]. MLNM may also
engage in collaborative development and commercialization activities with third
parties that have products, technology or capability that will enhance the value
of MLN341.
Caveats
It must be emphasized that the above timelines are estimates only, based on
currently available information and good faith estimates by MLNM personnel, and
cannot be taken to predict the outcome of further development of MLN341.
Millennium cannot be certain that any product will ultimately prove to be safe
or effective, will receive regulatory approvals, or will be successfully
commercialized.
Commercialization Activities
MLNM's marketing and sales organization has an ongoing market research program
to identify the required MLN341 clinical profile and market dynamics in each
clinical indication, and is
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shaping its product profiles according to this data and direct input from
clinical investigators and thought leaders in Oncology practice.
Communication with clinicians on the clinical benefits of MLN341 and feedback on
clinical trial design is the responsibility of the MLNM product team. MLNM is
actively engaged in educational activities as it prepares for the registration
and launch of MLN341. MLNM is an active participant in key scientific meetings
such as the American Society of Clinical Oncology and the American Society of
Hematology, where it has published numerous findings from its preclinical and
clinical research. MLN341 has been and will be the subject of publications in
peer-reviewed medical journals based on the data from the clinical program. MLNM
has created an advisory board of clinical experts for MLN341 and is in active
dialog with key advocacy groups.
MLNM's oncology marketing organization is actively planning MLN341 sales and
marketing activities consistent with the advanced stage of development of the
product, including product labeling, package inserts, pricing, reimbursement,
and product branding with MD's and other health practitioners.
To date, MLNM has retained commercial rights to market MLN341 directly, and is
expanding its medical affairs, marketing and sales groups consistent with an
aggressive timeline for product launch in multiple indications. In the event
that MLNM elects to collaborate with a third party with synergistic products,
technology or capability that will enhance the value of MLN341, MLNM may offer
commercialization rights to the collaborator as part of the transaction.
Commercial scale manufacturing contracts are in place for producing the initial
cGMP commercial scale manufacturing runs. Based on the data from these initial
runs, longer term commercial supply contracts will be negotiated with key
suppliers for MLN341. Accordingly, MLNM is now well-positioned to manufacture
and supply MLN341 for the initial launch. MLNM is also engaged in the sourcing
of second suppliers to ensure adequate capacity for all market conditions and
guard against potential supply chain interruptions.
LICENSED FIELDS OF USE II
Licensee is currently conducting preclinical evaluation in the area of [**].
Provided the license under S. 3.02 is in effect, Licensee will provide to PHS,
on or before [**], a Commercial Development Plan for research and development of
compounds under Licensed Fields of Use II.
Summary
The MLN341 commercialization program is designed to ensure that this exciting
compound is developed, registered, launched and marketed with a level of
diligence that equals or exceeds that normally in place at the time a customary
patent license is entered into by the NCI, and the significant investment made
to date demonstrates MLNM's strong commitment and motivation to completing this
effort with all deliberate speed.
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