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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.
75 Sidney Street
Cambridge, MA 02139
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
