1
Certain confidential portions of this Exhibit were omitted by means of
blackout of the text (the "Xxxx"). This Exhibit has been filed separately with
the Secretary of the Commission without the Xxxx pursuant to the Company's
Application Requesting Confidential Treatment under Rule 406 under
the Securities Act.
EXHIBIT 10.1
AGREEMENT
This agreement, effective as of November 6. 1990 (the "Effective Date"),
by and between Xxxx-Xxxxxx Cancer Institute, a Massachusetts corporation
("DFCI"), and Anthra Pharmaceuticals, Inc., a Delaware corporation ("ANTHRA").
WITNESSETH THAT:
WHEREAS, N-trifluoroacetyladriamycin-14-valerate ("AD 32") and congeners,
pharmaceutical compounds with antineoplastic application, were discovered by Dr.
Mervyn Israel and colleagues while engaged as a professional at DFCI; and
WHEREAS, N-Trifluoroacetyladriamycin-14-0-hemiadipate ("AD 143") and
congeners, pharmaceutical compounds with antineoplastic application, were
discovered by Dr. Mervyn Israel and colleagues while engaged as a professional
at DFCI; and
WHEREAS, Dr. Israel and other inventors of AD 32 and AD 143 previously
assigned their rights in AD 32 and AD 143 to DFCI and DFCI has obtained United
States Patent No. 4,035,566 (July 12, 1977) and United States Patent No.
4,299,822 covering AD 32 and AD 143 and congeners in the United States. DFCI has
also obtained corresponding foreign patents for AD 32 in Canada and for AD 143
in France, Switzerland, Canada, West Germany, the United Kingdom, The
Netherlands and Japan; and,
WHEREAS, ANTHRA desires to acquire from DFCI an unrestricted exclusive
worldwide patent and know-how license on both AD 32 and AD 143 and congeners,
subject to such restrictions that have been or may be imposed by the U.S.
Department of Health and Human Services ("HHS"); and,
WHEREAS, DFCI is willing to grant such a license to ANTHRA;
NOW, THEREFORE, the parties agree as follows:
ARTICLE 1 -- DEFINITION
1.1 "Patent Rights" means all United States and foreign patents granted
thereon, owned or controlled by DFCI, relating to the manufacture, use
and/or sale of AD 32, AD 143, and AD 32 and AD 143 congeners, and any
division, reissue, extension, patent of addition, registration or
continuation of the foregoing patents.
*** CONFIDENTIAL TREATMENT REQUESTED.
2
1.2 "Net Sales Price" means ANTHRA' s gross invoice price to customers of
AD 32, AD 143 or a congener, in whatever form, loss discounts,
transportation costs, costs of premiums for product liability and shipping
insurance, delivery, expenses, packaging costs, taxes based directly On
manufacture, use, sale or delivery (other than incomes taxes), duties and
allowances to customers; provided, however, that in determining Net Sales
Price to any customer in any way affiliated with ANTHRA, through stock
ownership, management or otherwise, invoice price shall be the same as if
sold at arm's length to an unrelated customer. The Net Sales of any AD 32,
AD 143 or a congener that is a combination or mixture of a therapeutic or
prophylactic agent, shall be the Net Sales Price of a corresponding
quantity of AD 32 or AD 143 or congener when sold separately in the form
in which said combination or mixture is sold. In the event that there is
no established net Sales Price for AD 32 or AD 143 or a congener sold as a
component of such combination or mixture in the form in which such
combination or mixture is sold, ANTHRA shall so notify DFCI in writing and
ANTHRA and DFCI shall negotiate in good faith to establish a basis that is
equivalent to the Net Sales Value for AD 32 or AD 143 or a congener in
the form in which said combination or mixture is sold.
ARTICLE 2 -- GRANT
2.1 DFCI hereby grants to ANTHRA an exclusive license and right, as of the
Effective Date, for the maximum period permissible under applicable
federal regulations in the United States, and for a period ending at the
termination of the Patents Rights outside the United States, to
sublicense, to manufacture, have manufactured, use and sell AD 32 and AD
143 and congeners under the patent rights and accompanying know-how,
subject to the restrictions and limitation enumerated in the agreement
between DFCI and HHS, accepted April 22, 1985, and attached hereto as
Attachment A and made a part hereof (the "HHS Agreement"), or to other
similar restrictions and limitations applicable to AD 32 or to
restrictions imposed by applicable law.
2.2 DFCI hereby grants to ANTHRA the non-exclusive license and right upon
termination of the exclusive license (in the United States) and for a
period ending at the termination of this agreement, to sublicense, to
manufacture, have manufactured, use and sell AD 32 and AD 143 and
congeners under the patent Rights (including know-how relating thereto)
subject to the restrictions and limitations enumerated in the agreement
between DFCI and HHS, accepted April 22, 1985 and attached hereto as
Attachment A and made a part hereof (the "HHS Agreement") or to other
similar restrictions and limitations applicable to AD 32 or to
restrictions imposed by applicable law.
2.3 ANTHRA herewith grants back to DFCI the right for DFCI, to conduct
research on a royalty-free basis on AD 32 and AD 143 and congeners. It is
understood, however, that specific arrangements for DFCI's participation
in Phase I/II clinical studies under ANTHRA's sponsorship and support
shall be the subject of a separate agreement. DFCI reserves the right to
transfer to other not-for-profit organizations the technology described
herein as long as such technology is utilized in non-commercial research
with the agreement of DFCI and that Anthra is apprised by written notice
that such transfer is taking place.
*** CONFIDENTIAL TREATMENT REQUESTED. 2
3
2.4 ANTHRA shall have the right to filet, at ANTHRA's expense, a New Drug
Application ("NDA") or an Investigational New Drug Application ("IND") to
be prepared by and submitted in the name of ANTHRA to the Food and Drug
Administration ("FDA") or any successor thereto. ANTHRA shall be free to
arrange for clinical studies of AD 32 and AD 143 and congeners within and
outside the United States.
2.5 ANTHRA will use its best efforts to bring AD 32 and AD 143 to early
clinical trial and to commercial development; and will provide DFCI with
reports at regular intervals relative to its progress along these
objectives.
ARTICLE 3 -- DISCLOSURE
3.1 DFCI shall disclose and make available to ANTHRA all data in its
possession on the Effective Date regarding AD 32 and AD 143 and congeners,
including, but not limited to, formula, method of preparation, testing and
any other data useful in the preparation of the IND or NDA on AD 32, AD
143 and/or congeners.
3.2 ANTHRA shall make available to DFCI without charge, all clinically
related data on AD 32, AD 143 and congeners generated or caused to be
generated by ANTHRA such data to be used by DFCI for clinical research
purposes only.
3.3 ANTHRA may wish, from time to time, during the term of this Agreement,
to disclose its confidential and proprietary information to DFCI
personnel. Any agreement relating to the terms and conditions of such
disclosure shall be negotiated separately by ANTHRA with the individuals
and shall require that any such information disclosed must be in writing
and designated by ANTHRA, in writing, as confidential. It is understood
that DFCI will not require individuals to enter into such agreements and
will not provide assistance to ANTHRA in enforcing such agreements. If
ANTHRA and DFCI personnel enter into such agreements, DFCI shall have no
obligations to protect the confidentiality of information transmitted
under them. Notwithstanding the foregoing, DFCI shall be responsible for
assuring the confidentiality of ANTHRA proprietary information disclosed
in writing to members of the DFCI administration, responsible for
administering this Agreement, where such information is clearly designated
in writing as confidential.
3.4 Nothing in this Agreement or in any license or sublicense granted
under the provisions hereof shall in any way restrict the right and
obligation of either DFCI or ANTHRA to comply with any requirement for the
supply of information imposed by HHS in granting the aforesaid petition by
DFCI, provided, however, that either DFCI or Anthra will give the other
party prior notice of any potential required disclosure of Confidential
Information, a right to appeal such required disclosure to appropriate
authorities, and a right to cause the disclosing party to comply with the
required disclosure so as to limit any adverse affect such disclosure may
have on the value, uniqueness or protection of such Confidential
Information.
*** CONFIDENTIAL TREATMENT REQUESTED. 3
4
ARTICLE 4 -- PAYMENT
4.1 If and when AD 32 and/or AD 143 become(s) commercially available
ANTHRA agrees to pay DFCI a royalty ("running royalty") equal to *** which
are sold by ANTHRA under an exclusive license during the life of the
respective product patents; *** which are sold by ANTHRA in the United
States after the expiration of the patent, as consideration of the
technical information, know-how, tangible research property and other
commercially advantageous material and/or information conveyed by DFCI to
ANTHRA. This royalty will continue until the introduction of any
generically equivalent version of such product. *** received by ANTHRA
from sublicenses outside of the United States until the expiration of the
applicable patent and from sublicenses inside the United States until the
termination of this Agreement.
4.2 ANTHRA agrees to pay DFCI a minimum royalty ("minimum royalty") of
Fifteen Thousand Dollars ($15,000.00) for each twelve month period
commencing on the anniversary of the KDA approval in the United States of
AD 32 ("anniversary date") and ending on the termination of the Agreement
(see Article 11.5); if the royalty under Article 4.1 for any such twelve
month period (or portion thereof as provided in the foregoing proviso) is
less than the minimum royalty for the same period, the difference between
the running and minimum royalty shall be paid to DFCI within sixty (60)
days after the anniversary date (or the termination of this Agreement, as
the case may be). If the royalty for any such twelve month period (or
portion thereof as provided in the foregoing proviso) is equal to or
exceeds the minimum royalty, no minimum royalty shall be paid. This
obligation to pay minimum royalties shall cease upon the termination of
this Agreement, OR at such times as minimum royalties have been paid for
eight (8) successive twelve month periods.
4.3 All payments to DFCI under this Agreement shall be in United States
dollars and shall be accompanied by a written statement, duly certified by
an officer of ANTHRA or an independent certified public accountant,
showing, in reasonable detail, the calculation of the sums paid. As to all
sales on which royalties are payable in respect of which payment has been
made to ANTHRA or a sublicensee in a currency other than United States
dollars, conversion to United States dollars shall be made at the rate of
exchange reported in The Wall Street Journal for the last business day of
the calendar quarter in which such sales have taken place, or if no rate
of exchange is reported therein, at the rate quoted for that day by the
First National Bank of Boston, 000 Xxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx.
4.4 ANTHRA shall pay DFCI upon the execution and delivery of this
Agreement a payment of *** as reimbursement of expenses incurred by DFCI
in obtaining patents relating to AD 32 and AD 143. DFCI represents and
warrants that it has, and on the Effective Date will have, full ownership
of the following patents, and that it has the right to license each of
them pursuant hereto: for AD 00 Xxxxxx Xxxxxx Patent No. 4,035,566;
Canadian Patent No. 1,060,003 and for AD 000 Xxxxxx Xxxxxx Patent No.
4,299,822; Canadian Patent No. 1,150,245; British Patent No. 2,077,265;
French Patent No. 2,483,928; Swiss Patent No. 645,387; West German Patent
No. 3,122,689; Holland Patent No. 184,420; and Japan Patent No. 1,458,104.
ARTICLE 5 -- ACCOUNTING
5.1 ANTHRA shall keep true books of account containing an accurate and
complete record of all data necessary for the computation of monies
payable to DFCI according to this Agreement. ANTHRA shall permit access to
such books during regular business hours (at DFCI's expense and upon at
least five (5) days' notice) by an independent public accountant selected
by DFCI (except one to whom ANTHRA has some reasonable objection) to
examine and take abstracts from the relevant records of ANTHRA to such
extent as may be reasonably necessary to enable such accountant to verify
or determine monies paid or payable by ANTHRA under this Agreement. In the
event such auditing discloses a deficiency in monies paid to DFCI, the
accountants' expenses shall be borne by ANTHRA.
5.2 A provision equivalent to Article 5.1 shall be included for the
benefit of DFCI in each sublicense granted by ANTHRA under this Agreement.
ARTICLE 6 -- SUBLICENSES
6.1 Any sublicense granted by ANTHRA hereunder shall be in conformity with
the mandatory restrictions and limitations imposed upon DFCI and HHS,
including those enumerated in the HHS Agreement.
*** CONFIDENTIAL TREATMENT REQUESTED. 4
5
ARTICLE 7 -- CONVERSION TO NONEXCLUSIVE LICENSE
7.1 In the event ANTHRA shall default in payment of any minimum royalty
due under Article 4.2, DFCI may notify ANTHRA and if the default is not
remedied within ninety (90) days after the date of notice, then, whether
it is during the period of exclusivity or non-exclusivity of the license
to ANTHRA, DFCI shall have the right to terminate ANTHRA's license under
this Agreement by a second notice to ANTHRA. A default by ANTHRA in
payment of the minimum or running royalty under Articles 4.1 and 4.2 or
any other default by ANTHRA shall be subject to the provision of Article
11.
7.2 ANTHRA's exclusive license under this Agreement shall be automatically
converted to a nonexclusive license at such time, if any, as is specified
in the HHS Agreement.
ARTICLE 8 -- PROSECUTION AND MAINTENANCE OF PATENT RIGHTS
8.1 The costs and responsibility of filing, prosecuting and maintaining
all domestic and foreign and other patent applications and patents within
the Patent Rights shall be borne by ANTHRA. ANTHRA, in coordination with
DFCI will be responsible for the maintenance of all such patents.
ARTICLE 9 -- MOST FAVORED LICENSEE
9.1 If, after conversion of ANTHRA's license to a nonexclusive license
under other provisions of this Agreement, DFCI shall grant to any third
party a license under any of the Patent Rights on royalty or other
monetary terms, or on other condition, More favorable than those provided
to ANTHRA in this Agreement, ANTHRA shall be entitled to such more
favorable terms. DFCI shall notify ANTHRA of the grant of any license to a
third party (whether or not more favorable) and the terms and conditions
within thirty (30) days of such grant. ANTHRA shall be entitled to the
benefit of such more favorable royalty or other monetary terms or other
terms or conditions from the effective date of and for the term of such
license to such third party but subject to the same conditions of
enjoyment as said third party.
ARTICLE 10 -- PROSECUTION OF INFRINGERS; ADVERSE GOVERNMENTAL ACTIONS
10.1 If a third party shall infringe any granted patent within the Patent
Rights on a substantial commercial scale, or if any adverse governmental
actions are taken relating to AD 32 or AD 143 or any congener (such as
actions by the FDA), ANTHRA shall give notice to DFCI. If by the end of
three months after the date of such notice DFCI has not brought suit
against the infringer or procured a cessation of the infringement, then
(a) if ANTHRA's license is still an exclusive license, ANTHRA shall be
entitled to bring suit at its own expense against the infringer in its own
name and any recoveries made in a suit brought by ANTHRA shall be for the
sole benefit of ANTHRA, or (b) if ANTHRA's
*** CONFIDENTIAL TREATMENT REQUESTED. 5
6
license has been converted to a nonexclusive license, ANTHRA shall be
excused from paying any royalty in respect to the infringed patent until
such time as the. infringement has ceased or suit has been brought against
the infringer.
ARTICLE 11 -- TERM AND TERMINATION
11.1 Upon the default by ANTHRA of any obligations under this Agreement,
DFCI may give notice to ANTHRA specifying the default and indicating
intent to terminate this Agreement if the default is not cured within
ninety (90) days after the date of notice. If the default is not cured
within said ninety day (90) period, DFCI may terminate this Agreement
forthwith by further notice to ANTHRA.
11.2 ANTHRA shall have the right to terminate this Agreement at any time
by giving ninety (90) days' advance written notice.
11.3 Termination under Article 11.1, 11.2, or 11.3 shall not relieve
ANTHRA of the obligation to pay any monies earned by DFCI up to the date
of termination.
11.4 If not earlier terminated under the provisions of Article 11.1, 11,2,
or 11.3, this Agreement shall terminate upon the fifth anniversary of the
expiration of the applicable U.S. patent in the United States and upon the
expiration of the applicable patent outside the United States.
ARTICLE 12 -- NOTICES
12.1 All notices and other communications hereunder shall be in writing.
Such notices and communications shall be sent by first class mail, or hand
delivered, and if relating to a default, alleged default or termination,
by registered mail or by personal hand delivery. All notices and
communications shall be addressed to the other party at the following
addresses, or to such other address as the addressee shall have last
furnished to the communicating party:
XXXX XXXXXX CANCER INSTITUTE
00 Xxxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Xx. Xxxxxxx X. Xxxxxxx
Director for Research
ANTHRA PHARMACEUTICALS, INC.
00 Xxxxxx Xxxx
Xxxxxxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxx
Chief Executive officer
*** CONFIDENTIAL TREATMENT REQUESTED. 6
7
With a copy to:
Xxxxxxxxx Xxxxxxx and Xxxxx
000 Xxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxxx Xxxxxxxxx
The date of giving any notices or other communications shall be the date on
which the envelope was deposited or hand delivered. A post office receipt
shoving the date of deposit shall be prima facie evidence of the date of giving
a mailed notice.
ARTICLE 13 -- AMENDMENT AND WAIVER
13.1 Neither this Agreement nor any term, covenant, condition or other
provision hereof may be changed, waived, discharged or terminated orally,
but only by an instrument in writing signed by the party against whom
enforcement of the change, waiver, discharge or termination is sought. No
waiver by either party of any breach of this Agreement by the other party
shall be effective an to any breach occurring before or after the date of
such waiver.
ARTICLE 14 -- GOVERNING LAW; SUCCESSION; ENTIRE AGREEMENT AND ARBITRATION
14.1 This Agreement shall be construed in accordance with and shall be
governed by the laws of the Commonwealth of Massachusetts.
14.2 This Agreement shall be binding upon and shall inure to the benefit
of the successors of the parties hereto, but shall not be otherwise
assignable by either of the parties without the prior written consent of
the other.
14.3 This document, together with the HHS Agreement, constitutes the
entire agreement between the parties hereto with reference to the subject
matter hereof and there are no understandings or representations of any
kind except as expressly set forth herein.
14.4 Any controversy or claim arising out of or relating to this Agreement
shall be submitted to final and binding arbitration in Boston,
Massachusetts, to the exclusion of all other remedies, in accordance with
the rules of the American Arbitration Association then in effect. The
party in whose favor a decision is rendered shall be entitled to recover
reasonable attorneys' fees in an amount determined by the arbitrators.
*** CONFIDENTIAL TREATMENT REQUESTED. 7
8
ARTICLE 15 -- INDEMNIFICATION AND INSURANCE
15.1 ANTHRA shall indemnify, defend and hold harmless DFCI and its
trustees, officers, medical and professional staff, employees and agents
and their respective successors, heirs and assigns, (the "Indemnitees"),
against any liability, damage, loss or expense (including reasonable
attorney's fees and expenses of litigation) incurred by or imposed upon
the Indemnitees, or any one of them in connection with any claims, suits,
actions, demands or judgements (a) arising out of the design, production,
manufacture, sale, use in commerce, lease, or promotion by ANTHRA or by a
licensee, affiliate or agent of ANTHRA of any product, process or service
relating to, or developed pursuant to, this Agreement or (b) arising out
of any other activities to be carried out pursuant to the Agreement.
15.2 ANTHRA'S indemnification under 15.1(a) shall apply to any liability,
damage, loss or expense whether or not it is attributable to the negligent
activities of the Indemnitees. ANTHRA'S indemnification under 15. 1 (b)
shall not apply to any liability, damage, loss or expense to the extent
that it is attributable to (A) the negligent activities of the
Indemnitees, (B) failure to adhere to the study protocol by the
Indemnitees, or (C) the intentional wrongdoing or intentional misconduct
of the Indemnitees.
15.3 ANTHRA agrees, at its own expense, to provide attorneys reasonably
acceptable to DFCI to defend against any actions brought or filed against
any party indemnified hereunder with respect to the subject of indemnity
contained herein, whether or not such actions are rightfully brought.
15.4 At such time as any product, process or service relating to, or
developed pursuant to, this Agreement is being commercially distributed or
sold (other than for the purpose of obtaining regulatory approvals) by
ANTHRA or by a licensee, affiliate or agent of ANTHRA, ANTHRA shall at its
sole cost and expense procure and maintain policies of comprehensive
general liability insurance in amounts not less than $2,000,000 per
incident and $2,000,000 annual aggregate and naming the Indemnities as
additional insureds. Such comprehensive general liability insurance shall
provide (i) product liability coverage and (ii) broad form contractual
liability coverage for ANTHRA'S indemnification under section 15.1 through
15.3 of this Agreement. If ANTHRA elects to self-insure all or part of the
limits described above (including deductibles or retentions which are in
excess of $250,000 annual aggregate) such self-insurance program must be
acceptable to the DFCI and DFCI's associated Risk Management Foundation.
The minimum amounts of insurance coverage required under these provisions
shall not be construed to create a limit of ANTHRA's liability with
respect to its indemnification obligation under section 15.1 through 15.3
of this Agreement.
15.5 ANTHRA shall provide DFCI with written evidence of such insurance
upon request of DFCI. ANTHRA shall provide DFCI with written notice at
least fifteen (15) days prior to the cancellation, non-renewal or material
change in such insurance; if ANTHRA does not obtain replacement insurance
providing comparable coverage with such fifteen (15) day period, DFCI
shall have the right to terminate this Agreement effective at the and of
such fifteen (15) day period without any notice or additional waiting
periods.
15.6 ANTHRA shall maintain such comprehensive general liability insurance
beyond the expiration or termination of this Agreement during (a) the
period that any product, process, or service relating to or developed
pursuant to this Agreements being commercially distributed or sold (other
than for the purpose of obtaining regulatory approvals) by ANTHRA or by a
licensee, affiliate or agent of ANTHRA and (b) a reasonable period after
the period referred to in 15.6 (a) above which in no event shall be less
than fifteen (15) years.
15.7 In the event any such action is commenced or claim made or threatened
against DFCI or other Indemnitees as to which ANTHRA is obligated to
indemnify it (them) or hold it (them) harmless, DFCI or the other
Indemnitees shall promptly notify ANTHRA of such event. ANTHRA shall
assume the defense of, and may settle, that part of any
*** CONFIDENTIAL TREATMENT REQUESTED. 8
9
such claim or action commenced or made against DFCI (or other Indemnitees)
which relates to ANTHRA's indemnification and ANTHRA may take such other
steps as may be necessary to protect itself . ANTHRA shall not be liable
to DFCI or other Indemnitees on account of any settlement of any such
claim or litigation effected without ANTHRA's consent. The right of ANTHRA
to assume the defense of any action shall be limited to that part of the
action commenced against DFCI and /or Indemnitees which relates to
ANTHRA's obligation of indemnification and holding harmless.
15.8 This section 15 shall survive expiration or termination of this
Agreement.
ARTICLE 16 -- DISCLAIMER OF WARRANTY
16.1 DFCI MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT, TRADEMARK, SOFTWARE, TRADE
SECRET, TANGIBLE RESEARCH PROPERTY, INFORMATION OR DATA LICENSED OR
OTHERWISE PROVIDED TO ANTHRA HEREUNDER AND HEREBY DISCLAIMS THE SAME.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives to be effective as of the year and the
day first above written.
XXXX XXXXXX CANCER INSTITUTE
By /s/ Xxxxxxx X. Xxxxxxx Phd
-------------------------------
Name: Xx. Xxxxxxx X. Xxxxxxx
Title: Director for Research
ANTHRA PHARMACEUTICALS, INC.
By /s/ Xxxxxxx x. Xxxxxx
-------------------------------
Name: Xxxxxxx X. Xxxxxx
Title: Chief Executive Officer
*** CONFIDENTIAL TREATMENT REQUESTED. 9
10
Attachment A
[Department of Health & Human Services Letterhead]
Our reference: G-91-80
Xx. Xxxxx X. Xxxxxxxx
Director of Research
Xxxx-Xxxxxx Cancer Institute
00 Xxxxxx Xxxxxx
Xxxxxx, XX 00000
Dear Xx. Xxxxxxxx:
Reference is made to the report of an invention entitled,
"N-Trifluoroacetyladriamycin 14-0-Hemiglutarate and -Hemiadipate and Therapeutic
Compositions Containing Same," which was developed by Drs. Xxxxxx Israel and
Gopalakrishnan P.G. Potti at the Dana-Faber Cancer Institute with support from
National Institutes of Health research grant: Nos. CA-17263, CA-19118, and
CA-06516.
Reference is also made to the petition submitted by you on August 31,
1983, requesting that Xxxx-Xxxxxx Cancer Institute (hereinafter sometimes
referred to an "DFCI") be permitted to retain and administer the principal
patent rights in the invention. United States Patent No. 4,299,822, which
describes and claims this invention, issued November 10, 1981.
Evaluated to determine whether it is consistent under Section 8.2(b) of
the Federal Procurement Regulations, with Section 8.1(a) of the HHS regulations
(45 C.F.R., Parts 6 and 8), more specifically with Section 8.2(b), and with the
intent of the Presidents' Statements and Memoranda on Government Patent Policy
(36 FR 16887, August 26, 1971, and 2B FR 10943, October 12, 1963). Consideration
has also been given to whether the invention will be more adequately and quickly
developed for widest use if it is assigned to DFCI for development and
administration.
Consistent with the regulations cited supra, it is my determination
that:
1. The public interest will be best served by the expeditious development
of the invention described in United States Patent No. 4,299,822. The estimated
time required for the continued development and clinical investigation of this
invention is 8-10 years at an estimated cost of approximately $750,000. It is
anticipated that the company receiving the license from DFCI will perform the
work and bear a significant portion of the above costs. It is not anticipated
that the Government will make additional monetary contributions to the
development of the invention.
11
2. To encourage the above development, all right, title and interest in
the invention is hereby left to DFCI for development and administration, subject
to the following terms and conditions:
(a) The inventors, Drs. Xxxxxx Israel and Gopalakrishnan P.G. Potti, shall
assign all of their rights in the invention, including their rights in the
patent application, to DFCI. The assignment under the patent application shall
be recorded by the DFCI in the United States patent and Trademark Office, and
copies thereof shall be furnished to this office.
(b) The DFCI shall not assign its U.S. patent rights in the invention to
parties other than the United States government, except that it may assign such
rights in the invention to a patent management organization, provided that the
patent administration agreement between such organization and the DFCI is
approved by the HHS. Any reference in this determination to the DFCI shall also
include such patent management organization when applicable, and any assignment
to such an organization shall be subject to all the terms and conditions of this
determination.
(c) The determination of whether or not patent application shall be filed
in foreign countries is left to the discretion of the DFCI. Foreign patent
rights may be licensed or assigned by the DFCI to any party of its choice.
However, any exclusive license or assignment of foreign patent rights to such
party shall include a provision for royalty payments to the DFCI based on
foreign sales related to such license or assignment and, provided that such
party has a license or right to market in the United States, a provision for
nonexclusive licensing in the country covered by the licensed or assigned rights
on the basis of not having made the invention available in the United States
within a reasonable time after marketing abroad.
(d) In the event that such party has a license or right to market in the
United States, such party shall agree to grant nonexclusive licenses for
sublicenses for marketing rights in the invention outside the United States, as
directed by the United States Government;
(1) if that party is marketing a product embodying the invention
outside the United States for at least two (2) years and
(a) such product is not then being marketed in the United
States, or
(b) if required, Food and Drug Administration approval for
marketing in the United States is not being actively pursued, or
(2) if that party is marketing a product embodying the invention
outside the United States for at least two (2) years from the date the
product has Food and Drug Administration approval for marketing in the
United States, and such product is not then being marketed in the United
States.
(e) The DFCI shall grant to the Government of the United States (including
any agency thereof, state, or domestic municipal government) a nonexclusive,
irrevocable, royalty-free license for governmental purposes, and on behalf of
any foreign government pursuant to any existing or future treaty or agreement
with the United States under each United
2
12
States or foreign patent application filed. The form of license to be granted
under each patent application is enclosed.
(f) The DFCI shall provide written annual reports to the HHS commencing
one (1) year from the date of this agreement regarding the development and
commercial use that is being made and is intended to be made of the invention,
including the amounts and source of money expended in such development and such
other data and information as the HHS may specify. After the first commercial
sale of any product embodying the invention, such report shall specify the date
of the first commercial sale and shall include information relating to gross
sales by licensees, and gross royalties received by the DFCI.
(g) With regard to the U.S. patent application, the DFCI agrees that if it
or its licensee has not taken effective steps within three (3) years after a
patent issues on the invention to bring the invention to the point of practical
application, or has not made the invention available for licensing royalty-free
or on terms that are reasonable in the circumstances, or cannot show cause why
it should retain all right, title and interest for a further period of time, the
HHS shall have the right to require (1) assignment of the invention and the U.S.
patent to the United States; (2) cancellation of any outstanding exclusive
licenses; and/or (3) the granting of licenses to an applicant on a nonexclusive,
royalty-free basis or on terms that are reasonable in the circumstances.
(h) With regard to the United States patent application, the HHS reserves
the right to license or to require the granting of a nonexclusive or exclusive
license to a responsible applicant or applicants to practice the invention on
terms that are reasonable in circumstances, if the DFCI and/or any of its
licensees fail to comply with any of the provisions of this determination, or if
the HHS determines that the public health, safety, or welfare requires the
issuance of such licenses, or that the public interest would otherwise suffer
unless such licenses were granted.
The DFCI and its licensee shall be given written notice of any proposed
determination pursuant to the provisions of this paragraph not less than thirty
(30) days prior to the effective date of such determination and, if requested,
shall be granted a hearing before the determination is put into effect.
(i) The DFCI shall use all reasonable effort to bring the invention to the
commercial market through licensing on a nonexclusive, royalty-free or
reasonable royalty basis. However, exclusive licenses may be granted after
reasonable efforts have been made to license on a nonexclusive basis, or where
the DFCI has determined that an exclusive license is necessary as an incentive
for development of the invention, or where market conditions are such as to
require exclusive licensing.
(j) Any exclusive license granted by the DFCI under the U.S. patent
application to a qualified manufacturer for research, development, and marketing
shall be for a limited period of time, and in no event shall the period be
longer than five (5) years from the date of the first commercial sale in the
United States of products embodying said invention, or eight (8) years from the
date of the exclusive license, whichever occurs first (excepting that time
before regulatory agencies necessary to obtain premarket clearance unless, on a
case-by-case
3
13
basis, the government approves a longer period of exclusivity), provided that
the licensee shall use all reasonable effort to effect introduction into the
commercial market as soon as practicable, consistent with sound and reasonable
business practices and judgment.
(k) Any extension of the maximum five (5)-year period of exclusivity shall
be subject to the approval of the HHS. Any request for such an extension shall
be considered on its merits upon written request and justification, it being
understood that, upon expiration of the period of exclusivity or any extension
thereof, any license thereafter shall be granted to all competent and properly
qualified applicants either royalty-free or at a uniform rate to all licensees,
and not in excess of the royalty rate of the previously granted exclusive
license.
(l) Unless otherwise provided in this determination, nothing herein shall
be construed as a requirement that DFCI obtain the agreement from any of its
licensees to license its improvement inventions or technical data to subsequent
licensees.
(m) The DFCI or its patent management organization may not grant to any
person the exclusive right to use or sell any subject invention in the United
States unless such person agrees that any products embodying the subject
invention, or produced through the use of the subject invention, will be
manufactured substantially in the United States. However, the Department may
waive such requirement upon a showing by the DFCI or the patent management
organization that reasonable but unsuccessful efforts have been made to grant
licenses on similar terms to potential licenses that would be likely to
manufacture substantially in the United States, or that under the circumstances
domestic manufacture is not commercially feasible.
(n) Any license granted by the DFCI under the U.S. patent application
shall include adequate safeguards against unreasonable royalties and repressive
practices. royalties shall not in any event be in excess of normal trade
practice. Such license shall also provide that all sales to the U.S. Government
shall be royalty-free.
(o) In accordance with Section 202(c)(7)(c) of P.L. 96-517, the DFCI is
required to share royalties received with the inventors. The balance of the
royalty income, after payment of expenses incident to the administration of the
invention, shall be utilized for the support of educational and research
pursuits.
(p) All licenses issued by the DFCI shall be subject to the conditions of
this determination, and shall specifically incorporate by reference all
applicable provisions contained herein. The DFCI shall promptly furnish copies
of any license agreements entered into by it to the HHS.
(q) The DFCI shall upon request grant a power of attorney authorizing the
HHS to inspect and make copies of any documents in the United States Patent and
Trademark Office pertaining to the prosecution of the U.S. patent application.
(r) The DFCI shall not abandon the patent application without first
offering to transfer all rights to in and to such application to the United
States Government as represented by the Secretary, HHS, not less than forty-five
(45) days prior to the date a reply to a Patent and Trademark Office action is
due. If the Government does not request assignment within thirty (30) days of
receipt of this offer, the DFCI may permit the application to go abandoned.
4
14
(s) Any United States patent application filed by the grantee institution
shall include the following statement in the first paragraph of the
specification following abstract: the Invention described herein was made in the
course of work under a grant or award from the Department of Health and Human
Services. If the application does not now contain this statement, please request
the Patent and Trademark Office to amend the application, and furnish this
office with a copy of your request.
If the foregoing determination is acceptable to the Xxxx-Xxxxxx Cancer
Institute, we request that such acceptance be indicated in the space provided
below, and that a signed copy be returned to the Patent Branch, HHS, c/o
National Institutes of Health, Xxxx 0X00, Xxxxxxxx Xxxxxxxx, Xxxxxxxx, Xxxxxxxx
00000.
This determination will become effective upon receipt of the signed copy.
Executed copies of the appropriate assignments and licenses required by this
determination should be submitted to the Patent Branch as soon as possible.
Sincerely Yours,
/s/ Xxxxx X. Xxxxx
Xxxxx X. Xxxxx, M.D., Ph.D.
Acting Assistant Secretary
for Health
Accepted: Xxxx-Xxxxxx Cancer Institute
By: /s/ Xxxxx Xxxxxxxx
------------------
Type Name: Xxxxx Xxxxxxxx
Title: Director for Research
Date: April 22, 1985
Enclosure
cc: Dr. Israel
Dr. Potti
5
