EXHIBIT 10.23
JOINT DEVELOPMENT
AND
MASTER LICENSE AGREEMENT
BETWEEN
PROGENICS PHARMACEUTICALS, INC.
AND
XXXXXXX-XXXXX SQUIBB COMPANY
DATED AS OF
APRIL 15, 1997
[Note: Certain portions of this document have been
marked "[xxx]" to indicate that confidentiality has
been requested for this information. The confidential
portions have been omitted and filed separately with the
Securities and Exchange Commission.]
TABLE OF CONTENTS
Page
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1. DEFINITIONS ......................................................... 2
1.1 "Adjuvant ............................................... 2
1.2 "Affiliate" ............................................. 2
1.3 "Aquila Field of Use" ................................... 2
1.4 "Aquila Knowhow" ........................................ 2
1.5 "Aquila Licensed Patent Rights" ......................... 2
1.6 "Aquila Licensed Product" ............................... 2
1.7 "Aquila Sublicense Agreement" ........................... 2
1.8 "BCG" ................................................... 2
1.9 "BMS Clinical Trials" ................................... 2
1.10 "Clinical Trial Agreements" ............................. 3
1.11 "Compound" .............................................. 3
1.12 "Confidential Information" .............................. 3
1.13 "Derivative" ............................................ 3
1.14 "Effective Date" ........................................ 3
1.15 "FDA" ................................................... 3
1.16 "First Commercial Sale" ................................. 4
1.17 "GD2" ................................................... 4
1.18 "Generic Product" ....................................... 4
1.19 "GM2" ................................................... 4
1.20 "GMK Development Completion" ............................ 4
1.21 "GMK Vaccine" ........................................... 4
1.22 "Joint Steering Committee" .............................. 4
1.23 "KLH" ................................................... 4
1.24 "Licensed Patents" ...................................... 4
1.25 "Licensed Products" ..................................... 4
1.26 "Licensed Technical Information" ........................ 4
1.27 "MGV Development Completion" ............................ 4
1.28 "MGV Vaccine" ........................................... 5
1.29 "Net Sales" ............................................. 5
1.30 "Party" ................................................. 5
1.31 "Person" ................................................ 5
1.32 "PROGENICS Clinical Trials" ............................. 5
1.33 "PROGENICS License" ..................................... 5
1.34 "PROGENICS Technical Information" ....................... 5
1.35 "QS-2l" ................................................. 5
1.36 "Regents' Field" ........................................ 6
1.37 "Regents' Method" ....................................... 6
1.38 "Regents' Patent Rights" ................................ 6
1.39 "Regents' Products" ..................................... 6
1.40 "S-K Field" ............................................. 6
1.41 "S-K Licensed Patents" .................................. 6
1.42 "S-K Products" .......................................... 6
1.43 "S-K Technical Information" ............................. 6
1.44 "Xxxxx-Xxxxxxxxx Sublicense Agreement" .................. 6
1.45 "Sub-sublicensee" ....................................... 6
1.46 "Territory" ............................................. 6
1.47 "The Regents Sublicense Agreement" ...................... 6
(i)
TABLE OF CONTENTS (continued)
Page
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1.48 "Third Party" ........................................... 6
1.49 "Valid Claim" ........................................... 6
2. REPRESENTATIONS AND WARRANTIES ...................................... 6
2.1 Representations and Warranties of Both Parties .......... 6
2.2 Representations and Warranties of PROGENICS ............. 7
3. JOINT STEERING COMMITTEE ............................................ 8
3.1 Creation ................................................ 8
3.2 Purpose ................................................. 8
3.3 Meetings ................................................ 8
3.4 Deadlock ................................................ 9
4. PRODUCT DEVELOPMENT ................................................. 9
4.1 Current Research Collaborations ......................... 9
4.2 Continued Development of Licensed Products by
PROGENICS ............................................... 10
4.3 Conduct of Development by PROGENICS ..................... 12
4.4 Delivery of Data; Transfer of IND ....................... 12
4.5 Development by BMS ...................................... 13
4.6 BMS Diligence Milestones ................................ 14
4.7 Conduct of BMS Clinical Trials .......................... 15
4.8 Records ................................................. 16
4.9 Pricing Matters ......................................... 16
4.10 Adverse Reaction Reporting .............................. 16
5. GRANT OF RIGHTS ..................................................... 17
5.1 Grant of License Under this Agreement ................... 17
5.2 Grant of Sublicense Under Xxxxx-Xxxxxxxxx License
Agreement ............................................... 18
5.3 Grant of Sublicense Under The Regents License
Agreement ............................................... 18
5.4 Grant of Sublicense Under Aquila License and Supply
Agreement ............................................... 18
5.5 Sublicense Rights ....................................... 18
5.6 Reservation of Rights by PROGENICS ...................... 19
6. UP-FRONT; MILESTONE AND ROYALTY PAYMENTS ............................ 19
6.1 Reimbursement of Expenses ............................... 19
6.2 Up-front Fee ............................................ 19
6.3 Milestone Payments Regarding GMK Vaccine ................ 20
6.4 Milestone Payments Regarding MGV Vaccine ................ 21
6.5 Royalty Payments ........................................ 22
6.6 Reductions to Royalties ................................. 26
6.7 Obligation to Pay Royalties ............................. 26
(ii)
TABLE OF CONTENTS (continued)
Page
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7. PAYMENTS AND REPORTS ................................................ 27
7.1 Reports; Payments ....................................... 27
7.2 Mode of Payment; Taxes .................................. 27
7.3 Records Retention ....................................... 27
7.4 Audit Request ........................................... 27
7.5 Cost of Audit ........................................... 28
7.6 No Non-Monetary Consideration for Sales ................. 28
8. INDEMNIFICATION; INFRINGEMENT ..................................... 28
8.1 Indemnification ......................................... 28
8.2 Conditions to Indemnification ........................... 29
8.3 Infringement Action by Third Parties .................... 30
9. CONFIDENTIALITY AND NON-USE ......................................... 30
9.1 Notification ............................................ 30
9.2 Review of Proposed Publications ......................... 31
9.3 Confidentiality and Non-use; Exceptions ................. 31
9.4 Authorized Disclosure ................................... 31
10. TERMINATION ......................................................... 32
10.1 Term .................................................... 32
10.2 Breach .................................................. 32
10.3 Termination by BMS ...................................... 33
10.4 Effect of Termination ................................... 34
10.5 Right to Sell Stock on Hand ............................. 38
10.6 Termination of Sublicenses .............................. 38
10.7 Accrued Rights, Surviving Obligations ................... 38
11. MISCELLANEOUS ....................................................... 38
11.1 Relationship of Parties ................................. 38
11.2 Force Majeure ........................................... 38
11.3 Assignment .............................................. 39
11.4 Further Actions ......................................... 39
11.5 Notice .................................................. 39
11.6 Use of Name ............................................. 40
11.7 Public Announcements .................................... 40
11.8 Costs and Expenses ...................................... 40
11.9 Waiver .................................................. 40
11.10 Inconsistency ........................................... 41
11.11 Compliance with Law ..................................... 41
11.12 Severability ............................................ 41
11.13 Amendment ............................................... 41
11.14 Governing Law ........................................... 41
11.15 Arbitration ............................................. 41
11.16 Entire Agreement ........................................ 41
11.17 Counterparts ............................................ 42
11.18 Descriptive Headings .................................... 42
(iii)
LIST OF EXHIBITS
EXHIBIT A List of Licensed Patents
EXHIBIT B Description of PROGENICS Clinical Trials
EXHIBIT C Budget for PROGENICS Clinical Trials
EXHIBIT D Adverse Event Reporting Form
EXHIBIT E Xxxxx-Xxxxxxxxx Sublicense Agreement
EXHIBIT F The Regents Sublicense Agreement
EXHIBIT G Aquila Sublicense Agreement
(iv)
JOINT DEVELOPMENT AND MASTER LICENSE AGREEMENT
THIS JOINT DEVELOPMENT AND MASTER LICENSE AGREEMENT (this "Agreement")
is dated as of April 15, 1997 between Progenics Pharmaceuticals, Inc., a
Delaware corporation, having offices at 000 Xxx Xxx Xxxx Xxxxx Xxxx,
Xxxxxxxxx, Xxx Xxxx 00000 ("PROGENICS"), and Xxxxxxx-Xxxxx Squibb Company, a
Delaware corporation, having offices at X.X. Xxx 0000, Xxxxx 000 and Province
Xxxx Xxxx, Xxxxxxxxx, Xxx Xxxxxx 00000-0000, for and on behalf of itself and
its Affiliates ("BMS").
PRELIMINARY STATEMENTS
A. PROGENICS has acquired a license to certain patents and technology
relating to the treatment of human cancers using vaccines pursuant to a
license agreement dated November 17, 1994 (the "Xxxxx-Xxxxxxxxx License
Agreement") between PROGENICS and Xxxxx-Xxxxxxxxx Institute for Cancer
Research, a not-for-profit membership corporation of the State of New York
("Xxxxx-Xxxxxxxxx").
B. PROGENICS has also entered into a license agreement dated June 25,
1996 ("The Regents License Agreement") with The Regents of The University of
California, a California corporation ("The Regents") pursuant to which
PROGENICS acquired a license to certain patent rights relating to such
vaccines.
C. In addition, PROGENICS has entered into a license and supply
agreement dated August 31, 1995 (the "Aquila License and Supply Agreement")
with Aquila Biopharmaceuticals, Inc. (formerly known as Cambridge Biotech
Corporation) ("Aquila"), pursuant to which PROGENICS has acquired a license
to certain Aquila technology and patent rights needed to formulate certain of
such vaccines, and Aquila supplies to PROGENICS one of the ingredients in
certain of the vaccines being developed by PROGENICS.
D. Research and development of certain of the technology licensed to
PROGENICS by Xxxxx-Xxxxxxxxx, The Regents and Aquila is being conducted on
behalf of PROGENICS by various cancer centers and cooperative cancer research
groups in the United States, Europe, Australia and New Zealand.
E. The Parties desire to collaborate with respect to the development,
commercialization and marketing of the Licensed Products upon the terms and
conditions set forth in this Agreement and in the agreements contemplated
hereby. In connection therewith, BMS desires to obtain, and PROGENICS desires
to grant to BMS, a license to certain technical information of PROGENICS and
sublicenses for certain of the Xxxxx-Xxxxxxxxx technology, The Regents
technology and the Aquila technology pursuant to sublicense agreements as
contemplated by this Agreement.
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F. It is anticipated that BMS and Aquila will enter into a supply
agreement, pursuant to which it is contemplated that Aquila will provide BMS
with one of the ingredients in certain of the vaccines being developed by BMS
and PROGENICS under this Agreement, on terms and conditions substantially the
same as those between PROGENICS and Aquila pursuant to the Aquila License and
Supply Agreement.
NOW, THEREFORE, in consideration of the mutual covenants and agreements
of the Parties contained in this Agreement, the Parties agree as follows:
1. DEFINITIONS.
As used in this Agreement, the following terms will have those meanings
set forth in this Section 1 unless the context dictates otherwise.
1.1 "Adjuvant" shall have the meaning ascribed to such term in the
Aquila Sublicense Agreement.
1.2 "Affiliate", with respect to any Party, shall mean any Person
which, directly or indirectly, controls, is controlled by, or is under common
control with, such Party. For these purposes, "control" shall refer to: (i)
the possession, directly or indirectly, of the power to direct the management
or policies of a Person or to veto any material decision relating to the
management or policies of a Person, in each case, whether through the
ownership of equity participation, voting securities or beneficial interests,
by contract, by agreement, or otherwise.
1.3 "Aquila Field of Use" shall have the meaning ascribed to such term
in the Aquila Sublicense Agreement.
1.4 "Aquila Knowhow" shall have the meaning ascribed to such term in
the Aquila Sublicense Agreement.
1.5 "Aquila Licensed Patent Rights" shall have the meaning ascribed to
such term in the Aquila Sublicense Agreement.
1.6 "Aquila Licensed Product" shall have the meaning ascribed to such
term in the Aquila Sublicense Agreement.
1.7 "Aquila Sublicense Agreement" shall have the meaning set forth in
Section 5.4.
1.8 "BCG" shall mean bacille de Calmette et Xxxxxx, a nonspecific
immune stimulant (cow tuberculosis) vaccine.
1.9 "BMS Clinical Trials" shall have the meaning set forth in Section
4.5(c).
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1.10 "Clinical Trial Agreements" shall have the meaning set forth in
Section 4.1.
1.11 "Compound" shall mean any of XXX, XX0, XX0, KLH and QS-21.
1.12 "Confidential Information" shall mean the collection of technical
information included in the Licensed Technical Information or technical
information of BMS, all information required to be kept confidential by
PROGENICS pursuant to the terms of the Xxxxx-Xxxxxxxxx License Agreement, The
Regents License Agreement or the Aquila License and Supply Agreement, and
confidential non-public information concerning BMS's or PROGENICS's business
plans, strategy and the like. All information which shall be disclosed in
confidence by the disclosing party to the receiving party, and which affords
a competitive advantage to the disclosing party or its Affiliates, shall be
presumed to be Confidential Information, even though limited portions of such
technical information may be in the public domain. In addition, the material
financial terms of this Agreement shall be considered Confidential
Information of both Parties.
The following information shall be excluded from the definition
of Confidential Information: (a) information which the receiving party
demonstrates was in the receiving party's possession in written or other
tangible form prior to any disclosure; (b) information which the receiving
party demonstrates was received from a third party without restriction and
not in violation of any duty of nondisclosure on the part of such third
party; (c) information which is independently discovered or invented by
personnel of a party who do not have direct or indirect access to the
information provided to that party by the other party; or (d) from the time
it becomes so known, any information which the receiving party demonstrates
was generally known to the trade. Information shall not be considered to be
generally known to the trade if, in order to acquire such information from
publicly available sources, the receiving party used the disclosing party's
Confidential Information to guide it in reviewing such sources in order to
select therefrom a series of relatively unconnected information which may be
fit together to match the Confidential Information first learned from the
disclosing party.
1.13 "Derivative" shall mean a chemical substance derived from another
substance either directly or by modification or partial substitution.
1.14 "Effective Date" shall mean the date first above written as the
date of this Agreement.
1.15 "FDA" shall mean the United States Food and Drug Administration,
or the successor thereto.
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1.16 "First Commercial Sale" shall mean, in each country of the
Territory, the date that Licensed Product(s) are first sold, marketed or
publicly made available for sale. Licensed Products distributed or used for
clinical trials or experimental purposes only shall not be considered sold,
marketed or made publicly available and shall not establish the First
Commercial Sale.
1.17 "GD2" shall mean [XXX].
1.18 "Generic Product" shall mean, on a country-by-country basis, a
Licensed Product: (i) the manufacture, use or sale of which is not covered by
a Valid Claim in such country, and (ii) that is also marketed by an
unlicensed Third Party or Parties in such country, which Third Party or
Parties have, in the aggregate, at least [XXX] in such country, as measured
by IMS.
1.19 "GM2" shall mean [XXX].
1.20 "GMK Development Completion" shall have the meaning set forth in
Section 4.5(f).
1.21 "GMK Vaccine" shall mean that certain Licensed Product composed of
GM2 conjugated to KLH and combined with QS-21.
1.22 "Joint Steering Committee" shall have the meaning set forth in
Section 3.1.
1.23 "KLH" shall mean keyhole limpet hemocyanin.
1.24 "Licensed Patents" shall mean all S-K Licensed Patents, Regents'
Patent Rights and Aquila Licensed Patent Rights. All Licensed Patents
existing on the Effective Date are set forth on Exhibit A attached.
1.25 "Licensed Products" shall mean any product for the treatment or
prevention of neoplastic human disease or the treatment or prevention of
human cancer which contains as an active ingredient: (i) GM2, (ii) GD2, or
(iii) any combination of the foregoing, including, without limitation, S-K
Products, Regents' Products and Aquila Products.
1.26 "Licensed Technical Information" shall mean all S-K Technical
Information, all Aquila Knowhow and all PROGENICS Technical Information.
1.27 "MGV Development Completion" shall have the meaning set forth in
Section 4.5(g).
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1.28 "MGV Vaccine" shall mean that certain Licensed Product composed of
GM2 conjugated to KLH and combined with GD2 conjugated to KLH and further
combined with QS-21.
1.29 "Net Sales" shall mean the gross amount invoiced by BMS [XXX].
Such amounts shall be determined from the books and records of BMS, its
Affiliates or Sub-sublicensees, maintained in accordance with the accounting
principles used by such entity, consistently applied.
1.30 "Party" shall mean PROGENICS or BMS and, when used in the plural,
shall mean PROGENICS and BMS.
1.31 "Person" shall mean any natural person, corporation, firm,
business trust, joint venture, association, organization, company,
partnership or other business entity, or any government or any agency or
political subdivision thereof, or any organization which can exercise
independent legal standing.
1.32 "PROGENICS Clinical Trials" shall have the meaning set forth in
Section 4.1.
1.33 "PROGENICS License" shall have the meaning set forth in Section
5.1.
1.34 "PROGENICS Technical Information" shall mean unpublished research
and development information, unpatented inventions, formulae, processes,
know-how, trade secrets, and technical data which PROGENICS owns or has
acquired a license to or to which PROGENICS has the right to grant licenses
or sublicenses (other than the S-K Technical Information or the Aquila
Knowhow), as of the Effective Date or at any time during the term of this
Agreement, which relate to the Compounds and/or the Licensed Products or
which are needed to produce or gain government approvals to market Licensed
Products.
1.35 "QS-21" shall mean [XXX].
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1.36 "Regents' Field" shall have the meaning ascribed to such term in
The Regents Sublicense Agreement.
1.37 "Regents' Method" shall have the meaning ascribed to such term in
The Regents Sublicense Agreement.
1.38 "Regents' Patent Rights" shall have the meaning ascribed to such
term in The Regents Sublicense Agreement.
1.39 "Regents' Products" shall have the meaning ascribed to such term
in The Regents Sublicense Agreement.
1.40 "S-K Field" shall have the meaning ascribed to such term in the
Xxxxx-Xxxxxxxxx Sublicense Agreement.
1.41 "S-K Licensed Patents" shall have the meaning ascribed to such
term in the Xxxxx-Xxxxxxxxx Sublicense Agreement.
1.42 "S-K Products" shall have the meaning ascribed to such term in the
Xxxxx-Xxxxxxxxx Sublicense Agreement.
1.43 "S-K Technical Information" shall have the meaning ascribed to
such term in the Xxxxx-Xxxxxxxxx Sublicense Agreement.
1.44 "Xxxxx-Xxxxxxxxx Sublicense Agreement" shall have the meaning set
forth in Section 5.2.
1.45 "Sub-sublicensee" shall mean any non-Affiliate Third Party who is
granted sublicense rights by BMS pursuant to this Agreement, the
Xxxxx-Xxxxxxxxx Sublicense Agreement, The Regents Sublicense Agreement or the
Aquila Sublicense Agreement.
1.46 "Territory" shall mean the entire world.
1.47 "The Regents Sublicense Agreement" shall have the meaning set
forth in Section 5.3.
1.48 "Third Party" shall mean any Person who or which is neither a
Party nor an Affiliate of a Party.
1.49 "Valid Claim" shall mean a claim of any Licensed Patent which has
not been held invalid or unenforceable by final decision of a court or other
governmental agency of competent jurisdiction, unappealed or unappeased
within the time allowed for appeal, and which is not admitted to be invalid
or unenforceable through reissue, disclaimer or otherwise.
2. REPRESENTATIONS AND WARRANTIES.
2.1 Representations and Warranties of Both Parties. Each Party
represents and warrants to the other Party that: (i) it is free to enter into
this Agreement; (ii) in so doing, it will not violate any other agreement to
which it is a party; (iii) it has
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taken all corporate action necessary to authorize the execution and delivery
of this Agreement and the performance of its obligations under this
Agreement; and (iv) no person or entity has or will have, as a result of the
transactions contemplated by this Agreement, any right, interest or valid
claim against or upon such Party for any commission, fee or other
compensation as a finder or broker because of any act or omission by such
Party or any of its agents.
2.2 Representations and Warranties of PROGENICS. PROGENICS hereby
represents and warrants to BMS that:
(a) Each of the Xxxxx-Xxxxxxxxx License Agreement, The Regents
License Agreement, the Aquila License and Supply Agreement and the Clinical
Trial Agreements which have been executed as of the Effective Date are in
full force and effect; PROGENICS has complied with all provisions of all said
agreements; there does not exist any event of default with respect to
PROGENICS under any said agreement which, after notice or lapse of time or
both, would constitute an event of default with respect to PROGENICS under
said agreement; and PROGENICS has no knowledge of any breach or anticipated
breach by any other party to any said agreement;
(b) PROGENICS has all consents necessary to grant the rights and
licenses granted to BMS under this Agreement;
(c) PROGENICS has: (1) exclusive rights to all of the S-K
Licensed Patents in the S-K Field; (2) exclusive rights to all of the
Regents' Patent Rights in the Regents' Field; and (3) co-exclusive rights to
all of the Aquila Licensed Patent Rights in the Aquila Field of Use; and has
the exclusive right (except with respect to the Aquila Licensed Patent
Rights, for which it has the co-exclusive right) to grant sublicenses to each
of the foregoing;
(d) To the best of PROGENICS's knowledge, PROGENICS has: (1)
exclusive rights to all of the PROGENICS Technical Information; (2) exclusive
rights to all of the S-K Technical Information in the S-K Field; and (3)
co-exclusive rights to all of the Aquila Knowhow in the Aquila Field of Use,
and has the exclusive right (except with respect to the Aquila Knowhow, for
which it has the co-exclusive right) to grant sublicenses to each of the
foregoing;
(e) To the best of PROGENICS's knowledge, all of the Licensed
Patents in existence on the Effective Date are in full force and effect and
have been maintained to date;
(f) PROGENICS is not aware of any asserted or unasserted claim or
demand which it believes can be enforced against such Licensed Patents;
(g) To the best of PROGENICS's knowledge, after due
investigation, the Licensed Patents and the Licensed Technical Information
constitute all of the proprietary rights necessary for
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the formulation of that certain GMK Vaccine and that certain MGV Vaccine,
each as currently under development, in finished form, and the distribution
and sale of that certain GMK Vaccine and that certain MGV Vaccine, each as
currently under development, by BMS in accordance with the terms of this
Agreement, and such formulation, distribution and sale do not infringe upon
or conflict with any patent or other proprietary rights of any Third Party;
and
(h) PROGENICS has not entered into any agreement with any Third
Party which is in conflict with the rights granted to BMS pursuant to this
Agreement.
3. JOINT STEERING COMMITTEE.
3.1 Creation. PROGENICS and BMS shall establish a joint steering
committee (the "Joint Steering Committee"), which shall consist of an equal
number of representatives appointed by each of the Parties. Within 30 days
after the execution of this Agreement by both Parties, PROGENICS and BMS
shall determine the number of representatives to be appointed initially to
the Joint Steering Committee, and each shall appoint its representatives to
serve on the Committee. Each Party may designate appropriate personnel who
shall assist the representatives of the Party. Each Party shall be free to
change its representatives, on notice to the other Party. The Joint Steering
Committee shall meet at such times and in such places as agreed upon from
time to time by the Parties. The Joint Steering Committee will be chaired by
one representative, who shall be appointed by BMS from time to time. The
Joint Steering Committee shall exist until the expiration or termination of
this Agreement.
3.2 Purpose. The Joint Steering Committee shall have the following
responsibilities: (i) to select Licensed Products for development pursuant to
this Agreement, provided that the Parties agree that the GMK Vaccine and the
MGV Vaccine shall be chosen for such development; (ii) to plan, supervise and
coordinate the development of Licensed Products; (iii) to review overall
strategic development plans and budgets, clinical study protocols, clinical
study write-ups, NDA submissions, and the like; (iv) to review all studies
relating to the Licensed Products and any other studies proposed to be
performed by either Party in connection with the registration process for the
Licensed Products; (v) to make changes to development strategies, as deemed
necessary or desirable; (vi) to provide a mechanism for the exchange of
information with regard to Licensed Technical Information and the Licensed
Products; (vii) to resolve disputes between the Parties with respect to the
foregoing; and (viii) to have such other responsibilities assigned to the
Joint Steering Committee pursuant to this Agreement or as may be mutually
agreed upon by the Parties from time to time.
3.3 Meetings. The Joint Steering Committee will meet at least once each
calendar quarter during the term of this Agreement, or less frequently as the
Parties may mutually agree is appropriate
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from time to time, at such dates and times as agreed to by the Parties.
Meetings in person shall alternate between the offices of the Parties or such
other place as may be mutually agreed upon. The Joint Steering Committee may
also convene or be polled or consulted from time to time by means of
telecommunications or correspondence. All decisions made or actions taken by
the Joint Steering Committee will be made unanimously by its members with the
PROGENICS members cumulatively having one vote and the BMS members
cumulatively having one vote. The Secretary of the Joint Steering Committee
will prepare written minutes of each meeting and a written record of all
decisions, whether made at a formal meeting or not. A quorum for a meeting
shall require at least one PROGENICS member and at least one BMS member.
3.4 Deadlock. If there are issues on which the Joint Steering Committee
cannot reach agreement because of a deadlock (as hereinafter defined), such
matters shall be referred for further review and resolution to the President
of the Pharmaceutical Research Institute at BMS, or such other similar
position designated by BMS from time to time, and the President and Chief
Executive Officer at PROGENICS, or such other similar position designated by
PROGENICS from time to time. If they cannot resolve the issues within 30
days, such matters shall be decided by the President of the Pharmaceutical
Research Institute at BMS, or such other similar position designated by BMS
from time to time. For the purpose of this Section 3.4, "deadlock" will mean
(i) with respect to any matter considered and voted upon by the Joint
Steering Committee, that one Party votes in favor of such matter and the
other Party does not vote in favor of such matter, or (ii) a quorum cannot be
established for the Joint Steering Committee to vote on a matter.
4. PRODUCT DEVELOPMENT.
4.1 Current Research Collaborations. The Parties acknowledge that
PROGENICS has entered into, or has commenced negotiations for, contracts
(collectively, the "Clinical Trial Agreements") with the following cancer
research organizations for the conduct of the following clinical trials
(collectively, the "PROGENICS Clinical Trials"):
(a) [XXX];
(b) [XXX]
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[XXX];
(c) [XXX];
(d) [XXX];
(e) [XXX];
(f) [XXX];
(g) [XXX];
(h) [XXX]; and
(i) [XXX].
A description of each of the PROGENICS Clinical Trials currently
being conducted, or scheduled to commence pursuant to any of the Clinical
Trial Agreements, is set forth in Exhibit B.
4.2 Continued Development of Licensed Products by PROGENICS. During the
term of this Agreement, PROGENICS shall continue the development of the GMK
Vaccine and the MGV Vaccine pursuant to the Clinical Trial Agreements, under
the auspices of,
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and subject to review and approval by, the Joint Steering Committee; provided
that BMS shall pay PROGENICS for all reasonable costs paid or incurred by
PROGENICS with respect to the performance of the PROGENICS Clinical Trials by
the respective cancer research organizations. In the event that any of the
PROGENICS Clinical Trials are terminated prior to completion for any reason,
PROGENICS shall use all reasonable efforts to promptly close-out such
PROGENICS Clinical Trial in a cost-efficient manner. BMS shall pay PROGENICS
for any non-cancelable third party costs and any internal costs paid or
incurred by PROGENICS with respect to such close-out for a period of six
months after termination of such PROGENICS Clinical Trial.
(a) Attached to this Agreement as Exhibit C is a budget (the
"Budget") that details [XXX]. The Budget is not intended to provide a maximum
amount of funding to be provided by BMS to PROGENICS pursuant to this Section
4.2. However, the Budget is intended to set forth all of the tasks currently
contemplated as necessary to complete the PROGENICS Clinical Trials, [XXX].
(b) BMS shall make payments to PROGENICS based on the amount
included in the Budget for each calendar quarter. Such amount shall be paid
in quarterly installments in advance on the first day of January, April, July
and October of each year, with adjustments made from time to time as
required, but in any event at the end of each calendar year, based on the
statements submitted by PROGENICS to BMS pursuant to Section 4.2(c). However,
the first payment shall be made in the amount of [XXX] on the Effective Date
of this Agreement (in lieu of any payment on April 1, 1997).
(c) Within 30 days following the end of each calendar quarter,
PROGENICS shall submit a statement to BMS showing [XXX].
(d) BMS shall have the right, at reasonable times and upon
reasonable notice, to examine those records as may be necessary to determine
the correctness of any statement submitted
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by PROGENICS pursuant to Section 4.2(c). Results of any such examination
shall be made available to both Parties.
4.3 Conduct of Development by PROGENICS. During the conduct of the
PROGENICS Clinical Trials, PROGENICS shall:
(a) Use all reasonable efforts and proceed diligently to cause
the PROGENICS Clinical Trials to be conducted pursuant to the time schedule
anticipated in the respective Clinical Trial Agreements;
(b) Cause the PROGENICS Clinical Trials to be conducted in good
scientific manner, and in compliance in all material respects with all
requirements of applicable laws, rules and regulations, and all other
requirements of any applicable good laboratory practices to attempt to
achieve its objectives efficiently and expeditiously;
(c) Provide written progress reports to the Joint Steering
Committee within 30 days after the end of every second calendar quarter
(ending for each particular PROGENICS Clinical Trial upon completion of such
PROGENICS Clinical Trial), indicating efforts and progress toward achieving
research tasks and development milestones described in the respective
Clinical Trial Agreements; and
(d) Allow representatives of BMS, upon reasonable notice and
during normal business hours, to consult informally, during visits to
PROGENICS and by telephone, with personnel involved in the PROGENICS Clinical
Trials.
4.4 Delivery of Data: Transfer of IND.
(a) During the term of this Agreement, promptly upon the
completion of each of the PROGENICS Clinical Trials, PROGENICS shall deliver
to BMS copies of all reports, data, results and other information relating to
the GMK Vaccine and/or the MGV Vaccine from such PROGENICS Clinical Trial,
including, without limitation, all reports, data, results and other
information received under any of the Clinical Trial Agreements.
(b) Upon completion of all of the PROGENICS Clinical Trials
relating to the GMK Vaccine pursuant to all of the Clinical Trial Agreements,
or such earlier time as the Parties may agree, PROGENICS shall promptly
transfer to BMS the IND relating to the GMK Vaccine.
(c) Upon completion of all of the PROGENICS Clinical Trials
relating to the MGV Vaccine pursuant to all of the Clinical Trial Agreements,
or such earlier time as the Parties may agree, PROGENICS shall promptly
transfer to BMS the IND relating to the MGV Vaccine.
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(d) At the request of BMS at any time after the Effective Date,
PROGENICS shall promptly provide to BMS a copy of the IND relating to the GMK
Vaccine and/or the MGV Vaccine.
4.5 Development by BMS.
(a) Except for the PROGENICS Clinical Trials to be conducted
pursuant to any of the Clinical Trial Agreements with respect to the GMK
Vaccine and the MGV Vaccine, as of the Effective Date, BMS shall be obligated
to conduct all development and regulatory activity with respect to Licensed
Products, including the payment of all costs and expenses associated
therewith except as otherwise provided in this Agreement, necessary to obtain
approvals throughout the Territory. Such development and regulatory
activities shall include, without limitation, those set forth in Section 5 of
the Xxxxx-Xxxxxxxxx Sublicense Agreement, Section 5 of The Regents Sublicense
Agreement and Section 5 of the Aquila Sublicense Agreement.
(b) BMS shall provide to the Joint Steering Committee a
development plan, as amended from time to time by BMS (each, a "Development
Plan"), outlining BMS's development objectives for Licensed Products during
the forthcoming period. A new Development Plan shall be submitted to the
Joint Steering Committee in writing at least three months prior to the end of
the period covered by the Development Plan in effect at the time of such
submission. Development Plans shall be submitted, as provided herein, until
the later of: (i) the First Commercial Sale of a Licensed Product has
occurred in any country in the Territory; or (ii) a Licensed Product has been
approved for marketing by the FDA.
(c) BMS shall be responsible for the preparation of all further
protocols and the conduct of all further studies proposed to be conducted or
required to be conducted by any regulatory authority in any country in the
Territory in connection with the registration process for each Licensed
Product in accordance with the Development Plan in effect at such time for
such Licensed Product (all of the foregoing studies, collectively, the "BMS
Clinical Trials"), including, without limitation, payment for all costs and
expenses associated with all of the foregoing.
(d) BMS shall use all commercially reasonable efforts necessary
or desirable to register each Licensed Product in all countries in the
Territory, in the name of BMS (or its designated Affiliate or
Sub-sublicensee), as soon as practicable; provided, however, that BMS shall
not be obligated under this Section 4.5(d) or Sections 4.5(c) or 4.5(e) with
respect to any country in the Territory where BMS does not have all legal
rights deemed reasonably necessary by BMS for BMS to sell and market Licensed
Products in such country. BMS shall be responsible for all costs associated
with the regulatory filing and approval processes for the Licensed Products
in all countries in the Territory. PROGENICS shall provide all technical data
and support necessary for BMS to make such regulatory filings. BMS shall keep
PROGENICS informed as
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to the status of such efforts from time to time. During such process, the
Parties shall cooperate in the preparation and filing of all documents
necessary therefor and all regulatory interactions and compliance with
regulatory authorities in the Territory.
(e) BMS shall use all commercially reasonable efforts necessary
or desirable to market and sell each Licensed Product in each country in the
Territory as soon as practicable following receipt of all governmental
approvals in such country necessary therefor.
(f) Consistent with BMS's development obligations with respect to
the GMK Vaccine as provided in Section 4.5(a), except as provided in Section
10.3(a), BMS shall be obligated to develop the GMK Vaccine pursuant to this
Agreement through the completion (including, without limitation, the
compilation of data and reporting of results) of the 001 and 002 Phase III
trials (the "GMK Development Completion").
(g) Consistent with BMS's development obligations with respect to
the MGV Vaccine as provided in Section 4.5(a), except as provided in Section
10.3(d), BMS shall be obligated to develop the MGV Vaccine pursuant to this
Agreement through the completion (including, without limitation, the
compilation of data and reporting of results) of the randomized Phase II
trial, or any other trial design approved by the Joint Steering Committee and
intended to demonstrate the efficacy of the MGV Vaccine, in extensive stage
small cell lung cancer or in any other cancer type mutually agreed upon by
the Parties (the "MGV Development Completion").
4.6 BMS Diligence Milestones.
(a) BMS, its Affiliates or its Sub-sublicensees shall achieve the
following objectives in accordance with the following schedule:
(i) [XXX].
(ii) [XXX].
(b) Failure to achieve these objectives shall result in PROGENICS
having the option to terminate the PROGENICS License granted under this
Agreement, subject to BMS's right to achieve the missed objective within 60
days of receipt of written notice of termination from PROGENICS. PROGENICS
shall not unreasonably withhold its consent to any revision in the preceding
schedule requested in writing by BMS and supported by evidence of technical
difficulties or delays in the clinical studies or regulatory process that
could not have been reasonably avoided. Notwithstanding the foregoing,
PROGENICS shall not have the right
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to terminate the PROGENICS License for the failure of BMS to meet a goal if
such failure is a result of (i) causes beyond BMS's direct control; (ii)
PROGENICS's failure to meet its obligations hereunder; (iii) infringement of
Third Party patents; or (iv) actions or inactions of a federal or state
agency whose approval is required for commercial sales.
(c) The Parties further acknowledge and agree that the milestones
contained in this Section 4.6 were established on the assumption that the
milestones would apply to development of the GMK Vaccine. In the event that
development of the GMK Vaccine is terminated due to safety or efficacy
reasons, the parties agree that the milestones set forth in this Section 4.6
shall not apply and the Parties will negotiate in good faith to establish new
milestones.
(d) PROGENICS agrees that, in the event that Xxxxx-Xxxxxxxxx
agrees to change the schedule for achievement of any comparable milestone
contained in the Xxxxx-Xxxxxxxxx License Agreement, or otherwise waives
compliance with such milestone, the comparable milestone in this Section 4.6
shall automatically be changed or waived by PROGENICS in like manner.
4.7 Conduct of BMS Clinical Trials. During the conduct of the BMS
Clinical Trials, BMS shall:
(a) Use all reasonable efforts and proceed diligently to conduct
the development of Licensed Products as set forth in the applicable
Development Plan(s) and as required by Sections 4.5 and 4.6;
(b) Conduct the development of the Licensed Products in good
scientific manner, and in compliance in all material respects with all
requirements of applicable laws, rules and regulations, and all other
requirements of any applicable good laboratory practices to attempt to
achieve its objectives efficiently and expeditiously;
(c) Provide written progress reports to the Joint Steering
Committee within 30 days after the end of every second calendar quarter
(ending for each particular Licensed Product with the First Commercial Sale
of that particular Licensed Product), indicating efforts and progress toward
achieving research tasks and development milestones described in the
Development Plan; and
(d) Allow representatives of PROGENICS, upon reasonable notice
and during normal business hours, to visit the facilities where any aspect of
the BMS Clinical Trials are being conducted, and consult informally, during
such visits and by telephone, with personnel performing work on the BMS
Clinical Trials.
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4.8 Records.
(a) Each Party shall maintain records, in sufficient detail and
in good scientific manner, which shall be complete and accurate and shall
fully and properly reflect all work done and results achieved in the
performance of the PROGENICS Clinical Trials and the BMS Clinical Trials,
respectively (including all data in the form required under all applicable
laws and regulations).
(b) Each Party shall have the right, during normal business hours
and upon reasonable notice, to inspect and copy all such records of the other
Party to the extent reasonably required for the performance of its
obligations under this Agreement. Each Party shall maintain such records and
information contained therein in confidence in accordance with Section 9 and
shall not use such records or information except to the extent otherwise
permitted by this Agreement.
4.9 Pricing Matters. Notwithstanding anything in this Agreement to the
contrary, BMS may elect not to pursue a product registration for a Licensed
Product or market a Licensed Product in any country in the European Union
because the government-approved reimbursement price or government fixed price
in such country is substantially lower than the price BMS is selling or
proposes to sell such Licensed Product for in other countries in the
Territory. In such event, BMS shall notify PROGENICS of such and PROGENICS
shall not have the right and option to terminate this Agreement as to such
country pursuant to Section 10.2; provided that BMS shall use its best
efforts to obtain a satisfactory government-approved reimbursement price or
government fixed price in such country.
4.10 Adverse Reaction Reporting.
(a) Each Party shall record, investigate, summarize and review
all adverse drug experiences associated with the Compounds and the Licensed
Products. In order that each Party may be fully informed of the adverse drug
experiences known to the other Party associated therewith, each Party shall
report:
(1) In the case of PROGENICS, to:
Progenics Pharmaceuticals, Inc.
000 Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, XX 00000
Attention: Xx. Xxxx Xxxxxx
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
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(2) In the case of BMS, to:
Xxxxxxx-Xxxxx Squibb Company
X.X. Xxx 0000
Xxxxx 000 & Province Line Road
Princeton, New Jersey 08543-4000
Attention: Xxxxxx Xxxxxxxx, M.D.
Vice President, Worldwide Safety and Surveillance
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
all "adverse events" involving the Compounds and/or the Licensed Products
("AE Reports"). "Serious" adverse events shall be reported to the other Party
within three (3) working days of a Party's becoming aware of such an event (a
"reporting party") and shall either be reported by facsimile or telephone.
The reporting party shall report all other adverse events on a monthly basis.
In addition, the reporting party shall report all known instances of use of a
Licensed Product during pregnancy. Attached as Exhibit D is a sample of an
adverse event reporting form which may be used by the reporting party as a
basis for such reports. The form indicates the information sought with each
report. In any event, each Party shall promptly notify the other of any
complaint received by such Party in sufficient detail and in sufficient time
to allow the responsible party to comply with any and all regulatory
requirements imposed upon it in any country in their respective territories.
Each Party shall also advise the other of any regulatory developments (e.g.,
proposed recalls, labeling and other registrational dossier changes, etc.)
affecting the Compounds or the Licensed Products in any country.
(b) An "adverse event" is any negative symptom experienced at the
time of or after the taking of the drug, whether or not considered drug
related, including any side effects, injury, toxicity or sensitivity
reaction, or significant failure of expected pharmacological action. Also
included are instances of symptomatic overdose, abuse or withdrawal reactions.
(c) A "serious" adverse event is one that is life-threatening;
that is, an adverse event that puts the patient at risk of dying, requires
hospitalization, prolongs existing hospitalization or results in permanent
disability, birth defect, cancer or death.
5. GRANT OF RIGHTS.
5.1 Grant of License Under this Agreement. PROGENICS hereby grants to
BMS an exclusive (even as to PROGENICS) right and license to use the
PROGENICS Technical Information to make, have made, use, sell, have sold and
develop Licensed Products throughout the Territory, pursuant to the terms and
conditions set forth in this Agreement, in connection with BMS's performance
of its
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obligations and exercise of its rights under this Agreement, the
Xxxxx-Xxxxxxxxx Sublicense Agreement, The Regents Sublicense Agreement and
the Aquila Sublicense Agreement (the "PROGENICS License").
5.2 Grant of Sublicense Under Xxxxx-Xxxxxxxxx License Agreement.
PROGENICS grants BMS an exclusive (even as to PROGENICS) sublicense, under
the Xxxxx-Xxxxxxxxx License Agreement, to use the S-K Licensed Patents and
the S-K Technical Information to make, have made, use, sell, have sold and
develop S-K Products in the S-K Field throughout the Territory, pursuant to
the terms and conditions set forth in the Sublicense Agreement by and between
BMS and PROGENICS, dated as of the date hereof (the "Xxxxx-Xxxxxxxxx
Sublicense Agreement"), a copy of which is attached as Exhibit E.
5.3 Grant of Sublicense Under The Regents License Agreement. PROGENICS
grants BMS an exclusive (even as to PROGENICS) sublicense, under The Regents
License Agreement, to use the Regents' Patent Rights in jurisdictions where
the Regents' Patent Rights exist, to make, have made, use, sell, have sold
and offer to sell Regents' Products and to practice the Regents' Method in
the Regents' Field, pursuant to the terms and conditions set forth in the
Sublicense Agreement by and between BMS and PROGENICS, dated as of the date
hereof ("The Regents Sublicense Agreement"), a copy of which is attached as
Exhibit F.
5.4 Grant of Sublicense Under Aquila License and Supply Agreement.
PROGENICS grants BMS a non-exclusive, worldwide sublicense under the Aquila
License and Supply Agreement to use the Aquila Knowhow and practice the
Aquila Licensed Patent Rights to develop, manufacture, have manufactured,
use, sell, and have sold Aquila Licensed Products, pursuant to the terms and
conditions set forth in the Sublicense Agreement by and between BMS and
PROGENICS, dated as of the date hereof (the "Aquila Sublicense Agreement"), a
copy of which is attached as Exhibit G.
5.5 Sublicense Rights.
(a) BMS shall have the right to grant sublicenses to its
Affiliates of the PROGENICS License granted to BMS herein, provided that: (i)
BMS shall guarantee and be responsible for the making of all payments due,
and the making of reports under this Agreement, by reason of sales of any
Licensed Products by its Affiliates and their compliance with all applicable
terms of this Agreement; and (ii) each Affiliate agrees in writing to keep
books and records and permit PROGENICS to review such books and records
pursuant to the relevant provisions and to observe all other applicable terms
of this Agreement. No consent or approval of PROGENICS shall be required in
connection with the granting of such sublicenses.
(b) BMS shall have the right to grant sublicenses to
Sub-sublicensees of the PROGENICS License granted to BMS herein,
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except that BMS does not have the right to grant such sublicenses with
respect to the United States, provided that: (i) PROGENICS shall have
consented to such sublicense, which consent shall not be unreasonably
withheld (it will be reasonable for PROGENICS to withhold consent if
PROGENICS determines that the capabilities of the proposed Sub-sublicensee
are not comparable to BMS's capabilities in the country or countries to be
sublicensed); (ii) BMS shall guarantee and be responsible for the making of
all payments due, and the making of reports under this Agreement, by reason
of sales of any Licensed Products by its Sub-sublicensees and their
compliance with all applicable terms of this Agreement; and (iii) each
Sub-sublicensee agrees in writing to keep books and records and permit
PROGENICS to review such books and records pursuant to the relevant
provisions and to observe all other applicable terms of this Agreement.
(c) BMS hereby unconditionally guarantees the performance of any
of its Affiliates and Sub-sublicensees hereunder. In the event of a breach by
an Affiliate or Sub-sublicensee in the observance of applicable terms of this
Agreement, PROGENICS shall be entitled to proceed against either such
Affiliate or Sub-sublicensee or directly against BMS, as PROGENICS may
determine in its sole discretion, to enforce this Agreement.
5.6 Reservation of Rights by PROGENICS. The PROGENICS License granted
under this Agreement and the sublicenses granted under each of the
Xxxxx-Xxxxxxxxx Sublicense Agreement, The Regents Sublicense Agreement and
the Aquila Sublicense Agreement are exclusive to BMS, except that PROGENICS
reserves the right to use the Licensed Patents and the Licensed Technical
Information, without cost, and subject to the confidentiality provisions of
this Agreement, for non-commercial internal research and development purposes.
6. UP-FRONT, MILESTONE AND ROYALTY PAYMENTS.
6.1 Reimbursement of Expenses. As reimbursement to PROGENICS for
expenses incurred by PROGENICS in the development of the GMK Vaccine and the
MGV Vaccine conducted by PROGENICS prior to the Effective Date, BMS shall pay
to PROGENICS the sum of: [XXX] upon the execution of this Agreement by both
Parties. Such sum shall be non-refundable.
6.2 Up-front Fee. As consideration to PROGENICS for the grant of the
sublicenses to BMS pursuant to the Xxxxx-Xxxxxxxxx Sublicense Agreement, The
Regents Sublicense Agreement and the Aquila Sublicense Agreement, BMS shall
pay to PROGENICS the sum of: [XXX] reduced by the sum of the up-front fees
being made by BMS to PROGENICS pursuant to Section 4.1 of the Xxxxx-Xxxxxxxxx
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Sublicense Agreement, Section 4.1 of The Regents Sublicense Agreement and
Section 4.1 of the Aquila Sublicense Agreement. Such up-front fee shall be
paid upon the execution of this Agreement by both Parties. Such sum shall be
non-refundable.
6.3 Milestone Payments Regarding GMK Vaccine. As consideration to
PROGENICS for the development of the GMK Vaccine conducted by PROGENICS prior
to the Effective Date, the PROGENICS License granted to BMS by PROGENICS
under this Agreement and the sublicense granted to BMS by PROGENICS pursuant
to The Regents Sublicense Agreement, and subject to prior termination of this
Agreement in whole or in all countries in the Territory with respect the
Licensed Product to which any milestone payment relates, BMS shall pay to
PROGENICS the following milestone payments upon the occurrence of each event
set forth below:
(a) [XXX];
(b) [XXX];
(c) [XXX];
(d) [XXX];
(e) [XXX];
(f) [XXX];
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(g) [XXX];
(h) [XXX];
(i) [XXX]; and
(j) [XXX].
Each of the foregoing milestone payments shall be reduced by the
amount of the milestone payment made by BMS to PROGENICS for the comparable
milestone pursuant to Section 4.2 of The Regents Sublicense Agreement.
Each of the payments required pursuant to this Section 6.3 shall
be paid within 30 days after such milestone has been achieved, and shall be
non-refundable.
6.4 Milestone Payments Regarding MGV Vaccine. As consideration to
PROGENICS for the development of the MGV Vaccine conducted by PROGENICS prior
to the Effective Date, the PROGENICS License granted to BMS by PROGENICS
under this Agreement and the sublicense granted to BMS by PROGENICS pursuant
to The Regents Sublicense Agreement, and subject to prior termination of this
Agreement in whole or in all countries in the Territory with respect the
Licensed Product to which any milestone payment relates, BMS shall pay to
PROGENICS the following milestone payments upon the occurrence of each event
set forth below:
(a) [XXX];
(b) [XXX];
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(c) [XXX];
(d) [XXX];
(e) [XXX];
(f) [XXX]; and
(g) [XXX].
With respect to the milestones set forth in Sections 6.4(b)
through (g) above, the Parties may mutually agree to cause any of such
milestones to apply to another cancer type with comparable projected market
potential as the cancer type set forth in such milestone.
Each of the foregoing milestone payments shall be reduced by the
amount of the milestone payment made by BMS to PROGENICS for the comparable
milestone pursuant to Section 4.3 of The Regents Sublicense Agreement.
Each of the payments required pursuant to this Section 6.4 shall
be paid within 30 days after such milestone has been achieved and shall be
non-refundable.
6.5 Royalty Payments. As consideration to PROGENICS for the development
of the GMK Vaccine and the MGV Vaccine conducted by PROGENICS prior to the
Effective Date and for the PROGENICS License and other rights (excluding the
sublicenses) granted to BMS by PROGENICS under this Agreement, during the
term of this Agreement, BMS shall pay to PROGENICS a royalty on Net Sales of
any Licensed Product commencing on the First Commercial Sale of such Licensed
Product by BMS, its Affiliates or its Sub-sublicensees as follows:
(a) With respect to the GMK Vaccine:
(i) With respect to those countries in the Territory where
such Licensed Product is not a Generic Product:
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(A) [XXX] of the Net Sales of such Licensed Product in
such countries for any calendar year until Net Sales of such
Licensed Product throughout the Territory in such calendar
year equal [XXX]; and
(B) After Net Sales of such Licensed Product throughout
the Territory in such calendar year exceed [XXX], [XXX] of any
further Net Sales of such Licensed Product in such countries
until the end of such calendar year;
reduced by:
(C) The sum of the royalty payments due by BMS to
PROGENICS during the comparable period with respect to such
Licensed Product pursuant to Sections 4.2(a)(i) and (ii) of
the Xxxxx-Xxxxxxxxx Sublicense Agreement, Section 4.4(a) of
The Regents Sublicense Agreement and Sections 4.2(a)(i) and
(ii) of the Aquila Sublicense Agreement.
(ii) With respect to those countries in the Territory
where such Licensed Product is a Generic Product:
(A) [XXX] of the Net Sales of such Licensed Product in
such countries for any calendar year until Net Sales of such
Licensed Product throughout the Territory in such calendar
year equal [XXX]; and
(B) After Net Sales of such Licensed Product throughout
the Territory in such calendar year exceed [XXX], [XXX] of any
further Net Sales of such Licensed Product in such countries
until the end of such calendar year;
reduced by:
(C) The sum of the royalty payments due by BMS to
PROGENICS during the comparable period with respect to such
Licensed Product pursuant to Section 4.2(a)(iii) of the
Xxxxx-Xxxxxxxxx Sublicense Agreement and Section 4.2(a)(iii)
of the Aquila Sublicense Agreement.
(iii) Royalties shall be paid at the royalty rates
set forth in Sections 6.5(a)(i)(A) and 6.5(a)(ii)(A) (reduced by the amounts
set forth in Sections 6.5(a)(i)(C) and 6.5(a)(ii)(C), respectively) through
the end of the calendar quarter preceding the calendar quarter in which
annual Net Sales in all countries throughout the Territory first exceed [XXX]
in any year. Royalties shall be paid at the royalty rates set forth in
Sections
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6.5(a)(i)(B) and 6.5(a)(ii)(B) (reduced by the amounts set forth in Sections
6.5(a)(i)(C) and 6.5(a)(ii)(C), respectively) for the calendar quarter in
which annual Net Sales in all countries throughout the Territory first exceed
[XXX] in any year, and for each calendar quarter in such year thereafter
other than the last calendar quarter of such year. Following the end of the
last calendar quarter of each year, the total amount of royalties actually
due for such year shall be calculated as provided in Section 6.5(a)(iv) (as
such amount has been reduced by the amounts set forth in Sections
6.5(a)(i)(C) and 6.5(a)(ii)(C)), and such amount of royalties shall be paid,
reduced by (A) the total amount of royalties paid with respect to such
Licensed Product throughout the Territory for the first three calendar
quarters of such year (as such amount has been reduced by the amounts set
forth in Sections 6.5(a)(i)(C) and 6.5(a)(ii)(C), respectively), and further
reduced by (B) the total amount of royalties paid or due with respect to such
Licensed Product throughout the Territory for such year pursuant to Section
4.2(a)(iv) of the Xxxxx-Xxxxxxxxx Sublicense Agreement, Section 4.4(a) of The
Regents Sublicense Agreement and Section 4.2(a)(iv) of the Aquila Sublicense
Agreement (after giving effect, for purposes of this calculation, to any
credit due to BMS pursuant to any of the foregoing sections of any of the
sublicense agreements, which credit shall be extinguished to the extent given
effect therefor). The calculation of the amount to be paid with respect to
the fourth calendar quarter of each year shall be included on the royalty
report for such calendar quarter. In the event that BMS has paid more
royalties during the first three calendar quarters of any year than BMS owes
for the entire year, BMS shall be entitled to a credit, equal to the amount
of such excess royalties paid, to be applied against [XXX] of accrued
royalties until the entire credit has been used.
(iv) The total amount of royalties actually due for
each year under this Section 6.5(a) (before such amount has been reduced by
the amounts set forth in Sections 6.5(a)(i)(C) and 6.5(a)(ii)(C)) shall be
calculated as follows:
(A) The royalty rate set forth in Section 6.5(a)(i)(A)
shall be applied to that amount of Net Sales of such Licensed
Product determined under the formula X(1) x Y(1)/Z;
(B) The royalty rate set forth in Section 6.5(a)(i)(B)
shall be applied to that amount of Net Sales of such Licensed
Product determined under the formula X(2) x Y(1)/Z;
(C) The royalty rate set forth in Section 6.5(a)(ii)(A)
shall be applied to that amount of Net Sales of such Licensed
Product determined under the formula X(1) x Y(2)/Z; and
(D) The royalty rate set forth in Section 6.5(a)(ii)(B)
shall be applied to that amount of
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Net Sales of such Licensed Product determined under the
formula X(2) x Y(2)/Z;
Where:
X(1) = the smaller of: (i) the actual annual Net Sales of
such Licensed Product throughout the Territory for
such year, or (ii) [XXX]
X(2) = the actual annual Net Sales of such Licensed Product
throughout the Territory for such year in excess of
[XXX]
Y(1) = the annual Net Sales of such Licensed Product for such
year in all countries when Section 6.5(a)(i) applies
Y(2) = the annual Net Sales of such Licensed Product for such
year in all countries when Section 6.5(a)(ii) applies
Z = the annual Net Sales of such Licensed Product for such
year in all countries in the Territory
(b) With respect to the MGV Vaccine and any other Licensed Products:
(i) With respect to those countries in the Territory where
such Licensed Product is not a Generic Product:
(A) [XXX] of the Net Sales of such Licensed Product in
such countries for any calendar year;
reduced by:
(B) the sum of the royalty payments due by BMS to
PROGENICS during the comparable period with respect to such
Licensed Product pursuant to Sections 4.2(b)(i), (ii) and (iv)
of the Xxxxx-Xxxxxxxxx Sublicense Agreement, Section 4.4(b)
of The Regents Sublicense Agreement and Sections 4.2(b)(i) and
(ii) of the Aquila Sublicense Agreement.
(ii) With respect to those countries in the Territory
where such Licensed Product is a Generic Product:
(A) [XXX] of the Net Sales of such Licensed Product in
such countries for any calendar year;
reduced by:
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(B) the sum of the royalty payments due by BMS to
PROGENICS during the comparable period with respect to such
Licensed Product pursuant to Section 4.2(b)(iii) of the
Xxxxx-Xxxxxxxxx Sublicense Agreement and Section 4.2(b)(iii)
of the Aquila Sublicense Agreement.
(c) The royalty rates applicable to Generic Products pursuant to
Sections 6.5(a)(ii) and 6.5(b)(ii), respectively, shall apply to Net Sales in
any country commencing with the calendar quarter during which such Licensed
Product first becomes a Generic Product in such country.
6.6 Reductions to Royalties. BMS shall be entitled to deduct from the
royalties payable pursuant to Section 6.5:
(a) All costs and expenses incurred by BMS in connection with the
exercise of its rights under: (i) Section 3 of that certain side letter
agreement proposed to be entered into among Xxxxx-Xxxxxxxxx, PROGENICS and BMS;
(ii) Section 3 of that certain side letter agreement proposed to be entered into
among The Regents, PROGENICS and BMS; and (iii) Section 3 of that certain side
letter agreement proposed to be entered into among Aquila, PROGENICS and BMS;
and
(b) The amount of any credit to which BMS is entitled pursuant to
Section 8.3(c).
6.7 Obligation to Pay Royalties. The obligation to pay royalties to
PROGENICS under this Section 6 is imposed only once with respect to the same
unit of Licensed Product regardless of the number of Licensed Patents pertaining
thereto. BMS shall only be entitled to a credit against royalties or a reduction
of the royalty rate once with respect to any Licensed Product in any country
pursuant to any provision in this Agreement. There shall be no obligation to pay
royalties to PROGENICS under this Section 6 on sales of Licensed Products among
BMS, its Affiliates and Sub-sublicensees, but in such instances the obligation
to pay royalties shall arise upon the sale by BMS, its Affiliates or
Sub-sublicensees to Third Parties. Payments due under this Section 6 shall be
deemed to accrue when Licensed Products are shipped or billed, whichever event
shall first occur. In the instance where BMS, its Affiliates or Sub-sublicensees
use the Licensed Product or provide it as part of some other service or product,
a royalty shall be due to PROGENICS at the time such Licensed Product is used or
provided based on a Net Sales amount equal to the price at which BMS or its
Affiliate or Sub-sublicensee sells such Licensed Product to Third Parties in the
country in which the Licensed Product was used or provided.
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7. PAYMENTS AND REPORTS.
7.1 Reports; Payments. Except as otherwise specifically provided in
this Agreement, all payments due under this Agreement shall be paid quarterly
within 50 days after the end of each calendar quarter. Each such payment for
running royalties shall be accompanied by a statement, Licensed
Product-by-Licensed Product and country-by-country, of the amount of Net
Sales during such quarter and the amount of royalties due on such Net Sales
and, with respect to the last calendar quarter of each year, such report
shall include the calculation of the adjustment referred to in Section
6.5(a)(iii).
7.2 Mode of Payment; Taxes. All payments due under this Agreement shall
be paid by wire transfer of funds to an account at PROGENICS's designated
bank in New York, New York, and shall be paid in U.S. Dollars, calculated at
BMS's customary internal corporate monthly exchange rates for the last month
of the calendar quarter for which remittance is made for royalties. Such
payments shall be free of any taxes, charges, or remittance fees, except for
income tax levied upon or required to be withheld and paid by BMS, its
Affiliates or its Sub-sublicensees for the account of PROGENICS. BMS shall
provide PROGENICS appropriate receipts of payment of such withholding taxes
or other proof thereof. For each month and each currency, BMS's customary
internal corporate monthly exchange rate shall equal the arithmetic average
of the daily exchange rates (obtained as described below) during the period
from (i) the 20th day of the preceding month (or, if such 20th day is not a
business day, the immediately preceding business day) through (ii) the 19th
day of the current month (or, if such 19th day is not a business day, the
immediately preceding business day); each daily exchange rate shall be
obtained from the Reuters Daily Rate Report or The Wall Street Journal,
Eastern U.S. Edition, or, if not so available, as furnished by BMS's local
Affiliates.
7.3 Records Retention. BMS and its Affiliates and Sub-sublicensees
shall keep accurate records of all operations affecting payments hereunder,
and shall permit PROGENICS or its duly authorized agent to inspect all such
records and to make copies of or extracts from such records during regular
business hours throughout the term of this Agreement and for a reasonable
period of not less than 3 years thereafter.
7.4 Audit Request. At the request and expense of PROGENICS, BMS and its
Affiliates and Sub-sublicensees shall permit PROGENICS or an independent,
certified public accountant appointed by PROGENICS and reasonably acceptable
to BMS, at reasonable times and upon reasonable notice, to examine those
records as may be necessary to: (i) determine the correctness of any report
or payment made under this Agreement; or (ii) obtain all information as to
Net Sales and the royalties payable for any calendar quarter. If an
accountant is used, said accountant shall not disclose to PROGENICS any
information other than information relating to said
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reports, royalties, and payments. Results of any such examination shall be
made available to both Parties.
7.5 Cost of Audit. PROGENICS shall bear the full cost of the
performance of any such audit except as hereinafter set forth. If, as a
result of any inspection of the books and records of BMS, its Affiliates or
its Sub-sublicensees, it is shown that BMS's payments under this Agreement
were less than the amount which should have been paid, then BMS shall make
all payments required to be made to eliminate any discrepancy revealed by
said inspection within 30 days after PROGENICS's demand therefor, plus
interest at the prime rate from the date payment should have been made.
Furthermore, if the payments were less than the amount which should have been
paid by an amount in excess of five percent of the payments actually made
during the period in question, BMS shall also reimburse PROGENICS for the
costs of such audit in addition to the payment required to be made to
eliminate any discrepancy.
7.6 No Non-Monetary Consideration for Sales. Without the prior written
consent of PROGENICS, BMS and its Affiliates and Sub-sublicensees shall not
accept or solicit any non-monetary consideration in the sale of Licensed
Products other than as would be reflected in Net Sales. The use by BMS and
its Affiliates and Sub-sublicensees of commercially reasonable amounts of
Licensed Products for clinical trials and promotional sampling shall not
violate this provision.
8. INDEMNIFICATION; INFRINGEMENT.
8.1 Indemnification.
(a) PROGENICS shall defend, indemnify and hold BMS and its
Affiliates and Sub-sublicensees, and each of their respective directors,
officers and employees, harmless from and against any and all claims, suits
or demands for liability, damages, losses, costs and expenses (including the
costs and expenses of attorneys and other professionals) arising out of Third
Party claims or suits resulting from a breach of PROGENICS's representations
and warranties set forth in Section 2, or from the performance of the
PROGENICS Clinical Trials.
(b) If required by Section 10.4(g), PROGENICS shall defend,
indemnify and hold BMS and its Affiliates and Sub-sublicensees, and each of
their respective directors, officers and employees, harmless from and against
any and all claims, suits or demands for liability, damages, losses, costs
and expenses (including the cost and expenses of attorneys and other
professionals) arising out of PROGENICS' use of any data, information or
government registrations returned or provided to PROGENICS pursuant to
Section 10.4(g), including any use by any subsequent sublicensee of
PROGENICS, or the development, manufacture, marketing, use and/or sale of
products or services from any of the foregoing.
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(c) BMS shall defend, indemnify and hold PROGENICS, its
Affiliates, and their respective directors, officers and employees, harmless
from and against any and all claims, suits or demands for liability, damages,
losses, costs and expenses (including the costs and expenses of attorneys and
other professionals) arising out of: (i) Third Party claims or suits
resulting from (1) a breach of BMS's representations and warranties set forth
in Section 2, (2) the performance of the BMS Clinical Trials, (3) the
manufacture, packaging, use, sale, rental or lease of Licensed Products, even
if altered or used for a purpose not intended, or (4) the use of Licensed
Patents or Licensed Technical Information by BMS, its Affiliates or its
Sub-sublicensees or its (or their) customers and any representation made or
warranty given by BMS, its Affiliates or its Sub-sublicensees with respect to
Licensed Products, Licensed Patents or Licensed Technical Information, or
(ii) claims or suits by Xxxxx-Xxxxxxxxx, The Regents and/or Aquila against
PROGENICS as a result of BMS's actions under this Agreement.
(d) As the Parties intend complete indemnification, all costs and
expenses of enforcing this Section 8.1 shall also be reimbursed by the
indemnifying Party.
8.2 Conditions to Indemnification. A person or entity that intends to
claim indemnification under Section 8.1 (the "Indemnitee") shall promptly
notify the other Party (the "Indemnitor") of any loss, claim, damage,
liability or action in respect of which the Indemnitee intends to claim such
indemnification, and the Indemnitor shall assume the defense thereof with
counsel mutually satisfactory to the Indemnitee whether or not such claim is
rightfully brought; provided, however, that an Indemnitee shall have the
right to retain its own counsel, with the fees and expenses to be paid by the
Indemnitor if Indemnitor does not assume the defense, or if representation of
such Indemnitee by the counsel retained by the Indemnitor would be
inappropriate due to actual or potential differing interests between such
Indemnitee and any other person represented by such counsel in such
proceedings. The indemnity agreement in Section 8.1 shall not apply to
amounts paid in settlement of any loss, claim, damage, liability or action if
such settlement is effected without the consent of the Indemnitor, which
consent shall not be withheld or delayed unreasonably. The failure to deliver
notice to the Indemnitor within a reasonable time after the commencement of
any such action, only if prejudicial to its ability to defend such action,
shall relieve such Indemnitor of any liability to the Indemnitee under
Section 8.1, but the omission so to deliver notice to the Indemnitor will not
relieve it of any liability that it may have to any Indemnitee otherwise than
under Section 8.1. The Indemnitee under Section 8.1, its officers, directors,
employees and agents, shall cooperate fully with the Indemnitor and its legal
representatives in the investigations of any action, claim or liability
covered by this indemnification.
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8.3 Infringement Action by Third Parties.
(a) In the event of the institution of any suit by a Third Party
against BMS for patent infringement involving the manufacture, sale,
distribution or marketing of any Licensed Products in the Territory and such
infringement claim is a result of the use of the PROGENICS Technical
Information, BMS shall promptly notify PROGENICS in writing of such suit.
PROGENICS may defend such action at PROGENICS's sole expense on behalf of BMS
with attorneys of its own selection, and BMS hereby agrees to assist and
cooperate with PROGENICS, at its own expense, to the extent necessary in the
defense of such suit. In such event (i.e., where PROGENICS has elected to
defend in accordance with the preceding sentence), PROGENICS shall bear the
full costs and expenses of such defense (including fees of attorneys and
other professionals) and, in any event, whether or not PROGENICS has elected
to defend such action, PROGENICS shall assume full responsibility for the
payment of any award for damages, or any amount due pursuant to any
settlement entered into by PROGENICS with such Third Party, which PROGENICS
shall have the right to do in its sole discretion. In addition, BMS shall be
entitled to retain its own counsel in such proceedings, at BMS's sole
expense. During the pendency of such action, BMS shall continue to make all
payments due under this Agreement.
(b) If PROGENICS does not commence a defense of such action with
90 days after receiving notice thereof, BMS shall have the right to defend
such suit at its own expense, and PROGENICS hereby agrees to assist and
cooperate with BMS, at its own expense, to the extent necessary in the
defense of such suit. In such event, BMS shall not enter into any settlement
arrangement or other amicable arrangement without the prior written consent
of PROGENICS. During the pendency of such action, BMS shall continue to make
all payments due under this Agreement.
(c) If as a result of any judgment, award, decree or settlement
resulting from an action instituted by a Third Party, BMS is required to pay
a royalty to such Third Party, BMS shall continue to pay the royalties for
such Licensed Product in the country which is the subject of such action,
[XXX].
9. CONFIDENTIALITY AND NON-USE.
9.1 Notification. Both Parties recognize that each may wish to publish
the results of their work relating to the Compounds and the Licensed
Products. However, both Parties also recognize the importance of acquiring
patent protection. Consequently,
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subject to any applicable laws or regulations obligating either Party to do
otherwise (including any laws or regulations applicable to any of the
cooperative research groups conducting any of the PROGENICS Clinical Trials,
to the extent applicable to the Parties), any proposed publication by either
Party shall comply with this Section 9. At least 60 days before a manuscript
is to be submitted to a publisher, the publishing Party will provide the
other Party with a copy of the manuscript. If the publishing Party wishes to
make an oral presentation, it will provide the other Party with a copy of the
abstract (if one is submitted) at least 40 days before it is to be submitted.
The publishing Party will also provide to the other Party a copy of the text
of the presentation, including all slides, posters, and any other visual
aids, at least 40 days before the presentation is made.
9.2 Review of Proposed Publications. The receiving Party will review
the manuscript, abstract, text or any other material provided under Section
9.1 to determine if patentable subject matter is disclosed. The reviewing
Party will notify the publishing Party within 30 days of receipt of the
proposed publication if the reviewing Party, in good faith, determines that
patentable subject matter is or may be disclosed, or if the reviewing Party,
in good faith, believes Confidential Information or proprietary information
is or may be disclosed. If it is determined by the reviewing Party that
patent applications should be filed, the publishing Party shall delay its
publication or presentation for a period not to exceed 90 days from the
reviewing Party's receipt of the proposed publication to allow time for the
filing of patent applications covering patentable subject matter. In the
event that the delay needed to complete the filing of any necessary patent
application will exceed the 90 day period, the Parties will discuss the need
for obtaining an extension of the publication delay beyond the 90 day period.
If it is determined in good faith by the reviewing Party that Confidential
Information or proprietary information is being disclosed, the Parties will
consult in good faith to arrive at an agreement on mutually acceptable
modifications to the proposed publication to avoid such disclosure.
9.3 Confidentiality and Non-use; Exceptions. Except to the extent
expressly authorized by this Agreement or otherwise agreed in writing, the
Parties agree that, for the term of this Agreement and for five (5) years
thereafter the receiving Party and its Affiliates and Sub-sublicensees shall
keep, and shall ensure that its officers, directors, employees and agents
keep, completely confidential and shall not publish or otherwise disclose and
shall not use for any purpose any Confidential Information furnished to it by
the other Party or its Affiliates or Sub-sublicensees or developed under the
PROGENICS Clinical Trials, the BMS Clinical Trials or otherwise pursuant to
this Agreement.
9.4 Authorized Disclosure. Each Party may disclose the other's data and
information, including Confidential Information, to its Affiliates, licensors
and Sub-sublicensees, and its and
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their officers, directors, employees and outside consultants, as reasonably
necessary, and to others to the extent such disclosure is reasonably
necessary in filing or prosecuting patent applications, prosecuting or
defending litigation, complying with applicable governmental laws and
regulations, undertaking basic research with outside collaborators, or
conducting preclinical or clinical trials, provided that if a Party is
required to make any such disclosure of the other Party's Confidential
Information it will, except where impracticable for necessary disclosures,
for example to physicians conducting studies or to health authorities, give
reasonable advance notice to the other Party of such disclosure requirement
and, except to the extent inappropriate in the case of patent applications,
will use its best efforts to secure confidential treatment of such
information required to be disclosed.
10. TERMINATION.
10.1 Term. This Agreement shall commence as of the Effective Date of
this Agreement and, unless sooner terminated as provided hereunder, shall
terminate as follows:
(a) As to each Licensed Product in each country in the Territory,
upon the later of: (i) 15 years from the First Commercial Sale of such
Licensed Product in such country, or (ii) the expiration of the last Valid
Claim to expire that covers the manufacture, use or sale of such Licensed
Product in such country.
(b) This Agreement shall terminate in its entirety upon its
expiration with respect to all Licensed Products in all countries in the
Territory pursuant to Section 10.1(a).
10.2 Breach.
(a) Failure by either Party to comply with any of the material
obligations of such Party contained in this Agreement shall entitle the other
Party to give notice to the defaulting Party specifying the nature of the
default and requiring it to cure such default. If such default is not cured
within 60 days after the receipt of such notice (or, if such default cannot
be cured within such 60 day period, if the defaulting Party does not commence
and diligently continue actions to cure such default), the other Party shall
be entitled, without prejudice to any of its other rights conferred on it by
this Agreement, in addition to any other remedies available to it by law or
in equity, to terminate this Agreement by giving written notice to take
effect immediately. The right to terminate this Agreement, as hereinabove
provided, shall not be affected in any way by the other Party's waiver or
failure to take action with respect to any previous default.
(b) Notwithstanding Section 10.2(a), in the event that BMS fails
materially to satisfy its development and/or marketing obligations with
respect to any Licensed Product in any country in
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the Territory under this Agreement, the Xxxxx-Xxxxxxxxx Sublicense Agreement,
The Regents Sublicense Agreement or the Aquila Sublicense Agreement, such
failure shall not be deemed a breach of a material obligation of BMS pursuant
to Section 10.2(a) if such failure is by reason of force majeure as provided
in Section 11.2 or as provided in Section 4.9.
10.3 Termination by BMS.
(a) Prior to the GMK Development Completion, BMS shall only have
the right to terminate this Agreement with respect to the GMK Vaccine
throughout the Territory, including without limitation BMS's obligation to
pay any amounts that have not accrued under Section 6.3 as of the effective
date of such termination, if any clinical trial relating to the GMK Vaccine
is terminated, or suspended for a period of at least 6 months, for safety
reasons related to the GMK Vaccine. BMS shall be entitled to exercise such
right, from time to time, within 60 days after it receives actual notice of
such termination or within 60 days after any suspension has been ongoing for
6 months. Such termination shall be effective immediately upon receipt by
PROGENICS of BMS's notice thereof, and BMS shall have no further obligations
to PROGENICS pursuant to this Agreement with respect to the GMK Vaccine other
than to pay the close-out costs associated therewith pursuant to Section 4.2
and to pay other amounts previously accrued under this Agreement.
(b) Following the GMK Development Completion, BMS shall have the
right to terminate this Agreement with respect to the GMK Vaccine throughout
the Territory at any time upon 60 days' prior written notice to PROGENICS.
(c) Following regulatory approval of the GMK Vaccine in any
country in the Territory, BMS shall have the right to terminate this
Agreement with respect to the GMK Vaccine in such country at any time upon 60
days' prior written notice to PROGENICS. In addition, following the GMK
Development Completion but prior to regulatory approval of the GMK Vaccine in
Japan, BMS shall have the right to terminate this Agreement with respect to
the GMK Vaccine in Japan during such time upon 60 days' prior written notice
to PROGENICS.
(d) Upon the MGV Development Completion, BMS shall have the
right, at its sole discretion, to terminate this Agreement, but only with
respect to the MGV Vaccine, upon written notice to PROGENICS, sent not later
than 90 days after the MGV Development Completion. In such event, from and
after the date of such notice, BMS shall have no further obligations to
PROGENICS pursuant to this Agreement with respect to the MGV Vaccine,
including, without limitation, any obligation to make the milestone payments
set forth in Section 6.4 or to continue to fund any clinical trials or
ongoing development thereof, other than to pay the close-out costs associated
therewith pursuant to Section 4.2. Such termination shall be without
prejudice to the rights of BMS to develop the GMK Vaccine or any other
Licensed Product pursuant to
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this Agreement. If within such 90-day period BMS does not make such
termination, it shall be required to make the milestone payment required
under Section 6.4(a).
(e) Following the MGV Development Completion, BMS shall have the
right to terminate this Agreement with respect to the MGV Vaccine throughout
the Territory at any time upon 60 days' prior written notice to PROGENICS.
(f) Following regulatory approval of the MGV Vaccine in any
country in the Territory, BMS shall have the right to terminate this
Agreement with respect to the MGV Vaccine in such country at any time upon 60
days' prior written notice to PROGENICS. In addition, following the MGV
Development Completion but prior to regulatory approval of the MGV Vaccine in
Japan, BMS shall have the right to terminate this Agreement with respect to
the MGV Vaccine in Japan during such time upon 60 days' prior written notice
to PROGENICS.
(g) With respect to all other Licensed Products, BMS shall have
the right to terminate this Agreement with respect to any Licensed Product
throughout the Territory at any time upon 60 days' prior written notice to
PROGENICS.
(h) Following regulatory approval of any other Licensed Product
in any country in the Territory, BMS shall have the right to terminate this
Agreement with respect to such Licensed Product in such country at any time
upon 60 days' prior written notice to PROGENICS. In addition, at any time
prior to regulatory approval of any other Licensed Product in Japan, BMS
shall have the right to terminate this Agreement with respect to such other
Licensed Product in Japan during such time upon 60 days' prior written notice
to PROGENICS.
10.4 Effect of Termination.
(a) Upon termination of this Agreement with respect to the GMK
Vaccine throughout the Territory pursuant to Section 10.3(a) or 10.3(b), so
long as BMS is using commercially reasonable efforts either (i) to develop
and commercialize any Licensed Product for any melanoma indication, or (ii)
to develop and commercialize the MGV Vaccine for one or more indications, one
of which is melanoma, the PROGENICS License and the sublicenses with respect
to the GMK Vaccine granted to BMS pursuant to this Agreement, the
Xxxxx-Xxxxxxxxx License Agreement, The Regents Sublicense Agreement and the
Aquila Sublicense Agreement shall remain in effect. In the event that, upon
termination, BMS is not engaged in either of the foregoing or if BMS ceases
doing either of the foregoing after such termination, then BMS shall promptly:
(1) provide to PROGENICS, at BMS's expense, all data and information in BMS's,
or its Affiliates' or Sub-sublicensees', possession or control relating to the
GMK Vaccine throughout the Territory; (2) transfer, at BMS's expense, to
PROGENICS or such other Person as PROGENICS shall designate, any and all
rights that it may have
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under any government registrations or authorizations in every country in the
Territory with respect to the GMK Vaccine; (3) cancel, at BMS's expense, any
government registrations or authorizations with respect to the GMK Vaccine as
may not be transferable; (4) provide to PROGENICS, at BMS's expense, all data
and information in BMS's, or its Affiliates' or Sub-sublicensees', possession
or control relating to any such governmental registrations or authorizations
in every country in the Territory with respect to the GMK Vaccine; and (5)
discontinue all use, sale and distribution of the GMK Vaccine throughout the
Territory and the use of the Licensed Patents and Licensed Technical
Information in connection therewith. In such event, the PROGENICS License and
the sublicenses with respect to the GMK Vaccine granted to BMS pursuant to
this Agreement, the Xxxxx-Xxxxxxxxx License Agreement, The Regents Sublicense
Agreement and the Aquila Sublicense Agreement shall terminate with respect to
the GMK Vaccine throughout the Territory, subject to any rights BMS may have
hereunder and thereunder to continue to sell stock on hand pursuant to
Section 10.5 of this Agreement, Section 8.5 of the Xxxxx-Xxxxxxxxx Sublicense
Agreement, Section 9.4 of The Regents Sublicense Agreement and Section 9.4 of
the Aquila Sublicense Agreement, respectively, but shall continue in effect
for all other Licensed Products in all countries throughout the Territory.
(b) Upon termination of this Agreement with respect to the MGV
Vaccine throughout the Territory pursuant to Section 10.3(d) or 10.3(e), so
long as BMS is using commercially reasonable efforts to develop and
commercialize any Licensed Product for any melanoma indication, the PROGENICS
License and the sublicenses with respect to the MGV Vaccine granted to BMS
pursuant to this Agreement, the Xxxxx-Xxxxxxxxx License Agreement, The
Regents Sublicense Agreement and the Aquila Sublicense Agreement shall remain
in effect solely for any melanoma indication. All rights with respect to the
MGV Vaccine for other indications shall immediately revert to PROGENICS. In
the event that, upon termination, BMS is not engaged in the foregoing or if
BMS ceases doing the foregoing after such termination, then BMS shall
promptly: (1) provide to PROGENICS, at BMS's expense, all data and
information in BMS's, or its Affiliates' or Sub-sublicensees', possession or
control relating to the MGV Vaccine throughout the Territory; (2) transfer,
at BMS's expense, to PROGENICS or such other Person as PROGENICS shall
designate, any and all rights that it may have under any government
registrations or authorizations in every country in the Territory with
respect to the MGV Vaccine; (3) cancel, at BMS's expense, any government
registrations or authorizations with respect to the MGV Vaccine as may not be
transferable; (4) provide to PROGENICS, at BMS's expense, all data and
information in BMS's, or its Affiliates' or Sub-sublicensees', possession or
control relating to any such governmental registrations or authorizations in
every country in the Territory with respect to the MGV Vaccine; and (5)
discontinue all use, sale and distribution of the MGV Vaccine throughout the
Territory, and the use of the Licensed Patents and Licensed Technical
Information in connection therewith. In such event, the PROGENICS License and
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the sublicenses with respect to the MGV Vaccine granted to BMS pursuant to
this Agreement, the Xxxxx-Xxxxxxxxx License Agreement, The Regents Sublicense
Agreement and the Aquila Sublicense Agreement shall terminate with respect to
the MGV Vaccine throughout the Territory, subject to any rights BMS may have
hereunder and thereunder to continue to sell stock on hand pursuant to
Section 10.5 of this Agreement, Section 8.5 of the Xxxxx-Xxxxxxxxx Sublicense
Agreement, Section 9.4 of The Regents Sublicense Agreement and Section 9.4 of
the Aquila Sublicense Agreement, respectively, but shall continue in effect
for all other Licensed Products in all countries throughout the Territory.
(c) Upon termination of this Agreement with respect to any other
Licensed Product throughout the Territory pursuant to Section 10.3(g), then
BMS shall promptly: (1) provide to PROGENICS, at BMS's expense, all data and
information in BMS's, or its Affiliates' or Sub-sublicensees', possession or
control relating to such Licensed Product throughout the Territory; (2)
transfer, at BMS's expense, to PROGENICS or such other Person as PROGENICS
shall designate, any and all rights that it may have under any government
registrations or authorizations in every country in the Territory with
respect to such Licensed Product; (3) cancel, at BMS's expense, any
government registrations or authorizations with respect to the GMK Vaccine as
may not be transferable; (4) provide to PROGENICS, at BMS's expense, all data
and information in BMS's, or its Affiliates' or Sub-sublicensees', possession
or control relating to any such governmental registrations or authorizations
in every country in the Territory with respect to such Licensed Product; and
(5) discontinue all use, sale and distribution of such Licensed Product
throughout the Territory, and the use of the Licensed Patents and Licensed
Technical Information in connection therewith. In such event, the PROGENICS
License and the sublicenses with respect to such Licensed Product granted to
BMS pursuant to this Agreement, the Xxxxx-Xxxxxxxxx License Agreement, The
Regents Sublicense Agreement and the Aquila Sublicense Agreement shall
terminate with respect to such Licensed Product throughout the Territory,
subject to any rights BMS may have hereunder and thereunder to continue to
sell stock on hand pursuant to Section 10.5 of this Agreement, Section 8.5 of
the Xxxxx-Xxxxxxxxx Sublicense Agreement, Section 9.4 of The Regents
Sublicense Agreement and Section 9.4 of the Aquila Sublicense Agreement,
respectively, but shall continue in effect for all other Licensed Products in
all countries throughout the Territory.
(d) Upon termination of this Agreement in part with respect to
any country in the Territory and/or as to any Licensed Product pursuant to
Section 10.3(c), 10.3(f) or 10.3(h), BMS shall promptly: (1) transfer, at
BMS's expense, to PROGENICS or such other Person as PROGENICS shall
designate, any and all rights that it may have under any government
registrations or authorizations in such country with respect to such Licensed
Product; (2) cancel, at BMS's expense, any government registrations or
authorizations in such country with respect to such Licensed Product as may
not be transferable; (3) provide to PROGENICS, at BMS's expense, all data
-36-
and information in BMS's, or its Affiliates' or Sub-sublicensees', possession
or control relating to any such governmental registrations or authorizations
in such country with respect to such Licensed Product; (4) grant to
PROGENICS, or such other Person as PROGENICS shall designate, a royalty-free
license to use any trademark and/or trade name used by BMS in connection with
such Licensed Product in such country; and (5) discontinue all use, sale and
distribution of such Licensed Product in such country and the use of the
Licensed Patents and the Licensed Technical Information in connection
therewith. In such event, the PROGENICS License and the sublicenses with
respect to such Licensed Product granted to BMS pursuant to this Agreement,
the Xxxxx-Xxxxxxxxx License Agreement, The Regents Sublicense Agreement and
the Aquila Sublicense Agreement in such country shall terminate and revert to
PROGENICS, subject to any rights BMS may have hereunder and thereunder to
continue to sell stock on hand pursuant to Section 10.5 of this Agreement,
Section 8.5 of the Xxxxx-Xxxxxxxxx Sublicense Agreement, Section 9.4 of The
Regents Sublicense Agreement and Section 9.4 of the Aquila Sublicense
Agreement, respectively, but shall continue in effect for all other Licensed
Products in all other countries throughout the Territory.
(e) Upon termination of this Agreement in its entirety pursuant
to any provision in this Section 10 other than Section 10.1, BMS shall
promptly: (1) return to PROGENICS, at BMS's expense, all relevant data and
other information concerning the Licensed Patents and Licensed Technical
Information in the possession or control of BMS, its Affiliates and
Sub-sublicensees; (2) transfer, at BMS's expense, to PROGENICS or such other
Person, as PROGENICS shall designate, any and all rights that it may have
under any government registrations or authorizations in any country in the
Territory with respect to the Licensed Products; (3) cancel, at BMS's
expense, any government registrations or authorizations with respect to the
Licensed Products as may not be transferable; (4) provide to PROGENICS, at
BMS's expense, all data and other information in BMS's, or its Affiliates' or
Sub-sublicensees', possession or control relating to such governmental
registrations or authorities in any country in the Territory with respect to
all Licensed Products; and (5) discontinue all use, sale and distribution of
all Licensed Products throughout the Territory, and the use of the Licensed
Patents and Licensed Technical Information in connection therewith. In such
event, the PROGENICS License and the sublicenses with respect to the Licensed
Products granted to BMS pursuant to this Agreement, the Xxxxx-Xxxxxxxxx
License Agreement, The Regents Sublicense Agreement and the Aquila Sublicense
Agreement shall terminate and revert to PROGENICS, subject to any rights BMS
may have hereunder and thereunder to continue to sell stock on hand pursuant
to Section 10.5 of this Agreement, Section 8.5 of the Xxxxx-Xxxxxxxxx
Sublicense Agreement, Section 9.4 of The Regents Sublicense Agreement and
Section 9.4 of the Aquila Sublicense Agreement, respectively.
(f) Upon termination of this Agreement with respect to any
Licensed Product in any country in the Territory , or in its
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entirety, pursuant to Section 10.1, BMS shall have the right to make, have
made, use, sell, have sold, and offer to sell such Licensed Product(s) in
such country or countries without further obligations to PROGENICS, and as
provided in Section 8.4(a) of the Xxxxx-Xxxxxxxxx Sublicense Agreement,
Section 9.3(a) of The Regents Sublicense Agreement and Section 9.1 of the
Aquila Sublicense Agreement, respectively.
(g) In the event that BMS is required, pursuant to any provision
of this Section 10.4, to provide, return, transfer or otherwise convey any
data, information or government registrations or authorizations relating to
any Licensed Product in any country in the Territory, PROGENICS shall
indemnify BMS as provided in Section 8.1(b).
10.5 Right to Sell Stock on Hand. If BMS is not in material breach of
this Agreement at the time of termination of this Agreement, then BMS shall
have the right for one year thereafter to dispose of all Licensed Products
then in its inventory, and shall pay royalties thereon, in accordance with
the provisions of this Agreement, as though this Agreement had not terminated.
10.6 Termination of Sublicenses. Upon any termination of this
Agreement, all sublicenses granted by BMS under this Agreement shall
terminate simultaneously, subject, nevertheless, to Section 10.5.
10.7 Accrued Rights, Surviving Obligations.
(a) Termination, relinquishment or expiration of this Agreement
for any reason shall be without prejudice to any rights which shall have
accrued to the benefit of either Party prior to such termination,
relinquishment or expiration. Such termination, relinquishment or expiration
shall not relieve either Party from obligations which are expressly indicated
to survive termination or expiration of this Agreement.
(b) All of the Parties' rights and obligations under Sections
4.8, 4.10, 7, 8, 9, 10.4, 10.5, 10.7, 11.14 and 11.15 shall survive
termination.
11. MISCELLANEOUS.
11.1 Relationship of Parties. Nothing in this Agreement is intended or
shall be deemed to constitute a partnership, agency, employer-employee or
joint venture relationship between the Parties. No Party shall incur any
debts or make any commitments for the other, except to the extent, if at all,
specifically provided herein.
11.2 Force Majeure. Neither Party shall be liable to the other for loss
or damages or shall have any right to terminate this Agreement for any
default or delay attributable to any act of God,
-38-
flood, fire, explosion, strike, lockout, labor dispute, shortage of raw
materials, casualty or accident, war, revolution, civil commotion, act of
public enemies, blockage or embargo, injunction, law, order, proclamation,
regulation, ordinance, demand or requirement of any government or
subdivision, authority or representative of any such government, or any other
cause beyond the reasonable control of such Party, if the Party affected
shall give prompt notice of any such cause to the other Party. The Party
giving such notice shall thereupon be excused from such of its obligations
hereunder as it is thereby disabled from performing for so long as it is so
disabled and for 30 days thereafter. Notwithstanding the foregoing, nothing
in this Section 11.2 shall excuse or suspend the obligation to make any
payment due hereunder in the manner and at the time provided.
11.3 Assignment. Neither Party shall be entitled to assign its rights
hereunder, except that PROGENICS may otherwise assign its rights and transfer
its duties hereunder to any assignee of all or substantially all of its
business. No assignment and transfer shall be valid and effective unless and
until the assignee/transferee shall agree in writing to be bound by the
provisions of this Agreement.
11.4 Further Actions. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of
this Agreement.
11.5 Notice. Any notice or request required or permitted to be given
under or in connection with this Agreement shall be deemed to have been
sufficiently given if in writing and personally delivered by messenger,
facsimile transmission (receipt verified), express courier service (signature
required), or telegram, prepaid, to the Party for which such notice is
intended, at the address set forth for such Party below:
(a) In the case of PROGENICS, to:
Progenics Pharmaceuticals, Inc.
000 Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, Xxx Xxxx 00000
Attention: Xx. Xxxx Xxxxxx
Facsimile No.: (000) 000-0000
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(b) In the case of BMS, to:
Xxxxxxx-Xxxxx Squibb Company
X.X. Xxx 0000
Xxxxx 000 & Province Line Road
Princeton, New Jersey 08543-4000
Attention: Vice President and Senior Counsel,
Pharmaceutical Research Institute, and
Worldwide Franchise Management and
Strategic Business Development
Facsimile No.: (000) 000-0000
or to such other address for such Party as it shall have specified by like
notice to the other Party, provided that notices of a change of address shall
be effective only upon receipt thereof. If sent by messenger, facsimile
transmission, express courier service, or telegram, the date of mailing or
transmission shall be deemed to be the date on which such notice or request
has been given.
11.6 Use of Name. Except as otherwise provided herein, neither Party
shall have any right, express or implied, to use in any manner the name or
other designation of the other Party or any other trade name or trademark of
the other Party for any purpose in connection with the performance of this
Agreement.
11.7 Public Announcements. Except as required by applicable law,
neither Party shall issue any press release or make any other public
announcement concerning this Agreement or the subject matter hereof without
the prior written consent of the other Party, which consent shall not be
unreasonably withheld. In the event of a required press release or other
public announcement, the Party making such announcement shall provide the
other Party with a copy of the proposed text prior to such announcement. The
Parties agree that if either is required to file this Agreement with any
governmental agency, such Party will redact the financial terms of this
Agreement to the extent possible in order to keep the financial terms of this
Agreement confidential to the extent permitted by law.
11.8 Costs and Expenses. Except as otherwise expressly provided in this
Agreement, each Party shall bear all costs and expenses associated with the
performance of such Party's obligations under this Agreement.
11.9 Waiver. A waiver by either Party of any of the terms and
conditions of this Agreement in any instance shall not be deemed or construed
to be a waiver of such term or condition for the future, or of any subsequent
breach hereof. All rights, remedies, undertakings, obligations and agreements
contained in this Agreement shall be cumulative and none of them shall be in
limitation of any other remedy, right, undertaking, obligation or agreement
of either Party.
-40-
11.10 Inconsistency. If there is any inconsistency between the
provisions of this Agreement and any purchase order or other document passing
between the Parties, the provisions of this Agreement shall control and be
determinative.
11.11 Compliance with Law. Nothing in this Agreement shall be deemed to
permit a Party to export, reexport or otherwise transfer any Licensed Product
sold under this Agreement without compliance with applicable laws.
11.12 Severability. When possible, each provision of this Agreement
will be interpreted in such manner as to be effective and valid under
applicable law, but if any provision of this Agreement is held to be
prohibited by or invalid under applicable law, such provision will be
ineffective only to the extent of such prohibition or invalidity, without
invalidating the remainder of this Agreement.
11.13 Amendment. No amendment, modification or supplement of any
provisions of this Agreement shall be valid or effective unless made in
writing and signed by a duly authorized officer of each Party.
11.14 Governing Law. This Agreement shall be governed by and
interpreted in accordance with the laws of the State of New York without
regard to its choice of law principles.
11.15 Arbitration. Any dispute arising out of or relating to any
provisions of this Agreement shall be finally settled by arbitration to be
held in New York, New York, under the auspices and then current commercial
arbitration rules of the American Arbitration Association. Such arbitration
shall be conducted by three (3) arbitrators appointed according to said
rules. Judgment upon any award rendered may be entered in any court having
jurisdiction, or application may be made to such court for a judicial
acceptance of the award and an order of enforcement, as the case may be.
11.16 Entire Agreement. This Agreement, together with the
Xxxxx-Xxxxxxxxx Sublicense Agreement, The Regents Sublicense Agreement, the
Aquila Sublicense Agreement, the side letter agreements proposed to be
entered into among BMS, PROGENICS and each of Xxxxx-Xxxxxxxxx, The Regents
and Aquila, and the Exhibits attached hereto and thereto, sets forth the
entire agreement and understanding between the Parties as to the subject
matter hereof and merges all prior discussions and negotiations between them,
and neither of the Parties shall be bound by any conditions, definitions,
warranties, understandings or representations with respect to such subject
matter other than as expressly provided herein or as duly set forth on or
subsequent to the date hereof in writing and signed by a proper and duly
authorized officer or representative of the Party to be bound thereby.
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11.17 Counterparts. This Agreement may be executed simultaneously in
any number of counterparts, any one of which need not contain the signature
of more than one Party but all such counterparts taken together shall
constitute one and the same agreement.
11.18 Descriptive Headings. The descriptive headings of this Agreement
are for convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be
executed and delivered by its duly authorized officer as of the day and year
first above written.
PROGENICS PHARMACEUTICALS, INC.
By: /s/ Xxxx X. Xxxxxx
-----------------------------
Name: Xxxx X. Xxxxxx, M.D., Ph.D.
Title: Chairman and Chief
Executive Officer
XXXXXXX-XXXXX SQUIBB COMPANY
By: /s/ Xxxxxxx Xxxxxxx
-----------------------------
Name: Xxxxxxx Xxxxxxx
Title: Vice President
-42-
EXHIBIT A
LIST OF LICENSED PATENTS
A. S-K Licensed Patents
Application or Patent Number Filing or Issue Date
---------------------------- --------------------
[XXX] [XXX]
X. Xxxxxx Licensed Patent Rights
Application or Patent Number Filing or Issue Date
---------------------------- --------------------
U.S. Patent No. 5,057,540 October 15, 1991
[XXX] [XXX]
Canadian Patent No. 1,331,443 August 16, 1994
European Patent No. 362,279 January 11, 1995
German Patent No. 3,852,761 February 23, 1995
C. Regents' Patent Rights
Application or Patent Number Filing or Issue Date
---------------------------- --------------------
U.S. Patent No. 4,557,931 December 10, 1985
EXHIBIT B
DESCRIPTION OF PROGENICS CLINICAL TRIALS
1. 001 GMK Phase III Clinical Trial
[XXX].
2. 002 GMK Phase III Clinical Trial
[XXX].
3. 003 GMK Phase III Clinical Trial
[XXX].
4. 004 MGV Phase I/II Clinical Trial
[XXX].
EXHIBIT C
BUDGET FOR PROGENICS CLINICAL TRIALS
[XXX]
Costs in subsequent years through completion are estimated to be equivalent.
EXHIBIT D
ADVERSE EVENT REPORTING FORM
[LOGO] Xxxxxxx-Xxxxx Squibb Company
Pharmaceutical Research Institute
Approved by FDA: 11/01/93
-------------------------
Mfr report #
-------------------------
UF/Dist report #
-------------------------
MED WATCH
------------------------------------------ FDA Use Only
THE FDA MEDICAL PRODUCTS REPORTING PROGRAM -------------------------
------------------------------------------
Page of
--------------------------------------------------------------------------------
A. Patient information
--------------------------------------------------------------------------------
1. Patient identifier 2. Age at time 3. Sex 4. Weight
of event: [_] female ________ lbs
or ________________ or
Date [_] male ________ kgs
in confidence of birth:
--------------------------------------------------------------------------------
B. Adverse event or product problem
--------------------------------------------------------------------------------
1. [_] Adverse event and/or [_] Product problem
--------------------------------------------------------------------------------
2. Outcomes attributed to adverse event
(check all that apply) [_] disability
[_] death ______________________ [_] congenital anomaly
[_] life-threatening [_] required intervention to prevent
permanent impairment/damage
[_] hospitalization-initial or prolonged
[_] other
--------------------------------------------------------------------------------
3. Date of 4. Date of
event this report
--------------------------------------------------------------------------------
5. Describe event or problem
--------------------------------------------------------------------------------
6. Relevant tests/laboratory data
--------------------------------------------------------------------------------
7. Other relevant history, including preexisting medical conditions
--------------------------------------------------------------------------------
C. Suspect medication(s)
--------------------------------------------------------------------------------
1. Name
________________________________________________________________________________
--------------------------------------------------------------------------------
2. Dose, frequency & route used 3. Therapy dates
___________________________________ ____________________________________
--------------------------------------------------------------------------------
4. Diagnosis for use 5. Event abated after use
stopped or dose reduced
____________________________________ [_] yes [_] no [_] doesn't apply
___________________________________
-----------------------------------------
[_] yes [_] no [_] doesn't apply
6. Lot # 7. Exp. date
-------------------------------------
___________________ _______________
8. Event reappeared after
reintroduction
------------------------------------------
9. NDC # [_] yes [_] no [_] doesn't apply
____________________________________
[_] yes [_] no [_] doesn't apply
--------------------------------------------------------------------------------
10. Concomitant medical products
--------------------------------------------------------------------------------
G. All manufacturers
--------------------------------------------------------------------------------
1. Contact office - name/address 2. Phone number
_________________________
3. Report source
(check all that apply)
[_] foreign
[_] study
[_] literature
[_] consumer
------------------------------------------------------
[_] health
4. Date received by manufacturer 5. professional
(A)NDA # _________
[_] user facility
-------------------------------- IND # _________
[_] company
6. If IND, protocol # PLA # __________ representative
pre-1938 [_] yes [_] distributor
---------------------------------
7. Type of report OTC [_] other:
(check all that apply) product [_] yes
_____________
[_] 5-day [_] 15-day --------------------------------------------
8. Adverse event terms(s)
[_] 10-day [_] periodic
[_] initial [_] follow-up # _____
---------------------------------
9. Mfr. report number
--------------------------------------------------------------------------------
E. Initial reporter
--------------------------------------------------------------------------------
1. Name, address & phone number
--------------------------------------------------------------------------------
2. Health professional? 3. Occupation 4. Initial reporter also
sent report to FDA
[_] yes [_] no [_] yes [_] no [_] unk
--------------------------------------------------------------------------------
FDA Submission of a report does not constitute an
Facsimile Form 3500A admission that medical personnel, user facility,
distributor, manufacturer or product caused or
contributed to the event.
