Exhibit 10.23
JOINT DEVELOPMENT
AND
MASTER LICENSE AGREEMENT
BETWEEN
PROGENICS PHARMACEUTICALS, INC.
AND
▇▇▇▇▇▇▇-▇▇▇▇▇ 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 "▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ Sublicense Agreement" .................. 6
1.45 "Sub-sublicensee" ....................................... 6
1.46 "Territory" ............................................. 6
1.47 "The Regents Sublicense Agreement" ...................... 6
(i)
TABLE OF CONTENTS (continued)
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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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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)
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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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇,
▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ("PROGENICS"), and ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company, a Delaware
corporation, having offices at ▇.▇. ▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇ and Province ▇▇▇▇ ▇▇▇▇,
▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇, 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 "▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ License Agreement")
between PROGENICS and ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ Institute for Cancer Research, a
not-for-profit membership corporation of the State of New York
("▇▇▇▇▇-▇▇▇▇▇▇▇▇▇").
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇, 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇, 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 ▇▇▇, ▇▇▇, ▇▇▇, 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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
▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ Sublicense Agreement.
1.41 "S-K Licensed Patents" shall have the meaning ascribed to such term
in the ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ Sublicense Agreement.
1.42 "S-K Products" shall have the meaning ascribed to such term in the
▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ Sublicense Agreement.
1.43 "S-K Technical Information" shall have the meaning ascribed to such
term in the ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ Sublicense Agreement.
1.44 "▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 [XXX]. 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇
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 [XXX].
(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 [XXX].
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ agrees
to change the schedule for achievement of any comparable milestone contained in
the ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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.
▇▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇. ▇▇▇▇ ▇▇▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
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(2) In the case of BMS, to:
▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company
▇.▇. ▇▇▇ ▇▇▇▇
▇▇▇▇▇ ▇▇▇ & Province Line Road
Princeton, New Jersey 08543-4000
Attention: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, M.D.
Vice President, Worldwide Safety and Surveillance
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇
Sublicense Agreement, The Regents Sublicense Agreement and the Aquila Sublicense
Agreement (the "PROGENICS License").
5.2 Grant of Sublicense Under ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ License Agreement. PROGENICS
grants BMS an exclusive (even as to PROGENICS) sublicense, under the
▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 "▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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
▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇
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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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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
▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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
▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇, 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.
-26-
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇, 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
-31-
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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) [XXX] 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 [XXX], 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 [XXX], BMS shall have the
right to terminate this Agreement with respect to the GMK Vaccine [XXX] during
such time upon 60 days' prior written notice to PROGENICS.
(d) Upon [XXX], 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 [XXX]. 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 [XXX], 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 [XXX], BMS shall have the
right to terminate this Agreement with respect to the MGV Vaccine [XXX] 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 [XXX], BMS shall have the
right to terminate this Agreement with respect to such other Licensed Product
[XXX] 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), [XXX],
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
-34-
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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), [XXX],
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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
-37-
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ 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.
▇▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇. ▇▇▇▇ ▇▇▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
-39-
(b) In the case of BMS, to:
▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company
▇.▇. ▇▇▇ ▇▇▇▇
▇▇▇▇▇ ▇▇▇ & 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.: (▇▇▇) ▇▇▇-▇▇▇▇
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇
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 ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇, 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.
-41-
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/ ▇▇▇▇ ▇. ▇▇▇▇▇▇
-----------------------------
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇, M.D., Ph.D.
Title: Chairman and Chief
Executive Officer
▇▇▇▇▇▇▇-▇▇▇▇▇ SQUIBB COMPANY
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
-----------------------------
Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
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]
▇. ▇▇▇▇▇▇ 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] ▇▇▇▇▇▇▇-▇▇▇▇▇ 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.