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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) JANUARY 12, 1998
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PROGENICS PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in its charter)
Delaware 000-23143 13-3379479
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
777 OLD SAW MILL RIVER ROAD, TARRYTOWN, NEW YORK 10591
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (914) 789-2800
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(Former name or former address, if changed since last report.)
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Item 5. Other Events.
On January 12, 1998, the Company announced that it and the Roche Group
had entered into a collaboration to discover and develop novel human immuno-
deficiency virus ("HIV") therapeutics which target the recently identified
fusion co-receptors of the virus. Under the terms of the collaboration, Roche
has received from Progenics an exclusive world-wide license to its HIV co-
receptor technology. Roche will provide to Progenics up-front and milestone
payments, research funding for up to three years, as well as royalty payments on
the sale of any products commercialized as a result of the collaboration.
Item 7. Financial Statements and Exhibits.
(c) Exhibits
*10.32 Heads of Agreement, effective as of December 23, 1997, among
F. Hoffmann-LaRoche Ltd., Hoffmann-LaRoche Inc. and
Progenics Pharmaceuticals, Inc.
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* Confidential treatment requested.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
PROGENICS PHARMACEUTICALS, INC.
By /S/ ROBERT A. MCKINNEY
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Robert A. McKinney
Vice President-Finance and Operations
(Principal financial and accounting officer)
Date FEBRUARY 6, 1998
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EXHIBIT INDEX
*10.32 Heads of Agreement, effective as of December 23, 1997, among F.
Hoffmann-LaRoche Ltd., Hoffmann-LaRoche Inc. and Progenics
Pharmaceuticals, Inc.
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Confidential treatment has been requested for portions of this Agreement and
the portions for which confidential treatment have been requested are
indicated by asterisks.
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EXHIBIT 10.32
CONFIDENTIAL TREATMENT
Heads of Agreement
__________________
between
F.Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070 Basel, Switzerland and
Hoffmann-La Roche Inc., 340 Kingsland Street, Nutley, New Jersey 07110 USA,
(hereinafter called "Roche"),
and
Progenics Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, New
York 10591, USA (hereinafter called "Progenics")
_____________________________
WHEREAS:
Progenics is a biopharmaceutical company with considerable experience in the
field of HIV research.
Progenics has been granted by Columbia University, New York, New York 10027 (US)
a worldwide exclusive license to the CD4 receptor with the right to sublicense,
which receptor can be used for the screening of compounds which can inhibit the
adhesion and fusion of HIV to cell membranes.
Progenics has developed original screening assays which could allow the
identification of inhibitors of the interaction between chemokine receptors that
act as HIV co-receptors, including CCR5 and CXCR4, and HIV, which interaction
results in fusion of HIV with cells, and Progenics has filed relevant patent
applications thereto.
Progenics has produced or has access to a variety of reagents used in connection
with the assays described above.
Roche desires to screen its libraries of compounds using Progenics technology to
identify such inhibitors.
Therefore, Roche and Progenics have agreed to enter into a binding Heads of
Agreement as follows:
1. Definitions
1.1 "Affiliated Companies," with respect to a party to this Agreement, shall
mean:
a. an organization fifty percent or more of the voting stock of which is
owned and/or controlled directly or indirectly by such party;
b. an organization which directly or indirectly owns and/or controls
fifty percent or more of the voting stock of such party; or
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c. an organization which is directly or indirectly under common control
of such party through common share holdings.
The term Affiliated Companies of Roche shall not include Genentech Inc, 460
Point San Bruno Blvd, South San Francisco, California, USA unless Roche
opts for such inclusion by giving a written notice to Progenics.
1.2 "Compound" shall mean a Molecule identified or developed for use in the
Field through the use of Progenics Intellectual Property Rights or as a
result of the Research Collaboration.
1.3 "Field" shall mean the area of the therapy of HIV infection by the
inhibition of the interaction between chemokine receptors that act as HIV
co-receptors, including CCR5 and CXCR4, and HIV, which interaction results
in fusion of HIV with cells.
1.4 "Major Markets" shall mean any of [ *** ]
1.5 "HIV" shall mean human immunodeficiency virus.
1.6 "Net Sales" shall mean the gross sales of the Product invoiced by
[ *** ]
In the case of combination products, [ *** ]
1.7 "Product" shall mean a pharmaceutical composition containing at least one
Compound as active ingredient.
1.8 a. "Progenics Intellectual Property Rights" shall mean all patents and
patent applications, including any addition, continuation,
continuation-in-part, or division thereof or any substitute application
therefor; any patent issued with respect to such patent application; any
reissued, re-examination or extension of any such patent, any confirmation
patent or registration patent or patent of addition based on any such
patent and any assays, reagents and materials furnished by Progenics to
Roche in connection with the Research
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CONFIDENTIAL TREATMENT
Collaboration, in each case related to the Field and in which Progenics has
an ownership or licensable right during the term of this Agreement.
b. "Progenics Confidential Information" shall mean information and
materials, including but not limited to pharmaceutical, chemical and
biological substances, technical and non-technical data, tests, assays,
cell lines and other materials, methods, processes and drawings, plans,
diagrams and specifications and other know-how, related to the Field and in
which Progenics has an ownership or licensable right during the term of
this Agreement.
1.9 "Research Collaboration" shall mean the research performed by the parties
as defined in Appendix A hereto.
1.10 a. "Roche Intellectual Property Rights" shall mean all patents and patent
applications including any addition, continuation, continuation-in part, or
division thereof or any substitute application therefor; any patent issued
with respect to such patent application; any reissue, re-examination or
extension of any such patent, any confirmation patent or registration
patent or patent of addition based on any such patent, and in which Roche
has an ownership or licensable right during the term of this Agreement.
b. "Roche Confidential Information shall mean information and materials,
including but not limited to pharmaceutical, chemical and biological
substances, technical and non-technical data, tests, assays, cell lines and
other materials, methods and processes and drawings, plans, diagrams and
specification and other know-how, related to the Field and in which Roche
has an ownership or licensable right during the term of this Agreement.
1.11 "Molecule" shall mean all chemical entities, excluding:
a. any molecule [ *** ] and
b. any molecule that [ *** ]
It is understood that a [ *** ] as described above, is a molecule made only
of [ *** ]
1.12 The "Effective Date" shall mean the date on which the last signatory to
this Agreement signs the Agreement.
2. Research Collaboration
2.1 Progenics and Roche shall jointly perform the Research Collaboration. The
specific tasks of either party are defined in Appendix A hereto. Progenics
shall assign to the Research Collaboration, and its research obligations
under the Research Collaboration shall be limited to, [ *** ]
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2.2. The parties shall establish a Joint Steering Committee which will:
a. review the progress of the Research Collaboration,
b. adapt the tasks of the parties set forth in Appendix A to reflect the
results being achieved or changing scientific interest,
c. meet at least twice a year, with additional informal communications as
appropriate.
The Joint Steering Committee shall consist of an equal number of
representatives from each party. Decisions relevant to the research
collaboration shall be made by consensus. If no consensus decision can be
made, the matter shall be escalated to and resolved by the Chief Executive
Officer of Progenics and the Director of Roche Discovery Welwyn, UK. In
case no consensus is reached after escalation, the matter shall be finally
decided by the Head of Global Research of Roche.
No action shall be taken by the Joint Steering Committee that adversely
affects the contract rights or obligations of the parties hereunder.
2.3 During the term of the Research Collaboration Progenics shall identify and
provide to Roche at no additional cost such reagents, cell lines and other
materials (including soluble CD4) constituting Progenics Intellectual
Property Rights and Progenics Confidential Information as Roche shall
reasonably request in connection with the research and development
activities contemplated by the Research Collaboration.
Progenics hereby grants to Roche an immunity from suit by Progenics and
Columbia University under the US patent 5,126,433. and European Patent EP
280 710 B and Progenics Intellectual Property rights, for the use by Roche
of such reagents, cell lines and other materials in the Research
Collaboration.
2.4 Roche will [ *** ] If Roche elects to discontinue development of a
Compound, it shall promptly so notify Progenics.
2.5 The Research Collaboration shall have a term of three years from the
effective date of these Heads of Agreement. Thereafter, the Research
Collaboration may be extended upon mutual agreement.
3. License Grant
3.1 Progenics hereby grants to Roche and its Affiliates a sole and exclusive,
world-wide license solely in the Field under Progenics Intellectual
Property Rights and Progenics Confidential Information to develop, make,
have made, use, sell, offer to sell and import Products. Notwithstanding
the foregoing, Progenics reserves the right to use Progenics Intellectual
Property Rights and Progenics Confidential Information without cost (i) in
the Field for
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non-commercial internal research purposes and (ii) outside the Field for
any purpose.
The license granted by Progenics hereby expressly does not extend to the
use of the Progenics Intellectual Property Rights or Progenics Confidential
Information outside the Field.
3.2 The license includes the right to grant sublicenses to the extent
hereinafter provided. Roche shall have the right to grant sublicenses to
third parties in all countries (i) during the research phase of the
Research Collaboration to accelerate or improve the research, only upon
approval by the Joint Steering Committee (ii) after the research phase,
without any restriction in countries that are not Major Markets. In Major
Markets, Roche shall be entitled to sublicense Progenics Intellectual
Property Rights and Progenics Confidential Information only to the extent
necessary to support the licensing of Roche Intellectual Property Rights
and provided that Roche shall have obtained Progenics' prior written
consent, which consent shall not be unreasonably withheld. If Roche grants
a sublicense such sublicense shall, at a minimum, be in accordance with all
of the terms of this Agreement and all obligations and requirements of this
Agreement shall apply to the sublicensee to the same extent as they apply
to Roche for the performance of all obligations so imposed on such licensee
and Roche itself will pay and account to Progenics for all royalties due
under this Agreement by reasoons of the operations of any such sublicensee.
The details of such arrangements will be discussed for the final agreement.
As a condition to any sublicense hereunder, (i) Roche shall promptly after
the execution of any such sublicense furnish to Progenics a complete and
correct copy of the sublicensing agreement which Progenics will treat as
Confidential Information subject to Section 6, infra (ii) the sublicensee
shall agree with Progenics in writing to keep (and to permit Progenics to
review) books and records so as to otherwise comply with the applicable
terms of this Agreement and (iii) Roche shall remain responsible for the
performance of any such sublicensee's obligations.
4. Consideration
4.1 Research contribution
Roche shall pay Progenics during the Term of the Research Collaboration USD
[ *** ] per year, inclusive of taxes and overhead, for the funding of the
positions of [ *** ] The amount of funding payable for each year after the
first year of the Research Collaboration shall increase by [ *** ](relative
to the prior year) to reflect cost of operations increases.
Such payments will be made in four equal installments at the beginning of
each calendar quarter upon receipt of an invoice from Progenics.
4.2 Milestone payments
Roche shall pay Progenics the following milestone payments in USD:
a. [ *** ]
b. [ *** ]
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c. [ *** ]
d. [ *** ]
e. [ *** ]
f. [ *** ]
g. [ *** ]
h. [ *** ]
i. [ *** ]
Milestone payments shall be non-refundable, paid only once, whatever the
number of Compounds that reach such milestone, and shall not be credited
against future royalties.
Notwithstanding the foregoing, Roche is free to terminate the development
of a Compound and, in such case, may terminate its obligations under this
paragraph at any time with three (3) months prior written notice. Any such
termination shall not relieve Roche of its obligation to make milestone
payments with respect to milestones achieved prior to notifying Progenics
of such termination.
4.3 Royalties
Roche shall pay to Progenics a royalty based on the sum of world-wide
annual Net Sales of Products, as follows:
a. [ *** ]
b. [ *** ]
c. [ *** ]
d. [ *** ]
Royalties shall be paid with respect to Net Sales in any country for [ ***
] commencing with the first sale of the each Product in such
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country. Thereafter, the license granted by Progenics to Roche with respect
to such country and to such product shall become a fully paid-up license.
The royalties due to Progenics shall be reduced in case of third party
royalties and license fees paid as a result of dominating third-party
patents. In case of dominating third party's patent, [ *** ] of the
royalties and fees paid by Roche to such third party(ies) for deblocking
license(s), will be deducted from the royalties to be paid to Progenics. In
no case shall the royalty reduction exceed [ *** ] of the royalties
otherwise due to Progenics.
The details of the provision dealing with multiple products discount shall
be included in the definitive agreement. [ *** ]
Roche and any sublicensee thereof shall keep for three (3) years from the
date of each payment of royalties records of sales and all other information
necessary to calculate Net Sales The conditions in which Progenics shall have
the right to audit such records will be described in the final agreement.
5. Contingent License to Progenics
5.1 In case that in the Field, Roche and its Affiliated Companies discontinue
the active funding and staffing of the research and development of
Compounds and no Compound at all [ *** ] then:
a. The License granted pursuant to Section 3.1 shall immediately
terminate; and
b. Roche shall grant to Progenics exclusively in the Field a
royalty-bearing exclusive worldwide license, with the right to sublicense,
to the Roche Intellectual Property Rights relating to any Compound that [
*** ] If Progenics wishes to have access to the data on any such Compound
produced by Roche and its Affiliated Companies, Roche will propose to
Progenics a fair price for such data which will reflect the cost of the
development by Roche of such Compound.
5.2 In case that Roche decides to license out a Compound, [ *** ] and to
sublicense concurrently Progenics Intellectual Property rights and
Progenics Confidential Information pursuant to Article 3.2, [ *** ] The
conditions for such license to Progenics will be similar to the conditions
offered by Roche to third parties.
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6. Secrecy Provisions
6.1 During the term of this Agreement, a party (the recipient party) may obtain
certain Confidential Information, as defined in section 1.8 (b) and 1.10
(b), from the other party.
6.2 The parties hereto agree that the recipient party of Confidential
Information received hereunder shall treat such Confidential Information as
it would treat its own Confidential Information of a like nature and shall
not disclose it to any third party nor use it other than in connection with
this Agreement during the Term of this Agreement, but in any event for 10
(ten) years from disclosure thereof except as follows (in each case as
proven by competent evidence):
a. to the extent such Confidential Information is general public
knowledge or which, after disclosure hereunder, becomes general or
public knowledge through no fault of the recipient party; or
b. to the extent such Confidential Information can be shown by the
recipient party to have been in its possession prior to receipt
thereof hereunder; or
c. to the extent such Confidential Information is received by the
recipient party from any third party not under any lawful obligation
(by contract or otherwise) to refrain from such disclosure.
A party may also disclose Confidential Information it receives hereunder to
the extent (i) submitted by the party to governmental authorities, experts,
and regulatory authorities to facilitate the issuance of marketing
approvals of Products, (ii) such Confidential Information is required in
filing patent applications related to Compounds and/or Products, or (iii)
otherwise required to be disclosed in compliance with applicable laws or
regulations or order by a court or other regulatory body having competent
jurisdiction; provided that in any of (i), (ii) or (iii) above if a party
intends to make any disclosure of the other party's Confidential
Information it will give reasonable advance notice to the other party of
such intent and use its best efforts to secure confidential treatment of
such Confidential Information required to be disclosed.
Notwithstanding the foregoing, to the extent required by law or regulation,
Progenics shall be entitled to summarize the terms of this Agreement in and
file this Agreement, excluding the financial terms, as an exhibit to a
registration statement or other document filed by Progenics with the U.S.
Securities and Exchange Commission or any self-regulatory organization in
connection with or occasioned by Progenics' initial public offering,
provided that Roche shall be furnished with a copy of any proposed summary
and the opportunity to comment thereon a reasonable time prior to
submission.
6.3 For purposes of this Section 6, Affiliated Companies of Roche are not
considered third parties provided that such Affiliated Companies assume the
same obligations according to Article 6.2 of this Agreement and are
therefore bound to the obligations of Roche, provided that Roche shall be
liable for any disclosure. The same applies with regard to sublicensees of
Roche.
6.4 The provisions of this Section 6 shall survive any termination of this
Agreement pursuant to Section 7 or otherwise.
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7. Term and Termination
7.1 This Agreement shall enter into full force on the Effective Date and shall
remain in force, except as expressly stated herein, until the expiration of
all obligations to pay royalties pursuant to any of the licenses granted
herein. Roche is free to terminate this Agreement at any time with three
months prior notice. In such case, the license granted by Section 3.1
hereof shall immediately terminate and the obligations of the Parties will
cease except Roche's obligation of research funding of [ *** ] for a
minimun of [ *** ] measured from the Effective Date pursuant to Article
4.1. In addition, Roche may terminate the Research Collaboration at any
time after December 31, 1999 with six months' prior written notice
effective as of the end of the calendar quarter specified in such notice
(subject to continuation of research funding for a [***] year period as
specified in the prior sentence).
7.2 Failure by one party to comply with any of its respective material
obligations contained in this Agreement shall entitle the other party to
give the party in default written notice in order to cure such default. If
such default is not cured within sixty (60) days after receipt of such
written notice, the notifying party shall be entitled without prejudice to
any and all rights conferred to it by this Agreement to terminate this
Agreement by giving notice with immediate effect.
7.3 Neither of the undersigned parties shall be liable for failure to perform
its obligations under this Agreement when occasioned by contingencies
beyond its control, including, without limitation, strikes or other work
stoppages, lock-outs, riots, wars, delay of carriers and Acts of God,
including, without limitation, fire, floods, storms, earthquakes, and acts
or failures to act of government or govermental agencies or
instrumentalities (Force Majeure). Each party will notify the other
immediately should any such contingencies occur.
7.4 Expiration or termination of the Research Collaboration or termination of
the Agreement or licenses granted or contemplated hereby shall not relieve
the parties of any accrued obligation under this Agreement. It is expressly
understood that no such expiration or termination shall relieve either
party hereto of its obligations to make milestone payments or to pay
royalties in respect of Net Sales of Products for the duration specified in
Article 4.3.
7.5 In the event of the termination or expiration of the Research Collaboration
or any license granted hereby, except as otherwise provided herein each
party shall return to the other party all Confidential Information and
materials of the other furnished by such party pursuant to this Agreement,
except for one archival copy.
8. Governing Law and Arbitration
8.1 In the event of any controversy or claim arising out of or relating to any
provision of this Agreement the breach, termination or validity thereof,
the parties shall try to settle those conflicts amicably between
themselves.
8.2 Should they fail to agree, any such controversy or claim shall be settled
by final and binding arbitration pursuant to the American Arbitration
Association as hereinafter provided:
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a. The Arbitration Tribunal shall consist of three arbitrators. Each
party shall nominate in the request for arbitration and the answer
thereto one arbitrator and the two arbitrators so named will then
jointly appoint the third arbitrator as chairman of the Arbitration
Tribunal. If one party fails to nominate its arbitrator or if the
parties' arbitrators cannot agree on the person to be named as
chairman within sixty (60) days, such arbitrator(s) shall be chosen in
accordance with the rules of the American Arbitration Association.
b. The place of arbitration shall be in New York, New York, and the
arbitration proceedings shall be held in English. The procedural law
of the place of arbitration shall apply where the said Rules are
silent.
c. The award of the Arbitration Tribunal shall be final and judgment upon
such an award may be entered in any competent court of application may
be made to any competent court for judicial acceptance of such an
award and order of enforcement.
8.3 The provisions of this Section 8 shall become effective only upon entry
into a Final Agreement.
9. Certain Patent Matters
9.1 Progenics shall have the right but not the obligation to maintain and
prosecute at its expense, patent rights constituting Progenics Intellectual
Property Rights. If Progenics decides not to pursue patent protection at
any time for any Progenics Intellectual Property Rights subject to this
agreement in any country, it shall give reasonable notice to Roche to this
effect and Roche shall have the right but not the obligation at its expense
to prosecute and maintain such patent protection with respect to such
Progenics Intellectual Property Rights in such country. In such case, Roche
shall have the right to apply royalty reduction to Progenics as to
out-of-pocket expenses reasonably incurred by Roche in maintaining and
prosecuting such patents in such countries.
9.2 Roche shall have the right but not the obligation. to maintain, prosecute
at its expense, patent rights constituting Roche Intellectual Property
Rights, subject to this agreement. If Roche decides not to pursue patent
protection at any time for such Roche Intellectual Property Rights in any
country, it shall give reasonable notice to Progenics to this effect, and
Progenics shall have the right, but not the obligation, at its expense, to
prosecute and maintain such patent protection with respect to such Roche
intellectual Property Rights in such country. In such case, Progenics shall
have the right to apply royalty reduction to Roche as to out-of-pocket
expenses reasonably incurred by Progenics in maintaining and prosecuting
such patents in such countries.
9.3 Provisions regarding the enforcement of patents covering either the
Progenics Intellectual Property Rights or the Roche Intellectual Property
Rights will be addressed in the full Agreement.
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10. Miscellaneous
10.1 During the term of this Agreement Roche and Progenics will make available
and disclose to each other the relevant information relating to the Field
which is required for the performance of the program. In addition, from
and after the termination of the Research Collaboration and until
termination of this Agreement, Roche shall provide Progenics semi-annually
a summary progress report with respect to Compounds under development.
10.2 Roche [ *** ]
10.3 Neither party shall be entitled to assign its rights hereunder without the
express written consent of the other party hereto. No assignment and
transfer shall be valid unless and until the assignee agrees in writing to
be bound by the provisions of this Agreement.
10.4 This Agreement shall be governed, construed and interpreted in accordance
with the laws of the State of New Jersey (US).
10.5 The terms of this Heads of Agreement will become binding on the parties and
effective on the Effective Date Although binding upon the parties, the
terms hereof shall be incorporated into a definitive full agreement
containing additional terms usual and customary for this kind of
transaction and of this magnitude which the parties agree to negotiate in
good faith. Such Agreement shall also contain customary and usual
provisions for Agreements of this nature for pharmaceutical products of
like stage of development including without limitation, warranty,
infringement, and indemnification provisions. The parties agree to make
diligent efforts to expediently conclude such full definitive agreement
provided, however that failure to conclude such agreement shall not affect
the validity or enforceability of this Agreement.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as of
the respective dates written below.
Hoffmann-La Roche Inc. Progenics Pharmaceuticals, Inc.
By:_________________________ By:_________________________
____________________________ ____________________________
Print Name Print Name
____________________________ ____________________________
Title Title
____________________________ ____________________________
Date Date
F. Hoffmann-La Roche Ltd.
By:_________________________
____________________________
Print Name
____________________________
Date
By:_________________________
____________________________
Print Name
____________________________
Date
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APPENDIX A
PROGENICS AND ROCHE
RESEARCH COLLABORATION ON HIV CO-RECEPTORS
[ *** ]
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