SUPPLY AND OPTION AGREEMENT
Between
Merck and Co., Inc.
And
Bioject Medical Technologies, Inc.
Effective As Of:
June 8, 1998
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO CERTAIN PORTIONS OF
THIS EXHIBIT PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH
THE COMMISSION UNDER RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
SUPPLY AND OPTION AGREEMENT
TABLE OF CONTENTS
Section Page No.
1 Defined Terms......................................................2
2 Covenants of Bioject...............................................6
3 Options............................................................8
4 License And Know-How Agreement and Supply Agreement................9
5 Payment............................................................9
6 Representations and Warranties of Bioject.........................10
7 Regulatory and Intellectual Property..............................11
8 Termination.......................................................12
9 Bankruptcy of Bioject.............................................13
10 Notices...........................................................14
11 Successors and Assigns............................................15
12 Governing Law.....................................................15
13 Headings..........................................................15
14 Severability......................................................15
15 Force Majeure.....................................................15
16 Entire Agreement..................................................16
17 Public Announcement...............................................16
18 Confidentiality...................................................16
Schedule 1
SUPPLY AND OPTION AGREEMENT
THIS SUPPLY AND OPTION AGREEMENT (the "AGREEMENT") is made effective as of
June 8, 1998 ("EFFECTIVE DATE"), by and between Merck & Co., Inc., a New Jersey
corporation having its principal place of business at Xxx Xxxxx Xxxxx, X.X. Xxx
000, Xxxxxxxxxx Xxxxxxx, Xxx Xxxxxx 00000-0000 ("MERCK"), and Bioject Medical
Technologies, Inc. ("BIOJECT"), an Oregon corporation having its principal place
of business at 0000 X.X. Xxxxxxxxxx Xxxx, Xxxxxxxx, Xxxxxx 00000.
W I T N E S S E T H:
WHEREAS, BIOJECT is the manufacturer of B2000 SYSTEMS (defined
hereinafter), owns PATENT ASSETS (defined hereinafter), owns certain KNOW-HOW
(defined hereinafter), and is able to provide SUPPORT SERVICES (defined
hereinafter);
WHEREAS, MERCK desires to obtain from BIOJECT, and BIOJECT is willing to
provide to MERCK, sufficient numbers of B2000 SYSTEMS to enable MERCK to [* * *]
and [* * *] (defined hereinafter);
WHEREAS, MERCK desires to obtain from BIOJECT, and BIOJECT is willing to
provide to MERCK, KNOW-HOW and SUPPORT SERVICES to be used by MERCK in
connection with [* * *]; and
WHEREAS, MERCK desires to obtain from BIOJECT, and BIOJECT is willing to
grant to MERCK, an [* * *] for the [* * *] (defined hereinafter) to (i) [* * *]
from [* * *] under the [* * *] and [* * *] in connection with the [* * *]
(defined hereinafter) and (ii) [* * *] a [* * *] (defined hereinafter) in
connection with [* * *];
NOW THEREFORE, in consideration of the premises and the mutual covenants
contained herein, the sufficiency of which is hereby acknowledged, the parties
hereto, intending to be legally bound, agree as follows:
1. Defined Terms. As used herein, the following terms have the following
respective meanings.
(a) "AFFILIATE" means (i) any corporation or business entity of which
fifty percent (50%) or more of the securities or other ownership
interest, including equity, voting stock, or general partnership
interest, is owned, controlled, or held, directly or indirectly, by
MERCK or BIOJECT; or (ii) any corporation or business entity which,
directly or indirectly, owns, controls, or holds fifty percent (50%)
or more of the securities or other ownership interest, including
equity, voting stock or, if applicable, a general partnership
interest, of MERCK or BIOJECT.
(b) "BIOJECT" has the meaning set forth in the preamble hereof.
(c) "B2000 SYSTEMS" means the needle-free injection system marketed by
BIOJECT in the United States as of the EFFECTIVE DATE under FDA 510(k)
Application Number 960373, as approved by the FDA on March 5, 1997,
and marketed elsewhere in the world under counterparts of that 510(k)
Application, and any modification, improvement, or variant of that
system which is marketed by BIOJECT in reliance upon or under that
510(k) Application or its counterparts, together with all components
and accessories associated with the intramuscular or subcutaneous use
of that system, including but not limited to actuators, gas
cartridges, syringes, and vial adapters.
(d) "DERMAL ADAPTOR" means the adaptor used in connection with B2000
SYSTEMS for purposes of dermal injection which is the subject of
BIOJECT's pending FDA 510(k) Application K974194, filed November 12,
1997, and supplemented on March 26, 1998.
(e) "EFFECTIVE DATE" shall have the meaning set forth in the preamble
hereto.
(f) "FDA" means the United States Food and Drug Administration.
(g) "FIELD" means prophylactic and/or therapeutic DNA vaccination against
any and all of the INFECTIOUS DISEASES using (i) [* * *], (ii) [* *
*], or (iii) combinations of [* * *] and [* * *].
(h) [* * *] means [* * *].
(i) "INFECTIOUS DISEASES" means [* * *], and [* * *].
(j) "KNOW-HOW" means any and all BIOJECT information, including but not
limited to discoveries, inventions, improvements, processes, formulae,
and data, whether or not patentable, which during the TERM is not
generally known and which is related to the use of B2000 SYSTEMS or
DERMAL ADAPTORS in the FIELD.
(k) [* * *] means a [* * *] by and between [* * *] and [* * *] in which [*
* *] or [* * *], on terms and conditions to be agreed to by the
parties, rights:
(i) to [* * *] under the [* * *] and [* * *],
(ii) which may be [* * *] by [* * *] or its [* * *],
(iii)to [* * *], or [* * *] on a [* * *] with respect to [* * *] for
[* * *] within the [* * *],
(iv) which shall be SEMI-EXCLUSIVE RIGHTS with respect to the use of
[* * *] within the FIELD and which shall be exclusive with
respect to the use of [* * *] or combinations of [* * *] and [* *
*] within the FIELD.
(l) "MERCK" shall have the meaning set forth in the preamble hereto.
(m) "MERCK PRODUCTS" means any product marketed by MERCK or MERCK's
designated AFFILIATE in connection with the FIELD.
(n) "MERCK RESEARCH" means any and all preclinical or clinical research by
MERCK or any AFFILIATE of MERCK in connection with the FIELD.
(o) "OPTION PERIOD" means the period beginning on the EFFECTIVE DATE and
ending on [* * *]; provided, however, that MERCK may extend the OPTION
PERIOD with respect to the use of [* * *] within the FIELD for [* * *]
(ending [* * *]) upon written notice to BIOJECT and by paying BIOJECT
[* * *] for the first of such extension periods and [* * *] for the
second of such extension periods. The first of any such extension
payment shall be due by [* * *] and the second of any such extension
payment shall be due by [* * *]. These payments shall be made by wire
transfer to a bank to be designated by BIOJECT.
(p) "PATENT ASSETS" means any and all patents or patent applications,
including all continuations, continuations-in-part, divisions, patents
of addition, reissues, renewals, extensions, or foreign equivalents
thereof, which, as of the EFFECTIVE DATE and thereafter, are owned by
BIOJECT or any AFFILIATE of BIOJECT or can be licensed by BIOJECT, and
which (i) are filed, issued, or published as of the EFFECTIVE DATE or
thereafter, including but not limited to the patents listed in
Schedule 1, and (ii) claim or otherwise cover B2000 SYSTEMS, the
DERMAL ADAPTOR, or the use of B2000 SYSTEMS or the DERMAL ADAPTOR in
the FIELD.
(q) "SEMI-EXCLUSIVE RIGHTS" shall mean rights which are held by MERCK and
no more than one third party for the use of [* * *] within the FIELD.
(r) [* * *] means an [* * *] entered into by and between [* * *] or [* *
*] and [* * *] in accordance with [* * *] in which [* * *] to [* * *],
on terms and conditions to be agreed to by the parties, [* * *] and [*
* *] or [* * *].
(s) "SUPPORT SERVICES" means (i) training and assistance rendered by
BIOJECT to MERCK or its designated agents or clinicians at locations
to be specified by MERCK, with respect to the use of B2000 SYSTEMS or
KNOW-HOW in MERCK RESEARCH; and (ii) information and assistance
provided by BIOJECT, at MERCK`s request, to MERCK, its agents,
clinicians, or any regulatory agency responsible for the approval of
MERCK RESEARCH or MERCK PRODUCTS, relating to the use of B2000 SYSTEMS
or KNOW-HOW in connection with the MERCK RESEARCH or MERCK PRODUCTS.
(t) "TERM" means the period beginning on the EFFECTIVE DATE and ending on
May 1, 2000.
(u) [* * *] means [* * *] and [* * *] after the [* * *] reflecting their
understanding of certain terms and conditions of the [* * *] and [* *
*], including but not limited to, with respect to the [* * *].
2. Covenants of BIOJECT.
(a) (i) BIOJECT covenants that it shall, at its own expense, and upon
thirty (30) days notice by MERCK , deliver to recipients to be
designated by MERCK [* * *] B2000 SYSTEMS, including components
and accessories for such B2000 SYSTEMS in amounts sufficient for
the administration of [* * *] injections. MERCK and its
designated recipients shall have an unrestricted license to use
these B2000 SYSTEMS and components and accessories in MERCK
RESEARCH notwithstanding the termination of this AGREEMENT for
reasons other than a judicial finding that MERCK is in breach.
(ii) BIOJECT covenants that it shall, during the TERM, at its own
expense, and as requested by MERCK or MERCK's agents, clinicians
or designated AFFILIATE, provide MERCK, its agents, clinicians,
AFFILIATE, or any regulatory agency designated by MERCK, with
KNOW-HOW and SUPPORT SERVICES in connection with MERCK RESEARCH
relating to [* * *].
(b) BIOJECT covenants that it shall, to the extent it has not done so by
the EFFECTIVE DATE, disclose and provide copies to MERCK by July 31,
1998, of (i) any and all patents or pending patent applications which
BIOJECT owns or is licensed under (including those listed in Schedule
1), or any patents or patent applications otherwise owned by an
AFFILIATE of BIOJECT, which relate to the B2000 SYSTEM or the DERMAL
ADAPTOR, any feature of the B2000 SYSTEM or the DERMAL ADAPTOR, or any
use or manufacture of the B2000 SYSTEM or the DERMAL ADAPTOR; and (ii)
any other patents or patent applications of which BIOJECT is aware,
whether or not owned or licensed by BIOJECT, which relate to B2000
SYSTEMS, the DERMAL ADAPTOR, or the use or manufacture of B2000
SYSTEMS or the DERMAL ADAPTOR.
(c) [* * *] that it shall, in any [* * *] of [* * *], including any [* *
*] relating to [* * *] that it [* * *] and during the [* * *],
expressly provide that the [* * *] shall not be [* * *] in connection
with the [* * *]. [* * *] that such [* * *] on the [* * *]. It is
expressly understood and agreed to by the parties that the covenants
of this paragraph [* * *].
(d) [* * *] that it [* * *], and [* * *] would [* * *] within the [* * *]
for the use of [* * *] and [* * *] within the [* * *] for the use of
[* * *], or combinations of [* * *] and [* * *] within the [* * *].
3. Options.
(a) During the [* * *], shall have a [* * *] to [* * *] the [* * *] and
the [* * *]. In this regard, it is expressly understood and agreed to
by the parties that, (i) for the use of [* * *] within the [* * *]
under this [* * *] and the [* * *] shall be [* * *] but for any [* *
*] which [* * *] or may, consistent with [* * *]; and (ii) [* * *]
under this [* * *] and the [* * *] shall be [* * *] with respect to
the use of [* * *] and combinations of [* * *] and [* * *] within the
[* * *].
(b) During the [* * *], or [* * *], shall have [* * *] to [* * *] a [* *
*] under the [* * *] and [* * *] to [* * *] in connection with the [*
* *].
4. [* * *]. It is expressly understood and agreed to by the parties that, upon
execution of this AGREEMENT, they shall promptly [* * *] (a) to prepare the
[* * *] by no later than [* * *] from the signing by all parties of this
AGREEMENT, and (b) thereafter to [* * *] as to [* * *] of the [* * *] and
[* * *].
5. Payment. In consideration for BIOJECT's provision of B2000 SYSTEMS to
MERCK, the covenants of BIOJECT, and the options granted by BIOJECT to
MERCK, MERCK shall make payments to BIOJECT by wire transfer to a bank to
be designated by BIOJECT as follows.
(a) MERCK shall pay BIOJECT the sum of [* * *] within thirty (30) days of
the signing by both parties of this AGREEMENT; and
(b) MERCK shall pay BIOJECT [* * *] within thirty (30) days of the earlier
of [* * *] that the parties have agreed to the [* * *]; or (ii) four
(4) months from the signing by all parties of this AGREEMENT;
provided, however, that no payment shall be owed under this paragraph
if MERCK has terminated this AGREEMENT in accordance with Section 8
before MERCK's written confirmation that the parties have agreed to
the TERM SHEET.
6. Representations and Warranties of BIOJECT.
(a) BIOJECT represents and warrants to MERCK that, as of the EFFECTIVE
DATE: (i) BIOJECT has the full right, power, and authority to enter
into this AGREEMENT and the transactions contemplated herein, and that
it has not entered into any agreement which would preclude BIOJECT
from performing its obligations under this AGREEMENT, including but
not limited to [* * *]; (ii) no opinion or judgment against BIOJECT
has been issued or entered which would in any way preclude BIOJECT's
conveyance as of the EFFECTIVE DATE or thereafter of any rights with
respect to B2000 SYSTEMS, DERMAL ADAPTORS, KNOW-HOW, or PATENT ASSETS,
and that it is not aware of any pending claim against BIOJECT seeking
such judgment; (iii) it has not received any communication from the
FDA or other regulatory agency regarding defects with respect to B2000
SYSTEMS or issues with respect to the safety and efficacy of B2000
SYSTEMS; (iv) Schedule 1 is accurate and complete as of the EFFECTIVE
DATE; (v) it is not aware of any fact which would call into question
the suitability of B2000 SYSTEMS or DERMAL ADAPTORS for use in MERCK
RESEARCH; (vi) that it is not aware of any intellectual property right
of any third party which could preclude MERCK RESEARCH or the
manufacture, use, sale, offer for sale, or importation of MERCK
PRODUCTS in connection with the FIELD; (vii) it has not and will not
enter into any agreement inconsistent with MERCK's rights under this
AGREEMENT; and (vii) it shall take all steps and perform all acts
necessary for it to be able to grant licenses under the LICENSE AND
KNOW-HOW AGREEMENT to any and all PATENT ASSETS owned by any BIOJECT
AFFILIATE.
(b) BIOJECT represents and warrants to MERCK that, at the time of delivery
to MERCK, or its designated clinicians or agents, the B2000 SYSTEMS
supplied pursuant to this AGREEMENT will meet published design
specifications, be free from defects of materials and workmanship, and
be suitable for use in connection with MERCK RESEARCH. BIOJECT will
repair or replace at its own cost any nonconforming or defective B2000
SYSTEM within forty-eight (48) hours of receipt from MERCK of written
notice specifying in detail the nonconformity or defect. MERCK shall
thereafter return any such defective or nonconforming B2000 SYSTEM to
BIOJECT and BIOJECT shall provide to MERCK a written report explaining
the reason for the nonconformity or defect.
(c) BIOJECT represents and warrants to MERCK that it shall indemnify and
hold MERCK harmless from any and all claims by any third party against
MERCK (i) arising out of or relating in any way to this AGREEMENT;
(ii) not resulting from a breach by MERCK of this AGREEMENT; and (iii)
not resulting from the negligence of MERCK or its employees, agents,
clinicians, or contractors.
7. Regulatory and Intellectual Property.
(a) MERCK shall be responsible for the conduct and supervision of MERCK
RESEARCH and the preparation and filing of any application for
approval to market MERCK PRODUCTS. BIOJECT shall, at its own expense,
cooperate with MERCK as necessary to obtain any regulatory approval
needed by MERCK to use B2000 SYSTEMS in connection with MERCK RESEARCH
or MERCK PRODUCTS and will, at MERCK's request, address any issues or
answer any questions raised by regulatory authorities in connection
with such use. MERCK shall inform BIOJECT of any adverse reaction
reports made in connection with MERCK RESEARCH that involve B2000
SYSTEMS, KNOW-HOW, or SUPPORT SERVICES.
(b) It is expressly understood and agreed to by the parties that BIOJECT
shall not have any rights with respect to any preclinical or clinical
information or intellectual property generated, developed, or invented
solely by MERCK's employees or its clinicians, contractors, or agents
as a result of MERCK RESEARCH. MERCK and BIOJECT shall, as between
each other (and subject to any ownership interest held by MERCK's
clinicians, contractors, or agents), own jointly any invention made by
both (i) MERCK's employees or its clinicians, contractors, or agents,
and (ii) any BIOJECT employee. MERCK shall have the first right to
negotiate and enter into an assignment or exclusive license of
BIOJECT's interest in such invention.
(c) It is expressly understood and agreed to by the parties that MERCK, or
its designated AFFILIATE, clinicians, or agents shall, upon
termination of this AGREEMENT for reasons other than a finding that
MERCK is in breach and subject to any continuing obligations under
Section 18, be entitled free of charge to retain and use any KNOW-HOW
or other information conveyed by BIOJECT to MERCK under this AGREEMENT
prior to such termination.
8. Termination. Subject to and in accordance with Sections 2. (a)(i), 7. (c),
9., and 18., this AGREEMENT shall terminate on May 1, 2000, and may be
terminated earlier:
(a) by notice by either party during the TERM:
(i) if it is shown by credible evidence that the other party is in
breach of its material obligations hereunder by causes and
reasons within its control and has not cured such breach within
sixty (60) days after written notice requesting cure of the
breach; or
(ii) upon the filing or institution of bankruptcy, reorganization,
liquidation or receivership proceedings, or upon an assignment of
a substantial portion of the assets for the benefit of creditors
by the other party; or
(b) by MERCK, upon thirty (30) days written notice to BIOJECT.
9. Bankruptcy of BIOJECT. In the event this AGREEMENT is terminated based on
the bankruptcy of BIOJECT or by an appointed bankruptcy trustee, all rights
and licenses granted under or pursuant to this AGREEMENT by BIOJECT to
MERCK are, and shall otherwise be deemed to be for purposes of Section
365(n) of the Bankruptcy Code, licenses of rights to "intellectual
property" as defined under Section 101(52) of the Bankruptcy Code. The
parties agree that MERCK as licensee of such rights under this AGREEMENT,
shall retain and may fully exercise all of its rights and elections under
the Bankruptcy Code. The parties further agree that, in the event of the
commencement of a bankruptcy proceeding by or against BIOJECT under the
Bankruptcy Code, MERCK shall be entitled to a complete duplicate of (or
complete access to, as appropriate) any such intellectual property and all
embodiments of such intellectual property upon written request therefore by
MERCK. Such intellectual property and all embodiments thereof shall be
promptly delivered to MERCK (i) upon any such commencement of a bankruptcy
proceeding and upon written request therefore by MERCK, unless BIOJECT
elects to continue to perform all of its obligations under this AGREEMENT
or (ii) if not delivered under (i) above, upon the rejection of this
AGREEMENT by or on behalf of BIOJECT in the event of written request
therefore by MERCK.
10. Notices. Any notices under or pursuant to this AGREEMENT shall be in
writing. Such notices shall be delivered either by hand delivery, by
telecopy or similar electronic medium, nationally recognized overnight
courier or by certified or registered mail, return receipt requested
addressed as follows:
If to BIOJECT, to:
President
Bioject Medical Technologies, Inc.
0000 X.X. Xxxxxxxxxx Xxxx
Xxxxxxxx, Xxxxxx 00000
If to MERCK, to:
Office of the Secretary
WS-3AB-05
Merck & Co., Inc.
X.X. Xxx 000
Xxx Xxxxx Xxxxx
Xxxxxxxxxx Xxxxxxx, Xxx Xxxxxx 00000-0000
with a required copy to:
Vice President, Corporate Licensing
Merck & Co., Inc.
X.X. Xxx 000
One Merck Drive
Whitehouse Station, New Jersey 08889-0100
-- or at such other address as the party affected shall have previously
designated by written notice in the manner hereinabove set forth.
Notices shall be deemed given when sent, if sent by telecopy or
similar electronic medium with delivery confirmed (conditioned upon
the prompt mailing of the original of such transmission by first class
mail or nationally recognized overnight courier); when delivered and
receipted for (or upon the date of attempted delivery when delivery is
refused), if hand delivered or sent by nationally recognized overnight
courier; or when receipted for (upon the date of attempted delivery
when delivery is refused or a properly addressed and mailed notice is
returned as undeliverable or unclaimed), if sent by certified or
registered mail.
11. Successors and Assigns. This AGREEMENT and all rights and powers granted
hereby, will bind and inure to the benefit of the parties hereto and their
respective successors and assigns.
12. Governing Law. This AGREEMENT shall be governed by, and construed in
accordance with, the laws of the State of Delaware, exclusive of its choice
of law provisions. The parties hereby consent to the jurisdiction of the
courts of the State of Delaware with respect to the resolution of any claim
or cause of action arising out of, or related in any way to, this
AGREEMENT.
13. Headings. The headings preceding the text of the sections and paragraphs
hereof are inserted solely for convenience of reference, and shall not
constitute a part of this AGREEMENT, nor shall they affect its meaning,
construction or effect.
14. Severability. In the event that any portion of this AGREEMENT shall be held
illegal, void, or unenforceable, the remaining portions hereof shall remain
in full force and effect.
15. Force Majeure. Neither party shall be found to be in breach or default of
this AGREEMENT as a result of their failure to perform any obligation
hereunder where such failure to perform is the result of an act of God,
regulations or laws of any government, civil commotion, or strikes.
16. Entire Agreement. This AGREEMENT sets forth all of the promises, covenants,
agreements, conditions and undertakings among the parties hereto with
respect to the subject matter hereof, and supersedes all prior and
contemporaneous agreements and understandings, inducements, or conditions,
express or implied, oral or written.
17. Public Announcement. Neither BIOJECT nor MERCK shall make any public
announcement regarding this AGREEMENT without the prior written approval of
the other, which approval shall not be unreasonably withheld.
18. Confidentiality. The parties and their respective representatives shall
keep confidential the terms of this AGREEMENT and other information
disclosed under or in connection herewith and shall not divulge such terms
of or other information to any third party, except:
(a) with the prior written consent of the other party;
(b) as may be required by law, rule or regulation;
(c) to legal counsel representing any party hereto with a notification of
confidentiality;
(d) to the parties' auditors, with a notification of confidentiality; and
(e) to any court and court personnel in a judicial proceeding to enforce
this AGREEMENT.
To the extent feasible, prior notification of any disclosure pursuant to
Section 18 (b) above shall be provided by the disclosing party to the
non-disclosing parties twenty (20) days before the required disclosure date in
order to allow the non-disclosing parties sufficient time to respond and object.
It is understood and agreed to by the parties that the obligations of this
section (a) shall survive the termination of this AGREEMENT, and (b) shall not
apply to: (i) information which is now or which becomes part of the public
domain without the fault of any party, (ii) information disclosed to a party by
a third party having no obligation of confidentiality to any party, and (iii)
information developed by a party independent of any disclosure by any other
party.
IN WITNESS WHEREOF, the undersigned, intending this to be a sealed
instrument, have duly executed this AGREEMENT.
MERCK & CO., INC.
By: /s/ Xxxxxx X. Xxxxxxxx (SEAL)
Xxxxxx X. Xxxxxxxx M.D.
Title: President, MRL
Date:__________________________
BIOJECT MEDICAL TECHNOLOGIES, INC.
By: /s/ Xxxxx X'Xxxx (SEAL)
Xxxxx X'Xxxx
Title: CEO
Date:__________________________
SCHEDULE 1
BIOJECT PATENTS AND PATENT APPLICATIONS
PATENT NUMBER COUNTRY ISSUE DATE
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[* * *]
