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EXHIBIT 10.3
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
LICENSE AND INTELLECTUAL PROPERTY ACCESS AGREEMENT
This License and Intellectual Property Access Agreement (the
"Agreement") dated the 31st day of July 2001 is by and between Becton, Xxxxxxxxx
and Company, a corporation organized and existing under the laws of New Jersey
and having a place of business at 0 Xxxxxx Xxxxx, Xxxxxxxx Xxxxx, Xxx Xxxxxx
00000 ("BD") and TriPath Imaging, Inc., a corporation organized and existing
under the laws of Delaware and having its principal office at 000 Xxxxxxxxxx
Xxxxx, Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000 ("TriPath").
INTRODUCTION
1. BD has agreed to purchase a certain number of shares of
TriPath stock by means of a certain Stock Purchase Agreement to be executed
concurrently herewith; and
2. BD desires to receive from TriPath, and TriPath desires to
grant to BD, a license in and to, and access to, certain intellectual property
rights owned by TriPath.
NOW, THEREFORE, BD and TriPath agree as follows:
Article I
Definitions
When used in this Agreement, each of the following terms shall have the
meanings set forth in this Article I:
Section 1.1 "Agreement" means this agreement and any exhibits,
attachments or addenda hereto, and any renewals or extensions of this agreement.
Section 1.2 "BD" includes all of the divisions, subsidiaries and
Affiliates of BD.
Section 1.3 "Effective Date" means the date on which the last of
the conditions set forth in Article XI of that certain development agreement by
and among BD, TriPath Oncology, Inc. and TriPath dated on even date herewith
shall have been fulfilled or waived.
Section 1.4 "TriPath Intellectual Property" means any information
(including without limitation any clinical trial data and information and data
relating to any submissions to any regulatory agencies), copyrights, trade
secrets, data, trademarks, software and patent rights in any way related to
[*****] products that are owned or controlled by TriPath at any time during the
term of this Agreement.
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Section 1.5 "Field" means all aspects of clinical trials and
regulatory submissions for [*****], or any successor BD instrument thereto,
solely with the TriPath's [*****].
Section 1.6 "Stock Purchase Agreement" means that certain stock
purchase agreement by and between TriPath and BD executed on even date herewith.
Section 1.7 "TriPath" includes all of the divisions, subsidiaries
and Affiliates of TriPath.
Article II
Grants
Section 2.1 Grant and Access to BD.
Subject to the terms and conditions of this Agreement, and to
the extent TriPath has the right to do so, TriPath hereby grants to BD a [*****]
right and license, with the right to grant sublicenses with TriPath's written
consent [*****], in and to the TriPath Intellectual Property solely for use in
the Field. Such right and license includes TriPath's covenant and commitment to
permit BD access to originals and copies of all tangible manifestations of
TriPath Intellectual Property solely for use in the Field.
Section 2.2 Grant to TriPath.
To the extent that it has the right to do so, BD hereby grants
to TriPath a [*****], with the right to grant sublicenses with BD's written
consent (such consent not to be unreasonably withheld or delayed), to any
inventions, discoveries, or improvements (whether or not patentable) that are
derived directly from the use of TriPath Intellectual Property in the Field by
BD's employees, consultants or agents, to make, use, offer to sell, sell and
import products, and provide services inside and outside of the Field. This
Section shall not be interpreted to imply the grant by BD of any right in or to
intellectual property that exists prior to the Effective Date or intellectual
property that is not directly derived from the use of TriPath Intellectual
Property in the Field.
Article III
Regulatory Covenants
Section 3.1 Covenants of TriPath Regarding Regulatory Filings.
(a) TriPath hereby agrees and covenants during the term
of this Agreement that if BD seeks any regulatory approval relating to the
practice of [*****] with the [*****], or any successor BD instrument, [*****]
product, then TriPath will consider concurrently seeking to amend its regulatory
approval relating to such [*****] products to be consistent with, and
acknowledge, the BD regulatory submission.
(b) TriPath hereby agrees and covenants that during the
term of this Agreement and during the time period that BD has the regulatory
approval referenced in (a) above, TriPath will not amend any regulatory
approvals relating to [*****] products without first providing BD written
notification of such amendment to enable BD to amend any of its corresponding
regulatory filings, submissions and/or approvals.
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(c) TriPath hereby agrees and covenants that during the
term of this Agreement and during the time period during which BD is conducting
clinical trials for purposes of obtaining the regulatory approval referenced in
(a) above and during the time period that BD has such regulatory approval,
TriPath will provide BD with prior written notification of any proposed changes
to its [*****] products, such notification to enable BD to perform any testing
necessary to amend or supplement its regulatory filings, submissions and/or
approvals relating to the practice of [*****] any successor BD instrument
[*****].
Article IV
Intent to Co-Market Products
Section 4.1 Possible Co-Marketing Agreement. TriPath and BD
hereby express their intent to negotiate in good faith an agreement pursuant to
which the Parties would co-market TriPath's [*****] products and the [*****], or
any successor BD instrument, provided that any clinical trials that BD may
undertake using TriPath Intellectual Property in the Field yield results that
the Parties believe would be sufficient to support a regulatory submission.
Article V
Term and Termination
Section 5.1 Term. This Agreement shall remain in effect for a
period ending on the earlier of: (a) the expiration date of the last to expire
of all rights in and to the TriPath Intellectual Property; (b) the date on which
all rights in and to the TriPath Intellectual Property have been finally
adjudicated to be invalid and/or unenforceable in an action that may not be
appealed or for which the time period to bring an appeal has expired; (c) the
[*****] anniversary of the Effective Date if BD has not sought regulatory
approval relating to the practice of nucleic acid based testing with the [*****]
System, or any successor BD instrument, with an [*****] product; (d) the [*****]
anniversary of the Effective Date if BD has not received regulatory approval
relating to the practice of [*****] System, or any successor BD instrument, with
[*****] product; (e) the date of termination of this Agreement in accordance
with Section 5.2, 5.3 or 5.4.
Section 5.2 BD's Right to Terminate. BD may, at any time, without
cause, terminate this Agreement upon [*****] prior written notice to TriPath.
Upon such a termination by BD, all rights granted to BD herein shall immediately
terminate, and the rights granted to TriPath under Section 2.2 shall survive.
Section 5.3 Breach. Termination for Default or Breach. This
Agreement may be terminated by either party upon default or breach of a material
obligation or condition by the other, such termination being effective [*****]
after receipt by the alleged defaulting or breaching party of written notice of
such termination pursuant to this Section specifying the default or breach;
provided, however, that if the default or breach is cured or shown to the
reasonable satisfaction of the non-breaching party to be non-existent within the
[*****] period after receipt of written notice, the notice shall be deemed
automatically withdrawn and of no effect. If the parties do not agree on whether
a default or breach is of a "material" obligation or condition, then the parties
shall resolve such a dispute in accordance with
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Article VIII of this Agreement, and no termination shall occur unless such
breach is determined to be of a "material" obligation or condition in accordance
with the dispute resolution procedures of Article VIII.
Section 5.4 Bankruptcy. In the event that BD shall make an
assignment for the benefit of creditors or voluntarily or involuntarily file a
petition for bankruptcy or reorganization, TriPath shall have the right to
terminate this Agreement effective immediately upon written notice, but without
prejudice to any other rights.
Section 5.5 Surviving Rights. Upon termination, the parties
hereto will have no further obligations to each other or rights except for those
obligations or rights accrued or effective pursuant to Section 2.2, Article VI
and Section 7.5 of this Agreement that shall survive termination.
Article VI
Confidentiality
Section 6.1 Confidential Information. All Confidential
Information disclosed by a Party to the other Party during the term of this
Agreement shall not be used by the receiving Party except in connection with the
activities contemplated by this Agreement, shall be maintained in confidence by
the receiving Party, and shall not otherwise be disclosed by the receiving Party
to any other person, firm, or agency, governmental or private, without the prior
written consent of the disclosing Party, except to the extent that the
Confidential Information (as determined by competent documentation):
(a) was known or used by the receiving Party prior to its
date of disclosure to the receiving Party; or
(b) either before or after the date of the disclosure to
the receiving Party is lawfully disclosed to the receiving Party by sources
other than the disclosing Party rightfully in possession of the Confidential
Information and not bound by confidentiality obligations to the disclosing
party; or
(c) either before or after the date of the disclosure to
the receiving Party is or becomes published or generally known to the public
(including information known to the public through the sale of products in the
ordinary course of business) through no breach hereof on the part of the
receiving Party or its sublicensees; or
(d) is independently developed by or for the receiving
Party without reference to or reliance upon the Confidential Information; or
(e) is required to be disclosed by the receiving Party to
comply with applicable laws, to defend or prosecute litigation or to comply with
governmental regulations, provided that the receiving Party provides prior
written notice of such disclosure to the disclosing Party and takes reasonable
and lawful actions to avoid and/or minimize the degree of such disclosure.
Section 6.2 Disclosure of Provisions of Agreement.
(a) Each Party agrees to hold as confidential the terms
of this Agreement except that each Party shall have the right to disclose such
terms to potential investors and other third parties in connection with
financing activities, provided that any such third party has entered into a
written obligation with the disclosing Party to treat such information and
materials as confidential. At the
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request of the other Party, the disclosing Party shall use commercially
reasonable efforts to enforce such obligations against such third parties.
(b) In the event that this Agreement shall be included in
any report, statement or other document filed by either Party or an Affiliate of
either Party with the SEC, such Party shall use, or shall cause its Affiliate,
as the case may be, to use, reasonable efforts to obtain confidential treatment
from the SEC of any financial information or other information of a competitive
or confidential nature, and shall include in such confidentiality request such
provisions of this Agreement as may be reasonably requested by the other Party.
Section 6.3 Employee and Advisor Obligations. BD and TriPath each
agree that they shall provide Confidential Information received from the other
Party only to their respective employees, consultants and advisors, and to the
employees, consultants and advisors of such Party's Affiliates, who have a need
to know, provided that such employees, consultants and advisors agree to treat
such information and materials as confidential.
Section 6.4 Term. All obligations of confidentiality imposed
under this Article VI shall expire [*****] following termination or expiration
of this Agreement.
Article VII
Representations and Warranties
Section 7.1 Representations of Authority. BD and TriPath each
represents and warrants to the other that as of the date hereof and the
Effective Date, it has full right, power and authority to enter into this
Agreement and to perform its respective obligations under this Agreement.
TriPath represents and warrants to BD that it has the right to grant the
licenses granted pursuant to this Agreement. BD and TriPath each represents and
warrants that (a) the execution, delivery and performance by it of this
Agreement, and the consummation by it of the transactions contemplated hereby,
have been duly authorized by all necessary corporate action, and (b) this
Agreement has been duly executed and delivered by it and constitutes a valid and
binding obligation of it, enforceable in accordance with its terms.
Section 7.2 Consents. BD and TriPath each represents and warrants
that all necessary consents, approvals and authorizations of all government
authorities and other persons required to be obtained by such Party in
connection with the execution, delivery and performance of this Agreement have
been obtained.
Section 7.3 No Conflict. BD and TriPath each represents and
warrants that the execution and delivery of this Agreement, and the performance
of such Party's obligations (a) do not conflict with or violate any requirement
of applicable laws or regulations and (b) do not and shall not conflict with,
violate or breach or constitute a default (with or without the giving of notice
or lapse of time, or both) or require any consent under, any contractual
obligations of such Party or order, judgement or decree to which such Party or
any of its assets are bound, except such consents as shall have been obtained
prior to the date hereof or the Effective Date.
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Section 7.4 Third Party Rights. TriPath represents and warrants
that, as of the date hereof and as of the Effective Date, there is no claim or
demand of any person pertaining to, or any proceeding which is pending or, to
the knowledge of TriPath, threatened, that challenges the rights of TriPath in
respect of TriPath Intellectual Property.
Section 7.5 No Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET
FORTH HEREIN OR IN THE STOCK PURCHASE AGREEMENT, THE PARTIES MAKE NO
REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
AND PARTICULARLY THAT LICENSED PRODUCTS OR LICENSED SERVICES WILL BE
SUCCESSFULLY DEVELOPED HEREUNDER, AND IF DEVELOPED, WILL HAVE COMMERCIAL UTILITY
OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. EXCEPT AS MAY OTHERWISE
BE EXPRESSLY SET FORTH HEREIN OR IN THE STOCK PURCHASE AGREEMENT, TRIPATH MAKES
NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, CONCERNING THE TRIPATH INTELLECTUAL PROPERTY, INCLUDING, WITHOUT
LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
NONINFRINGEMENT, VALIDITY OF PATENT CLAIMS, WHETHER ISSUED OR PENDING, AND THE
ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE.
IN NO EVENT SHALL EITHER PARTY, ITS DIRECTORS, OFFICERS, EMPLOYEES AND
AFFILIATES BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND,
INCLUDING ECONOMIC DAMAGES OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF
WHETHER SUCH PARTY SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT
SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.
Article VIII
Dispute Resolution
Section 8.1 Alternative Dispute Resolution. Any controversy,
claim or dispute arising out of or relating to Section 5.3 of this Agreement
that has not been resolved by the Parties within [*****] of first written notice
of such controversy by one Party to the other, may be referred by either party
to the Chief Executive Officers or other designated corporate officers of the
Parties for resolution. If such referred controversy has not been resolved by
the Chief Executive Officers or other designated corporate officers within
[*****] of referral thereto by a Party, or if the Chief Executive Officers or
other designated corporate officers fail to meet within such [*****], then
either BD or TriPath may initiate an Alternative Dispute Resolution ("ADR")
proceeding as provided in Exhibit A hereto. The Parties shall have the right to
be represented by counsel in such a proceeding.
Section 8.2 No Limitation. Notwithstanding the foregoing, nothing
in this Article VIII shall be construed as limiting in any way the right of a
Party to bring suit with respect to any matter relating to this Agreement or to
seek injunctive or other equitable relief from a court of competent jurisdiction
with respect to any actual or threatened breach of this Agreement.
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Article IX
Miscellaneous Provisions
Section 9.1 Governing Law. This Agreement shall be construed and
the respective rights of the Parties determined (including in any arbitration
proceeding under Article VIII) according to the substantive laws of the State of
Delaware notwithstanding the provisions governing conflict of laws under such
Delaware law to the contrary and without giving effect to the United Nations
Convention on Contracts for the International Sale of Goods, the 1974 Convention
on the Limitation Period in the International Sale of Goods (the "1974
Convention") and the Protocol amending the 1974 Convention, done at Vienna April
11, 1980, except matters of intellectual property law which shall be determined
in accordance with the national intellectual property laws relevant to the
intellectual property in question.
Section 9.2 Assignment. Neither BD nor TriPath may assign this
Agreement in whole or in part without the consent of the other Party, which
consent shall not be unreasonably withheld. Notwithstanding the foregoing,
either Party may assign this Agreement in whole or in part without the consent
of the other Party in the event of a Change of Control. For the purposes of this
Section 9.2, "Change of Control" shall mean (a) a merger, consolidation or other
transaction or series of related transactions as a result of which persons who
were shareholders of a Party immediately prior thereto would not immediately
thereafter beneficially own (as defined in Rule 13d-3 promulgated under the
Securities Exchange Act of 1934) at least fifty percent (50%) of the combined
voting power of such Party or the surviving entity immediately after such
transaction; or (b) any one person or group, as such terms are used in Section
13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the
"Exchange Act") (other than any trustee or other fiduciary holding securities
under an employee benefit plan of such Party), together with any of such
person's "affiliates" or "associates", as such terms are used in the Exchange
Act, becoming the beneficial owner (as defined in Rule 13d-3 promulgated under
the Exchange Act) of fifty percent (50%) or more of the combined voting power of
the outstanding securities of such Party, or (c) any sale of all or
substantially all of the assets of such Party relating to the subject matter of
this Agreement, in one or a series of related transactions.
Section 9.3 Amendments. This Agreement constitutes the entire
agreement between the Parties with respect to the subject matter hereof, and
supersedes all previous arrangements with respect to the subject matter hereof,
whether written or oral. Any amendment or modification to this Agreement shall
be made in writing signed by both Parties.
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Section 9.4 Notices.
Notices to BD shall be addressed to:
BD Diagnostic Systems
0 Xxxxxxx Xxxxxx
Xxxxxx, Xxxxxxxx 00000
Attn: Vice President, Business Development
Telecopy No.: 0-000-000-0000
with a copy to:
Becton, Xxxxxxxxx and Company
0 Xxxxxx Xxxxx
Xxxxxxxx Xxxxx, Xxx Xxxxxx 00000
Attn: Vice President and Chief Intellectual Property Counsel
Telecopy No.: 0-000-000-0000
Notices to TriPath shall be addressed to:
TriPath Imaging, Inc.
000 Xxxxxxxxxx Xxxxx
Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000
Attn: Xxxx Xxxxxx, M.D.
with a copy to:
Xxxxxx & Dodge LLP
Xxx Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxxx, Esq.
Telecopy No.: 1-617-227-4420
Either Party may change its address by giving notice to the other Party
in the manner herein provided. Any notice required or provided for by the terms
of this Agreement shall be in writing and shall be (a) sent by registered or
certified mail, return receipt requested, postage prepaid, (b) sent via a
reputable overnight courier service, or (c) sent by facsimile transmission with
an original to be followed the same day via a reputable overnight courier
service, in each case properly addressed in accordance with the paragraph above.
The effective date of notice shall be the actual date of receipt by the Party
receiving the same.
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Section 9.5 Force Majeure. No failure or omission by the Parties
in the performance of any obligation of this Agreement shall be deemed a breach
of this Agreement or create any liability if the same shall arise from any cause
or causes beyond the control of the Parties, including, but not limited to, the
following: acts of God; acts or omissions of any government; any rules,
regulations or orders issued after the Effective Date by any governmental
authority or by any officer, department, agency or instrumentality thereof;
fire; storm; flood; earthquake; accident; war; rebellion; insurrection; riot;
and invasion and provided that such failure or omission resulting from one of
the above causes is cured as soon as is practicable after the occurrence of one
or more of the above-mentioned causes.
Section 9.6 Public Announcements. Any announcements or similar
publicity with respect to the execution of this Agreement shall be agreed upon
among the Parties in advance of such announcement as set forth herein. Either
Party may make such public announcements with respect hereto. The Parties agree
that any such announcement shall not contain Confidential Information and, if
disclosure of Confidential Information is required by law or regulation, shall
make reasonable efforts to minimize such disclosure and obtain confidential
treatment for any such information which is disclosed to a governmental agency
or group. Each Party agrees to provide to the other Party with a copy of any
public announcement as soon as reasonably practicable under the circumstances
prior to its scheduled release. Except under extraordinary circumstances, each
Party shall provide the others with an advance copy of any public announcement
at least [*****] prior to the scheduled disclosure. Each Party shall have the
right to expeditiously review and recommend changes to any announcement
regarding this Agreement or the subject matter of this Agreement, provided that
such right of review and recommendation shall only apply for the first time that
specific information is to be disclosed, and shall not apply to the subsequent
disclosure of substantially similar information that has previously been
disclosed. Except as otherwise required by law, the Party whose public
announcement has been reviewed shall remove or revise any information the
reviewing Party reasonably deems to be inappropriate for disclosure.
Section 9.7 Independent Contractors. It is understood and agreed
that the relationship between the Parties hereunder is that of independent
contractors and that nothing in this Agreement shall be construed as
authorization for either BD or TriPath to act as agent for the other.
Section 9.8 No Strict Construction. This Agreement has been
prepared jointly and shall not be strictly construed against any Party.
Section 9.9 Headings. The captions or headings of the sections or
other subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meaning of the provisions hereof.
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Section 9.10 No Implied Waivers; Rights Cumulative. No failure on
the part of BD or TriPath to exercise, and no delay in exercising, any right,
power, remedy or privilege under this Agreement, or provided by statute or at
law or in equity or otherwise, shall impair, prejudice or constitute a waiver of
any such right, power, remedy or privilege or be construed as a waiver of any
breach of this Agreement or as an acquiescence therein, nor shall any single or
partial exercise of any such right, power, remedy or privilege preclude any
other or further exercise thereof or the exercise of any other right, power,
remedy or privilege.
Section 9.11 Severability. If any provision hereof should be held
invalid, illegal or unenforceable in any respect in any jurisdiction, then, to
the fullest extent permitted by law, (a) all other provisions hereof shall
remain in full force and effect in such jurisdiction and shall be liberally
construed in order to carry out the intentions of the Parties as nearly as may
be possible and (b) such invalidity, illegality or unenforceability shall not
affect the validity, legality or enforceability of such provision in any other
jurisdiction.
Section 9.12 Execution in Counterparts. This Agreement may be
executed in counterparts, each of which counterparts, when so executed and
delivered, shall be deemed to be an original, and all of which counterparts,
taken together, shall constitute one and the same instrument.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.
BECTON, XXXXXXXXX AND COMPANY
By: /s/ Xxxxxxx X. Xxxxxxxx
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Name: Xxxxxxx X. Xxxxxxxx
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Title: Sr. Vice President - Technology, Strategy
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and Development
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TRIPATH IMAGING, INC.
By: /s/ Xxxx X. Xxxxxx, M.D.
--------------------------------------------
Name: Xxxx X. Xxxxxx, M.D.
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Title: President and Chief Executive Office
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Exhibit A
Alternative Dispute Resolution Procedures
[*****]
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