Exhibit 10.39
Confidential treatment has been requested for portions of this document.
Brackets indicate portions of text that have been omitted. A separate filing
of such omitted text has been made with the Commission as part of the
Company's application for confidential treatment.
RESEARCH COLLABORATION AND LICENSE AGREEMENT (U.S.)
This Agreement is made and entered into this 7th day of March, 1997 by and
between BIOGEN, INC. (hereinafter referred to as "BIOGEN"), a Massachusetts
corporation located at 00 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000, and CV
THERAPEUTICS, INC., a Delaware corporation, located at 0000 Xxxxxx Xxxxx, Xxxx
Xxxx, XX 00000 (hereinafter referred to as "CVT").
WHEREAS, BIOGEN is a biopharmaceutical company which develops,
manufactures, markets and sells pharmaceutical products for human healthcare;
and
WHEREAS, CVT is the owner and/or exclusive licensee of certain technology,
patent rights and other proprietary know-how related to PRODUCTS as hereinafter
defined; and
WHEREAS, BIOGEN desires to obtain an exclusive right and license in and to
such technology, patent rights and proprietary know-how in the TERRITORY as
hereinafter defined; and
WHEREAS, BIOGEN desires to support additional research related to PRODUCTS;
and
WHEREAS, CVT is willing to grant the exclusive right and license desired by
BIOGEN and to participate in the conduct of research supported by BIOGEN; and
WHEREAS, CVT is granting an exclusive right and license in and to such
technology, patent rights and proprietary know-how outside the TERRITORY to
Biotech Manufacturing Limited ("BML") pursuant to a Research Collaboration and
License Agreement (Europe) of even date herewith (the "BML AGREEMENT") .
NOW, THEREFORE, in consideration of the mutual promises and other good and
valuable consideration, the parties agree as follows:
SECTION 1. DEFINITIONS.
The terms used in this Agreement have the following meaning:
1.1 The term "Adenosine A(1) Antagonist" shall mean a molecule that
[ * ] compound being referred to herein as a "Test Compound"), the
[ * ], and such Test Compound meets the following specifications measured
concurrently in a validated in vitro assay:
(I) [ * ]
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(II) [ * ]
Notwithstanding the foregoing, if CVT is able to establish in a model
reasonably acceptable to BIOGEN that the principal activity of a Test
Compound IN VIVO is as [ * ] such Test Compound shall be excluded from the
definition of Adenosine A(1) Antagonists.
1.2 The term "AFFILIATE" as applied to either party shall mean any
company or other legal entity other than the party in question, in whatever
country organized, controlling, controlled by or under common control with
that party. The term "control" means ownership or control, directly or
indirectly, of at least fifty percent (50%) of the outstanding stock or
voting rights or the right to elect or appoint a majority of the directors.
1.3 The term "first AGREEMENT YEAR" shall mean the twelve month period
commencing on the EFFECTIVE DATE. With respect to any year after the first
AGREEMENT YEAR, the term "AGREEMENT YEAR" shall mean the twelve month period
commencing upon an anniversary of the Effective Date.
1.4 The term "BIOGEN CVT-124 TECHNOLOGY" shall mean any information,
data (including all chemical, pharmacological, toxicological, clinical,
assay, manufacturing and control information, data and test results,
including negative results), ideas, concepts, formulas, trade secrets,
methods, procedures, designs, materials, compositions, plans, diagrams,
applications, specifications, techniques, records, practices, processes,
research, know-how, inventions, discoveries and the like first conceived and
first reduced to practice by BIOGEN or its AFFILIATES in the performance of
any of its work under or pursuant to this Agreement which are necessary or
useful for the manufacture or use of CVT-124 or other PRODUCTS.
1.5 The term "BIOGEN CVT-124 PATENTS" shall mean all patents and pending
patent applications (which for purposes of this Agreement shall be deemed to
include certificates of invention and applications for certificates of
invention and priority rights, provisional patent applications, statutory
invention registrations, applications for statutory invention registrations,
and any foreign equivalents thereof) owned by BIOGEN or its AFFILIATES
throughout the TERRITORY which claim the BIOGEN CVT-124 TECHNOLOGY or any
part thereof, including any provisional applications, substitutions,
extensions, reissues, reexaminations, renewals, continuations,
continuations-in-part, divisionals and supplemental protection certificates.
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1.6 The term "CALENDAR QUARTER" shall mean the period of three (3)
consecutive calendar months ending on March 31, June 30, September 30 or
December 31, as the case may be.
1.7 The term "CVT-124" shall mean the [ * ] of epoxy norbornyl
xanthine as defined as CVT-124 in the IND filed on September 20, 1995 and as
further described in U.S. Patent Application Serial No. [ * ].
1.8 The term "CVT PATENT RIGHT(S)" shall mean all patents and pending
patent applications (which for purposes of this Agreement shall be deemed to
include certificates of invention and applications for certificates of
invention and priority rights, provisional patent applications, statutory
invention registrations, applications for statutory invention registrations,
and any foreign equivalents thereof) throughout the TERRITORY that claim CVT
TECHNOLOGY or any part thereof, including any provisional applications,
substitutions, extensions, reissues, reexaminations, renewals, continuations,
continuations-in-part, divisionals and supplemental protection certificates,
which CVT owns (in whole or in part) or to which CVT otherwise has a
transferable right as of the EFFECTIVE DATE or at any time during the term of
this Agreement, including but not limited to CVT's rights in any RESEARCH
PATENT RIGHTS and CVT's rights obtained under the UFRFI LICENSE. CVT PATENT
RIGHTS as of the EFFECTIVE DATE are set forth in APPENDIX A hereto.
1.9 "CVT TECHNOLOGY" shall mean any information, data (including all
chemical, pharmacological, toxicological, clinical, assay, manufacturing and
control information, data and test results, including negative results),
ideas, concepts, formulas, trade secrets, methods, procedures, designs,
materials, compositions, plans, diagrams, applications, specifications,
techniques, records, practices, processes, research, know-how, inventions,
discoveries and the like which CVT owns (in whole or in part) or to which CVT
otherwise has a transferable right as of the EFFECTIVE DATE or at any time
during the term of this Agreement, which relate to CVT-124 or any other
Adenosine A(1) Antagonist, including but not limited to CVT's rights in the
RESEARCH INFORMATION, the RESEARCH MATERIALS and the RESEARCH INVENTIONS, and
CVT's rights under the UFRFI LICENSE.
1.10 The term "EFFECTIVE DATE" shall mean March 10, 1997.
1.11 The term "FTE" shall mean the equivalent of a full year of effort on
a full time basis of a scientist or other professional possessing skills and
experience necessary to carry out applicable tasks under the RESEARCH PROGRAM.
1.12 The term "FIRST COMMERCIAL SALE" shall mean the initial transfer by
BIOGEN or any of its AFFILIATES or SUBLICENSEES of a PRODUCT to a
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THIRD PARTY in exchange for consideration, following marketing approval by
the appropriate governmental agency for the country in which the transfer is
made.
1.13 The term "MAA" shall mean an application for regulatory approval to
sell PRODUCT in the European Union and similar in purpose to an NDA in the
United States.
1.14 The term "MAJOR MARKET" shall mean the United States.
1.15 The term "NDA" shall mean a New Drug Application or Product License
Application or equivalent filing filed for PRODUCT with the U.S. Food and
Drug Administration ("FDA").
1.16 The term "NDR" shall mean an application for regulatory approval to
sell PRODUCT in Japan and similar in purpose to an NDA in the United States.
1.17 The term "NET SALES" shall mean the [ * ] of BIOGEN and its
AFFILIATES with respect to the sale of PRODUCT, less:
(i) trade, quantity, cash or other discounts [ * ] allowed not
exceeding amounts customary in the trade, including, without limitation,
governmental program discounts and rebates (e.g., Medicaid, Medicare, VA,
etc.)
(ii) sales taxes, tariff duties and/or use taxes directly imposed
on and with reference to particular sales;
(iii) packing, transportation and insurance prepaid or allowed; and
(iv) amounts allowed or credited on rejects, returns or retroactive
price reductions.
A sale or transfer of PRODUCT by BIOGEN to an AFFILIATE for re-sale of
PRODUCT by such AFFILIATE shall not be considered a sale for the purpose of
this provision but the resale of PRODUCT by such AFFILIATE to a THIRD PARTY
shall be a sale for such purposes. A "sale" shall mean a transfer or other
disposition for consideration, but shall not include transfers or
dispositions at no cost for pre-clinical, clinical, regulatory or
governmental purposes or disposition of PRODUCT at no cost for promotional
purposes.
In the event that PRODUCT is sold in the form of a combination product
containing one or more active ingredients or components in addition to CVT-124
or, if applicable, another Adenosine A(1) Antagonist, NET SALES shall be
determined by multiplying NET SALES of the combination product (as defined by
reference to the
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standard NET SALES definition) during the applicable payment period by the
fraction A/A+B where A is the average sale price of PRODUCT when sold
separately in finished form and B is the average sale price of the other
active ingredients or components when sold separately in finished form in
each case during the applicable payment period in the country in which the
sale of the combination product was made, or if sales of both the PRODUCT and
the other active ingredients or components did not occur in such period, then
in the most recent payment period in which sales of both occurred. In the
event that such average sale price cannot be determined for both PRODUCT and
all other active ingredients or components included in the combination
product, NET SALES for purposes of determining payments under this Agreement
shall be calculated by multiplying the NET SALES of the combination product
by the fraction C/C+D where C is the fair market value of the CVT-124 (or
other Adenosine A(1) Antagonist) contribution to the combination and D is the
sum of the fair market values of all other active components or ingredients
included in the combination product, in each case, as determined by BIOGEN in
good faith.
1.18 The term "OPERATING COMMITTEE" shall have the meaning set forth in
Section 7.1 of this Agreement.
1.19 The term "PHASE II PERFORMANCE ASSESSMENT STUDY" shall mean a Phase
II study of intravenous CVT-124 in patients with [ * ] congestive heart
failure (CHF). The study will be designed to demonstrate as a primary
endpoint, [ * ] The study design may be optimized by BIOGEN as additional
data is gathered from other trials.
1.20 The term "PHASE III TRIAL" shall mean a randomized clinical trial
designed to show efficacy and safety of a PRODUCT and intended to be
submitted as part of the application for marketing approval of such PRODUCT.
1.21 The term "PRODUCT" shall mean any article, composition or material
that comprises, contains or is CVT-124 or another Adenosine A(1) Antagonist,
the manufacture, import, use or sale of which is covered by a VALID CLAIM of
the CVT PATENT RIGHTS or includes any of the CVT TECHNOLOGY.
1.22 The term "RESEARCH INFORMATION" shall mean any data, results,
formulas, process information or other information which results from the
RESEARCH PROGRAM.
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1.23 The term "RESEARCH INVENTION(S)" shall mean any invention, know-how,
method, process, use, article of manufacture, or composition of matter
conceived or first actually or constructively reduced to practice as part of
the RESEARCH PROGRAM or which results from the RESEARCH PROGRAM.
1.24 The term "RESEARCH MATERIAL" shall mean any material, reagent or
substance which results from the RESEARCH PROGRAM.
1.25 The term "RESEARCH PATENT RIGHT(S)" shall mean all patents and
patent applications throughout the TERRITORY that claim RESEARCH INFORMATION,
RESEARCH INVENTIONS or RESEARCH MATERIAL or any part thereof, including any
provisional applications, substitutions, extensions, reissues,
reexaminations, renewals, continuations, continuations-in-part, divisionals
and supplemental protection certificates, statutory invention registrations,
applications for statutory invention registrations, and any foreign
equivalents thereof.
1.26 The term "RESEARCH PLAN" shall mean the written descriptions of the
research and development to be performed by CVT as part of the RESEARCH
PROGRAM for the first AGREEMENT YEAR and for each subsequent AGREEMENT YEAR
of the RESEARCH PROGRAM as approved in accordance with Section 8.2.
1.27 The term "RESEARCH PROGRAM" shall have the meaning set forth in
Section 8.1 of this Agreement.
1.28 The term "SUBLICENSE INCOME" shall mean any royalties or other
consideration received by a party hereto from any SUBLICENSEES in respect of
sales of PRODUCTS, excluding amounts paid to such party for research or other
services conducted by such party, for clinical trials, for purchases of
PRODUCTS or of other goods or products at fair market value, or for equity
investments at fair market value in such party.
1.29 The term "SUBLICENSEE" shall mean any non-AFFILIATE third party
expressly licensed by BIOGEN to make, have made or formulate any PRODUCT and
to sell the PRODUCT made or formulated. A SUBLICENSEE shall not include a
distributor or other party licensed to sell PRODUCT but not to make, have
made or formulate PRODUCT.
1.30 The term "TERRITORY" shall mean the United States, including Puerto
Rico, Guam and all other territories of the United States, and all other
countries and territories in North America and South America.
6.
1.31 The term "THIRD PARTY(IES)" shall mean a person or entity who or
which is neither a party hereto nor an AFFILIATE or SUBLICENSEE of a party
hereto.
1.32 The term "UFRFI LICENSE" shall mean a certain License Agreement
dated as of June 27, 1994 by and between CVT and University of Florida
Research Foundation, Inc. ("UFRFI"), as amended.
1.33 The term "VALID CLAIM" shall mean (i) a claim of a pending patent
application which claim shall not have been canceled, withdrawn, abandoned or
rejected by an administrative agency from which no appeal can be taken and
which application shall not have been pending for more than [ * ] or (ii) a
claim of an issued and unexpired patent which has not lapsed or become
abandoned or been declared invalid or unenforceable by a court of competent
jurisdiction or an administrative agency from which no appeal can be or is
taken.
1.34 The use herein of the plural shall include the singular, and the use
of the masculine shall include the feminine.
SECTION 2. GRANT AND OTHER RIGHTS.
2.1 CVT hereby grants to BIOGEN and BIOGEN hereby accepts from CVT an
exclusive, royalty-bearing right and license under the CVT TECHNOLOGY and CVT
PATENT RIGHTS to make, have made, import, use, offer for sale and sell
PRODUCTS in the TERRITORY. CVT shall be responsible for paying any royalty
obligations which CVT may have to any THIRD PARTY under agreements between
CVT and such THIRD PARTIES in effect as of the EFFECTIVE DATE arising from
the exercise of the license grant set forth above.
2.2 (a) AFFILIATES. BIOGEN shall have the full and unrestricted right
to extend the license granted to it herein to AFFILIATES. BIOGEN shall
advise CVT of any such extension to AFFILIATES.
(b) SUBLICENSES. BIOGEN shall have the right to grant sublicenses
in the TERRITORY under the license granted to it herein in accordance with
the following:
BIOGEN shall have the full and unrestricted right to grant sublicenses at
any time after the [ * ] for such PRODUCT, but may not grant a sublicense
prior to that time.
BIOGEN agrees to forward to CVT a copy of any sublicense agreements
within thirty (30) days of the execution of such sublicense agreements and
further agrees to
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forward to CVT annually a copy of such reports received by BIOGEN from its
sublicensees during the preceding twelve (12) month period under the
sublicenses as shall be pertinent to a royalty accounting under said
sublicense agreements.
2.3 To the extent CVT PATENT RIGHTS or CVT TECHNOLOGY licensed to BIOGEN
under this Agreement are rights which CVT has licensed from UFRFI under the
UFRFI LICENSE, BIOGEN and CVT understand and agree that the rights licensed
to BIOGEN by CVT are subject to the terms of the UFRFI LICENSE.
SECTION 3. INTENTIONALLY OMITTED.
SECTION 4. MANUFACTURE AND SUPPLY OF PRODUCT; CONDUCT OF CLINICAL TRIALS;
TECHNOLOGY TRANSFER.
4.1 PRODUCT SUPPLY. BIOGEN and its AFFILIATES shall be responsible for
the manufacture and supply of PRODUCT hereunder for clinical trials and
commercial sales in the TERRITORY. Notwithstanding the foregoing, within
thirty (30) days of the Effective Date, CVT shall deliver to BIOGEN CVT's
existing inventory of CVT-124 as described in Appendix C, along with copies
of all quality control release test results and other relevant documentation
relating to such inventory. In addition, upon BIOGEN's request, CVT shall
[ * ] the manufacturing contract, dated December 2, 1996, between CVT and
the [ * ]
4.2 COLLABORATION. CVT's representatives on the OPERATING COMMITTEE
shall work with BIOGEN to establish programs to optimize the chemical
manufacturing process for PRODUCT.
4.3 CLINICAL PROGRAMS. BIOGEN will, at its sole expense, be responsible
for the worldwide design and conduct of all pre-clinical, clinical,
development and regulatory work under this Agreement for PRODUCTS being
developed for sale hereunder and under the BML AGREEMENT, with input from CVT
through its representation on the OPERATING COMMITTEE and the Strategy
Committee. Notwithstanding the foregoing, CVT shall lead the protocol design
and selection of key investigators for the following clinical studies which
are in the planning stages as of the Effective Date, subject to BIOGEN's
guidance and right of final approval:
(i) Phase II clinical trial of intravenous CVT-124 for [ * ]
(ii) Phase II clinical trial of intravenous CVT-124 for protection
against [ * ] at BIOGEN's option; and
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(iii) Phase I [ * ] study.
Protocols for the above clinical trials shall be approved by the
OPERATING COMMITTEE, as defined below, as soon as possible after the
Effective Date.
4.4 TRANSFER OF CVT TECHNOLOGY. From and after the Effective Date, CVT
shall make available sufficient personnel and resources to accomplish the
swift and orderly transfer of copies and/or samples, as the case may be, of
all CVT Technology to Biogen.
4.5 [ * ] REGULATORY FILINGS. CVT [ * ] all INDs and other regulatory
filings relating to CVT-124. CVT shall promptly deliver copies of such
filings to BIOGEN and [ * ] of such filings. CVT and BIOGEN shall
cooperate in [ * ] in such a way as not to harm either CVT's or BIOGEN's
relationship with the relevant regulatory authorities. To that end, BIOGEN
may elect to have one or more of CVT's employees participate in meetings
between BIOGEN and regulatory authorities [ * ] CVT's regulatory filings.
4.6 CLINICAL CONTRACTS, TRANSFER OF CLINICAL DATABASE. The transition of
planning for the conduct of planned clinical trials of CVT-124 shall proceed
in accordance with Appendix B. If BIOGEN elects to enter into contracts with
the parties with whom CVT has been negotiating, whether or not upon the terms
previously negotiated by CVT, CVT shall provide its full cooperation, as
requested by BIOGEN. CVT shall, within five (5) days after the EFFECTIVE
DATE, provide BIOGEN with a full and complete copy, including all raw data,
of [ * ] In addition, upon BIOGEN's request, CVT shall provide to BIOGEN
all of the original Case Report Forms from such study.
SECTION 5. DUE DILIGENCE.
5.1 PRODUCT DEVELOPMENT. BIOGEN shall use commercially reasonable
efforts to develop and market a PRODUCT, which efforts shall be at least
commensurate with those efforts undertaken in BIOGEN's own internal programs
with the same profit potential and risk.
5.2 [ * ] BIOGEN shall use commercially reasonable efforts
to develop a PRODUCT for [ * ] which efforts shall be at least
commensurate with those efforts undertaken in BIOGEN's own internal programs
with the same profit potential and risk. Subject to technical and regulatory
delays, BIOGEN will use commercially reasonable efforts to meet the following
development timeline:
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(I) Within [ * ] of the successful completion of a [ * ] BIOGEN
shall [ * ]
(II) Within [ * ] of commencing [ * ] BIOGEN shall commence a
Phase I trial of such PRODUCT; and
(III) Within [ * ] of the successful completion of [ * ]
BIOGEN shall make its decision to commence a [ * ] of such PRODUCT.
Provided that BIOGEN has used commercially reasonable efforts as
aforesaid, failure to meet the foregoing timeline shall not constitute a
breach of this Agreement, or result in any limitation on the licenses and
rights granted to BIOGEN pursuant to this Agreement.
5.3 STATUS REPORTS. Within sixty (60) days of the end of each calendar
year during the term hereof, BIOGEN shall provide to CVT a written report
summarizing the status of BIOGEN's development efforts hereunder and the
results of the prior year's efforts.
SECTION 6. CONFIDENTIALITY AND INFORMATION.
6.1 During the term of this Agreement, it is contemplated that each
party may disclose to the other, proprietary and confidential technology,
inventions, technical information, material, reagents, biological materials
and the like which are owned or controlled by the party providing such
information or which that party is obligated to maintain in confidence
("Confidential Information"). Each party shall have the right to refuse to
accept the other party's Confidential Information. Each party agrees not to
disclose and to maintain the Confidential Information of the other party in
strict confidence, to cause all of its agents, representatives and employees
to maintain the disclosing party's Confidential Information in confidence and
not to disclose any such Confidential Information to a third party without
the prior written consent of the disclosing party and not to use such
Confidential Information for any purpose other than as licensed under this
Agreement.
6.2 The obligations of confidentiality will not apply to information
which:
(i) was known to the receiving party or generally known to the
public prior to its disclosure hereunder through no fault of the receiving
party or any agent, representative or employee thereof; or
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(ii) subsequently becomes known to the public by some means other
than a breach of this Agreement, including publication and/or laying open to
inspection of any patent applications or patents;
(iii) is subsequently disclosed to the receiving party by a third
party having a lawful right to make such disclosure and who is not under an
obligation of confidentiality to the disclosing party;
(iv) is approved for release by the parties.
6.3 The obligations of Section 6.1 notwithstanding, BIOGEN may disclose
the Confidential Information of CVT licensed to BIOGEN hereunder (a) to
SUBLICENSEES and (b) to THIRD PARTIES who (i) need to know the same in order
to secure regulatory approval for the sale of PRODUCT, (ii) who need to know
the same in order to work towards the commercial development of PRODUCT or to
manufacture PRODUCT, or (iii) who are approved by CVT, provided that such
parties, other than regulatory authorities, are bound by obligations of
confidentiality and non-use at least as stringent as those set forth herein.
Further, either party may disclose Confidential Information of the other
party to the extent such disclosure is required by law, rule, regulation or
bona fide legal process to be disclosed, provided that the receiving party
takes all reasonable steps to restrict and maintain confidentiality of such
disclosure and provides reasonable notice to the disclosing party.
6.4 CVT shall provide to BIOGEN, or if required to the applicable
regulatory authority, all documents and information, to the extent in CVT's
possession or otherwise reasonably accessible to CVT with the right to
disclose, requested by the regulatory authority or reasonably requested by
BIOGEN in support of BIOGEN's regulatory submissions. Copies of all
documents provided directly to a regulatory authority shall be provided to
BIOGEN in advance, if practicable, or otherwise within [ * ] of
delivery to the regulatory authority. In addition, CVT shall provide to
BIOGEN any information, to the extent in CVT's possession or otherwise
reasonably accessible to CVT with the right to disclose, related to PRODUCT
that is (a) reasonably required in support of BIOGEN's applications to patent
offices and such governmental offices as regulate the price of PRODUCT and/or
(b) reasonably required to support a legal action by BIOGEN against a THIRD
PARTY.
6.5 Neither party may disclose the existence or terms of this Agreement
without the prior written consent of the other party; provided, however, that
either party may make such disclosure to the extent required by law. The
parties have approved an initial press release as set forth in APPENDIX D
attached hereto. Once any written statement is approved for disclosure by both
parties, either party may make
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subsequent public disclosure of the contents of such statement without the
further approval of the other party.
SECTION 7. GOVERNANCE.
7.1 OVERALL RESPONSIBILITY.
(a) Overall direction of the parties' strategic alliance under this
Agreement and the BML AGREEMENT will be provided by an Oversight Committee
consisting of an equal number of senior management representatives from each
party. The Oversight Committee will meet on an ad hoc basis during the term
of this Agreement to monitor the overall performance of the collaboration
hereunder and to resolve any disputes which may arise regarding the operation
of the collaboration, such resolution to be within a reasonable period of
time under the relevant circumstances, in any event not to exceed [ * ]
(b) The following committees shall also be established under this
Agreement as set forth below.
(i) the OPERATING COMMITTEE; and
(ii) the Strategy Committee.
7.2 OPERATING COMMITTEE. An OPERATING COMMITTEE (a/k/a, the "CVT-124
Development Team") shall be established by BIOGEN to manage the worldwide
development of PRODUCTS. The activities of the RESEARCH PROGRAM, described
hereinafter in Section 8, will also be overseen and monitored by the
OPERATING COMMITTEE.
(a) MEMBERSHIP. Within ten (10) days of the date hereof, CVT shall
designate up to [ * ] representatives to serve on the OPERATING COMMITTEE.
Additional representatives of CVT may attend OPERATING COMMITTEE meetings on
an as needed basis with the prior approval of BIOGEN, such approval not to be
unreasonably withheld. CVT will have the right to change its representation
on the OPERATING COMMITTEE upon written notice to BIOGEN. BIOGEN
representatives on the OPERATING COMMITTEE shall include representatives of
all relevant line functions, as determined by BIOGEN.
(b) CHAIR. The OPERATING COMMITTEE chair (a/k/a "Program
Executive") shall be designated by BIOGEN.
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(c) RESPONSIBILITIES. The OPERATING COMMITTEE will have authority to
take and perform all actions necessary to accomplish its responsibilities,
including but not limited to, authority to:
(i) oversee and manage the day-to-day development of PRODUCTS;
(ii) oversee the RESEARCH PROGRAM, and monitor performance
thereunder;
(iii) coordinate programs to optimize the chemical
manufacturing process;
(iv) review and propose RESEARCH PLANS and budgets; and
(v) review any and all proposed publications or communications
relating to the RESEARCH PROGRAM and the results therefrom, in accordance with
the procedure set forth in Section 8.
(d) MEETINGS. The OPERATING COMMITTEE will meet not less than
monthly. Meetings will be held at BIOGEN's premises or such other place as may
be mutually agreed upon. CVT representatives may participate in person or by
telephone. In the event of disagreement, [ * ]
7.3 STRATEGY COMMITTEE. A Strategy Committee will be established which
will meet as needed to set worldwide clinical, regulatory and marketing
strategies for PRODUCTS. CVT may designate up to four (4) representatives
who may participate in meetings of the Strategy Committee in person or by
telephone. Additional representatives of CVT may attend Strategy Committee
meetings on an as needed basis with the prior approval of BIOGEN, such
approval not to be unreasonably withheld. In the event of disagreement,
[ * ]
SECTION 8. RESEARCH PROGRAM.
8.1 OBJECT. CVT shall conduct a program of research in accordance with
annual RESEARCH PLANS established in accordance with Section 8.2 (the
"RESEARCH PROGRAM"). The objectives of the RESEARCH PROGRAM shall be first
to [ * ] of CVT-124, and thereafter to explore [ * ] CVT-124, to
identify [ * ] CVT agrees to conduct and manage
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the RESEARCH PROGRAM pursuant to the RESEARCH PLAN and BIOGEN agrees to support
such RESEARCH PROGRAM at CVT in accordance with the terms and conditions set
forth below.
8.2 (a) DEFINITION OF PHASES OF RESEARCH PROGRAM. The RESEARCH
PROGRAM shall be divided into two phases. Phase 1 of the RESEARCH PROGRAM
shall begin with the EFFECTIVE DATE and end at such time that a [ * ] by
either party. Phase 2 of the RESEARCH PROGRAM shall commence after the
completion of Phase 1 and continue for as long as the RESEARCH PROGRAM is in
effect.
(b) CONDUCT OF PHASE 1 OF THE RESEARCH PROGRAM. The RESEARCH PLAN
and budget for Phase 1 of the RESEARCH PROGRAM is attached hereto as Appendix
E. CVT will use commercially reasonable efforts to perform the RESEARCH
PLAN for Phase 1 of the RESEARCH PROGRAM in accordance with the agreed-upon
schedule and budget contained in Appendix E. Such budget includes the number
of FTEs to be devoted to the RESEARCH PROGRAM during each AGREEMENT YEAR
during Phase 1 (at [ * ] per FTE), together with a breakdown of any other
fees and expenses to be incurred, and totals [ * ] per year.
(c) CONDUCT OF PHASE 2 OF THE RESEARCH PROGRAM. The RESEARCH
PLAN and budget for Phase 2 of the RESEARCH PROGRAM shall be approved by the
parties at least ninety (90) days prior to the beginning of Phase 2 and at
least ninety (90) days prior to the beginning of each AGREEMENT YEAR
commencing during Phase 2. CVT will use commercially reasonable efforts to
perform the RESEARCH PLAN during Phase 2 of the RESEARCH PROGRAM in
accordance with the agreed-upon schedule and budget.
(d) EXCHANGE OF INFORMATION AND REPORTS. To further the efforts of
the parties under this Agreement, CVT shall promptly disclose to BIOGEN any
RESEARCH INVENTIONS arising out of the RESEARCH PROGRAM, but in any event
within [ * ] for potentially patentable, significant RESEARCH INVENTIONS,
and within [ * ] of the end of each CALENDAR QUARTER for all others. CVT
shall keep BIOGEN and the OPERATING COMMITTEE reasonably informed of its
progress in the RESEARCH PROGRAM and shall deliver reasonably detailed
written progress reports to BIOGEN semi-annually.
(e) VISITATION. For the purpose of facilitating the parties
understanding of the research and development activities conducted hereunder,
CVT will permit duly authorized employees or representatives of BIOGEN to
visit its facilities where the
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14.
RESEARCH PROGRAM activities are conducted, at reasonable times and with
reasonable notice, subject to appropriate confidentiality provisions.
8.3 SOURCE OF FUNDS. During the term of the RESEARCH PROGRAM as
specified in Section 8.5, CVT will dedicate [ * ]
in each AGREEMENT YEAR from the proceeds of BML's equity investments in CVT
to be made pursuant to the BML AGREEMENT to support the conduct of the
RESEARCH PROGRAM at CVT. Such funds shall be utilized solely for performance
of the RESEARCH PROGRAM in accordance with the approved budget.
8.4 REPORTS [ * ]. Xxxxxx Xxxxx 0 of the RESEARCH PROGRAM, CVT shall
prepare annual financial reports of actual and budgeted expenditures under
the RESEARCH PROGRAM. BIOGEN [ * ] provided under the BML AGREEMENT for
Phase 1 of the RESEARCH PROGRAM in accordance with the approved budget. The
[ * ] in any report from CVT, in which case [ * ]
8.5 TERM AND TERMINATION OF THE RESEARCH PROGRAM. The term of the
RESEARCH PROGRAM will be the first three (3) AGREEMENT YEARS. BIOGEN shall
be entitled to terminate the RESEARCH PROGRAM and BML shall be entitled to
cease funding thereof in the event of termination of this Agreement or in the
event of a breach by CVT of any of CVT's material obligations in the RESEARCH
PROGRAM following written notice of such breach to CVT. If such breach is
not cured within [ * ] after written notice is given by BIOGEN to CVT
specifying the breach, BIOGEN may terminate the RESEARCH PROGRAM without
terminating the entire Agreement and BML may cease funding of the RESEARCH
PROGRAM forthwith upon written notice to CVT after expiration of such [ * ]
In the event BIOGEN terminates the RESEARCH PROGRAM as provided above, BIOGEN
may, at its option, require CVT to repurchase from BML shares of CVT Common
Stock sold to BML pursuant to the BML AGREEMENT, [ * ] in an amount equal
to [ * ] less the amount of CVT's actual expenditures incurred during the
AGREEMENT YEAR prior to such termination of the RESEARCH PROGRAM. In
addition to BIOGEN's right to terminate the RESEARCH PROGRAM for breach as
provided above, either BIOGEN or CVT may terminate the RESEARCH PROGRAM
without terminating the entire Agreement upon [ * ] written notice
delivered prior to the commencement of the second AGREEMENT YEAR or the third
AGREEMENT YEAR; provided, however, that notwithstanding the foregoing, CVT
may not terminate the RESEARCH PROGRAM prior to the end of Phase 1 of the
RESEARCH PROGRAM.
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15.
8.6 THIRD PARTY SUPPORT CVT shall not apply any of the funding provided
by BML under the BML AGREEMENT for Phase 1 of the RESEARCH PROGRAM towards
R&D to be conducted in whole or in part by a THIRD PARTY without BIOGEN's
approval, such approval not to be unreasonably withheld or delayed. CVT may
apply any of the funding provided by BML under the BML AGREEMENT for Phase 2
of the RESEARCH PROGRAM towards R&D to be conducted in whole or in party by a
THIRD PARTY provided that BIOGEN has approved in advance the form of
agreement to be used in contracting with such THIRD PARTY, such approval not
to be unreasonably withheld or delayed.
8.7 CONFIDENTIALITY. In order to facilitate the operation of the
RESEARCH PROGRAM, either party may disclose confidential or proprietary
information owned or controlled by it to the other. It is hereby understood
and agreed that such information shall be treated in accordance with Section
6 hereof.
8.8 RESULTS OF THE RESEARCH PROGRAM.
(a) All right, title and interest in and to any RESEARCH
INFORMATION, RESEARCH INVENTIONS and RESEARCH MATERIAL (the "RESULTS"), and
any RESEARCH PATENT RIGHTS based thereon, conceived and reduced to practice
solely by employees or agents of CVT shall be owned solely by CVT ("CVT
RESULTS"), subject to the licenses granted to BIOGEN under Section 2 hereof
and the licenses granted to BML under Section 2 of the BML AGREEMENT. All
right, title and interest in or to any RESULTS and any RESEARCH PATENT RIGHTS
based thereon, conceived and reduced to practice solely by employees or
agents of BIOGEN shall be owned solely by BIOGEN. All right, title and
interest in and to any RESULTS and any RESEARCH PATENT RIGHTS based thereon
conceived and reduced to practice by employees or agents of CVT and employees
or agents of BIOGEN shall be owned jointly by CVT and BIOGEN ("JOINT
RESULTS"), with CVT's ownership interest therein being subject to the
licenses granted to BIOGEN under Section 2 hereof and the licenses granted to
BML under Section 2 of the BML AGREEMENT. Invention, conception and reduction
to practice of RESEARCH INVENTIONS, RESEARCH INFORMATION, RESEARCH MATERIALS,
and RESEARCH PATENT RIGHTS shall be determined in accordance with United
States intellectual property laws.
(b) There will be no publication of the RESULTS by CVT, or any
employee of CVT unless the OPERATING COMMITTEE has reviewed the proposed
scientific publication concerning the RESULTS and each party has consented in
writing to the publication, which review shall be conducted within [ * ] of
submission of the proposed publication to the OPERATING COMMITTEE, and which
approval shall not be unreasonably withheld or delayed. CVT will, upon
request of
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16.
BIOGEN, delay publication for up to [ * ] to allow for the filing
of patent applications incorporating RESULTS.
(c) Notwithstanding any provision in this Agreement and/or the BML
AGREEMENT to the contrary, BIOGEN shall have no rights pursuant to Section 2
hereof, and BML shall have no rights pursuant to Section 2 of the BML
AGREEMENT to any compounds developed in the RESEARCH PROGRAM that are not
Adenosine A(1) Antagonists ("Non- A(1) Compounds"). With respect to such
Non- A(1) Compounds, BIOGEN shall have a right of first refusal as follows:
CVT shall give written notice to BIOGEN specifying in reasonable detail the
rights and data, including preclinical data establishing IN VIVO activity,
relating to Non-A(1) Compounds that CVT has developed (the "Offer"). BIOGEN
shall have [ * ] after the date of the Offer to provide a written response
to CVT (the "Response") as to whether or not BIOGEN wishes to enter into
negotiations with CVT with respect to such rights. If the Response states
that BIOGEN wishes to enter into negotiations with CVT, the parties shall
negotiate in good faith the licensing of such rights for a period of [ * ]
from the date of the Response. If BIOGEN declines to enter into negotiations
or if the parties do not agree upon and execute a written agreement within
the [ * ] negotiation period, CVT shall deliver to BIOGEN in writing its
last best offer for licensing such rights. BIOGEN shall have [ * ] from
receipt of CVT's last best offer to accept such offer in writing. If BIOGEN
declines to accept CVT's last best offer, CVT shall thereafter have the right
to negotiate with third parties with respect to such rights; provided,
however, that the terms of any such definitive agreement with any third party
shall not be more favorable to the third party than CVT's last best offer to
BIOGEN. The foregoing BIOGEN rights shall terminate [ * ] after the end of
the RESEARCH PROGRAM.
SECTION 9. PATENTS.
9.1 (a) CVT shall promptly advise BIOGEN, in writing, of each potentially
patentable or otherwise potentially useful RESEARCH INVENTION arising from the
RESEARCH PROGRAM. Representatives of CVT and BIOGEN shall then discuss whether
a patent application or applications pertaining to such RESEARCH INVENTION
should be filed and in which countries. The titles, serial numbers and other
identifying data of patent applications claiming a RESEARCH INVENTION to which
BIOGEN is granted rights hereunder and filed after the EFFECTIVE DATE by mutual
agreement of CVT and BIOGEN, or by BIOGEN alone pursuant to the last sentence of
this section or pursuant to subsection (c) hereof, shall be added to APPENDIX A
of this Agreement and to Appendix A of the BML AGREEMENT and CVT's interest
therein shall become CVT PATENT RIGHTS for purposes of both this Agreement and
the BML AGREEMENT. CVT shall file, prosecute and maintain patent applications
and patents worldwide relating to such CVT RESULTS as the parties agree
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17.
hereunder, [ * ] through patent counsel selected by CVT and reasonably
acceptable to BIOGEN, except as provided in subsection (c) below. BIOGEN
shall have the opportunity to provide substantive review and comment on any
such filing, prosecution and or maintenance and the rights as set forth in
Section 9.2 below. In the event CVT declines to prepare, file, prosecute or
maintain a patent application on a RESEARCH INVENTION, then BIOGEN may
prepare, file, prosecute and maintain such patent application, in which
events [ * ] after the date of its election to assume responsibility for
such patent application.
(b) BIOGEN shall, as of the EFFECTIVE DATE, assume responsibility
to prepare, file, prosecute and maintain patent applications and patents
worldwide relating to CVT PATENT RIGHTS identified on Appendix A as of the
EFFECTIVE DATE and relating to JOINT RESULTS, and [ * ] related thereto.
Notwithstanding the foregoing, CVT shall maintain CVT PATENT RIGHTS for a
period of 6 weeks from the EFFECTIVE DATE and shall cooperate fully in the
orderly transfer to BIOGEN's patent counsel of all files and necessary powers
of attorney related to such CVT PATENT RIGHTS within 4 weeks from the
EFFECTIVE DATE. BIOGEN shall also have the option pursuant to subsection (a)
above to prepare, file, prosecute and maintain patent applications and
patents worldwide relating to CVT RESULTS that CVT declines to file,
prosecute and/or maintain, and shall have the option under subsection (c)
below.
(c) BIOGEN shall have the option, commencing at such time as a
PRODUCT to which RESEARCH PATENT RIGHTS relate enters human clinical trials,
to assume CVT's responsibility to file, prosecute and maintain patent
applications and patents worldwide relating to such RESEARCH PATENT RIGHTS in
which events [ * ] after the date of its election to assume control of such
RESEARCH PATENT RIGHTS.
(d) The term "Patent Costs" shall mean all reasonable [ * ]
incurred for the filing, prosecution, issuance, and maintenance of the
identified CVT PATENT RIGHTS, but not including the costs of any opposition
or interference proceedings, which shall [ * ] BIOGEN shall use patent
counsel selected by BIOGEN and reasonably acceptable to CVT. CVT shall have
the opportunity to provide substantive review and comment on any such filing,
prosecution and or maintenance and the rights as set forth in Section 9.2
below.
(e) Notwithstanding anything in this Section 9.1 to the contrary,
BIOGEN may, at its discretion, elect to discontinue financial support of any
patent
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18.
application for which it is providing support under this Agreement, provided,
however, that BIOGEN will notify CVT of its intention at least sixty (60)
days prior to taking such action. In any country in which BIOGEN has elected
to discontinue its support of any patent application, CVT, upon receiving
notice, may elect at its own expense to assume all financial responsibility
for the prosecution of such patent application; provided, however, that if
CVT obtains issuance of any such patent application, BIOGEN shall reimburse
CVT for such expenses. BIOGEN's determination to [ * ] with respect to such
patent application pursuant to [ * ] hereof or pursuant to [ * ] of the
BML AGREEMENT.
9.2 With respect to any CVT PATENT RIGHTS, all substantive communication
to or from the United States Patent and Trademark Office or its equivalent in
any other jurisdiction, including, but not limited to, each patent
application, office action, response to office action, amendment,
restriction, election, request for terminal disclaimer, and request for
reissue or reexamination of any patent issuing from such application, as well
as any intention to discontinue prosecution or financial support of any
patent or patent applications shall be provided to BIOGEN or CVT, as the case
may be, by the party controlling the prosecution or maintenance sufficiently
prior to the filing of such document to allow for review and comment by
BIOGEN or CVT, respectively. However, BIOGEN and CVT shall have the right to
take any action that in its judgment is necessary to preserve such CVT
PATENT RIGHTS for which it is responsible. Both parties shall cooperate
fully to facilitate the preparation, filing, prosecution and maintenance of
CVT PATENT RIGHTS. Notwithstanding anything herein to the contrary, neither
BIOGEN nor CVT shall abandon a CVT PATENT RIGHT or allow a CVT PATENT RIGHT
to lapse without first giving the other notice of such intention at least
[ * ] prior to the date on which such CVT PATENT RIGHT will lapse or become
abandoned. BIOGEN or CVT shall have the right to assume the prosecution,
maintenance and defense of any CVT PATENT RIGHT which the other intends to
abandon. If this Agreement terminates for any reason, BIOGEN shall
immediately thereafter transfer to CVT control of the prosecution and
maintenance of all CVT PATENT RIGHTS and original copies of all documents
relating to such CVT PATENT RIGHTS in the possession or control of BIOGEN.
9.3 (a) If any of the CVT PATENT RIGHTS under which BIOGEN is licensed
hereunder, or under which BML is licensed under the BML AGREEMENT, is
infringed by a THIRD PARTY's manufacture, import, use, sale or offer to sell
of CVT-124 or another Adenosine A(1) Antagonist, or a product comprising or
containing CVT or another Adenosine A(1) Antagonist, BIOGEN shall have the
right and option but not the obligation to bring an action for infringement,
at its sole expense, against such THIRD PARTY in the name of CVT or its
licensors and/or in the name of BIOGEN,
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19.
and to join CVT or its licensors, at BIOGEN's expense, as a party plaintiff
if required or if it would promote the success of the litigation. Each party
shall promptly notify the other party of any such infringement. BIOGEN shall
keep CVT informed as to the prosecution of any action for such infringement.
No settlement, consent judgment or other voluntary final disposition of the
suit which adversely affects CVT PATENT RIGHTS may be entered into without
the consent of CVT, which consent shall not unreasonably be withheld.
(b) In the event that BIOGEN shall undertake the enforcement and/or
defense of the CVT PATENT RIGHTS by litigation as provided above any recovery
of damages by BIOGEN for any such suit shall be applied first in satisfaction
of any unreimbursed expenses and legal fees of BIOGEN relating to the suit.
The balance remaining from any such recovery shall [ * ] considering where
the infringing sales were made.
(c) In the event that, and only if, BIOGEN specifically elects not
to pursue an action for infringement, CVT (or its licensor) shall have the
right and option, but not the obligation at its cost and expense to initiate
infringement litigation and [ * ]
(d) In any infringement suit either party may institute to enforce
the CVT PATENT RIGHTS pursuant to this Agreement, the other party hereto
shall, at the request of the party initiating such suit, cooperate in all
respects and, to the extent possible, have its employees testify when
requested and make available relevant records, papers, information, samples,
specimens, and the like. All reasonable out-of-pocket costs incurred in
connection with rendering cooperation requested hereunder shall be paid by
the party requesting cooperation.
SECTION 10. COMPENSATION.
10.1 (a) As consideration for research and development already performed
by CVT with respect to PRODUCTS, upon execution of this Agreement, BIOGEN
shall pay to CVT a non-creditable, non-refundable payment in the amount of
Five Million Dollars ($5,000,000).
(b) Upon execution of this Agreement, BIOGEN shall pre-pay the
[ * ] required to be paid upon the successful completion of a [ * ]
pursuant to Section 10.3(a)(ii). In the event the planned [ * ] of CVT-124
is unsuccessful [ * ] Biogen shall notify CVT in writing, whereupon CVT
shall refund to Biogen such pre-paid milestone within
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20.
thirty (30) days. If Biogen shall thereafter successfully complete a [ * ]
with another PRODUCT, Biogen shall pay the milestone as provided in Section
10.3(a)(ii).
10.2 (a) BIOGEN shall pay to CVT royalties on NET SALES of PRODUCTS in the
TERRITORY ("Royalties") as follows:
(i) Royalties payable to CVT on NET SALES of PRODUCTS in the
TERRITORY shall be [ * ] and determined based on worldwide annual NET
SALES (i.e., including NET SALES of PRODUCTS under the BML AGREEMENT) in each
calendar year in accordance with the following table:
[ * ] Annual Net Sales Royalty
------------------------------------------
Up to [ * ] Million [ * ]
[ * ] Million to [ * ] Million [ * ]
Over [ * ] Million [ * ]
(ii) Notwithstanding subparagraph (i) above, in the event there
are two consecutive twelve month periods in which worldwide NET SALES exceed
[ * ] Million but are less than [ * ] Million, then, unless subparagraph
(iii) applies, Royalties shall thereafter be determined based on annual
worldwide NET SALES in any subsequent calendar year in accordance with the
following table:
[ * ] Annual Net Sales Royalty
------------------------------------------
Up to [ * ] Million [ * ]
[ * ] Million to [ * ] Million [ * ]
(iii) Notwithstanding subparagraph (ii), if at any time after
paragraph (ii) applies worldwide NET SALES exceed [ * ] Million for one
full twelve month period or are less than [ * ] Million for one full twelve
month period, the Royalties owed on NET SALES shall thereafter be determined
in accordance with subparagraph (i), regardless of the subsequent annual
overall levels of NET SALES.
(iv) Royalties shall be payable under this Agreement solely for
PRODUCT sold in the TERRITORY. However, for the purposes of determining the
applicable [ * ] royalty rate, worldwide annual NET SALES shall be deemed
to include NET SALES under both this Agreement and the BML AGREEMENT.
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21.
(b) Notwithstanding the foregoing, if the use or sale of PRODUCT by
BIOGEN or its AFFILIATES in the country in which the PRODUCT is sold is not
covered by a VALID CLAIM of a CVT PATENT RIGHT in such country, the Royalties
payable with respect to NET SALES in such country shall be [ * ] of the
amounts otherwise due pursuant to Section 10.2(a) above; PROVIDED, however,
that if, in any such country, any one or more THIRD PARTY(S) is/are selling
a generic version of the PRODUCT being sold by BIOGEN or its AFFILIATES and
such THIRD PARTY(S)' sales of such generic product exceeds [ * ] of
BIOGEN's sales of the PRODUCT in such country, the Royalties in such country
shall be reduced to [ * ] during such period of generic sales.
(c) The obligation to pay Royalties for each PRODUCT shall continue
on a country-by-country and product-by-product basis until the last to expire
VALID CLAIM of the CVT PATENT RIGHTS in such country covering such PRODUCT;
provided, however, that in any country in which there is no such VALID CLAIM,
the obligation to pay Royalties shall continue only until the expiration of
[ * ] from the FIRST COMMERCIAL SALE of such PRODUCT in such country
by BIOGEN or its AFFILIATES or SUBLICENSEES.
(d) (i) In the event that after the EFFECTIVE DATE BIOGEN becomes
obligated to pay any royalties or other sums to THIRD PARTIES because the
manufacture, use or sale of CVT-124 or another Adenosine A(1) Antagonist
contained in a PRODUCT sold by BIOGEN hereunder in the TERRITORY infringes
such THIRD PARTIES' intellectual property rights, then BIOGEN shall be
entitled to credit [ * ] of any such obligations against
Royalties due to CVT pursuant to this Section 10.2.
(ii) In the event that after the EFFECTIVE DATE BIOGEN becomes
obligated to pay any royalties or other sums to THIRD PARTIES because the
manufacture, use or sale of a PRODUCT sold by BIOGEN hereunder in the
TERRITORY infringes such THIRD PARTIES' intellectual property rights on
account of a fact other than [ * ] then the matter shall be referred to the
Oversight Committee to determine in good faith whether or not BIOGEN shall be
entitled to a credit of up to [ * ] of any such obligations against
Royalties due to CVT pursuant to this Section 10.2. In the event the
Oversight Committee cannot agree within forty-five (45) days after referral
of the matter to them for resolution, then the [ * ] representatives to the
Oversight Committee shall [ * ]
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22.
(iii) In no event shall any credits under subsections (d)(i)
and (d)(ii), or any cost-sharing pursuant to subsection (e) below, reduce
Royalties payable to CVT hereunder for any CALENDAR QUARTER by more than [ * ]
of the amounts otherwise due. [ * ]
(e) In the event that [ * ] of CVT-124 identified during Phase 1
of the RESEARCH PROGRAM results in [ * ] (including, but not limited to,
any cost to BIOGEN of [ * ] as compared to what it would have been using
[ * ] CVT-124 in the [ * ] BIOGEN and CVT agree to negotiate a [ * ] and
[ * ] to reflect a [ * ] BIOGEN may initiate any such negotiation by
delivering a written notice to CVT, whereupon the relevant representatives
of the parties on the OPERATING COMMITTEE parties shall meet and negotiate a
reduction as aforesaid in good faith. In the event the OPERATING COMMITTEE
representatives cannot agree within thirty (30) days of delivery of such
notice by BIOGEN, the matter shall be referred to the OVERSIGHT COMMITTEE for
resolution. In the event the representatives to the OVERSIGHT COMMITTEE
cannot agree within fifteen (15) days of referral of the matter to them for
resolution, the matter shall be submitted to binding arbitration pursuant to
the provisions of Appendix F hereof.
(f) NET SALES of PRODUCT in a country in the TERRITORY for which
BIOGEN has no royalty obligation, pursuant to Section 10.2(c), shall not be
included in the calculation of the level of NET SALES for purposes of Section
10.2(a).
(g) In addition to the foregoing, CVT shall receive a percentage of
BIOGEN's SUBLICENSE INCOME in accordance with this subsection (g).
(i) In MAJOR MARKET countries, CVT shall receive [ * ] of
SUBLICENSE INCOME, subject to the following floors and cap. For sublicenses
executed prior to the [ * ] in no event shall CVT receive less than [ * ]
of net sales of SUBLICENSEES (calculated using the NET SALES definition) for
any PRODUCTS covered by a VALID CLAIM of CVT PATENT RIGHTS in the country in
which they are sold. For sublicenses executed after [ * ] for such
PRODUCT, in no event shall CVT receive pursuant to this
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23.
subsection less than [ * ] of net sales of SUBLICENSEES (calculated using the
NET SALES definition) for any PRODUCTS covered by a VALID CLAIM of CVT PATENT
RIGHTS in the country in which they are sold. Notwithstanding the foregoing,
if the use or sale of PRODUCT by a SUBLICENSEE in the country in which the
PRODUCT is sold is not covered by a VALID CLAIM of a CVT PATENT RIGHT in such
country, the minimum percentages set forth in the previous two sentences
shall be [ * ] respectively. In no event shall CVT receive pursuant to
this subsection an amount greater than the Royalties which would have been
due pursuant to this Section 10.2 on NET SALES of SUBLICENSEES if such NET
SALES had been made by BIOGEN.
(ii) In non-MAJOR MARKET countries, CVT shall receive [ * ]
of SUBLICENSE INCOME, subject to the following floors and cap. In no event
shall CVT receive pursuant to this subsection less than [ * ] of net sales
of SUBLICENSEES (calculated using the NET SALES definition) for any PRODUCTS
covered by a VALID CLAIM of CVT PATENT RIGHTS in the country in which they
are sold. Notwithstanding the foregoing, if the use or sale of PRODUCT by a
SUBLICENSEE in the country in which the PRODUCT is sold is not covered by a
VALID CLAIM of a CVT PATENT RIGHT in such country, the minimum percentage set
forth in the previous sentence shall be [ * ] In no event shall CVT receive
pursuant to this subsection an amount greater than the Royalties which would
have been due pursuant to this Section 10.2 on NET SALES of SUBLICENSEES if
such NET SALES had been made by BIOGEN.
(h) CVT hereby grants BIOGEN the right to [ * ] on sales of
PRODUCT by BIOGEN, BML, their AFFILIATES and SUBLICENSEES; provided that if
CVT also desires to [ * ] BIOGEN and CVT shall [ * ] In the event BIOGEN is
successful in [ * ] on such sales, the royalties otherwise payable by
BIOGEN to CVT hereunder, and the royalties otherwise payable by BML to CVT
under the BML AGREEMENT, shall be [ * ] and the royalties otherwise payable
by CVT to BIOGEN pursuant to Section 14.8 hereof, and by CVT to BML pursuant
to the corresponding provision of the BML AGREEMENT, shall be [ * ]
provided that CVT shall share in the benefits of any such [ * ] in an
amount commensurate with [ * ]
10.3 (a) BIOGEN shall pay the following amounts within [ * ]
of the occurrence of the following milestone events with respect to the first
PRODUCT to reach such milestone:
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24.
Milestone Amount
--------- ------
(i) [ * ] [ * ]
(ii) [ * ] [ * ]
(iii) [ * ] [ * ]
(iv) [ * ] [ * ]
(v) [ * ] [ * ]
(vi) [ * ] [ * ]
(vii) [ * ] [ * ]
(viii) [ * ] [ * ]
(ix) [ * ] [ * ]
(x) [ * ] [ * ]
* Provided that BIOGEN has not given notice of termination of this
Agreement prior to expiration of such [ * ] period.
** [ * ] shall be determined by Biogen's decision to commence [ * ] with
respect to such chemical entity. Biogen has pre-paid this milestone in
anticipation of the successful completion of a [ * ] study with CVT-124,
pursuant to Section 10.1(e) hereof.
(b) In the event BIOGEN does not [ * ] and this
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25.
Agreement has not been terminated, and (i) [ * ] planning or ongoing and
(ii) no material health or safety issue has arisen with respect to the
clinical use of PRODUCT, BIOGEN will pay CVT the related milestone fee as set
forth in Section 10.3(a)(iii) above as if it had reached such milestone at
such time, but such milestone payment shall not be due thereafter when a
[ * ] is actually commenced. In the event that any material health or
safety issue arises with respect to PRODUCT, BIOGEN shall nevertheless
continue to use commercially reasonable efforts to develop a PRODUCT.
(c) In the event BIOGEN has not [ * ] of the notice of decision
by BIOGEN to commence [ * ] of a PRODUCT in the United States, and this
Agreement has not been terminated, BIOGEN will nevertheless pay CVT the
related milestone set forth in Section 10.3(a)(vii) above in advance as if it
had reached such milestone at such time, but such milestone shall not be due
thereafter when such [ * ]
10.4 BIOGEN shall keep, and shall cause each of its AFFILIATES to keep,
full and accurate books of account containing all particulars relevant to its
sales of PRODUCTS that may be necessary for the purpose of calculating all
compensation payable to CVT hereunder. Such books of account shall be kept
at their principal place of business and for the three (3) years next
following the end of the calendar year to which each shall pertain, be open
for inspection by an independent certified public accountant reasonably
acceptable to BIOGEN, upon reasonable notice during normal business hours at
CVT's expense for the sole purpose of verifying compensation due under this
Agreement. In the event the inspection determines that compensation due CVT
for any period has been underpaid by [ * ] or more, then BIOGEN shall pay
for all costs of the inspection, otherwise the costs of the inspection shall
be borne by CVT. In all cases, BIOGEN shall pay to CVT any underpaid
compensation promptly and CVT shall promptly pay to BIOGEN any overpaid
compensation. All information and data reviewed in the inspection shall be
used only for the purpose of verifying compensation due and shall be treated
as BIOGEN Confidential Information subject to the obligations of this
Agreement. No audit by an agent of CVT shall occur more frequently than once
during any twelve (12) month period.
10.5 In each year the amount of compensation due shall be calculated
quarterly as of the end of each CALENDAR QUARTER and shall be paid quarterly
within the [ * ] days next following such date, unless such CALENDAR
QUARTER is the last CALENDAR QUARTER of the year, in which case the
compensation due shall be paid within [ * ] days next following such date.
Every such payment shall be supported by the accounting prescribed in Section
10.6 and shall be made in United States currency. Whenever for the purpose
of calculating compensation, conversion
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26.
from any foreign currency shall be required, such conversion shall be at the
rate of exchange published in The Wall Street Journal for the last business
day of the CALENDAR QUARTER.
10.6 With each quarterly payment, BIOGEN shall deliver to CVT a full and
accurate accounting to include at least the following information:
(a) Total xxxxxxxx for PRODUCT subject to Royalty;
(b) Deductions applicable as provided in Section 1.17;
(c) Applicable royalty rates (including any credits as provided in
Section 10.2(b) or (d));
(d) SUBLICENSEE income and royalties thereon; and
(e) Total compensation payable to CVT.
10.7 If the transfer of or the conversion into United States Dollars of
any remittance due hereunder is not lawful or possible in any country, such
remittance shall be made by the deposit thereof in the currency of the
country to the credit and account of CVT or its nominee in any commercial
bank or trust company located in that country, prompt notice of which shall
be given to CVT. CVT shall be advised in writing in advance by BIOGEN and
provide to BIOGEN a nominee, if so desired.
10.8 Any tax required to be withheld by BIOGEN under the laws of any
foreign country for the account of CVT, shall be promptly paid by BIOGEN for
and on behalf of CVT to the appropriate governmental authority, and BIOGEN
shall use its best efforts to furnish CVT with proof of payment of such tax.
Any such tax actually paid on CVT's behalf shall be deducted from royalty
payments due CVT.
10.9 Compensation shall be due and payable for the manufacture, use and
sale of an individual PRODUCT only once with respect to the same unit of
PRODUCT irrespective of the number of patents or claims thereof which cover
the manufacture, use and sale of such PRODUCT. In no event shall
compensation shall be due and payable hereunder for the manufacture, use or
sale of an individual PRODUCT for which CVT receives compensation in the way
of royalties under the BML AGREEMENT.
SECTION 11. REPRESENTATIONS AND WARRANTIES.
11.1 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; and (iii) it has taken all
corporate action necessary to authorize the
27.
execution and delivery of this Agreement and the performance of its
obligations under this Agreement.
11.2 (a) Each party represents that it is not aware of any action, suit,
inquiry or investigation or any claim, demand or notice of default which if
adversely determined would affect the rights granted under this Agreement.
(b) Each party acknowledges that in entering into this Agreement
the other party has relied upon information supplied by the disclosing party,
including, in the case of information supplied by CVT, data and information
concerning CVT-124 and preclinical and clinical studies and information
related to CVT PATENT RIGHTS. Neither party is aware of any data or
information given to the other party which is untrue or inaccurate or of any
other data or information which is necessary to make the data and information
provided to the other party complete and not misleading. To the best of
CVT's knowledge, [ * ]
11.3 CVT hereby represents, warrants and covenants to BIOGEN that:
(a) It is the [ * ] under this Agreement and has the right and
has taken all necessary action to [ * ] provided that the foregoing shall
not be interpreted as a warranty of non-infringement;
(b) To the best of CVT's knowledge, CVT has disclosed to BIOGEN all
facts that CVT reasonably believes to be [ * ] known to CVT as of the
EFFECTIVE DATE;
(c) All patent applications included in CVT PATENT RIGHTS existing
as of the Effective Date are pending and have not been abandoned;
(d) CVT [ * ] to BIOGEN pursuant to this Agreement.
(e) CVT will not take any action that would in any way prevent CVT
from granting the rights granted to BIOGEN under this Agreement with respect
to CVT PATENT RIGHTS or CVT TECHNOLOGY acquired after the EFFECTIVE DATE or
which would otherwise [ * ] BIOGEN under this Agreement. Nothing herein
shall prohibit the amendment or modification of the scope of claims during
the patent prosecution process.
--------------------------
* Confidential treatment requested.
28.
(f) CVT has [ * ]
(g) CVT will take all actions required by it to maintain its rights
under the UFRFI LICENSE as in effect on the EFFECTIVE DATE, and shall
immediately send to BIOGEN any notice of default or breach received by CVT
under the UFRFI LICENSE.
(h) All employees of CVT who perform research and development for
CVT in connection with CVT's obligations under this Agreement are required to
assign their rights in any intellectual property arising from such work to
CVT.
(i) Appendix A contains a complete and accurate list of all CVT
PATENT RIGHTS in existence as of the EFFECTIVE DATE.
(j) CVT will not enforce any patent rights owned or controlled by
it to prevent the manufacture, use or sale of any PRODUCT for which BIOGEN
has a royalty obligation to CVT hereunder subject to the license granted
herein by BIOGEN or its AFFILIATES or SUBLICENSEES, or any person or entity
purchasing a PRODUCT from any of them.
11.4 CVT represents that it has not as of the EFFECTIVE DATE [ * ] the
manufacture, use or sale of PRODUCT and it is not aware of any infringement
by a THIRD PARTY of the CVT PATENT RIGHTS.
SECTION 12. INDEMNIFICATION.
12.1 INDEMNIFICATION BY BIOGEN. BIOGEN will defend, indemnify and hold
harmless CVT, its AFFILIATES and their employees, agents, officers,
shareholders and directors and each of them (the "CVT Indemnified Parties")
from and against any and all third party claims, causes of action and costs
(including reasonable attorney's fees) of any nature made or lawsuits or
other proceedings filed or otherwise instituted against the CVT Indemnified
Parties resulting from or arising out of the manufacture, use or sale of any
PRODUCT by BIOGEN, its AFFILIATES or SUBLICENSEES, other than those claims
which result or arise from breach of this Agreement by CVT or failure by CVT
to comply in any material respect with applicable laws or regulations or the
negligence or willful misconduct of CVT or any its AFFILIATES or any of their
employees, agents, officers, shareholders or directors.
--------------------------
* Confidential treatment requested.
29.
12.2 INDEMNIFICATION BY CVT. CVT will defend, indemnify and hold
harmless BIOGEN, its AFFILIATES and their employees, agents, officers,
shareholders and directors and each of them (the "BIOGEN Indemnified
Parties") from and against any and all third party claims, causes of action
and costs (including reasonable attorney's fees) of any nature made or
lawsuits or other proceedings filed or otherwise instituted against any of
the BIOGEN Indemnified Parties resulting from or arising out of breach of
this Agreement by CVT or failure of CVT to comply in any material respect
with applicable laws or regulations or the negligence or willful misconduct
of CVT or its AFFILIATES or any of their employees, agents, officers,
shareholders or directors.
12.3 CONDITIONS TO INDEMNIFICATION. A person or entity that intends to
claim indemnification under this Section (the "Indemnitee") shall promptly
notify the indemnifying 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 this Section 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 this Section, 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 this Section. The Indemnitee under this Section, its
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.
SECTION 13. ASSIGNMENT; SUCCESSORS.
13.1 This Agreement shall not be assignable by either of the parties
without the prior written consent of the other party (which consent shall not
be unreasonably withheld), except that BIOGEN without the consent of CVT may
assign this Agreement or any of its rights and obligations hereunder to an
AFFILIATE or to an entity with which BIOGEN shall merge or consolidate or to
which BIOGEN shall sell or assign all or substantially all of its assets, and
except that CVT without the consent of BIOGEN
30.
may assign this Agreement to an entity with which CVT shall merge or
consolidate or to which CVT shall sell or assign all or substantially all of
its assets.
13.2 Subject to the limitations on assignment herein, this Agreement
shall be binding upon and inure to the benefit of said successors in interest
and assigns of CVT and BIOGEN.
SECTION 14. TERMINATION.
14.1 Except as otherwise specifically provided herein and unless sooner
terminated pursuant to Sections 14.2, 14.3, 14.4 or 14.9 of this Agreement,
this Agreement and the licenses and rights granted hereunder shall remain in
full force and effect until BIOGEN's obligations to pay compensation
hereunder terminate. Upon expiration of BIOGEN's obligation to pay
compensation hereunder with respect to a specific country and specific
PRODUCT as to which BIOGEN's license is then in effect, the license granted
to BIOGEN with respect to such country and such PRODUCT pursuant to Section
2.1 shall be deemed to be fully paid and BIOGEN shall thereafter have a
royalty-free right to use the CVT PATENT RIGHTS and CVT TECHNOLOGY and to
make, use, import and sell such PRODUCT in such country.
14.2 Upon breach of any material provisions of this Agreement by either
party to this Agreement, in the event the breach is not cured within [ * ]
days after written notice to the breaching party by the other party, in
addition to any other remedy it may have, the other party at its sole option
may terminate this Agreement, provided that such other party is not then in
breach of this Agreement.
14.3 Either party to this Agreement may, upon giving notice of
termination, immediately terminate this Agreement upon receipt of notice that
the other party has become insolvent or has suspended business in all
material respects hereof, or has consented to an involuntary petition
purporting to be pursuant to any reorganization or insolvency law of any
jurisdiction, or has made an assignment for the benefit of creditors or has
applied for or consented to the appointment of a receiver or trustee for a
substantial part of its property; provided, however, that the insolvency or
bankruptcy of CVT shall not operate to terminate the licenses granted to
BIOGEN hereunder unless BIOGEN elects to terminate the Agreement as provided
herein, and BIOGEN may elect to retain its licenses as provided in 11 U.S.C.
Section 356.
14.4 In addition to the foregoing, within [ * ] days of BIOGEN's
receipt of the data from the [ * ] BIOGEN may terminate this Agreement upon
written notice in its sole discretion. At any time after [ * ] BIOGEN may
terminate this Agreement for any reason upon [ * ] days prior written
notice to CVT.
--------------------------
* Confidential treatment requested.
31.
14.5 Upon any termination of this Agreement, all licenses and rights
granted to BIOGEN shall terminate forthwith, except that BIOGEN shall be
entitled to, but shall not be obligated [ * ] covered by this Agreement
which exists as of the date of the termination, so long as BIOGEN [ * ] in
accordance with the same terms and conditions as set forth in this Agreement.
14.6 The obligations of Sections 6 and 12, as well as Sections 14.5,
14.6, 14.7, 14.8, 15.4, and 15.8 and the repayment obligation under the
Note(s) shall survive any termination of this Agreement.
14.7 In the event of any termination under Section 14.4 or 14.9 or in the
event CVT terminates this Agreement pursuant to Sections 14.2 or 14.3, BIOGEN
shall grant to CVT a non-exclusive, worldwide, royalty-bearing license under
[ * ] and [ * ] solely to make, have made, import, use and sell PRODUCTS
and shall make available to CVT copies of all documents containing or
comprising such [ * ] and [ * ] CVT shall [ * ] BIOGEN in making such
[ * ] and [ * ] available to CVT. Furthermore, in the event that, at the
time of termination under Section 14.4 or 14.9 or of termination by CVT
pursuant to Sections 14.2 or 14.3, [ * ] funding for such [ * ] unless
[ * ] Upon such termination the [ * ] shall, to the extent permissible by
law, be [ * ] To this end, BIOGEN agrees that upon such termination it
shall [ * ] relating to CVT-124 and for [ * ] by CVT hereunder. BIOGEN
shall promptly deliver copies of such filings to CVT and execute any and all
documents and instruments reasonably requested by CVT to confirm the
assignment of such filings. CVT and BIOGEN shall cooperate in the transition
of BIOGEN's regulatory filings to CVT in such a way as not to harm either
CVT's or BIOGEN's relationship with the relevant regulatory authorities. To
that end, CVT may elect to have one or more of BIOGEN's employees participate
in meetings between CVT and regulatory authorities regarding assignment of
BIOGEN's regulatory filings.
14.8 In the event that, following any termination of this Agreement, CVT,
or its permitted successor or assignee, subsequently commercializes a PRODUCT
by itself or in conjunction with a THIRD PARTY, CVT, or its permitted
successor or assignee,
--------------------------
* Confidential treatment requested.
32.
shall pay a royalty to BIOGEN on sales of PRODUCT in the TERRITORY in
accordance with the following:
(a) If the Agreement has been terminated prior to receipt by CVT of
the [ * ] milestone payable in accordance with Section 10.3(a)(i) hereof
[ * ] and the manufacture, use or sale of the commercialized PRODUCT is
covered by a VALID CLAIM of the BIOGEN CVT-124 PATENTS or includes any of the
BIOGEN CVT-124 TECHNOLOGY, CVT shall pay BIOGEN royalties on net sales of
PRODUCT and a percentage of CVT'S SUBLICENSE INCOME as follows:
(i) Royalties payable to BIOGEN shall be [ * ] and
determined based on worldwide annual net sales (calculated in accordance with
the NET SALES definition set forth in Section 1.17 hereof, and including NET
SALES under the BML AGREEMENT) in each calendar year in accordance with the
following table:
[ * ] Annual Net Sales Royalty
-----------------------------------------------
Up to [ * ] Million [ * ]
[ * ] Million to [ * ] Million [ * ]
Over [ * ] Million [ * ]
(ii) CVT shall pay to BIOGEN [ * ] of SUBLICENSE INCOME
received by it from sublicensees. Prior to calculation of Biogen's [ * ]
CVT may deduct from SUBLICENSE INCOME any royalty paid by CVT to [ * ] on
account of sales of PRODUCT in the TERRITORY in such period.
(b) If the Agreement has been terminated after receipt by CVT of
the [ * ] but prior to completion of a [ * ] of the PRODUCT, CVT shall
pay BIOGEN royalties on net sales of PRODUCT and a percentage of SUBLICENSE
INCOME as follows:
(i) Royalties payable to BIOGEN shall be [ * ] and
determined based on worldwide annual net sales (calculated in accordance with
the NET SALES definition set forth in Section 1.17 hereof, and including NET
SALES under the BML AGREEMENT) in each calendar year in accordance with the
following table:
--------------------------
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33.
[ * ] Annual Net Sales Royalty
-----------------------------------------------
Up to [ * ] Million [ * ]
[ * ] Million to [ * ] Million [ * ]
Over [ * ] Million [ * ]
(ii) CVT shall pay to BIOGEN [ * ] of SUBLICENSE INCOME
received by it from sublicensees. Prior to calculation of Biogen's [ * ]
share, CVT may deduct from SUBLICENSE INCOME any royalty paid by CVT to
[ * ] on account of sales of PRODUCT in the TERRITORY in such period.
(c) If the Agreement has been terminated after completion of a
[ * ] of the PRODUCT, but prior to the availability of [ * ] CVT shall
pay BIOGEN royalties on net sales of PRODUCT and a percentage of SUBLICENSE
INCOME as follows:
(i) Royalties payable to BIOGEN shall be [ * ] and
determined based on worldwide annual net sales (calculated in accordance with
the NET SALES definition set forth in Section 1.17 hereof, and including NET
SALES under the BML AGREEMENT) in each calendar year in accordance with the
following table:
[ * ] Annual Net Sales Royalty
-----------------------------------------------
Up to [ * ] Million [ * ]
[ * ] Million to [ * ] Million [ * ]
Over [ * ] Million [ * ]
(ii) CVT shall pay to BIOGEN [ * ] of SUBLICENSE INCOME
received by it from sublicensees. Prior to calculation of Biogen's [ * ]
share, CVT may deduct from SUBLICENSE INCOME any royalty paid by CVT to
[ * ] on account of sales of PRODUCT in the TERRITORY in such period.
(d) If the Agreement has been terminated after the availability of
[ * ] of the PRODUCT, CVT shall pay BIOGEN royalties on net sales of
PRODUCT and a percentage of SUBLICENSE INCOME as follows:
--------------------------
* Confidential treatment requested.
34.
(i) Royalties payable to BIOGEN shall be [ * ] and
determined based on worldwide annual net sales (calculated in accordance with
the NET SALES definition set forth in Section 1.17 hereof, and including NET
SALES under the BML AGREEMENT) in each calendar year in accordance with the
following table:
[ * ] Annual Net Sales Royalty
-----------------------------------------------
Up to [ * ] Million [ * ]
[ * ] Million to [ * ] Million [ * ]
Over [ * ] Million [ * ]
(ii) CVT shall pay to BIOGEN [ * ] of SUBLICENSE INCOME
received by it from sublicensees. Prior to calculation of Biogen's [ * ]
share, CVT may deduct from SUBLICENSE INCOME any royalty paid by CVT to
[ * ] on account of sales of PRODUCT in the TERRITORY in such period.
(e) In the event that after the EFFECTIVE DATE CVT becomes
obligated to pay any royalties or other sums to THIRD PARTIES because the
manufacture, use or sale of PRODUCTS in the TERRITORY infringes the
intellectual property rights of such THIRD PARTIES, CVT shall be entitled to
credit [ * ] of any such obligations against Royalties due to BIOGEN
pursuant to this Section 14.8; provided, however, that in no event shall such
credit reduce Royalties payable to BIOGEN hereunder for any CALENDAR QUARTER
by more than [ * ] of the amounts otherwise due. [ * ]
(f) CVT shall keep full and accurate books of account containing
all particulars relevant to its sales of PRODUCTS that may be necessary for
the purpose of calculating all compensation payable to BIOGEN hereunder, and
shall be subject to the same provisions as are contained in Section 10.4
hereof.
(g) All payments due to BIOGEN pursuant to this Section 14.8 shall
be made in accordance with Sections 10.5, 10.6 (excluding the section
references therein), 10.7 and 10.8 hereof, in each case substituting CVT for
BIOGEN as appropriate, and vice versa.
14.9 This Agreement shall automatically terminate upon the termination of
the BML AGREEMENT.
--------------------------
* Confidential treatment requested.
35.
SECTION 15. GENERAL PROVISIONS.
15.1 Neither party shall be liable to the other party for damages or loss
occasioned by failure of performance by the defaulting party if the failure
is occasioned by war, fire, explosion, flood, strike or lockout, embargo, or
any similar cause beyond the control of the defaulting party, provided that
the party claiming this exception has exerted all reasonable efforts to avoid
or remedy such event and provided such event does not extend for more than
six (6) months.
15.2 The relationship between CVT and BIOGEN is that of independent
contractors. CVT and BIOGEN are not joint venturers, partners, principal and
agent, master and servant, employer or employee, and have no relationship
other than as independent contracting parties. CVT shall have no power to
bind or obligate BIOGEN in any manner. Likewise, BIOGEN shall have no power
to bind or obligate CVT in any manner.
15.3 This Agreement and the BML AGREEMENT set forth the entire agreement
and understanding between the parties as to the subject matter hereof and
supersede all prior agreements in this respect. There shall be no amendments
or modifications to these Agreements, except by a written document which is
signed by both parties.
15.4 This Agreement shall be construed and enforced in accordance with
the laws of the State of Delaware, U.S.A. without reference to its
choice-of-law principles.
15.5 The headings in this Agreement have been inserted for the
convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular or section or paragraph.
15.6 Any delay in enforcing a party's rights under this Agreement or any
waiver as to a particular default or other matter shall not constitute a
waiver of a party's right to the future enforcement of its rights under this
Agreement, excepting only as to an expressed written and signed waiver as to
a particular matter for a particular period of time.
15.7 In conducting any activities under this Agreement or in connection
with the manufacture use or sale of PRODUCT, BIOGEN shall comply with all
applicable laws and regulations including, but not limited to, all Export
Administration Regulations of the United States Department of Commerce.
15.8 NOTICES. Any notices given pursuant to this Agreement shall be in
writing and shall be deemed delivered upon the earlier of (i) when received
at the address set forth below, or (ii) three (3) business days after mailed
by certified or registered mail
36.
postage prepaid and properly addressed, with return receipt requested, or
(iii) when sent, if sent, by facsimile, as confirmed by certified or
registered mail. Notices shall be delivered to the respective parties as
indicated:
If to CVT: CV Therapeutics, Inc.
0000 Xxxxxx Xxxxx
Xxxx Xxxx, XX 00000
Attn: CEO
with a copy to: Cooley Godward LLP
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
Attn: Xxxxxx X. Xxxxx, Esq.
Xxxxxxx Xxxxxxxx, Esq.
If to BIOGEN: Biogen, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attn: President
with a copy to Vice President - General Counsel
15.9 This Agreement may be executed in any number of separate
counterparts, each of which shall be deemed to be an original, but which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date set forth above.
CV THERAPEUTICS, INC. BIOGEN, INC.
By: /s/ Xxxxx Xxxxx By: /s/ Xxxxx X. Xxxxx
-------------------------------- --------------------------------
Name: Xxxxx Xxxxx Name: Xxxxx X. Xxxxx
------------------------------ ------------------------------
Title: CEO Title: President and CEO
----------------------------- -----------------------------
37.
APPENDIX A
PATENT RIGHTS
[SEE ATTACHED]
U. S. PATENTS
Docket No./ Issue Date/ Patent
Patent No. Serial No. Title Inventor(s) Date File Expires
--------------------------------------------------------------------------------------------------------------------
[ * ]
[ * ]
--------------------------
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1
U.S. PENDING PATENT APPLICATIONS
Docket No./
Serial No. Descriptive Title Inventor(s) Date Filed Status
------------------------------------------------------------------------------------------------------------
[ * ]
[ * ]
--------------------------
* Confidential treatment requested.
2
U.S. PENDING PATENT APPLICATIONS (CONT'D)
Docket No./
Serial No. Descriptive Title Inventor(s) Date Filed Status
----------------------------------------------------------------------------------------------------------------
[ * ]
--------------------------
* Confidential treatment requested.
[ * ]
3
U.S. PENDING PATENT APPLICATIONS (CONT'D)
Docket No./
Serial No. Descriptive Title Inventor(s) Date Filed Status
-------------------------------------------------------------------------------------------------------------
[ * ]
[ * ]
--------------------------
* Confidential treatment requested.
4
U.S. PENDING PATENT APPLICATIONS (CONT'D)
Docket No./
Serial No. Descriptive Title Inventor(s) Date Filed Status
----------------------------------------------------------------------------------------------------------------
[ * ]
[ * ]
--------------------------
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5
FOREIGN PATENT APPLICATIONS
Docket No./
Serial No. Descriptive Title Inventor(s) Date Filed Status
------------------------------------------------------------------------------------------------------------------------------
[ * ]
--------------------------
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6
FOREIGN PATENT APPLICATIONS (CONT'D)
Docket No./
Serial No. Descriptive Title Inventor(s) Date Filed Status
-------------------------------------------------------------------------------------------------------------------------------
[ * ]
--------------------------
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7
APPENDIX B
CLINICAL TRANSITION
This Appendix shall govern the transition of the conduct of clinical trials
for CVT-124 from CVT to BIOGEN. In the event of any inconsistencies between
this Appendix and the provisions of the Agreement, the provisions of this
Appendix shall govern.
A. [ * ] In the interest of avoiding any
delay in the commencement of such study, BIOGEN and CVT agree as follows:
CVT has entered into contracts with [ * ] and a [ * ] prior to the
EFFECTIVE DATE for the conduct of CVT2123, true and correct copies of which
have been provided to BIOGEN. CVT is in the process of negotiating the
remaining contracts necessary for the conduct of CVT2123, but shall not enter
into any such contracts without the prior approval of BIOGEN. Promptly after
the EFFECTIVE DATE, BIOGEN and CVT shall enter into a contract pursuant to
which CVT agrees INTER ALIA to manage the study pursuant to the direction of,
and for the sole and exclusive benefit of, BIOGEN and agrees to assign
exclusively to BIOGEN all rights and data from the study, and BIOGEN agrees
to reimburse CVT for [ * ] Such amounts shall be paid net thirty (30) days
on CVT's invoices submitted at the end of each quarter. Said agreement shall
also provide for [ * ] as is necessary to comply with applicable law for so
long as [ * ] In no event shall [ * ]
Notwithstanding the provisions of Section 4.1 of the Agreement, CVT shall
directly supply all materials needs for CVT2123. Delivery of any inventory
of CVT-124 not needed for CVT2123 shall be made to BIOGEN in accordance with
Section 4.1.
B. ALL OTHER CLINICAL STUDIES. Notwithstanding Section 4.3 of the
Agreement, CVT shall not enter into any contracts, or make any commitments to
any THIRD PARTIES, with respect to any other clinical studies. In the event
that CVT does enter into any such contracts, or make any such commitments,
BIOGEN shall not be bound by such contracts or commitments, and all
responsibility therefor shall remain with CVT.
--------------------------
* Confidential treatment requested.
The provisions of the second sentence of Section 4.3 of the Agreement are
solely for the benefit of BIOGEN and shall not confer upon CVT any rights
with respect the design, conduct or results of any clinical studies.
APPENDIX C
CVT-124 INVENTORY
[See attached]
CVT-124 INVENTORY
---------------------------------------------------------------------
PRODUCT CURRENT STOCK
---------------------------------------------------------------------
[ * ]
--------------------------
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APPENDIX D
PRESS RELEASE
[See attached]
CONTACT
Xxxxx Xxxxxxxx
Chief Financial Officer
CV Therapeutics
000-000-0000
Biogen Media Contact:
Xxxxxxx X. Xxxxx
Director of Communications
Biogen, Inc.
000-000-0000
Biogen Investment Community Contact:
Xxxxxxx E.N. Xxxxxxxx
Manager, Investor Relations
Biogen, Inc.0000-000-0000
BIOGEN AND CV THERAPEUTICS ANNOUNCE COLLABORATION ON CVT-124
FOR CONGESTIVE HEART FAILURE
CAMBRIDGE, MA (March 10, 1997) -- Biogen, Inc. (NASDAQ/BGEN) and CV
Therapeutics (NASDAQ/CVTX) today announced that they have signed an agreement
to collaborate on the development of CVT-124, a novel therapeutic for the
treatment of edema associated with Congestive Heart Failure (CHF) that is
expected to enter a multi-center Phase II clinical trial within the next
month.
Under the terms of the agreement, Biogen and its wholly owned subsidiary,
Biotech Manufacturing Limited, will receive exclusive worldwide rights to
develop and sell CVT-124. Biogen and CV Therapeutics will participate in
developing the drug, but Biogen will pay all costs of commercializing the
product. CV Therapeutics will receive from Biogen upfront payments totaling
$16 million, including a $5 million upfront cash payment, a $7 million equity
investment of CV Therapeutics stock at $10.45 per share, advance funding of a
development milestone and partial access to a line of credit. In addition,
Biogen will pay CV Therapeutics significant milestone payments and royalties
on clinical progress and product sales. Further details of the agreement
were not announced.
Congestive Heart Failure is a chronic, progressive disease that affects
approximately four-to-five million people in the United States. Its
prevalence is increasing at 10 percent per year, primarily
due to the aging population as well as improved survival in heart disease
patients. Patients with CHF experience both a chronic course of the disease,
as well as acute episodes that, in many cases, require hospitalization.
Edema, or fluid retention in the lungs and extremities, is a significant
symptom of the disease, leading to increased morbidity and need for
hospitalization. In its most severe form, CHF results in a 50 percent
one-year mortality rate.
CVT-124, a highly selective adenosine A(1)-receptor antagonist, could
represent a novel therapy for the treatment of edema associated with CHF.
Proof of this new mechanism of action has been demonstrated both in animal
models and in a clinical Phase I study completed in 1996. This new approach
could be a significant advance because current therapies can lead to clinical
resistance and unwanted side effects, such as potassium loss and impairment
of kidney function. Because of some of its potential properties, CVT-124 may
be particularly useful in CHF patients who are resistant to current therapies
and/or have renal impairment.
Xxx Xxxxx, Biogen's President and Chief Executive Officer, said, "Developing
Biogen's pipeline is a major strategic imperative for the Company, and we are
pleased to be collaborating with CV Therapeutics to help meet this objective.
CVT-124 represents a very promising commercial opportunity to enter an
underserved market with a late-stage therapeutic. We believe CVT-124, with
its novel mechanism of action, may have a major impact in the treatment and
management of Congestive Heart Failure. It is a very attractive fit with
Biogen's strategy of developing therapeutics for large underserved markets,
such as neurological, cardiovascular and renal diseases."
Xxx Xxxxx, Chairman and Chief Executive Officer of CV Therapeutics, said, "In
Biogen, we believe we have found partner for CVT-124 who can bring the
product to market quickly and with whom we can work closely on development of
this promising compound. Biogen's outstanding performance in commercializing
AVONEX-TM- gives us confidence that they will maximize the potential of
CVT-124."
In addition to historical information, this press release contains
forward-looking statements that involve risks and uncertainties that could
cause actual results to differ materially from those reflected in such
forward-looking statements. Reference is made in particular to
forward-looking statements regarding the timing of clinical trials, the
potential results of drug development and the commercial opportunity for
CVT-124. Drug development involves a high degree of risk. There are many
factors which could cause actual results to differ from the Company's current
expectations, including the Company's ability to demonstrate that CVT-124 is
safe and effective at each stage of the clinical trial process; to meet
applicable regulatory standards and receive required regulatory approval; to
obtain and maintain necessary patents and licenses; to be capable of
producing the product in commercial quantities at reasonable costs and to
compete successfully against other products.
Biogen, Inc., headquartered in Cambridge, MA, is a biopharmaceutical company
principally engaged in discovering and developing drugs for human healthcare
through genetic engineering. The Company's revenues are generated from U.S.
sales of AVONEX-TM- (Interferon beta-1a) for treatment of relapsing forms of
multiple sclerosis and from the worldwide sales by licenses of a
number of products, including alpha interferon and hepatitis B vaccines and
diagnostic products. Biogen is focused primarily on developing and testing
novel products for multiple sclerosis, inflammatory, respiratory and kidney
diseases and certain viruses and cancers. For copies of press releases and
additional information about the Company, please consult Biogen's Homepage on
the World Wide Web at xxxx://xxx.xxxxxx.xxx.
CV Therapeutics, headquartered in Palo Alto, CA, is a biopharmaceutical
company focused exclusively on the application of molecular cardiology to the
discovery, development and commercialization of novel, small molecule drugs
for the treatment of cardiovascular diseases.
# # #
030796
s.97draft.cvt
APPENDIX E
RESEARCH PLAN - PHASE 1
[SEE ATTACHED]
RESEARCH PROGRAM
OBJECTIVE
[ * ]
STRUCTURE OF COLLABORATION
[ * ]
PROGRAM PRIORITIES
[ * ]
APPROACH
[ * ]
RESOURCE ALLOCATION AT [ * ] PER FULL TIME EQUIVALENT (FTE)
[ * ]
--------------------------
* Confidential treatment requested.
[LOGO] THERAPEUTICS
RESEARCH
[ * ]
--------------------------
* Confidential treatment requested.
APPENDIX F
ARBITRATION PROCEDURE
In the event of a disagreement between the parties under Section 10.2(e) of
the Agreement, which disagreement cannot be amicably resolved by the good
faith efforts of the parties pursuant to such Section 10.2(e), then such
dispute shall be resolved by binding Alternative Dispute Resolution ("ADR")
in the manner described below:
(a) If a party intends to begin the ADR to resolve the disagreement,
such party shall provide written notice to the other party informing the
other party of such intention. Within 5 business days following the receipt
of the original ADR notice ("Notice Date") a neutral shall be selected by the
then President of the American Arbitration Association ("AAA") or by such
other individual as the parties may agree in good faith. The neutral
selected shall have experience in the biotechnology and/or pharmaceutical
industry and shall not be an employee, director or shareholder of either a
party or of an AFFILIATE of either party.
Each party shall have ten (10) business days from the date the neutral is
selected to object in good faith to the selection of that person. If either
party makes such an objection, the then President of AAA shall as soon as
possible thereafter, elect another neutral under the same conditions set
forth above. This second selection shall be final.
(b) No later than (90) business days after selection, the neutral shall
hold a hearing to resolve the issue.
(i) Each party shall have the right to be represented by counsel at
the hearing.
(ii) The hearing shall be held at such place as agreed upon by the
parties or if they are unable to agree at a place designated by the
neutral.
(c) The ADR proceeding shall be confidential and the neutral shall issue
appropriate protective orders to safeguard each party's Confidential
Information. Except as required by law, no party shall make (or instruct the
neutral to make) any public announcement with respect to the proceedings or
decision of the neutral without the prior written consent of each other
party. The existence of the dispute submitted to ADR, and the award of the
neutral, shall be kept in confidence by the parties and the neutral, except
as required in connection with the enforcement of such award or as otherwise
required by applicable law.
(d) It is the intention of the parties that discovery, although
permitted as described herein, will be extremely limited except in
exceptional circumstances. The neutral shall permit such limited discovery
necessary for an understanding of any legitimate issue raised in the ADR,
including the production of documents. Each party shall be permitted but not
required to take the deposition of not more than five (5) persons, each such
deposition not to exceed six (6) hours in length. If the neutral believes
that exceptional circumstances exist, and additional discovery is necessary
for a full and fair resolution of the issue, the neutral may order such
discovery as the neutral deems necessary. At the hearing the parties may
present testimony (either by live witness or deposition) and documentary
evidence. The neutral shall have sole discretion with regard to the
admissibility of any evidence and all other matters relating to the conduct
of the hearing.
(e) Each party shall be entitled to no more than four (4) hours of
hearing to present testimony or documentary evidence, unless such time period
is extended by mutual agreement between the parties or is otherwise allowed
by the neutral. The testimony of both parties shall be presented during the
same calendar day. Such time limitation shall include any direct, cross or
rebuttal testimony, but such time limitation shall include any direct, cross
or rebuttal testimony, but such time limitation shall only be charged against
the party conducting such direct, cross or rebuttal testimony. It shall be
the responsibility of the neutral to determine whether the parties have had
the presentation time to which they are entitled.
(f) At least fifteen (15) business days prior to the date set for the
hearing, each party shall submit to each other party and the neutral a list
of all documents on which such party intends to rely in any oral or written
presentation to the neutral and a list of all witnesses, if any, such party
intends to call at such hearing and a brief summary of each witness'
testimony.
At least five (5) business days prior to the hearing, each party must
submit to the neutral and serve on each other party a proposed ruling on the
issue to be resolved. Such writing shall be limited to representing the
proposed ruling, shall contain no argument or analysis of the facts or
issues, and shall be limited to not more than ten (10) pages, unless such
writing is extended by mutual agreement between the parties or is otherwise
allowed by the neutral.
(g) Not more than fifteen (15) business days following the close of
hearings, the parties may each submit post hearing briefs to the neutral
addressing the evidence and issues to be resolved. Such post hearing briefs
shall not be more than fifty (50) pages, unless such writing is extended by
mutual agreement between the parties or is other wise allowed by the neutral.
(h) The neutral shall rule on the disputed issue after the hearing as
expeditiously as possible, but in no event more than forty-five (45) days
after the close of the hearings. Such ruling shall adopt in its entirety the
proposed ruling of one of the parties. The neutral shall, in rendering his
decision, apply the substantive law of the State of Delaware, without giving
effect to its principles of conflicts of law, and without giving effect to
any rules or laws relating to arbitration.
(i) Any judgment upon the award rendered by the neutral may be entered
in any court having jurisdiction thereof. The decision rendered in any such
ADR shall be final and not appealable, except in cases of fraud or bad faith
on the part of the neutral or any party to the ADR proceeding in connection
with the conduct of such proceedings, and shall be enforceable in any court
of competent jurisdiction. No punitive damages shall be recoverable by
either party in such a proceeding.
(j) Each party shall pay its own costs (including, without limitation,
attorneys fees) and expenses in connection with such ADR.
(k) In the event either party contends that there has been fraud or bad
faith by the other party or in connection with the conduct of any ADR, a
second ADR shall be held to determine whether there has been fraud or bad
faith. If, as a result of the second ADR, it is determined that there has
been fraud or bad faith, the decision affected by such fraud or bad faith
shall be vacated and another ADR shall be held to resolve the original
dispute.
