RESEARCH COLLABORATION AND LICENSE AGREEMENT
This
Research Collaboration and License Agreement (the “Agreement”) is
entered into as of the 13th day of January 2010 (the “Effective Date”) by
and between GenVec, Inc., a Delaware corporation, having an office at 00 Xxxx
Xxxxxxx Xxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxxx 00000 (“GenVec”), and
Novartis Institutes for BioMedical Research, Inc., a Delaware corporation having
an office at 000 Xxxxxxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 (“Novartis”).
INTRODUCTION
1.
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GenVec
has developed Adenovectors (defined below), Atonal Vectors (defined below)
and Gene Fragments (defined below) and possesses certain intellectual
property relating thereto.
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2.
|
Novartis
desires to exclusively license from GenVec such intellectual property for
the purpose of researching, developing and commercializing Products
(defined below), and GenVec desires to grant such a license to Novartis in
accordance with the terms and conditions of this
Agreement.
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In
consideration of the mutual covenants contained herein, and other good and
valuable consideration, the receipt of which is hereby acknowledged, Novartis
and GenVec agree as follows:
1.
|
DEFINITIONS
|
When used
in this Agreement, each of the following terms, whether used in the singular or
plural, shall have the meanings set forth in this Section 1.
1.1
“Accounting Standards”
means, with respect to GenVec, US GAAP (United States Generally Accepted
Accounting Principles), and means, with respect to Novartis, the IFRS
(International Financial Reporting Standards), in each case, as generally and
consistently applied throughout the Party’s organization.
1.2
“[*]” shall mean
[*].
1.3
“Adenovectors” shall
mean the vectors listed in Exhibit A and any
derivatives of the foregoing that are Controlled by GenVec or its
Affiliates.
1.4
“Affiliate” means,
with respect to a Party, any Person that controls, is controlled by, or is under
common control with that Party. For the purpose of this definition,
“control” shall mean, direct or indirect, ownership of fifty percent (50%) or
more of the shares of stock entitled to vote for the election of directors, in
the case of a corporation, or fifty percent (50%) or more of the equity interest
in the case of any other type of legal entity, status as a general partner in
any partnership, or any other arrangement whereby the entity or Person controls
or has the right to control the board of directors or equivalent governing body
of a corporation or other entity, or the ability to cause the direction of the
management or policies of a corporation or other entity. In the case
of entities organized under the laws of certain countries, the maximum
percentage ownership permitted by law for a foreign investor may be less than
fifty percent (50%), and in such case such lower percentage shall be substituted
in the preceding sentence, provided that such foreign investor has the power to
direct the management and policies of such entity. In the case of
Novartis, “Affiliates” shall also expressly be deemed to include the Novartis
Institute for Functional Genomics, Inc., the Xxxxxxxxx Xxxxxxxx Institute for
Biomedical Research and their respective Affiliates.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
1.5
“Annual Net Sales”
means the Net Sales of a Covered Product in the Territory during a Calendar
Year.
1.6
“Atonal Vector” means
an Adenovector comprising a Gene Fragment.
1.7
“[*] License
Agreement” means the Exclusive License Agreement between GenVec and [*],
as amended by the First Amendment thereto dated J[*], and as may be further
amended after the Effective Date in accordance with Sections 2.1 and
11.3.
1.8
“[*] Patent Rights”
means all Patent Rights licensed to GenVec under the [*] License
Agreement.
1.9
“Business Day” means
any day other than a Saturday or a Sunday on which the banks in both Boston,
Massachusetts and Gaithersburg, Maryland are open for business.
1.10
“Calendar
Quarter” means the respective
periods of three (3) consecutive calendar months ending on March 31, June 30,
September 30 and December 31.
1.11
“Calendar
Year” means a period of twelve (12) consecutive calendar months ending on
December 31. For purposes hereof, the period from the Effective Date
through December 31, 2010 shall be deemed the first (1st) Calendar
Year.
1.12
“CFR” means the United
States Code of Federal Regulations.
1.13
“Clinical Trial” means
a Phase I Clinical Trial, a Phase IIb Clinical Trial or a Phase III Clinical
Trial.
1.14
“Commercially
Reasonable Efforts” means the expenditure of those efforts and resources
used consistent with the usual practice of Novartis in pursuing development or
commercialization of its other similar pharmaceutical products with similar
market potential and at a similar stage in development.
1.15
“Competing Product”
means any pharmaceutical or biologic composition used in or for the treatment of
hearing loss or vestibular disorders, including any biogeneric or biosimilar
products.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
2
1.16 “Confidential
Information” means, with respect to a Party (the “Disclosing Party”),
information, regardless of the form in which that information is constituted,
which (a) is treated by the Disclosing Party as confidential; and (b) relates
either directly or indirectly to the business of such Disclosing Party or its
Affiliates or the Third Party from whom the Disclosing Party received such
information.
Confidential
Information of the Disclosing Party excludes any information that the other
Party (the “Receiving
Party”) can establish by written records or other written
evidence:
(i) was
known by the Receiving Party prior to the receipt from the Disclosing
Party;
(ii)
was disclosed to the Receiving
Party by a Third Party having the right to do so;
(iii) was, or subsequently
became, publicly known through no fault of the Receiving Party, its Affiliates
or any of the officers, directors, employees or agents of the Receiving Party or
its Affiliates; or
(iv) was concurrently or
subsequently developed by personnel of the Receiving Party without having had
access to the Disclosing Party’s Confidential Information.
1.17 “Control” or “Controlled” means,
with respect to any Intellectual Property Right, the possession of the right
(whether by ownership, license or otherwise (other than pursuant to a license
granted under this Agreement)), to assign, or grant a license, sublicense or
other right to or under, such Intellectual Property Right as provided for herein
without violating the terms of any agreement or other arrangement with any Third
Party.
1.18 “Cover”, “Covered” or “Covering” means, with
respect to a patent, that, in the absence of a license granted to a Person under
a Valid Claim included in such patent, the research, development, use, making,
having made, marketing, offer for sale, sale, having sold, distribution,
importation or exportation by such Person of an invention claimed in such patent
would infringe such Valid Claim.
1.19 “Covered Product”
means any Product, the research, development, use, making, having made,
marketing, offer for sale, sale, having sold, distribution, importation or
exportation of which by Novartis, its Affiliates or its Sublicensees in the
Territory is Covered by a Valid Claim included in the Product Patent
Rights.
1.20 “EMEA” means the
European Medicines Agency or any successor entity thereto.
1.21 “Executive Officer”
means, with respect to GenVec, GenVec’s Chief Executive Officer, and with
respect to Novartis, the Global Head, Strategic Alliances of NIBR.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
3
1.22 “FDA” means the United
States Food and Drug Administration or any successor entity
thereto.
1.23 “Field” means all
fields of use.
1.24 “First Commercial
Sale” means, with respect to a Product, the first sale of such Product by
or under the authority of Novartis, an Affiliate of Novartis, or their licensees
or sublicensees to a Third Party in a country following Regulatory Approval of
such Product in that country or, if no such Regulatory Approval or similar
approval is required, the date upon which such Product is first commercially
sold in such country; provided that First
Commercial Sale shall not include any distribution or other sale solely for
so-called treatment investigational new drug sales, named patient sales,
compassionate or emergency use sales or pre-license sales.
1.25 “First Indication”
means hearing loss Indications in humans.
1.26 “First Patient First
Visit” means, with respect to a Covered Product, the administration of
the first dose of such Covered Product to the first patient at such patient’s
first visit in a Phase I Clinical Trial, Phase IIb Clinical Trial or Phase III
Clinical Trial, as applicable.
1.27 “FTE” means
the equivalent of the work of one (1) GenVec scientist, full time for one year,
which equates to one thousand nine hundred twenty (1920) hours per year of work
on or directly related to the Research Collaboration. Overtime and
work on weekends, holidays and the like shall not be counted with any multiplier
(i.e., time-and-a-half or double time) toward the number of hours that are used
to calculate the number of FTEs under this Agreement. GenVec shall
ensure that each FTE assigned to the Research Collaboration has the appropriate
level of expertise, experience, training and, where applicable, licenses,
necessary to perform the Research Collaboration. For the avoidance of
doubt, FTE activities shall be restricted to the performance and oversight of
scientific work related directly to the Research Collaboration and shall exclude
time spent on administrative work and time spent in travel. For
purposes of clarity, a single individual who works more than one thousand nine
hundred twenty (1920) hours in a single year shall be treated as one FTE
regardless of the number of hours worked.
1.28 “FTE Rate” means a
rate per FTE equal to [*] (which may be prorated on a daily or hourly basis as
necessary) with respect to Research Collaboration activities conducted pursuant
to this Agreement. “FTE Rate” includes direct and indirect costs of
internal scientific, medical, technical or commercial personnel (including
personnel and travel expenses, but, for the avoidance of doubt, does not include
the costs of managerial, financial, legal or business development
personnel).
1.29 “Gene Fragments” means
(i) animal atonal genes or gene fragments, (ii) human atonal genes (HATH1) or
gene fragments, and (iii) nucleic acid encoding an atonal protein polypeptide or
peptide.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
4
1.30 “GenVec Indemnitees”
means GenVec, its Affiliates, and the agents, directors, officers and employees
of GenVec and its Affiliates.
1.31 “GenVec IP” means,
collectively, Product IP and Production IP, and specifically excludes Research
Collaboration IP and Joint IP.
1.32 “GenVec Know-How”
means all Product Know-How and Production Know-How.
1.33 “GenVec Patent Rights”
means all Product Patent Rights and Production Patent Rights. The
GenVec Patent Rights that exist as of the Effective Date are set forth in Exhibit
B. For the avoidance of doubt, the Patent Rights Controlled by
GenVec include the [*] Patent Rights.
1.34 “Governmental
Authority” means any court, agency, department, authority or other
instrumentality of any national, state, county, city or other political
subdivision.
1.35 “IND” means an
Investigational New Drug Application or similar foreign application or
submission for approval to conduct human clinical investigations.
1.36 “Indication” means any
disease, condition or syndrome.
1.37 “Intellectual Property
Rights” means Patent Rights, Know-How, trade secret rights, copyrights,
trademarks and other forms of proprietary rights.
1.38 “Joint IP” means Joint
Know-How, Joint Patent Rights and any other Intellectual Property Rights
covering the Joint Know-How. Joint IP specifically excludes Research
Collaboration IP and GenVec IP.
1.39 “Joint Know-How” means
all Know-How invented, developed, conceived, reduced to practice or authored
jointly by or on behalf of Novartis and its Affiliates, on the one hand, and
GenVec and its Affiliates, on the other hand, during the Term and in course of
researching, developing, using, making, having made, marketing, offering to
sell, selling, having sold, distributing, importing, exporting or otherwise
commercializing Atonal Vectors, Gene Fragments and/or Products.
1.40 “Joint Patent Rights”
means all Patent Rights throughout the world covering the Joint
Know-How.
1.41 “Know-How” means any
information, ideas, data, inventions, works of authorship, materials (including
biological and chemical materials), trade secrets or
technology whether or not proprietary or patentable, all to the
extent not covered by Patent Rights, and whether stored or transmitted in oral,
documentary, electronic or other form, including all Regulatory
Documentation.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
5
1.42 “Law” means any law,
statute, rule, regulation, ordinance or other pronouncement having the effect of
law, of any federal, national, multinational, state, provincial, county, city or
other political subdivision.
1.43 “Loss of Market
Exclusivity” means with respect to any Product in the relevant country,
(a) the Net Sales of such Product in that country in any Calendar Year are less
than [*] of the Product’s highest level of Net Sales in such country in any
preceding Calendar Year, and (b) the decline in such sales is reasonably
attributable in material part to the marketing or sale in such country of a
Competing Product by Third Parties in such country, as measured in the local
currency, and which Competing Product sales are evidenced by independent market
data, such as that published by IMS.
1.44 “Major EU Countries”
means France, Germany, Italy, Spain and the United Kingdom.
1.45 “Net Sales” means the
net sales invoiced by Novartis or any of its Affiliates or Sublicensees for any
Product sold to Third Parties other than Sublicensees in bona fide, arms length
transactions, as determined in accordance with Novartis’ Accounting Standards as
consistently applied, less a deduction of [*] for direct expenses related to the
sales of Product, distribution and warehousing expenses and uncollectible
amounts on previously sold products. With respect to the calculation
of Net Sales:
(a) Net
Sales only include the value charged or invoiced on the first arm’s length sale
to a Third Party; any sales between or among Novartis and its Affiliates and
Sublicensees shall be disregarded for purposes of calculating Net
Sales;
(b) If
a Product is delivered to the Third Party before being invoiced (or is not
invoiced), Net Sales will be calculated at the time all the revenue recognition
criteria under Novartis’ Accounting Standards are met;
(c) If
a Product is sold or otherwise disposed for value (such as barter or counter
trade) other than in an arm’s length transaction exclusively for money, Net
Sales will be calculated on the value of the non-cash consideration received or
the fair market price (if higher) of the Product in the country of sale or
disposal;
(d) In
the event the Product is sold in a finished dosage form containing the Product
in combination with one or more other active ingredient(s) (a “Combination
Product”), the Net Sales will be calculated by multiplying the net sales
of the Combination Product (calculated as above) by the fraction, A/(A+B) where
A is the weighted average sale price (by sales volume) in the relevant country
of the Product as the sole active ingredient in finished form, and B is the
weighted average sale price (by sales volume) in that country of the product(s)
containing the other component(s) as the sole active ingredient(s) in finished
form. If the weighted average sale price cannot be determined for the
Product and other product(s) containing such other active ingredient(s), the
calculation of Net Sales for Combination Products will be agreed by the Parties
based on the relative value contributed by each component (each Party’s
agreement not to be unreasonably withheld or delayed).
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
6
1.46 “Novartis Indemnitees”
means Novartis, its Affiliates, and the agents, directors, officers and
employees of Novartis and its Affiliates.
1.47 “Party” means GenVec
or Novartis and “Parties” means GenVec
and Novartis.
1.48 “Patent Rights” means
(a) any patents and certificates of invention; (b) patent applications
(including provisional applications); (c) all patents and patent applications
issuing from, based on or corresponding to any of the foregoing; (d) any
substitutions, extensions (including supplemental protection certificates),
registrations, confirmations, reissues, divisionals, continuations,
continuations-in-part, re-examinations, renewals and foreign counterparts
thereof; and (e) all patents or patent applications claiming the priority
date(s) of any of the foregoing.
1.49 “Patent Term
Extension” means any patent term extension, adjustment or restoration or
supplemental protection certificates.
1.50 “Person” means any
individual, corporation, limited or general partnership, limited liability
company, joint venture, trust, unincorporated association, governmental body,
authority, bureau or agency, or any other entity or body.
1.51 “Personal Information”
means any information that can be used to identify, describe, locate or contact
an individual, including (a) name or initials; (b) home or other physical
address; (c) telephone number; (d) email address or online identifier associated
with the individual; (e) social security number or other similar government
identifier; (f) employment, financial or health information; (g) information
specific to an individual’s physical, physiological, mental, economic, racial,
political, ethnic, ideological, cultural or social identity; (h) photographs;
(i) dates relating to the individual (except years alone); (j) financial account
numbers; (k) genetic material or information; (l) business contact information
and (m) any other information relating to an individual that, alone or in
combination, with any of the above, can be used to identify an
individual.
1.52 “Phase I Clinical
Trial” means any clinical study conducted on sufficient numbers of human
subjects to establish that the Product is reasonably safe for continued testing
and to support its continued testing in clinical trials. “Phase I
Clinical Trial” shall include any clinical trial that would satisfy requirements
of 21 C.F.R. § 312.21(a) or its non-United States equivalent.
1.53 “Phase IIb Clinical
Trial” means a human clinical trial of a Product that is intended to
evaluate the effectiveness of such Product in human patients for purposes of
identifying the appropriate dose for a Phase III Clinical Trial for a particular
Indication or Indications in human subjects with the disease or Indication under
study or that would otherwise satisfy the requirements of 21 CFR 312.21(b)
or its non-United States equivalent.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
7
1.54 “Phase III Clinical
Trial” means a human clinical trial
of a Product in patients, which trial is designed to: (a) establish that a
Product is safe and efficacious for its intended use; (b) define warnings,
precautions and adverse reactions that are associated with the Product in the
dosage range to be prescribed; (c) support Regulatory Approval of such
Product; and (d) be consistent with 21 CFR § 312.21(c) or its non-United
States equivalent.
1.55 “Prior Confidentiality
Agreement” means the Confidentiality Agreement by and between the
Parties, dated June 4, 2009, as amended October 5, 2009.
1.56 “Product” means a
composition or therapy in the Field that contains, incorporates or employs
either of (a) an Atonal Vector; or (b) a Gene Fragment.
1.57 “Product IP” means all
Product Know-How and Product Patent Rights.
1.58 “Product Know-How”
means all Know-How in the Territory that (a) is Controlled by GenVec or any of
its Affiliates as of the Effective Date or during the Term, and (b) (i) consists
of or relates to Gene Fragments, Atonal Vectors, Adenovectors or Products and/or
(ii) is necessary or useful for the exercise of the Product Patent
Rights.
1.59 “Product Patent
Rights” means all Patent Rights that (a) are Controlled by GenVec or any
of its Affiliates as of the Effective Date or during the Term; and (b) Cover
Gene Fragments, Atonal Vectors, Adenovectors or Products.
1.60 “Product IP Royalty
Term” means, with respect to a Covered Product and a country, the period
of time beginning with the First Commercial Sale of such Covered Product in such
country and continuing until the earlier of (a) the expiration of the last Valid
Claim of the Product Patent Rights Covering the manufacture, use or sale of such
Covered Product in such country, and (b) the first day of the Calendar Year
following a Calendar Year in which there is a Loss of Market Exclusivity in such
country.
1.61 “Production IP” means
all Production Know-How and Production Patent Rights.
1.62 “Production Know-How”
means all Know-How in the Territory that (a) is Controlled by GenVec or any of
its Affiliates as of the Effective Date or during the Term, and (b) is
reasonably necessary or useful for researching, developing, using, making,
having made, marketing, offering to sell, selling, having sold, distributing,
importing, exporting or otherwise commercializing Adenovectors, Gene Fragments
or Products, including the[*] master cell bank and the master viral bank(s)
Controlled by GenVec; provided that Production IP specifically excludes Joint
Know-How, Research Collaboration IP and Product Know-How.
1.63 “Production Patent
Rights” means all Patent Rights in the Territory that (a) are Controlled
by GenVec or any of its Affiliates as of the Effective Date or during the Term,
and (b) are reasonably necessary or useful for researching, developing, using,
making, having made, marketing, offering to sell, selling, having sold,
distributing, importing, exporting or otherwise commercializing Adenovectors,
Gene Fragments or Products; provided that Production
Patent Rights specifically excludes Joint Patent Rights, Research Collaboration
IP and Product Patent Rights.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
8
1.64 “Production IP Royalty
Term” means, with respect to a Product and a country, the period of time
beginning with the expiration of the Product IP Royalty Term and continuing five
(5) years thereafter.
1.65 “Regulatory Approval”
means, with respect to a Product in any country or jurisdiction, any approval
(including when applicable approval for clinical trials and where required or
necessary, as a matter of reasonable commercial practice, pricing and
reimbursement approvals), registration, license or authorization from a
Regulatory Authority in a country or other jurisdiction that is necessary to
market and sell such Product in such country or jurisdiction.
1.66 “Regulatory Authority”
means any governmental agency or authority responsible for granting Regulatory
Approvals for Products, including the FDA, EMEA and any corresponding national
or regional regulatory authorities.
1.67 “Regulatory
Documentation” means, with respect to a Product, all INDs, Regulatory
Approvals, pre-clinical and clinical data and information, regulatory materials,
drug dossiers, master files, and any other reports, records, regulatory
correspondence and other materials relating to the pre-clinical and clinical
development and Regulatory Approval of such Product, or required to manufacture,
distribute and sell such Product, including any safety database.
1.68 “Research
Collaboration” shall mean the collaboration between the Parties regarding
the development of Products, which the Parties shall conduct pursuant to the
terms of Section 4.1.
1.69 “Research Collaboration
IP” means all inventions, discoveries, Know-How, Patent Rights and other
Intellectual Property Rights that are conceived, discovered, developed or
otherwise made or created by employees, agents and consultants of GenVec, solely
or jointly with Novartis and its Affiliates, either in the course of the
Research Collaboration or in the course of providing support and expertise
pursuant to Section 4.2. Research Collaboration IP specifically
excludes GenVec IP and Joint IP.
1.70 “Research Collaboration
Term” shall mean the period commencing on the Effective Date and ending
two (2) years after the Effective Date, subject to Novartis’ ability to
terminate the Research Collaboration pursuant to Section 4.1(b).
1.71 “Royalty Term” means,
with respect to a Product and a country, the Product IP Royalty Term and the
Production IP Royalty Term.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
9
1.72 “Sales & Royalty
Report” means a written report
or reports showing each of: (a) the Net Sales of each Product in the
Territory during the reporting period by Novartis and its Affiliates and
Sublicensees and the calculation thereof and (b) the royalties payable, in
United States Dollars, which shall have accrued hereunder with respect to such
Net Sales.
1.73 “Second Indication”
means non-hearing loss Indications in humans.
1.74 “Sublicensee” means a
Person to whom Novartis, or its Affiliate or another Sublicensee, has granted a
sublicense in accordance with the terms of this Agreement, but specifically
excludes distributors and wholesalers so long as such distributors and
wholesalers are not Affiliates of Novartis.
1.75
“Territory”
means the world.
1.76 “Third Party” means
any Person other than the Parties and their Affiliates.
1.77 “U.S.C.” means the
United States Code.
1.78 “Valid Claim” means a
claim in an issued, unexpired patent within the GenVec Patent Rights that: (a)
has not lapsed or been finally cancelled, withdrawn, abandoned, refused, or
rejected by any administrative agency or other body of competent jurisdiction,
that is unappealable or unappealed within the time allowed for appeal, (b) has
not been revoked, held invalid, or declared unpatentable or unenforceable in a
decision of a court or other body of competent jurisdiction that is unappealable
or unappealed within the time allowed for appeal, (c) has not been rendered
unenforceable through disclaimer or otherwise, (d) has not been found to be a
claim to which the patentee is not entitled through an interference proceeding
for which a final decision has been entered by the Board of Patent Appeals and
Interferences (or its equivalent) and the interference is terminated and (e) has
not been explicitly disclaimed, or admitted by GenVec to be invalid or
unenforceable through reissue, disclaimer or otherwise.
1.79 Other Defined
Terms. Each of the following definitions is set forth in the
section of this Agreement indicated below:
Definition
|
Section
|
|
Agreement
|
Preamble
|
|
Alliance
Manager
|
3.1
|
|
Auditee
|
6.8(b)
|
|
Audit
Rights Holder
|
6.8(b)
|
|
Audit
Team
|
6.8(b)
|
|
Bankruptcy
Code
|
2.3
|
|
[*]
|
1.7
|
|
Breaching
Party
|
13.2(b)
|
|
Combination
Product
|
1.45
|
|
Common
Stock Purchase Agreement
|
6.1(b)
|
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
10
Definition
|
Section
|
|
Convicted
Entity
|
11.4(d)
|
|
Convicted
Individual
|
11.4(d)
|
|
Debarred
Entity
|
11.4(b)
|
|
Debarred
Individual
|
11.4(a)
|
|
Disclosing
Party
|
1.16
|
|
Effective
Date
|
Preamble
|
|
Excluded
Entity
|
11.4(c)
|
|
Excluded
Individual
|
11.4(c)
|
|
GenVec
|
Preamble
|
|
GenVec
Atonal Vector Patent Rights
|
7.2(a)(i)
|
|
HIPAA
|
8.4(a)
|
|
JSC
|
3.2(a)
|
|
Losses
|
9.1
|
|
Milestone
|
6.2
|
|
Milestone
Payment
|
6.2
|
|
Novartis
|
Preamble
|
|
Non-Breaching
Party
|
13.2(b)
|
|
Paragraph
IV Certification
|
7.4(a)
|
|
Prior
License
|
2.1
|
|
Receiving
Party
|
1.16
|
|
Research
Collaboration Plan
|
4.1(a)
|
|
Severed
Clause
|
14.10
|
|
Term
|
13.1
|
1.80 Construction. In
construing this Agreement, unless expressly specified otherwise;
(a) references to
Sections and Exhibits are to sections of, and exhibits to, this
Agreement;
(b) use of either
gender includes the other gender, and use of the singular includes the plural
and vice versa;
(c) headings and
titles are for convenience only and do not affect the interpretation of this
Agreement;
(d) any list or
examples following the word “include” or “including” shall be interpreted
without limitation to the generality of the preceding words; and
(e) the language
used in this Agreement shall be deemed to be the language chosen by the Parties
to express their mutual intent, and no rule of strict construction shall be
applied against either Party.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
11
2.
|
LICENSES
|
2.1 Licenses to
Novartis.
(a) Grants. Subject
to the rights retained by GenVec pursuant to Section 2.2 and the other terms and
conditions of this Agreement, GenVec hereby grants to Novartis and its
Affiliates (i) an exclusive (even as to GenVec and its Affiliates),
royalty-bearing, sublicenseable (in accordance with Section 2.1(b)),
non-transferable (except in accordance with Section 14.1) license, under the
Product IP, to research, develop, use, make, have made, market, offer to sell,
sell, have sold, distribute, import, export and otherwise commercialize Atonal
Vectors, Gene Fragments and/or Products in the Field in the Territory, (ii) a
non-exclusive, royalty-bearing, sublicensable (in accordance with Section
2.1(b)), non-transferable (except in accordance with Section 14.1) license,
under the Product IP to use, make, have made, import and export the Adenovectors
solely for (A) research purposes in the Field in the Territory and (B)
exercising the license grants set forth in subclauses (i) or (iii) of this
Section 2.1(a); (iii) a non-exclusive, royalty-bearing, sublicenseable (in
accordance with Section 2.1(b)), non-transferable (except in accordance with
Section 14.1) license, under the Production IP, to research, develop, use, make,
have made, market, offer to sell, sell, have sold, distribute, import, export
and otherwise commercialize Atonal Vectors, Gene Fragments and/or Products in
the Field in the Territory; and (iv) a non-exclusive, royalty-bearing,
sublicensable (in accordance with Section 2.1(b)), non-transferable (except in
accordance with Section 14.1) license, under the Production IP, to use, make,
have made, import and export the Adenovectors solely for (A) research purposes
in the Field in the Territory and (B) exercising the license grants set forth in
subclauses (i) or (iii) of this Section 2.1(a). Notwithstanding the
foregoing, Novartis acknowledges that prior to the Effective Date GenVec granted
a license to [*] and patent applications or foreign patents claiming priority
therefrom in the field of [*] (the “Prior License”) and
that GenVec obtained the [*] Patent Rights subject to and conditioned upon the
terms of the [*] License Agreement, and that the foregoing licenses are subject
to, and limited by, the Prior License and the [*] License Agreement,
respectively, provided that GenVec shall not modify or amend the Prior License
or the [*] License Agreement in any manner without Novartis’ prior written
consent, such consent (with respect to the Prior License only) not to be
unreasonably withheld, delayed or conditioned. For the avoidance of
doubt, nothing in this Agreement shall be construed as granting to Novartis or
its Affiliates or Sublicensees any rights to commercialize any Adenovector
(whether itself or in combination with any other rights), except and solely to
the extent (A) that such Adenovector constitutes an Atonal Vector, and (B) is
covered by the license grants in Section 2.1(a)(i) or Section
2.1(a)(iii).
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
12
(b) Sublicense and Subcontract
Rights. Novartis may exercise its rights and perform its
obligations under this Agreement itself or through any of its Affiliates without
the prior written consent of GenVec; provided, that each such
Affiliate shall be bound by the terms and conditions of this Agreement and the
exercise of any such rights or the performance of such obligations by an
Affiliate of Novartis shall not relieve Novartis of its obligations under this
Agreement. Subject to this Section 2.1(b), Novartis shall have the
right to grant sublicenses under the licenses granted in Section 2.1(a) at any
time in its sole discretion and without the prior written consent of
GenVec. In addition, subject to this Section 2.1(b), Novartis may
subcontract to Third Parties the performance of tasks and obligations (i) with
respect to the research, development, use, manufacture, marketing, sale,
distribution, importation, exportation and other commercialization of Atonal
Vectors, Gene Fragments and/or Products; and (ii) with respect to the research,
use, manufacture, importation and exportation of Adenovectors, each as Novartis
deems appropriate and without the prior written consent of
GenVec. Novartis shall remain responsible for its obligations under
this Agreement that have been delegated, subcontracted or sublicensed to any of
its Affiliates, Sublicensees and/or subcontractors.
(c) Research Use Only
License. Novartis hereby grants to GenVec a non-exclusive,
non-sublicensable, non-transferable, royalty-free license under the Research
Collaboration IP and Joint IP, (i) during the period of time GenVec is
performing its obligations under Sections 4.1 and 4.2, to conduct the Research
Collaboration, and (ii) to fulfill GenVec’s responsibilities to Novartis and its
Affiliates under this Agreement in the Territory.
2.2 Retained
Rights. GenVec hereby retains, on behalf of itself and its
Affiliates, all rights necessary to perform GenVec’s obligations and exercise
GenVec’s rights under this Agreement. Except as expressly provided in
this Agreement, all rights in and to any Intellectual Property Rights and other
rights of GenVec and its Affiliates not licensed or otherwise granted to
Novartis and its Affiliates hereunder, are hereby retained by GenVec and its
Affiliates.
2.3 Section 365(n) of The
Bankruptcy Code. All rights and licenses granted under or
pursuant to any section of this Agreement, including the licenses granted under
this Section 2, are and will otherwise be deemed to be for purposes of Section
365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), as amended
(the “Bankruptcy
Code”), licenses of rights to “intellectual property” as defined in
Section 101(35A) of the Bankruptcy Code. Novartis will retain and may
fully exercise all of its respective rights and elections under the Bankruptcy
Code (to the extent permitted under the Bankruptcy Code). GenVec
agrees that if and to the extent permitted under the Bankruptcy Code and other
applicable Laws, Novartis, as licensee of such rights under this Agreement, will
retain and may fully exercise all of its rights and elections under the
Bankruptcy Code or any other provisions of applicable Law outside the United
States that provide similar protection for “intellectual
property.” Subject to the Bankruptcy Code and other applicable Laws,
GenVec further agrees that, in the event of the commencement of a bankruptcy
proceeding by or against GenVec under the Bankruptcy Code or analogous
provisions of applicable Law outside the United States, Novartis will be
entitled to a complete duplicate of (or complete access to, as Novartis deems
appropriate) such intellectual property licensed to Novartis and its Affiliates
pursuant to this Agreement and all embodiments of such intellectual property,
which, if not already in Novartis’ possession, will be promptly delivered to it
upon Novartis’ written request thereof. Any agreements supplemental
hereto will be deemed to be “agreements supplementary to” this Agreement for
purposes of Section 365(n) of the Bankruptcy Code.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
13
2.4 Non-Compete. Until
the last to expire Royalty Term for all Products, neither GenVec nor its
Affiliates will, directly or indirectly (including by granting a license or
otherwise granting rights to a Third Party), conduct any research, development,
commercialization, distribution, or marketing or sales activities, in the field
of hearing loss (including activities with respect to any Competing Product),
except for the activities conducted by GenVec pursuant to and in accordance with
this Agreement.
3.
|
GOVERNANCE
|
3.1 Alliance
Managers. Each Party shall appoint a person who shall oversee
contact between the Parties for all matters between meetings of the JSC and
shall have such other responsibilities as the Parties may agree in writing after
the Effective Date (each, an “Alliance
Manager”). Each Party may replace its Alliance Manager at any
time by notice in writing to the other Party.
3.2 Joint Steering
Committee.
(a) Within
thirty (30) days after the Effective Date the Parties shall establish a Joint
Steering Committee (the “JSC”) that shall
oversee the research activities of the Parties under the Research
Collaboration. The JSC shall be comprised of the Alliance Managers
and two (2) additional representatives designated by GenVec and two (2)
additional representatives designated by Novartis. Novartis shall
appoint a chairperson from among its representatives. Each Party’s
JSC representatives shall be of the seniority and experience appropriate for
service on the JSC in light of the functions, responsibilities and authority of
the JSC. Each Party may replace any or all of its representatives on
the JSC with individual(s) of appropriate experience and seniority at any time
upon written notice to the other Party. Other representatives of each
Party involved with the Product may attend meetings as non-voting
participants. Each Party’s representatives and any substitute for a
representative shall be bound by the obligations of confidentiality set forth in
Section 8.
(b) The
JSC will perform the following functions: (i) managing and overseeing
the performance of the Research Collaboration, (ii) reviewing and recommending
amendments to the Research Collaboration Plan as necessary, (iii) managing the
performance of the Research Collaboration Plan, including overseeing the
allocation and assignment of tasks with respect to the Research Collaboration,
and (iv) assuming such other responsibilities as may be assigned to the JSC
pursuant to this Agreement or as may be mutually agreed upon in writing by the
Parties from time to time. The JSC shall exist and conduct its
functions during the Research Collaboration Term. At the conclusion
of the Research Collaboration Term, the JSC shall complete its activities and
disband.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
14
3.3 Subcommittees. The
JSC may establish and disband such subcommittees as deemed necessary by the
JSC. Each such subcommittee shall consist of the same number of
representatives designated by each Party, which number shall be mutually agreed
by the Parties. Each Party shall be free to change its
representatives on notice to the other or to send a substitute representative to
any subcommittee meeting; provided, however, that each
Party shall ensure that at all times during the existence of any subcommittee,
its representatives on such subcommittee are appropriate in terms of expertise
and seniority for the then-current stage of development of the Products then
under development and have the authority to bind such Party with respect to
matters within the purview of the relevant subcommittee. Other
representatives of each Party involved with the Product may attend meetings as
non-voting participants. Each Party’s representatives and any
substitute for a representative shall be bound by the obligations of
confidentiality set forth in Section 8. Except as expressly provided
in this Agreement, no subcommittee shall have the authority to bind the Parties
and each subcommittee shall report to, and any decisions shall be made by, the
JSC.
3.4 Meetings. The
JSC and any subcommittees shall meet at least once per Calendar Quarter, and
more frequently as the Parties shall agree, on such dates, and at such places
and times, as the Parties shall agree; provided that the Parties
shall endeavor to have the first meeting of the JSC within thirty (30) days
after the establishment of the JSC. Meetings of the JSC and
subcommittees in person shall alternate between the offices of Novartis and
GenVec, or such other place as the Parties may agree. The members of
the JSC and subcommittees also may convene or be polled or consulted from time
to time by means of telecommunications, video conferences, electronic mail or
correspondence, as deemed necessary or appropriate. The chairperson
or the chairperson’s designee shall be responsible for preparing the minutes of
the meeting. Such minutes shall be in English and provide a
description in reasonable detail of the discussions held at the meeting and a
list of any actions, decisions or determinations approved by the
JSC. Novartis agrees that it shall endeavor to ensure that draft
minutes of each meeting shall be distributed within twenty (20) days after the
meeting, and final minutes shall be approved by both Parties within thirty (30)
days after the meeting. Final minutes of each meeting shall be
distributed to the members of the JSC by the chairperson. Each Party
shall be responsible for all of its own expenses incurred in connection with
participating in all such meetings.
3.5 Decision-Making
Authority.
(a) Subject
to the provisions of this Section 3.5, actions to be taken by the JSC and each
of the subcommittees shall be taken only following a unanimous vote, with each
Party having one (1) vote. If any subcommittee fails to reach
unanimous agreement on a matter before it for decision for a period in excess of
fifteen (15) days, the matter shall be referred to the JSC.
(b) If
the JSC fails to reach unanimous agreement on a matter before it for decision
for a period in excess of fifteen (15) days, the matter shall be referred to the
Executive Officer of each Party, or a designee of the Executive Officer with
decision-making authority for resolution. In the event that the
Executive Officers are unable to resolve such dispute within ten (10) days after
such dispute being referred to the Executive Officers, then the Novartis
Executive Officer or designee shall have the final decision-making authority on
such issue.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
15
3.6 Limitation on JSC’s
Authority. Notwithstanding anything to the contrary in this
Agreement, none of the JSC, a subcommittee of the JSC nor the Novartis Executive
Officer pursuant to Section 3.5(b) shall have the power to (a) amend or modify
the Parties’ respective rights and obligations under this Agreement or (b)
resolve any dispute between the Parties regarding such rights and
obligations.
3.7 Reports to
Committees. Each Party shall provide the JSC on a Calendar
Quarter basis with reports regarding the activities performed by such Party
under the Research Collaboration. Each such report shall summarize in
reasonable detail the activities undertaken by such Party during the prior
Calendar Quarter, as well as the results of such activities. Such
reports will be accurate and, where appropriate, will contain raw data from
studies carried out by or on behalf of such Party.
3.8 Expenses. Each
Party shall be responsible for all costs and expenses for its members and other
representatives to attend meetings of, and otherwise participate on, the JSC and
any subcommittee(s) thereof, including all travel and related costs and
expenses. For purposes of clarity, the costs and expenses incurred by
GenVec for, and time spent by, its members and other representatives to attend
meetings of, and otherwise participate on, the JSC and any subcommittee(s)
thereof, including all travel and related costs and expenses are not to be
charged to Novartis pursuant to Section 4.2.
4.
|
RESEARCH
COLLABORATION; TECHNOLOGY
TRANSFER
|
4.1 Research
Collaboration.
(a) General. The
Parties shall conduct the Research Collaboration during the Research
Collaboration Term in accordance with the research plan attached as Exhibit C, as the
same may be amended from time to time upon the written consent of the Parties
(“Research
Collaboration Plan”). The Research Collaboration Plan sets
forth each Party’s obligations and responsibilities during the Research
Collaboration Term in connection with the Research Collaboration.
(b) GenVec
FTEs. During the Research Collaboration Term, GenVec shall
deploy the equivalent of five FTEs to perform the activities allocated to GenVec
under the Research Collaboration Plan. Novartis may, on [*] prior
written notice to GenVec, reduce the number of FTEs deployed under the Research
Collaboration (such reduction may occur in any whole number increment of FTEs,
and any number of times), and/or may terminate the Research Collaboration
entirely. Such notice(s) shall not be provided sooner
than[*]. If Novartis reduces the number of FTEs deployed under the
Research Collaboration, then the Research Collaboration Plan shall be amended
promptly thereafter pursuant to the written consent of both Parties in a manner
that is mutually agreeable to the Parties, and such amendment shall expressly
provide for changes to the objectives and deliverables set forth in the Research
Collaboration Plan to account for the reduced number of
FTEs. Payments for FTEs deployed to the Research Collaboration shall
be as set forth in Section 6.4(a). GenVec shall not subcontract its
obligations under the Research Collaboration Plan to any Third Party without the
prior written consent of Novartis.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
16
4.2 Additional Technical
Support. During the first [*] after the Effective Date, at
Novartis’ discretion and upon Novartis’ reasonable request, GenVec shall use
commercially reasonable efforts to make available to Novartis and its Affiliates
up to one-third of the time (as measured over each Calendar Year) of two senior
managers who have appropriate relevant experience and are knowledgeable about
the Products then under development for scientific and technical explanations,
advice and related additional support and expertise, if and to the extent
necessary or useful in connection with the research, development and
commercialization activities conducted by Novartis and its Affiliates
hereunder. GenVec shall make such personnel identified by GenVec
available to Novartis and its Affiliates during regular business hours to
facilitate such support and expertise. As part of such support,
GenVec shall use commercially reasonable efforts to make such senior managers
available to participate in meetings, hearings and other proceedings before
and/or with Regulatory Authorities (which may occur on short notice and at times
outside of regular business hours). Nothing in this Section 4.2 shall
be deemed to require that GenVec continue to employ any specific individuals nor
require that GenVec continue to maintain any functional expertise or departments
in any specific area. Novartis shall pay GenVec on an hourly basis
for the time of GenVec personnel spent to provide such additional support and
expertise, as set forth in Section 6.4(b).
4.3 Primary Data
Access. GenVec shall provide to Novartis and its Affiliates
access to and a copy of all data (including all primary data and data contained
in laboratory notebooks (which laboratory notebooks shall be used solely in
connection with the performance of this Agreement and shall be maintained in
accordance with Novartis’ procedures as described below)) generated in
connection with and that relates to the Research Collaboration and/or is
generated in the course of performing GenVec’s obligations under this
Agreement. GenVec shall comply with Novartis’ standard procedures for
maintaining laboratory notebooks and associated accessory records in accordance
with Novartis’ Global Laboratory Notebook Guidelines, a copy of which is
attached hereto as Exhibit
D. Such original notebooks shall be the property of Novartis,
and GenVec shall provide all original notebooks (both completed and uncompleted)
to Novartis at Novartis’ request and expense. Prior to providing such
original notebooks to Novartis, GenVec shall make and retain at least one true
and complete copy of each such notebook. Novartis and its Affiliates
shall also have the right, at reasonable intervals, upon reasonable notice to
GenVec, to have authenticated copies of such data and notebooks made to use and
transfer as permitted hereunder. Any data not otherwise contained in
laboratory notebooks shall be provided to Novartis in the format mutually agreed
by the Parties. GenVec may retain for itself copies of all data
provided to Novartis for all purposes permitted under this
Agreement.
4.4 Technology Transfer to
Novartis.
(a) On
the Effective Date, GenVec shall provide to Novartis, or its designated
Affiliate(s), the data, materials, reports and other information listed on Exhibit
E. Within thirty (30) days after the Effective Date, GenVec
shall make available to Novartis, in a mutually-agreed upon format, material
information regarding the GenVec Know-How, and during the Term, shall make its
relevant scientific and technical personnel available to Novartis to answer any
questions or provide instruction, as reasonably requested by Novartis,
concerning the GenVec Know-How.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
17
(b) At
Novartis’ expense and reasonable request, GenVec will provide to Novartis and
its Affiliates (i) access to and (ii) the right to reference technical
information in, any biologic master file (BMF) or similar, and any and all
Regulatory Documentation Controlled by GenVec relating to Products and existing
as of the Effective Date or generated from any Clinical Trial commenced by
GenVec prior to the Effective Date, and agrees to sign, and cause its Affiliates
to sign, any instruments reasonably requested by Novartis in order to effect
such reference rights.
5.
|
DEVELOPMENT AND
COMMERCIALIZATION
|
5.1 Responsibility. Subject
to Section 4.1, Novartis shall be responsible for the worldwide development and
commercialization of the Product(s), including regulation, manufacturing,
distribution, marketing and sales activities.
5.2 Diligence. Novartis
shall use Commercially Reasonable Efforts to develop and commercialize at least
one Product in the Field.
5.3 Reports. Within
[*] during the Term of this Agreement, Novartis shall submit to GenVec a report
summarizing in reasonable detail Novartis’ and its Affiliates’ activities
related to the development of Products in the Field in the Territory during [*],
including any key issues encountered during such development.
5.4 Compliance with
Laws. Each Party shall, and shall ensure that its Affiliates
and Sublicensees shall, comply with all relevant Laws in exercising their rights
and fulfilling their obligations under this Agreement.
6.
|
PAYMENTS
|
6.1 Up-front Fee and Equity
Investment.
(a) Within
ten (10) days after the Effective Date, GenVec shall submit an invoice to
Novartis for a one-time, non-creditable, non-refundable license fee of Five
Million U.S. Dollars (US$5,000,000), which Novartis shall pay, as partial
consideration for the license granted to Novartis under the GenVec IP, within
thirty (30) days after receipt.
(b) In
partial consideration for the license granted to Novartis under the GenVec IP,
as of the Effective Date, GenVec and Novartis Pharma AG have entered into that
certain Stock Purchase Agreement (the “Common Stock Purchase
Agreement”) pursuant to which Novartis Pharma AG has agreed to purchase
approximately Two Million United States dollars (US$2,000,000) of GenVec Common
Stock (as defined in the Common Stock Purchase Agreement).
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
18
6.2 Milestone
Payments. Novartis shall pay GenVec the following amounts
(each a “Milestone
Payment”) after the first achievement by Novartis, its Affiliates or its
Sublicensees, or in the case of Section 6.2(a)(i) or 6.2(a)(ii), GenVec or its
Affiliates, of the corresponding milestone events (each a “Milestone”) set forth
below:
(a) Development and Regulatory
Milestones.
Milestone Event:
|
Milestone Payment for
First Indication:
|
Milestone Payment
for Second
Indication:
|
||
[*]
|
[*]
|
|||
[*]
|
[*]
|
|||
(iii)
Non-rejection of an IND with respect to a Covered Product
|
[*]
|
|||
(iv)
The First Patient First Visit with a Covered Product in a Phase I Clinical
Trial
|
[*]
|
|||
(v)
The First Patient First Visit with a Covered Product in a Phase IIb
Clinical Trial
|
[*]
|
[*]
|
||
(vi)
The First Patient First Visit with a Covered Product in a Phase
III Clinical Trial
|
[*]
|
[*]
|
||
(vii)
Receipt of Regulatory Approval by the FDA with respect to a Covered
Product
|
[*]
|
[*]
|
||
(viii)
Receipt of Regulatory Approval by the EMEA (including reimbursement
approval in at least three (3) of the Major EU Countries) with respect to
a Covered Product
|
|
[*]
|
|
[*]
|
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
19
(b) Sales
Milestones.
Milestone
Event:
|
Milestone
Payment:
|
|
(i) First
Calendar Year in which total Annual Net Sales by Novartis, its Affiliates
and Sublicensees for a Covered Product [*]
|
[*]
|
|
(ii) First
Calendar Year in which total Annual Net Sales by Novartis, its Affiliates
and Sublicensees for a Covered Product [*]
|
[*]
|
|
(iii) First
Calendar Year in which total Annual Net Sales by Novartis, its Affiliates
and Sublicensees for a Covered Product [*]
|
[*]
|
|
(iv) First
Calendar Year in which total Annual Net Sales by Novartis, its Affiliates
and Sublicensees for a Covered Product [*]
|
[*]
|
(c) Each
of the Milestone Payments set forth in Section 6.2 shall be payable
once. If a Milestone described in clauses (iv) to (vi) in Section
6.2(a) occurs before or concurrently with a Milestone described in a preceding
clause in Section 6.2(a), Novartis shall pay the Milestone Payment described in
such earlier clause when the Milestone Payment described in such later clause is
paid. If a Milestone described in Section 6.2(b) occurs before or
concurrently with a Milestone described in a preceding clause in Section 6.2(b),
Novartis shall pay the Milestone Payment described in such earlier clause when
the Milestone Payment described in such later clause is paid. For
example, if the first Milestone that GenVec shall achieve under Section 6.2(b)
is the realization of Annual Net Sales in excess of [*], then in connection with
the payment of [*] to GenVec pursuant to Section 6.2(b)(iv), Novartis shall also
pay to GenVec an additional [*] for achievement of the other Milestones under
Section 6.2(b)(i), (ii) and (iii) in the same Calendar Year.
6.3 Royalties Payable by
Novartis.
(a) Royalty
Rates.
(i) Novartis
shall pay to GenVec royalties on Annual Net Sales of each Covered Product in the
Territory, on a Covered Product-by-Covered Product basis with respect to the
Product IP, at the following rates:
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
20
Annual Net Sales of a Covered Product in the
Territory
|
Royalty Rate
|
|
On
Annual Net Sales less than or equal to [*]
|
[*]
|
|
On
Annual Net Sales greater than [*] and less than or equal to
[*]
|
[*]
|
|
On
Annual Net Sales greater than [*] and less than or equal to
[*]
|
[*]
|
|
On
Annual Net Sales greater than [*] and less than or equal to
[*]
|
[*]
|
|
On
Annual Net Sales greater than [*] and less than or equal to
[*]
|
[*]
|
|
On
Annual Net Sales greater than [*]
|
[*]
|
(ii) Novartis
shall pay to GenVec royalties on Net Sales of each Product in the Territory, on
a Product-by-Product basis with respect to the Production IP, at the following
rates:
Net Sales of a Product in the
Territory in a Calendar Year
|
Royalty Rate
|
|
On
Net Sales in a Calendar Year less than or equal to [*]
|
[*]
|
|
On
Net Sales in a Calendar Year greater than [*]
|
[*]
|
(b) Royalty
Term. The royalties set forth in Section 6.3(a)(i) shall be
payable with respect to a Covered Product and a country during the applicable
Product IP Royalty Term. The royalties set forth in Section
6.3(a)(ii) shall be payable with respect to a Product and a country during the
applicable Production IP Royalty Term. For purposes of clarity, only
one royalty shall be paid on the sale of a Product, either under Section
6.3(a)(i) during the Product IP Royalty Term or Section 6.3(a)(ii) during the
Production IP Royalty Term.
(c) Third Party
Payments.
(i) GenVec
shall be responsible for all payments to Third Parties with respect to licenses
of Intellectual Property Rights granted to GenVec existing as of the Effective
Date. All GenVec agreements with Third Parties with respect to
licenses relating to GenVec IP granted to GenVec and existing as of the
Effective Date are set forth on Exhibit G along with
a description of the payment obligations thereunder. Complete and
correct copies of each such Third Party agreement relating to GenVec IP have
been made available to Novartis.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
21
(ii) If
[*] (A) determines that it is necessary, in order to avoid infringement of any
Intellectual Property Right of a Third Party, to obtain a license from such
Third Party in order to research, develop, use, make, have made, market, offer
to sell, sell, have sold, distribute, import, export or otherwise commercialize
any Atonal Vectors, Gene Fragments or Products in a country in the Territory and
to pay a royalty or other consideration under such license (including in
connection with the settlement of a patent infringement claim), or (B) shall be
subject to a final court or other binding order or ruling requiring any
payments, which may include the payment of a royalty or other consideration, to
a Third Party Intellectual Property Right holder in order to research, develop,
use, make, have made, market, offer to sell, sell, have sold, distribute,
import, export or otherwise commercialize any Atonal Vectors, Gene Fragments or
Products in a country in the Territory, then the amount of Novartis’ Milestone
Payments and royalty payments under, as applicable, Sections 6.2 and
6.3(a)(i) shall, subject to subclause (v), be reduced by [*] of the
amount payable by Novartis to such Third Party.
(iii) If
[*] (A) determines that it is useful (but not necessary) to obtain a license
from a Third Party in order to research, develop, use, make, have made, market,
offer to sell, sell, have sold, distribute, import, export or otherwise
commercialize any Atonal Vectors, Gene Fragments or Products in a country in the
Territory and to pay a royalty or other consideration under such license
(including in connection with the settlement of a patent infringement claim),
then the amount of Novartis’ Milestone Payments and royalty payments under, as
applicable, Sections 6.2 and 6.3(a)(i) shall, subject to subclauses (iv) and
(v), be reduced by [*] of the amount payable by Novartis to such Third
Party.
(iv) In
no event will a deduction, or deductions, under Section 6.3(c)(iii) reduce any
royalty payment made by Novartis pursuant to Section 6.3(a) by more than [*] of
the amount otherwise payable, such royalty rate subject to further reduction
under Section 13.3(b).
(v) In
no event will a deduction, or deductions, under Section 6.3(c)(ii) or Section
6.3(c)(iii) reduce any Milestone Payment made by Novartis pursuant to Section
6.2 by more than [*] of the amount otherwise payable, such Milestone Payments
subject to further reduction under Section 13.3(b), or reduce the royalty rate
payable by Novartis on Net Sales of each Covered Product pursuant to Section
6.3(a)(i) below [*], such royalty rate subject to further reduction under
Section 13.3(b).
(d) Loss of Market
Exclusivity. If, in any Calendar Year, there is a Loss of
Market Exclusivity in a particular country with respect to a Product, then, (i)
if applicable, the Product IP Royalty Term for each such country and each such
Product in each such country shall immediately terminate and (ii) the royalties
payable pursuant to Section 6.3(a)(ii) shall be reduced by [*].
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
22
6.4 Payments for
Research Collaboration and
Additional Research Support.
(a) Novartis
shall make research payments to GenVec in connection with the Research
Collaboration equal to the FTE Rate per FTE assigned to the Research
Collaboration per year. Such payments shall be (i) invoiced to
Novartis in arrears once per Calendar Quarter and (ii) based on the actual
number of FTEs assigned to the Research Collaboration during the preceding
Calendar Quarter. The total payments to GenVec for FTEs assigned to
the Research Collaboration shall not exceed [*] per twelve (12) month period of
the Research Collaboration Term.
(b) Novartis
shall pay GenVec on an hourly basis for the time of GenVec personnel spent to
provide support and expertise at Novartis’ request, as provided for under
Section 4.2, at the rate of [*] per hour, plus travel expenses and out of pocket
costs incurred during and as a result of such travel. Such payments
shall be (i) invoiced to Novartis in arrears once per Calendar Quarter and (ii)
based on the actual number of hours requested by Novartis and spent by such
personnel under Section 4.2 during the preceding Calendar
Quarter. Total payments for such time, including out of pocket and
travel expenses, shall not exceed [*] in any Calendar Year. All out
of pocket and travel expenses shall (i) be approved in writing in advance by
Novartis, (ii) conform to Novartis’ applicable travel and expense policies
(which Novartis shall provide to GenVec and shall periodically update GenVec
regarding any material changes thereto) and (iii) be verified through written
receipts submitted to Novartis.
6.5 Payment
Terms.
(a) Novartis
shall provide GenVec with written notice of the achievement of each Milestone as
soon as reasonably practicable and in any case within [*] after such Milestone
is achieved. After receipt of such notice, GenVec shall submit an
original invoice to Novartis substantially in the form of Exhibit F for the
corresponding Milestone Payment, provided that for any
Milestone no such invoice shall be submitted prior to the Effective Date.
Novartis shall make the corresponding Milestone Payment within [*] after receipt
of such original invoice.
(b) Within
sixty (60) days after each Calendar Quarter during the Term following the First
Commercial Sale of a Product, Novartis will provide to GenVec a Sales &
Royalty Report. After receipt of such report, GenVec shall submit an original
invoice to Novartis substantially in the form of Exhibit F with
respect to the royalty amount and other payments with respect to the royalty
amount shown therein. Novartis shall pay all royalty amounts within
sixty (60) days after receipt of such invoice.
(c) After
each Calendar Quarter during which payments are owed by Novartis under each of
Sections 6.4(a) and 6.4(b), GenVec shall submit an original invoice to Novartis
substantially in the form of Exhibit F with
respect to the amount(s) due under each of Sections 6.4(a) and
6.4(b). Novartis shall make payment on each such invoice within [*]
after Novartis’ receipt of such invoice.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
23
(d) Each
Party shall provide to the other Party an original invoice for all amounts due
to it under this Agreement. Unless otherwise noted, payments on such
invoices shall be made within [*] after the other Party’s receipt of the
applicable invoice. Invoices to Novartis shall be substantially in
the form set forth in Exhibit
F.
(e) All
payments from Novartis to GenVec shall be made by wire transfer in US Dollars to
the credit of such bank account as may be designated by GenVec in this Agreement
or in writing to Novartis. Any payment which falls due on a date
which is not a Business Day may be made on the next succeeding Business
Day.
(f) If
at any time legal restrictions in any country in the Territory prevent the
prompt remittance of any payments with respect to sales therein, Novartis, or
its Affiliate(s), shall have the right and option to make such payments by
depositing the amount thereof in local currency to GenVec’s account in a bank or
depository designated by GenVec in the relevant country.
6.6 Currency. All
payments under this Agreement shall be payable in United States
dollars. When conversion of payments from any foreign currency is
required to be undertaken by Novartis, the United States dollar equivalent shall
be calculated using Novartis’ then-current standard exchange rate methodology as
applied in its external reporting.
6.7 Taxes. GenVec
will pay any and all taxes levied on account of any payments made to it under
this Agreement. If any taxes are required to be withheld by Novartis,
Novartis will: (a) deduct such taxes from the payment made to GenVec;
(b) timely pay the taxes to the proper taxing authority; (c) send
proof of payment to GenVec; and (d) reasonably assist GenVec in its efforts
to obtain a credit for such tax payment. Each Party agrees to
reasonably assist the other Party in lawfully claiming exemptions from and/or
minimizing such deductions or withholdings under double taxation laws or similar
circumstances.
6.8 Records and Audit
Rights.
(a) Each
Party shall keep complete, true and accurate books and records in accordance
with its Accounting Standards in relation to this Agreement, including, with
respect to Novartis, in relation to Net Sales and royalties in sufficient detail
to confirm the accuracy of such amounts. Each Party will keep such
books and records for at least [*] following the Calendar Quarter to which they
pertain.
(b) Subject
to Section 6.8(c), each Party (the “Audit Rights Holder”)
may, upon written request and at its expense (except as provided for in
Section 6.8(f) below), cause an internationally-recognized independent
accounting firm selected by such Party (except one to whom the auditee has a
reasonable objection) (the “Audit Team”) to audit
during ordinary business hours the books and records of the other Party (“Auditee”) and its
Affiliates related to this Agreement, including the correctness of
any payments made or required to be made to or by such Party pursuant to this
Agreement, and any report, data or calculation underlying such payment (or lack
thereof), pursuant to the terms of this Agreement. Prior to
commencing its work pursuant to this Agreement, the Audit Team shall enter into
an appropriate confidentiality agreement with the Auditee. The Audit
Team shall have the right to disclose to the Party requesting the audit its
conclusions regarding any payments owed under this Agreement, and said Party
shall treat such conclusions as Confidential Information pursuant to
Section 8 hereto. For the avoidance of doubt, notwithstanding
the foregoing, the Audit Team shall not disclose to the Party requesting the
audit any more detailed information than such Party would have otherwise been
entitled to receive pursuant to this Agreement.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
24
(c) In
respect of each audit of the Auditee’s books and records: (i) the Auditee shall
be audited not more frequently than once per year; (ii) no records for any given
year for an Auditee may be audited more than once; and (iii) the Audit Rights
Holder shall only be entitled to audit books and records of an Auditee from no
earlier than the [*] prior to the Calendar Year in which the audit request is
made.
(d) In
order to initiate an audit pursuant to this Section 6.8, the Audit Rights Holder
must provide written notice to the Auditee, which notice shall include one or
more proposed dates for the audit and which notice shall be given not less than
[*] prior to the first proposed audit date. The Auditee will
reasonably accommodate the scheduling of such audit. The Auditee
shall provide the Audit Team(s) with full and complete access to the applicable
books and records and otherwise reasonably cooperate with such
audit.
(e) The
audit report and basis for any determination by an Audit Team shall be made
available for review and comment by the Auditee, and the Auditee shall have the
right, at its expense, to request a further determination by such Audit Team as
to matters which the Auditee disputes (to be completed no more than [*] after
the applicable audit report is provided to such Auditee and to be limited to the
disputed matters). If the Parties disagree as to such further
determination, the Audit Rights Holder and the Auditee shall mutually select an
internationally-recognized independent accounting firm that shall make a final
determination as to the remaining matters in dispute, which determination shall
be binding upon the Parties.
(f) If
any audit shows any under-reporting or underpayment, or overcharging by any
Party, the underpaying or overcharging Party shall remit such underpayment or
reimburse such overcompensation to the underpaid or overcharged Party within
sixty (60) days after receiving the final audit report establishing such
obligation and the corresponding original invoice. Further, if the
audit for any one or more Calendar Years shows an under-reporting or
underpayment or an overcharge by the Auditee for that period in excess of [*] of
the amounts properly determined, the Auditee shall reimburse the Audit Rights
Holder for its out-of-pocket expenses, including the fees and expenses paid by
it to the Audit Team(s), in connection with such audit, which reimbursement
shall be made within sixty (60) days of receiving appropriate invoices and other
support for such audit-related costs.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
25
7.
|
INTELLECTUAL
PROPERTY
|
7.1 Ownership of Know-How and
Patent Rights.
(a) Ownership. As
between the Parties, (i) GenVec shall solely own all of the GenVec IP (except
for the [*] Patent Rights, which GenVec shall continue to Control subject to the
rights and licenses granted hereunder and subject to the [*] License Agreement)
and (ii) Novartis shall solely own all of the Research Collaboration IP and
Joint IP.
(b) Inventorship. Inventorship,
for the purposes of this Section 7.1, shall be determined by the Parties in good
faith in accordance with United States patent laws.
(c) Assignment. GenVec
hereby assigns, and shall cause its Affiliates to assign, to Novartis all right,
title and interest that it and its Affiliates may have in the Research
Collaboration IP and Joint IP. GenVec agrees to sign, and cause its
Affiliates to sign, any instruments reasonably requested by Novartis in order to
effect such assignment and to assist Novartis, at the sole cost and expense of
Novartis, in applying for, obtaining and enforcing Patent Rights, copyrights and
other Intellectual Property Rights in any jurisdiction with respect to any
Research Collaboration IP and Joint IP. If GenVec or any of its
Affiliates fails to sign any such instruments as reasonably requested by
Novartis, GenVec hereby appoints, and causes its Affiliates to appoint, any
officer of Novartis or its Affiliates as its duly authorized attorney to
execute, file, prosecute and protect the same before any government agency,
court or authority.
7.2 Prosecution and Maintenance
of Patent Rights.
(a) Research Collaboration IP,
GenVec Patent Rights (other than the [*] Patent Rights) and Joint Patent
Rights.
(i) Initial
Right. As between the Parties, Novartis shall have the sole
right to file, prosecute and maintain any Patent Rights included in the Research
Collaboration IP and the Joint Patent Rights, and the initial right to file,
prosecute and maintain any Product Patent Rights (other than the [*] Patent
Rights) that are solely directed to an Atonal Vector and/or its use in the Field
(the “GenVec Atonal
Vector Patent Rights”), at Novartis’ expense. GenVec shall
have the initial right to file, prosecute and maintain any Production Patent
Rights at GenVec’s expense.
(ii) Coordination of
Prosecution.
(A) GenVec
shall, at Novartis’ expense and reasonable request, assist and cooperate in the
filing, prosecution and maintenance of or any related necessary action for, as
applicable, any Patent Rights included in the Research Collaboration IP, GenVec
Atonal Vector Patent Rights or Joint Patent Rights.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
26
(B) Novartis
shall, where reasonable and where the provision of such materials would not
result in a loss of attorney-client privilege, provide GenVec, sufficiently in
advance for GenVec to comment, with copies of all patent applications and other
material submissions and communications with any patent counsel or patent
authorities pertaining to the GenVec Atonal Vector Patent Rights.
(C) Novartis
shall give due consideration to GenVec’s comments, but shall make the final
determination whether or not to incorporate such comments.
(iii) GenVec Step-In
Right. If Novartis declines to file, prosecute or maintain any
GenVec Atonal Vector Patent Rights, elects to allow any GenVec Atonal Vector
Patent Rights to lapse in any country, or elects to abandon any GenVec Atonal
Vector Patent Rights before all appeals within the respective patent office have
been exhausted, then:
(A) Novartis
shall provide GenVec with reasonable notice of such decision so as to permit
GenVec to decide whether to file, prosecute or maintain such GenVec Atonal
Vector Patent Rights and to take any necessary action.
(B) GenVec
may assume control of the filing, prosecution and/or maintenance of such GenVec
Atonal Vector Patent Rights in the name of the owner(s) of such GenVec Atonal
Vector Patent Rights, at GenVec’s expense.
(C) GenVec
shall have the right to transfer the responsibility for such filing, prosecution
and maintenance of such GenVec Atonal Vector Patent Rights to patent counsel
(outside or internal) selected by GenVec.
(D) Novartis
shall, at GenVec’s expense and reasonable request, assist and cooperate in the
filing, prosecution and maintenance of such GenVec Atonal Vector Patent
Rights.
(iv) Novartis Step-In
Right. If GenVec declines to file, prosecute or maintain any
GenVec Patent Right, elects to allow any GenVec Patent Right to lapse in any
country, or elects to abandon any GenVec Patent Right before all appeals within
the respective patent office have been exhausted, then:
(A) GenVec
shall provide Novartis with reasonable notice of such decision so as to permit
Novartis to decide whether to file, prosecute or maintain such GenVec Patent
Right and to take any necessary action.
(B) Novartis
may assume control of the filing, prosecution and/or maintenance of such GenVec
Patent Right in the name of the owner(s) of such GenVec Patent Right, at
Novartis’s expense.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
27
(C) Novartis
shall have the right to transfer the responsibility for such filing, prosecution
and maintenance of such GenVec Patent Right to patent counsel (outside or
internal) selected by Novartis.
(D) GenVec
shall, at Novartis’s expense and reasonable request, assist and cooperate in the
filing, prosecution and maintenance of such GenVec Patent Right.
(b) [*] Patent
Rights
(i) Initial Right and
Cooperation. Novartis acknowledges that in accordance with
Section 7.1 of the [*] License Agreement, [*] has the first right to file, have
filed, prosecute and maintain the [*] Patent Rights. Novartis is
responsible for payment of all expenses associated with the filing, prosecution
and maintenance of the [*] Patent Rights. GenVec (A) shall comply
with Novartis’ instructions and comments with respect to the filing,
registration, prosecution and maintenance of the [*] Patent Rights and (B)
shall, to the fullest extent permitted under the [*] License Agreement, cause
[*] to comply with such instructions and comments.
(ii) Step-In
Right. GenVec shall, in accordance with Section 11.3(e)(i),
provide Novartis immediate written notice in the event [*] provides GenVec any
notice pursuant to Section 7.2.2 of the [*] License Agreement, and shall provide
Novartis with a copy of any such notice received from [*]. Following
such written notice from GenVec, Novartis, by providing written notice to
GenVec, may exercise the following rights and GenVec shall comply with Novartis’
instructions as follows:
(A) GenVec
shall, at Novartis’ expense and request, file, and continue to prosecute and
maintain such [*] Patent Right in accordance with Novartis’
instructions.
(B) Subject
to the confidentiality provisions of the [*] License Agreement, GenVec shall
provide Novartis, sufficiently in advance for Novartis to comment and direct the
actions of GenVec and/or its agents with respect to such [*] Patent Right, with
copies of all patent applications and other material submissions and
correspondence with any patent counsel or patent authorities pertaining to such
[*] Patent Right.
(C) GenVec
shall not take any action with respect to the filing, prosecution or maintenance
of any [*] Patent Right without prior consultation with
Novartis. GenVec may provide Novartis comments with respect to any
patent applications and other material submissions and correspondence with any
patent counsel or patent authorities pertaining to such [*] Patent Right, but
Novartis shall make the final determination whether or not to incorporate such
comments.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
28
7.3 Patent Rights Term
Extensions. Novartis may select which, if any, GenVec Patent
Rights for which a Patent Term Extension is to be sought or obtained in any
country in the Territory. GenVec shall promptly provide Novartis with
such information as Novartis may reasonably request to comply with any filing
requirements in connection with any such Patent Term Extension.
7.4 Enforcement.
(a) Notice. Within
[*] after becoming aware of any known or alleged infringement by a Third Party
of the Research Collaboration IP, GenVec Patent Rights and/or Joint Patent
Rights, including any “patent certification” filed in the United States under 21
U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other
jurisdictions (a “Paragraph IV
Certification”), and of any declaratory judgment, opposition, or similar
action alleging the invalidity, unenforceability or non-infringement of the
Research Collaboration IP, GenVec Patent Rights and/or Joint Patent Rights, each
Party shall provide the other Party written notice reasonably detailing such
known or alleged infringement.
(b) Initial
Right. As between the Parties, Novartis shall have the first
right, but not the obligation, to protect the GenVec Patent Rights from any
actual or suspected infringement or misappropriation. In any legal
action so brought by Novartis, GenVec shall at Novartis’ request join in such
action as a party at Novartis’ expense in the event that an adverse party
asserts, the court rules or other Laws provide, or Novartis determines in good
faith, that a court would lack jurisdiction based on GenVec’s absence as a party
in such suit; but control of such action shall remain with
Novartis. At Novartis’ request and expense, GenVec shall provide
reasonable assistance to Novartis in connection with such action. Any
recoveries resulting from such an action shall be first applied against payment
of Novartis’ costs and expenses in connection therewith. Any remainder shall be
treated as Net Sales and any applicable royalty thereon paid to
GenVec.
(c) Third Party Enforcement
Rights. Novartis acknowledges that after the Effective Date
GenVec may license certain rights in Adenovectors and GenVec Patent Rights
related to such Adenovectors to Third Parties and that such Third Parties may
require the right to protect such GenVec Patent Rights from any actual or
suspected infringement or misappropriation. In such case, the Parties
agree to negotiate in good faith terms under which such Third Parties may
enforce such GenVec Patent Rights. For the purposes of clarity, in no
event shall the foregoing apply to Atonal Vector Patent Rights.
(d) Step-In on GenVec Patent
Rights. If Novartis does not commence a legal action to enjoin
an infringement of GenVec Patent Rights anywhere in the Territory, within [*]
(or, with respect to a Paragraph IV Filing, within [*]) of being notified of
such infringement, GenVec may, at its expense, commence the
action. Novartis shall join in such action as a party at GenVec’s
request and expense in the event that an adverse party asserts, the court rules
or other Laws provide, or GenVec determines in good faith, that a court would
lack jurisdiction based on Novartis’ absence as a party in such suit, but
control of such action shall remain with GenVec. Any recoveries
resulting from such an action shall be retained by GenVec.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
29
7.5 Claimed
Infringement. If a Party becomes aware that the research,
development, use, making, having made, marketing, offering to sell, selling,
having sold, distribution, importation, exportation or other commercialization
of Atonal Vectors, Gene Fragments or Products in the Field in the
Territory by Novartis, its Affiliates or Sublicensees, infringes or
misappropriates, or is likely or is alleged to infringe or misappropriate, the
Intellectual Property Rights of any Third Party, such Party shall promptly
notify the other Party, and Novartis shall have the sole right and
responsibility to take any action it deems appropriate with respect
thereto.
8.
|
CONFIDENTIAL
INFORMATION AND PERSONAL
INFORMATION
|
8.1 Non-Use and Non-Disclosure
of Confidential Information. Each Receiving Party agrees that
all Confidential Information of the Disclosing Party (a) shall not be used by
the Receiving Party except to perform its obligations or exercise its rights
under this Agreement, (b) shall be maintained in confidence by the Receiving
Party, and (c) except as permitted by Sections 8.2 and 8.3, shall not be
disclosed by the Receiving Party to any Person without the prior written consent
of the Disclosing Party. Notwithstanding the foregoing, GenVec agrees
not to disclose to any Third Party any GenVec Know-How that is exclusively
licensed to Novartis and its Affiliates hereunder without the prior written
consent of Novartis.
8.2 Permitted
Disclosures. The Receiving Party may provide the Disclosing
Party’s Confidential Information:
(a) to
the Receiving Party’s and its Affiliates’ employees, consultants and advisors
who have a need to know such Confidential Information and are bound by an
obligation to maintain the confidentiality of the Disclosing Party’s
Confidential Information to the same extent as if they were parties
hereto;
(b) to
the employees, consultants and advisors of Sublicensees and potential
Sublicensees who have a need to know such Confidential Information for purposes
of the Receiving Party or its Affiliates granting sublicenses under Intellectual
Property Rights as permitted herein and who are bound by an obligation to
maintain the confidentiality of the Disclosing Party’s Confidential Information
to the same extent as if they were parties hereto;
(c) to
patent offices or Regulatory Authorities in order to seek or obtain Patent
Rights or approval to conduct Clinical Trials, or to gain Regulatory Approval as
provided herein; provided, that such
disclosure may be made only to the extent reasonably necessary to seek or obtain
such Patent Rights or approvals; and
(d) if
such disclosure is required by Law (including by rules or regulations of any
securities exchange or NASDAQ) or to defend or prosecute litigation or
arbitration; provided that prior
to such disclosure, to the extent permitted by Law or such rules or regulations,
the Receiving Party promptly notifies the Disclosing Party of such requirement
and furnishes only that portion of the Disclosing Party’s Confidential
Information that the Receiving Party is legally required to
furnish.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
30
8.3 Publicity. Neither
Party shall have the right to make any public announcements or scientific
publications with respect to this Agreement, nor publicly disclose the terms of
this Agreement, without the prior written consent of the other Party, except as
follows:
(a) Each
Party may disclose the terms of this Agreement to the extent such disclosure is
required by Law (including by rules or regulations of any securities exchange or
NASDAQ) or to defend or prosecute litigation or arbitration; provided, that, prior
to such disclosure, to the extent permitted by Law or such rules or regulations,
the disclosing Party promptly notifies the other Party of such requirement and
the disclosing Party furnishes only those terms of this Agreement that the
disclosing Party is legally required to furnish.
(b) Each
Party may make subsequent disclosures of information which has been previously
disclosed in accordance with this Agreement.
(c) Each
Party may publicly file this Agreement with the United States Securities and
Exchange Commission or any other relevant securities commission in any country,
and shall request, and use commercially reasonable efforts to obtain
confidential treatment of all terms permitted to be redacted; provided, that the
redaction of such terms is permitted by the applicable rules and regulations of
the United States Securities and Exchange Commission or any such securities
commission.
(d) GenVec
may disclose this Agreement to [*] as required by the [*] License
Agreement.
(e) Novartis
may disclose this Agreement to Novartis’ Affiliates and then-current and
potential Third Party licensors and Sublicensees; provided, that such
Persons are bound to maintain the confidentiality of this Agreement to the same
extent as if they were parties hereto.
8.4 Privacy of Personal
Information.
(a) In
the course of performance of this Agreement, GenVec may acquire the Personal
Information of individuals from various sources and countries. GenVec
will, and will cause its Affiliates and agents to, process all Personal
Information it acquires under or in connection with this Agreement in compliance
with all applicable data protection laws, including the data protection laws of
the European Union, European Economic Area, Switzerland, the United States and
various localities therein. The Parties acknowledge and agree that,
with respect to such Personal Information, GenVec is not a Covered Entity or a
Business Associate, as such terms are defined in the Health Insurance
Portability and Accountability Act of 1996 and the regulations promulgated
thereto (“HIPAA”). GenVec
acknowledges that the requirements under such data protection laws may exceed
the requirements applicable to Confidential Information as defined or otherwise
set forth in this Section 8, and in such cases, the data protection laws shall
control. Novartis may, on reasonable prior notice to GenVec, audit
GenVec’s compliance with such data protection laws.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
31
(b) This
Agreement contains the Personal Information of one or more
individuals. This Agreement, and the Personal Information contained
herein, from time to time may be transferred to, stored or otherwise processed
in the United States or other countries that have privacy and data protection
laws that differ from, or are not as stringent as, those where the Agreement was
executed or where the individual(s) resides. The Personal Information
disclosed in this Agreement will be used for the purposes of administration and
enforcement of this Agreement and/or other actual or potential legal and
business transactions involving the Parties. Storage or processing of
Personal Information disclosed in this Agreement may be electronic and/or off
line. Execution and delivery of this Agreement constitutes the
representation by each Party to this Agreement that if required by the privacy
laws applicable to such individuals, the individuals identified herein by such
Party have been notified of and have consented to, the transfer, storage, and
processing of such Personal Information, as described in this
paragraph.
9.
|
INDEMNIFICATION
|
9.1 Indemnification by
Novartis.
Novartis
agrees to defend the GenVec Indemnitees, at Novartis’ cost and expense, and will
indemnify and hold harmless the GenVec Indemnitees from and against any and all
losses, costs, damages, fees or expenses (“Losses”) relating to
or in connection with a Third Party claim arising out of (a) any actual or
alleged death, personal bodily injury or damage to real or tangible personal
property claimed to result, directly or indirectly, from the possession, use or
consumption of, or treatment with, any Product, developed or commercialized by
or on behalf of Novartis, its Affiliates or Sublicensees; or (b) any breach by
Novartis of its representations or warranties made under this Agreement; provided, however, that the
foregoing indemnity shall not apply to the extent that any such Losses (i) are
attributable to the negligence or willful misconduct of the GenVec Indemnitees,
or (ii) are otherwise subject to an obligation by GenVec to indemnify the
Novartis Indemnitees under Section 9.2. In the event of any such
claim against any GenVec Indemnitee, GenVec shall promptly notify Novartis in
writing of the claim; provided, however, that failure
or delay to notify Novartis shall not relieve Novartis of any obligation or
liability that it may have to any GenVec Indemnitee, except to the extent that
such failure or delay adversely affected Novartis’ ability to defend or resolve
such claim. Novartis shall manage and control, at its sole expense,
the defense of the claim and its settlement. The relevant GenVec
Indemnitees shall cooperate with Novartis and may, at such GenVec Indemnitees’
option and expense, be represented in any such action or
proceeding. Novartis shall not be liable for any settlements,
litigation costs or expenses incurred by any GenVec Indemnitees without
Novartis’ written authorization.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
32
9.2 Indemnification by
GenVec. GenVec agrees to defend the Novartis Indemnitees, at
GenVec’s cost and expense, and will indemnify and hold harmless the Novartis
Indemnitees from and against any and all Losses, relating to or in connection
with a Third Party claim arising out of (a) any breach by GenVec of its
representations or warranties made under this Agreement, or (b) any negligent
act or omission or willful misconduct of any GenVec Indemnitees in performing
GenVec’s obligations or exercising GenVec’s rights under this Agreement; provided, however, that the
foregoing indemnity shall not apply to the extent that any such Losses are
attributable to (i) the negligence or willful misconduct of the Novartis
Indemnitees, or (ii) are otherwise subject to an obligation by Novartis to
indemnify the GenVec Indemnitees under Section 9.1. In the event of
any such claim against any Novartis Indemnitee, Novartis shall promptly notify
GenVec in writing of the claim; provided, however, that failure
or delay to notify GenVec shall not relieve GenVec of any obligation or
liability that it may have to any Novartis Indemnitee, except to the extent that
such failure or delay adversely affected GenVec’s ability to defend or resolve
such claim. GenVec shall manage and control, at its sole expense, the
defense of the claim and its settlement. The relevant Novartis
Indemnitees shall cooperate with GenVec and may, at such Novartis Indemnitees’
option and expense, be represented in any such action or
proceeding. GenVec shall not be liable for any settlements,
litigation costs or expenses incurred by any Novartis Indemnitees without
GenVec’s written authorization.
9.3 Allocation. In
the event a claim is based partially on an indemnified claim and partially on a
non-indemnified claim or based partially on a claim indemnified by one Party and
partially on a claim indemnified by the other Party, any payments in connection
with such claims are to be apportioned between the Parties in accordance with
the degree of cause attributable to each Party.
10.
|
INSURANCE
|
Each
Party shall use commercially reasonable efforts to maintain Third Party
insurance and/or self-insurance, as applicable, with respect to its activities
hereunder in amounts customary to such insurance and sufficient to meet its
obligations under this Agreement, and shall claim upon such insurance policy
according to such policy’s relevant terms and conditions before relying upon
indemnification from the other Party.
11.
|
WARRANTIES AND
COVENANTS
|
11.1 Mutual
Warranties. Each Party warrants that:
(a) it
is a corporation duly organized and in good standing under the Laws of the
jurisdiction of its incorporation, and it has full power and authority and the
legal right to own and operate its property and assets and to carry on its
business as it is now being conducted and as it is contemplated to be conducted
by this Agreement;
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
33
(b) it
has the full right, power and authority to enter into this Agreement, to perform
its obligations under this Agreement and to grant the rights and licenses
granted by it under this Agreement;
(c) as
of the Effective Date, there are no existing or, to its knowledge, threatened
actions, suits or claims pending with respect to the subject matter of this
Agreement or its right to enter into and perform its obligations under this
Agreement;
(d) as
of the Effective Date, it has taken all necessary action on its part to
authorize the execution and delivery of this Agreement and the performance of
its obligations under this Agreement;
(e) this
Agreement has been duly executed and delivered on behalf of it, and constitutes
a legal, valid, binding obligation, enforceable against it in accordance with
the terms hereof, subject to the general principles of equity and to bankruptcy,
insolvency, moratorium and other similar Laws affecting the enforcement of
creditors’ rights generally;
(f) as
of the Effective Date, all necessary consents, approvals and authorizations of
all Regulatory Authorities and Governmental Authorities and other Persons
required to be obtained by it in connection with the execution and delivery of
this Agreement and the performance of its obligations under this Agreement have
been obtained; and
(g) the
execution and delivery of this Agreement and the performance of its obligations
hereunder do not conflict with, or constitute a default under, any of its
contractual obligations.
11.2 Additional GenVec
Warranties. GenVec warrants to Novartis that, as of the
Effective Date:
(a) GenVec
has the right to grant to Novartis and its Affiliates the rights so granted
hereunder under the GenVec IP, Research Collaboration IP and Joint
IP.
(b) To
the knowledge of GenVec, the patents and patent applications encompassed within
the GenVec Patent Rights, are, or, upon issuance, will be, valid and enforceable
patents and no Third Party (i) is infringing any such patents as of the
Effective Date or (ii) has challenged the extent, validity or enforceability of
such patents (including by way of example through the institution or written
threat of institution of interference, nullity or similar invalidity proceedings
before the United States Patent and Trademark Office or any analogous foreign
entity).
(c) To
the knowledge of GenVec the research, development, manufacture, use, sale, offer
for sale, distribution, importation or exportation by Novartis (or its
respective Affiliates) of Products does not and will not infringe any issued
patent of any Third Party.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
34
(d) GenVec
has heretofore disclosed to Novartis all material information relevant or
relating to validity and enforceability of the GenVec IP.
(e) To
the knowledge of GenVec, GenVec has heretofore disclosed to Novartis all
material information relevant or relating to validity and enforceability of the
[*] Patent Rights.
(f) GenVec
has heretofore disclosed to Novartis all material information relating to an
issue of possible infringement or misappropriation of Intellectual Property
Rights of Third Parties with respect to Adenovectors, Atonal Vectors, Gene
Fragments or Products.
(g) Exhibit B contains a
complete and correct list of all patents and patent applications owned by or
otherwise Controlled by GenVec as of the Effective Date (and identifies the
entity that owns and the entity that Controls each patent and patent
application) relating to Adenovectors, Atonal Vectors, Gene Fragments and
Products.
(h) Except
for the Intellectual Property Rights under the Prior License and [*] Patent
Rights (which are indicated on Exhibit B) (i) GenVec
is the sole legal and beneficial owner of all the GenVec IP, free of any lien,
encumbrance, charge, security interest, mortgage or other similar restriction,
and (ii) no Person (including any Affiliate of GenVec) has any right, interest
or claim in or to, and neither GenVec nor any of its Affiliates has entered into
any agreement granting any right, interest or claim in or to, any GenVec IP to
any Third Party.
(i) GenVec
and its patent counsel have complied with all applicable Laws, including any
disclosure requirements, in connection with the filing, prosecution and
maintenance of the GenVec Patent Rights in the Territory.
(j) With
the exception of the [*] Patent Rights, the GenVec IP was not developed with
funding from the United States government or any other Governmental Authority
and no Governmental Authority has any rights in any GenVec IP.
(k) Except
with respect to the [*] Patent Rights, GenVec has obtained assignments from the
disclosed and named inventors of all inventorship and ownership rights relating
to the GenVec Patent Rights, all inventors are disclosed and named in the GenVec
Patent Rights and all such assignments of inventorship rights relating to the
GenVec Patent Rights are valid and enforceable. GenVec has paid all remuneration
or other compensation required under applicable Law to inventors of the GenVec
Patent Rights.
(l) To
the knowledge of GenVec, [*] has obtained assignments from the inventors of all
inventorship and ownership rights relating to the [*] Patent Rights, all
inventors are disclosed and named in the [*] Patent Rights and all such
assignments of inventorship rights relating to the [*] Patent Rights are valid
and enforceable. To the knowledge of GenVec, [*] has paid all
remuneration or other compensation required under applicable Law to inventors of
the [*] Patent Rights.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
35
(m) None
of the GenVec IP has been licensed or otherwise made available (including
pursuant to any immunity from suit arrangement) to GenVec or any of its
Affiliates from a Third Party.
(n) GenVec
has heretofore disclosed to Novartis all material correspondence and contact
information between GenVec and the FDA and any other Regulator Authorities
regarding Adenovectors, Atonal Vectors, Gene Fragments or Products.
(o) GenVec
has heretofore disclosed to Novartis all material information relating to safety
known to it or its Affiliates with respect to Adenovectors, Atonal Vectors, Gene
Fragments or Products.
(p) There
is no action, claim, demand, suit, proceeding, arbitration, grievance, citation,
summons, subpoena, inquiry or investigation of any nature, civil, criminal,
regulatory or otherwise, in law or in equity, pending or, to the knowledge of
GenVec, threatened against GenVec, any of its Affiliates or any Third Party, in
each case in connection with the GenVec IP, Adenovectors, Atonal Vectors, Gene
Fragments or Products.
(q) All
GenVec employees, agents and consultants who will be involved in any aspect of
the Research Collaboration or in providing support and expertise to Novartis or
its Affiliates pursuant to Section 4.2 have executed agreements or have existing
obligations under Law requiring assignment to GenVec of all inventions made
during the course of and as the result of their association with
GenVec.
11.3 Covenants of
GenVec. GenVec hereby covenants and agrees that:
(a) GenVec
shall not incur or permit to exist (and shall cause each of its Affiliates not
to incur or permit to exist), with respect to any GenVec IP, any lien,
encumbrance, charge, security interest, mortgage, liability, grant of license to
Third Parties or other restriction (including in connection with any
indebtedness).
(b) GenVec
shall fulfill its obligations under the [*] License Agreement to the extent such
obligations have not been delegated to Novartis.
(c) GenVec
shall not enter into any subsequent agreement with [*] that modifies or amends
the [*] License Agreement without Novartis’ prior written consent, and shall
provide Novartis with a copy of all proposed modifications to or amendments of
the [*] License Agreement.
(d) GenVec
shall not terminate the [*] License Agreement in whole or in part without
Novartis’ prior written consent.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
36
(e) GenVec
shall promptly furnish Novartis with copies of all communications GenVec
receives from [*] that relate to (i) the [*] License Agreement, including any
determination by [*] not to file, have filed, prosecute or maintain any [*]
Patent Rights; or (ii) researching, developing, using, making, having made,
marketing, offering to sell, selling, having sold, distributing, importing,
exporting or otherwise commercializing Adenovectors, Atonal Vectors, Gene
Fragments or Products in the Field in the Territory.
(f) GenVec
shall promptly furnish Novartis with copies of all reports and other
communications that GenVec furnishes to [*] that relate to researching,
developing, using, making, having made, marketing, offering to sell, selling,
having sold, distributing, importing, exporting or otherwise commercializing
Adenovectors, Atonal Vectors, Gene Fragments or Product in the Field in the
Territory, and GenVec shall, to the extent permitted under the [*] License
Agreement, allow Novartis to review and comment on such reports or before they
are transmitted to [*].
(g) GenVec
shall, within two (2) Business Days after GenVec’s receipt thereof, furnish
Novartis with copies of all notices received by GenVec relating to any alleged
breach or default by GenVec under the [*] License Agreement. GenVec
shall determine within five (5) Business Days of its receipt of such notice from
[*] if it can and/or will cure such alleged breach or default. If
GenVec determines that it cannot or will not cure such alleged breach or
default, GenVec shall so notify Novartis within two (2) Business Days after such
determination. In such case, GenVec shall allow Novartis, in its sole
discretion, to cure such alleged breach or default on behalf of GenVec, under
the terms of the [*] License Agreement, and shall fully cooperate with Novartis
to cure such alleged breach or default.
(h) GenVec
shall pay all remuneration or other compensation required under applicable Law
to all inventors of Research Collaboration IP and Joint IP who are employees,
agents or consultants of GenVec.
11.4 No Debarment. GenVec
certifies that neither it, nor any of its employees nor agents, have ever been,
are currently, or are the subject of a proceeding that would reasonably be
expected to lead to it or such employees or agents becoming, as applicable, a
Debarred Entity or Debarred Individual, an Excluded Entity or Excluded
Individual or a Convicted Entity or Convicted Individual. GenVec
certifies that if, during the Term, it, or any of its employees or agents,
become or are the subject of a proceeding that would reasonably be expected to
lead to a person becoming, as applicable, a Debarred Entity or Debarred
Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or
Convicted Individual, GenVec shall immediately notify Novartis in
writing. For purposes of this provision, the following definitions
shall apply:
(a) A
“Debarred
Individual” is an individual who has been debarred by the FDA pursuant to
21 U.S.C. §335a (a) or (b) from providing services in any capacity to a person
that has an approved or pending drug or biological product
application.
(b) A
“Debarred
Entity” is a corporation, partnership or association that has been
debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or
assisting in the submission of any abbreviated drug application.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
37
(c) An
“Excluded
Individual” or “Excluded Entity” is
(i) an individual or entity, as applicable, who has been excluded, debarred,
suspended or is otherwise ineligible to participate in Federal health care
programs (as defined in 43 U.S.C. §1320a-7b(f)(1)), such as Medicare or
Medicaid, by the Office of the Inspector General (OIG/HHS) of the U.S.
Department of Health and Human Services, or (ii) is an individual or entity, as
applicable, who has been excluded, debarred, suspended or is otherwise
ineligible to participate in federal procurement and non-procurement programs,
including those produced by the U.S. General Services Administration
(GSA).
(d) A
“Convicted
Individual” or “Convicted Entity” is
an individual or entity, as applicable, who has been convicted of a criminal
offense described in 21 U.S.C. §335a (a) or 42 U.S.C. §1320a - 7(a), but has not
yet been excluded, debarred, suspended or otherwise declared ineligible as
described in clauses (a), (b) or (c) of this provision.
11.5 Disclaimer. EXCEPT
AS OTHERWISE EXPRESSLY SET FORTH IN THIS SECTION 11, NEITHER PARTY MAKES ANY
REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, QUALITY, FITNESS FOR A
PARTICULAR PURPOSE, NONINFRINGEMENT, OR VALIDITY OF PATENT
CLAIMS. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A
REPRESENTATION MADE OR WARRANTY GIVEN BY EITHER PARTY THAT EITHER PARTY WILL BE
SUCCESSFUL IN OBTAINING ANY PATENT RIGHTS, THAT ANY PATENTS WILL ISSUE BASED ON
A PENDING APPLICATION.
12.
|
LIMITATION OF
LIABILITY
|
UNLESS
RESULTING FROM A PARTY’S WILLFUL MISCONDUCT OR FROM A PARTY’S BREACH OF SECTION
8, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR
SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, PUNITIVE, MULTIPLE OR OTHER
INDIRECT DAMAGES, OR FOR LOSS OF PROFITS, LOSS OF DATA, LOSS OF REVENUE, OR LOSS
OF USE DAMAGES, ARISING FROM OR RELATING TO THIS AGREEMENT, WHETHER BASED XXXX
XXXXXXXX, XXXXXXXX, XXXX, XXXXXXXXXX, XXXXXX LIABILITY OR OTHERWISE, REGARDLESS
OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 12 IS INTENDED
TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY
UNDER THIS AGREEMENT.
13.
|
TERMINATION
|
13.1 Term. This
Agreement becomes effective as of the Effective Date and shall continue until
the earlier of (a) the termination of this Agreement in accordance with Section
13.2 or (b) following the First Commercial Sale of any Product, the expiration
of the last-to-expire of all Royalty Terms with respect to all Products (the
“Term”).
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
38
13.2 Termination
(a) Termination For
Convenience. Novartis shall have the right to terminate this
Agreement for convenience upon sixty (60) days prior written notice to
GenVec.
(b) Termination For Material
Breach. If either Party (the “Non-Breaching Party”)
believes that the other Party (the “Breaching Party”) is
in material breach of this Agreement (including any material breach of a
representation or warranty made in this Agreement), then the Non-Breaching Party
may deliver notice of such breach to the Breaching Party. If the
Breaching Party fails to cure such breach within the [*] period after the
Breaching Party’s receipt of such notice, the Non-Breaching Party may terminate
this Agreement in its entirety upon written notice to the Breaching
Party.
(c) Partial Termination For
Material Breach. If GenVec is in material breach of this
Agreement (including any material breach of a representation or warranty made in
this Agreement), then Novartis may deliver notice of such breach to
GenVec. If GenVec fails to cure such breach within the [*] period
after GenVec’s receipt of such notice, Novartis may (in lieu of its right to
terminate the entire Agreement under Section 13.2(b)) terminate any or all of
Sections 3, 4.1, 4.2, 5.2 and 5.3 of this Agreement upon written notice to
GenVec.
13.3 Effects Of
Termination.
(a) Upon
termination of this Agreement by Novartis pursuant to Section 13.2(a) or by
either Party pursuant to Section 13.2(b) all licenses granted by GenVec to
Novartis hereunder shall terminate; provided that should Novartis or any of its
Affiliates or Sublicensees have any inventory of any Products, each of them
shall have eighteen (18) months thereafter in which to dispose of such
inventory (subject to the obligation to pay to GenVec any amounts due GenVec
hereunder thereon).
(b) Upon
termination of one or more Sections of this Agreement by Novartis pursuant to
Section 13.2(c), any amounts payable by Novartis to GenVec pursuant to Section
6.2 and Section 6.3 shall be reduced to [*] of the amount that would otherwise
have been payable under the terms of the Agreement during its term, but the
other terms of this Agreement which have not been so terminated shall remain in
full force and effect.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
39
(c) In
addition, upon termination of this Agreement by Novartis pursuant to Section
13.2(a) or by GenVec pursuant to Section 13.2(b), then GenVec shall have the
option, with respect to all Product(s), to assume worldwide responsibility for
development and commercialization of such Product(s), including regulation,
manufacturing, distribution, marketing and sales activities for such
Product(s). GenVec may exercise such option for each such Product by
providing written notice to Novartis within [*] after the termination of this
Agreement by Novartis pursuant to Section 13.2(a) or by GenVec pursuant to
Section 13.2(b), as the case may be. If GenVec exercises its option
with respect to one or more such Product(s), then Novartis shall grant to GenVec
(i) an exclusive, royalty-bearing, sublicenseable (in accordance with Section
2.1(b), with changes mutatis
mutandis), non-transferable (except in accordance with Section 14.1)
license, under the Joint IP and Research Collaboration IP necessary to research,
develop, use, make, have made, market, offer to sell, sell, have sold,
distribute, import, export and otherwise commercialize such Product(s) in the
Field in the Territory, and (ii) a non-exclusive, royalty-bearing,
sublicenseable (in accordance with Section 2.1(b), with changes mutatis mutandis),
non-transferable (except in accordance with Section 14.1) license, under the
Intellectual Property Rights Controlled by Novartis and its Affiliates, as
necessary to research, develop, use, make, have made, market, offer to sell,
sell, have sold, distribute, import, export and otherwise commercialize such
Product(s) in the First Indication in the Territory. GenVec shall pay
to Novartis consideration for the rights to develop and commercialize such
Product(s) and for the licenses granted in the preceding
sentence. Such consideration shall be negotiated in good faith by the
Parties at the time of such option exercise, and shall consist, at a minimum, of
[*].
(d) The
following provisions shall survive the expiration or termination of this
Agreement: Sections 1, 4.3, 6.5, 6.6, 6.7, 6.8, 7.1, 8, 9, 12,
13.2(c) and 14, and, with respect to Joint IP and Research Collaboration IP,
7.2(a)(i) and 7.2(a)(ii)(A).
(e) Upon
the expiration of all applicable Royalty Terms with respect to a Product and a
country, Novartis and its Affiliates shall have a fully paid-up, non-exclusive,
perpetual license to use the GenVec IP to research, develop, use, make, have
made, market, offer to sell, sell, have sold, distribute, import, export or
otherwise commercialize such Product in the Field in such country.
(f) Expiration
or termination of this Agreement shall not relieve the Parties of any obligation
which has accrued prior to such expiration or
termination. Termination of this Agreement shall be in addition to,
and shall not prejudice, the Parties’ remedies at law or in equity, including
the Parties’ ability to receive legal damages and/or equitable relief with
respect to any breach of this Agreement, regardless of whether or not such
breach was the reason for the termination.
14.
|
MISCELLANEOUS
|
14.1 Assignment. Neither
this Agreement nor any of the rights or obligations hereunder may be assigned by
a Party without the prior written consent of the other Party, except (a)
Novartis may assign this Agreement, in whole or in part, to an Affiliate of
Novartis; and (b) each Party may assign this Agreement, in whole, to a Person
that acquires, by merger, sale of assets or otherwise, all or substantially all
of the business of the assigning Party to which the subject matter of this
Agreement relates. Any assignment not in accordance with the
foregoing shall be void. This Agreement shall be binding upon, and
shall inure to the benefit of, all permitted successors and
assigns. Each Party agrees that, notwithstanding any provisions of
this Agreement to the contrary, in the event that this Agreement is assigned by
a Party in connection with the sale or transfer of all or substantially all of
the business of such Party to which the subject matter of this Agreement
relates, such assignment shall not provide the non-assigning Party with rights
or access to the Intellectual Property Rights of the acquirer of such assigning
Party.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
40
14.2 Force
Majeure. Neither Party will be held liable or responsible to
the other Party nor be deemed to have breached this Agreement for failure or
delay in fulfilling or performing any provision of this Agreement when such
failure or delay results from causes beyond the reasonable control of the
affected Party, which may include embargoes, acts of war (whether declared or
not), insurrections, riots, civil commotions, acts of terrorism, strikes,
lockouts or other labor disturbances, or acts of God. The affected
Party will notify the other Party of such force majeure circumstances as soon as
reasonably practical (including its best estimate of the likely extent and
duration of the interference with its activities), and will make every
reasonable effort to mitigate the effects of such force majeure circumstances
and to resume performance of its obligations hereunder.
14.3 Notices.
Notices
to Novartis shall be addressed to:
Novartis Institutes for
BioMedical Research, Inc.
000 Xxxxxxxxxxxxx
Xxxxxx
Xxxxxxxxx, XX 00000
XXX
Attention: General
Counsel
Fax: (000)
000-0000
Notices
to GenVec shall be addressed to:
00
Xxxx Xxxxxxx Xxxx Xxxx
Xxxxxxxxxxxx, XX 00000
XXX
Attention: President
Fax: (000) 000-0000
With a
copy to:
XxXxxxxxx Will & Xxxxx
LLP
000 Xxxxxxxxxx Xxxxxx,
XX
Xxxxxxxxxx, XX
00000
XXX
Attention: Xxxxxx
Xxxxxxxx and Xxxxxx Xxxxx
Fax: (000)
000-0000
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
41
Any Party
may change its address by giving notice to the other Party in the manner
provided in this Section 14.3. Any notice required or provided for by
the terms of this Agreement shall be in writing, in the English language, and
shall be (a) sent by certified or registered mail, return receipt requested,
postage prepaid, (b) sent via an internationally recognized overnight courier
service, (c) sent by facsimile transmission, or (d) delivered by
hand. The effective date of the notice shall be the actual date of
receipt by the receiving Party.
14.4 Corporate
Citizenship. Novartis gives
preference to Third Parties who share Novartis’ societal and environmental
values, as set forth in the Novartis Policy on Corporate Citizenship and
Novartis Corporate Citizenship Guideline #5, both of which are attached as Exhibit H and
incorporated herein by reference. Accordingly, GenVec represents and
warrants that this Agreement will be performed in material compliance with all
applicable laws and regulations, including laws and regulations relating to
health, safety and the environment, fair labor practices and unlawful
discrimination.
14.5 Relationship of the
Parties. The Parties shall be deemed independent contractors
for all purposes hereunder. This Agreement does not constitute a
partnership, joint venture or agency between the Parties. Neither
Party is an agent of the other Party and has no authority to represent the other
Party as to any matters.
14.6 Governing
Law. This Agreement shall be governed by and construed in
accordance with the Laws of the State of New York, other than any principle of
conflict or choice of laws that would cause the application of the Laws of any
other jurisdiction; provided, that
matters of intellectual property law concerning the existence, validity,
ownership, infringement or enforcement of intellectual property shall be
determined in accordance with the national intellectual property Laws relevant
to the intellectual property in question.
14.7 Dispute
Resolution. Matters before the JSC shall be governed by the
process specified in Section 3.5. Any controversy, claim or dispute
arising out of or relating to this Agreement that is not subject to Section 3.5,
shall be settled, if possible, through good faith negotiations between the
Parties. All negotiations pursuant to this Section 14.7 are
confidential and shall be treated as compromise and settlement negotiations for
purposes of applicable rules of evidence. If the Parties are unable
to settle the dispute within twenty (20) days after commencement of good faith
negotiations pursuant to this Section 14.7, then each Party reserves its right
to any and all remedies available under law or equity with respect to the
dispute; provided that any Party may seek immediate injunctive or other interim
relief from any court of competent jurisdiction as necessary to enforce the
provisions of Section 8 and to enforce and prevent infringement or
misappropriation of the Patent Rights, Know-How or Confidential Information
Controlled by such Party
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
42
14.8 Consent to
Jurisdiction. Each
Party irrevocably submits to the exclusive jurisdiction of the United States
District Court for the Southern District of New York for the purposes of any
suit, action or other proceeding arising out of the this
Agreement. Each Party agrees to commence any such action, suit or
proceeding in the United States District Court for the Southern District of New
York or if such suit, action or other proceeding may not be brought in such
court for jurisdictional reasons, in the Supreme Court of the State of New York,
New York County. Each Party further agrees that service of any
process, summons, notice or document by U.S. registered mail to such Party’s
respective address set forth in Section 14.3 shall be effective service of
process for any action, suit or proceeding in New York with respect to any
matters to which it has submitted to jurisdiction in this Section 14.8. Each
Party irrevocably and unconditionally waives any objection to the laying of
venue of any action, suit or proceeding arising out of this Agreement in the
United States District Court for the Southern District of New York, and hereby
and thereby further irrevocably and unconditionally waives and agrees not to
plead or claim in any such court that any such action, suit or proceeding
brought in any such court has been brought in an inconvenient
forum.
14.10 Severability. If,
under applicable Law, any provision of this Agreement is invalid or
unenforceable, or otherwise directly or indirectly affects the validity of any
other material provision(s) of this Agreement (“Severed Clause”), the
Parties mutually agree that this Agreement shall endure except for the Severed
Clause. The Parties shall consult and use commercially reasonable
efforts to agree upon a valid and enforceable provision that best accomplishes
the original intentions of the Parties. Notwithstanding the
foregoing, in the event that the Parties cannot reach a mutually agreeable and
enforceable replacement for such provision, then (a) such provision shall be
excluded from this Agreement, (b) the balance of this Agreement shall be
interpreted as if such provision were so excluded such that the objectives
contemplated by the Parties when entering into this Agreement may be realized,
and (c) the balance of this Agreement shall be enforceable in accordance with
its terms.
14.11 Entire
Agreement. This Agreement constitutes the entire agreement
among the Parties with respect to the subject matter herein and supersedes all
previous agreements (including the Prior Confidentiality Agreement), whether
written or oral, with respect to such subject matter. The Parties
hereby also reference the Common Stock Purchase Agreement.
14.12 Amendment and
Waiver. This Agreement may not be amended, nor any rights
hereunder waived, except in a writing signed by the properly authorized
representatives of each Party.
14.13 No Implied
Waivers. The waiver by a Party of a breach of any provision of
this Agreement by the other Party shall not be construed as a waiver of any
succeeding breach of the same or any other provision, nor shall any delay or
omission on the part of a Party to exercise or avail itself of any right that it
has or may have hereunder operate as a waiver of any right by such
Party.
14.14 Execution In
Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original, and all of which
together shall constitute one and the same instrument. Signatures
provided by facsimile transmission or in Adobe™ Portable Document Format (PDF)
sent by electronic mail shall be deemed to be original signatures.
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
43
[Remainder
of Page Intentionally Left Blank]
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
44
IN WITNESS WHEREOF, the Parties hereto
have set their hand as of the date first above written.
NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC. | ||
By:
|
|
|
Name:
|
||
Title:
|
||
GENVEC, INC. | ||
By:
|
|
|
Name:
|
||
Title:
|
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
45
EXHIBIT
A
ADENOVECTORS
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
46
EXHIBIT
B
GENVEC
PATENT RIGHTS
Technology
Group
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Application
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Filing Date
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Title or Identifier
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[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
47
Technology
Group
|
Application
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Filing Date
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Title or Identifier
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[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
48
Technology
Group
|
Application
|
Filing Date
|
Descriptive/Short
Title or Identifier
|
Publication/Patent
|
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[*]The asterisk denotes that confidential portions of this exhibit have
been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934.
The confidential portions have been submitted separately to the Securities and
Exchange Commission
49
EXHIBIT
C
RESEARCH
COLLABORATION PLAN
[*]
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
50
EXHIBIT
D
GLOBAL
LABORATORY NOTEBOOK GUIDELINES
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
51
EXHIBIT
E
TECHNOLOGY
TRANSFER
|
a.
|
[*]
|
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
52
EXHIBIT
F
FORM OF
INVOICE
Company
Name
|
INVOICE
|
Street
Address
|
DATE:
Month Day, Year
|
City,
State ZIP Code
|
INVOICE
#: XX
|
Phone
1xxxxxx
|
NOVARTIS
PO#: XXXXXXXX
|
Fax
1xxxxxx
|
Xxxx To:
Novartis
Institutes for Biomedical Research
Attn:
Novartis Contact Name
XX Xxx
0000
Xxxxxxxx
XX, 00000-0000
Upfront/Milestone/Royalty or any
other payment debit in reference to Research Collaboration and
License Agreement between GenVec, Inc. and Novartis
Institutes for BioMedical Research, Inc. effective as of (date).
PO Line
Number
|
DESCRIPTION
|
AMOUNT
|
||||
1
|
Upfront
payment with reference made to the relevant section of the
contract
|
$ | XX.XX | |||
2
|
Detailed
description of milestone payment and achievement with reference made to
the relevant section of the contract
|
$ | XX.XX | |||
TOTAL
|
$ | XX.XX |
Remit
to:
Bank Wire
Information:
Bank
Name:
|
XX
|
Account
No.:
|
XX
|
ABA#:
|
XX
(only applicable in the US)
|
IBAN:
|
XX
(only applicable in Europe)
|
SWIFT
CODE:
|
XX
(applicable US and Europe)
|
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
53
EXHIBIT
G
GENVEC
IN-LICENSE AGREEMENTS
[*]
[*]The
asterisk denotes that confidential portions of this exhibit have been omitted in
reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential
portions have been submitted separately to the Securities and Exchange
Commission
54
EXHIBIT
H
NOVARTIS
POLICY ON CORPORATE CITIZENSHIP AND
NOVARTIS
CORPORATE CITIZENSHIP GUIDELINE #5
[See
attached]
55