EXHIBIT 10.23
CONFIDENTIAL TREATMENT HAS BEEN SOUGHT FOR
PORTIONS OF THIS EXHIBIT PURSUANT TO RULE 24b-2
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
LICENSE AGREEMENT
LICENSE AGREEMENT dated as of September 14, 1998 (the "Effective Date"), by
and between BIOCRYST PHARMACEUTICALS, INC., a Delaware corporation having its
principal place of business at 0000 Xxxxxxx Xxxx Xxxxx, Xxxxxxxxxx, Xxxxxxx
00000 (hereinafter referred to as "BIOCRYST") and ORTHO-XxXXXX PHARMACEUTICAL,
INC., a Delaware corporation having its principal xxxxxx xx X.X. Xxxxx 000,
Xxxxxxx, XX 00000 and THE X. X. XXXXXXX PHARMACEUTICAL RESEARCH INSTITUTE, a
division of ORTHO-XxXXXX PHARMACEUTICAL, INC., having its principal place of
business at X.X. Xxxxx 000, Xxxxxxx, XX 00000 (hereinafter collectively referred
to as "ORTHO"). BIOCRYST and ORTHO are sometimes referred to herein
individually or as a "Party" and collectively as the "Parties" and all
references to BIOCRYST and ORTHO shall include their respective Affiliates
(hereinafter defined), where appropriate under the terms of this Agreement.
W I T N E S S E T H
WHEREAS, ORTHO is a part of the multinational health care company Xxxxxxx &
Xxxxxxx, with research, development and marketing activities worldwide, and
ORTHO desires to obtain for itself and its Affiliates rights to additional
products for sale;
WHEREAS, BIOCRYST is developing through its research activities certain
neuraminidase inhibitors and has the right to grant rights and licenses under
certain Licensed Patents (hereinafter defined) and Existing Know-How
(hereinafter defined);
WHEREAS, ORTHO has expressed to BIOCRYST its interest in obtaining from
BIOCRYST certain rights and licenses to develop, use, manufacture, formulate,
market, sell and distribute Licensed Products (hereinafter defined) in the
Territory (hereinafter defined);
WHEREAS, Xxxxxxx and Xxxxxxx Development Corporation, in connection
therewith, is interested in making a $6,000,000 equity investment in BIOCRYST
upon terms and conditions set forth in a certain Stock Purchase Agreement (the
"Stock Purchase Agreement") of even date herewith attached as an exhibit to a
certain Master Agreement between BIOCRYST and Xxxxxxx and Xxxxxxx Development
Corporation; and
WHEREAS, BIOCRYST is willing to (i) grant such rights and licenses to ORTHO
under the terms and conditions hereinafter set forth and (ii) issue to Xxxxxxx
and Xxxxxxx Development Corporation shares of stock in BIOCRYST upon the terms
and conditions set forth in the Stock Purchase Agreement.
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NOW, THEREFORE, in consideration of the foregoing premises, mutual
promises, covenants and agreement hereinafter set forth, both Parties to this
Agreement mutually agree as follows:
ARTICLE 1 - DEFINITIONS
The following terms as used in this Agreement shall, unless the context
clearly indicates to the contrary, have the meanings set forth in this Article:
1.1 "AFFILIATE" shall mean any entity which directly or indirectly
controls, or is controlled by, or is under common control with another entity.
For purposes of this Agreement, an entity is deemed to be in control of another
entity if the former owns directly or indirectly more than fifty percent (50%)
of the outstanding voting equity or owns more than fifty percent (50%) of the
assets of the latter, but in each case only for so long as such control exists.
ORTHO is currently an Affiliate of Xxxxxxx & Xxxxxxx, a New Jersey corporation.
1.2 "AGREEMENT" shall mean this License Agreement.
1.3 "APPROVAL LETTER" shall mean written notice by the FDA, including labeling
approval, which signifies all necessary approvals by the FDA on an NDA
required to market the Licensed Product.
1.4 "DEVELOPMENT" shall mean those activities related to formulating a product
containing a neuraminidase inhibitor, characterizing the properties of such
a product and/or identifying a particular method to manufacture such a
product and shall include but not be limited to synthesis of product for
development purposes, preclinical testing, toxicology, formulation, bulk
production, manufacturing process development, quality assurance and
quality control, technical support, pharmacokinetics, clinical studies and
regulatory affairs.
1.5 "EXISTING COMPOUNDS" shall mean any and all of the chemical compounds
claimed in the Existing Patents, and shall also include all salts, esters,
isomers, metabolites and pro-drug forms thereof.
1.6 "EXISTING KNOW-HOW" shall mean any and all Know-How (as hereinafter
defined) relating to the Existing Compounds, neuraminidase receptor sites,
neuraminidase inhibitors and the formulation, manufacture and use thereof
held by BIOCRYST as of the Effective Date.
1.7 "EXISTING PATENTS" shall mean any and all of the following: (a) the United
States patents listed in Schedule 1A; (b) the United States patent
applications listed in Schedule 1B and any division, continuation, or
continuation-in-part of any such application and any patent which shall
issue based on such application, division, continuation or
continuation-in-part; (c) any patent which is a reissue or extension of or
a patent of addition to, any patent defined in (a) or (b) above; and (d)
any patent application or patent
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corresponding to any patent application or patent identified in (a), (b),
or (c), above which is filed or issued in any country in the Territory. The
term "Existing Patents" shall also include any Supplementary Certificate
of Protection of a Member State of the European Community and other
similar protective rights in any other country of the Territory to the
extent that they protect any invention or discovery that is also claimed
in any of the patents or patent applications defined in (a), (b), (c) or
(d) above.
1.8 "FDA" shall mean the United States Food & Drug Administration and when
appropriate hereinafter shall also mean any corresponding regulatory agency
in any country in the Territory.
1.9 "FIELDS" shall mean the Influenza Field and the Non-Influenza Field,
collectively.
1.10 "IMPROVEMENTS" shall mean any and all of the following to the extent made,
licensed or acquired by BIOCRYST during the term of this Agreement: (i) an
improvement upon or modification to the inventions and discoveries
disclosed or claimed in any of the Existing Patents; (ii) an improvement
upon or modification to any of the Existing Know-How; and (iii) any
chemical compound which is a neuraminidase inhibitor and which is useful in
the Influenza Field.
1.11 "IMPROVEMENT PATENT" shall mean any and all of the following: (a) any
patent that claims an Improvement; (b) any patent application that claims
an Improvement and any division, continuation, or continuation-in-part of
any such application and any patent which shall issue based on such
application, division, continuation or continuation-in-part; (c) any patent
which is a reissue or extension of or a patent of addition to, any patent
or patent application defined in (a) or (b) above; and (d) any patent
application or patent corresponding to any patent application or patent
identified in (a), (b), or (c), above which is filed or issued in any
country in the Territory. The term "Improvement Patent" shall also include
any Supplementary Certificate of Protection of a Member State of the
European Community and other similar protective rights in any other country
of the Territory to the extent that that they protect any invention or
discovery that is or was also claimed in any of the patents or patent
applications defined in (a), (b), (c) or (d) above.
1.12 "IND" shall mean an Investigational New Drug Application filed pursuant to
the requirements of the FDA as more fully defined in 21 C.F.R. Section
312.3 as well as equivalent submissions to the appropriate health
authorities in other countries in the Territory.
1.13 "INFLUENZA FIELD" shall mean the use of neuraminidase inhibitors for the
diagnosis, prevention, treatment or amelioration of influenza.
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1.14 "JOINT INVENTIONS" shall mean any and all inventions and discoveries either
(a) made jointly by personnel of ORTHO and BIOCRYST or (b) deemed to be
Joint Inventions pursuant to Section 3.2 herein.
1.15 "JOINT PATENTS" shall mean any and all of the following: (a) any patent
that claims a Joint Invention; (b) any patent application that claims a
Joint Invention and any division, continuation, or continuation-in-part of
any such application and any patent which shall issue based on such
application, division, continuation or continuation-in-part; (c) any patent
which is a reissue or extension of or a patent of addition to, any patent
or patent application defined in (a) or (b) above; and (d) any patent
application or patent corresponding to any patent application or patent
identified in (a), (b), or (c), above which is filed or issued in any
country in the Territory. The term "Joint Patent" shall also include any
Supplementary Certificate of Protection of a Member State of the European
Community and other similar protective rights in any other country of the
Territory to the extent that that they protect any invention or discovery
that is or was also claimed in any of the patents or patent applications
defined in (a), (b), (c) or (d) above.
1.16 KNOW-HOW" shall mean any and all information, processes, techniques, data,
methods, materials, compositions, and trade secrets, including but not
limited to the toxicological, pharmacological, clinical and chemical data,
specifications, medical uses, adverse reactions, formulations and quality
control.
1.17 "LEAD COMPOUNDS" shall mean those certain compounds identified as BCX 1812,
1827, 1898 and 1923.
1.18 "LICENSED PATENTS" shall mean collectively, the Existing Patents, any
Improvement Patents and any Joint Patents.
1.19 "LICENSED PRODUCT(s)" shall mean any and all Neuraminidase Inhibitor
Products that are either (i)Existing Compounds or are otherwise claimed in
a Licensed Patent or (ii) were developed using, or embody or utilize,
Existing Know-How, an Improvement or a Joint Invention. For the purposes of
this Agreement, Licensed Product shall include OTC Licensed Products and Rx
Licensed Products.
1.20 "MAJOR COUNTRY" shall mean [***]
1.21 "NDA" shall mean a New Drug Application and all supplements filed pursuant
to the requirements of the FDA, including all documents, data and other
information concerning Licensed Product which are necessary for or included
in, FDA approval to market Licensed Product as more fully defined in 21
C.F.R. Sections 314.50 et seq. as well as equivalent submissions to the
appropriate health authorities in other countries in the Territory.
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1.22 "NET SALES" shall mean the gross amount invoiced by ORTHO, its Affiliates
and its sublicensees and distributors for sales of Licensed Product to a
Third Party less estimates which will be adjusted to actual on a quarterly
basis of: (i) discounts, including cash discounts, discounts to managed
care or similar organizations, rebates paid, credited, accrued or actually
taken, including government rebates such as Medicaid chargebacks, and
retroactive price reductions or allowances actually allowed or granted from
the billed amount, and commercially reasonable and customary fees paid to
distributors (excluding any payments in respect of marketing and other
expenses of the distributor) but all solely to the extent attributable to
the sale of Licensed Product, (ii) credits or allowances actually granted
upon claims, rejections or returns of such sales of Licensed Product,
including recalls, (iii) taxes (other than taxes on income), duties or
other governmental charges levied on or measured by the billing amount when
included in billing for Licensed Product, as adjusted for rebates,
chargebacks, and refunds, (iv) all shipping and insurance charges paid for
delivery of such Licensed Product, to the extent billed, and provisions for
uncollectable accounts for Licensed Product determined in accordance with
ORTHO's normal accounting procedures consistently applied within and across
its pharmaceutical operating units.
In the event that Licensed Products are sold in the form of combination
products containing one or more therapeutically active ingredients other
than the Licensed Product or any other neuraminidase inhibitor of
influenza, Net Sales for the Licensed Product forming part of such
combination products will be calculated on a country-by-country basis by
multiplying actual Net Sales of such combination products by the fraction
A/(A+B) where A is the gross amount invoiced for the amount of Licensed
Product used in the combination if sold separately, and B is the gross
amount invoiced for all other active components used in the combination,
if sold separately by ORTHO or an Affiliate.
If on a country-by-country basis the other active component or components
in the combination are not sold separately in a country by ORTHO or an
Affiliate, Net Sales of the Licensed Product forming part of the
combination products shall be calculated by multiplying actual Net Sales of
such combination products by the fraction A/C where A is the gross amount
invoiced for the Licensed Product used in the combination if sold
separately and C is the gross amount invoiced for the combination product.
If on a country-by-country basis neither the Licensed Product nor the
combination product is sold separately in said country by ORTHO or an
Affiliate, Net Sales of the Licensed Product forming part of the
combination products shall be reasonably determined by allocating value
between the Licensed Product and the other active components based on their
relative value as determined by the Parties in good faith.
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The Net Sales of Licensed Product within combination products calculated
using the foregoing formula shall be included in the Net Sales of Licensed
Product for purposes of Section 4.4 hereof.
1.23 "NON-INFLUENZA FIELD" shall mean the use of neuraminidase inhibitors for
the diagnosis, prevention, treatment or amelioration of any indication
other than influenza.
1.24 "NEURAMINIDASE INHIBITOR PRODUCT" shall mean any and all products
containing neuraminidase inhibitors as well as neuraminidase inhibitors per
se.
1.25 "OTC LICENSED PRODUCT" shall mean a Licensed Product that is a
non-prescription medicine in the country of sale.
1.26 "PHASE I" shall mean that portion of the FDA submission on which approval
will be based which provides for the initial trials assessing the first
introduction into humans of Licensed Product with the purpose of
determining human toxicity, metabolism, absorption, elimination and other
pharmacological action as more fully defined in 21 C.F.R. Section 312.21(a)
regardless whether these trials were conducted in or outside the United
States.
1.27 "PHASE II" shall mean that portion of the FDA submission on which approval
of an NDA will be based which provide for the adequate initial trials of
Licensed Product on a limited number of patients and/or healthy volunteers
for the purposes of determining dose and evaluating safety and efficacy in
the proposed therapeutic indication as more fully defined in 21 C.F.R.
Section 312.21(b).
1.28 "PHASE III" shall mean that portion of the FDA submission on which approval
of an NDA will be based which provides for the well-controlled clinical
trials of Licensed Product on sufficient numbers of patients and/or healthy
volunteers to generate safety, efficacy and pharmacoeconomic data to
support regulatory approval in the proposed therapeutic indication as more
fully defined as 21 C.F.R. Section 312.21(c) including any study referred
to or denominated as a Phase II/III study in the United States or the
equivalent elsewhere.
1.29 "REGULATORY APPROVAL" shall mean any and all approvals (including but not
limited to appropriate pricing and reimbursement approvals), product and/or
establishment licenses, registrations or authorizations of any appropriate
regulatory agency, department, bureau or other governmental entity,
necessary for marketing a Licensed Product in a Major Country or Japan, as
applicable.
1.30 "REGULATORY EXCLUSIVITY" shall mean the time period during which any other
drug manufacturer is statutorily and/or regulatorily prohibited from
obtaining approval of a generic drug based upon the
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approval of a Licensed Product. In the United States, Regulatory
Exclusivity shall mean exclusivity under the Xxxxxx-Xxxxx Act, 21 USC
355(j)(5)(D) et seq., as may be amended, or any successor legislation.
1.31 RX LICENSED PRODUCT" shall mean a Licensed Product that is a prescription
medicine in the country of sale.
1.32 "TERRITORY" shall mean all countries of the world.
1.33 "THIRD PARTY" shall mean any person, corporation or unincorporated body
other than ORTHO and BIOCRYST and their Affiliates.
1.34 "VALID CLAIM" shall mean a claim in a Licensed Patent which has not lapsed
or become abandoned and which claim has not been declared invalid by an
unreversed or unappealable decision or judgment of a court of competent
jurisdiction or of an arbitration panel conducted in accordance with
Article 19 of this License Agreement.
ARTICLE 2 - LICENSE GRANT
2.1 Subject to the terms and conditions of this Agreement, BIOCRYST hereby
grants to ORTHO on a worldwide exclusive basis the rights and licenses
under the Existing Patents and Existing Know-How to make, have made, use,
market, sell, have sold and distribute Licensed Products for all Fields in
the Territory.
2.2 Subject to the terms and conditions of this Agreement, BIOCRYST hereby
grants to ORTHO on a worldwide exclusive basis the rights and licenses
under any Improvements, Improvement Patents and Joint Patents to make, have
made, use, market, sell, have sold and distribute Licensed Product for the
Influenza Field in the Territory.
2.3 The rights and licenses granted hereunder shall be sublicensable by ORTHO
to a Third Party in any country in the Territory, provided that, BIOCRYST's
prior written consent shall be required, which shall not be unreasonably
withheld for a sublicense by ORTHO to a Third Party of this Agreement in
its entirety or for (a)the United States or (b) any [***] of the Major
Countries. Notwithstanding the foregoing, nothing herein shall prevent
ORTHO from entering into co-marketing arrangements with any Third Party in
any country of the Territory without BIOCRYST's written consent. ORTHO may
sell Licensed Product through its Affiliates in any country in the
Territory or grant sublicenses to its Affiliates in any country of the
Territory. All sublicenses and co-marketing arrangements shall include
terms and conditions consistent
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with the terms of this Agreement, and ORTHO shall use diligent efforts to
ensure that each such agreement shall be assignable to comply with the
provisions of Article 14. If ORTHO grants a sublicense, ORTHO shall
promptly provide to BIOCRYST documentation evidencing such sublicense
relationship with Third Parties other than Affiliates.
2.4 At the request of ORTHO, BIOCRYST will extend the rights and licenses
granted herein to an Affiliate of ORTHO on a direct basis in any country of
the Territory and any such Affiliate may make the pertinent reports and
royalty payments specified in Article 4 directly to BIOCRYST on behalf of
ORTHO; otherwise, such reports and payments on account of sales by
Affiliates and Sublicensees shall be made by ORTHO, provided however, that
in the event such direct license to an Affiliate would subject BIOCRYST to
withholding tax it would not otherwise be liable for, ORTHO shall be
responsible for such additional withholding tax.
2.5 Notwithstanding the granting of a sublicense to a Third Party or an
Affiliate or a direct license to an Affiliate, ORTHO assumes full
responsibility to BIOCRYST for the performance of all obligations of ORTHO,
its Affiliates and any sublicensee Third Party.
2.6 Nothing herein shall preclude ORTHO and/or its Affiliates from utilizing a
distributor to promote and distribute the Licensed Product in any country
of the Territory.
2.7 Notwithstanding the foregoing license, BIOCRYST retains (i) all rights to
the Licensed Patents, Existing Know-How and Improvements not granted
herein, (ii) rights to use, license and sublicense the Existing Know-How
and Improvements to make, have made, use, market, sell, have sold and
distribute products for the Non-Influenza Field in the Territory; and (iii)
rights to use the Licensed Patents, Existing Know-How and Improvements for
research purposes (including for example, chemical compound design and
synthesis work) only. The Parties acknowledge and agree that BIOCRYST's
retained rights are subject to the restrictions set forth in Section 2.8,
2.9 and 2.10, below.
2.8 During the Term of this Agreement, BIOCRYST shall not (i) make, have made,
use, market, sell, have sold, and distribute Neuraminidase Inhibitor
Products for use in the Influenza Field, (ii) grant a Third Party rights to
do any of the activities defined in (i), or (iii) conduct any clinical
development of any Neuraminidase Inhibitor Product until the chemical
compound that is the active compound of such Neuraminidase Inhibitor
Product has been shown by BIOCRYST to be Inactive (as defined in Schedule
2)
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against the influenza virus at a level less than or equal to [***] using
the assays identified in Schedule 2 or using such other assay or method
that the Parties may agree upon from time to time.
2.9 Further, during the Term of this Agreement, BIOCRYST shall not (i) develop,
make, have made, use, market, sell, have sold, or distribute for use in any
Field, or (ii) grant a Third Party rights to do any of the activities
defined in (i), as to any Neuraminidase Inhibitor Product shown to be
Active (as defined in Schedule 2) against the influenza virus at a level of
[***] or less using the assays identified in Schedule 2 or using such other
assay or method that the Parties may agree upon from time to time.
2.10 To the extent that (i) a neuramidase inhibitor compound is not covered by
either Sections 2.8 or 2.9, (ii) ORTHO or its Affiliates or Sublicensees
has the compound in Development or commercialization for the Influenza
Field, (iii) such compound has been identified to BIOCRYST pursuant to
Section 3.4 hereof or a separate written notice, and (iv) such compound
would constitute a Licensed Product (an "Active Development Compound"),
ORTHO shall have exclusive rights in all Fields to such Active Development
Compound and BIOCRYST shall not make, have made, use, market, sell, have
sold, and distribute any such Neuraminidase Inhibitor Products for use in
any Field, or grant a Third Party rights to do any such activities in any
Field, provided, however, that if BIOCRYST can document that prior to
ORTHO's notice to BIOCRYST identifying an Active Development Compound, one
of BIOCRYST's licensees or sublicensees for the Non-Influenza Field was
already developing, making, having made, using, marketing, selling, having
sold, or distributing for use in the Non-Influenza Field the same Active
Development Compound, or a salt, ester, isomer, metabolite, or pro-drug
form thereof, then the foregoing restrictions in this Section 2.10 shall
not apply to the Active Development Compound that is the subject of such
notice. If at any time after a notice is received ORTHO ceases active
Development or commercialization of the Active Development Compound that is
the subject of such notice, ORTHO shall so notify BIOCRYST and the
restrictions set forth in this Section 2.10 shall no longer apply to such
Active Development Compound.
2.11 In the event BIOCRYST intends to exercise its rights pursuant to Sections
2.8 or 2.9 with respect to any chemical compound, BIOCRYST shall perform
the Schedule 2 assay on each such chemical compound, and shall provide the
written results of each Schedule 2 assay to ORTHO.
ARTICLE 3 - DEVELOPMENT
3.1 ORTHO shall, within fifteen (15) days after the Effective Date, pay to
BIOCRYST the amount of [***] as reimbursement for research and pre-clinical
development expenses incurred by BIOCRYST with respect to Licensed Product
prior to the Effective Date. Such payment shall be non-refundable and
non-creditable.
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3.2 ORTHO shall be solely responsible for (i) all research, Development, and
all other pre-market activities to be performed in relation to the Licensed
Products; and (ii) for making or having made, and marketing the Licensed
Product. However, it is understood that any research or Development work
that involves use of the Existing Know-How or Improvements by ORTHO or any
of its Affiliates or sublicensees shall be conducted solely pursuant to the
terms of this Agreement and all inventions, discoveries or other results
("ORTHO Results") from such research or Development work that involves use
of the Existing Know-How or Improvements shall be deemed Joint Inventions.
ORTHO hereby makes, and shall ensure that all of its Affiliates and
sublicensees shall make, all assignments to BIOCRYST that are necessary to
give BIOCRYST joint ownership interests in any such ORTHO Results and any
patent rights thereto.
3.3 In performing the activities set forth in Section 3.2, ORTHO shall bear all
costs and expenses thereof and shall use reasonable efforts, commensurate
with the efforts it would normally exercise for products derived from its
internal research or development programs including programs for licensed
products with similar potential sales volume consistent with its overall
business strategy.
3.4 Within thirty (30) days of the Effective Date, ORTHO and BIOCRYST shall
establish a Scientific Advisory Committee ("Committee"). The Committee
shall be comprised of at least two representatives of each Party (with at
least one ORTHO representative being a senior member from research and
development). An ORTHO representative shall serve as chairperson. The
Committee shall ensure a smooth transfer of the Development
responsibilities to ORTHO and provide BIOCRYST periodic updates on the
further Development of Licensed Product. It shall meet on at least a
quarterly basis to review the status of all research, Development,
preclinical, clinical, regulatory and all other pre-market activities for
Licensed Products and ORTHO shall consider in good faith all comments and
suggestions made by BIOCRYST regarding such activities but all final
decisions on such activities shall rest with ORTHO. ORTHO shall prepare a
plan for the Development of Licensed Products (the "Development Plan") and
shall provide a copy of such Development Plan to BIOCRYST as soon as it is
available. Updated plans will be provided by ORTHO to BIOCRYST at least
annually. Thereafter until a Licensed Product is commercially launched,
ORTHO shall provide BIOCRYST with quarterly (i) notice of each chemical
compound in Development; and (ii) written confirmation that it is actively
maintaining a program for the Development of a Licensed Product consistent
with the provisions of Section 3.3 and the then current Development Plan.
3.5 Based on ORTHO's sole decision and BIOCRYST's approval, ORTHO may request
BIOCRYST to conduct discovery research according to a mutually agreed upon
Research Plan including a budget for same, including capital equipment.
BIOCRYST shall be reimbursed for (i) all capital expenditures made, and
costs incurred (including but not limited to the costs of goods consumed),
by BIOCRYST in
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connection with such discovery research as agreed to in the Research Plan
and budget; and (ii) personnel devoted to the discovery research at the
rate of [***] per year, per FTE. For the purposes of this Agreement, "FTE"
means services equivalent to those of a full-time scientist based upon a
total of fifty-two (52) weeks or 2,080 hours per year of scientific work.
BIOCRYST shall have sole discretion over which of its employees are used to
conduct discovery research pursuant to the BioCryst Research Plan. In the
event capital equipment exceeding thirty thousand dollars ($30,000) is
necessary to perform the research, such capital equipment shall be
purchased by BIOCRYST upon ORTHO's approval with additional funds provided
by ORTHO, and such capital equipment shall be owned by ORTHO and returned
to ORTHO upon its request.
3.6 All marketing commercial decisions including pricing, discounting policy
and other commercial decisions with respect to Licensed Products shall be
made solely by ORTHO.
3.7 The Parties recognize that ORTHO, as the holder of all Regulatory Approval
Applications, may be required to submit information and file reports to
various governmental agencies on Licensed Product under clinical
investigation, Licensed Product proposed for marketing, or marketed
Licensed Product and, therefore, BIOCRYST agrees to provide requested
information to, and when requested, assist, ORTHO in connection with the
foregoing. In the event ORTHO requests the in-person participation of
BIOCRYST employees in connection with such regulatory approval, ORTHO
agrees to limit such requests to requiring BIOCRYST employees to
participate on no more than five (5) days in the aggregate, in any
twelve-month period.
ARTICLE 4 - PAYMENTS AND ROYALTIES
4.1 In consideration of the rights and licenses granted to ORTHO under Article
2 of this Agreement, ORTHO shall pay to BIOCRYST the following payments:
a) the sum of [***] payable within fifteen (15) days of the Effective
Date.
b) the sum of [***];
c) the sum of [***];
d) the sum of [***];
e) the sum of [***];
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f) the sum of [***];
g) the sum of [***];
h) the sum of [***];
i) the sum of [***]
j) the sum of [***];
k) the sum of [***]; and
l) the sum of [***]
4.2 The payments specified under Sections 4.1(a) through (e) and (j) shall not
be creditable against royalties or refundable. In the event one or more of
the aforesaid milestone payments have been paid in respect of a given
Licensed Product for which Development or commercialization is subsequently
discontinued, ORTHO shall receive a credit for such milestone payments
against milestone payments due for the next Licensed Product to meet such
milestone. It is understood that in no event shall ORTHO be obligated to
make the payment due on any milestone event more than once, regardless of
the number of Licensed Products to reach such milestone or the number of
treatment or prophylaxis indications for which a Licensed Product is
developed. If at the time a milestone is achieved by a Licensed Product
any applicable prior milestones have not been achieved, the payments for
such prior milestones shall then be due.
4.3 The payments specified under Sections 4.1(f) through (i), (k) and (l)
shall not be refundable but a portion of same shall be creditable against
royalties as follows: [***] of all such payments shall be creditable to
royalties due and owing with the proviso that no more than [***] of the
royalties due in any period may be so deducted as a credit based on said
payments.
4.4 In further consideration of the rights and licenses granted to ORTHO under
Article 2 of this Agreement, ORTHO shall pay to BIOCRYST on a country by
country and compound-by-compound basis in the Territory the following
royalties based on the cumulative annual Net Sales of all Licensed Products
containing a given Active Compound, including sales of Rx Licensed
Products, OTC Licensed Product and Licensed Product within combination
products containing such Active Compound:
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a) in countries where a Licensed Patent has issued or is pending and
claims an Rx Licensed Product, then for all Net Sales of that Rx
Licensed Product in such countries a royalty of: [***] of said Net
Sales that fall within the first [***] of Net Sales worldwide of said
Licensed Product; [***] of said Net Sales that fall within the range
of [***] and [***] of Net Sales worldwide of said Licensed Product;
[***] of said Net Sales that are in the range of [***] and [***] of
Net Sales worldwide of said Licensed Product; and [***] of Net Sales
that are greater than [***] of Net Sales worldwide of such Licensed
Product; provided that the Licensed Product is claimed by a Valid
Claim of a Licensed Patent in force or pending in that country and
further provided that, for purposes of this sub-section, that Licensed
Patent shall not include either (i) a patent application pending for
more than five (5) years if in the country in which the patent
application is pending there is no Regulatory Exclusivity for the
Licensed Product, or (ii) a patent that only claims a process for the
manufacture of the Licensed Product.
b) in countries where a Licensed Patent has issued or is pending and
claims an OTC Licensed Product, then for all Net Sales of that OTC
Licensed Product in such countries, a royalty of [***] of said Net
Sales that fall within the first [***] of Net Sales worldwide of said
Licensed Product; [***] of said Net Sales that fall within the range
of [***] and [***] of Net Sales worldwide of said Licensed Product;
[***] of said Net Sales that fall within the range of [***] and [***]
of Net Sales worldwide of said Licensed Product; and [***] of said Net
Sales that are greater than [***] of Net Sales worldwide of said
Licensed Product provided that the Licensed Product is claimed by a
Valid Claim of a Licensed Patent in force or pending in that country
and further provided that, for purposes of this sub-section, that
Licensed Patent shall not include either (i) a patent application
pending for more than five (5) years if in the country in which the
patent application is pending there is no Regulatory Exclusivity for
the Licensed Product, or (ii) a patent that only claims a process for
the manufacture of the Licensed Product;
c) in countries where a Licensed Product does not qualify for the
royalties payable under Sections 4.4 (a) or (b) above, for all Net
Sales of that Licensed Product in each country, a royalty of [***] of
Net Sales in said country for a period of [***] from the date of first
sale of that Licensed Product in said country. In the case of sales of
any Existing Know-How Licensed Product (as defined below) in any
country of the European Union, the date of first sale for purposes of
determining the royalty term under this Paragraph, shall mean the date
such Licensed Product was first put on the market within the common
market of the European Union. "Existing Know-How Licensed Product" (a)
shall mean a Licensed Product that only qualifies as a Licensed
Product
------------------------
*** Information ommitted and filed separately with the Commission under Rule
24b-2.
13
because it was developed using, or embodies, or utilizes, Existing
Know-How and (b) excludes any Licensed Product that qualifies as such
on any additional basis to (a), including, but not limited to, any
Licensed Product that qualifies as such because it also uses or
embodies an Improvement or a Joint Invention.
d) if, in any given calendar year, there are Net Sales of the same
Licensed Product containing the same Active Compound both as an Rx
Licensed Product and an OTC Licensed Product (including Licensed
Products within combination products sold either as OTC or Rx Licensed
Products), then in determining the appropriate royalty range, the
cumulative worldwide Net Sales of the Rx Licensed Product and the OTC
Licensed Product shall be utilized as follows: the royalty for a
given Net Sales range shall be calculated by multiplying the fraction
of Rx Licensed Product Net Sales as the numerator over the cumulative
Licensed Product Net Sales times the applicable Rx Licensed Product
royalty for said range plus the fraction of OTC Licensed Product Net
Sales as the numerator over the cumulative Licensed Product Net Sales
times the applicable OTC Licensed Product royalty for said range. For
the purpose of clarification, a non-limiting example of the
calculation of royalties under this paragraph 4.4(d) is attached
hereto as Exhibit B.
e) In countries where a Licensed Patent has issued or is pending and
claims a Licensed Product which is a diagnostic product or an animal
health product, then for all Net Sales of such products a royalty of
[***] and in countries where there is no Licensed Patent issued or
pending or where a Patent Application is pending for more than five
(5) years if in the country in which the patent application is pending
there is no Regulatory Exclusivity for the Licensed Product, a royalty
of [***] for a period of [***] from the date of first sale of such
Licensed Product.
f) For purposes of determining the royalty rate under this Section 4.4,
an "Active Compound" shall mean a chemical compound which is a
neuramidase inhibitor and its salts, esters, isomers, metabolites and
pro-drug forms. In determining the royalty rate ranges under Section
4.4 a) and b), the worldwide sales of all Licensed Products containing
a given Active Compound shall be aggregated, regardless of differences
in application, indication, dosage, formulation, form of delivery,
pricing, branding, packaging, marketing approval, marketing strategy
or techniques, additives, flavorings, inclusion in various combination
drugs and the like, but sales of Licensed Products containing
different Active Compounds shall not be aggregated.
------------------------
*** Information ommitted and filed separately with the Commission under Rule
24b-2.
14
ARTICLE 5 - REPORTS AND RECORDS
5.1 ORTHO shall keep and shall cause its Affiliates and sublicensees to keep
true and accurate records of Net Sales of Licensed Product and the
royalties payable to BIOCRYST under Article 4 hereof and shall deliver to
BIOCRYST a written statement thereof on or before the sixtieth (60) day
following the end of each ORTHO's and/or Affiliates' accounting quarter (or
any part thereof in the first or last calendar quarter of this Agreement)
for such accounting quarter. Said written statements shall set forth
ORTHO's and its sublicensees Net Sales and the calculation thereof on a
country by country basis for each Licensed Product and the royalties due
thereon.
5.2 All royalty payments by ORTHO to BIOCRYST shall be converted into U.S.
Dollars in accordance with ORTHO's current customary and usual procedures
for calculating same which are the following: the rate of currency
conversion shall be calculated using a simple average of monthly period end
"spot rates" provided by Xxxxx Brothers Xxxxxxxx, 00 Xxxx Xxxxxx, XX, XX
00000 for each quarter, or if such rate is not available, the spot rate as
published by a leading United States commercial bank for such accounting
period. ORTHO shall give BIOCRYST prompt written notice of any changes to
ORTHO's customary and usual procedures for currency conversion, which shall
only apply after such notice has been delivered and provided that such
changes continue to maintain a set methodology for currency conversion.
All royalty payments due hereunder shall be made by wire transfer to a
designated BIOCRYST account set forth in Section 5.6, below within sixty
(60) days following the end of each ORTHO accounting quarter. If the
transfer or the conversion into U.S. Dollars in any such instance is not
lawful or possible, the payment of each part of the royalties due as is
necessary, shall be made by the deposit thereof, in whatever currency is
allowable, to the credit and account of BIOCRYST in any commercial bank or
trust company of BIOCRYST's choice located in that country. Prompt notice
of said deposit shall be given by ORTHO to BIOCRYST and ORTHO shall use
reasonable efforts to assist BIOCRYST in securing the payment of such funds
to BIOCRYST's U.S. bank account.
5.3 Subject to Section 2.4 hereof, any income or other taxes which ORTHO is
required to pay or withhold on behalf of BIOCRYST with respect to royalties
and any other monies payable to BIOCRYST under this Agreement shall be
deducted as required by law and treaty from the amount of such royalties
and monies due. ORTHO shall furnish BIOCRYST with receipt of confirmation
of payment from taxing authorities evidencing payment of amounts withheld,
and shall cooperate and discuss with BIOCRYST the basis for such
withholding. Any such tax required to be paid or withheld shall be an
expense of, and borne solely by, BIOCRYST. ORTHO shall cooperate with
BIOCRYST to claim exemption from such deductions or withholdings under any
double taxation or similar agreement in force from time to time. If ORTHO
makes any payment without reduction for withholding and it later transpires
that an amount of tax should have
15
been withheld on such royalty payment ("underwithheld tax"), ORTHO shall be
entitled to recover the underwithheld tax by an additional withholding from
any later payment due to BIOCRYST under this Agreement. Similarly, if
ORTHO withholds an amount of tax which is later determined to have not been
due, ORTHO shall reimburse BIOCRYST for such overwithheld amounts.
BIOCRYST shall have the right to audit correspondence and records relating
to such tax issues on the same terms as described in Section 5.4 below.
5.4 BIOCRYST shall have the right to nominate an independent certified public
accountant reasonably acceptable to and approved by ORTHO who shall have
access to ORTHO and its Affiliates' records during reasonable business
hours for the purpose of verifying the royalties payable as provided in
this Agreement for the three (3) preceding years but this right may not be
exercised more than twice in any calendar year, once for the United States
and once for ex-US, and said accountant shall disclose to BIOCRYST only
information relating solely to the accuracy of the royalty report and the
royalty payments made according to this Agreement. BIOCRYST will bear the
full cost of such audit unless such audit discloses an underpayment of five
percent (5%) or more from the amount of royalties due for the audited
period, in which event ORTHO shall promptly reimburse BIOCRYST for the
expense of such audit. ORTHO shall promptly pay any underpayment found in
any audit pursuant to this Section and pay any late payment fees due
thereon pursuant to Section 5.5 below. The terms of this Section 5.4 shall
survive for a period of three (3) years after termination or expiration of
this Agreement.
5.5 Late payments shall bear interest at the rate of 1.5% per month to cover
BIOCRYST's costs of collection as well as interest, or, if lower, the
maximum rate allowed by law.
All payments due hereunder shall be made to the designated bank account of
BIOCRYST as follows:
Wire transfer to: [***]
For further credit to: [***]
ARTICLE 6 - CONFIDENTIALITY
6.1 All information transmitted by either Party to the other in furtherance of
either Party's obligations under this Agreement, including all confidential
information developed pursuant to this Agreement, shall be confidential
information. BIOCRYST's confidential information specifically includes,
without limitation, the Existing Know-How and Improvements. Each receiving
Party shall, while this Agreement is in effect and for five (5) years after
termination hereof, make no use of confidential information of the
disclosing
------------------------
*** Information ommitted and filed separately with the Commission under Rule
24b-2.
16
Party other than in furtherance of this Agreement and shall use the same
efforts, but no less than reasonable efforts, to keep secret and prevent
the disclosure of such information to Parties other than its agents,
officers, employees and representatives authorized to receive such
information, as it would its own confidential information except for such
confidential information that:
a) was known to the receiving Party at the time of its disclosure and not
previously subject to any obligation of confidentiality at the time of
its disclosure;
b) was generally available to the public or was otherwise part of the
public domain at the time of its disclosure;
c) became generally available to the public or became otherwise part of
the public domain after its disclosure and other than through any act
or omission of the receiving Party in breach of this Agreement; or
d) became known to the receiving Party after its disclosure (a) from a
source other than the disclosing Party without reference to the
disclosing Party (including from independent development by the
receiving Party without reference to the confidential information of
the disclosing Party), (b) other than from a Third Party who had an
obligation to the disclosing Party not to disclose such information to
others, and (c) other than under an obligation of confidentiality.
6.2 The receiving Party may disclose any of the confidential information of the
disclosing Party to the extent such disclosure is necessary to comply with
the November 23, 1994 Joint Research and License Agreement between BIOCRYST
and the UAB Research Foundation, as amended, applicable laws or
regulations, or to make and use Licensed Product in accordance with the
terms of this Agreement.
6.3 The Parties recognize the importance of publishing the information
developed in studies undertaken by ORTHO or on behalf of ORTHO and/or
BIOCRYST under the provisions of this Agreement. Therefore, the
non-publishing Party will endeavor to provide the publishing Party with its
response to the publishing Party's request for consent to publish any
paper, abstract or presentation within thirty (30) days of receipt of such
request. The failure of the non-publishing Party to respond to such a
request within such thirty (30) day period shall be deemed to be an
approval of such request and the publishing Party shall then be free to
disclose such information in a paper, abstract or presentation.
17
ARTICLE 7 - PATENTS
7.1 BIOCRYST agrees to faithfully continue the prosecution of all patent
applications listed in Schedule 1B and, when necessary and appropriate, to
file and prosecute additional patent applications claiming patentable
inventions or discoveries that are (i) claimed in the Existing Patents,
(ii) within the Existing Know-How, or (iii) constitute Improvements, in at
least the countries set forth in Schedule 3, which may be updated from time
to time with the mutual agreement of both Parties. The Parties shall
equally share the reasonable costs incurred in connection with the
prosecution and maintenance of all Licensed Patents during the term of this
Agreement, and ORTHO agrees to promptly reimburse BIOCRYST for its share of
such expenses after being presented with evidence of such expenses by
BIOCRYST. If so requested by ORTHO, BIOCRYST shall provide ORTHO with
copies of all patent applications listed in Schedule 1B, all future filed
patent applications within the Licensed Patents and all correspondence with
the patent offices in any countries of the Territory relating to Licensed
Patents and ORTHO shall have the opportunity to comment on any aspect
concerning prosecution of such Licensed patents, including the costs
incurred and the selection of patent counsel, it being understood that all
final decisions thereon shall be made by BIOCRYST.
7.2 If BIOCRYST chooses not to prosecute and maintain any Licensed Patents
under this Agreement, BIOCRYST shall promptly and timely so notify ORTHO
and ORTHO shall, in its sole discretion, decide whether to assume the
responsibility and sole expenses therefor on a country by country basis for
each such Licensed Patent. In that event, the Licensed Patents for which
ORTHO shall assume responsibility on a country-by-country basis shall be
assigned to ORTHO, and ORTHO's royalty obligations with respect to the said
assigned Licensed Patents under this Agreement shall be in accordance with
the provisions of Section 4.4(c) hereof.
7.3 The Parties agree to cooperate in order to avoid loss of any rights which
may otherwise be available to the Parties under the U.S. Drug Price
Competition and Patent Term Restoration Act of 1984, the Supplementary
Certificate of Protection of the Member States of the European Community
and other similar measures in any other country in the Territory. Without
limiting the foregoing, ORTHO agrees to notify BIOCRYST promptly upon
receipt of an Approval Letter for a Licensed Products in the U.S. and to
timely supply BIOCRYST with all information necessary to file an
application for patent term extension within the sixty (60) day period
following NDA approval. The same shall apply with respect to the approval
by the health authorities in a country of the European Community or
approval by the appropriate authorities in any other country in the
Territory.
18
7.4 Joint Inventions and Joint Patents shall be jointly owned by the Parties.
BIOCRYST's interest in such Joint Inventions and Joint Patents shall be
subject to the license to ORTHO granted in Section 2.2 above and each
Party's interest in such Joint Inventions and Joint Patents shall be
subject to its compliance with the terms of this Agreement including in the
case of ORTHO, its payment of the sums due BIOCRYST hereunder. To the
extent that this Agreement does not expressly address an issue in relation
to Joint Inventions or Joint Products, the law of joint ownership of
inventions of the U.S. shall apply to the joint ownership of Joint
Inventions and Joint Patents outside the U.S. Neither Party may assign its
rights under any Joint Invention or Joint Patent except with the prior
written consent of the other Party; provided, however, that either Party
may assign such rights to an Affiliate.
ARTICLE 8 - INFRINGEMENT
8.1 If, as a result of the manufacture, use or sale of a Licensed Product in
any country of the Territory, ORTHO and/or its Affiliates is sued for
patent infringement or threatened with such a lawsuit or other action by a
Third Party, ORTHO and BIOCRYST shall meet to analyze the infringement
claim and avoidance of same. If it is necessary to obtain a license from
such Third Party, ORTHO and BIOCRYST in negotiating such a license shall
make every effort to minimize any license fees and/or royalty payable to
such Third Party. If the settlement of a lawsuit or threatened lawsuit or
other action requires any payments, including but not limited to royalty
payments, to a Third Party in respect of the manufacture, use or sale of a
Licensed Product in that country, then ORTHO or its Affiliates shall make
said payments and a cash amount equal to fifty percent (50%) of the portion
of such payments payable to the Third Party because of the manufacture, use
or sale of Licensed Product in such country shall be deducted from the
amount of royalty due to BIOCRYST for such country, provided, however,
that, in the aggregate, the royalty due to BIOCRYST for that Licensed
Product for that country shall not drop below fifty percent (50%) of the
amount of the royalty that would, absent such payment, be otherwise payable
under Article 4.
8.2 In the event that there is infringement of a Licensed Patent on a
commercial scale by a Third Party in any given country resulting in
Substantial Unlicensed Sales by the Third Party of a product claimed in a
Valid Claim of a Licensed Patent, ORTHO or its Affiliates shall notify
BIOCRYST in writing to that effect, including with said written notice
reasonable evidence, reviewed with local counsel in such country,
establishing a prima facie case of infringement of a Licensed Patent by the
Third Party. Upon request, BIOCRYST shall be given an opportunity to speak
with such local counsel in such country concerning such evidence of
infringement. For the purposes of this section, "Substantial Unlicensed
Sales" shall mean a market share by such Third Party of at least [***] of
the total market of the Licensed Product in said
------------------------
*** Information ommitted and filed separately with the Commission under Rule
24b-2.
19
country for a consecutive [***](on a unit basis as reported by IMS
International or, if unavailable, from a recognized, mutually accepted
database or market survey service).
a) Prior to the expiration of one hundred and twenty (120) days from the
date of receipt of said notice, BIOCRYST may obtain a discontinuance
of such infringement or bring suit against the Third Party infringer.
In such event, the obligation of ORTHO to pay full royalties under
such Licensed Patent shall continue unabated. BIOCRYST shall bear all
the expenses of any suit brought by it and shall retain all damages or
other monies awarded or received in settlement of such suit. ORTHO
and/or its Affiliates will cooperate with BIOCRYST in any such suit
and shall have the right to consult with BIOCRYST and be represented
by its own counsel at its own expense.
b) If after the expiration of said one hundred and twenty (120) days from
the date of receipt of said notice (or earlier upon notice by BIOCRYST
that BIOCRYST does not intend to exercise its rights pursuant to
8.2(a)) BIOCRYST has not overcome the case of infringement, obtained
a discontinuance of such infringement, or brought suit against the
Third Party infringer, then ORTHO shall have the right but not the
obligation, exercisable in its sole discretion, to bring such suit
against the Third Party infringer previously identified in ORTHO's
notice to BIOCRYST. If ORTHO brings any such actions, it shall be at
ORTHO's own expense and in its own name, if possible. If necessary,
BIOCRYST will permit the suit to be brought in its name. BIOCRYST
will cooperate with ORTHO in any such suit and shall have the right to
consult with ORTHO and be represented by its own counsel at its own
expense. In the event ORTHO wishes to commence such suit prior to the
expiration of such one hundred and twenty (120) day period, it may do
so, subject to first notifying BIOCRYST of the actions it plans to
take and affording BIOCRYST a reasonable opportunity to take such
actions itself and the right of BIOCRYST to take over such suit prior
to the expiration of such one hundred twenty (120) day period,
provided BIOCRYST reimburses ORTHO for reasonable attorneys' fees and
out of pocket expenses incurred in such suit prior to the time
BIOCRYST regained control of such suit.
c) ORTHO shall bear all the expenses of any suit brought by it and shall
be entitled to deduct its reasonable attorneys' fees and out of pocket
expenses incurred in connection with the prosecution of such suit from
the royalties otherwise due to BIOCRYST in respect of Net Sales of
Licensed Product claimed in the Licensed Patent being infringed in the
country where such suit is being brought by ORTHO, for the time period
during which there is Substantial Unlicensed Sales in
------------------------
*** Information ommitted and filed separately with the Commission under Rule
24b-2.
20
such country, subject to the maximum deduction of fifty percent (50%)
of the Net Sales otherwise due for sales of Licensed Products by ORTHO
(collectively, the "Holdback"). In the event a monetary award or
settlement is made, ORTHO shall first recoup reasonable attorneys'
fees and out of pocket expenses incurred in connection with such suit,
and out of the balance of the settlement shall (a) pay to BIOCRYST the
Holdback, and (b) retain all other damages or other monies awarded or
received in settlement of such suit.
8.3 In no event shall the cumulative effect of the royalty adjustments
specified in provisions of this Article 8 have the effect of reducing any
royalty payable for any applicable accounting quarter pursuant to Article
5.1 of this Agreement by more than 50%, provided however that ORTHO shall
receive a credit for any sums which would have resulted in royalty
deductions exceeding said 50%, which credit ORTHO may apply against
royalties due in future accounting quarters.
ARTICLE 9 - TRADEMARKS AND LABELING
9.1 All trademarks to be utilized by ORTHO and/or its Affiliates on Licensed
Products (the "Marks") under this Agreement shall be chosen by ORTHO and/or
its Affiliates and shall be owned by ORTHO and/or its Affiliates.
9.2 In the event this Agreement is terminated in its entirety before the end of
the Term by ORTHO, ORTHO, at BIOCRYST'S request, shall assign the Marks to
BIOCRYST at BIOCRYST's expense.
ARTICLE 10 - MANUFACTURE AND SUPPLY
10.1 ORTHO shall be solely responsible for making or having made Licensed
Product for Development and commercialization. During Development of the
Licensed Product, the Parties may agree that BIOCRYST shall manufacture and
supply to ORTHO quantities of certain compounds. In such event, the
Parties shall enter into a separate supply agreement on terms to be
mutually agreed by the Parties.
ARTICLE 11 - DURATION
11.1 This Agreement shall become effective from the Effective Date and shall
continue in full force and effect for as long as royalties are payable
according to the provisions of Article 4 herein and for as long as any of
the term of any of the Licensed Patents remains (the "Term"), unless sooner
terminated pursuant to any other provision of this Agreement. In the event
that this Agreement is in effect for the full Term and is not earlier
terminated, ORTHO and/or its Affiliates shall have a fully paid-up,
irrevocable, non-exclusive license to make and have made Licensed Product
and to use, market, sell and distribute Licensed Product in the Territory.
21
ARTICLE 12 - TERMINATION BY ORTHO
12.1 Notwithstanding any other provision herein, ORTHO can terminate this
Agreement for any reason in its entirety or on a country by country basis
upon four (4) months prior written notice to BIOCRYST. During said four
(4) month period, ORTHO shall (i) maintain any work then in progress in
connection with the Licensed Product, and (ii) remain obligated to perform
all of its obligations and pay any expenses previously committed to and/or
contracted for under this Agreement or in connection with any Development
work then in progress in connection with the Licensed Product (except that
ORTHO shall not be liable for any milestone payments that become due to
BIOCRYST during said four (4) month period); and (iii) otherwise comply
with the provisions of Article 14.
12.2 XXXX shall have the right to terminate this Agreement upon ten (10) days
written notice and without any further payment obligations to BIOCRYST,
other than obligations incurred but not paid as of the date of notice of
termination, in the event issues regarding the safety of a Licensed Product
arise during Development or Commercialization that in ORTHO's good faith
judgment (a) would prohibit obtaining Regulatory Approval or (b) could
result in ORTHO incurring material product liability exposure or (c) would
be materially adverse to the reputation of ORTHO and/or Xxxxxxx and
Xxxxxxx. (The reference in this Section 12.2 to product liability exposure
is for the sole purpose of determining ORTHO's termination rights and is
not intended to minimize the Parties' responsibility to manage safety
issues.) In the event of termination by ORTHO under this Section 12.2
ORTHO shall have the right to immediately discontinue all Development and
commercialization activities, notwithstanding the invocation of arbitration
by BIOCRYST under Section 19.2 and the provisions of Section 19.3(g) shall
not apply.
ARTICLE 13 - TERMINATION FOR CAUSE
13.1 Failure by ORTHO or BIOCRYST to comply with any of their respective
obligations and conditions contained in this Agreement shall entitle the
other Party to give the Party in default notice requiring it to make good
such default. If such default, other than a monetary payment default, is
not cured within ninety (90) days after receipt of such notice, the
notifying Party shall be entitled (without prejudice to any of its other
rights conferred on it by this Agreement) to terminate this Agreement by
giving a notice to take effect immediately. The time period for curing a
monetary payment default shall be thirty (30) days. The right of either
Party to terminate this Agreement as hereinabove provided shall not be
affected in any way by its waiver of, or failure to take action with
respect to any previous default.
13.2 In the event that one of the Parties hereto shall go into liquidation, a
receiver or a trustee be appointed for the property or estate of that Party
and said receiver or trustee is not removed within sixty (60) days, or the
Party makes an assignment for the benefit of creditors, and whether any of
the aforesaid events be the
22
outcome of the voluntary act of that Party, or otherwise, the other
Party shall be entitled to terminate this Agreement forthwith by
giving a written notice to the first Party.
13.3 ORTHO shall have the right, at its sole option, to terminate this
Agreement in its entirety on thirty (30) days written notice, if there
shall occur in any transaction or series of related transactions, a
sale or other disposition of all or substantially all of the assets of
BIOCRYST, whether by merger, consolidation, reorganization or other
similar means. If ORTHO exercises this right and so terminates, ORTHO
shall be obligated to comply with the provisions of Section 12.1 for
the duration of the notice period and for such longer period up to
four (4) months until the work in progress in connection with the
Licensed Product has been transitioned to BIOCRYST.
13.4(a) For purposes of this Section 13.4, a Willful Material Breach by
BIOCRYST shall mean a knowing and willful breach of the particular
matters specified in this Section 13.4 by BIOCRYST which after notice
and cure as provided in this Section 13.4, ORTHO demonstrates by clear
and convincing evidence is material to this Agreement taken as a
whole.
(b) For purposes of this Section 13.4, the particular breaches which
are potential Willful Material Breaches shall be : (i) BIOCRYST
granting a Third Party a license to the Licensed Patents in violation
of the exclusivity provided for by Section 2 hereof, and such Third
Party uses such license in accordance with the terms thereof to sell a
product which is a significant competitor to a Licensed Product then
being actively marketed by ORTHO, either in a particular country or
countries (a "Country Breach") or worldwide (a "Territory Breach"); or
(ii) BIOCRYST fraudulently providing to ORTHO material misleading
information required under this Agreement.
(c) If ORTHO believes a potential Willful Material Breach has
occurred it shall provide a written notice to BIOCRYST specifying in
detail the particulars of the potential Willful Material Breach.
BIOCRYST shall have ninety (90) days after receipt of such notice to
cure the potential Willful Material Breach. Any disputes regarding
this Section 13.4 shall be resolved in accordance with Article 19 of
this Agreement.
(d) Upon the establishment of a Willful Material Breach by BIOCRYST,
ORTHO may elect by written notice, within thirty (30) days after such
establishment, to either (i) reduce the royalty payable by ORTHO to
that specified under Section 4.4(c); provided that if the Willful
Material Breach in question is only a Country Breach, the reduced
royalty rate shall apply only in the country or countries affected; or
(ii) elect to proceed with its other remedies in law or equity under
this Agreement, including its right to terminate this Agreement in the
manner specified in Section 13.1;
23
(e) Election by ORTHO to declare a Willful Material Breach and to
proceed under Section 13.4(d)(i) shall be conclusively deemed to be an
election of remedies and shall be in lieu of all other remedies of
ORTHO for such Willful Material Breach, whether such remedies are
provided for by law or equity or by this Agreement, provided, however,
that if ORTHO does not elect to seek a remedy under Section
13.4(d)(i), it shall retain its rights to all other remedies under
this Agreement or in law or equity with respect to such matter.
(f) Nothing herein shall be construed in any way to limit ORTHO's
remedies provided for by law or equity or by this Agreement, in the
case of any breach or default by BIOCRYST other than a Willful
Material Breach covered by this Section 13.4.
ARTICLE 14 - RIGHTS AND OBLIGATIONS UPON TERMINATION
14.1 In the event that this Agreement is terminated by ORTHO in accordance
with Article 12, ORTHO hereby assigns, and shall ensure that all of
its Affiliates and sublicensees, shall assign to BIOCRYST all of its
right, title and interest in and to all Joint Inventions and Joint
Patents. ORTHO, its Affiliates and sublicensees shall execute and
deliver any additional documents or instruments that BIOCRYST
reasonably requests to give effect to the foregoing assignment.
14.2 In the event that this Agreement is terminated by either party in
accordance with Article 13, the breaching party hereby assigns, and
shall ensure that all of its Affiliates and sublicensees, shall assign
to the non-breaching party all of its right, title and interest in and
to all Joint Inventions and Joint Patents. The breaching party, its
Affiliates and sublicensees shall execute and deliver any additional
documents or instruments that the non-breaching party reasonably
requests to give effect to the foregoing assignment.
14.3 In the event that this Agreement is terminated by ORTHO in accordance
with either Article 12 or 13 or is terminated by BIOCRYST pursuant to
Article 13, ORTHO agrees that all of its rights under this Agreement
to the Existing Know-How, Improvements, Joint Inventions and Licensed
Patents will be terminated in connection with the countries that are
the subject of such termination or the whole of the Territory if the
Agreement is terminated in its entirety (the "Terminated Countries"),
and ORTHO further undertakes to promptly:
a) if the Agreement has been terminated in its entirety, deliver to
BIOCRYST the Existing Know-How and Improvements and all tangible
examples and copies thereof;
b) make all payments accrued under this Agreement up to the
effective termination date in respect of Net Sales in the
Terminated Countries;
24
c) transfer all regulatory filings and approvals for the Terminated
Countries to BIOCRYST upon BIOCRYST's written request for same;
d) within 30 days of the notice of termination, provide BIOCRYST
with copies of all sublicenses, agreements with clinical research
organizations and other Third Party agreements relating to
Licensed Products hereunder, and allow BIOCRYST 30 days from the
date of such delivery to choose whether to assume any or all of
such contracts;
e) subject to ORTHO's legal ability to do so, assign to BIOCRYST
those Third Party agreements BIOCRYST chooses to assume
responsibility for and control of;
f) ensure a swift and orderly transition to BIOCRYST of all work in
progress in connection with the Licensed Product, with the
continuing costs for such work assumed by BIOCRYST as of the
effective date of termination; and
g) ORTHO shall be entitled to recover from BIOCRYST its reasonable
out-of-pocket expenses incurred in connection with discharging
its responsibilities under this Section 14.3. For the purposes of
this Section 14.3, "reasonable out of pocket expenses" shall
include, but not be limited to, costs for things such as
shipping and photocopying, but shall not include costs such as
attorney' fees, overhead, amortization, recovery of past
expenditures, labor costs and salaries.
14.4 In the event this Agreement expires or is terminated for any reason,
the provisions of this Article 14 and Articles 5, 6, 9.2, 19, 20 and
26 shall survive, as shall any right to payment for payments that fell
due prior to expiration or termination and any other causes of action
in connection with this Agreement.
14.5 In the event that ORTHO terminates this Agreement, in whole or in
part, BIOCRYST may thereafter exercise all of its rights to the
Licensed Patents, Existing Know-How, Improvements, and Joint
Inventions in the Terminated Countries, and Sections 2.8, 2.9, 2.10 or
any other provision hereunder shall not apply to or in any way
restrict BIOCRYST in relation thereto.
ARTICLE 15 - RIGHTS UPON INSOLVENCY
15.1 All rights and licenses to Licensed Patents, Know-How, Improvements
and Joint Inventions granted under or pursuant to this Agreement by
BIOCRYST to ORTHO are, for all purposes of Section 365(n) of Title 11
of the U.S. Code ("Title 11"), licenses of rights to intellectual
property as defined in Title 11. BIOCRYST agrees during the term of
this Agreement to create and maintain current copies or, if not
amenable to copying, detailed descriptions or other appropriate
embodiments, of all Licensed Patents, Know-How, Improvements and Joint
Inventions. If a case is commenced by or against BIOCRYST under Title
11,
25
then, unless and until this Agreement is rejected as provided in Title
11, BIOCRYST (in any capacity, including debtor-in-possession) and its
successors and assigns (including, without limitation, a Title 11
trustee) shall either perform all of the obligations provided in this
Agreement to be performed by BIOCRYST or provide to ORTHO all such
intellectual property (including all embodiments thereof) held by
BIOCRYST and such successors and assigns, as ORTHO may elect in a
written request, promptly upon such request. If a Title 11 case is
commenced by or against BIOCRYST, this Agreement is rejected as
provided in Title 11 and ORTHO elects to retain its rights hereunder
as provided in Title 11, then BIOCRYST (in any capacity, including
debtor-in-possession) and its successors and assigns (including,
without limitation, a Title 11 trustee) shall provide to ORTHO all
such intellectual property (including all embodiments thereof) held by
BIOCRYST and such successors and assigns promptly upon ORTHO's written
request therefor. All rights, powers and remedies of ORTHO, as a
licensee hereunder, provided herein are in addition to and not in
substitution for any and all other rights, powers and remedies now or
hereafter existing at law or in equity (including, without limitation,
Title 11) in the event of the commencement of a Title 11 case by or
against BIOCRYST. ORTHO, in addition to the rights, powers and
remedies expressly provided herein, shall be entitled to exercise all
other such rights and powers and resort to all other such remedies as
may now or hereafter exist at law or in equity (including Title 11) in
such event.
ARTICLE 16 - REPRESENTATIONS
16.1 BIOCRYST represents and warrants that it has produced or provided
access to ORTHO to all data requested by ORTHO including, but not
limited to all information concerning side effects, injury, toxicity
or sensitivity reaction and incidents or severity thereof with respect
to any tests conducted by BIOCRYST or its contractors in BIOCRYST's
possession as of the Effective Date relating to Licensed Product.
ORTHO acknowledges that such tests have been entirely preclinical and
may not be indicative of results that may be obtained in humans.
16.2 BIOCRYST represents and warrants that, to the best of its knowledge,
it has title to and ownership of, free and clear of all liens, claims
and encumbrances of any nature, all Licensed Patents set forth on
Schedule 1 attached hereto.
16.3 BIOCRYST represents and warrants that, to the best of its knowledge,
it has title to and ownership of, or sufficient license rights, free
and clear of all liens, claims and encumbrances of any nature, to all
of the Existing Know-How licensed by BIOCRYST to ORTHO hereunder.
16.3 BIOCRYST has not, and during the term of the Agreement will not, grant
any right to any Third Party in violation of the exclusive nature of
the licenses granted to ORTHO under Section 2 above.
26
16.4 As of the Effective Date, BIOCRYST represents and warrants that it has
no knowledge of the existence of any published patent application or
patent issued prior to the Effective Date which is owned by a Third
Party and would prevent ORTHO from making, using or selling any
chemical compound claimed in the Existing Patents. BIOCRYST further
declares that to its best knowledge during Development of the Lead
Compounds BIOCRYST did not infringe any patent issued to a Third Party
prior to the Effective Date. To the best of BIOCRYST's knowledge and
belief, as of the Effective Date, the Licensed Patents listed in
Schedule 1 are owned by BIOCRYST and BIOCRYST is not in possession of
information that would, in its opinion, render invalid and/or
unenforceable claims directed to any of the Lead Compounds.
Notwithstanding the foregoing, if at any time prior to the expiration
of twenty-four (24) months after the Effective Date hereof a patent or
published patent application held by a Third Party is identified which
claims any of the Lead Compounds, the Parties will meet and discuss
possible resolutions of the patent situation. If the resolution
involves a license from the Third Party to its patent rights and/or a
license to the Third Party under BIOCRYST or ORTHO patent rights, the
Parties acknowledge that the economic assumptions underlying this
Agreement may no longer be valid, and in such case the Parties will
renegotiate the terms of this Agreement in good faith in order to
reflect such resolution.
16.5 NO OTHER REPRESENTATIONS OR WARRANTIES. THE EXPRESS REPRESENTATIONS
AND WARRANTIES STATED IN THIS ARTICLE 16 ARE IN LIEU OF ALL OTHER
REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE. SPECIFICALLY, BIOCRYST MAKES NO OTHER
REPRESENTATIONS OR WARRANTIES IN RELATION TO THE LICENSED PATENTS, THE
EXISTING KNOW-HOW, IMPROVEMENTS OR JOINT INVENTIONS
ARTICLE 17 - INTERPRETATION
17.1 The construction, validity and performance of this Agreement shall be
governed in all respects by the laws of the State of New York, without
giving effect to principles of conflict of laws.
ARTICLE 18 - FORCE MAJEURE
18.1 No failure or omission by the Parties hereto in the performance of any
obligation of this Agreement shall be deemed a breach of this
Agreement nor create any liability if the same shall arise from any
cause or causes beyond the control of the Parties, including but not
limited to the following which, for the purposes of this Agreement,
shall be regarded as beyond the control of the Party in question: act
of God, acts or omissions of any government or any rules, regulations
or orders of any governmental authority or any
27
officer, department, agency or instrument thereof; fire, storm, flood,
earthquake, accident, acts of the public enemy, war, rebellion,
insurrection, riot, invasion, strikes, or lockouts.
ARTICLE 19 - DISPUTE RESOLUTION
19.1 a) The Parties shall attempt in good faith to resolve any dispute arising
out of or relating to this Agreement promptly by negotiations between
the Chief Executive Officer of BIOCRYST and the Chairman of the X.X.
Xxxxxxx Pharmaceutical Research Institute if relating to research or
Development issues or the President of Ortho-XxXxxx Pharmaceutical,
Inc. for all other issues, who each have authority to settle the
controversy and who are at a higher level of management than the
persons with direct responsibility for administration of this
Agreement. Any Party may give the other Party written notice of any
dispute not resolved in the normal course of business. Within five
business days after receipt of the notice, the receiving Party shall
submit to the other a written response. The notice and the response
shall include a detailed statement of each Party's position and a
summary of arguments supporting that position. Within five days after
delivery of the response, the representatives of BIOCRYST and ORTHO
mentioned above shall meet at a mutually acceptable time and place,
and thereafter as often as they reasonably deem necessary, to attempt
to resolve the dispute. All reasonable requests for information made
by one Party to the other will be honored. All negotiations pursuant
to this clause will be confidential and shall be treated as compromise
and settlement negotiations for the purposes of the Federal Rules of
Evidence and all other evidentiary purposes.
b) If the matter has not been resolved within twenty days of the
disputing Party's notice, or if the representatives of BIOCRYST and
ORTHO set forth in Section 19.1a fail to meet within the time frame
set forth in 19.1 a), either Party may initiate mediation of the
dispute as set forth in Section 19.2 of this Agreement.
19.2 a) Any dispute, controversy or claim arising out of or related to this
agreement, or the interpretation, application, breach, termination or
validity thereof, including any claim of inducement by fraud or
otherwise, shall, before submission to arbitration, first be mediated
through non-binding mediation in accordance with the Model Procedures
for the Mediation of Business Disputes promulgated by the Center for
Public Resources ("CPR") then in effect, except where those rules
conflict with these provisions, in which case these provisions
control. The mediation shall be conducted in New York, New York and
shall be attended by a senior executive with authority to resolve the
dispute from each of the operating companies that are Parties.
28
b) The mediator shall be an attorney specializing in business
litigation who has at least 15 years of experience as a lawyer
with a law firm of over 25 lawyers or was a judge of a court of
general jurisdiction and who shall be appointed from the list of
neutrals maintained by CPR.
c) The Parties shall promptly confer in an effort to select a
mediator by mutual agreement. In the absence of such an
agreement, the mediator shall be selected from a list generated
by CPR with each Party having the right to exercise challenges
for cause and two peremptory challenges within three business
days of receiving the CPR list.
d) The mediator shall confer with the Parties to design procedures
to conclude the mediation within no more than forty-five (45)
days after initiation. Unless agreed upon by the Parties in
writing, under no circumstances shall the commencement of
arbitration under Section 19.3 be delayed more than forty-five
(45) days by the mediation process specified herein.
e) Each Party agrees to toll all applicable statutes of limitation
during the mediation process and not to use the period or
pendancy of the mediation to disadvantage the other Party
procedurally or otherwise. All negotiations pursuant to this
clause will be confidential and shall be treated as compromise
and settlement negotiations for the purposes of the Federal Rules
of Evidence and all other evidentiary purposes.
f) Each Party has the right to pursue provisional relief from any
court, such as attachment, preliminary injunction, replevin,
etc., to avoid irreparable harm, maintain the status quo, or
preserve the subject matter of the arbitration, even though
mediation has not been commenced or completed.
19.3 a) Following the mediation procedures set forth in Section 19.2, Any
dispute, claim or controversy arising from or related in any way
to this Agreement or the interpretation, application, breach,
termination or validity thereof, including any claim of
inducement of this Agreement by fraud or otherwise, will be
submitted for resolution to arbitration pursuant to the
commercial arbitration rules then pertaining of the Center for
Public Resources ("CPR"), except where those rules conflict with
these provisions, in which case these provisions control. The
arbitration will be held in New York, New York.
b) The panel shall consist of three arbitrators chosen from the CPR
Panels of Distinguished Neutrals each of whom is a lawyer
specializing in business litigation with at least 15 years
experience with a law firm of over 25 lawyers or was a judge of a
court of general jurisdiction.
c) The Parties agree to cooperate (1) to obtain selection of the
arbitrators within thirty (30) days of initiation of the
arbitration, (2) to meet with the arbitrators within thirty (30)
days of selection and (3) to agree at that meeting or before upon
procedures for discovery and as to the conduct of the hearing
which will result in
29
the hearing being concluded within no more than nine (9) months
after selection of the arbitrators and in the award being
rendered within sixty (60) days of the conclusion of the
hearings, or of any post-hearing briefing, which briefing will be
completed by both Parties with twenty (20) days after the
conclusion of the hearings. In the event no such agreement is
reached, the CPR will select arbitrators, allowing appropriate
strikes for reasons of conflict or other cause and three
peremptory challenges for each side. The arbitrators shall set a
date for the hearing, commit to the rendering of the award within
sixty (60) days of the conclusion of the evidence at the hearing,
or of any post-hearing briefing (which briefing will be completed
by both sides in no more than twenty (20) days after the
conclusion of the hearings), and provide for discovery according
to these time limits, giving recognition to the understanding of
the Parties hereto that they contemplate reasonable discovery,
including document demands and depositions, but that such
discovery be limited so that the time limits specified herein may
be met without undue difficulty. In no event will the
arbitrators allow either side to obtain more than a total of
forty (40) hours of deposition testimony from all witnesses,
including both fact and expert witnesses. In the event multiple
hearing days are required, they will be scheduled consecutively
to the greatest extent possible.
d) The arbitrators shall render their award following the
substantive law of New York. The arbitrators shall render an
opinion setting forth findings of fact and conclusions of law
with the reasons therefor stated. A transcript of the evidence
adduced at the hearing shall be made and shall, upon request, be
made available to either Party.
e) To the extent possible, the arbitration hearings and award will
be maintained in confidence.
f) Any United States District Court having jurisdiction of the
matter may enter judgment upon any award. In the event the
panel's award exceeds Five Million Dollars (5,000,000) in
monetary damages or includes or consists of equitable relief,
then the court shall vacate, modify or correct any award where
the arbitrators' findings of fact are clearly erroneous, and/or
where the arbitrators' conclusions of law are erroneous; in other
words, it will undertake the same review as if it were a federal
appellate court reviewing a district court's findings of fact and
conclusions of law rendered after a bench trial. An award for
less than Five Million Dollars (5,000,000) in damages and not
including equitable relief may be vacated, modified or corrected
only upon the grounds specified in the Federal Arbitration Act.
The Parties consent to the jurisdiction of the District Court for
the enforcement of these provisions, the entry of judgment on any
award, and the vacatur, modification and correction of any award
as above specified.
g) Each Party has the right before or during the arbitration to seek
and obtain from the appropriate court provisional remedies such
as attachment, preliminary injunction, replevin, etc. to avoid
irreparable harm, maintain the status quo, or preserve the
subject matter of the arbitration.
30
h) EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY.
i) EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE, EXEMPLARY AND
CONSEQUENTIAL DAMAGES FROM THE OTHER.
ARTICLE 20 - NOTICES
20.1 Any notice required or permitted to be given under this Agreement
shall be mailed by registered or certified mail, postage prepaid,
addressed to the Party to be notified at its address stated
below, or at such other address as may hereafter be furnished in
writing to the notifying Party or by telefax (with confirmation
sent by mail) to the numbers set forth below or to such changed
telefax numbers as may thereafter be furnished.
If to BIOCRYST:
BIOCRYST Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxx Xxxxx
Xxxxxxxxxx, Xxxxxxx 00000
Telefax No.: (000) 000-0000
Attention: Chief Executive Officer
with a copy to:
Xxxxxxx, Xxxxxxx & Xxxxxxxx LLP
0000 Xxxxxxxx, 00xx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telefax No.: (000) 000-0000
Attention: Xxxxxxx X. Xxxxxxxxx, Esq.
Xxxxx X. Xxxxxx, Esq.
If to ORTHO:
President
ORTHO-XxXxxx Pharmaceutical, Inc.
X.X. Xxxxx 000 Xxxxx
Xxxxxxx, XX 00000-0000
Telefax No.: (000) 000-0000
with a copy to:
Office of General Counsel
Xxxxxxx & Xxxxxxx
Xxx Xxxxxxx & Xxxxxxx Xxxxx
Xxx Xxxxxxxxx, XX 00000
Telefax No.: (000) 000-0000
31
Any such notice shall be deemed to have been received when it has been
delivered in the ordinary course of post or received by telefax.
ARTICLE 21 - WAIVER
21.1 The failure on the part of BIOCRYST or ORTHO to exercise or enforce
any rights conferred upon it hereunder shall not be deemed to be a
waiver of any such rights nor operate to bar the exercise or
enforcement thereof at any time or times thereafter.
ARTICLE 22 - LEGALITY
22.1 In the event that any term of this Agreement shall contravene the laws
and/or regulations in any country of the Territory, the Parties shall
immediately meet in order to agree on any necessary amendments,
provided that any clauses thereby rendered unenforceable shall in no
way affect the validity of this Agreement.
ARTICLE 23 - ENTIRE AGREEMENT
23.1 This Agreement constitutes the entire agreement between the Parties
hereto concerning the subject matter hereof and any representation,
promise or condition in connection therewith, not incorporated herein,
shall not be binding upon either Party. Before signing this Agreement
the Parties have had numerous conversations, including preliminary
discussions, formal negotiations and informal conversations at meals
and social occasions, and have generated correspondence and other
writings, in which the Parties discussed the transaction which is the
subject of this Agreement and their aspirations for its success. In
such conversations and writings, individuals representing the Parties
may have expressed their judgements and beliefs concerning the
intentions, capabilities, and practices of the Parties, and may have
forecasted future events. The Parties recognize that such
conversations and writings often involve an effort by both sides to be
positive and optimistic about the prospects for the transaction.
However, it is also recognized that all business transactions contain
an element of risk, as does the transaction contemplated by this
Agreement, and that it is normal business practice to limit the legal
obligations of contracting Parties to only those promises and
representations which are essential to their transaction so as to
provide certainty as to their respective future rights and remedies.
Accordingly, this Agreement including without limitation the exhibits,
schedules and attachments thereto are intended to define the full
extent of the legally enforceable undertakings of the Parties hereto,
and no promise or representation, written or oral, which is not set
forth explicitly is intended by either Party to be legally binding.
Both Parties acknowledge that in deciding to enter into the Agreement
and to consummate the transaction contemplated thereby neither has
relied upon any statement or representations, written or oral, other
than those explicitly set forth therein.
32
ARTICLE 24 - ASSIGNMENT
24.1 This Agreement, and all rights and obligations hereunder, are personal
as between the Parties and shall not be assigned in whole or in part
by any of the Parties to any other person or company without the prior
written consent of the other Party. When assigned as permitted herein
this Agreement shall be binding on each Party's successors and
assigns.
ARTICLE 25 - TITLES
25.1 It is agreed that the marginal headings appearing at the beginning of
the numbered Articles hereof have been inserted for convenience only
and do not constitute any part of this Agreement.
ARTICLE 26 - PUBLICITY
26.1 Neither Party shall originate any publicity, news release or public
announcements, written or oral, whether to the public or press,
stockholders or otherwise, relating to this Agreement, including its
existence, the subject matter to which it relates, performance under
it or any of its terms, to any amendment hereto or performances
hereunder without the prior written consent of the other Party, which
shall not be unreasonably withheld applying a reasonableness standard
applicable to a large pharmaceutical company, save only such
announcements that are required by law to be made or that are
otherwise agreed by the Parties. Such announcements shall be factual.
If a Party decides to make an announcement required by law, it will
give the other Party at least five (5) business days advance notice,
where possible, of the text of the announcement so that the other
Party will have an opportunity to comment upon the announcement. To
the extent that the receiving Party reasonably requests that any
information in the materials proposed to be disclosed be deleted, the
disclosing Party shall request confidential treatment of such
information pursuant to Rule 406 of the Securities Act of 1933 or Rule
24b-2 of the Securities Exchange Act of 1934 as amended, as applicable
(or any other applicable regulation relating to the confidential
treatment of information) so that there be omitted from the materials
that are publicly filed any information that the receiving Party
reasonably requests to be deleted, unless in the opinion of the
disclosing Party's legal counsel such Confidential Information is
legally required to be fully disclosed.
ARTICLE 27 - UNENFORCEABLE PROVISIONS
27.1 Any provision hereof which is prohibited or unenforceable in any
jurisdiction shall, as to such jurisdiction, be ineffective only to
the extent of such prohibition or unenforceability without
invalidating the remaining provisions hereof or affecting the validity
or enforceability of such provisions in any other jurisdiction.
33
ARTICLE 28 - OTHERS
28.1 As used in this Agreement, singular includes the plural and plural
includes the singular, wherever so required by fact or context.
ARTICLE 29 - EXECUTION
29.1 This Agreement shall be executed in two (2) counterparts each of which
shall for all purposes be deemed an original.
ARTICLE 30 - HSR CONDITION
30.1 The effectiveness of this Agreement and the Parties' rights and obligations
under this Agreement are conditioned upon expiration or termination of the
waiting period under the Xxxx-Xxxxx-Xxxxxx Anti-Trust Improvements Act of
1976 (the "HSR Waiting Period"). The Parties agree to request early
termination or waiver of the HSR Waiting Period. All payments that would
otherwise have been payable during the period between the Effective Date
and the termination of the HSR Waiting Period shall be paid within three
(3) business days of termination of the HSR Waiting Period.
34
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed by their respective duly authorized officers or representatives as of
the day and year first above written.
BIOCRYST PHARMACEUTICALS, INC.
Witness:
-------------------------
By: /s/ Xxxxxxx X. Xxxx
-------------------------
Name: Xxxxxxx X. Xxxx
Title: Chairman/CEO
-------------------------
Date: September 14, 1998
-------------------------
ORTHO-XxXXXX PHARMACEUTICAL, INC.
Witness:
------------------------- By: /s/ Xxxxxx X. Xxxxxx
-------------------------
Name: Xxxxxx X. Xxxxxx
Title: President
-------------------------
Date: September 14, 1998
--------------------------
X.X. XXXXXXX PHARMACEUTICAL RESEARCH
INSTITUTE, DIVISION OF ORTHO-XxXXXX
PHARMACEUTICAL, INC.
Witness:
-------------------------
By: /s/ Xxxxxxx A.M. Xxxxxx
-------------------------
Name: Xxxxxxx A. M. Xxxxxx
Title: Chairman
-------------------------
Date: September 14, 1998
-------------------------
35
SCHEDULE 1
EXISTING PATENTS
SCHEDULE 1A - U.S. PATENTS
Schedule 1A - U. S. Patents
Date of
Patent Number Title Inventors Issuance
5,602,277 Substituted Benzene Babu et al. Feb. 11,
Derivatives Useful as 1997
Neuraminidase Inhibitors
Schedule 1B - U. S. and International Patent Applications
[***]
---------------
*** Information omitted and filed separately with the Commission under Rule
24b-2.
36
SCHEDULE 2
ASSAYS FOR DETERMINING WHETHER A COMPOUND IS ACTIVE
AGAINST THE INFLUENZA VIRUS
[***]
---------------
*** Information omitted and filed separately with the Commission under Rule
24b-2.
37
SCHEDULE 3
COUNTRIES WHERE PATENT APPLICATIONS WILL BE FILED AND PROSECUTED
US
[***]
------------------------
*** Information omitted and filed separately with the Commission under Rule
24b-2.
38
EXHIBIT A
THE PLAN
39
EXHIBIT B
ROYALTY CALCULATION EXAMPLE
[***]
---------------
*** Information omitted and filed separately with the Commission under Rule
24b-2.
40
