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Exhibit
10.4
EXCLUSIVE LICENSE
AGREEMENT
This Agreement, effective
August 10, 2005 ( the “Effective Date”) is between
VIA Pharmaceuticals, Inc. a corporation organized and existing
under the laws of the State of Delaware and having its principal
place of business at 750 Battery Street, Suite 400, San Francisco
CA 94111 (“ VIA ”) and Abbott Laboratories, a
corporation organized and existing under the laws of the State of
Illinois and having its principal place of business at 100 Abbott
Park Road, Abbott Park, IL 60064 (“ Abbott
”).
WITNESSETH
THAT:
WHEREAS, Abbott owns certain
intellectual property relating to the Compound as hereinafter later
defined; and
WHEREAS, VIA wishes to obtain
a worldwide exclusive license under such intellectual property to
develop and commercialize the Compound in the Field, as hereinafter
later defined; and
WHEREAS Abbott is willing to
grant such a license to VIA on the terms and subject to the
conditions set forth herein.
NOW, THEREFORE, in
consideration of the premises and the mutual covenants and
agreements herein contained, Abbott and VIA agree as
follows:
ARTICLE I
DEFINITIONS
As used in this Agreement,
each capitalized term listed below shall have the meaning that is
given after it:
“ ABT-761
” means the active ingredient
((R)-{3-[5-(4-fluorophenylmethyl)-2-thienyl]-1-methyl-2-propynyl}N-hydroxyurea)
together with all salts, esters, non-covalent complexes, chelates,
hydrates, stereo isomers, crystalline or amorphous forms or
prodrugs of the molecule, as more frilly described in the Patent
Rights.
“ Affiliate
” means a corporation or any other entity that directly, or
indirectly through one or more intermediaries, controls, is
controlled by, or is under common control with, the designated
Party. As used herein, the term “control” means
possession of power to direct or cause the direction of the
management and policies of a corporation or other entity whether
through the ownership of voting securities, by contract or
otherwise; provided, however, that for purposes of this Agreement,
TAP Pharmaceutical Products, Inc. and its subsidiaries, which
comprises Abbott Laboratories joint venture with Takeda Chemical
Industries, Ltd., shall not be considered an
“Affiliate” of Abbott unless and until Abbott has
elected to include TAP Pharmaceutical Products, Inc., as an
Affiliate hereunder by providing VIA written notice of the
same.
“ Alleged
Infringement Action ” shall have the meaning ascribed to
it under the provisions of Section 7.4(b)(1).
“ Backup
Compound(s) ” means any compound included in Patented
Compounds, providing that such Patented Compound is determined by
Abbott to be available for licensing under the provisions of
Section 2.5.
“ Commercially
Reasonable Efforts ” means continuous and diligent
efforts of a degree and kind, including the level of attention and
care and providing of funding and manpower, as are consistent with
a company similarly situated as VIA with the then current stage of
product life cycle, and such efforts will in no event be less than
the efforts that VIA applies with respect to its own products of
similar commercial potential and stage of product life cycle to the
maximum extent feasible, consistent with the exercise of good
business judgment.
“ Compound
” means ABT-761 or, if a Backup Compound is substituted for
ABT-761 under the provisions of Section 2.5, Compound shall
mean such Backup Compound and not ABT-761.
“ Confidential
Information ” means all data, information, or Licensed
Technology (and all tangible and intangible embodiments thereof),
which is controlled and disclosed by a Party (“Disclosing
Party”) to the other Party (“Receiving Party”)
pursuant to this Agreement, except, and only to the extent a
Receiving Party can establish by written documentation, that
which:
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(a) |
is or becomes part of the public domain without the fault of
the Receiving Party; |
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(b) |
has been received by the Receiving Party at any time from a
source, other than the Disclosing Party, rightfully having
possession of and the right to disclose such information free of
confidentiality obligations; |
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(c) |
has been otherwise known by the Receiving Party free of
confidentiality obligations prior to disclosure of such information
by the Disclosing Party to the Receiving Party; or |
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(d) |
has been independently developed by employees or others on
behalf of the Receiving Party without access to, use of, reference
to, or reliance upon the Confidential Information. |
(Each of the categories under
(a),(b), (c) and (d) are defined as a
“Confidentiality Exception”).
Notwithstanding the above, specific
aspects or details of Confidential Information will not be deemed
to be within the public domain or in the prior possession of the
Receiving Party merely because the aspects or details of the
Confidential Information are embraced by general disclosures in the
public domain. In addition, any combination of Confidential
Information will not be considered in the public domain or in the
prior possession of the Receiving Party merely because individual
elements thereof are in the public domain or in the prior
possession of the Receiving Party unless the combination is in the
public domain or in the prior possession of the Receiving
Party.
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Further, for avoidance of doubt,
Confidential Information will include Confidential Information
received by the Disclosing Party from a Third Party. Prior to
disclosure of such Third Party Confidential Information to the
Receiving Party, the Disclosing Party will determine that it has
the right to make such disclosure, advise the Receiving Party that
the disclosure includes Third Party Confidential Information and
provide the Receiving Party with the terms and conditions of any
agreement between the Third Party and the Disclosing Party
respecting such Third Party Confidential Information.
“ Contact Person
” shall have the meaning ascribed to it under the provisions
of Section 2.7.
“ Development
Data ” means all preclinical toxicology, stability study
and related production, clinical and regulatory information or data
related to the Licensed Product that supports any MAA for the
Licensed Product.
“ Extension
” shall have the meaning ascribed to it under the provisions
of Section 6.3(a).
“ FDA ”
means the United States Food and Drug Administration, or any
successor agency having substantially the same functions and/or any
foreign equivalents.
“ Field ”
means the treatment and/or prevention of diseases in
humans.
“ First Commercial
Sale ” means the first sale by VIA or its Sublicensees of
a Licensed Product in a country within the Territory to any Third
Party following Regulatory Approval.
“ HSR Act
” means the Hart-Scott-Rodino Antitrust Improvements Act of
1976, as amended (see 15 U.S.C. § 18a).
“ IND ”
shall mean any Investigational New Drug Application and any
amendments thereto filed with the FDA.
“ Invention
” means any technology, discovery, know-how, invention
(including new uses and substances) or data (whether or not
protectable under state, federal or foreign patent, trademark,
copyright or similar laws) that is conceived, made, discovered or
reduced to practice during the course of this Agreement, or results
in whole or in part from activities carried out under this
Agreement that were reduced to practice within ninety
(90) days following expiration or termination of this
Agreement.
“ Licensed
Product ” means any formulation containing the
Compound.
“ Licensed
Technology ” means information, trade secrets, data,
Inventions (whether patentable or unpatentable), trademarks and
know-how relating to Licensed Product, which is owned or controlled
by or licensed to Abbott as of the Effective Date, including the
USAN name for ABT-761, manufacturing technology, analytical and
process techniques, regulatory filings, research and development
reports, methods, protocols, clinical and safety data in both paper
and electronic formats, statistical programs, preclinical data,
research data, manufacturing data, analytical data, batch records,
standard operating procedures, improvements related to the Compound
or Licensed Product or useful in the manufacture, use, sale or
registration of the
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Compound or Licensed Product. Licensed
Technology shall also include inventory, reagents, samples,
analytical standards, metabolites, serum samples, tissue samples,
active pharmaceutical ingredients, drug product stocks, and other
materials and compositions related to the Compound or Licensed
Product or useful for the manufacture, use, sale or registration of
the Compound or Licensed Product (sometimes also referred to as
“Tangible Licensed Technology”). For the avoidance of
doubt, Licensed Technology does not include any Patents
Rights.
“ MAA ”
means a marketing authorization application filed with the relevant
regulatory authority.
“ Manufacturing
Agreement ” means the Agreement entered into on the
Effective Date between Abbott and VIA concurrent with this
Agreement that is aimed at supplying the Compound as active
pharmaceutical ingredients only and not as finished commercial
product.
“ Net Sales
” means the amount invoiced by VIA or its Sublicensee(s) on
sales of Licensed Products to unrelated Third Parties, less the
following:
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(a) |
discounts, including cash discounts, customary trade allowances
or rebates actually taken, governmental rebates, chargebacks,
commissions, and group purchasing management fees for formulary
access; |
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(b) |
credits or allowances given or made for rejection, recall or
return of previously sold Product actually taken; |
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(c) |
any tax or government charge, duty or assessment (including any
tax such as a value added or similar tax or government charge)
levied on the sale, transportation or delivery of Licensed Product
when included on the invoice or other written document between the
parties as payable by the purchaser and collectable by VIA, its
Affiliate or Sublicensee; |
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(d) |
freight, postage, transportation, insurance and duties on
shipment of Licensed Product when included on the invoice or other
written document between the parties as payable by the purchaser
and collectable by VIA, its Affiliates or Sublicensees;
and |
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(e) |
credit losses, up to 1% of the total amount
invoiced. |
With respect to a Licensed Product which
contains one or more Compounds combined as a single pharmaceutical
product with one or more other therapeutically active ingredients
(a “ Combination Product ”), the Net Sales of
such Combination Product shall first be calculated in accordance
with the definition of Net Sales under paragraphs (a), (b), (c),(d)
and (e), and then the Net Sales of such Combination Product shall
be determined on a country-by-country basis as follows:
(i) multiply the Net Sales of
such Combination Product by the fraction A/(A+B), where A is the
total of the average selling prices of such Compound(s) when sold
separately as a pharmaceutical product in such country and B is the
total of the average selling prices of each other active ingredient
when sold alone as a pharmaceutical product in such country;
or
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(ii) if either the average
selling price of all Compound(s) in such Combination Product or the
average selling price of all other active ingredients in such
Combination Product is not available, multiply the Net Sales of
such Combination Product by a percentage, determined by mutual
agreement of the Parties, which represents the proportionate
economic value contributed by all other active ingredients in such
Combination Product.
“ NDA ”
means a New Drug Application filed with the FDA, or any similar
filing with any Regulatory Authority.
“ Party ”
or “ Parties ” mean(s) VIA and/or Abbott,
depending on the context.
“ Patented
Compound(s) ” means any compound claimed in US Patent
No. 5,288,751.
“ Patent Rights
” mean those claims pertaining to the Compound in the patents
and patent applications listed in Appendix A attached hereto,
including any division, continuation or continuation-in-part,
substitute, renewal, reissue, extension, confirmation,
reexamination or registration thereof and any patent issuing
thereon, including any substitute, renewal, reissue, extension,
confirmation, reexamination, registration or foreign counterpart
thereof, including any Patent Term Extensions or Supplementary
Protection Certificates.
“ Phase III Clinical
Trial ” means a trial on sufficient numbers of patients
that is designed to establish that a pharmaceutical product is safe
and efficacious for its intended use, and to define warnings,
precautions and adverse reactions that are associated with the
pharmaceutical product in the dosage range to be prescribed, and to
support Regulatory Approval of such pharmaceutical product or label
expansion of such pharmaceutical product, as more fully defined in
21 CFR § 312.21(c), or its foreign equivalent.
“ Press Release
” means the press release set forth in Appendix D.
“ Regulatory
Approval ” means (a) the governmental authorization
and/or approval required by a Regulatory Authority of such country
to commence sale of a Licensed Product and (b) any required
pricing or reimbursement approval outside of the United States of
America (“Pricing Reimbursement”). For the purpose of
Section 4.2(a), a Licensed Product will be deemed to have met
the definition of Regulatory Approval at the earlier of meeting the
requirements of (a) and (b) of this definition or if such
Licensed Product met the provisions of section (a) of this
definition then nine months from such date, whether or not Pricing
Reimbursement has been received by such date.
“ Regulatory
Authority(ies) ” means any of the FDA or any comparable
national or territorial regulatory entity within the Territory
having substantially the same functions.
“ Reporting
Period ” begins on the first day of each calendar quarter
and ends on the last day of such calendar quarter.
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“ Royalty Term
” means the period of time for which VIA’s royalty
obligations are due to Abbott hereunder, which shall commence, on a
country by country basis, upon the First Commercial Sale of the
Licensed Product and shall terminate, on a country by country
basis, upon the expiration of all Valid Claims covering the
researching, developing, making, having made, using, offering to
sell, selling, and importing/exporting of Licensed Product in such
country, including any Extension(s) thereto.
“ Step-Down Royalty
Term ” means a period of time, if any, for which
VIA’s step down royalty obligations are due to Abbott
hereunder, which shall commence, on a country by country basis,
after the Royalty Term but in no event shall exceed 10 years from
the date of the First Commercial Sale of the Licensed
Product.
“ Sublicensee
” means any Third Party, including Affiliates of VIA that is
granted a sublicense pursuant to Section 2.2.
“ Third Party
” or “ Third Parties ” means any party
other than VIA or Abbott.
“ Term ”
shall have the meaning ascribed to it under the provisions of
Section 12.1.
“ Territory
” means the entire world.
“ Valid Claim
” means a claim of any issued and unexpired patent or any
claim or product definition or equivalents thereof in any patent
term extension or supplementary protection certificate thereof or
pending patent term extension or supplementary protection
certificate application thereof, included within the Patent Rights
which claim or product definition or equivalents thereof has not
been invalidated by one or more of any of the following:
(l) irretrievable lapse, revocation or abandonment and/or
(2) holding of unenforceability or invalidity by a decision of
a court or other appropriate body of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal,
and/or (3) disclaimed or declared invalid or unenforceable
through reissue or re-examination or opposition, nullity action or
invalidation suit by a decision beyond review by a court or other
appropriate body of competent jurisdiction.
ARTICLE II
LICENSE GRANT;
OWNERSHIP
2.1 (a) License Grant to
Patent Rights and Licensed Technology . Subject to the terms of
this Agreement, Abbott hereby grants to VIA for the Term an
exclusive, milestone and royalty-bearing license to the Patent
Rights and Licensed Technology to research, develop, make, have
made, use, offer to sell, sell, and import/export Licensed Products
in the Field in the Territory, subject to a non-transferable right
by Abbott and its Affiliates to utilize the Compound for internal
research purposes and derivatization of new compounds. For the
avoidance of doubt, Abbott shall not grant to TAP Pharmaceutical
Products (“TAP”), Inc. any rights to conduct internal
research or derivation by use of the Compound, even if TAP is later
designated by Abbott to be an Affiliate. Abbott and its Affiliates
shall not have the right to conduct pre-clinical or clinical
development of the Compound in any clinical trials nor shall Abbott
and its Affiliates submit any reports with regulatory authorities
seeking regulatory approval of the Compound. Abbott and its
Affiliates also shall not publish nor otherwise disclose to any
Third Party any data generated by using the Compound for internal
research purposes.
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(b) Assignment of Tangible
Licensed Technology . Abbott hereby assigns to VIA all right,
title and interest to all Tangible Licensed Technology. Abbott
shall take all necessary actions, including executing documents of
assignment, to vest title to all Tangible Licensed Technology with
VIA.
2.2 Sublicenses . VIA
shall have the right to grant sublicenses of its rights under
Section 2.1, provided:
(a) VIA shall incorporate
terms and conditions into its sublicense agreements to ensure that
both VIA and its Sublicensee comply with the terms of this
Agreement.
(b) VIA shall promptly
furnish Abbott with an appropriately redacted photocopy of any
sublicense agreement. VIA shall not redact any information that is
necessary for Abbott to determine that VIA has incorporated
applicable requirements of this agreement in the
sublicense.
2.3 No Additional
Rights . Nothing in this Agreement shall he construed to confer
any rights upon VIA by implication, estoppel, or otherwise to any
technology or patent rights of Abbott other than the grant of
license to Patent Rights and Licensed Technology pursuant to
Section 2.1, regardless of whether such technology or patent
rights shall be dominant or subordinate to any Patent
Rights.
2.4 (a) Transfer of
Licensed Technology .
Abbott will use commercially
reasonable and diligent efforts to transfer all available Licensed
Technology listed in Appendix B within the timeframes specified
therein. These activities shall commence upon execution of this
Agreement. If, after the transfer of Licensed Technology, Abbott
becomes aware of any additional Licensed Technology, it will notify
VIA and the Parties shall arrange for the transfer of such Licensed
Technology. VIA agrees to reimburse Abbott for up to a maximum of
$40,000 in direct costs incurred by Abbott in carrying out the
transfer of Licensed Technology, upon presentation by Abbott of
invoices showing the time spent and costs incurred.
(b) Access to Regulatory
Filings .
Consistent with the
requirements of 21 CFR 312, Abbott will transfer to VIA the
complete IND file for ABT-761 (“Original IND”) and all
such available documentation relevant to the Original IND as is
necessary to enable VIA to transfer the Original IND under its own
name and assume regulatory responsibility for development of
ABT-761 after transfer of the Original IND into VIA’s name
becomes effective, including all supplements to the Original IND,
all regulatory tiles and FDA correspondence related thereto, and
all records and reports required to be kept that are necessary to
enable VIA to effect the transfer (but excluding, for the avoidance
of doubt, records of Abbott that arc not so necessary such as
confidential personnel records, facility design records or quality
assurance batch records). Within ten (10) days after VIA
confirms in writing the receipt of the IND file from Abbott, Abbott
will execute and deliver a letter to the FDA authorizing the
transfer of the Original IND filings to VIA and
authorizing
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VIA to do and take all actions that are
necessary to transfer the Original IND filings for the Compound in
the name of VIA. Abbott shall use commercially reasonable and
diligent efforts to ensure that it has located and provided to VIA
all such documentation related to the Original IND and all other
Licensed Technology and Abbott shall immediately convey to VIA any
such documentation or other Licensed Technology that Abbott locates
after the Effective Date.
2.5 (a) Procedure for
Requesting Substitution of Backup .
If VIA, at its sole
discretion, determines that it wishes to substitute a Backup
Compound for the Compound, then VIA shall notify Abbott which
Patented Compound it would like to nominate as a Backup Compound.
If the Non-Use Period, (as defined in Section 2.9) has not
expired, then VIA shall have the right to substitute any Patented
Compound. If the Non-Use Period has expired, Abbott shall review
whether or not such compound: (i) is already subject to any
grant of rights to a third party, or (ii) is under active
consideration by Abbott for an internal research or development
program or (iii) is currently being researched or developed by
Abbott.
(b) Substitution of Backup
Compound .
If after following the
procedures in 2.5(a), Abbott finds the compound is available for a
grant of rights to VIA then, (i) VIA’s rights to the
original Compound shall cease and (ii) all rights granted to
the original Compound shall immediately terminate and
(iii) the Backup Compound shall immediately be classified as
the Compound and shall be so treated for all rights granted and
duties owed under this Agreement.
2.6 Supply of Compound
. Supply of the Compound by Abbott to VIA shall be exclusively
governed under the terms and conditions contained in the
Manufacturing Agreement.
2.7 Contacts for
Technology Transfer . Abbott and VIA shall each designate a
contact person (the “Contact Person(s)”) for the
transfer activities to be undertaken under the provisions of
Section 2.4. Abbott’s initial Contact Person shall be
Director, Technology Licensing and VIA’s Contact Person shall
be Vice President of Business Development. Either Party may change
the Contact Person named above by written notification to the other
Party. Routine correspondence relevant to the transfer activities
to be undertaken under the provisions of Section 2.4 shall be
sent to the above-named Contact Persons. All notices or similar
communications in regard to the terms or a proposed change of terms
of this Agreement are to be sent to the Parties named in
Section 13,1, Notice .
2.8 Covenant Not to
Sue . In the event the making, having made, use, offer for
sale, sale or import by VIA, its Affiliates, Sublicensees or
distributors of Licensed Product, would infringe during the Term of
this Agreement a claim of an issued patent which is owned by or
licensed to Abbott and which issued patent is not covered by the
grant in Section 2.1 (the “Issued Patent(s)”),
Abbott hereby covenants not to sue VIA, its Affiliates,
Sublicensees or distributors under such Issued Patent solely for
VIA, its Affiliates, Sublicensees or distributors to develop, make,
have made, use, sell, offer for sale or import Licensed Product in
the Field, to the extent that Abbott has the authority to grant
such a non-suit to any such Issued Patent(s). Notwithstanding any
other provisions of this Agreement, if Abbott’s authority to
grant such a non-suit to any such Issued Patents is subject to any
Third Party restrictions and: (a) if a royalty,
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or any other consideration, would be
owed to a Third Party for any grant of rights to such Issued Patent
that would otherwise be covered under this Section 2.8, and
(b) Abbott has the ability to grant an unlimited number of
sublicenses to such Issued Patent then (i) Abbott shall not
grant VIA a non-suit to such Issued Patent and (ii) at
VIA’s option, Abbott and VIA shall enter into a sublicense
for such Issued Patent and (iii) VIA shall be responsible for
all payments and other obligations to such Third Party that are
required under the sublicense for such Issued Patent. If Third
Party restrictions on Issued Patents do not allow Abbott to grant
either a non-suit or a license then no non-suit or license shall be
granted.
2.9 Restriction on Use of
Patented Compound(s) . For a period of five years (the
“Non-Use Period”) from the Effective Date, Abbott:
(i) shall not license a Patented Compound to a Third Party in
the Field and (ii) Abbott and its Affiliates shall also not
undertake pre-clinical or clinical development on a Patented
Compound. Abbott may, however, conduct internal research and make
derivatives of Patented Compounds during the Non-Use
Period.
ARTICLE III
UNDERTAKING AND DUE
DILIGENCE
3.1 Diligence
Requirements .
At all times during the Term,
VIA shall use and will cause its Sublicensees to use Commercially
Reasonable Efforts, at its own expense, to (a) initiate and
complete the clinical development of the Licensed Product,
(b) obtain Regulatory Approvals for the Licensed Product in
major markets, and (c) obtain and carry out subsequent
worldwide marketing, distribution and sale of the Licensed Product
in such major markets.
3.2 Pre-clinical/clinical
Development Plan . Within three (3) months after the
Effective Date, VIA shall furnish Abbott with a summary written
pre-clinical/clinical development plan. Any material modifications
to the original pre-clinical/clinical development plan shall be
furnished to Abbott in summary form within thirty (30) days of
making the change. VIA shall use Commercially Reasonable Efforts to
perform in accordance with pre-clinical/clinical development
plan.
3.3 Reporting of
Development Activities . Within sixty (60) days after the
end of each annual calendar period, until First Commercial Sale of
Licensed Product, VIA shall furnish Abbott with a summary written
report on the progress of its efforts during the immediately
preceding calendar quarter to implement the pre-clinical/clinical
development plan and the related Development Data.
3.4 Adverse Events .
Within ninety (90) days after the date of this Agreement, the
Parties shall use good faith efforts to enter into an agreement to
initiate a process for the exchange of adverse event safety data in
a mutually agreed format, including but not limited to,
postmarketing spontaneous reports received by a Party or its
Affiliates in order to monitor the safety of the Compound or the
Licensed Product and to meet reporting requirements with any
applicable Regulatory Authority.
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3.5 Compliance with Laws
and Regulations . VIA shall comply with all present and future
laws, including, without limitation, the Federal Food, Drug and
Cosmetic Act, rules, orders, ordinances, regulations, statutes,
requirements, codes, executive orders, rules of common law, and any
judicial interpretations thereof, extraordinary as well as
ordinary, of all governmental authorities, including, without
limitation, the FDA. Furthermore, each Party acknowledges and
understands that it has no authority to represent the other Party
in any way before the FDA and as such each Party will not make any
representations or commitments in the other Party’s name with
the FDA.
ARTICLE IV
PAYMENTS; ROYALTIES;
PAYMENT TERMS
4.1 License Issue and
Technology Transfer Fees .
(a) License Issue Fee
. In consideration of the rights granted hereunder, VIA shall pay
to Abbott within thirty (30) days of the Effective Date a
non-refundable, non-creditable license issue fee of One Million
United States Dollars (US$1,000,000). In addition VIA shall pay
Abbott a non-refundable, non-creditable fee of One Million United
States Dollars (US$1,000,000), at the later of (i) six months
after the Effective Date or (ii) the date the Technology
Transfer Fee described in Section 4.1(b) below becomes
payable.
(b) Technology Transfer
Fee . VIA shall pay Abbott a non-refundable, non-creditable fee
of One Million United States Dollars (US$1,000,000) within thirty
(30) days of completion of the transfer of the Licensed
Technology listed in Appendix B.
4.2 Milestone Payments
.
(a) Development Milestone
Payments . Within thirty (30) days following the
achievement of each of the following milestones with respect to the
first Licensed Product, (for clarification, each milestone shall be
paid only once), VIA shall give written notice to Abbott thereof
and VIA shall pay to Abbott the corresponding milestone payments
for the events set out below:
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Milestone
|
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Payment |
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First dosing of a patient in a Phase III
clinical trial
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$ |
1,000,000 |
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Acceptance of the filing of the first
NDA in the U.S.
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$ |
3,000,000 |
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Acceptance of the first filing of an MAA
in Europe
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$ |
2,000,000 |
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Regulatory Approval in the
U.S.
|
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$ |
6,000,000 |
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First Regulatory Approval in one of the
following countries*: United Kingdom, France, Italy, Germany,
Spain
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$ |
4,000,000 |
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First Regulatory Approval in
Japan*
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$ |
3,000,000 |
| * |
The applicable milestone shall be paid, if at the time of
achieving the milestone in any of the listed countries, a Valid
Claim claiming the composition of matter for the Compound exists in
that country. |
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(b) Sales Milestone
Payments . VIA shall pay Abbott the following sales milestones
upon the first achievement of annual worldwide Net Sales at the
levels shown below within thirty (30) days following said
achievement. For clarification, each milestone is to be paid a
maximum of one time, and, if more than one sales level is first
achieved in a single calendar year, then only the highest
applicable milestone shall be paid. For example, if in the first
calendar year $l10,000,000 of worldwide Net Sales are achieved,
$5,000,000 would be payable by VIA to Abbott. If in the subsequent
calendar year, $410,000,000 of worldwide Net Sales were achieved,
only the $13,000,000 milestone would be due and payable by VIA to
Abbott.
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Sales Level
|
|
Payment |
|
Annual worldwide sales of $100
million
|
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$ |
5,000,000 |
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Annual worldwide sales of $250
million
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$ |
9,000,000 |
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Annual worldwide sales of $400
million
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$ |
13,000,000 |
4.3 VIA shall promptly notify
Abbott upon the achievement of any milestone for which a payment is
due under this Agreement. All milestone payments payable under the
provisions of Sections 4.2 shall be non-refundable and
non-creditable and shall be due to Abbott within thirty
(30) days of the achievement of the stated event. If at any
time VIA abandons the development of the first Product, after the
payment of one or more milestone payments and subsequently
commences or continues the development of another Product, then VIA
shall have no obligation to pay a milestone payment upon the
occurrence of a milestone event for the subsequent Product, for
which VIA previously has paid a milestone payment for the abandoned
Product.
4.4 Royalties . During
the Royalty Term, VIA shall pay to Abbott a royalty on annual
aggregate worldwide Net Sales on the following schedule, which is
based on incremental levels of annual Net Sales subject to the
royalty step down provisions of Section 4.5 and t
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