Exhibit 10.1
LICENSE AGREEMENT
This License
Agreement, effective as of March 22, 2005 (the
“Effective Date”), is by and between Angiotech
Pharmaceuticals, Inc. , a corporation organized and existing
under the laws of the Province of British Columbia, Canada
(“Angiotech Parent”), Angiodevice International
GmbH , a corporation organized and existing under the laws of
Switzerland (“Angiodevice”), Angiotech International
AG , a corporation organized and existing under the laws of
Switzerland (“Angiotech International”), Angiotech
BioCoatings Corp. , a corporation organized and existing under
the laws of the State of New York, USA (“Angiotech
BioCoatings”) and CABG Medical, Inc. , a corporation
organized and existing under the laws of the State of Minnesota,
USA (“CABG”). Each of the parties hereto is referred to
herein as “Party” and collectively as the
“Parties”.
WITNESSETH
WHEREAS Angiodevice, Angiotech International and Angiotech
BioCoatings are all subsidiaries of Angiotech Parent (hereinafter
collectively referred to as “Angiotech”) and are all
Affiliates (as that term is defined below) of each
other;
AND WHEREAS Angiotech owns, or has acquired licenses to,
certain domestic and foreign patents and patent applications and
has developed know-how, relating to the use of paclitaxel as a
therapeutic agent in local medical applications;
AND WHEREAS Angiotech has the right to grant licenses with
respect to such patents, patent applications, licenses and know-how
for use in specified areas;
AND WHEREAS CABG desires to receive a license for the use of
certain of such patents, patent applications, licenses and
know-how, and Angiotech is willing to grant such a license to
CABG;
NOW THEREFORE , in consideration of the mutual promises and
agreements set forth herein, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, Angiotech and CABG hereby agree as
follows:
1.
Definitions.
Capitalized terms
used in this Agreement and not otherwise defined herein shall have
the meaning as set forth below:
“
Affiliate ” means any entity that, directly or
indirectly, through one or more intermediaries, controls, is
controlled by or is under common control with a Party to this
Agreement. For purposes of this definition, control means the
direct or indirect ownership of at least fifty percent (50%) (or
such lesser percentage which is the maximum allowed to be owned by
a foreign corporation in a particular jurisdiction), of
(a) the outstanding voting securities of such entity, or
(b) the decision making authority of such entity.
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“
Agreement ” means this License Agreement, together
with all exhibits annexed hereto, as the same shall be modified and
in effect from time to time.
“ CABG
License ” has the meaning ascribed to it in
Section 2.1.
“ CABG
Technology ” means CABG’s Holly Graft™ System
which is designed to bypass blockages in coronary arteries by a
single graft attached at one anastomosis/aperture to the aorta, and
any other proprietary information or technology developed or
acquired by CABG that relates to the bypass of blockages in
coronary arteries.
“ Change
of Control ” means the acquisition by any person, or by
any person acting jointly or in concert with an offeror
(“Joint Actor”), whether directly or indirectly, of
voting securities of CABG which, when added to all other voting
securities of CABG held at same time by such person, or by such
person and a Joint Actor, totals for the first time not less than
fifty percent (50%) of the outstanding voting securities of
CABG.
“
Clinical Data ” means the results and analysis of data
arising from the testing of a drug, device or a combination thereof
in vitro , in vivo in non-human subjects and in human
subjects, including safety and toxicity testing, or other
pre-clinical testing, patient screening, patient enrollment,
patient status, any communications with regulatory authorities,
actions taken or modification in study design/conduct and summary
of data collected on CRFs (Case Report Forms) either paper or
electronic.
“
Competitive Product ” means in a given jurisdiction,
(i) a drug or biologic approved for marketing or in Phase III
clinical development, (ii) a 510(k) device approved for
marketing, or (iii) a PMA device approved for marketing or in
pivotal study clinical development, other than an Eligible Product,
that acts (or is being developed to act) for one or more target
label indications substantially similar to one or more approved or
target label indications for an Eligible Product.
“
Confidential Information ” means all information and
data provided by the parties to each other hereunder in written or
other tangible medium and marked as confidential or, if disclosed
orally or displayed, identified as confidential at the time of
disclosure and confirmed in summary written form as confidential
within thirty (30) days after disclosure, except any portion
thereof which:
(a) is
known to the receiving Party, as evidenced by the receiving
Party’s written records, before receipt thereof under this
Agreement or any other agreement between the parties hereto
providing for confidentiality;
(b) is
disclosed to the receiving Party by a third person who is under no
obligation of confidentiality to the disclosing Party hereunder
with respect to such information and who otherwise has a right to
make such disclosure;
(c) is
or becomes generally known in the trade through no fault of the
receiving Party;
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(d) is
independently developed by the receiving Party, as evidenced by the
receiving Party’s written records, without access to such
information; or
(e) is
required to be disclosed by applicable statute, rule or regulation
of any court or regulatory authority with competent jurisdiction;
provided that the Party whose information is to be disclosed shall
be notified as soon as possible and the Party that is being
required to disclose such information shall, if requested by the
Party whose information is to be disclosed, use reasonable good
faith efforts, at the expense of the requesting Party, to assist in
seeking a protective order (or equivalent) with respect to such
disclosure or otherwise take reasonable steps to avoid making such
disclosure.
“
Calendar Quarter ” means a calendar quarter or any
part thereof.
“
Contract Year ” means each successive period of four
consecutive Calendar Quarters, with the first such Contract Year
beginning on the first day of the first full Calendar Quarter that
begins after the Effective Date.
“
Diligence Date(s) ” means one or more of the date(s)
set out in Section 4.1 as the context requires.
“
Dollars ” or “ $ ” means the lawful
currency of the United States of America.
“
Eligible Product ” means any synthetic and/or biologic
coronary artery bypass graft products or systems that release or
elute paclitaxel and that incorporate both Licensed Technology and
CABG Technology. For further clarification, “Eligible
Product” does not include vascular grafts, vascular wraps,
products used in bypass procedures involving vessels harvested from
the patient, or products that fall within the scope of
Angiotech’s 1997 license agreement with Boston Scientific
Corporation and Cook Inc., a copy of which is attached hereto as
Exhibit D .
“ FDA
” means the United States Food and Drug Administration or any
successor agency.
“ First
Commercial Sale ” means the date of the first sale made
pursuant to Regulatory Approval, unless such Regulatory Approval is
not required in such country, of an Eligible Product in a country
in CABG’s normal course of business.
“ IDE
” means an Investigational Device Exemption under 21 C.F.R.
Part 812, or such other form of application or filing as may
be required as a legal prerequisite to the commencement of human
clinical testing of an Eligible Product in the United
States.
“ IND
” means an Investigational New Drug Application under 21
C.F.R. Part 312, or such other form of application or filing
as may be required as a legal prerequisite to the commencement of
human clinical testing of an Eligible Product in the United
States.
“
Improvements ” means all improvements, variations,
updates, modifications, and enhancements made to the Licensed
Patent Rights and/or Technical Information during the term of the
Agreement.
“
Investment Agreement ” has the meaning ascribed to it
in Section 3.3.
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“ License
Fee ” has the meaning ascribed to it in
Section 3.1.
“
Licensed Field of Use ” means coronary artery bypass
graft field.
“ License
Milestone Fee ” has the meaning ascribed to it in
Section 3.2.
“
Licensed Patent Rights ” means all of the existing
patents and patent applications set out in Exhibit A ,
and all patent applications hereafter filed by Angiotech or its
Affiliates, or that Angiotech or its Affiliates have rights to,
that are related to the existing patents and patent applications
set out in Exhibit A by way of any continuations,
continuations-in-part, divisions, provisionals or any substitute
applications, any patent issued with respect to any such patent
applications, any reissue, re-examination, renewal or extension
(including any supplemental patent certificate) of any such patent,
and any confirmation patent or registration patent or patent of
addition based on any such patent, and all foreign counterparts of
any of the foregoing, in each case to the extent they relate
directly to the claims in the parent application(s).
“Licensed Patent Rights” includes “Core Patent
Rights and “Focused Patent Rights”, as those terms are
defined in Article 7.
“
Licensed Technology ” means Licensed Patent Rights,
Technical Information in existence as of the Effective Date, and
any Improvements that CABG elects to have included in Licensed
Technology pursuant to Section 2.4.
“ Net
Sales ” means, with respect to any Eligible Product,
gross sales from the sale, rent, lease or otherwise making
available of such Eligible Product to end-user third parties by or
on behalf of CABG and its Affiliates and permitted sublicensees,
less the following, to the extent the same are credited or
deducted from the invoiced amount:
(a) discounts,
refunds, replacements, credits, rebates, allowances, adjustments,
rejections, recalls and returns (in the amount of the credit
provided to the customer), all as usual and customary in the
business;
(b) freight,
postage, insurance, and other transportation charges;
(c) sales
and use taxes, customs duties, and any other governmental tax or
charge (except income taxes) imposed on or at the time of the
production, importation, use, or sale of Eligible Products (if
separately invoiced), including any value added taxes (VAT), as
adjusted for reasonable and customary rebates and refunds;
and
(d) transfers
at or below cost by or on behalf of CABG of Eligible Products in
connection with compassionate use, emergency use, bona fide
research, treatment, Investigational New Drug Applications (INDs)
or the like, authorized by the FDA or corresponding foreign
agencies.
“ NIH
” means the National Institutes of Health (U.S.), also known
as the “PHS”.
“ NIH
Agreement ” means the license agreement dated as of
November 19, 1997, between Angiotech and the NIH, as amended
from time to time.
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“ Patent
Coverage ” means, for a particular Eligible Product in a
given country, there is a Valid Claim that, but for the license
granted to CABG under this Agreement, would be infringed by the
manufacture, use or sale of such Eligible Product in such country
or, where such Eligible Product is used or sold but not
manufactured, in such country, by the manufacture of such Eligible
Product in the country of manufacture.
“
Royalty ” has the meaning ascribed to it in
Section 3.4.
“
Regulatory Approval ” means any approvals, licenses,
registrations or authorizations of any federal, state, provincial
or local regulatory agency, department, bureau or other
governmental entity necessary for the manufacture and sale of a
product in a regulatory jurisdiction.
“ Senior
Staff at Angiotech ” means individuals employed by
Angiotech Parent who are at the level of Senior Vice President or
above.
“
Technical Information ” means all know-how,
information, materials, formulations, trade secrets, data and other
proprietary information in the possession of, developed by, or
acquired by Angiotech or its Affiliates that are necessary or
useful to practice the Licensed Patent Rights, but excluding the
Licensed Patent Rights and Confidential Information of third
parties that cannot be shared; provided however that any know-how,
information, materials, formulations, trade secrets, data and other
proprietary information disclosed by Angiotech to CABG shall
continue to be Confidential Information of Angiotech.
“ Third
Party License ” means any license between Angiotech and a
third party, including but not limited to NIH and UBC, as such
license may be amended from time to time, that includes in its
terms a grant of rights to Angiotech to use, and to sublicense the
use of, technology that forms part of the Licensed
Technology.
“
Term ” means that this Agreement shall, subject to the
early termination provisions specifically provided for herein, have
a term from the Effective Date until the expiration of all of the
United States or foreign patents included in the Licensed
Technology, including any United States or foreign patents which
become part of the Licensed Technology after the date of this
Agreement as provided for herein.
“
Territory ” means worldwide.
“
Triggering Event ” has the meaning ascribed to it in
Section 3.2.
“ UBC
” means The University of British Columbia and its
sublicensees and assigns.
“ UBC
Agreement ” means the license agreement executed as of
November 7, 1997 between Angiotech and UBC, as amended from
time to time.
“ Valid
Claim ” shall mean a claim in an issued patent or
unexpired patent or patent application within the Licensed Patent
Rights that, (a) has not been finally cancelled, withdrawn,
abandoned or rejected by any administrative agency or other body of
competent jurisdiction not subject to further appeal, (b) has
not been revoked, held invalid, or declared unpatentable or
unenforceable in a decision of a court or other body of competent
jurisdiction that is
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unappealable or unappealed within
the time allowed for appeal, and (c) has not been rendered
unenforceable through disclaimer or otherwise.
“ Warrant
Agreement ” means the Warrant Agreement entered into by
Angiodevice and CABG on March 22, 2005, a copy of which is
attached hereto as Exhibit B.
2. License
Grant.
2.1
Grant . Subject to terms and conditions of this Agreement,
including but not limited to the reservation of rights set forth
below in Section 2.3, Angiotech hereby grants to CABG an
exclusive right and license to use the Licensed Technology to make,
have made, use, offer to sell, sell and import Eligible Products
solely in the Licensed Field of Use in the Territory (the
“CABG License”). The Parties agree that, for the
avoidance of doubt, the granting of the CABG License in this
Section 2.1, (a) does not give CABG any rights to make,
have made, use, offer for sale, sell or import any component parts
of the Eligible Products for use in any third party devices, and
(b) Subject to Section 2.3, Angiotech has no rights to
grant any further right or license in the Licensed Technology to
any third party to make, have made, use, offer for sale, sell or
import any Eligible Products in the Licensed Field of Use in the
Territory, and does not itself have the right to make, have made,
use, offer for sale, sell or import any Eligible Products in the
Licensed Field of Use in the Territory. As soon as is reasonably
practical after the execution of this Agreement, Angiotech shall
disclose to CABG all Technical Information and shall make their
employees available to CABG to answer any questions CABG may have
regarding such Technical Information.
2.2
Sublicensing . CABG shall not have any rights to sublicense
its rights to the Licensed Technology obtained pursuant to
Section 2.1, except to (a) its Affiliates with written
notice to be provided to Angiotech at least thirty (30) days
in advance of any such sublicense or, (b) as otherwise
consented to by Angiotech, with such consent to be granted or
withheld at the sole discretion of Angiotech. No granting of any
sublicense by CABG shall relieve CABG from, or diminish any
obligation of CABG, under this Agreement and CABG shall be
responsible for the performance by its permitted sublicensees under
such sublicense. Any sublicense granted by CABG under this
Agreement shall be subject to the terms and conditions of this
Agreement and any applicable Third Party License.
2.3
Reservation of Rights . Angiotech reserves the following
rights, among others, to the Licensed Technology; (a) any use
or purpose outside the Licensed Field of Use, (b) research
purposes in all fields and applications, including in the Licensed
Field of Use, (c) to the extent reserved or specified under
any Third Party Licenses, including but not limited to the
reservation by UBC of rights to use the Licensed Technology for
research, or (d) to the United States Government by applicable
legislation and regulations.
2.4
Angiotech Improvements . Angiotech hereby grants to CABG a
right to elect to include in the Licensed Technology any
Improvements made by or for Angiotech after the Effective Date, to
the extent that such Improvements relate to the Eligible
Product(s). Angiotech shall notify CABG in writing of such
Improvements, providing a description of the Improvements and any
financial and other obligations under any applicable Third Party
License, and CABG may, by giving written notice to Angiotech within
thirty (30) days following receipt
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of Angiotech’s written
notice describing such Improvements, elect to include such
Improvements as Licensed Technology under this Agreement;
provided that :
(a) CABG
will be obligated to reimburse Angiotech for all of the costs and
expenses of Angiotech under any Third Party License (if applicable,
to be apportioned by Angiotech acting reasonably, among CABG,
Angiotech and other sublicensees of such technology from Angiotech,
notice of such apportionment to be given to CABG together with the
basis upon which the apportionment determination was made) and CABG
will be obligated to pay royalties on sales as required by any
Third Party License in addition to the Royalties payable under this
Agreement; and
(b) CABG
will be subject to all performance, minimum sales and other
obligations set forth in the Third Party License (as apportioned by
Angiotech, if applicable) relating to such Improvements.
In the event that CABG does not
elect to include such Improvements as Licensed Technology within
such thirty (30) day period, then CABG shall have no rights to
such Improvements thereafter. If CABG does not elect to include
such Improvement as Licensed Technology, Angiotech agrees it shall
not grant any right or license to any third party to use the
Improvement to make, have made, use, offer to sell, sell and import
Eligible Products in the Licensed Field of Use in the
Territory.
2.5
Improvements Made by CABG . Any Improvements made by CABG to
Licensed Patent Rights and Licensed Technology other than to
Licensed Patent Rights or Technical Information licensed to
Angiotech Parent under the UBC Agreement, shall be owned by CABG.
CABG hereby grants to Angiotech a non-exclusive, perpetual,
non-royalty bearing, worldwide right and license, excluding the
Licensed Field of Use, to make, use, offer to sell, sell and
import, with the right to sublicense all such rights, to any
Improvements made by or for CABG. Any Improvements made by CABG to
the Licensed Patent Rights or Technical Information licensed to
Angiotech Parent under the UBC Agreement shall be owned by
Angiotech and shall automatically be included in Licensed
Technology. CABG hereby agrees that it shall promptly provide
Angiotech with notice of any Improvements that could be covered
under this Section 2.5 and that it will take all steps
necessary to transfer ownership to Angiotech of Improvements
relating to the UBC rights as described above.
2.6
Stand-Still and Potential Expansion of Eligible Products
Definition .
(a) Angiotech
hereby agrees that it will not develop, or enter into any agreement
with a third party that would have the effect of permitting such
third party to develop, a system or products to be used in
conventional coronary artery bypass procedures involving vessels
harvested from the patient, using all or any part of the Licensed
Technology, for a period of twelve (12) months after the
Effective Date. If, during that twelve (12) month period, CABG
successfully completes, or has made material progress towards the
completion of, feasibility studies on products for use in
conventional coronary artery bypass procedures involving
vessels
harvested
from the patient and the Parties have agreed on development
milestone timelines for such product, Angiotech agrees that it will
amend the definition of Eligible Products to read as
follows:
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“ Eligible Product ” means
any synthetic and/or biologic (including but not limited to vessels
harvested from the patient) coronary artery bypass graft products
or systems that release or elute paclitaxel and that incorporate
both Licensed Technology and CABG Technology. For further
clarification, “Eligible Product” does not include
vascular grafts, vascular wraps or products that fall within the
scope of Angiotech’s 1997 license agreement with Boston
Scientific Corporation and Cook Inc., a copy of which is attached
hereto as Exhibit D .
(b) During
the twelve (12) month period set out in (a) above, the
Parties agree to negotiate in good faith to define what
“successful completion of feasibility studies or material
progress towards the completion of feasibility studies” will
involve and to agree on development milestone timelines (similar to
those provided for herein) for the product and, in the event that
the Parties agree to a definition and to milestones, the Parties
shall amend this Agreement to incorporate any such language and to
give effect to the other provisions of this Section 2.6. In
the event that (a) the parties have agreed on what
“successful completion of feasibility studies or material
progress towards the completion of feasibility studies” will
involve and on development milestone timelines for such product,
and CABG fails to “successfully complete feasibility studies,
or to make material progress towards the completion of feasibility
studies”, or (b) the Parties fail, after good faith
negotiations, to agree on what “successful completion of
feasibility studies or material progress towards the completion of
feasibility studies” will involve and/or on development
milestone timelines for such product, all within the twelve
(12) month time period, then Angiotech will be free to
develop, or enter into any agreement with a third party that would
have the effect of permitting such third party to develop, a system
or products to be used in conventional coronary artery bypass
procedures involving vessels harvested from the patient, using all
or any part of the Licensed Technology.
3. CABG License Fees &
Royalties.
3.1
License Maintenance Fees . In consideration for the license
granted under Section 2.1 of this Agreement, CABG shall issue to
Angiotech Angiodevice penny warrants for CABG voting common shares
with a value equivalent to five million Dollars ($5,000,000)
(“License Fee”) under the terms and conditions of the
Warrant Agreement attached hereto as Exhibit B (the
“Warrant Agreement”). The CABG voting common shares
will be valued as provided for in the Warrant Agreement.
3.2
CABG License Milestone Fees . As additional consideration
for the license granted under Section 2.1 of this Agreement,
CABG shall pay the following license milestone fees (each, a
“License Milestone Fee”) to Angiotech Angiodevice
within thirty (30) days of the occurrence of the applicable
event triggering payment of the License Milestone Fee (each, a
“Triggering Event”):
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(a) Receipt
by CABG of a CE Mark for an Eligible Product, *** Dollars ($***)
shall be payable by CABG to Angiotech,
(b) Receipt
by CABG of approval of a Premarket Approval Application
(“PMA”) from the FDA to sell an Eligible Product in the
United States, *** Dollars ($***) shall be payable by CABG to
Angiotech.
3.3
Election to Pay in Common Stock . CABG shall have the option
under Section 3.2(a) and (b) of electing to pay Angiotech
in equivalent value of CABG common shares, under terms that are at
least as favorable to Angiotech as provided for in the Investment
Agreement entered into by Angiotech Parent and CABG on
March 22, 2005 (“Investment Agreement”), rather
than in cash. In the event that CABG wishes to elect to pay
Angiotech in equivalent value of CABG voting common shares, written
notice of such election shall be provided to Angiotech within ten
(10) business days after the occurrence of the applicable
Triggering Event. In the event that CABG makes an election as
provided for in this Section 3.3, the voting common shares of
CABG will be valued by taking an average of the closing price of
the CABG common shares over the ten (10) trading days
immediately subsequent to the date of the applicable Triggering
Event. In the event that Angiotech has not received such notice of
CABG’s election as provided for hereunder within ten
(10) business days after the occurrence of the applicable
Triggering Event, CABG shall pay Angiotech in cash as provided for
in Section 3.2 (a) and/or (b) as applicable. CABG
shall not be entitled to elect to pay Angiotech in CABG voting
common shares if such payment would take Angiotech’s total
ownership of CABG’s outstanding voting common shares above
20% without the express written approval of Angiotech’s Board
of Directors.
3.4
Royalty .
(a)
Royalty Where Patent Coverage Exists . As further additional
consideration for the license granted under Section 2.1,
within sixty (60) days after the end of each Calendar Quarter
during the Term, CABG shall pay to Angiotech Angiodevice a Royalty
of *** percent (***%) of all Net Sales in jurisdictions where
Patent Coverage exists. In the event that CABG undergoes a Change
of Control during the Term, CABG shall be required to pay a Royalty
of *** percent (***%) of all Net Sales in jurisdictions where
Patent Coverage exists.
(b)
Royalty Where No Patent Coverage Exists . As further
additional consideration for the license granted under
Section 2.1, within sixty (60) days after the end of each
Calendar Quarter during the Term, CABG shall pay to Angiotech
Angiodevice a Royalty of *** percent (***%) of all Net Sales in
jurisdictions where no Patent Coverage exists in consideration for
the license granted to CABG pursuant to Section 2.1 to the
Technical Information within the Licensed Technology.
(c)
First Commercial Sale . A Royalty shall become due and
payable to Angiotech Angiodevice by CABG in a country within sixty
(60) days after the end of the
***
Confidential Treatment Required
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Calendar Quarter
within which the First Commercial Sale of an Eligible Product takes
place in that country.
3.5
Non-Arm’s Length Sales . On sales made in other than
an arm’s length transaction, the value of the Net Sales
attributed under this Section 3 to such a transaction shall be
that which would have been received in an arm’s length
transaction. Sales between and among CABG and its Affiliates that
are intended for resale shall not be included in Net Sales until
those Eligible Products are sold to a third party by the
Affiliate.
3.6
Sales of Eligible Products in Combination . In the event
that CABG or any Affiliate sells an Eligible Product together with
any other distinct product for a single price, such as in a kit,
(collectively, the “Combination Product”) the Net Sales
of the Eligible Product for the purposes of determining Royalties
payable hereunder, shall be calculated by multiplying the total Net
Sales of the Combination Product by the fraction A/B, where A is
the price of the Eligible Product and B is the price of the
Combination Product. The price of the Eligible Product and the
Combination Product shall be CABG’s standard, published
resale price for each product. If CABG does not have standard
published resale prices for such products, the values shall be
determined by the mutual written agreement between the Parties,
acting reasonably, or, failing agreement, within thirty
(30) days from written notice by one Party to the other, as
determined by the dispute resolution steps described in
Article 9.
3.7
Reporting of CABG Royalties . CABG shall deliver to
Angiotech Angiodevice, together with each Royalty payment due under
Section 3.4 a written Royalty report setting forth for the
applicable Calendar Quarter, at least the following
information:
(a) The
date of the First Commercial Sale of an Eligible Product in each
country in the Territory;
(b) The
number of Eligible Products sold, rented, leased or otherwise made
available to third parties by or on behalf of CABG and its
Affiliates, reported on a country-by-country basis (including a
separate item for sales where there is Patent Coverage and where
there is not);
(c) Total
gross sales amounts received for such Eligible Products by
jurisdiction, including separate items for the value of any goods
or services received in exchange for Eligible Products, any
additional amounts to be added to Net Sales pursuant to
Section 3.5;
(d) Deductions
applicable to determine Net Sales for such period by
jurisdiction;
(e) The
amount of Royalties due or, if no Royalties are due, a statement
that no Royalties are due; and
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(f) Such
other information as may reasonably be requested by Angiotech for
purposes of determining the amount of Royalties owing by CABG
hereunder and for Angiotech to fulfill its obligations under the
Third Party Licenses.
Each Royalty report shall be
certified as correct by the CFO of CABG and shall include a
reasonably detailed listing of all deductions made to determine Net
Sales and to calculate the Royalties payable hereunder.
3.8
Payment of Maintenance License Fees, Milestone License Fees and
Royalties . All Royalties due under this Article 3 are to
be paid in Dollars. For conversion of foreign currency to Dollars,
the conversion rate shall be the New York foreign exchange rate
quoted in The Wall Street Journal on the day that the payment is
due. All payments shall be made by wire transfer to
Angiotech’s account in accordance with the following
instructions (unless amended by written notice):
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Correspondent bank:
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Angiotech Angiodevice
UBS AG
Postfach, CH-8098 Zurich
Konto-Nr. 230-375751.60Z
IBAN CH82
0023 0230 3757 5160 Z
BIC UBSWCHZH80A
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Any loss of exchange, value,
taxes, or other expenses incurred in the transfer or conversion to
Dollars shall be paid entirely by CABG. The Royalty report required
by Section 3.7 shall accompany each such payment.
3.9
Late Payments . Interest will be assessed by Angiotech
Angiodevice on any overdue payments at a rate of one percent (1%)
per month, compounded monthly beginning on the due date of the
applicable payment (an effective annual rate of 12.68 % per annum),
or at such lower maximum rate permitted by law. The payment of such
interest will not prevent Angiotech from exercising any other
rights it may have as a consequence of the lateness of any
payment.
3.10
Governmental Filings . Except for taxes based on
Angiotech’s income, CABG will be solely responsible for
determining if any tax on Net Sales and Royalty payments is owed to
any governmental authority and shall pay any such tax and be
responsible for all filings with appropriate governmental
authorities related thereto.
3.11 Audit
Rights . CABG shall keep accurate records of all of its
operations, and shall cause its Affiliates to keep accurate records
of all of their respective operations, within the scope of this
Agreement, for five (5) years following each reporting period
(as described in Section 3.7), and Angiotech, at its expense,
shall have the right to have a certified public accountant inspect
such records, solely for the purpose of verifying the calculation
and payment of the
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Royalties due hereunder, at the
offices of CABG and its Affiliates, as applicable, no later than
one (1) year after the end of the Calendar Quarter to which
they pertain upon two (2) weeks prior written notice by
Angiotech. The certified public accountant shall agree in writing
with CABG to be bound by reasonable confidentiality provisions with
respect to such information prior to receiving access to such
information. In the event the examination shows an underpayment for
any Contract Year, CABG shall pay to Angiotech the amounts
underpaid, together with interest pursuant to Section 3.9. In
the event the examination shows an overpayment for any Contract
Year, CABG shall offset the amount overpaid, together with interest
calculated at the rates set forth in Section 3.9, on the next
Royalty payment made to Angiotech hereunder. Where the amount of
any underpayment is more than three percent (3%) for any Contract
Year, CABG shall also reimburse Angiotech for the actual
out-of-pocket costs incurred by Angiotech to conduct such
examination.
4. CABG Diligence
Obligations.
4.1
Diligence Obligations . CABG is required to meet the
following obligations relating to the development and sale of
Eligible Products during the Term of this Agreement:
(a) In
the United States;
(i) A safety trial
in humans must be initiated for an Eligible Product by
January 1, 2007; and
(ii) A submission
for a product approval for an Eligible Product must be submitted to
the FDA in the U.S. by January 1, 2009.
(b) In
Europe;
(i) The first
clinical trial in humans must be initiated for an Eligible Product
by January 1, 2006;
(ii) An
application for a CE Mark for an Eligible Product must be submitted
by January 1, 2008; and
(iii) The first
commercial sale of an Eligible Product must be made by January 1,
2009.
(c) The
dates provided for in Sections 4.1(a) and (b) above shall
each be referred to as a “Diligence Date”.
4.2
Failure to Meet Diligence Timelines . In the event that CABG
has not fulfilled the required obligation by the applicable
Diligence Date, then Angiotech shall be entitled, at its
discretion, to treat any such failure as a material breach in
accordance with Section 8.1(a) of this
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Agreement; provided, however,
that the cure period shall be ninety (90) days rather than
forty five (45) days.
4.3
Progress Reports . CABG will provide written annual reports
on development progress for Eligible Products or efforts to
commercialize Eligible Products, as applicable, to be received by
Angiotech within thirty (30) days after the end of each
calendar year. These progress reports shall include, but not be
limited to, progress on research and development (including
detailed information and data, including any and all Clinical Data
generated), plans for future clinical studies, status of current
clinical studies, status of applications for regulatory approvals,
manufacturing, marketing and sales efforts during the preceding
calendar year, as well as plans for the present calendar year,
including the schedule of all upcoming clinical development
meetings. CABG agrees to provide any additional i