1
EXHIBIT 10.2
Agreement between Registrant and CIBA Vision Corporation dated July 10, 1997
(with certain confidential information deleted).
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CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4), 200.83
AND 240.24b-2. * INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST THAT IS FILED SEPARATELY WITH THE COMMISSION.
AGREEMENT
Between
ISIS PHARMACEUTICALS, INC.
and
CIBA VISION CORPORATION
JULY 10, 1997
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AGREEMENT
TABLE OF CONTENTS
SECTION PAGE NO.
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1. Definitions....................................................................2
2. Grant of Rights................................................................7
3. Product Development and Regulatory Approvals...................................9
4. Payments......................................................................12
5. Marketing.....................................................................14
6. Supply........................................................................16
7. Forecast/Orders/Invoices......................................................17
8. Isis' Supply Price to CV......................................................19
9. Quality ......................................................................24
10. Release of Product............................................................28
11. Labeling and Packaging........................................................29
12. Second Source and Supply Failure..............................................29
13. Manufacturing and Product Warranty............................................32
14. Post-Marketing Regulatory Matters.............................................32
15. Patents.......................................................................35
16. Infringement of Patent Rights.................................................36
17. Third Party Rights............................................................39
18. Patent Term Extension.........................................................41
19. License Agreements............................................................41
20. Warranties....................................................................42
21. Compliance with Law...........................................................43
22. Indemnification...............................................................43
23. Scientific Publications.......................................................45
24. Proprietary Information and Announcements.....................................46
25. Term and Termination..........................................................47
26. Force Majeure.................................................................49
27. Miscellaneous.................................................................50
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AGREEMENT
THIS AGREEMENT made effective as of July 10, 1997, by and between Isis
Pharmaceuticals, Inc., a Delaware corporation having its principal offices at
0000 Xxxxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxxxx 00000 ("Isis") and CIBA Vision
Corporation, a Delaware corporation having its principal offices at 00000 Xxxxx
Xxxxx Xxxxxxx, Xxxxxx, Xxxxxxx 00000 ("CV").
WHEREAS, Isis is developing an ophthalmic product containing fomivirsen
sodium, and has the rights to certain related compounds; and
WHEREAS, CV desires to obtain, and Isis is willing to grant to CV, the
exclusive worldwide right to market, sell and distribute such product and
certain rights with respect to the related compounds, subject to and in
accordance with the terms and conditions hereinafter set forth; and
WHEREAS, CV desires to obtain a supply of such product from Isis.
NOW THEREFORE, in consideration of the mutual covenants and obligations set
forth herein, the parties hereto agree as follows:
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1. Definitions
The following terms as used in this Agreement will have the meanings set
forth in this Section:
1.1 "API" means the active pharmaceutical ingredient of the Product (as
defined herein).
1.2 "Affiliate" will mean any person or entity that directly or indirectly
controls or is controlled by or is under common control of a party to
this Agreement. For purposes of this Agreement, "control" will be
presumed where, directly or indirectly, a person or entity owns at
least 50% of the common stock or voting ownership interests of the
entity in question. For purposes of this Agreement, any reference to a
party or to any Affiliate of a party will also include its employees,
officers, agents and consultants.
1.3 "Agreement Period" will mean the period referred to in Section 25.1
hereof, and any mutually agreed upon extensions thereto.
1.4 "Effective Date" will mean the date first above written.
1.5 "European Approval" or "European Registration" will mean the approval
of the Product (as hereinafter defined) for marketing by the European
Commission
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("EC"), or if the parties agree to seek approval through the mutual
recognition process, then: (i) for purposes of Section 4 hereof,
European Approval will mean approval by the Ministry of Health in
Germany, France, or the UK; and (ii) for purposes of Section 3 hereof,
European Approval will mean approval by the applicable governmental
authority in Germany, France, the UK, Spain, Italy, the Netherlands
and Portugal.
1.6 "FDCA" will mean the Federal Food, Drug and Cosmetics Act and all
regulations and rules promulgated thereunder.
1.7 "FDA" will mean the United States Food and Drug Administration, and
any successor entity thereto.
1.8 "Fill Facility" will mean the pharmaceutical production facility of [
* ] located in [ * ], or, if another production site is used, the
facility where the API is processed into Product and filled into
vials.
1.9 "IND" will be the Investigational New Drug application, as defined by
the FDCA, covering the Product.
1.10 "GMPs" will mean current good manufacturing practices as defined from
time to
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time in regulations promulgated under the FDCA or any successor laws
or regulations governing the manufacture of the Product.
1.11 "Know-How" will mean any technology, formulae, trade secrets,
technical data, pre-clinical and clinical data, and any other
information or experience owned, controlled or possessed by Isis
relating to, or useful in connection with, the development,
manufacture, use or sale of the Product as well as any improvements or
modifications to the Know-How developed by or for Isis during the
Agreement Period.
1.12 "Net Average Sales Price" or "NASP" will mean [ * ].
1.13 "1984 Act" will mean the United States Drug Price Competition and
Patent Term Restoration Act of 1984 (as amended), including 21 USC
355, 35 USC 155-156, 35 USC 271 and applicable regulations promulgated
thereunder.
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1.14 "Non-Commercial Product" will mean Product ordered by CV for use as
samples, in clinical trials, and for compassionate use, for which
Product CV does not receive any compensation.
1.15 "Patents" will mean (i) United States Patent No. [ * ] and U.S. Patent
No. [ * ]; (ii) any patents claiming priority to [ * ]; and (iii) any
continuations, continuations-in-part, divisions, reexaminations,
re-issues, extensions, or foreign equivalents of (i) or (ii) hereof,
as of the Effective Date or arising during the Agreement Period. The
foregoing definition is limited to claims of the Patents that read on
the Product or on a method of using the Product.
1.16 "NDA" will mean the New Drug Application, as defined by the FDCA,
covering the Product.
1.17 "Planned Indication" will be the indication for the Product for which
FDA approval and European Approval is currently being sought, namely
the treatment of "cytomegalovirus-related ("CMV") retinitis in
patients with AIDS", without any proviso that the Product be used only
after one or more other therapies have been utilized.
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1.18 "Product" will mean any ophthalmic product containing fomivirsen
sodium (formerly known as the compound ISIS 2922) as an API.
1.19 "Project Team" will mean the Isis team responsible for overseeing the
clinical development of the Product.
1.20 "Specifications" will mean the master formula, test methods/protocols,
and other data and requirements used to manufacture, test, measure
stability and store the Product, copies of which Specifications are
attached as Exhibit A and which may be amended from time to time by
the parties in accordance with the terms of this Agreement, or as
required by the FDA.
1.21 "Territory" will mean all the countries in the world.
1.22 "Third Party Distributors" will mean any person or entity with whom CV
or a CV Affiliate contracts to be responsible, in place of CV or such
Affiliate, for the registration, marketing, selling and distribution
of the Product.
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2. Grant of Rights.
2.1 Product Rights. Isis hereby grants to CV the exclusive worldwide right
to market, sell and distribute the Product, and CV accepts such rights
subject to the terms and conditions set forth herein.
2.2 Patent License. Subject to the terms and conditions of this Agreement
and during the Agreement Period, Isis hereby grants to CV a worldwide,
royalty-free, exclusive license under the Patents to make, have made,
use and sell the Product and practice the Know-How, but only insofar
as necessary to allow CV to take advantage of the provisions of
Sections 12 and 16 hereof (the "License"). This License does not
include the right to sublicense, unless necessary for the foregoing
purpose. For any country in which CV has transferred its rights to the
Product to Isis pursuant to Section 5.4, this License will then revert
to Isis for such country.
2.3 Option for ISIS 13312. Isis hereby grants to CV an option to acquire
an exclusive worldwide license to manufacture, have manufactured, use,
distribute and sell ISIS 13312 on the following basic terms and
conditions:
(a) The option must be exercised by [ * ], whichever
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is later. Isis will have given CV access to all information
related to such compound during the period between the execution
of this Agreement and the completion of such initial clinical
trial as may be reasonably necessary for CV to review in order to
decide whether to exercise the option.
(b) If CV elects to exercise the option, the parties will negotiate
in good faith for a period of at least three months, if
necessary, to conclude a definitive agreement which will include
provisions, inter alia, for [ * ], but will not include [ * ],
except that CV's share of such [ * ]. If the parties cannot reach
a good-faith agreement based on the foregoing within three
months, Isis will thereafter be entitled to negotiate and enter
into such an agreement with a third party, but not on terms more
favorable to the third party than those last offered to CV.
2.4 Right of First Offer to Other Compounds. Isis hereby grants to CV a
right of first offer to acquire the exclusive worldwide license (to
the extent Isis has the right to grant such license) or right to
manufacture, have manufactured, market, distribute and sell any
antisense compound other than ISIS 13312 for the treatment of CMV
retinitis, on terms to be negotiated in good faith by the parties.
Isis will keep CV informed about the status of development of, and any
significant information
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relating to, such related compounds. CV may notify Isis of its
interest in acquiring rights to any of such compounds by written
notice within ninety (90) days after written notice by Isis that such
compound has been identified by Isis for development and for the
initiation of pre-IND toxicology studies. The parties will thereafter
negotiate in good faith for a period of at least three months, if
necessary, to conclude a definitive exclusive distribution or license
agreement with respect to such compound. If the parties cannot reach a
good-faith agreement within three months, Isis will thereafter be
entitled to negotiate and enter into such an agreement with a third
party, but not on terms more favorable to the third party than those
last offered by CV.
3. Product Development and Regulatory Approvals
3.1 U.S. and Europe. Isis will diligently pursue completion of the
clinical development of the Product for the Planned Indication,
including obtaining FDA approval of the NDA and European Approval.
Isis will bear the cost of all studies and user fees required to
obtain such approvals, including any studies required to be performed
post-approval by the applicable regulatory agency as a condition of
initial approval, and including the cost of fulfilling any obligations
to provide post-study drugs to study participants; provided that, if
mutual recognition approval is sought in Europe, Isis' financial
responsibility with respect to filing and user fees will be limited to
the cost of a central EC filing at the time of submission in the first
country. Clinical studies will be conducted in accordance with the
protocols
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therefor and all applicable rules and regulations. CV will be kept
informed of the status of the development, and will be invited to
participate in all Project Team meetings. Isis will provide CV with
all information concerning communications with the FDA or the relevant
European regulatory agency, including, but not limited to, copies of
correspondence, minutes of meetings, and teleconference reports. Isis
will invite CV to participate in all meetings with the FDA and the
European Regulatory authorities. While Isis will bear the primary
responsibility for preparing and making the submissions for regulatory
approvals in the United States and Europe, CV will (i) provide input
into the regulatory strategy and (ii) will review drafts of all
regulatory submissions as such drafts are prepared. Specifically, CV
will have two weeks from receipt of a draft submission section to
comment thereon, except that ,with respect to the clinical trials
section, CV agrees to review the draft of such section on-site at
Isis' facility simultaneously with Isis' review thereof. The parties
will endeavor to come to mutual agreement on the final submission. If
Isis and CV are unable to reach agreement, Isis will make the final
determination with respect to any such issues. In the event the
parties agree that it is desirable or required that the application
for European Approval be submitted and held in CV's name, the parties
will cooperate to do so.
3.2 Registration Outside U.S. and Europe. CV will make commercially
reasonable efforts, at its expense, to obtain regulatory approval to
market the Product in jurisdictions other than the United States and
Europe. Isis will reasonably cooperate and provide CV with all
Know-How, copies of regulatory submissions,
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and other information necessary to assist CV in obtaining such
approval; provided, any additional studies required will be conducted
at CV's expense. CV will reimburse Isis for any out-of-pocket expenses
related to Isis' assistance in obtaining such regulatory approvals.
3.3 Phase IV Studies and Supplemental Indications. CV will be responsible
for conducting and bearing the cost of any studies or filings
following regulatory approval in the United States and Europe for the
Product for the Planned Indication, except for studies required to be
performed post-approval in order to obtain the initial approval. In
addition, CV will be responsible for the conduct and cost of
additional studies required to support expanded labeling outside the
indication or dosage administration instructions in the initial
approved prescribing information. Isis will assist CV as reasonably
requested in performing such studies, and CV will pay Isis'
out-of-pocket expenses for such assistance. CV will be responsible for
the cost of any change in presentation or packaging of the Product.
3.4 Site Approval. As part of obtaining regulatory approval to market the
Product in the U.S. and in Europe, Isis will simultaneously be
responsible for obtaining approval of its facility and the Fill
Facility for the production of the Product for marketing. CV will have
the option, but not the obligation, to participate in such site
approval process at CV's expense.
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3.5 Launch Promotional Materials. CV will consult with Isis during CV's
preparation of the launch promotional materials for the Product. CV
will make the final determination as to any issues regarding such
materials. Six weeks prior to the anticipated FDA approval of the
registration of the Product, Isis will submit such materials to the
FDA for approval. CV will have provided such materials to Isis at
least two weeks prior to such FDA submission.
3.6 Transfer of Registrations. Within ten (10) days of obtaining U.S.
and/or European Approval, Isis will request transfer of such
registrations to CV including the IND and its European equivalents
(unless, with respect to Europe, the registrations were submitted in
CV's name). After transfer, CV will be responsible, and will bear the
cost of, maintaining the registrations for the Product in the U.S. and
Europe during the Agreement Period in compliance with all applicable
laws, rules and regulations.
4. Payments
4.1 Payments. In consideration of the rights granted in Section 2 hereof,
CV will pay Isis:
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(a) Within ten (10) days of signing this Agreement, a non-refundable
payment of [ * ] in consideration of the patent license granted
in Section 2.2 and the Option for a license granted in Section
2.3 hereof (all "dollars" in this Agreement are U.S. dollars).
(b) [ * ] within ten (10) days of [ * ].
(c) [ * ] within ten (10) days of [ * ].
(d) [ * ] within ten (10) days of [ * ].
4.2 Termination Option.
(a) In the event Isis has not obtained such approval of the NDA in
the United States by at least [ * ], then CV may, at its option,
terminate the Agreement by giving written notice to Isis no later
than [ * ]. In the event of such termination: (i) Isis will repay
to CV [ * ]; (ii) Isis will refund to CV any payments CV has made
to Isis for Product ordered; and (iii) CV will return to Isis any
inventory of Product which it has at the time of termination.
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(b) If European Approval is not obtained by [ * ], then CV may, at
its option terminate the Agreement with respect to Europe by
giving written notice to Isis no later than [ * ]. In the event
of such termination, Isis will refund any payments CV has made to
Isis for Product ordered for Europe, unless such Product is
reasonably saleable elsewhere, and CV will return to Isis any
such Product which it has at the time of termination.
(c) If the Agreement terminates pursuant to Section 4.2(a), then all
of CV's rights under this Agreement will revert to Isis pursuant
to Section 25.6 hereof. If the Agreement terminates with respect
to Europe pursuant to Section 4.2(b), then CV's rights under this
Agreement for Europe will revert to Isis pursuant to Section 25.6
hereof.
5. Marketing
5.1 CV Responsibilities. CV and its Affiliates will use commercially
reasonable efforts to market, distribute and sell the Product
worldwide, provided that, on a country-by-country basis, the Product
has been granted a commercially reasonable regulatory approval (i.e.,
reasonable labeling or reasonable price in jurisdictions where price
is set by regulatory authority). CV will provide Isis with a copy of
its
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proposed marketing plans for the Product. Isis will be entitled to
provide input to the marketing plans and the parties will endeavor to
reach mutual agreement on such plans. If CV and Isis are unable to
reach agreement, CV will make the final determination with respect to
any marketing plan issues.
5.2 Compliance with Marketing Regulations. CV will comply with all
applicable laws, rules and regulations with respect to its promotion
of the Product. CV will provide Isis with post-launch promotional
materials containing substantially new material for Isis' review and
comment prior to finalizing such materials. CV will provide Isis with
copies of all other promotional materials for the Product in North
America and Europe. CV will also insure that any and all Third Party
Distributors in North America and Europe comply with the material
provisions of this Agreement, as well as with all applicable laws,
rules and regulations with respect to the promotion of the Product,
including but not limited to all applicable import/export laws and the
U.S. Foreign Corrupt Practices Act. CV will also insure that all Third
Party Distributors in North America and Europe have implemented a
sales tracking system which could be relied upon in the unlikely event
of a Product recall or need for patient notification.
5.3 Trademarks. The Product will be marketed by CV under a trademark
chosen, owned and maintained by CV (the "Trademark"); provided such
Trademark will be one to which Isis has no reasonable objection. If
Isis has already registered a
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trademark for the Product, or has submitted a trademark for the
Product to the FDA, Isis will assign such trademark to CV at CV's
request.
5.4 Return of Rights. For any country in which CV, an Affiliate or Third
Party Distributor: (i) fails to use commercially reasonable efforts to
obtain regulatory approval; (ii) ceases to market the Product; (iii)
fails to commercially reasonably market the Product where it has
obtained a commercially reasonable regulatory approval; or (iv)
substantially fails to market the Product in accordance with a
commercially reasonable marketing plan, and the events in (i), (ii)
(iii) and (iv) continue for a period of eighteen months if such events
are due to a force majeure, then for such countries, CV will transfer
the rights granted to it in Section 2 hereof and any applicable
Product registration, filing and Know-How to Isis, and the parties
will negotiate in good faith with respect to the transfer of the
Trademark in such country.
6. Supply
6.1 During the Agreement Period, Isis will manufacture, or have
manufactured, and supply to CV, subject to the terms and conditions
hereinafter set forth, such amounts of bulk filled vials of the
Product as CV may order, including performing the stability and
release testing of the Product. (CV will be responsible for the
labeling and packaging of the Product.) CV will be required to
purchase its requirements of the Product from Isis during the
Agreement Period, so long as Isis
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is able to supply such Product to CV in compliance with the terms and
conditions set forth herein.
7. Forecasts/Orders/Invoices
7.1 API. Isis will manufacture and test the API for the Product in
accordance with the Specifications therefor and all applicable laws,
rules and regulations, including current GMPs. Isis will maintain an
inventory of API equal to the greater of 0.25 kg or the amount
necessary to supply the next nine months of forecasted Product sales
as set forth in the rolling forecast submitted to Isis pursuant to
Section 7.2 hereof.
7.2 Rolling Forecast. Beginning in January, 1998, on or before the tenth
day of each month during the Agreement Period, CV will provide Isis,
with a copy to the Fill Facility, with a written eighteen month
rolling forecast of the quantities of Product which CV expects to
purchase during each of the next eighteen months. The forecast will be
non-binding and for planning purposes only.
7.3 Purchase Orders. For deliveries to be made in 1998 and 1999, CV will
provide Isis with purchase orders ("PO") at least nine (9) months in
advance of the delivery
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date set forth on the PO. Thereafter, orders will be placed six (6)
months in advance of their requested delivery date. Orders will be for
[ * ]; provided CV may, at its option, order [ * ] at an additional
cost of [ * ] for the first two [ * ], and an additional [ * ] for any
further [ * ]. Orders of [ * ] will be placed no more than twice in
one calendar year. If demand exceeds expectations, Isis will make
reasonable commercial efforts to supply additional Product within
shorter lead times. All POs will set forth the quantity and delivery
date. Within ten (10) days of receipt of a PO, Isis will return an
acknowledgment copy of the PO either confirming the PO or stating any
mutually agreed-upon changes to the PO.
7.4 Payment. For orders placed during 1997, 1998 and 1999, Isis will
invoice CV for [ * ] upon acknowledging the order pursuant to Section
7.3 hereof. The remaining [ * ], will be invoiced simultaneously with
such release. After January 1, 2000, CV will pay [ * ] upon placing
the order, and the remaining [ * ], similarly adjusted, upon release
thereof. Payment of undisputed invoiced amounts will be made within
thirty (30) days of the date of the invoice.
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7.5 Launch Inventory. In the event CV obtains inventory in anticipation of
a launch and such launch is delayed through no fault of CV, CV may
return to Isis, for a full credit, any unsold units of such inventory
when such units' shelf life has been reduced to eight (8) months.
8. Isis' Supply Price to CV
8.1 Definitions. As used in this Section:
(a) The "Supply Price" will mean Isis' price to CV for the Product,
except for Non-Commercial Product, [ * ]. The Supply Price for a
particular order will be [ * ].
(b) A "Delay" will be any time period equal to or exceeding one month
in length, determined in rolling one-month intervals starting
with the first full calendar month of delay.
(c) "FDA Delay" will mean a Delay in the approval of the Product past
[ * ], but will not include a Delay caused by an Isis Delay.
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(d) "Isis Delay" will mean: (i) Isis' failure to file a complete NDA
acceptable for filing by [ * ]; (ii) Isis' failure to timely
respond to FDA inquiries and requests; or failure to supply
Product for Launch in accordance with the terms of this
Agreement, in the absence of a Force Majeure.
(e) "CV Delay" will mean CV's failure to Launch the Product within [
* ] in the absence of any Isis Delay or Force Majeure.
(f) "Launch" will mean the date on which CV makes its first shipment
of Product to a third party customer.
8.2 Supply Price. The Supply Price for the [ * ] except as follows:
(a) If FDA approval occurs [ * ] due to an FDA Delay, then for each
month of such FDA Delay, there will be a corresponding [ * ]
during the last of the [ * ] during which the Supply Price will
be [ * ] instead of [ * ] (for example, a two-month FDA Delay
would result in the Supply Price being [ * ] for [ * ] after the
launch, and [ * ] for the next two months.)
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(b) If there is an FDA Delay and also a CV Delay, then for each month
of CV Delay, one month which would have been a [ * ] will be a [
* ].
(c) If FDA approval occurs after [ * ], or Launch occurs after [ * ]
due to an Isis Delay, then for each month of such Isis Delay, one
month which would have been a [ * ] month will be a [ * ] month
(for example, if there is an Isis Delay for one month, there will
be [ * ] and [ * ]. If there is an FDA Delay of one month and
Isis Delay of one month, then there will be [ * ], [ * ] and [ *
].
(d) [ * ].
8.3 Subsequent Price. For [ * ] after the expiration of the [ * ], with
the adjustments in Section 8.2 above, the Supply Price will be [ * ] .
Thereafter, the Supply Price will be [ * ].
8.4 Non-Commercial Product. Isis will provide CV, at its request as
specified on purchase orders, with [ * ] units of Non-Commercial
Product free of charge. The Supply Price for additional units of
Non-Commercial Product will be [ * ].
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8.5 Annual Adjustment.
(a) For purposes of calculating the Supply Price to be paid for the
initial order, CV will reasonably estimate its likely NASP for
the Launch of the Product no later than ten (10) months prior to
the expected Launch of the Product. Such estimate of the NASP
shall be used for purposes of calculating payments due for
Product until the end of the calendar year during which the
Product is launched, subject to adjustment after the end of such
year. Within forty-five (45) days of the end of such year and
each calendar year thereafter, CV will prepare an accounting of:
(i) the actual Supply Price for the Product based on the actual
NASP during such year; (ii) the number of units used as
Non-Commercial Product during such year; and (iii) the number of
unsaleable units returned from customers during such year. CV
will forward such accounting to Isis together with: (i) an
additional payment if the initial Supply Price was less than such
actual Supply Price or an invoice to Isis if the initial Supply
Price was greater than the actual Supply Price; and (ii) an
invoice for the difference between [ * ] and the actual Supply
Price for such year times the number of Non-Commercial units used
during such year in excess of such units which were provided to
CV free of charge pursuant to Section 8.4 hereof. Payment will be
made in U.S. dollars. At the same time, Isis will grant CV a
credit
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for the unsaleable returns, to be applied to CV's next order, for
up to one per cent of the total units sold during such year. The
credit for each unit shall be equal to the actual Supply Price
for such year less [ * ]. For each calendar year after the first
year during which Product is sold, the Supply Price for the
Product will be the actual Supply Price for the preceding
calendar year, subject to adjustment on the same basis as the
first initial Supply Price was adjusted under this Section 8.5.
8.6 Audits. CV will permit Isis, at Isis' expense, to have its books and
records reflecting its calculation of: (i) the NASP for the Product;
(ii) the number of units used as Non-Commercial Product; and (iii)
unsaleable returns, examined by an independent certified public
accountant retained by Isis and reasonably acceptable to CV during
regular business hours, on reasonable advance notice. Such independent
accountant will keep confidential any information obtained during such
examination and will report to Isis only its opinion as to whether and
by how much the NASP was miscalculated. If thereafter CV and Isis
cannot agree on the appropriate NASP, they will retain a second
independent public accountant whose decision will be binding upon both
parties. If CV's reported actual payments due Isis for the year
("Reported Payments") were incorrect by more than seven (7%), then CV
will bear the expense of such second audit, if CV's Reported Payments
were incorrect by less than two (2%) per cent, Isis will bear the
expenses of such second audit, otherwise the parties will share such
audit expenses equally.
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9. Quality
9.1 Compliance. The Product will be manufactured and tested by or for Isis
in compliance with the NDA and foreign approvals, Specifications
therefor, and all applicable federal, foreign, state and local laws,
rules and regulations.
9.2 Testing. For each batch of Product manufactured, retention and
stability samples will be drawn as required by the NDA and applicable
laws and regulations. Isis will conduct, or have conducted, such other
quality assurance tests and functions as may be required by the
Specifications or applicable laws or regulations. Isis will retain, or
will cause the Fill Facility to retain, all batch records for a period
of one year after the expiration date of the applicable batch. CV will
have access to all production and testing records related to the
Product after release or rejection by Isis, including copies thereof,
and any lot samples within seventy-two (72) hours of its request
therefor. Isis will notify CV immediately of any media or sterility
failures or problems related to the Product. Isis will provide CV with
copies of annual stability data, stability reports and interim
stability data. CV reserves the right to inspect and test any and all
Product and batch records for Product shipped to CV hereunder. If CV
rejects Product based on CV's own testing or inspection and the
parties cannot agree on the disposition of such Product, they will
retain a mutually agreeable third party to test such Product and will
share the cost therefor. The decision of such party will be binding.
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9.3 Inspections. CV and its authorized representatives will have the right
to inspect the production and quality assurance facilities where the
API and the Product are produced, as well as the records related to
such production, during normal business hours with reasonable advance
notice. Isis will promptly notify CV of any governmental inspection of
the facility, and, if possible, permit CV representatives to be
present at the inspection, and will provide CV with copies of any FDA
483 or any similar reports related to the Product, the Fill Facility
or the Isis facility where the active ingredient is produced.
9.4 Production Problems. Isis will promptly notify CV of any problems or
unusual production situations which have the potential to adversely
affect the production of the Product or its timely delivery to CV and
will allow CV to participate in the resolution of any such problem or
production situation.
9.5 Changes to Manufacturing Process and Specifications. As used in this
Section 9.5, "Product Process" will mean the manufacturing process by
which the API is made into finished Product and filled into vials, and
"API Process" will mean the manufacturing process for producing bulk
API. Either party may request changes to the manufacturing process or
to the Specifications.
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(a) Before Approval. Prior to FDA approval, Isis will not make any
substantive changes to the Product Process or to Specifications
until CV has had five business days from receipt of notification
in writing thereof from Isis to object to such change. If CV
fails to respond within such time period, CV will be deemed to
have acquiesced to such change and Isis may proceed with the
implementation of such change. In the event that CV does timely
object to the change and the parties cannot reach mutual
agreement, Isis will make the final determination as to such
change. Non-substantive changes to the Specifications or to the
Product Process, and changes to the API Process, may be
implemented by Isis upon sending written notice to CV.
(b) After Approval. After FDA approval, no substantive change to the
Product Process or to the Specifications will be implemented by
either party, whether requested by a party or requested or
required by a governmental agency until the other party has had
at least five business days from notice of such proposed change
to object to the change or state that it believes prior FDA
approval is required. If such party fails to respond within such
time period, it will be deemed to have acquiesced to the change
without FDA prior approval and the party responsible for the
implementation of such change may proceed with such
implementation. CV shall make the final determination after
discussion by the parties, as to whether to go forward with any
such change and as to whether to seek
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prior FDA approval. With respect to substantive changes to the
API Process, Isis will give CV at least five business days prior
written notice of such change so that CV can make a
determination, after consultation with Isis, as to whether prior
FDA approval should be sought for such change. Isis will make the
final determination as to whether or not to make any change in
the API Process itself. Non-substantive changes to the Product
Process, the API Process or to Specifications may be implemented
by either party (where applicable) upon sending written notice of
such change to the other party.
9.6 Costs of Changes. The cost associated with any changes made to the
manufacturing process or the Specifications which are requested by
Isis or required by any governmental agency in the U.S. or Europe will
be borne by Isis. With respect to changes required by any governmental
agency outside of the U.S. and Europe, the parties will mutually agree
on how to respond to such requirement and on the allocation of the
cost thereof. The costs associated with any change to the
Specifications which are requested by CV will be borne by CV.
9.7 FDA Prior Approval. In the event Isis treats as non-substantive a
change for which CV should have obtained FDA prior approval, and CV
suffers damages or costs arising therefrom, Isis will indemnify CV for
such losses and costs. In the event CV decides not to seek FDA prior
approval for a change, and the FDA later
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disagrees with that decision, CV will indemnify Isis from any damages
or costs Isis sustains arising therefrom.
9.8 Alternative Fill Facility. In the event the parties agree to utilize a
Fill Facility other than [ * ], the parties will share equally the
cost and the benefits of moving to such new Fill Facility.
10. Release of Product
10.1 Upon determination by Isis that the Product meets the Specifications
therefor, Isis will notify CV by facsimile that Product is ready for
release, along with a Certificate of Analysis and the Certificate of
Release. Any objections by CV to the release of Product will be made
within three (3) business days of receipt of the certificate of
analysis and certificate of release, unless CV decides to test or
inspect the batch records for such Product, in which case CV will make
any objections within two (2) business days of receiving copies of the
batch records or the results of the tests. If Isis disagrees with CV,
the issue will be resolved by a third party in the same manner as set
forth in Section 9.2 hereof.
*CONFIDENTIAL TREATMENT REQUESTED
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11. Labeling and Packaging
11.1 Artwork Approval. CV will supply Isis with the artwork for the initial
labeling and packaging of the Product in sufficient time to allow Isis
to have ten (10) business days to review and comment on the artwork
prior to its submission to the FDA. Isis will submit the initial
labeling and packaging to the FDA and other governmental agencies, as
necessary, for approval. All necessary translations of the labeling
and packaging will be the sole responsibility of CV.
11.2 Changes. The parties will cooperate and consult with each other with
respect to any future labeling or packaging changes whether requested
by one of the parties or by the FDA, but, as between the parties, CV
will have the final responsibility for the decisions with respect to
labeling and packaging. CV will bear the cost of any such changes,
except that Isis will bear the cost of changes requested by Isis.
12. Second Source and Supply Failure
12.1 Optional Second Source. Upon mutual agreement, the parties will
cooperate to qualify a second source to produce the API (if possible)
and the finished Product, and will share equally the costs and
benefits thereof. If Isis does not agree to qualify a second source,
then CV may do so at its own expense and Isis will
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provide CV with all manufacturing processes and Know-How with respect
to production of the Product.
12.2 Lost Profits Credit. In the event the Product is on backorder (CV
cannot fill customers' orders) for a period of at least two months due
to Isis' failure to supply Product in accordance with Section 7 hereof
for reasons other than a Force Majeure, and provided CV had maintained
at least three months' inventory prior to such supply failure, CV will
be entitled to a credit for lost profits for such unfilled orders,
which credit will be applied against future orders.
12.3 Supply Failure/Second Source.
(a) Intentional Failure. In the event Isis, or any successor to Isis,
intentionally ceases to supply API or Product in breach of this
Agreement, Isis will: (i) transfer its reserves of active
ingredient to CV; (ii) acknowledge CV's license to the Patents
and Know-How granted under Section 2.2 hereof; and (iii) assist
CV in obtaining an NIH license required for the production of the
API, all at Isis' cost, in order that CV will be able to qualify
a second source for the production of the API and/or the Product.
Thereafter, CV shall pay to Isis a royalty equal to the amount [
* ], or Isis will pay CV the amount [ * ]; provided CV has
*CONFIDENTIAL TREATMENT REQUESTED
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made reasonable commercial efforts to obtain a competitive third
party supply price. Isis will be responsible for the costs of
qualifying such second source or sources.
(b) Unintentional Failure. In the event Isis ceases to supply API or
Product by reason of its own negligence or a Force Majeure, Isis
and CV will share the costs and benefits of qualifying a second
source, and Isis will continue to supply Product to CV pursuant
to this Agreement.
12.4 Supply Failure/Second Source Not Available.
(a) Intentional Failure. In the event Isis intentionally ceases to
supply the Product and the parties are unable, after good faith
efforts, to secure a source for the Product within eighteen (18)
months after such supply failure, then CV may terminate this
Agreement and Isis will refund the payments made under Sections
4(b) through (d) less the amount of net profits, calculated in
accordance with CV's standard accounting practices, earned by CV
up to the time that CV is unable to obtain Product from Isis (the
"Break-Even Amount").
(b) Unintentional Failure. If no second source can be secured after
good faith efforts in such eighteen (18) months, and the failure
to supply is due to a Force Majeure or Isis' negligence, or the
Product is withdrawn from the
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market through no fault of Isis, then CV may terminate this
Agreement and Isis will refund one-half the Break-Even Amount to
CV.
(c) Termination. In the event of termination under this Section 12.4,
CV will transfer all Product registrations to Isis, and the
rights granted to CV under this Agreement will revert to Isis.
13. Manufacturing and Product Warranty
13.1 With respect to Product supplied to CV hereunder, Isis hereby warrants
that the Product: (i) will have been manufactured in accordance and
will be in compliance with the Specifications therefor and with all
applicable requirements of the FDCA, similar foreign laws and
regulations promulgated thereunder including, but not limited to,
current GMPs, continuing compliance with stability requirements and
any other applicable federal, foreign, state or local laws, rules or
regulations; (ii) will not be adulterated or misbranded within the
meaning of the FDCA or any applicable similar state, foreign or local
laws in which the definition of adulteration or misbranding is
substantially the same as in the FDCA; and (iii) will have at least
twenty-one (21) months shelf-life remaining.
14. Post-Marketing Regulatory Matters
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14.1 Maintenance of Registrations. Isis will maintain the Product's
registrations until such registrations are officially held by CV.
Thereafter, CV will be responsible for maintaining such registrations.
14.2 Adverse Drug Reactions. ("ADRs"). CV will be responsible for the
timely completion and submission of all ADR reports to the FDA and for
communications with all ADR complainants. Isis will summarize and
forward to CV any adverse reaction reports ("ADR") received by Isis
within five (5) business days of receipt; provided Isis will forward
any such complaints which involve death or life-threatening incidents
to CV within twenty-four (24) hours of receipt. CV will investigate
all ADRs; provided, Isis will be responsible for all analytical
testing of Product required by the investigation.
14.3 Technical Complaints. Physical or technical complaints relating to the
Product which are received by CV or Isis will be investigated by Isis.
CV will forward any Product sample to Isis for testing. Isis will
promptly inform CV of any such test results. CV will be responsible
for communicating with all such complainants and for all FDA
notification and contact with respect to such complaints, but will
keep Isis informed of such FDA contacts.
14.4 Field Alerts. The parties will exchange any information received by
either party which may meet Field Alert Report criteria (21 CFR
314.81b1). Wherever possible the parties will discuss the necessity of
filing a field alert report and collaborate in the submission thereof.
CV will forward a copy of any such report
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to Isis and the parties will continue to discuss follow-up action on
such field alert report after submission.
14.5 Product Recalls. The parties will immediately contact each other in
the event that either party has any reason to believe that a recall of
Product may be necessary. CV will, in consultation with Isis, resolve
any issues with respect to the recall of any such Product including
without limitation, the necessity of declaring the recall, the manner
in which the recall should be conducted and the duration of the
recall. Isis and CV will cooperate fully with respect to any such
recall.
14.6 Other Information. Isis will cooperate and provide timely information
to CV in order for CV to comply with any other regulatory
requirements. With respect to annual reports, Isis will provide the
required information to CV by the anniversary date of FDA approval
each year.
14.7 Information Exchange. All information exchanged by the parties under
this Section 14 will be forwarded to:
For CV in U.S.: Xxxxxxxx X. Xxxxx
Director, Regulatory & Medical Affairs
CIBA Vision Corporation
00000 Xxxxx Xxxxx Xxxxxxx
Xxxxxx, Xxxxxxx 00000
For CV in Europe and rest of world:
Xxxxxxx Xxxxxxxxx
Head, Central Drug Regulatory Affairs
CIBA Vision, A.G. Xxxxxxxxxx
00 Xxxxxxxxxxx
Xxxxxxx, XXXXXXXXXXX
00
00
For Isis: Xxxx X. Xxxx
Executive Director, Regulatory Affairs
Isis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
15. Patents
15.1 Prosecution and Maintenance.
(a) Isis will undertake, diligently pursue, and bear all costs of the
prosecution and maintenance of U.S. Patent No. [ * ] and the
foreign equivalents thereof in the countries listed on Exhibit B
hereto, and U.S. Patent No. [ * ] in the U.S. Isis will keep CV
fully and timely informed with respect to the course and conduct
of patent application prosecution matters related to such
Patents. CV will have the right but not the obligation to consult
with Isis regarding such prosecution.
(b) With respect to all Patents other than the U.S. Patents and the
foreign equivalents [ * ] referred to in 15.1 (a) above, Isis
will not terminate prosecution or maintenance of any Patent or
claim which reads on the Product, or on a method of using the
Product, without first giving CV forty-five (45) days prior
written notice of its intention to do so. If CV
*CONFIDENTIAL TREATMENT REQUESTED
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does not wish Isis to terminate such Patent or claim, Isis will,
at its option, transfer and assign such Patent or Patent
application to CV, or allow CV to reimburse Isis for the cost of
the further prosecution and maintenance of such Patent or Patent
application.
15.2 Additional Filings. CV will have the right to request that Isis file,
prosecute and maintain patents in jurisdictions other than those
listed on Exhibit B. Upon CV's request, Isis will file, prosecute, and
maintain such patents provided CV will be consulted with respect to
the preparation and filing of such patents and will share the expenses
therefor with CV paying [ * ] and Isis paying [ * ]. As used in this
subsection, expenses will include outside consultant fees (i.e.,
legal) translation fees, and filing fees but will not include the
internal costs of Isis or CV. Each party will bear its own internal
costs with respect to the filing of the patents in such additional
jurisdictions.
16. Infringement of Patent Rights
16.1 Notification. If either party will become aware of any infringement or
threatened infringement of any Patents, including that contained in a
notice provided under the 1984 Act by a party filing an ANDA or Paper
NDA for this Product, or an equivalent action in any other country,
then the party having such knowledge will
*CONFIDENTIAL TREATMENT REQUESTED
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give notice to the other within ten (10) days of becoming aware of
such infringement or threatened infringement.
16.2 Action by Isis. Isis will have the right, but not the obligation, to
take such action as it deems appropriate, whether by action, suit,
proceeding or otherwise, at its own expense to prevent or eliminate
the infringement of the Patents by others in the countries listed on
Exhibit B and to collect damages. CV agrees to cooperate with Isis in
any reasonable manner including, but not limited to, being named as a
co-plaintiff in an action brought by Isis. Isis agrees to pay all
reasonable out-of-pocket expense incurred by CV in the prosecution of
any such action, suit or proceeding for infringement.
16.3 Action by CV. In the event that Isis does not take action for patent
infringement to prevent or eliminate the infringement of Patents
within one hundred twenty (120) days of receipt of notice of the
infringement or threatened infringement thereof (or within thirty (30)
days in the event such infringement is by Notice Under the 1984 Act),
then within said one hundred twenty (120) days (or within said thirty
(30) days if such infringement is under the 0000 Xxx) CV may, at its
option, give notice to Isis that unless Isis undertakes such action,
CV will commence an action to terminate such infringement. If Isis
fails to take such action within said one hundred twenty (120) days
(or said thirty (30) days in the event such infringement is by Notice
Under the 0000 Xxx) then Isis will grant CV an exclusive license to
the applicable Patents so that CV will be able to take such
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action as it deems appropriate against any infringer of same. Such
action by CV may be undertaken in the name of Isis, if necessary, and
Isis agrees to cooperate with CV, and execute any necessary documents
relating to such action.
16.4 Apportionment of Damages and Expenses. Any damages recovered by the
party bringing the action for patent infringement will be used first
to compensate that party for its out-of-pocket expenses in the
prosecution of any such action, suit or proceeding for infringement.
Any remaining damages recovered by that party will be apportioned
between CV and Isis in proportion to the damage incurred by each party
as a result of the infringement [ * ]. With respect to an action
brought under the 1984 Act, the parties will share the expenses
equally, except that if CV brings such an action after Isis has
declined to do so, and CV loses such action, CV will bear [ * ] of the
expenses and Isis will bear [ * ].
16.5 Invalidity. In the event the claims reading on the Product contained
in the Patents are declared invalid or unenforceable by a judgment,
decree or decision of a court, tribunal or other authority of
competent jurisdiction such that patent protection in the U.S. or
Europe is thereby vitiated and a competitive product enters the
market, the applicable Supply Price of the Product set forth in
Section 8 hereof shall be reduced as follows:
*CONFIDENTIAL TREATMENT REQUESTED
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(a) If patent protection in both the U.S. and Europe is vitiated
within the first seven years after Launch (as defined in Section
8) of the Product, the Supply Price shall be reduced by [ * ]
until the end of the third year after Launch, by [ * ] for the
fourth and fifth year and by [ * ] for the sixth and seventh
year. Thereafter, there will be no Supply Price reduction under
this Section 16.5.
(b) If patent protection is vitiated only in the U.S., then the
provisions of subsection (a) above will apply except that the
Supply Price reduction will be [ * ].
(c) If patent protection is vitiated only in Europe, then the
provisions of subsection (a) above will apply except that the
Supply Price reduction will be [ * ].
17. Third Party Rights
17.1 Notification. If either party will become aware of any action, or
suit, or threat of action or suit, by a third party alleging that the
manufacture, use or sale or offer for sale of the Product or the
practice of Know-How infringes a patent, or violates any other
proprietary rights of any third party, the party aware will promptly
notify the other party of the same and fully disclose the basis
therefor.
*CONFIDENTIAL TREATMENT REQUESTED
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17.2 Isis Obligations. Isis agrees to use diligent efforts to defend any
such action. Isis agrees to cooperate and consult with CV during the
course of such defense and to keep CV fully informed with respect to
all significant aspects of such action. CV agrees to assist Isis by
providing information in the possession and control of CV and to
provide such fact witnesses as may be reasonably necessary to such
defense.
17.3 Third Party License. If, by the terms of any settlement or if by a
judgment, decree or decision of a court, tribunal or other authority
of competent jurisdiction, CV is required to obtain a license from a
third party in order to market, sell and distribute Product
(hereinafter "Third Party License") and/or to compensate or pay
damages to such third party and/or pay royalties under such a license,
then, (i) in the US and Europe, Isis will pay all such damages or
royalties, and (ii) in the rest of the world, the parties will share [
* ] the payment of such damages or royalties in the country to which
such settlement, judgment, decree or decision directly relates, so
long as the reason for such settlement, etc. does not arise from (i)
CV's failure to appropriately acquire regulatory approval in such
jurisdiction or from (ii) any other action or inaction on the part of
CV, its Affiliates or Third Party Distributor in such jurisdiction.
17.4 Injunction. If, by the terms of any settlement or of a judgment,
decree or decision of a court, tribunal or other authority of
competent jurisdiction, CV is enjoined
*CONFIDENTIAL TREATMENT REQUESTED
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entirely from selling the Product in the U.S. and Europe, Isis will
immediately reimburse CV for one-half of the amounts paid to Isis
under Section 4 hereof, less net profits already earned by CV from
sales of the Product. In addition, Isis will indemnify CV for any
direct or consequential damages and costs that are payable as the
result of any such settlement or judgment.
18. Patent Term Extension
18.1 Within sixty (60) days after approval of an NDA for the Product, and
at CV's request, Isis will file and prosecute, at its own cost and
expense, an application for an extension of the Patent. Isis will also
file any similar applications in Europe. CV will also list the
appropriate Patents in the "Orange Book".
19. License Agreements
19.1 Isis will maintain its license from [ * ] for so long as such license
is required to manufacture, use or sell the Product. Isis will
maintain its license agreement with [ * ] so long as such license is
required to manufacture, use or sell the Product. Isis will be
responsible for paying all royalties owed to [ * ] or any other third
party in connection with the manufacture, use or sale of the Product.
*CONFIDENTIAL TREATMENT REQUESTED
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20. Warranties
20.1 Isis Warranties. In addition to the Warranty set forth in Section 13
hereof, Isis warrants and represents that: (a) it is the owner of the
Patents and Know-How and has the right to grant the rights granted to
CV under Section 2 hereof free and clear of any encumbrance; (b) it
has not assigned or conveyed any interest in the Patents or Know-How
which may be inconsistent with the rights granted to CV hereunder; (c)
to the best of its knowledge and after a diligent search, the practice
of the Patents and Know-How in the United States and Europe does not
infringe any rights of third parties; (d) it is not aware of any third
party infringing the Patents in the Territory; (e) it has prosecuted
all patent applications within the Patents in good faith and has no
reason to believe any patent included in the Patents would be invalid
or would be held to be unenforceable by a court of competent
jurisdiction; and (f) it is a corporation duly incorporated and in
good standing in its state of incorporation and has all requisite
power to enter into and perform this Agreement, and, upon execution by
the parties hereto, this Agreement will constitute a valid and
legally-binding obligation of Isis enforceable in accordance with its
terms.
20.2 CV Warranties. CV warrants and represents that it is a corporation
duly incorporated and in good standing in its state of incorporation
and has all requisite power to enter into and perform this Agreement,
and, upon execution by the
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parties hereto, this Agreement will constitute a valid and legally
binding obligation of CV, enforceable in accordance with its terms.
21. Compliance with Law
The parties, their Affiliates, and Third Party Distributors will at all
times comply with any and all applicable federal, foreign, state and local
laws and regulations with respect to their obligations and activities under
this Agreement. In the event a governmental agency forces the cessation of
the manufacture or distribution of the Product due to any actual or alleged
violation or acts of non-compliance with laws or regulations by Isis, Isis
will use its best efforts to resume operations as soon as possible. It is
expressly understood that such governmental action will not be considered
an event of force majeure under Section 26 hereof.
22. Indemnification
22.1 Isis to CV. Isis will indemnify and hold harmless CV, its Affiliates
and their officers, agents and employees against any claim, loss,
damage, penalty, assessment, or expense including reasonable
attorneys' fees and the cost of any recall ("Claim") arising directly
or indirectly from any breach of any of Isis' warranties under
Sections 13 or 20 hereof, or breach of the other obligations or
covenants under this Agreement, or for any governmental action taken
as a result of any such breach.
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22.2 CV to Isis. CV will indemnify and hold harmless Isis, its Affiliates
and their officers, directors, agents and employees against any Claim
arising directly or indirectly from (a) any breach by CV, its
Affiliates, or Third Party Distributors of (i) the warranty under
Section 20 hereof or (ii) the other obligations or covenants under
this Agreement, or (b) any negligence, omission, or intentional
wrongdoing by CV, its Affiliates or Third Party Distributors in
connection with the sale and distribution of the Product, or (c) for
any governmental action taken as a result of any such breach or any
such act of negligence, omission or intentional wrongdoing.
22.3 Procedure. In the event that an indemnified party receives notice of,
or becomes aware of, a Claim in respect of which indemnity may be
sought hereunder, and the indemnified party intends to seek indemnity
hereunder, the indemnified party will promptly provide the
indemnifying party with notice of such Claim and the intention to seek
indemnity. The indemnifying party will have the right, at its option
and its own expense, to be represented by counsel of its own choice
and to defend against, negotiate, settle or otherwise deal with any
such Claim, provided that the indemnifying party will not enter into
any settlement or compromise of any such Claim which could lead to
liability or create any financial or other obligation on the part of
the indemnified party without the indemnified party's prior written
consent. The indemnified party may participate in the defense of any
Claim with counsel of its own choice and at its own expense. The
parties agree to cooperate fully with each other in connection with
the defense, negotiation or settlement of
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any such Claims. In the event that the indemnifying party does not
undertake the defense, compromise or settlement of a Claim the
indemnified party will have the right to control the defense or
settlement of such Claim with counsel of its choosing provided,
however, that the indemnified party will not settle or compromise any
such claim without the indemnifying party's prior written consent,
which consent will not be unreasonably withheld.
23. Scientific Publications.
23.1 Submission and Approval. Any scientific publication or presentation by
either party with respect to the Product, including publications
relating to clinical studies, will be approved by the other party
prior to publication or presentation, such approval not to be
unreasonably delayed or withheld. Due regard will be given to each
party's legitimate interests, i.e., protection of confidential
information, commercialization of the Product, etc. Any proposed
publications which are to make public any findings, data or results of
the studies relating to the Product will be provided to the other
party at least thirty (30) days prior to submission for publication
for the other party's approval, except that abstracts may be provided
seven (7) days prior to submission for publication.
23.2 Patent Considerations. If a party, in its reasonable judgment, needs
additional time to seek patent or other appropriate protection (the
"Patenting Party") for any of the information to be published or
presented by the other party (the "Publishing
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Party"), the Patenting Party will promptly notify the Publishing Party
of such need in writing, and the Publishing Party will defer such
publication or presentation until such time as the Publishing Party is
notified by the Patenting Party that such patent or other appropriate
protection has been applied for.
24. Proprietary Information and Announcements
24.1 "Proprietary Information." As used herein, "Proprietary Information"
will mean all technical, sales or other confidential business
information, including the Know-How, related to the subject matter of
this Agreement disclosed by one party to the other at any time prior
to or during the Agreement Period and identified as confidential,
together with all records generated or maintained Isis relating to
Product produced for CV. Proprietary Information will not include
information which, as demonstrated by competent evidence: (i) was
known to the receiving party prior to the disclosure; (ii) was
generally available to the public at the time of disclosure or becomes
available to the public after disclosure other than through any act or
omission of the receiving party in breach of this Agreement; (iii)
becomes known to the receiving party as the result of disclosure from
a third party under no obligation of secrecy to the other party; or
(iv) is required to be disclosed by law or pursuant to the disclosure
requirements of a governmental agency, provided that the party ordered
to disclose the Proprietary Information notifies the party which owns
or supplied the Proprietary Information sought to be disclosed
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pursuant to such request, requirement or order in sufficient time to
allow the owner/supplying party to oppose such request, requirement or
order.
24.2 Confidentiality Obligations. During the Agreement Period and for a
period of five (5) years after the expiration or earlier termination
of this Agreement, neither party will: (i) disclose, publish or make
available any Proprietary Information disclosed to it by the other
party: (a) to any third party, except to Affiliates which will be
bound by the same obligation of confidentiality; or (b) to any
employees who do not need to know or have access to such Proprietary
Information; or (ii) sell, transfer or otherwise use, except for the
purposes herein, any such Proprietary Information. After expiration or
earlier termination of this Agreement, each party will return the
Proprietary Information of the other party and will destroy all copies
thereof, other than records which must be retained as a matter of law.
24.3 Publicity. During the Agreement Period, neither party will make any
press release or other public announcement relating to this Agreement,
or otherwise disclose the terms of this Agreement to any third party
other than an Affiliate, without the prior written consent of the
other party except as required by a court of competent jurisdiction or
pursuant to the disclosure requirements of a governmental agency.
25. Term and Termination
25.1 Agreement Period. The term of this Agreement will commence as of the
Effective Date and will expire fifteen (15) years thereafter, unless
previously terminated and notwithstanding any suspension due to a
force majeure event under Section 26 hereof. If, at the time of such
expiration, CV is continuing to make commercially
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reasonable efforts to market the Product, it may extend the Agreement
for an additional five years, on six months' prior written notice,
unless Isis has a reasonable objection thereto.
25.2 Material Breach. This Agreement may by canceled by either party upon
written notice in the event the other party fails to perform a
material obligation under this Agreement within thirty (30) days after
receiving notice of such failure. If the nature of the failure is such
that it cannot be cured within the thirty-day period, no termination
will occur provided the defaulting party will have commenced to cure
such breach within thirty days and thereafter diligently proceeds to
effect and complete such cure within ninety (90) days from the date of
the original notice.
25.3 CV's Option. This Agreement may be terminated by CV pursuant to the
provisions of Section 4.2 hereof.
25.4 Bankruptcy. Either party may terminate this Agreement upon written
notice in the event that the other party will file for protection in
bankruptcy or will be adjudicated as bankrupt or will make an
assignment for the benefit of creditors or will have a receiver,
whether appointed by private instrument or court offices, appointed
for its property.
25.5 Survival. Termination or expiration of this Agreement will not relieve
either party from the liabilities and obligations approved prior to
the Effective Date of
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termination or expiration, and the provisions of Sections 13, 17, 20,
22 and 24 hereof will survive any termination or expiration of this
Agreement.
25.6 Post-Termination. All rights to the Patents, Know-How, Product
Registrations, and Isis trademarks granted to CV under this Agreement
will revert to Isis upon expiration or termination of this Agreement.
After the expiration or termination of this Agreement, so long as the
termination of the Agreement is not the result of a material breach on
the part of CV, its Affiliates and Third Party Distributors, then CV,
its Affiliates and Third Party Distributors will have the right to
sell all Products released for distribution before such date as well
as the right to sell all such Products in the process of manufacture
on such date, provided that CV will pay the applicable Supply Price
and render reports to Isis with respect to such Product in the manner
required hereunder.
26. Force Majeure
26.1 Neither party will be liable to the other for loss or damages, or,
except as expressly provided in this Agreement, have any right to
terminate this Agreement for any default or delay attributable to any
cause beyond the reasonable control of that party, including but not
limited to, an act of God, flood, fire, explosion, strike, lockout,
earthquake, labor dispute, war, revolution, civil commotion, act of a
public enemy, blockade, embargo, or governmental action other than one
resulting from the act, omission or negligence of a party. In the
event such a default or
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delay occurs, the party affected will notify the other party and will
exercise diligent efforts to resume performance of its obligations as
soon as possible.
27. Miscellaneous
27.1 No Waiver. Failure of either party to insist upon strict observance of
or compliance with any of the terms of this Agreement in one or more
instances will not be deemed to be a waiver of its right to insist
upon such observance or compliance with those or other terms of this
Agreement with respect to subsequent breaches of any of the terms of
this Agreement.
27.2 Notices. All notices and demands required or permitted hereunder will
be in writing and given by certified or registered mail, postage
prepaid or by a nationally recognized express mail service, or hand
delivered at the following addresses:
If to CV: CIBA Vision Corporation, U.S. Ophthalmics
00000 Xxxxx Xxxxx Xxxxxxx
Xxxxxx, Xxxxxxx 00000
Attn: President
cc: General Counsel
CIBA Vision Corporation
00000 Xxxxx Xxxxx Xxxxxxx
Xxxxxx, Xxxxxxx 00000
If to Isis: Isis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attn: President
cc: General Counsel
Isis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
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or to such other address as to which either party may notify the
other. Notice will be deemed to be effective three (3) days after
mailing, or upon receipt if hand delivered or sent by express mail
service.
27.3 Assignment. This Agreement will be binding upon and inure to the
benefit of the parties, their successors and permitted assigns.
Neither party may assign this Agreement without the prior written
consent of the non-assigning party, which consent will not be
unreasonably withheld.
27.4 Governing Law. This Agreement is governed by the laws of the State of
New York that are applicable to contracts negotiated, executed and
performed within that state.
27.5 Severability. In the event any one or more of the provisions of this
Agreement should for any reason be held by any court of authority
having jurisdiction over either the parties or this Agreement to be
invalid, illegal or unenforceable, such provision or provisions will
be validly reformed so as to nearly approximate the intent of the
parties as possible or, if unreformable, will be divisible and deleted
in such jurisdiction; otherwise, this Agreement will continue in full
force effect.
27.6 Independent Contractors. Nothing in this Agreement is intended or will
be deemed to constitute a partnership, agency, employer-employee or
joint venture relationship between the parties. All activities by the
parties hereunder will be
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performed by them as independent contractors. Neither party will incur
any debts or make any commitments for the other party, except to the
extent specifically provided herein.
27.7 Entire Agreement/Modification. The terms of this Agreement represent
the entire agreement of the parties with respect to the subject matter
herein and will not be modified or supplemented except in a written
document duly executed by the parties, which document will state that
it is an amendment of modification to this Agreement. This Agreement
will prevail in the event of any inconsistencies between it and the
terms of any purchase order, acknowledgment, invoice or other form
utilized by the parties.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives as of the day and year indicated below.
CIBA VISION CORPORATION ISIS PHARMACEUTICALS, INC.
By: Xxxxxxx X. Xxxxxx By: B. Xxxxx Xxxxxxxx
Title: President Title: Executive Vice President
Date: July 10, 1997 Date: July 10, 1997
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Attachment for Ciba Vision - Isis Agreement
Exhibit A
[*CONFIDENTIAL TREATMENT REQUESTED FOR
ENTIRE CONTENTS OF EXHIBIT A]
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Exhibit B
[*CONFIDENTIAL TREATMENT REQUESTED FOR
ENTIRE CONTENTS OF EXHIBIT B]
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