EXCLUSIVE DISTRIBUTION AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
NORTH AMERICAN VACCINE, INC.
October 11, 1996
TABLE OF CONTENTS
PAGE
I. DEFINITIONS...................................................... 1
II. APPOINTMENT...................................................... 8
2.1 Exclusive Appointment.................................. 8
2.2 Distribution Rights.................................... 8
2.3 Diligence.............................................. 8
2.4 Distribution Costs..................................... 8
2.5 Selling Price.......................................... 9
2.6 Competing Products..................................... 9
2.7 Diversionary Sales..................................... 10
2.8 Promotional Materials.................................. 10
2.9 Legends on Products.................................... 10
2.10 Sales Training......................................... 11
2.11 Product Storage and Shipping........................... 11
2.12 Marketing Information.................................. 11
III. CLINICAL DEVELOPMENT............................................. 11
3.1 Clinical Program Scope................................. 11
3.2 Research and Development Committee..................... 11
3.3 Management of the Clinical Program..................... 11
3.4 Annual Reports......................................... 13
3.5 Funding................................................ 13
3.6 Diligence in Conduct of the Clinical Program........... 13
IV. SUPPLY OF PRODUCTS............................................... 14
4.1 Purchase Requirements.................................. 14
4.2 Quality Control and Quality Assurance.................. 14
4.3 Forecasts.............................................. 15
4.4 Firm Orders............................................ 16
4.5 Allocation............................................. 16
4.6 [Intentionally Omitted]................................ 16
4.7 Returns................................................ 16
4.8 Product Recalls........................................ 17
4.9 Adjustments............................................ 17
4.10 Independent Transaction................................ 17
4.11 Delivery Terms......................................... 18
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TABLE OF CONTENTS
(CONTINUED)
PAGE
V. PRICE AND PAYMENTS................................................. 18
5.1 Price.................................................... 18
5.2 Floor Price.............................................. 19
5.3 Provisional Price........................................ 20
5.4 Sales Reports............................................ 20
5.5 Payment Procedure........................................ 21
5.6 Interest Charges on Account of Late Payment.............. 21
5.7 Application of Payments.................................. 21
5.8 Taxes.................................................... 21
5.9 Books and Records........................................ 21
5.10 Marketing Fees........................................... 23
5.11 Milestone Payments....................................... 23
5.12 Other Reports............................................ 24
VI. INDEMNITY.......................................................... 24
6.1 Acts of Abbott........................................... 24
6.2 Acts of NVX.............................................. 24
6.3 Settlements.............................................. 25
6.4 Limitation of Liability.................................. 25
VII. PACKAGING AND LABELING............................................. 25
VIII. TRADEMARKS AND TRADE NAMES......................................... 26
8.1 Trademark................................................ 26
8.2 Trademark Use............................................ 26
8.3 Trademark Rights Upon Expiration......................... 26
8.4 Trademark Rights Upon Termination........................ 26
8.5 Trade Names.............................................. 27
8.6 Infringement of Third Party Trademark Rights............. 27
8.7 Third Party Infringement................................. 27
8.8 Other Materials.......................................... 28
8.9 Trademark Opposition..................................... 28
IX. CONFIDENTIALITY.................................................... 28
9.1 Confidentiality Obligations.............................. 28
9.2 Press Releases........................................... 29
9.3 Use After Termination.................................... 30
9.4 Return of Confidential Information....................... 30
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TABLE OF CONTENTS
(CONTINUED)
PAGE
X. TERM AND TERMINATION............................................. 30
10.1 Term................................................... 30
10.2 Abbott Termination Right............................... 30
10.3 Change of Control of Abbott or its Xxxx
Products Division..................................... 30
10.4 Acquisition of NVX..................................... 30
10.5 Breach................................................. 31
10.6 No Release............................................. 32
10.7 Bankruptcy............................................. 32
10.8 Failure to Make Payments............................... 32
10.9 Obligations After Termination.......................... 33
10.10 Conduct of Business in Anticipation of Termination..... 34
10.11 Alternative Dispute Resolution......................... 34
XI. PATENT MATTERS................................................... 37
11.1 Notice of Infringement................................. 37
11.2 Enforcement and Defense of Patents by NVX.............. 37
11.3 Continuing Payment Obligations......................... 38
11.4 Infringement by Products............................... 38
11.5 Other Intellectual Property Matters.................... 40
XII. MISCELLANEOUS.................................................... 41
12.1 Relationship of the Parties............................ 41
12.2 Applicable Law......................................... 41
12.3 Jurisdiction........................................... 41
12.4 Counterparts........................................... 41
12.5 Notices................................................ 41
12.6 Force Majeure.......................................... 42
12.7 Binding Effect: Assignment............................. 43
12.8 Entire Agreement....................................... 43
12.9 Recitals and Schedules................................. 43
12.10 Amendment.............................................. 43
12.11 Severability........................................... 44
12.12 Headings............................................... 44
12.13 No Waiver of Rights.................................... 44
12.14 Usage.................................................. 44
12.15 No Third Party Rights.................................. 44
12.16 No Licenses............................................ 44
12.17 Interpretation......................................... 44
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TABLE OF CONTENTS
(CONTINUED)
PAGE
XIII. ADVERSE EVENT REPORTING/CUSTOMER AND TECHNICAL
SUPPORT........................................................... 44
XIV. REPRESENTATIONS AND WARRANTIES.................................... 46
XV. SURVIVAL.......................................................... 46
iv
EXCLUSIVE DISTRIBUTION AGREEMENT
THIS AGREEMENT is made this 11th day of October 1996 (the "Effective
Date") by and between Xxxxxx Laboratories, a corporation organized under the
laws of the State of Illinois having its principal place of business at Xxxxxx
Park, Illinois, through its Xxxx Products Division ("Abbott"), having offices at
000 Xxxxxxxxx Xxxxxx, Xxxxxxxx, Xxxx 00000-0000 and North American Vaccine, Inc.
("NVX"), a corporation organized and existing under the laws of Canada having
offices at 00000 Xxxxxx Xxxxx Xxxxx, Xxxxxxxxxx, Xxxxxxxx 00000.
WITNESSETH
WHEREAS, NVX is developing certain vaccines with the intention of
obtaining FDA approval for such vaccines for pediatric administration;
WHEREAS, Abbott is willing to provide funding towards the continued
development of such vaccines and to assist NVX in such development;
WHEREAS, Abbott desires to be become the exclusive distributor of such
vaccines in the private pediatric market in the United States; and
WHEREAS, NVX is willing to appoint Abbott as the exclusive distributor
of such vaccines in the United States, and Abbott is willing to accept such
appointment, all in accordance with the terms and conditions hereof.
NOW THEREFORE, for and in consideration of the foregoing, of the mutual
covenants and undertakings contained herein and of other consideration, the
receipt and sufficiency of which are hereby acknowledged, Abbott and NVX,
intending to be legally bound, hereby agree as follows:
I. DEFINITIONS
1. As used in the Agreement, the following capitalized terms shall have
the meanings set forth below. Capitalized terms in this Agreement used in the
plural shall have the same meaning as for the singular and vice-versa.
1.1 "ABBOTT INDEMNITIES" shall have the meaning set forth in Section
6.2.
1.2 "AFFILIATE" means, with respect to any Person, (a) any other
Person of which securities or other ownership interests representing more than
fifty percent (50%) of the voting interests are, at the time such determination
is being made, beneficially owned or Controlled by such Person, or (b) any other
Person which, at the time such determination is being made, is Controlling,
Controlled by or under common Control with such Person. For the purposes hereof,
(i) "Control," whether used as a noun or verb, refers to the possession,
directly or indirectly, of the power to affirmatively
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direct, or affirmatively cause the direction of, the management and policies of
a Person, whether through the ownership of voting securities, by contract or
otherwise, and (ii) a "beneficial owner" of a security is any Person who,
directly or indirectly, through any contract, arrangement, understanding,
relationship or otherwise has or shares (with the ability to unilaterally
exercise) (x) voting power, which includes the power to vote, or direct the
voting of, such security, or (y) investment power, which includes the power to
dispose, or to direct the disposition of, such security.
1.3 "AVERAGE UNIT NET SELLING PRICE" means, [*]
1.4 "BASE AMOUNT" shall have the meaning set forth in Section
5.1(c).
1.5 "cGMP" shall have the meaning set forth in Section 4.2.
1.6 "CHANGE OF CONTROL TRANSACTION" means any of the following
transactions between a Party and another corporation or other legal entity that
is not an Affiliate of such Party: a statutory merger, consolidation or similar
corporate transaction in which the stockholders or other Persons who
beneficially owned or Controlled the voting interests of the other corporation
or legal entity prior to such merger, consolidation or transaction beneficially
own or Control, after such merger, consolidation or transaction [*] of the
voting interests of the surviving corporation or legal entity; the sale or other
similar disposition in a transaction or series of transactions of all or
substantially all of the assets of the Party; the sale, spin-off or other
disposition by Abbott in a transaction or series of transactions of all or
substantially all of the equity interest in or the assets of the Xxxx Products
Division; and the sale of voting securities of the Party in a transaction or
series of transactions pursuant to which the acquiring Person(s) beneficially
owns or Controls, directly or indirectly, [*] of the voting securities of the
Party.
1.7 "CLINICAL PROGRAM" means the program of human clinical testing
of the Products described in Section 3.1.
1.8 "COMMITTEE" shall have the meaning as set forth in Section 3.2.
1.9 "COMPETITIVE VACCINE" means [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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1.10 "CONFIDENTIAL INFORMATION" means any and all technical data,
information, materials and other know-how presently owned by or developed by, or
on behalf of, either Party during the term of this Agreement which relates to
the Products, their preparation, marketing, sale or use and any and all
financial data and information relating to the businesses of either of the
Parties and/or of their Affiliates.
1.11 "CONTRACT YEAR" means, with respect to each Product, the
calendar year [*]
1.12 "CUSTOMER(S)" shall mean an authorized wholesaler(s) and/or
distributor(s) of Products and such other customers which Abbott bills directly
and acquires Product from Abbott for resale pursuant to contract with Abbott.
1.13 "DESIGNATED REPRESENTATIVE" shall have the meaning as set forth
in Section 3.2.
1.14 "DOSE" means, for each Product, the quantity of vaccine used
for a single administration of the Product to a patient.
1.15 "DTP VACCINE" means [*]
1.16 "DTP-HIB VACCINE" means [*]
1.17 "DTP-IPV VACCINE" means [*]
1.18 "DTP-IPV-HIB VACCINE" means [*]
1.19 "EFFECTIVE DATE" means the date first set forth above.
[*] Confidential information has been omitted and filed separately with the
Commission.
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1.20 "FDA" means the United States Food and Drug Administration, or
any successor to it responsibilities with respect to pharmaceutical products
such as the Products.
1.21 "FULLY-ABSORBED MANUFACTURING COST" means with respect to each
Product: [*]
1.22 "HMO" shall have the meaning as set forth in Section 1.37.
1.23 "LOSSES" means losses, liabilities, costs, expenses (including
reasonable attorneys' fees), claims, penalties, judgments and/or damages
(including personal injury or property damages or consequential damages).
1.24 "LRP" shall have the meaning as set forth in Section 10.4.
1.25 "NET SALES" of a Product means the total of the gross amount
billed or invoiced on the first sale or other disposition of the Product by
Abbott to Third Parties, plus any amounts due to or received by Abbott from such
Third Party in consideration of the sale of such Product, whether based on the
sale or resale of such Product, less:
a) Rebates granted and allowances, chargebacks and trade,
quantity or cash discounts actually allowed and taken, except rebates,
chargebacks or discounts granted wholly or partially in consideration of a Third
Party's agreement to purchase any service or any product other than a Product
(other than where such rebates or discounts are "across-the-board" rebates or
discounts applied uniformly to the Product and other products or services as
part of an overall program of rebates or discounts established by Abbott
covering a broad range of its products);
b) Retroactive price reductions imposed by government
authorities;
[*] Confidential information has been omitted and filed separately with the
Commission.
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c) Fees, commissions or rebates lawfully paid pursuant to
contracts with group purchasing organizations to the extent specifically related
to and based on the number of units of Products sold to members of the group;
d) Amounts actually repaid a Third Party by reason of
rejection, recall or return of Product as evidenced by written records, except
where such rejection, recall or return is due to expiration of Product dating or
is a cost or expense of Abbott under Section 4.8(b);
e) Actual freight and insurance costs in transporting such
Product to such Third Parties and paid by the Third Party, as evidenced by
written records; and
f) Sales, use, excise, value-added and other direct taxes,
customs duties and other government charges incurred and paid by the Third
Party, as evidenced by written records.
The "gross amount billed or invoiced" for calculating Net Sales of any Product
shall mean:
(i) If the Product is sold to a Third Party other than a
Special Party, Xxxxxx'x actual billing or invoice amount for such Product;
(ii) If the Product is sold to an Affiliate for subsequent
resale by or for such Affiliate, the greater of Xxxxxx'x actual billing or
invoice amount or the Affiliate's actual billing or invoice amount for such
Product; or
(iii) If the Product is sold to a Special Party for use by such
Special Party, the billing or invoice amount that would have resulted by
multiplying the number of Vials sold to such Special Party by the Average Unit
Net Selling Price for Product [*] or
(iv) If the Product is otherwise provided to a Third Party,
the billing or invoice amount that would have resulted by multiplying the number
of Vials provided to such Third Party by the Average Unit Net Selling Price for
Product [*]
In the event that Abbott receives any fixed payment, fee or other consideration
from a Third Party in consideration of any discount, credit or similar allowance
granted to such Third Party in connection with the sale of any Product or
Products, the dollar amount equal to such consideration shall be added to the
gross amount billed or invoiced for such sale for purposes of calculating Net
Sales.
[*] Confidential information has been omitted and filed separately with the
Commission.
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1.26 "NVX INDEMNITEES" shall have the meaning as set forth in
Section 6.1.
1.27 "NVX VACCINES" means collectively the DTP Vaccine, DTP-IPV
Vaccine, DTP-Hib Vaccine and DTP-IPV-Hib Vaccine.
1.28 "PARTY" means NVX or Abbott, and "PARTIES" means NVX and
Abbott.
1.29 "PATENTS" means:
a) The existing patents designated on Exhibit A attached
hereto; b) Any patents issued jointly to the Parties and patent applications
filed by or assigned jointly to the Parties that cover a Product and are in
existence prior to the date of first commercial sale of such Product in the
Territory; and c) Any reissues, reexaminations, renewals, extensions,
divisionals, continuations and continuations-in-part of the foregoing.
1.30 "PEDIATRIC ADMINISTRATION" means administration to any person
under seven (7) years of age.
1.31 "PERSON" means a natural person, a corporation, a partnership,
a trust, a joint venture, any governmental authority or any other entity or
organization.
1.32 "PHASE I CLINICAL TRIAL" means a clinical study of a Product
involving human subjects and designed primarily to assess the safety of the
Product under investigation.
1.33 "PHASE I/II CLINICAL TRIAL" means a clinical study of a Product
involving human subjects and designed primarily to assess the safety,
immunogenicity and optimal dosage of the Product under investigation.
1.34 "PHASE III CLINICAL TRIAL" means a clinical study of a Product
involving human subjects and designed primarily to assess the safety and
efficacy of the Product under investigation.
1.35 "PHASE IV CLINICAL TRIAL" means a clinical study of a Product
involving human subjects and conducted to maintain the marketing authorization
of the Product under investigation.
1.36 "PLA" means a Product License Application submitted to the FDA.
1.37 "PRIVATE PEDIATRIC MARKET" means private pediatricians, staff
and group model health maintenance organizations ("HMOs") and other Third
Parties that dispense vaccines for Pediatric Administration, but shall exclude
only U.S. (including
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Puerto Rico and all other territories and possessions) Federal, state, local and
other government entities including, without limitation, the U.S. Centers for
Disease Control.
1.38 "PRODUCT APPROVAL" means, with respect to a Product, one or
more licenses issued by the FDA for manufacturing, marketing and sale.
1.39 "PRODUCT" means any one of the NVX Vaccines and "PRODUCTS"
means the NVX Vaccines.
1.40 "PROJECT LEADER" shall have the meaning as set forth in Section
3.3.
1.41 "PURCHASE PRICE" shall have the meaning as set forth in Section
5.1(e).
1.42 "REQUIREMENTS" shall have the meaning as set forth in Section
4.1.
1.43 "SPECIAL PARTY" means an Affiliate of Abbott or any other
Person enjoying a special course of dealing with Abbott, or any of its
Affiliates, except for Customers operating in the normal course of business. A
"special course of dealing" shall mean co-marketing or other arrangements
between a Third Party and Abbott or one of its Affiliates wherein the Third
Party sells a Product and Abbott or its Affiliate receives additional
compensation based on the ultimate sale of the Product, or barter arrangements
in which Abbott or its Affiliate exchanges a Product with a Third Party for
another product or other products in-kind.
1.44 "SPECIFICATIONS" shall have the meaning as set forth in Section
4.2.
1.45 "TERRITORY" means the United States of America, its territories
and possessions, and Puerto Rico.
1.46 "THIRD PARTY" means any Person that is not a Party to this
Agreement.
1.47 "TRADEMARKS" means a trademark or trademarks to be co-owned by
Abbott and NVX during the term of this Agreement and agreed upon in writing by
the Parties for use by Abbott and NVX with the Products in the Territory in
accordance with the terms of this Agreement.
1.48 "VALID CLAIM" means a claim of an issued and unexpired patent
included in the Patents that has not been (a) held revoked, unenforceable or
invalid by a decision of a court or governmental agency of competent
jurisdiction over such claim, which decision is unappealable or unappealed
within the time allowed for appeal or (b) admitted by the holder to be invalid
or unenforceable through disclaimers, consent decrees or otherwise.
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1.49 "VIAL" means, with respect to each Product, a finally-packaged
form of the Product for sale to the customer. Each Vial may contain one or more
Doses of the Product.
II. APPOINTMENT
2.1 EXCLUSIVE APPOINTMENT. From the Effective Date and for the term of
this Agreement, subject to all of the provisions of this Agreement, NVX hereby
appoints Abbott as its exclusive distributor of Products solely for Pediatric
Administration to the Private Pediatric Market in the Territory, and Abbott
accepts such appointment as exclusive distributor.
2.2 DISTRIBUTION RIGHTS. Subject to the terms hereof, Abbott shall have
the exclusive rights to distribute, market, promote and sell Products solely for
Pediatric Administration to the Private Pediatric Market in the Territory. NVX
agrees not to voluntarily license any Third Party under any of the Patents to
distribute, market, promote or sell any of the Products for Pediatric
Administration to the Private Pediatric Market in the Territory.
2.3 DILIGENCE. Abbott shall use reasonable commercial efforts in
carrying out the commercialization of each of the Products for Pediatric
Administration in the Private Pediatric Market in the Territory. Pursuant to the
foregoing, Abbott, at its own expense, shall:
a) promptly introduce each of the Products for Pediatric
Administration to the Private Pediatric Market in the Territory as soon as
practicable after Product Approval is received by NVX, subject to NVX's ability
to supply adequate inventories of Product for Product introduction;
b) use reasonable, diligent commercial efforts to detail,
market, distribute and sell the Products to maximize the market potential of
each of the Products;
c) maintain an adequate inventory of each of the Products to
supply anticipated demand therefor, subject to NVX's ability to supply the same;
and
d) otherwise act in good faith to commercialize each of the
Products for Pediatric Administration in the Private Pediatric Market in the
Territory in a manner which, in Xxxxxx'x good faith exercise of its business
judgment, maximizes the commercial benefits of the Products.
2.4 DISTRIBUTION COSTS. Abbott shall be solely responsible for all
costs associated with the following relating to the sale of the Products to the
Private Pediatric Market in the Territory: transportation charges; quantity or
cash discounts; service allowances; commissions; credits or allowances given on
account of price adjustments, bad debts, returns, rebates or chargebacks;
returns or rejections other than Product
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recalls; and all taxes, surcharges, assessments or governmental charges imposed
upon Abbott measured by the sale, transportation or delivery of the Products by
Abbott. The Parties acknowledge that certain of the foregoing costs are
appropriate deductions from gross sales for the purpose of determining Net Sales
as defined in Section 1.25.
2.5 SELLING PRICE. The final sales price of each of the Products sold
by Abbott shall be determined by Abbott in its sole and absolute discretion.
2.6 COMPETING PRODUCTS. During the term of this Agreement, and subject
to Section 11.4(e):
a) Neither Party, nor any of its Affiliates, shall make, use
or sell in the Territory any Competitive Vaccine, [*]
b) [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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c) [*]
2.7 DIVERSIONARY SALES. Abbott covenants not to sell the Products
outside of the Private Pediatric Market in the Territory and anywhere outside of
the Territory and not knowingly to sell the Products to any Third Party for
diversion for sale outside of the Private Pediatric Market in the Territory or
anywhere outside of the Territory. NVX covenants not to sell the Products in the
Private Pediatric Market within the Territory and not knowingly to sell the
Products to any Third Party for diversion for sale in the Private Pediatric
Market in the Territory.
2.8 PROMOTIONAL MATERIALS. Abbott shall be solely responsible for all
costs associated with the development, production and distribution of
promotional materials associated with the Products for Pediatric Administration
in the Private Pediatric Market in the Territory. All matters regarding
promotion and advertising of the Products in the Private Pediatric Market in the
Territory shall be decided by Abbott with input from NVX, [*] consistent with
all statutory and regulatory requirements, including without limitation, FDA
rules and regulations governing the packaging and labeling of the Products. NVX
and Abbott shall keep each other informed of their respective on-going
promotional and advertising programs in the Territory.
2.9 LEGENDS ON PRODUCTS. NVX shall xxxx all Products supplied to Abbott
hereunder with an appropriate notice that such Products are patented. The form
of such notice shall conform to the requirements of 35 U.S.C. ss. 287(a) and
shall comply with any other notice or legend requirement of applicable law or
regulation.
[*] Confidential information has been omitted and filed separately with the
Commission.
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2.10 SALES TRAINING. Abbott shall be solely responsible for all costs
associated with training and updating its sales force in the Territory.
2.11 PRODUCT STORAGE AND SHIPPING. Abbott shall store and ship the
Products to customers in the Territory in accordance with all applicable laws
and regulations and labeling for the Products which are designed to provide that
the Products continue to meet Specifications, and take all reasonable efforts to
provide that its Customers adhere to the same standards. Abbott shall be
responsible, and NVX shall not be liable, for any Losses due to the failure of
Xxxxxx'x Customers to comply with the foregoing standards or for the failure of
Abbott or its Customers to resell or use the Products prior to the expiration of
the Products' respective dating periods.
2.12 MARKETING INFORMATION. NVX shall have the right at reasonable
intervals, [*] to request information regarding Xxxxxx'x marketing and
promotional activities undertaken with respect to the Products. Abbott shall
provide such information, in its sole discretion, to the extent it is available
in its ordinary course of business without any special effort or expense.
III. CLINICAL DEVELOPMENT
3.1 CLINICAL PROGRAM SCOPE. The Parties shall collaboratively undertake
a program of human clinical testing of the Products, commencing on the Effective
Date and continuing for each Product through all Phase I Clinical Trials, Phase
I/II Clinical Trials, Phase III Clinical Trials and any necessary or warranted
Phase IV Clinical Trials to maximize the commercial potential for each Product
for Pediatric Administration in the Private Pediatric Market. The program for
such development of the Products shall be conducted in accordance with the
provisions of this Article III.
3.2 RESEARCH AND DEVELOPMENT COMMITTEE. Each party shall designate two
representatives ("Designated Representatives") to serve on a Research and
Development Committee ("Committee") to determine and monitor the priorities,
goals, budgets, resource allocations and milestones for the ongoing clinical
development of the Products.
3.3 MANAGEMENT OF THE CLINICAL PROGRAM.
a) The Clinical Program shall be managed by the Committee. The
Committee may seek the input and advice of employees of the Parties of
sufficient qualifications such that the Committee will be in a position to
discuss the Clinical Program knowledgeably, evaluate the results thereof, and
make recommendations to the Parties regarding the priorities therefor. Such
people may be invited by a Party's Designated Representative to attend meetings
of the Committee, as appropriate. The Committee may also seek advice from Third
Parties relating to the Clinical Program, subject to appropriate confidentiality
requirements and the mutual agreement of the Parties. One of each Party's
Designated Representatives to the Committee shall be a "Project Leader," who is
responsible for coordinating that Party's part of the Clinical
[*] Confidential information has been omitted and filed separately with the
Commission.
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Program. The Project Leaders shall be the primary contacts between the Parties
with respect to the Clinical Program. Each Party initially shall designate its
Project Leader and its other representatives to the Committee by written notice
to the other Party within thirty (30) days after the Effective Date. Each Party
thereafter may change its Project Leader or its other Designated Representative
to the Committee upon delivering written notice to the other party.
b) The Committee shall hold an organizational meeting promptly
after designation of each Party's Designated Representatives, [*] Thereafter,
the Committee shall meet from time to time when reasonably requested by either
Project Leader as necessary to manage the conduct of the Clinical Program, [*]
All meetings of the Committee shall be at specific times and places agreed upon
by the two Project Leaders. Members of the Committee may attend meetings in
person or by telephone or video conferencing, provided that members attending by
telephone or video conferencing can hear and be heard. Each Party shall bear any
expenses incurred by its Designated Representatives and its employees and other
representatives of the Party in attending meetings of the Committee.
c) Each Party shall ensure that at least one of its Designated
Representatives is in attendance at each meeting of the Committee. All decisions
of the Committee shall [*] The Parties shall use all reasonable good faith
efforts to resolve any issues as to which the Committee cannot agree in order to
maximize the commercial potential for each Product in the Private Pediatric
Market in the Territory. In the event that a dispute cannot be resolved and
continues [*] each Party shall have the right to submit the matter to the
Parties' Presidents (the President of Xxxx Products Division in the case of
Xxxxxx) for resolution. [*]
d) [*] following each Committee meeting, the Project Leaders
shall prepare, and distribute to each Party, a reasonably detailed written
summary report [*]
e) The Committee may establish working groups of scientists and
others to carry out specific aspects of the Clinical Program.
[*] Confidential information has been omitted and filed separately with the
Commission.
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3.4 ANNUAL REPORTS. To keep each other apprised of its progress under
this Article 3, each Party shall submit annual progress reports as to its
Product development, approval and marketing activities, [*]
3.5 FUNDING. Subject to Section 10.4, Xxxxxx shall provide funding [*]
in support of the Clinical Program during the term of this Agreement. The
payments shall be made as follows: [*] Such funding shall be used first to
support out-of-pocket expenses of Phase I, II, III and IV Clinical Trials
(including a Phase IV Clinical Trial for the DTP Vaccine), and thereafter to
support NVX's labor and other internal costs related to the Clinical Program.
[*]
3.6 DILIGENCE IN CONDUCT OF THE CLINICAL PROGRAM. NVX shall use
reasonable commercial efforts in the conduct of its activities pursuant to the
Clinical Program in furtherance of obtaining marketing approvals for the
Products that maximize the commercial potential for the Products. Subject to
Section 3.5 and consistent with a reasonable allocation of NVX's internal
resources among its clinical programs, NVX shall accord a priority to the
Clinical Program as high as its other clinical programs for products of similar
market potential and expeditiously file with the FDA to obtain Product Approvals
for the Products. [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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[*] Xxxxxx shall cooperate with NVX in support of NVX's activities undertaken in
conducting the Clinical Program in accordance with the foregoing.
IV. SUPPLY OF PRODUCTS
4.1 PURCHASE REQUIREMENTS.
During the term and in accordance with the provisions of this
Agreement, Xxxxxx shall purchase exclusively from NVX all of its Requirements of
the Products, and NVX shall sell such quantities of Products to Xxxxxx, subject
to the provisions hereof, including without limitation the provisions of Section
4.4. [*]
4.2 QUALITY CONTROL AND QUALITY ASSURANCE.
a) Each of the Products supplied by NVX to Xxxxxx hereunder
shall conform to the release specifications for the Product as approved by the
FDA as set forth in the Product Approval for such Product ("Specifications") and
shall be manufactured in accordance with then-current Good Manufacturing
Practices ("cGMPs") as set forth in 21 C.F.R. Parts 211 and 600 through 680, and
any successor thereof.
b) NVX shall maintain a quality control program consistent with
cGMPS, as required by all applicable laws and regulations and all subsequent
additions and revisions thereto.
c) All Product received by Xxxxxx shall be deemed accepted,
unless Xxxxxx shall give written notice to NVX [*] specifying the manner in
which the Product does not conform to the Specifications. Such notice shall be
accompanied by written reports of any testing performed by Xxxxxx on the
Product. Acceptance of a Product shall not be deemed to supersede, alter or
limit any warranty, obligation or liability NVX may have under this Agreement.
d) Upon receipt of such notice, NVX may request Xxxxxx to
return the non-accepted Product, or samples thereof, for testing by NVX.
[*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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e) If as finally determined above a shipment of a Product does
not conform to the Specifications, or if the Product is not sellable and must be
recalled because of NVX's non-compliance with cGMPs with respect to the Product,
NVX will give full credit for such Product at the price invoiced by NVX or paid
by Xxxxxx and, at Xxxxxx'x request, shall replace such shipment with conforming
Product at the original invoice price per Vial of Product being replaced. All
transportation, shipping and insurance cost, and other fees incident to the
shipping of such replacement Product (to the extent previously paid by Xxxxxx
for the non-conforming Product) will be paid by NVX or if Xxxxxx has not
requested a replacement shipment, such costs and fees shall be credited to
Xxxxxx'x account. At NVX's expense, the non-conforming shipment shall be
returned to NVX. EXCEPT AS PROVIDED IN SECTION 6.2, THE FOREGOING SHALL BE NVX'S
SOLE LIABILITY FOR, AND XXXXXX'X SOLE AND EXCLUSIVE REMEDY WITH RESPECT TO, THE
SUPPLY OF ANY SHIPMENT OF A PRODUCT THAT DOES NOT CONFORM TO THE SPECIFICATIONS
OR WAS NOT MANUFACTURED IN ACCORDANCE WITH CGMPS.
f) Xxxxxx shall have the right during normal business hours and
with reasonable advance notice to visit NVX's facility for the purpose of
observing the manufacturing, packaging, testing, and warehousing of the
Products.
g) EXCEPT AS SET FORTH IN SECTION 4.2(a) ABOVE, NVX DISCLAIMS
ANY WARRANTIES, EXPRESS OR IMPLIED, TO XXXXXX WITH REGARD TO THE PRODUCTS
SUPPLIED BY NVX HEREUNDER, INCLUDING WARRANTIES WITH REGARD TO MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE.
h) The Parties hereto agree that the sale and supply of
Products by NVX and the purchase of Products by Xxxxxx hereunder shall be
subject to and governed by the terms and conditions hereof. None of the terms
and conditions set forth on any purchase or order form, invoice, acknowledgement
or the like shall change or modify the provisions of this Agreement unless it is
signed and delivered by authorized representatives of both of the Parties hereto
and it clearly indicates by specific reference to this Agreement that the
Parties intended to vary the provisions hereof.
4.3 FORECASTS.
Xxxxxx shall provide NVX with a written forecast (by Product and
month) of the quantity of Products that Xxxxxx expects to order [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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[*]
4.4 FIRM ORDERS.
a) Xxxxxx shall specify by firm written purchase order its
requirements for each of the Products for each calendar quarter [*] NVX shall
use reasonable commercial efforts to supply the Products to Xxxxxx in accordance
with its orders.
b) [*]
4.5 ALLOCATION. In the event that NVX is unable to fill Xxxxxx'x firm
purchase orders for the Products, NVX shall allocate the available Products
among its customers (including Xxxxxx) in accordance with [*]
4.6 [INTENTIONALLY OMITTED]
4.7 RETURNS. Except in the case of Section 4.8 where NVX is responsible
for the costs and expenses of a Recall, Xxxxxx shall not be permitted to return
for refund or credit any Products meeting Specifications therefor that Xxxxxx
has ordered and NVX has supplied hereunder, without the prior written consent of
NVX.
[*] Confidential information has been omitted and filed separately with the
Commission.
-16-
4.8 PRODUCT RECALLS.
a) Each Party shall promptly notify the other Party in
writing of any facts relating to a possible advisability of a recall or the
destruction or withholding from the market in the Territory of any Product
(collectively "Recall"). If at any time (i) any governmental or regulatory
authority in the Territory issues a request, directive or order for a Recall of
a Product from the market in the Territory, (ii) a court of competent
jurisdiction orders a Recall of such Product from the market in the Territory,
or (iii) either Party determines, after consultation with the other Party, that
a Recall of such Product from the market in the Territory is necessary or
advisable, Xxxxxx shall take all appropriate corrective action to effect the
Recall in the Private Pediatric Market in the Territory and NVX shall take all
appropriate corrective action to effect the Recall outside of the Private
Pediatric Market in the Territory. Each Party shall provide the other Party with
such cooperation in connection with the Recall as the other Party may reasonably
request. NVX shall give prior notice to Xxxxxx if NVX is instituting a Recall of
Product outside of the Territory.
b) [*]
4.9 ADJUSTMENTS. If Xxxxxx'x reasonably forecasted needs exceed NVX's
capabilities, NVX, in consultation with Xxxxxx, shall determine the best means
of resolving such capacity constraints, [*]
4.10 INDEPENDENT TRANSACTION. Each shipment of Product hereunder shall
constitute a separate and independent transaction and NVX shall be entitled to
payment for each such shipment without reference to any other. Notwithstanding
the foregoing, the Parties shall be entitled to reflect in the invoices any
appropriate credits or similar adjustments thereto.
[*] Confidential information has been omitted and filed separately with the
Commission.
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4.11 DELIVERY TERMS. All Products shall be sold and be delivered
F.O.B., NVX's manufacturing facility. Title and risk of loss shall pass to
Xxxxxx upon delivery by NVX to the carrier specified by Xxxxxx. Each shipment of
Product shall be accompanied or followed by an invoice and a statement in
compliance with 21 USC ss. 303(c)(2) or any successor thereto. NVX may ship
Product in accordance with Xxxxxx'x instructions via the carrier specified by
Xxxxxx directly to Customers of Xxxxxx. However, nothing in this Agreement shall
be construed as an obligation of NVX to inventory the Product or act or serve as
a wholesaler or distributor of Xxxxxx pursuant to which NVX would deliver
Products to end-users or final customers.
V. PRICE AND PAYMENTS
5.1 PRICE. The invoice price for each Product sold by NVX to Xxxxxx
pursuant to and during the term of this Agreement shall be determined in
accordance with Section 5.3. Adjustments in the amounts paid to NVX on account
of the sale of the Products to Xxxxxx in each calendar year shall be made as
follows:
a) [*]
b) [*]
c) [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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d) [*]
e) [*]
f) [*]
5.2 FLOOR PRICE. [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
-19-
5.3 PROVISIONAL PRICE. [*]
5.4 SALES REPORTS. On or before [*] of each year following the first
sale of a Product, Xxxxxx shall deliver to NVX a true and accurate written
report showing the following as they apply to the calendar quarter immediately
preceding the date of such report:
a) For each Product and differently-sized Vial, the total
quantity of Vials of each Product billed, invoiced or otherwise provided to a
Third Party during the immediately preceding calendar quarter; and
b) The computation of the Net Sales of each such Product,
including a detailed accounting of: [*]
[*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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[*] The correctness and completeness of each such report shall be certified in
writing by an authorized representative of Xxxxxx. On or before the date [*]
after the end of the calendar quarter in which this Agreement expires or is
terminated, Xxxxxx shall provide to NVX a written report that complies in all
respects with this Section 5.4.
5.5 PAYMENT PROCEDURE. All payments payable by Xxxxxx hereunder shall
be paid to NVX in U.S. Dollars by wire transfer, or by such other method
mutually agreed upon by the Parties, for value [*] to such bank account or
accounts as NVX shall designate in writing, within a reasonable period of time
prior to such due date. Xxxxxx shall provide NVX with [*] advance notice of each
such wire transfer.
5.6 INTEREST CHARGES ON ACCOUNT OF LATE PAYMENT. If Xxxxxx fails to pay
any payment required under this Agreement [*] Xxxxxx shall pay interest on such
amount at [*] which interest shall accrue from the date the payment not timely
made became due until the date such payment is paid in full. If such rate
exceeds the rate allowed by applicable law, then the highest rate allowed by law
shall apply.
5.7 APPLICATION OF PAYMENTS. Any payments received by NVX shall be
applied first to the satisfaction of any unpaid, accrued interest and then to
the satisfaction of any unpaid principal.
5.8 TAXES. If any law or regulation requires the withholding of any
taxes levied on the payment of any amounts payable to NVX under this Agreement,
such taxes shall be deducted by Xxxxxx from the amount otherwise payable to NVX
and paid by Xxxxxx to the proper taxing authority. Xxxxxx shall secure proof of
any such tax payment, and send such proof to NVX as evidence of such payment
together with such other documents as NVX may reasonably require in order to
secure a refund of or credit for the amount of such payment. Except for the
foregoing, each Party shall be responsible for any taxes that are levied on it
in connection with its obligations under this Agreement. Xxxxxx shall provide
NVX with a copy of its resale certificate in order to enable NVX to claim a
sales tax exemption for all sales of Product by NVX to Xxxxxx. NVX shall be
entitled to include and separately state on each invoice for Product the excise
tax imposed on the sales of Products to Xxxxxx, and Xxxxxx shall pay such
amounts to NVX at the time Xxxxxx pays the invoice price for such Product. NVX
shall be responsible for remitting the excise tax to the appropriate
governmental entity.
5.9 BOOKS AND RECORDS.
a) Xxxxxx shall keep full, true and accurate books of account
containing all particulars and reasonable supporting documentation which may be
necessary for the purpose of determining [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
-21-
[*] and Xxxxxx'x compliance in other respects with its financial
obligations under this Agreement. The books of account and reasonable supporting
documentation shall be kept at Xxxxxx'x and/or its Xxxx Products Division's
principal place of business and shall be open during normal business hours for
confidential inspection no more frequently than once each calendar year for [*]
following the end of the calendar year to which they pertain by any of the "big
six" independent certified public accounting firms retained by NVX for the
purpose of verifying Xxxxxx'x reports and/or Xxxxxx'x compliance in other
respects with its financial obligations under this Agreement. [*] If such
records are insufficient for the foregoing purposes or any such inspection
discloses an underpayment of [*] of the amount actually due, then, in addition
to any other rights and remedies available to NVX under this Agreement, Xxxxxx
shall promptly pay the reasonable cost of such inspection after Xxxxxx'x receipt
of the xxxx or invoice for such inspection. Xxxxxx shall be provided a copy of
the audit report and shall have the right to have its own audit conducted by a
"big six" independent certified public accounting firm with respect to the
subject matter of the audit report. In the case of any discrepancy and the
Parties are unable to agree on a resolution thereof, an independent auditor
mutually agreed to by the Parties shall be retained to conduct a final audit,
the results of which shall be binding on the Parties.
b) NVX shall keep full, true and accurate books of account
containing all particulars and reasonable supporting documentation [*] and NVX's
compliance in other respects with its financial obligations under this
Agreement. The books of account and reasonable supporting documentation shall be
kept at NVX's principal place of business and shall be open during normal
business hours for confidential inspection no more frequently than once each
calendar year [*] following the end of the calendar year to which they pertain
by any of the "big six" independent certified public accounting firms retained
by Xxxxxx for the purpose of verifying NVX's records and/or NVX's compliance in
other respects with its financial obligations under this Agreement. In no event
shall the auditor disclose to Xxxxxx any [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
-22-
[*] If such records are insufficient for the foregoing purposes or any such
inspection discloses a discrepancy resulting in an overpayment by Xxxxxx of [*]
of the amount actually due, then, in addition to any other rights and remedies
available to Xxxxxx under this Agreement, NVX shall promptly pay the reasonable
cost of such inspection after NVX's receipt of the xxxx or invoice for such
inspection. NVX shall be provided a copy of the audit report and shall have the
right to have its own audit conducted by a "big six" independent certified
public accounting firm with respect to the subject matter of the audit report.
In the case of any discrepancy and the Parties are unable to agree on a
resolution thereof, an independent auditor mutually agreed to by the Parties
shall be retained to conduct a final audit, the results of which shall be
binding on the Parties.
5.10 MARKETING FEES. In addition to any other amounts paid by Xxxxxx to
NVX, subject to Section 10.4, Xxxxxx shall pay NVX non-refundable marketing
fees, during the term of the Agreement, as follows:
[*]
5.11 MILESTONE PAYMENTS. In addition to the foregoing payments, subject
to Section 10.4, Xxxxxx shall pay NVX a milestone payment of [*] Xxxxxx shall
provide written notice to NVX of achievement of each milestone event within
thirty (30) days thereof and shall make the required payment to NVX no later
than the end of the thirty
[*] Confidential information has been omitted and filed separately with the
Commission.
-23-
(30) day notice period. The foregoing milestone payments shall be added to the
Purchase Price pursuant to and for the purpose stated in Section 5.2.
5.12 OTHER REPORTS. With respect to each Product, NVX shall provided
quarterly, written reports within thirty (30) days of the end of each quarter to
Xxxxxx of any significant variation of [*] the reasons for such variation and,
if appropriate, the steps that NVX is taking to control or correct such
variation.
VI. INDEMNITY
6.1 ACTS OF XXXXXX.
a) Xxxxxx shall indemnify and hold harmless NVX, NVX's
Affiliates and their respective directors, officers, employees and agents,
(collectively, the "NVX Indemnitees") from and against, any Losses incurred by
NVX Indemnitees arising out of or resulting from any Third Party claim based
upon: (i) the breach by Xxxxxx, or any Affiliate, of any covenant,
representation or warranty contained in this Agreement, or (ii) all decisions
made by Xxxxxx or any Affiliate pursuant to Section 2.8 or (iii) any negligent
act or omission or willful misconduct of Xxxxxx, any Affiliate, or any Customer
of Xxxxxx in the handling, storage, promotion, marketing, distribution or sale
of Products by Xxxxxx, any of Xxxxxx'x Affiliates of its Customers, or any other
activity conducted by Xxxxxx, any Affiliate under this Agreement which is the
proximate cause of injury, death or property damage to a Third Party, except to
the extent such Losses arise out of or result from the breach of this Agreement
by, or the negligence or willful misconduct of, NVX or any Affiliate.
b) If any claim or cause of action alleging any of the
foregoing is asserted by a Third Party against any of the NVX Indemnitees, then:
(i) NVX shall notify Xxxxxx promptly in writing of such claim or cause of
action; (ii) Xxxxxx shall assume, at its cost and expense, the sole defense of
such claim or cause of action through counsel selected by Xxxxxx and reasonably
acceptable to NVX, except that in the case of a conflict of interest between
Xxxxxx and NVX, Xxxxxx shall, at Xxxxxx'x cost and expense, provide separate
counsel for NVX selected by NVX; (iii) Xxxxxx shall maintain control of such
defense, including any decision as to settlement; (iv) NVX may, at its option
and expense, participate in such defense, and if NVX so participates, the
Parties shall cooperate with one another in such defense; and (v) Xxxxxx shall
bear the total costs of any court award or settlement of such claim or cause of
action and all other costs, fees and expenses related to the resolution thereof.
6.2 ACTS OF NVX.
a) NVX shall indemnify and hold harmless Xxxxxx, Xxxxxx'x
Affiliates and their respective directors, officers, employees and agents
(collectively, the "Xxxxxx Indemnitees") from and against, any Losses incurred
by the Xxxxxx Indemnitees arising out of or resulting from any Third Party claim
based upon: (i) the breach by
[*] Confidential information has been omitted and filed separately with the
Commission.
-24-
NVX or any Affiliate of any covenant, representation or warranty contained in
this Agreement, or (ii) any injury, death or property damage to a Third Party
resulting from the manufacture, use or sale of any Product, except to the extent
such Losses arise out of or result from the breach of this Agreement by, or the
negligence or willful misconduct of, Xxxxxx, or any Affiliate or Customer of
Xxxxxx, or any end-user, or arise out of or result from decisions made by Xxxxxx
or any Affiliate pursuant to Section 2.8, or (iii) any negligent act or omission
or willful misconduct of NVX, or any Affiliate, in the manufacture, promotion,
marketing, distribution or sale of Products by NVX or any of NVX's Affiliates or
any other activity conducted by NVX or any Affiliate under this Agreement which
is the proximate cause of injury, death or property damage to a Third Party,
except to the extent such Losses arise out of or result from the breach of this
Agreement by, or the negligence or willful misconduct of, Xxxxxx or any
Affiliate.
b) If any claim or cause of action alleging any of the
foregoing is asserted by a Third Party against any of the Xxxxxx Indemnitees,
then: (i) Xxxxxx shall notify NVX promptly in writing, of such claim or cause of
action; (ii) NVX shall assume, at its cost and expense, the sole defense of such
claim or cause of action through counsel selected by NVX and reasonably
acceptable to Xxxxxx, except that in the case of a conflict of interest between
NVX and Xxxxxx, NVX shall, at NVX's cost and expense, provide separate counsel
for Xxxxxx selected by Xxxxxx; (iii) NVX shall maintain control of such defense,
including any decision as to settlement; (iv) Xxxxxx may, at its option and
expense, participate in such defense, and if Xxxxxx so participates, the Parties
shall cooperate with one another in such defense; and (v) NVX shall bear the
total costs of any court award or settlement of such claim or cause of action
and all other costs, fees and expenses related to the resolution thereof.
6.3 SETTLEMENTS. The indemnifying Party shall not settle a claim or
action related to any Losses without the consent of the indemnified Party, if
such settlement would impose any monetary or other material obligation or burden
on the indemnified Party or require the indemnified Party to submit to a
temporary restraining order or an injunction or otherwise limit the indemnified
Party's rights under this Agreement. Any payment made by the indemnifying Party
to settle any such claim or action shall be at its own cost and expense.
6.4 LIMITATION OF LIABILITY. Except with respect to obligations of
indemnification under Section 6.1 and 6.2, with respect to any claim by one
Party against the other arising out of any breach under this Agreement, the
Parties expressly agree that the liability of the breaching Party to the
non-breaching Party for such breach shall be limited under this Agreement or
otherwise at law or equity to direct damages only and in no event shall a Party
be liable for, indirect, incidental, punitive, exemplary or consequential
damages.
VII. PACKAGING AND LABELING
NVX shall be solely responsible for all manufacturing, final fill,
labeling and packaging activities relating to the Products, which shall be
conducted in accordance with
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all applicable statutory and regulatory requirements. The Parties shall jointly
be responsible for the content of the labeling and packaging materials, with all
final decisions to be made by NVX in its sole business judgment consistent with
all applicable statutory and regulatory requirements, including, without
limitation, FDA rules and regulations governing the packaging and labeling of
Products.
VIII. TRADEMARKS AND TRADE NAMES
8.1 TRADEMARK. The Parties shall explore and agree upon the Trademarks
to be used in connection with the Products in the Territory. [*]
8.2 TRADEMARK USE. During the term of the Agreement, each Party and its
Affiliates shall have [*] such Trademarks solely for
the purpose of promoting, advertising, marketing, offering to sell and selling
the Products in its designated market in the Territory and for no other purpose.
Neither Party shall use or permit the use of the Trademarks outside the
Territory without the prior written consent of the other Party.
8.3 TRADEMARK RIGHTS UPON EXPIRATION. Upon expiration of the Agreement,
the Trademarks shall be the property of Xxxxxx, provided that NVX shall have a
royalty-free license to use such Trademarks solely with regard to continuing
promoting, advertising, marketing, offering to sell and selling of the Products
to governmental agencies in the Territory.
8.4 TRADEMARK RIGHTS UPON TERMINATION.
a) [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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b) [*]
8.5 TRADE NAMES. During the term of this Agreement and unless
prohibited by the responsible regulatory agency, the Parties shall not use any
trademark other than the Trademarks and shall use the trade name of Xxxxxx or
Xxxx and the NVX trade name on all Products and all product labelling,
advertising and promotional material pertaining thereto in the Territory. A
legend to the effect that the Product has been manufactured by NVX and is being
sold and distributed under rights granted by NVX will be printed on the package
and product labelling for each Product. All such use of the NVX trade name, and
the Xxxxxx and Xxxx tradenames, in accordance with this Agreement and applicable
law shall inure to the benefit of NVX, and Xxxxxx and Xxxx, respectively.
8.6 INFRINGEMENT OF THIRD PARTY TRADEMARK RIGHTS. Each Party shall
promptly notify the other Party of any claim of infringement by a Third Party
resulting from a Party's use of any Trademark hereunder, immediately upon such
claim of infringement becoming known, directly or indirectly. In the event of
any such Third Party notice, Xxxxxx and NVX shall meet in good faith to address
such claim of infringement, which may include defending against such claim,
seeking a license from such Third Party or selecting a new Trademark acceptable
to both Parties to be used with the Product. If one Party in its reasonable
judgment objects to using the Trademark in question, and the other Party desires
to continue to sell Product using the Trademark in question over the objections
of the other Party, the Party continuing to use the Trademark shall indemnify
and hold the other Party harmless from any such claim of infringement with
respect to future Product sales by such Party.
8.7 THIRD PARTY INFRINGEMENT. The Parties shall notify each other of
any apparent infringement by any Third Party of any Trademark [*] after becoming
aware thereof. In the event of an infringement of a Trademark, NVX and Xxxxxx
shall meet to discuss possible joint prosecution and sharing of costs therefor
and any award resulting therefrom. If the Parties are unable to agree on a joint
course of action, Xxxxxx shall have the right to enforce an action against a
Third Party infringer at its sole expense. Any judgment or award resulting from
such action undertaken by Xxxxxx shall be retained by Xxxxxx. In the event that
Xxxxxx does not
[*] Confidential information has been omitted and filed separately with the
Commission.
-27-
exercise its right to undertake an action against the Third Party infringer,
then NVX shall have the right to enforce an action at its expense against the
Third Party infringer and any judgment or award resulting from such action shall
be retained by NVX. The Parties shall cooperate in any action reasonably
necessary or desirable to protect or defend any Trademark used or proposed to be
used hereunder.
8.8 OTHER MATERIALS. Each Product and all labeling, advertising and
promotional material shall feature the applicable Trademark and the Xxxxxx
and/or Xxxx and NVX trade names and logos. Unless the Parties otherwise agree,
all labeling shall include the Xxxxxx and NVX tradenames and logos, which shall
be displayed with comparable size and prominence.
8.9 TRADEMARK OPPOSITION. Each Party, on behalf of itself and its
Affiliates, hereby consents to use of the Trademarks with respect to the Product
throughout the Territory as contemplated by this Agreement and agrees to waive,
and does hereby waive, any challenge that it or any Affiliate may have to the
use of the Trademarks by the other Party and its Affiliates with respect to the
Products in the Territory as contemplated by this Agreement.
IX. CONFIDENTIALITY
9.1 CONFIDENTIALITY OBLIGATIONS. Any Confidential Information of a
Party disclosed to the other Party shall, during the term of this Agreement and
for the period ending [*] be held in confidence by the receiving Party, used
only for the purposes contemplated herein and disclosed to its directors,
officers, employees and agents on a need-to-know basis only. A receiving Party
may also disclose the disclosing Party's Confidential Information to directors,
officers and employees of its Affiliates and agents, on a need-to-know basis,
provided such directors, officers, employees or consultants, as the case may be,
are bound by secrecy obligations with respect to such disclosures substantially
equivalent to those contained in this Agreement. The foregoing confidentiality
obligations shall not apply to Confidential Information which the receiving
Party can reasonably document:
(a) was already known by the receiving Party or is subsequently
obtained by the receiving Party without confidentiality obligation to the
disclosing Party or any Third Party,
(b) is independently developed by the receiving Party without
the aid, application or use of disclosures of Confidential Information of the
disclosing Party, or
(c) is or becomes public knowledge through no fault of the
receiving Party.
If a receiving Party is required by law or rules or
regulations of any governmental agency or authority or any stock exchange to
disclose Confidential
[*] Confidential information has been omitted and filed separately with the
Commission.
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Information of the disclosing Party, the receiving Party shall, prior to making
any such disclosure, give the disclosing Party sufficient advance written notice
to permit the disclosing Party to seek a protective order or other similar order
with respect to such information and thereafter shall disclose only the minimum
information which, in the opinion or its counsel, is required to be disclosed in
order to comply with such law, rule or regulation, whether or not a protective
order or other similar order is obtained, and to the extent possible only under
conditions of confidentiality. [*]
9.2 PRESS RELEASES.
a) Either Party shall be permitted to the extent in the opinion
of its counsel it is required by law or rules or policies of any governmental
agency or authority or any stock exchange, to issue a press release describing
the arrangements set forth in this Agreement. The Party issuing a press release
shall provide an advance copy of such press release to the other Party
twenty-four (24) hours in advance of its issuance.
b) Except for any press release issued subject to Section
9.2(a) above, NVX shall provide Xxxxxx with a copy of any press release
describing the arrangements set forth in this Agreement at least twenty-four
(24) hours prior to its issuance for comment and approval by Xxxxxx. If Xxxxxx
fails to comment within the twenty-four (24) hour period, then the press release
shall be deemed approved.
c) Except for any press release issued subject to Section
9.2(a) above, Xxxxxx shall provide NVX with a courtesy copy of any press release
describing the arrangements set forth in this Agreement at least twenty-four
(24) hours prior to its issuance.
[*] Confidential information has been omitted and filed separately with the
Commission.
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9.3 USE AFTER TERMINATION. Neither Party shall use any Confidential
Information of the other Party after the termination or expiration of this
Agreement with respect to any or all Products for so long as such Confidential
Information must be maintained confidential pursuant to Section 9.1.
9.4 RETURN OF CONFIDENTIAL INFORMATION. Upon expiration or termination
of this Agreement, at the request of the disclosing Party, the receiving Party
shall promptly deliver to the disclosing Party or its nominee all Confidential
Information furnished by the disclosing Party to the receiving Party pursuant to
this Agreement and relating to the Products and all copies thereof in its or its
Affiliates' possession, except for one copy that shall be retained in its
corporate legal department so that continuing obligations may be determined, and
the receiving Party shall not thereafter make any use thereof as long as
disclosure of same would have been prohibited under Article IX hereof.
X. TERM AND TERMINATION
10.1 TERM. Unless sooner terminated as provided for herein, this
Agreement shall remain in full force and effect for a period commencing on the
Effective Date and expiring on the last-to-expire Valid Claim of the Patents;
provided, however, that each Party's rights and obligations, except as such
rights and obligations shall expressly survive expiration or termination as set
forth herein, with respect to each Product shall expire on the last-to-expire
Valid Claim of the Patents covering such Product, its manufacture use or sale.
10.2 XXXXXX TERMINATION RIGHT. [*]
10.3 CHANGE OF CONTROL OF XXXXXX OR ITS XXXX PRODUCTS DIVISION. [*]
10.4 ACQUISITION OF NVX.
[*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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[*]
10.5 BREACH.
a) Subject to Section 10.11 and in addition to other
termination rights set forth in this Agreement, NVX shall have the right to
terminate this Agreement in the event Xxxxxx fails to meet diligence standards
for a Product as set forth in Section 2.3, upon giving [*] prior
written notice to Xxxxxx, provided that such failure is not cured within the
[*] notice period.
b) Subject to Sections 10.8 and 10.11(a), either Party shall
have the right to terminate this Agreement upon [*] prior written
notice if the
[*] Confidential information has been omitted and filed separately with the
Commission.
-31-
other party commits a material breach of this Agreement and does not cure such
default within the [*] period. Termination shall be effective upon
expiration of the [*] notice period if the default is not cured.
c) As long as NVX is using reasonable commercial efforts to
supply products to Xxxxxx in accordance with its orders, NVX shall not be a
material breach of this Agreement and NVX shall not be in default of this
Agreement solely because NVX fails to supply Xxxxxx'x Requirements of Products
pursuant to Section 4.1 or if NVX discontinues supply of Product(s) to Xxxxxx
pursuant to Section 11.4(d).
d) [*]
10.6 NO RELEASE. Termination of this Agreement shall not operate to
release any party from any obligation or liability incurred under the terms of
this Agreement prior to or upon termination hereof.
10.7 BANKRUPTCY. If a Party is adjudged bankrupt, files or has filed
against it any petition under any bankruptcy, insolvency or similar law, which
petition is not dismissed within sixty (60) days, has a receiver appointed for
its business or property, or makes a general assignment for the benefit of its
creditors. This Agreement may be terminated upon written notice at the option of
the other Party. Such termination shall be made effective the date notice of
termination is given.
10.8 FAILURE TO MAKE PAYMENTS.
a) Subject to Section 10.11(a), NVX shall also have the right
to terminate this Agreement if Xxxxxx fails to make (i) any payment pursuant to
Sections 3.5, 5.10 and 5.11 at the times provided therefor or (ii) any payment
pursuant to Sections 5.1(a), 5.1(c) and 5.1(d), Section 5.2, Section 5.3 and
Section 5.6 at the times provided therefor (and after completion of the final
audit pursuant to Section 5.9(a)) and continues in default for [*] after
receiving written notice from NVX that such payment had not been made within the
time provided therefor. Termination shall be immediately effective [*]
b) Subject to Section 10.11(a), NVX shall have the right to
terminate this Agreement if Xxxxxx is in default of any of its financial
obligations under this Agreement [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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[*]
10.9 OBLIGATIONS AFTER TERMINATION.
a) Upon termination of this Agreement by NVX pursuant to [*]
NVX shall have the right to repurchase Xxxxxx'x inventory of Product at a price
to be agreed by the Parties, [*] If the Parties are unable to reach agreement
[*] to continue selling Product in order to dispose of Xxxxxx'x inventory of
Products. During such period, Xxxxxx shall sell the Products consistent with its
past practices. Xxxxxx shall not take any action or fail to take any action that
would materially, detrimentally affect continued marketing, sale or distribution
of the Products by NVX or on NVX's behalf by Third Parties; [*] After the
expiration of such period, Xxxxxx shall not sell any of Xxxxxx'x remaining
inventory of Product. After the expiration of such period, NVX shall have the
right, but not the obligation, to repurchase all or part of such inventory from
Xxxxxx. [*]
b) The provisions of Sections 10.9(b)(i), 10.9(b)(ii) and
10.9(b)(iii) shall apply in the event of termination of this Agreement by NVX
pursuant to [*]
(i) Xxxxxx shall promptly deliver to NVX or its nominee all
Confidential Information furnished by NVX to Xxxxxx pursuant to this Agreement
and relating to the Products and all copies thereof in its or its Affiliates'
possession, except
[*] Confidential information has been omitted and filed separately with the
Commission.
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for one copy that shall be retained in its corporate legal department so that
continuing obligations may be determined, and Xxxxxx shall not thereafter make
any use thereof as long as disclosure of same would have been prohibited under
Article IX hereof.
(ii) Xxxxxx shall thereafter have no further rights to market,
distribute or sell the Products, except as may be expressly provided in this
Section 10.9.
(iii) To the extent that NVX has failed to fill a firm purchase
order of Xxxxxx for which delivery was due prior to termination and Xxxxxx has a
customer order that arose prior to termination to provide Product to a Third
Party that Xxxxxx is not able to supply from its inventory, then NVX shall
supply the amount of Product to Xxxxxx to meet its customer order.
c) [*]
10.10 CONDUCT OF BUSINESS IN ANTICIPATION OF TERMINATION. After
receiving notice of termination of this Agreement by NVX and until such time as
termination is effective, Xxxxxx shall continue to conduct its business with
respect to the Products in compliance with all the terms and conditions of this
Agreement.
10.11 ALTERNATIVE DISPUTE RESOLUTION.
a) The Parties recognize that a bona fide dispute as to certain
matters may arise from time to time during the term of this Agreement which
relates to either Party's rights and/or obligations. Accordingly, the Parties
agree that, prior to sending written notice of termination as provided under
Sections 10.5 or 10.8(b), a Party first will send written notice of the dispute
to the other Party for attempted resolution by good faith negotiations between
the Presidents of NVX and Xxxxxx'x Xxxx Products Division within [*] after such
notice is received. Any negotiations regarding a dispute shall be treated as
settlement negotiations for the purposes of the Federal Rules of Evidence and
any similar state rules of evidence. Such negotiations shall not be admissible
in any subsequent proceeding, whether alternative dispute resolution or
litigation. If the matter has not been resolved within [*] of the notice of the
dispute, or if the Parties fail to meet within such [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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[*] except as provided in Section 10.11(b) below, the Party providing
notice shall be free to send notice of termination as provided in Sections 10.5
and 10.8(b).
b) Any dispute regarding NVX's right to terminate this
Agreement pursuant to Section 10.5 or any dispute arising under Section 10.8(b),
after Xxxxxx has timely paid [*] of the amount claimed as owing under Section
10.8(b), if not resolved in accordance with Section 10.11(a), shall be resolved
in accordance with the following alternative dispute resolution ("ADR")
procedure:
Any negotiations regarding a dispute shall be treated as settlement
negotiations for purposes of the Federal Rules of Evidence and any similar state
rules of evidence. Such negotiations shall not be admissible in any ADR hearing.
The Federal Rules of Civil Procedure and the Federal Rules of Evidence
shall apply. Each Party shall have the right to take as much discovery,
including, without limitation, depositions, interrogatories, requests for
admissions or production of documents, as relevant discovery statutes and rules
permit and the neutral, as described below, shall be empowered to enforce the
discovery rights to the fullest extent possible, including the imposition of
sanctions. The Parties shall have the right to be represented by counsel in the
ADR proceeding.
1. To begin an ADR proceeding, the Party commencing the proceeding
shall provide written notice to the other Party of the issues to be resolved by
ADR.
2. [*] following receipt of the original ADR notice, the Parties shall
select a mutually acceptable neutral to preside in the resolution of any
disputes in this ADR proceeding. The neutral shall be an individual who shall
preside over and resolve any disputes between the Parties. The neutral selected
shall be a former judge of a state or federal court and shall not be an
employee, director or shareholder of either Party or its respective Affiliates,
and shall not otherwise be in a position which, as a judge, would have
disqualifed the neutral under the provisions of 28 U.S.C. ss. 455. If the
Parties are unable to agree on a mutually acceptable neutral within such period,
the neutral shall be selected by the Center of Public Resources, New York, New
York, consistent with the foregoing sentence.
3. [*] the neutral shall hold a hearing to resolve each of the issues
identified by the Parties. The ADR proceeding shall take place in Washington,
D.C. Each Party agrees to produce its and its Affiliate's, officers, employees
and/or agents to give depositions, and to appear at the hearing and give
testimony. The hearing shall be conducted in accordance with the Federal Rules
of Civil Procedure and the Federal Rules of Evidence.
4. [*] each Party shall submit the following to the other Party and the
neutral:
[*] Confidential information has been omitted and filed separately with the
Commission.
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(a) [*]
(b) [*]
(c) [*]
(d) [*]
5. The hearing shall be governed by the following rules:
(a) [*]
(b) [*]
(c) [*]
6. [*] each Party may submit to the other Party and the neutral a
post-hearing brief in support of its proposed rulings and remedies, provided
that such brief shall not contain or discuss any new evidence [*] This page
limitation shall apply regardless of the number of issues raised in the ADR
proceeding.
7. The neutral shall rule on each disputed issue [*] Such ruling shall
adopt in its entirety the proposed ruling and remedy of one of the Parties on
each disputed issue. The neutral shall not issue any written opinion or
otherwise explain the basis of the ruling.
[*] Confidential information has been omitted and filed separately with the
Commission.
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8. The neutral shall be paid a reasonable fee plus expenses. Each Party
shall be responsible for its own costs and expenses in such ADR procedure and
the cost of the neutral and any common administrative expenses shall be shared
equally.
9. The rulings of the neutral, including sanction awards, shall be
binding, non-reviewable, and non-appealable, and may be entered as a final
judgment in any court having jurisdiction.
10. Except as provided in paragraph 9 or as required by law, the
existence of the dispute, any settlement negotiations, the ADR hearing, any
submissions (including exhibits, testimony, proposed rulings, and briefs), and
the rulings shall be deemed Confidential Information. The neutral shall have the
authority to impose sanctions for unauthorized disclosure of Confidential
Information.
11. For the purposes of this Section 10.11(b), the Parties acknowledge
their diversity and agree to accept the jurisdiction of the Federal District
Court in the States of Maryland and Illinois for the purposes of enforcing
awards entered pursuant to this Section 10.11(b).
12. If Xxxxxx sues NVX relating to any matter for which NVX has a claim
for which it would have been or is obligated to utilize ADR pursuant to this
Section 10.8(b) to resolve, then NVX shall have the option to (i) counterclaim
in the action filed by Xxxxxx, and Xxxxxx shall not assert any objection to the
counterclaim on the basis that NVX's claim is or would have been the subject of
this Section 10.8(b), or (ii) to file its claim in ADR pursuant to the
provisions hereof. If such NVX claim is pending in an ADR at the time Xxxxxx
files its action, then at NVX's option, the ADR shall be suspended in order to
enable NVX's claim to be asserted in the action filed by Xxxxxx, or the pending
ADR shall be continued. NVX's joinder of its claim in any action filed by
Xxxxxx, unless such claim is heard and adjudicated, shall not constitute a
waiver of NVX's right to reinstate the ADR or initiate an ADR with respect to
such claim.
XI. PATENT MATTERS
11.1 NOTICE OF INFRINGEMENT. Each Party shall act in good faith to
inform the other Party of any infringement of which it becomes aware by any
Third Party of any of the Patents relating to the Products.
11.2 ENFORCEMENT AND DEFENSE OF PATENTS BY NVX.
a) NVX may, but shall not be required to, take legal action to
enforce the Patents against infringement by Third Parties and defend the Patents
against challenges by Third Parties. If NVX brings an action against a Third
Party, Xxxxxx shall be permitted to participate in such action, and Xxxxxx shall
share the expenses thereof upon mutually agreed terms. [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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[*]
b) Xxxxxx shall notify NVX immediately of sales of a
Competitive Vaccine by a Third Party in the Private Pediatric Market in the
Territory which Xxxxxx believes infringes any of the Patents. [*]
c) If it is agreed or otherwise determined that a Third Party is infringing
any of the Patents, and such infringement is having or is likely to have a
material adverse effect on the sales by Xxxxxx of Product(s) in the Private
Pediatric Market in the Territory, and NVX does not enforce the Patent(s) in
question [*]
11.3 CONTINUING PAYMENT OBLIGATIONS. Xxxxxx'x obligation to make any
payments required under this Agreement shall remain in effect notwithstanding
any alleged infringement of any of the Patents.
11.4 INFRINGEMENT BY PRODUCTS.
[*] Confidential information has been omitted and filed separately with the
Commission.
-38-
a) If any Third Party takes or threatens to take any legal
action to enforce any of its patent or other proprietary rights against alleged
infringement by a Party as a result of the manufacture, use, importation, offer
for sale or sale of a Product, then such Party shall notify the other Party
promptly in writing of such legal action. The Parties shall cooperate in the
defense of any such legal action.
b) [*]
c) [*]
d) [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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e) [*]
11.5 OTHER INTELLECTUAL PROPERTY MATTERS.
a) [*]
b) [*]
(i) [*]
(ii) [*]
(iii) [*]
(iv) [*]
[*] Confidential information has been omitted and filed separately with the
Commission.
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(v) [*]
(vi) [*]
(c) [*]
(d) [*]
XII. MISCELLANEOUS
12.1 RELATIONSHIP OF THE PARTIES. Nothing in this Agreement is intended
or shall be deemed to constitute a partnership, agency or joint venture
relationship between the Parties hereto.
12.2 APPLICABLE LAW. This Agreement shall be governed by the laws of
the State of New York (regardless of the laws that might be applicable under
principles of conflicts of law) as to all matters, including but not limited to
matters of validity, arbitrability, construction, effect and performance.
12.3 JURISDICTION. Each Party hereby submits to venue in and to the
non-exclusive personal jurisdiction of any federal or state court of competent
subject matter jurisdiction located within the State of New York in respect of
the interpretation and enforcement of the provisions of this Agreement. Each
Party waives and agrees not to assert, as a defense in any action, suit or
proceeding for the interpretation or enforcement of this Agreement, that it is
not subject to such jurisdiction; that such action, suit or proceeding may not
be brought or is not maintainable in said court; that this Agreement may not be
enforced in or by said court; that its property is exempt or immune from
execution; that such suit, action or proceeding is brought in an inconvenient
forum; or that the venue of such suit, action or proceeding is improper.
12.4 COUNTERPARTS. This Agreement may be executed simultaneously in any
number of counterparts and may be executed by facsimile. All counterparts shall
collectively constitute one and the same Agreement.
12.5 NOTICES. In any case where any notice or other communication is
required or permitted to be given hereunder, such notice or communication shall
be in writing and deemed to have been duly given and delivered, (a) if delivered
in person, on the date of such delivery, (b) if sent by confirmed facsimile
transmission (with answer back received), on the date of such facsimile
transmission, or (c) if sent by overnight express
[*] Confidential information has been omitted and filed separately with the
Commission.
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or registered or certified mail (with return receipt requested), on the date of
receipt of such mail, and shall be sent to the following address (or such other
address as a Party may designate from time to time in writing):
If to NVX:
North American Vaccine, Inc.
00000 Xxxxxx Xxxxx Xxxxx
Xxxxxxxxxx, Xxxxxxxx 00000
Telephone: (000) 000-0000
Telefax: (000) 000-0000
Attention: Senior Vice President - Legal Affairs and
General Counsel
If to Xxxxxx:
Xxxxxx Laboratories
Xxxx Products Division
000 Xxxxxxxxx Xxxxxx
Xxxxxxxx, Xxxx 00000-0000
Telephone: (000) 000-0000
Telefax: (000) 000-0000
Attention: Director, Licensing
with a copy to:
Xxxxxx Laboratories
Xxxx Products Division
000 Xxxxxxxxx Xxxxxx
Xxxxxxxx, Xxxx 00000-0000
Telephone: (000) 000-0000
Telefax: (000) 000-0000
Attention: Senior Counsel
12.6 FORCE MAJEURE. Except with respect to Xxxxxx'x obligation to make
payments to NVX on a timely basis, if any circumstance beyond the reasonable
control of either Party occurs which delays or renders impossible the
performance of that Party's obligations under this Agreement on the dates herein
provided, such obligation shall be postponed for such time as such performance
necessarily has had to be suspended or delayed on account thereof, provided such
Party shall notify the other Party in writing as
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soon as practicable, but in no event more than thirty (30) days after the
occurrence of such force majeure. In either such event, the Parties shall meet
promptly to determine an equitable solution to the effects of any such event,
provided that either Party who fails because of force majeure to perform its
obligations hereunder will upon the cessation of the force majeure take all
reasonable steps within its power to resume with the least possible delay
compliance with its obligations. Events of force majeure shall include, without
limitation, war, revolution, invasion, insurrection, riots, mob violence,
sabotage or other civil disorders, acts of God, and newly enacted, modified,
promulgated or issued acts, laws, regulations or rules of any government or
governmental agency. It shall be considered an event of force majeure hereunder
that NVX is unable to supply Products to Xxxxxx if NVX's suppliers fail to
provide timely or adequate supplies to NVX.
12.7 BINDING EFFECT: ASSIGNMENT.
(a) This Agreement shall be binding upon and inure to the
benefit of each of the Parties hereto and its successors, subject to Section
10.3, and permitted assigns.
(b) NVX shall have the right to assign to any Third Party NVX's
rights to receive payment under this Agreement.
(c) Either Party shall have the right to assign this Agreement,
in whole or in part, without the prior written consent of the other Party, to an
Affiliate, provided that the assigning Party guarantees the performance of such
Affiliate. Otherwise, neither Party shall have the right to assign this
Agreement, in whole or in part, without the prior written consent of the other
Party.
12.8 ENTIRE AGREEMENT. The terms and conditions herein contained,
together with the terms and conditions of the other documents attached as
Schedules hereto, constitute the entire agreement between the Parties relating
to the subject matter of this Agreement and shall supersede all previous
communications between the Parties with respect to the subject matter of this
Agreement, [*] Neither Party has entered into this Agreement in
reliance upon any representation, warranty, covenant or undertaking of the other
Party that is not set out or referred to in this Agreement.
12.9 RECITALS AND SCHEDULES. The Recitals set forth at the start of
this Agreement along with the Schedules attached to this Agreement shall be
deemed integral parts of this Agreement and all references in this Agreement to
this Agreement shall encompass such Recitals and Schedules.
12.10 AMENDMENT. This Agreement may be varied, amended or extended only
by the written agreement of the Parties through their duly authorized officers
or representatives, specifically referring to this Agreement.
[*] Confidential information has been omitted and filed separately with the
Commission.
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12.11 SEVERABILITY. If any provision of this Agreement is held to be
illegal, invalid or unenforceable in a final, unappealable order or judgment of
a court of competent jurisdiction, then such provision shall be severed from
this Agreement and shall be rendered inoperative and replaced with a provision
which accomplishes, to the extent possible, the original business purpose of
such provision in a valid and enforceable manner; and the remaining provisions
of this Agreement shall remain binding on the Parties hereto.
12.12 HEADINGS. The descriptive headings of the several articles and
sections of this Agreement are inserted for convenience only and do not
constitute a part of this Agreement.
12.13 NO WAIVER OF RIGHTS. No failure or delay on the part of either
Party in the exercise of any power or right hereunder shall operate as a waiver
thereof. No single or partial exercise of any right or power hereunder shall
operate as a waiver of such right or of any other right or power. The waiver by
either Party of a breach of any provision of this Agreement shall not operate or
be construed as a waiver of any other or subsequent breach hereunder.
12.14 USAGE. Wherever any provision of this Agreement uses the term
"including" (or "includes"), such term shall be deemed to mean "including
without limitation" and "including but not limited to" (or "includes without
limitation" and "includes but is not limited to") regardless of whether the
words "without limitation" or "but not limited to" actually follow the term
including" (or "includes").
12.15 NO THIRD PARTY RIGHTS. This Agreement shall not be deemed or
construed in any way to result in the creation of any rights or obligations in
any Third Party.
12.16 NO LICENSES. No rights or licenses with respect to any of NVX's
patents, trademarks, know-how, technical information, or other proprietary
rights are granted or deemed granted to Xxxxxx hereunder or in connection
herewith.
12.17 INTERPRETATION. This Agreement shall be interpreted and construed
as a binding agreement separate of and independent from any other agreement
between the Parties.
XIII. ADVERSE EVENT REPORTING/CUSTOMER AND TECHNICAL
SUPPORT
(a) The Parties shall establish procedures for handling
complaints and adverse event reporting to ensure compliance in all respects with
applicable statutes and regulations, including but not limited to, applicable
FDA regulations contained in 21 C.F.R. Chapter 1, Subchapter F, Subpart D (21
C.F.R. ss. 600.80(a) - 600.90) and any successor thereto. Such procedures shall
be modified as appropriate to ensure compliance with any changes or
modifications in applicable statutes or regulations. For the purposes of this
Article XIII, the terms "Adverse Experience" and "Serious" shall
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have the meanings ascribed to them in 21 C.F.R. ss. 600.80(a) and any successor
thereto. A "Non-Serious Adverse Experience" shall mean any Adverse Experience
that does not meet the criteria for a Serious Adverse Experience. Abbott shall
notify NVX promptly in writing of any Serious Adverse Experiences concerning the
Products or any Non- Serious Adverse Experiences or complaints concerning the
Products which come to its attention which may suggest significant hazards,
contraindications, side effects or precautions pertinent to the safety of the
Products or any therapeutic failure of a Product. Any Serious Adverse Experience
and all information relating thereto concerning a Product shall be immediately
notified to NVX by Abbott as soon as possible, but not later than twenty-four
(24) hours after an Xxxxxx safety officer has become aware of such event, by
facsimile and by confirmatory telephone communication to the responsible safety
officer or a designated alternate, if such safety officer is unavailable, of
NVX. Upon signing of this Agreement, each Party shall immediately notify the
other Party in writing of its respective safety officer and alternates to whom
communications regarding adverse event reporting shall be sent.
(b) With respect to any Non-Serious Adverse Experience, customer
complaint or therapeutic failure concerning a Product, Abbott shall as soon as
reasonably practicable and in any event within ten (10) calendar days of
becoming aware notify NVX of the occurrence and substance thereof.
(c) NVX shall be responsible for submitting required reports to
the FDA in accordance with all applicable regulations and Abbott shall cooperate
in all respects with NVX, including but not limited to providing to NVX on a
timely basis all relevant information in Xxxxxx'x possession or control, to
permit NVX to meet such requirements.
(d) Abbott shall provide NVX any and all information in Xxxxxx'x
possession or control that may be required by the FDA under 21 C.F.R. ss. 600.81
to allow NVX to prepare and timely file distribution reports, as such term is
defined therein, complying in all aspects with such subsection.
(e) [*]
(f) Abbott, at its own expense, shall be responsible for
establishing a program to provide for and coordinate customer support for each
of the Products in the Private Pediatric Market at a level reasonably calculated
to assure customer satisfaction, including establishing and implementing a
"customer-by-product" and "product-by-customer" tracking system.
[*] Confidential information has been omitted and filed separately with the
Commission.
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XIV. REPRESENTATIONS AND WARRANTIES
14.1 Each party represents and warrants to the other that:
a) It is a corporation duly organized and validly existing under
the laws of the state or other jurisdiction of incorporation or formation;
b) The execution, delivery and performance of this Agreement by it
has been duly authorized by all requisite corporate action;
c) It has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder;
d) This Agreement has been duly authorized, executed and delivered
and constitutes such party's legal, valid and binding obligation enforceable
against it in accordance with its terms subject, as to enforcement, to
bankruptcy, insolvency, reorganization and other laws of general applicability
relating to or affecting creditors' rights and to the availability of particular
remedies under general equity principles;
e) It shall comply with all applicable laws and regulations
relating to its activities under this Agreement.
XV. SURVIVAL
15.1 The provisions of Sections 5.4, 5.6, 5.9, 8.3, 8.4, 12.2, 12.3,
and 12.5 and Articles VI, IX, X, XIV, XV and XVI shall survive the termination
or expiration of this Agreement (as the case may be) and shall remain in full
force and effect.
15.2 The provisions of this Agreement which do not survive termination
or expiration hereof (as the case may be) shall, nonetheless, be used in
construing and interpreting the rights and obligations of the parties hereto
with regard to any dispute, controversy or claim which may arise under this
Agreement.
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IN WITNESS WHEREOF, this Agreement has been executed by the authorized
representatives of the parties.
XXXXXX LABORATORIES NORTH AMERICAN VACCINE, INC.
By: /s/ Xxxxxx X. XxXxxxx By: /s/ Xxxxxx Mates
------------------------------- ---------------------------
Title: Xxxxxx X. XxXxxxx Title: Xxxxxx Mates, Ph.D.
Senior Vice President President
Xxxxxx Laboratories
Date: October 11, 1996 Date: October 11, 1996
