EXHIBIT 10.31
Portions of this agreement
have been omitted and separately filed with the SEC with a request
for confidential treatment. The location of those omissions have
been noted by [**].
DISTRIBUTION AGREEMENT
FOR FLUVIRAL™ (INFLUENZA VACCINE)
between
ID BIOMEDICAL CORPORATION
and
HENRY SCHEIN, INC.
TABLE OF CONTENTS
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Page
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DEFINITIONS
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1
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APPOINTMENT AND
AUTHORITY OF DISTRIBUTOR
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3
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SUPPLY AND
PURCHASE OF PRODUCT
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4
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PURCHASE PRICE
AND PAYMENT
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7
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DELIVERY OF
PRODUCT
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7
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MARKETING OF
PRODUCT
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9
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REGULATORY
COMPLIANCE
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10
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TRADEMARKS AND
OTHER INTELLECTUAL PROPERTY
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12
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CONFIDENTIAL
INFORMATION; PUBLICITY
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13
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FORCE
MAJEURE
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14
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WARRANTIES OF
IDB AND HSI
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15
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INDEMNIFICATION
OBLIGATIONS OF IDB AND HSI
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17
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INSURANCE
OBLIGATIONS OF IDB AND HSI
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18
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LIMITATION OF
LIABILITY
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18
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TERM AND
TERMINATION
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19
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NOTICES
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21
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ASSIGNMENT
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21
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GOVERNING LAW,
JURISDICTION AND VENUE
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21
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MISCELLANEOUS
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22
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MINIMUM
QUANTITY; PURCHASE PRICE AND ADJUSTMENT; RESALE TO OTHER
DISTRIBUTORS; AND PAYMENT TERMS
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TRADEMARK(S)
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COMMITMENTS TO
GOVERNMENT OF CANADA
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ADVERSE
REACTION REPORTING
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PRODUCT RECALL
PROCEDURE
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i
Portions of this agreement
have been omitted and separately filed with the SEC with a request
for confidential treatment. The location of those omissions have
been noted by [**].
DISTRIBUTION AGREEMENT
This
DISTRIBUTION AGREEMENT (together with the attachments and exhibits
hereto, the “Agreement”) is entered into as of
December 2, 2004 (the “Effective Date”) by and
between ID BIOMEDICAL CORPORATION , a corporation organized
and existing under the laws of the Company Act of British Columbia
and having its principal office at 1630 Waterfront Centre, 200
Burrard Street, Vancouver, BC V6C 3L6 Canada (“IDB”),
and HENRY SCHEIN, INC. , a corporation organized and
existing under the laws of the State of Delaware, USA and having
its principal office at 135 Duryea Road, Melville, NY 11747 USA
(“HSI”).
WHEREAS:
A. IDB
develops and manufactures proprietary vaccines, including an
injectable vaccine for the prevention of influenza virus infection
in humans that is approved in Canada and under development for the
U.S. market, and has all right, title and interest in the Product
(as defined below); and
B. HSI
is a leading distributor of vaccines in the Territory (as defined
below), with expertise in sales, marketing and cold chain
logistics, and desires to and has agreed to act as non-exclusive
distributor of IDB for sales of Product in the Territory;
and
C. IDB
is willing to supply HSI with Product for resale in the Territory,
and HSI is willing to purchase Product for resale in the Territory,
on the terms and conditions of this Agreement.
Now,
therefore, in consideration of the foregoing premises and the
mutual covenants and undertakings set forth below, the Parties
hereby agree as follows:
1. DEFINITIONS
1.1 “
Affiliate ” means, with respect to a Party, any
corporation or other business entity that, directly or indirectly,
is Controlled by, Controls or is under common Control with such
Party, but only for so long as such relationship exists.
“Control,” as used in this Section 1.1, means
having the power to direct, or cause the direction of, the
management and policies of any entity, whether through ownership of
voting securities, by contract, or otherwise.
1.2 “
Average Sell Price ” shall mean [**]
1.3 “
Commencement Date ” shall mean the date that IDB
receives the initial Marketing Authorization from the Regulatory
Authority required to market Product in the Territory in the first
Flu Season, which shall in no event be later than April 1,
2008 or, if such initial Marketing Authorization is received prior
to such date, then the Commencement Date shall be as provided in
Section 7.2 below.
[**] -
Confidential or proprietary information redacted.
1.4 “
Confidential Information ” shall mean any confidential
or proprietary information (including, without limitation,
know-how, trade secrets, and other confidential or proprietary
information relating to Product research, development,
manufacturing, marketing, sales and financial information related
thereto), whether oral, visual or written, that is disclosed by one
Party hereto (the “ Disclosing Party ”) to the
other (the “ Receiving Party ”) in connection
with this Agreement, including, without limitation, reports
provided by HSI to IDB pursuant to Section 2.3
below.
1.5 “
Flu Season ” shall mean the period from approximately
October 1 through March 31.
1.6 “
Intellectual Property ” shall mean any patent,
copyright, trade secret, know-how, trademark, tradename, design
right, moral rights or other intellectual property right related to
the Product under the laws of any governmental authority, domestic
or foreign, including all applications and registrations related to
any of the foregoing.
1.7 “
Marketing Authorization ” shall mean the Biologics
License Application (BLA) approved by the Regulatory Authority
and required to distribute or to deliver for distribution Product
lawfully in the Territory, together with any renewals and
replacements thereof and amendments thereto.
1.8 “
Minimum Doses ” shall mean the number of doses of
Product set forth in clause (i) of Paragraph 1 of
Schedule 1 to this Agreement.
1.9 “
Minimum Percentage ” shall mean the percentage set
forth in clause (ii) of Paragraph 1 of Schedule 1 to
this Agreement.
1.10 “
Minimum Quantity ” shall mean the quantity of Product
that the Parties have agreed shall be the minimum quantity to be
purchased by HSI from IDB for each Flu Season, as specified in
Paragraph 1 of Schedule 1 to this Agreement, as such
Minimum Quantity may be modified from time to time in accordance
with the terms of this Agreement; such Minimum Quantity shall be
subject to IDB’s annual influenza vaccine commitments and
pandemic commitments to the Government of Canada during the Term
(as provided in Section 3.2).
1.11 “
Net Sales Revenue ” shall mean [**]
1.12 “
Other Distributors ” shall mean sub-distributors,
wholesalers and other resellers to which HSI may sell Product in
accordance with Paragraph 3 of Schedule 1 to this
Agreement.
1.13 “
Parties ” shall mean IDB and HSI, and
“Party” shall mean either of them as the context
indicates.
1.14 “
Product ” shall mean IDB’s injectable influenza
virus vaccine product [**]
1.15 “
Purchase Price ” shall mean the price to be paid by
HSI to IDB for all doses of Product supplied to HSI under this
Agreement, as set forth in Paragraph 2 of Schedule 1 to
this Agreement.
[**] -
Confidential or proprietary information redacted.
2
1.16 “
Regulatory Authority ” shall mean the United States
Food and Drug Administration, an agency of the U.S. Department for
Health and Human Services, and any successor agency
thereto.
1.17 “
Shipping Point ” shall mean a single distribution
center located in the continental United States to which Product
shall be shipped under this Agreement, which single distribution
center shall be nominated by HSI in its discretion from time to
time, but not more than once for any given Flu Season.
1.18 “
Specifications ” shall mean the specifications
provided in the Marketing Authorization, including, but not limited
to, those specifications to ensure that the Product is and will
continue to be safe, pure and potent, as such specifications may be
modified from time to time in accordance with the terms of this
Agreement or so as to comply with the requirements of the
Regulatory Authority.
1.19 “
Term ” shall mean the duration of this Agreement as
specified in Section 15.1.
1.20 “
Territory ” shall mean the United States of America,
including all fifty (50) states and the District of Columbia,
and all of its territories and possessions.
1.21 “
Third-Party Vaccine Products ” shall mean injectable
influenza virus vaccine products, manufactured by or on behalf of
any person or entity other than IDB or its Affiliates,
[**]
1.22 “
Trademark(s) ” shall mean the trademark(s), trade
names, service marks and logos identified in Schedule 2 to
this Agreement, and such other trademark(s), trade names, service
marks and logos as may be identified and indicated to HSI by IDB in
writing from time to time during the Term.
1.23 “
Transfer Price ” shall have the meaning given in
Paragraph 2(B) of Schedule 1 to this
Agreement.
2. APPOINTMENT AND AUTHORITY
OF DISTRIBUTOR
2.1 Subject
to the terms and conditions of this Agreement, IDB hereby appoints
HSI as its non-exclusive distributor for the resale of Product in
the Territory, and HSI hereby agrees to act in that capacity
beginning on the Commencement Date. HSI hereby agrees that
[**] . HSI shall have the non-exclusive, non-assignable
(except in accordance with Section 17 below), non-licensable
and non-sublicensable right, after the Commencement Date and
throughout the Term, to promote, sell, market and distribute
Product to customers (either directly or through Affiliates or
Other Distributors) in the Territory; provided, however, HSI shall
not resell to Other Distributors more than the allowable maximum
number of doses of Product specified in Paragraph 3 of
Schedule 1. HSI may, on and after the Commencement Date,
describe itself as a distributor of Product for IDB in the
Territory but it shall not hold itself out as IDB’s agent or
representative or as otherwise being authorized to bind IDB in any
way. IDB hereby grants to each of HSI’s Affiliates and Other
Distributors the rights granted to HSI in this Section 2.1
solely to the extent necessary to perform their obligations with
respect to the Product.
[**] -
Confidential or proprietary information redacted.
3
2.2 HSI
shall actively promote, distribute and sell Product only within the
Territory, and neither HSI nor its Affiliates or Other Distributors
shall promote or solicit orders for Product or donate, sell, offer
to sell or otherwise distribute Product outside the Territory, or
where they ought reasonably to be aware that the ultimate
destination for Product is outside the Territory. HSI and its
Affiliates and Other Distributors and their respective employees
and agents shall not promote Product for any indications not
approved for such Product by the Regulatory Authority. HSI shall
forward to IDB all inquiries relating to Product from customers or
potential customers outside the Territory.
2.3 As
Product distributor, HSI shall determine the prices and other terms
and conditions under which it offers Product for sale and sells
Product to customers within the Territory. On or prior to the
Commencement Date, HSI shall provide IDB with a resale certificate
in such form, and containing such information, as required by IDB.
On a monthly basis during the Term, beginning after the
Commencement Date, HSI shall provide a detailed written report to
IDB, in a mutually agreeable format, describing [**]. HSI
shall deliver such reports to IDB in connection with the monthly
meetings conducted pursuant to Section 6.3. Notwithstanding
the foregoing, HSI shall not be required to identify names or
addresses of customers of Product or Third-Party Vaccine Products
and shall not be required to provide information which HSI is
prohibited by contract or law from providing to third
parties.
2.4 HSI
shall not make any alterations or knowingly permit any alterations
to be made to Product without IDB’s express written consent,
which consent may be withheld in IDB’s sole
discretion.
2.5 The
Parties acknowledge and agree that IDB may sell Product to any
United States governmental agency or body at any time between the
Effective Date and the Commencement Date under a special
procurement process to address influenza vaccine shortages or other
immediate needs of the U.S. government, and such sales shall not be
subject to the terms of this Agreement; provided, however, that IDB
may indicate to the U.S. government a preference for distribution
of some quantity of Product under such circumstances by and through
HSI, although IDB shall not be deemed to be in breach of this
Agreement or to have any liability to HSI, and HSI shall have no
right to terminate this Agreement or exercise any other remedies
against IDB, if IDB does not indicate such preference to the U.S.
government or the U.S. government fails to distribute Product under
such circumstances by or through HSI.
3. SUPPLY AND PURCHASE OF
PRODUCT
3.1 Subject
to Section 3.2 and Paragraph 2(C) of Schedule 1 to
this Agreement, IDB agrees to use commercially reasonable efforts
to develop, manufacture, apply for Marketing Authorization of,
apply for the release of and deliver to HSI, on or before the
delivery dates specified in Schedule 1, the Minimum Quantity of
Product as a final, packaged product. HSI hereby commits to
purchase the Minimum Quantity of Product provided by IDB to HSI for
each Flu Season from and after the Commencement Date during the
Term, for the Purchase Price described in Schedule 1, provided
delivery and release of the Minimum Quantity occurs on or before
[**] of such Flu Season. IDB agrees to notify HSI promptly
of any delay in the manufacturing and shipping schedule, the cause
of such delay and the anticipated extent of such delay, or in the
event IDB is unable to manufacture (and the cause for such
inability to
[**] -
Confidential or proprietary information redacted.
4
manufacture) some or all of the
Minimum Quantity of Product for any given Flu Season. Recognizing
the difficulties involved in vaccine manufacturing, the Parties
acknowledge and agree that IDB shall not be deemed to be in breach
of this Agreement or to have any liability to HSI, and HSI shall
have no right to terminate this Agreement under this
Section 3.1 or exercise any other remedies against IDB, if IDB
fails to manufacture any or all of the Minimum Quantity of Product
for any given Flu Season provided that IDB has used commercially
reasonable efforts to develop, manufacture, apply for Marketing
Authorization of, apply for the release of and deliver to HSI, on
or before the delivery dates specified in Schedule 1, the
Minimum Quantity of Product as a final, packaged product.
[**]
3.2
Notwithstanding anything to the contrary in this Agreement, HSI
acknowledges and agrees that IDB’s obligation to supply the
Minimum Quantity of Product to HSI under this Agreement is subject
to, and the Minimum Quantity shall be reduced by, IDB’s
contractual annual commitments to provide Product to the Government
of Canada and additional contractual commitments to provide Product
to the Government of Canada in the event of influenza pandemics in
Canada, if any, which commitments shall have priority over
IDB’s commitments to HSI hereunder. Such commitments to the
Government of Canada are described further on Schedule 3. The
Parties agree that IDB shall not be deemed to be in breach of this
Agreement or to have any liability to HSI, and HSI shall have no
right to terminate this Agreement, in the event IDB is unable to
supply HSI with the Minimum Quantity of Product because of such
commitments to the Government of Canada. IDB shall keep HSI
informed, in the monthly meetings described in Section 6.3, of
the quantity (if any) of Product necessary to meet such commitments
to the Government of Canada for a given Flu Season and the impact
on the Minimum Quantity of Product available to HSI with respect to
such Flu Season.
3.3 Except
as otherwise specified in Section 3.4 below, IDB agrees that,
with respect to the timing of shipment of a given quantity of
Product into the Territory, IDB will allocate such quantity of
Product among HSI and IDB’s other distributors in the
Territory on a pro rata basis, based on HSI’s and each such
other distributor’s respective Minimum Percentage. Thus, IDB
will supply HSI with a percentage of each lot of Product that is
shipped into the Territory that is approximately equal to
HSI’s Minimum Percentage, subject to the overall Minimum
Quantity limitations set forth in this Agreement.
3.4 HSI
shall be granted a first right of refusal to acquire a percentage
of increased production of Product as provided in this
Section 3.4. [**]
3.5 All
Product shall be packaged and labeled for sale and delivered by IDB
to HSI in accordance with the regulations of the Regulatory
Authority, such packaging indicating that the Product is
manufactured by IDB and that the Trademarks are registered
trademarks of IDB. Subject to compliance with applicable
regulations of the Regulatory Authority, IDB may at any time
withdraw the Product from the market or alter the Specifications as
it deems necessary or appropriate and/or as may be required by the
Regulatory Authority, including without limitation changes in
design, production or packaging of Product.
3.6 IDB
shall be responsible for exporting Product from any location in
which IDB may manufacture or have manufactured Product and shall
obtain any necessary export licenses required for such export. IDB
shall be responsible for obtaining any necessary licenses
or
[**] -
Confidential or proprietary information redacted.
5
approvals of applicable
regulatory agencies in the Territory required for the importation
of Product into the Territory and for the payment of all duties,
fees and charges required for such importation; provided ,
that, HSI shall be the importer of record of Product into the
Territory and HSI shall cooperate with and assist IDB, upon
IDB’s written request and at IDB’s expense, in
obtaining approvals of regulatory agencies in the Territory
required for the importation of Product into the
Territory.
3.7 The
Regulatory Authority’s release of each lot of Product is
necessary before HSI is allowed to distribute Product. The Parties
recognize that the timing for obtaining Regulatory Authority
release is uncertain. However, IDB shall use its commercially
reasonable efforts to obtain the necessary Regulatory Authority
releases as soon as reasonably possible each Flu Season and, to the
extent reasonably possible, by [**] of each Flu Season after
the Commencement Date for [**] of the Minimum Quantity and
by [**] of each Flu Season after the Commencement Date for
[**] of the Minimum Quantity; provided , that, if and
to the extent that Product is not manufactured or available for
release, or that some or all Regulatory Authority releases are not
obtained, on or before either [**] in a given Flu Season
after the Commencement Date, irrespective of the reason therefor,
(i) IDB shall not be deemed to have breached any obligations
under this Agreement or to be liable to HSI hereunder provided that
IDB has used its commercially reasonable efforts to obtain the
necessary Regulatory Authority releases as soon as reasonably
possible each Flu Season, and (ii) notwithstanding the
provisions of Section 10 below, if [**] of the Minimum
Quantity of Product is not released by [**] in such Flu
Season, HSI shall not be obligated to purchase the amount of
Product that was not released by such date. Notwithstanding the
foregoing, HSI may elect to purchase Product released after
[**] (provided release is obtained by a date acceptable to
HSI), in which case it shall notify IDB in writing of HSI’s
decision to acquire Product released after [**] within five
(5) business days after [**] , which notice shall
include the quantity of Product HSI desires to purchase and the
acceptable post- [**] release date for such Product. If IDB
reasonably believes such release date is achievable, IDB shall use
its commercially reasonable efforts to obtain Product release by
such date (or by such other date as the Parties may mutually agree
in writing). HSI shall return to IDB (at IDB’s expense) any
Product not released by [**] that HSI decides not to
purchase. HSI shall pay IDB the Purchase Price for all Product
released by [**] , as well as all Product released after
[**] that HSI elects to purchase, in accordance with the
terms and conditions of this Agreement, with no right to return
such Product to IDB (except only as set forth in Sections 5.2
and 5.3) even if HSI is unable to sell such Product.
3.8 IDB will
provide HSI with a copy of IDB’s key clinical development
milestones for Product in the Territory (the
“Milestones”) promptly after execution of this
Agreement, which Milestones shall be subject to modification by IDB
from time to time. IDB will provide HSI with written reports
regarding progress made with respect to the Milestones (as
modified) as of June 30, 2005, December 31, 2005, and
quarterly thereafter through December 31, 2006. HSI agrees
that the Milestones and progress reports are being provided by IDB
for informational purposes only, and that IDB shall not be deemed
to be in breach of this Agreement or to have any liability to HSI,
and HSI shall have no right to terminate this Agreement under this
Section 3.8 or exercise any other remedies against IDB, in the
event the development of Product does not proceed in accordance
with the Milestones. HSI further agrees that the Milestones and all
progress reports shall be considered Confidential Information of
IDB under this Agreement.
[**] -
Confidential or proprietary information redacted.
6
3.9
[**]
4. PURCHASE PRICE AND
PAYMENT
4.1 HSI
shall pay IDB the Purchase Price for the Minimum Quantity of
Product, and all other Product supplied by IDB to HSI under this
Agreement, as the Purchase Price is described and calculated in
accordance with Paragraph 2 of Schedule 1.
4.2 IDB may
invoice HSI at any time after Product has been delivered to the
Shipping Point. Payment in full of the Transfer Price of all
Product in each shipment shall be due and paid by HSI to IDB within
thirty (30) days after the later of (i) the date of
delivery of such Product to the Shipping Point or (ii) the
date of release of such Product by the Regulatory Authority.
Reconciliation and payment or credit of the final Purchase Price
(the Transfer Price as adjusted in accordance with
Paragraph 2(B) of Schedule 1) shall be made as provided
in Paragraph 2(D) of Schedule 1. Should HSI fail to pay
IDB any amount due IDB on or before the due date for payment, HSI
shall pay IDB the full amount due plus interest on such unpaid
amount from its original due date until the date IDB receives full
payment, such interest to be at the rate specified in
Paragraph 5 of Schedule 1. For the avoidance of doubt, in
the event that Product is delivered to HSI and invoiced by IDB, but
subsequently is properly rejected by HSI in accordance with
Sections 5.2 and 5.3 of this Agreement, then HSI shall pay the full
Transfer Price, but IDB shall give appropriate credit to HSI unless
the rejected Product is replaced by IDB at IDB’s expense in
accordance with Section 5.3.
4.3 During
the term of this Agreement and for a period of three (3) years
thereafter, HSI and its Affiliates shall keep accurate books and
records with respect to the sale and distribution of Product in
accordance with U.S. generally accepted accounting principles
(“GAAP”) consistently applied and in sufficient detail
to enable IDB to determine the correctness of all payments made to
IDB hereunder. Upon written request by IDB, HSI shall permit an
independent certified public account or IDB in-house auditor or
accountant (“Accountant”) (to be determined and
selected by IDB and reasonably acceptable to HSI), to inspect
HSI’s books, records and facilities, and copy such books and
records, to the extent such Accountant reasonably deems necessary
or appropriate for the sole purposes of verifying the completeness
and accuracy of the reports delivered and payments made under this
Agreement and ascertaining HSI’s compliance with its
obligations under this Agreement. The Accountant’s report
based on such inspection shall be limited to a detailed report on
those subjects. [**] HSI will pay IDB the amount of any such
deficiency within thirty (30) days of the date of the invoice
therefor, and shall pay interest at the rate specified in
Paragraph 5 of Schedule 1 for any past due
amounts.
5. DELIVERY OF
PRODUCT
5.1 Subject
to HSI’s satisfaction of its importation obligations under
Section 3.6, IDB agrees to deliver all Product ordered by HSI
hereunder FOB Shipping Point.
5.2 All
Product is shipped on a non-returnable basis except only as set
forth in Sections 3.7 and 5.3 and except if there is a Product
recall. HSI shall pay IDB the Purchase Price for all Product
delivered to HSI and released by the Regulatory Authority even if
HSI is unable
[**] -
Confidential or proprietary information redacted.
7
to sell such Product, subject
only to HSI’s right to reject Product as provided below. Not
later than [**] days after its receipt of each shipment of
Product at the Shipping Point, and sooner if reasonably possible,
HSI shall notify IDB as provided in Section 5.3 of any basis
for rejecting any such Product (the only bases for rejection being
as specified in Section 5.3). If HSI fails to give such notice
to IDB within such period, then such Product shall be deemed to be
finally accepted by HSI. Notwithstanding the foregoing, if HSI
thereafter discovers a latent defect which could not readily be
identified upon a reasonable inspection of Product at the time of
delivery to the Shipping Point, and such latent defect constitutes
a Defective Product (as defined in Section 11.4 below), HSI
shall inform IDB of such Defective Product within five
(5) business days of such discovery, and the provisions of
Section 5.3 shall apply.
5.3 To
reject Product, HSI shall, within the rejection period specified in
Section 5.2, notify IDB of its rejection in writing,
describing in detail the basis for such rejection (which must be
either, and shall be limited to, (i) a Defective Product as
defined in Section 11.4 below, or (ii) physical damage to
Product in the course of shipment to HSI) and the amount of Product
affected, and request a return authorization (“RA”)
number. IDB shall provide the RA number to HSI within [**]
days after receipt of the request. Within [**] days after
HSI’s receipt of the RA number, HSI shall return to IDB the
rejected Product, freight prepaid, with the RA number displayed on
the outside of the carton. IDB reserves the right to refuse to
accept any rejected Product that does not bear an RA number on the
outside of the carton. As promptly as possible, and within
[**] days after receipt of properly rejected Product if
reasonably possible, IDB shall use commercially reasonable efforts
to replace the Product, at its expense, as provided in
Section 5.4. IDB shall pay the shipping charges back to HSI
for properly rejected Product; otherwise, HSI shall be responsible
for the shipping charges.
5.4 In the
event HSI rejects any shipment of Product in accordance with
Sections 5.2 and 5.3 or in the event of failure to obtain
Product releases from the Regulatory Authority by [**] of a
given Flu Season, then IDB shall use commercially reasonable
efforts to provide, but shall not guarantee to provide, replacement
Product, subject in all respects to IDB’s commitments to the
Government of Canada as provided in Section 3.2. In the event
IDB does not supply replacement Product to HSI within a reasonable
period (at least [**] days) and HSI notifies IDB in writing
that it elects not to wait beyond such period for replacement
Product, then IDB shall credit HSI for the amount, if any,
previously paid by HSI for such rejected or unreleased Product, but
IDB shall not be deemed to be in breach of this Agreement or to
have any liability to HSI because it failed to supply replacement
Product; provided, however, that if HSI has not yet paid for such
rejected or unreleased Product and IDB fails to supply replacement
Product, HSI shall have no obligation to pay for such rejected or
unreleased Product. If IDB will not be able to supply replacement
Product until after [**] of a given Flu Season, then HSI may
elect, at its option, to accept such replacement Product after such
date or to receive a credit for the amount, if any, previously paid
by HSI for the rejected or unreleased Product, provided that HSI
notifies IDB in writing of its election within five
(5) business days after [**] . If HSI wrongfully
rejects Product or wrongfully fails to take delivery of any
shipment of Product, then IDB shall be entitled to invoice HSI for
the Transfer Price and then the Purchase Price of such Product as
set forth in Schedule 1, together with the cost of disposing
of such Product, if applicable, and HSI shall pay such invoiced
amount within thirty (30) days of the invoice date.
[**] -
Confidential or proprietary information redacted.
8
5.5 Risk of
loss of or damage to Product supplied by IDB to HSI shall pass to
HSI at the time Product is delivered to the Shipping Point. If HSI
properly rejects Product in accordance with Sections 5.2 and
5.3, then risk of loss of or damage to Product will pass back to
IDB upon delivery by HSI to the first return carrier. Title to
Product shall pass to HSI at the time Product is delivered to the
Shipping Point. If any shipment of Product is delivered to the
Shipping Point before such Product is released by the Regulatory
Authority, HSI shall quarantine such Product, at its sole cost,
until such Product is released. HSI shall have title to, and shall
bear all responsibility and liability with respect to, all Product
after it is delivered to the Shipping Point, including all Product
in quarantine.
6. MARKETING OF
PRODUCT
6.1
Notwithstanding anything to the contrary in this Agreement, HSI
hereby agrees that [**] . Without limiting HSI’s
obligations under this Agreement, HSI may promote, sell and
distribute Third-Party Vaccine Products provided that such
promotion, sale and distribution are consistent with this
Section 6.1 and HSI’s other obligations under this
Agreement. [**]
6.2 Without
limiting its other obligations under this Agreement, HSI shall
exercise commercially reasonable efforts to actively promote the
use and sale of Product and the use of the Fluviral
™
brand name (or other Trademark as
may be indicated by IDB) throughout the Territory. In this context,
“commercially reasonable efforts” means at least the
quality and quantity of efforts that HSI does or would use to
promote the use and sale, and expand the sale, of any influenza
vaccine originated or sold by HSI that is distributed in
substantially the same quantities as the quantities of Product
contemplated in this Agreement (with at least the same level of
advertising, promotion and sales support). IDB agrees to provide
HSI with such technical and clinical data as HSI may reasonably
require in order to promote, distribute and sell Product in the
Territory, subject to the provisions of Section 9.
6.3 HSI and
IDB shall convene by telephone, videoconference or in person, on a
quarterly basis—and more frequently if reasonably requested
by either Party— until the initial Marketing Authorization
for Product is received and then monthly thereafter—and more
frequently if reasonably requested by either Party—to discuss
(as may be relevant at the time) regulatory developments affecting
Product, HSI’s marketing plan, strategy and marketing and
sales efforts proposed for Product for a given Flu Season,
IDB’s Product supply issues, if any, IDB’s Product
commitments to the Government of Canada for a given Flu Season, as
described in Section 3.2, and such other relevant issues as
either Party may propose. [**] Each Party shall consider in
good faith the views expressed by the other Party during such
meetings.
6.4 HSI
shall, and shall require its Affiliates and Other Distributors to,
conduct all promotion, marketing, distribution and sale of Product,
including, without
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