8
AGREEMENT
THIS AGREEMENT is made as of March 1, 1999 (the "Effective
Date"), at Princeton, New Jersey, USA
BETWEEN
(1) THE LIPOSOME COMPANY, INC., a corporation duly organised and
validly existing under the laws of the State of Delaware,
USA, and having an address at Xxx Xxxxxxxx Xxx, Xxxxxxxxx
Xxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000, XXX (hereinafter
called "TLC"); and
(2) WYETH-AYERST INTERNATIONAL INC., a corporation duly
organised and validly existing under the laws of the State
of New York, USA, with its principal place of business at
000 Xxxxxx-Xxxxxxx Xxxx, Xx. Xxxxxx, XX 00000, XXX
(hereinafter called "W-A").
WHEREBY IT IS AGREED as follows:
1. DEFINITIONS AND INTERPRETATION
1.1 In this Agreement and in the Schedules to this Agreement the
following words and phrases shall have the following
meanings unless the context requires otherwise:
1.1.1 "Affiliate" shall mean any company,
partnership or other entity which directly or
indirectly Controls, is Controlled by or is under
common Control with any Party to this Agreement
including as a Subsidiary or Holding Company;
1.1.2 "Agreed Minimum Sales Targets" shall mean
the Net Sales targets set out in Schedule 1 as these
may be amended from time to time in accordance with
Section 16, and such sales targets as may be agreed
on for Renewal Terms in accordance with Section 19.1;
1.1.3 "Business Day" shall mean any day excluding
Saturdays, Sundays and public holidays in the
Territory or the United States, as the case may be;
1.1.4 "Competent Authority" shall mean any local
or national agency, authority, department,
inspectorate, minister, ministry official or public
or statutory person (whether autonomous or not) of,
or of any government of, any country having
jurisdiction over the Agreement or any of the Parties
including the European Commission and the European
Court of Justice;
1.1.5 "Confidential Information" shall mean all
trade secrets, know-how and other confidential
information relating to the Product; the data, know-
how and other information generated by any clinical
trials or other studies carried out under this
Agreement or arising in connection with the marketing
and promotion of the Product in the Territory or
relating to the business affairs or finances of a
Party or its Affiliates coming into the possession of
the other Party pursuant to this Agreement;
1.1.6 "Contract Year" shall mean each successive
twelve-month period beginning on the Effective Date
during the term of this Agreement;
1.1.7 "Control" shall mean the ownership of fifty
percent (50%) or more of the issued share capital or
the legal power to direct or cause the direction of
the general management and policies of the entity in
question;
1.1.8 "DCM" shall mean the director of clinical
marketing to be appointed by TLC pursuant to Section
7.3;
1.1.9 "Directive" shall mean any present or future
directive, requirement, instruction, direction or
rule of any Competent Authority (but only, if not
having the force of law, if compliance with the
directive is in accordance with the general practice
of persons to whom the directive is addressed) and
includes any modification, extension or replacement
thereof then in force;
1.1.10 "Force Majeure" in relation to any Party
means any event or circumstance which is beyond the
reasonable control of such Party which results in or
causes the failure of that Party to perform any or
all of its obligations under this Agreement including
an act of God, lightning, fire, storm, flood,
earthquake, accumulation of snow or ice, lack of
water arising from weather or environmental problems,
strike, lockout or other industrial disturbance, act
of the public enemy, war declared or undeclared,
threat of war, terrorist act, blockage, revolution,
riot, insurrection, civil commotion, public
demonstration, sabotage, act of vandalism, prevention
from or hindrance in obtaining in any way materials,
energy or other supplies, explosion, fault or failure
of plant or machinery (which could not have been
prevented by good industry practice), governmental
restraint, act of legislature, or directive or
requirement of a Competent Authority governing any
Party, provided that lack of funds shall not be
interpreted as a cause beyond the reasonable control
of that Party;
1.1.11 "List Price" shall mean the price at which
the Product is approved for sale and reimbursement to
hospitals in the Territory, which price is set forth
on Schedule 4 annexed hereto;
1.1.12 "MAA" shall mean a marketing authorisation approval;
1.1.13 "Net Sales" shall mean the net amount invoiced for
the Product to customers by TLC or its distributor;
1.1.14 "Parties" shall mean TLC and/or W-A;
1.1.15 "Product" shall mean ABELCETr (amphotericin
B lipid complex injection) in finished form packaged
and ready for use by users, including developments or
improvements of the same;
1.1.16 "Quarter Days" shall mean each January 1,
April 1, July 1, and October 1;
1.1.17 "Specifications" shall mean the
specifications of the Product set out in Schedule 2,
as the same may be modified by TLC from time to time;
1.1.18 "Territory" shall mean the United Kingdom,
Northern Ireland, and such other countries as shall
be added by the mutual agreement of the Parties;
1.1.19 "TLC Patents" shall mean the patents listed
on Schedule 6 hereto; and
1.1.20 "TLC Trade Marks" shall mean the registered
trade marks owned by TLC or its Affiliate which cover
the Product, such as ABELCETr or other applicable
trade xxxx.
1.2 In this Agreement:
1.2.1 Unless the context requires otherwise, all
references to a particular Section, Schedule or
paragraph shall be a reference to that Section,
Schedule or paragraph in or to this Agreement as the
same may be amended from time to time pursuant to
this Agreement;
1.2.2 Unless the contrary intention appears, words
importing the masculine gender shall include the
feminine and vice versa, and words in the singular
shall include the plural and vice versa;
1.2.3 Unless the contrary intention appears, words
denoting persons shall include any individual
partnership, company, corporation, joint venture,
trust, association, organisation or other entity, in
each case whether or not having separate legal
personality; and
1.2.4 Reference to the words "include" or
"including" is to be construed without limiting the
generality of the preceding words.
2. CLINICAL TRIALS
2.1 TLC, or its Affiliate, has obtained an MAA authorising the
sale of the Product in the Territory. TLC shall sponsor and
carry out, or shall procure that one of its Affiliates
sponsors and carries out, any additional clinical trials or
studies under TLC protocols that may be required to be
carried out in the Territory in order to maintain the MAA or
support a revised, supplemental or additional MAA or other
application for regulatory approval required to market and
sell the Product in the Territory and shall co-ordinate any
such clinical activity in the Territory within their world-
wide clinical development program for the Product. W-A
shall provide at its own cost logistical support consisting
of assisting TLC staff with scheduling appointments,
selecting and visiting investigators, and assisting with
follow-up matters in order to further the timely completion
of these studies. TLC shall be responsible for all other
costs.
2.2 In addition to the clinical studies provided for in Section
2.1, the Operating Committee provided for in Section 7 may
also propose additional local clinical trials and/or studies
to advance jointly agreed marketing goals and to aid in
positioning the Product in the Territory. If TLC approves
the plans and protocols for such studies, they shall be
jointly sponsored by W-A and TLC, and TLC will provide an
adequate supply of Product required for such clinical trials
and studies. The cost of such Product and other study costs
will be shared equally between the Parties.
2.3 W-A may from time to time propose to TLC any additional
trials or studies initiated by W-A or investigators that
might be carried out in the Territory, but whether or not
such trials or studies are carried out shall be in the sole
discretion of TLC which approval shall not be unreasonably
withheld. W-A will sponsor and be fully responsible
financially for all clinical studies other than those
mentioned in Sections 2.1 and 2.2. Such additional trials
or studies shall be at the cost and expense of W-A.
2.4 W-A undertakes to assist TLC at TLC's expense in obtaining
any necessary authorisations and approvals required to carry
out any such additional clinical trials or studies including
arranging meetings with the relevant Competent Authorities
which will be attended by representatives of TLC and W-A.
2.5 W-A undertakes in relation to any additional clinical trials
or studies conducted in the Territory to recommend, at TLC's
request, investigators to be appointed by TLC to carry out
the trials or studies and to monitor the activities of those
investigators in accordance with the instructions of TLC
from time to time. If requested by TLC, W-A shall collect
and maintain all relevant data including at least case
histories, treatments, outcomes, adverse events and protocol
deviations. W-A shall prepare, maintain and deliver to TLC
complete and accurate written records and reports (progress,
safety and final), including manuscripts intended to be
submitted for publication, of all clinical trials or studies
that it monitors.
2.6 W-A shall inform TLC of any request made to it by a local
physician for supplies of the Product to enable such
physician to carry out his own trial and shall provide TLC
with sufficient information to enable TLC to decide in its
absolute discretion whether or not to supply such physician.
W-A shall be responsible for paying any relevant charges due
to be paid to such local physician and for ensuring that
such local physicians comply with all necessary regulatory
requirements when conducting the trial.
3. RIGHTS IN THE CLINICAL TRIALS DATA
3.1 All data, know-how and other information generated as a
result of the additional clinical trials or studies carried
out in or in relation to the Territory pursuant to Section 2
shall be owned by TLC or its Affiliate; however, during the
term of this Agreement (and any renewal term thereof), W-A
shall have a semi-exclusive right, title and interest in or
to such data. W-A undertakes to notify TLC of any impending
publication referring to the Product and obtain TLC's
written approval prior to releasing such publication for
submission to scientific journals or conferences.
4. MARKETING AUTHORISATION
4.1 TLC, or its Affiliate, has obtained an MAA for the Product
and shall be solely responsible at its own cost and expense
for the maintenance of such MAA and for the preparation and
filing and maintenance of all amended or supplemental XXXx
for the Product in the Territory from the relevant Competent
Authority and any other approvals, clearances and requisite
registrations required to market the Product in the
Territory. All such approvals and registrations shall be in
the name of TLC or its Affiliate.
4.2 W-A undertakes to assist TLC in obtaining any additional
necessary authorisations and approvals required to market
the Product in the Territory, including arranging meetings
with the relevant Competent Authorities which will be
attended by representatives of TLC and W-A.
4.3 In order to enable W-A to fulfil its obligations under
this Agreement, TLC shall supply W-A, as soon as reasonably
possible, with one copy of all XXXx for the Product and any
other documents related to the MAA filed by TLC with the
Competent Authorities in the Territory during the term of
this Agreement.
5. PRICING AND REIMBURSEMENT
5.1 In the event that the List Price shall fall below the
British pound equivalent of seventy U.S. dollars ($70 U.S.)
per 100mg vial, or a proportionate price reduction occurs
for other marketed units, TLC may terminate this Agreement
in accordance with Section 20.1.6.
6. PRODUCT SUPPLY, TRAINING AND SUPPORT SERVICES
6.1 With effect from the Effective Date, TLC shall supply the
Product to its appointed distributor for resale in the
Territory following the promotional activities of W-A,
subject to the terms and conditions of this Agreement.
Subject to the provisions of Section 10.7 and 10.8, TLC will
not be obligated to supply its distributor if the List Price
is reduced at the discretion of a relevant Competent
Authority in the Territory to an amount that is lower than
the British pound equivalent of seventy U.S. dollars ($70
U.S.) per 100mg vial, or a proportionate price reduction
occurs for other marketed units. TLC will promptly notify W-
A in writing of its decision not to supply its distributor
pursuant to the foregoing; provided however, that TLC will
consult W-A prior to giving any notice under this Section.
6.2 TLC shall make available to W-A such technical, training and
support services as W-A may request in connection with its
obligations under this Agreement and as TLC shall consider
reasonable. Specifically, TLC shall keep W-A reasonably
informed of all relevant developments and experience gained
by TLC and its Affiliates in the exploitation of the Product
internationally, except if such disclosure would breach
TLC's undertaking of confidentiality to a third party. TLC
shall provide W-A with such technical, scientific, medical
and commercial information, documentation and data developed
or acquired by TLC and its Affiliates which may in TLC's
judgement be useful to W-A for the purposes of this
Agreement.
6.3 Each Party agrees that in performing its rights and
obligations under this Agreement it will comply with its
obligations as set out in the Medical Information Procedures
set forth in Schedule 7 attached hereto.
7. OPERATING COMMITTEE
7.1 Forthwith following the Effective Date the Parties shall
establish a joint Operating Committee whose responsibilities
shall include:
7.1.1 approving a two (2) year marketing plan for
the Territory submitted by W-A;
7.1.2 discussing and approving marketing plan
updates proposed by W-A on an annual basis;
7.1.3 reviewing implementation of the marketing
plan on a quarterly basis;
7.1.4 determining the manner in which both Parties or their
Affiliates are to be identified on the labelling of
the Product for sale in the Territory;
7.1.5 reviewing progress toward achievement of Agreed
Minimum Sales Targets;
7.1.6 meeting from time to time, but at least two
(2) times per year; and
7.1.7 any other responsibilities determined by the
Parties.
7.2 The Operating Committee shall comprise four (4) persons
("Members"), and TLC and W-A respectively shall be entitled
to appoint two (2) Members, to remove any Member appointed
by it and to appoint any person to fill a vacancy arising
from the removal or retirement of such Member. TLC and W-A
respectively shall each notify the other in writing of the
identities of their Members from time to time.
7.3 TLC shall be entitled to appoint one of its Members to
preside at any meeting of the Operating Committee as
Chairman. TLC may at its discretion and at its own cost and
expense appoint a technical director and/or DCM to act as
liaison between TLC and W-A's management and who shall be
based at the premises of W-A in the Territory. If so
appointed, the technical director and/or DCM will act as the
Secretary of the Operating Committee and keep appropriate
minutes. The technical director and/or DCM may or may not,
at TLC's discretion, be designated as TLC's Committee
members, but as an alternate member and not as an additional
TLC committee member.
7.4 The quorum for meetings of the Operating Committee shall be
all four (4) Members. Decisions of the Operating Committee
shall be made by unanimous agreement of the Members present.
Should it prove impossible to obtain such agreement or to
arrange a quorate meeting within fourteen (14) days of a
Party calling a meeting, then the Parties shall discuss the
position in good faith in an effort to resolve their
differences and if it still does not prove possible to
obtain agreement then the outstanding matters requiring
resolution shall be referred to the Senior Managers of TLC
and W-A or their nominees for resolution who together shall
use reasonable efforts to resolve such matters within
fourteen (14) days of the date such matters are referred to
them for resolution. If those Senior Managers fail to reach
agreement within that period, the decision of TLC shall
apply.
7.5 The venue for meetings of the Operating Committee shall be
the United Kingdom. Both Parties shall be responsible for
their own expenses including travel and accommodation costs
incurred in connection with Operating Committee meetings.
7.6 The Operating Committee may establish a discount range, not
to exceed ten percent (10%) per order of the List Price,
being the basis on which W-A promotes the product to its
customers. W-A will obtain the approval in writing of TLC
if, as a result of negotiations with a customer, W-A
proposes to promote the Product at a discount outside the
approved range. In the event that W-A promotes the Product
at a price different than the List Price, W-A shall indicate
such promotional price rates in its reports to TLC pursuant
to Section 11.2 of the Agreement.
7.7 W-A undertakes to assist TLC in obtaining any necessary
pricing authorisations, reimbursement approvals and other
approvals required to market or continue to market the
Product in the Territory, including arranging meetings with
the relevant Competent Authorities, which may be attended by
representatives of TLC and W-A. Any pricing authorisation
and reimbursement approval for the Product in the Territory
granted from the relevant Competent Authority shall be in
the name of TLC or its Affiliate.
7.8 If the condition stipulated in Section 6.1 of the Agreement
occurs, the Parties agree jointly to explore means to remedy
such condition in good faith, including but not limited to,
renegotiating an amended price level, if applicable, with
the relevant Competent Authorities in the Territory. In the
event that no such remedy becomes available, ether party may
terminate this Agreement by giving to the other not less
than three (3) months written notice served at any time
after the date of TLC's notice to W-A in Section 6.1. Within
such notice period W-A shall be entitled to earn its
promotional allowance on Product sold at the prevailing
price.
8. FORECAST FOR PRODUCT NEEDS TO THE MARKET
8.1 Beginning no later than 15 days from the signature of this
Agreement, TLC shall deliver in writing to W-A's UK
Affiliate at such address as may from time to time be
designated by it, the quarterly level of inventory for the
Product stored at the warehouse of TLC's distributor.
Beginning no later than 30 days from the signature of this
Agreement, W-A shall deliver in writing to TLC on or before
the first day of each month, at such address as may from
time to time be designated by TLC, an indicative forecast of
the quantity of the Product which W-A reasonably believes
will be required in the Territory as a consequence of the
promotion activity implemented by W-A, during each month of
the twelve month period commencing six (6) weeks after the
date such estimate is delivered to TLC. Following the
second anniversary of the Effective Date such forecast will
be due every three (3) months.
8.2 The forecast by W-A shall be a rolling system. Each such
forecast by W-A shall constitute for the first three months
the quantity of Product for which TLC shall use all
reasonable commercial endeavours to make available to the
market the quantities in accordance with such forecasts. In
particular, but without prejudice to the generality of the
foregoing, TLC shall not be obliged to make available to the
market quantities of the Product against any such forecast
where such forecast exceeds by more than twenty percent
(20%) the previous monthly forecast for that month.
9. PACKAGING AND LABELLING
9.1 W-A shall consult with TLC on the requirements of all
relevant Competent Authorities concerning the packaging and
labelling of Product for sale in the Territory, including
translation of the text of the packaging and any inserts as
well as W-A's identification on the packaging (if any), and
TLC shall approve all packaging and labelling. W-A shall be
liable at its own cost and expense for all and any changes
required to such packaging to meet such requirements from
time to time, which cost and expense shall be reimbursed to
TLC forthwith upon demand. TLC shall endeavour to keep
reasonable quantities of packaging materials in stock in
order to service W-A's forecast set in Section 8.1 herein.
10. PROMOTIONAL ALLOWANCE
10.1TLC shall procure that all orders for the Product placed
with its distributor are converted to sales and that its
distributor shall on a weekly basis issue a copy of its
sales report by account showing orders received and sales
completed, in such format as may be agreed between TLC and W-
A. During each Contract Year TLC shall pay to W-A a
promotional allowance equal to thirty-one and one-half
percent (31.5%) of Net Sales with respect to the first one
million three hundred thousand British pounds (1,300,000)
of in-the-market sales, and then forty-one and one-half
percent (41.5%) of Net Sales for the remaining sales. Such
promotional allowance shall be paid quarterly, no later than
thirty-five (35) days after each Quarter Day irrespective of
whether TLC has received payment from its distributor in
respects of sales made in the Territory to its customers.
10.2TLC shall keep accurate records and books of account for the
purpose of showing all amounts to be calculated under this
Agreement, including Net Sales in local currency. Such
records and books of account shall, as between W-A and TLC,
be kept for one (1) year following the end of the calendar
year to which they relate and shall, solely for the purposes
of any governmental audit, be kept for three (3) years
following the end of the calendar year to which they relate
and certified extracts of such records and books of account
shall be open to inspection by W-A or its representatives
once each calendar quarter with notice of at least five
business days during normal business hours for the purpose
of verifying any matter relevant to this Agreement.
10.3In addition, during each Contract Year, TLC will calculate
the average selling price per Pack (ten (10) vials sold
together) in the Territory. In the first Contract Year, TLC
will pay W-A an additional promotional allowance equivalent
to ten percent (10%) of the number of Packs sold times sixty-
five percent (65%) of the average selling price per Pack
during the first six (6) months after the Effective Date
(the "Initial Six Months Additional Allowance"). In each
Contract Year, TLC will pay W-A an additional promotional
allowance equivalent to five percent (5%) of the number of
Packs sold times sixty-five percent (65%) of the average
selling price per Pack on the first one million three
hundred thousand British pounds (1,300,000) (except that in
the first Contract Year this allowance will not be paid on
the Packs for which the Initial Six Months Additional
Allowance was paid). In addition, if the Net Sales exceed
one million three hundred thousand British pounds
(1,300,000) in one single Contract Year, TLC will pay W-A a
promotional allowance equivalent to five percent (5%) of the
number of Packs sold times fifty-five percent (55%) of the
average hospital selling price per Pack for Packs exceeding
that level (except that in the first Contract Year this
allowance will not be paid on the Packs for which the
Initial Six Months Additional Allowance was paid). All such
promotional allowances shall be paid quarterly, no later
than thirty-five (35) days after each Quarter Day.
10.4Within thirty (30) days of any inspection under Section 10.2
or of any promotional allowance payment, W-A may give notice
to TLC that it does not accept the same, following which the
records or statement shall be audited and certified by an
independent accountant appointed by agreement between the
Parties or, in default of agreement within fourteen (14)
days, by the office of TLC's regular independent accountants
in the United Kingdom. TLC shall make available all books
and records required for the purpose of such audit and
certification and the determination of such independent
accountants so certified shall be final and binding between
the Parties. The cost of such audit and certification shall
be the responsibility of TLC if the audit discloses an error
benefiting TLC by more than five percent (5%) in respect of
monies due to W-A, and the responsibility of W-A if the
report is shown to have been accurate within such financial
parameters. Forthwith upon any such certification, the
Parties shall make any adjustments necessary in respect of
the sums already paid to W-A in relation to the calendar
quarter in question. Adjustments in favour of either Party
shall be paid in cash.
10.5All sums due to W-A pursuant to this Agreement shall be paid
in British pounds and shall be made to the designated
account of W-A by telegraphic transfer. If European
Currency Units should be subsequently created, the amount
due W-A shall be converted in accordance with the British
pound rate of exchange published in The Wall Street Journal
on the last business day of the week preceding the date of
payment.
10.6If TLC fails to make any payment to W-A hereunder within
thirty (30) days of the due date for payment, without
prejudice to any other right or remedy available to W-A, W-A
shall be entitled to charge TLC late charge penalties (both
before and after judgement) on the amount unpaid at the rate
of LIBOR plus five percent (5%) until payment in full is
made without prejudice to W-A's right to receive payment on
the due date.
10.7 For the avoidance of doubt in the event that either
Party shall terminate this Agreement in circumstances defined in
Section 20.1.6 then TLC shall be obliged to pay to W-A its
promotional allowance entitlement on sales effected by TLC's
distributor during such termination notice period.
10.8 Payment of the promotional allowance shall be due and
payable notwithstanding the failure by TLC to perform its
obligations hereunder or its obligations to TLC's distributor
(including without prejudice to the generality of the foregoing,
failure to ensure the provision and delivery to TLC's distributor
of adequate levels of stock of the Product in accordance with the
relevant forecast) or the failure of TLC's distributor to effect
the sale of the Product or otherwise to perform its distribution
obligations to TLC under its distributorship agreement (including
without prejudice to the generality of the foregoing, the
processing and fulfilment of orders generated from the detailing
of the Product by W-A to potential customers of TLC and its
distributor) provided that W-A shall have complied with the
contract procedures set out in the Marketing Plan and its
obligations hereunder.
11. MARKETING AND PROMOTION BY W-A
11.1W-A shall use its reasonable efforts to promote and extend
sales of the Product in the Territory and shall provide all
sales detailing, and promotion activities for the Product in
the Territory. W-A shall co-ordinate its marketing and
sales activity with TLC's European-wide marketing campaign.
TLC will provide to W-A free of charge camera-ready artwork
for promotional materials in the English language. In the
event that W-A wishes to develop customised promotional
materials for use in the Territory, it may do so at its own
cost, provided that it first submits the proposed materials
to TLC and TLC gives its written approval, which it will use
reasonable efforts to provide within thirty (30) days of
receiving the materials.
11.2TLC shall promptly report to W-A sales, in such form and
content as may be agreed between the Parties, on a weekly
basis during the term of the Agreement. W-A will have the
right to access marketing and sales information at any time
within the term on request.
11.3W-A shall promptly report to TLC detailing and promotion
activities in the Territory on a monthly basis during the
first Contract Year and on a quarterly basis during the
subsequent years of the Agreement. TLC will have the right
to access marketing information at any time within the term
on request.
11.4W-A shall use all reasonable endeavours to visit all of the
haematology, transplantation and infectious disease centres
in the Territory and to promote the Product to such extent
as to enable TLC's distributor to satisfy the Agreed Minimum
Sales Targets.
11.5Subject to the provisions of Section 10.8, in the event that
TLC's distributor does not receive sufficient orders to
satisfy the Agreed Minimum Sales Targets during the term of
the Agreement, the provisions of Sections 16.1 through 16.8
shall apply.
11.6Unless otherwise agreed in writing with TLC, W-A shall
concentrate its detailing and promotion of the Product
within the Territory, shall not seek any customers for the
Product outside the Territory and shall not establish any
branch or maintain any facility in relation to the Product
outside the Territory.
11.7W-A undertakes during the term of this Agreement that W-A or
its Affiliate will not promote, market, distribute or sell
in the Territory products which compete with the Product in
the hospital or home intravenous therapy setting. Without
limiting the generality of the foregoing, a product used to
treat systemic fungal infections will be considered as a
competitive product for purposes of this Section. W-A shall
promptly notify TLC of all inquiries related to the sale or
distribution of the Product outside of the Territory, except
for territories which may be the subject of other agreements
between the Parties.
11.8W-A will not detail or promote the Product as part of a
basket of products with other products without TLC's prior
written approval.
11.9In relation to the promotion of the Product W-A undertakes
to comply with the requirements of the Contract Procedure
more particularly set out in the Marketing Plan and TLC
undertakes to procure the agreement of its distributor to
the same.
12. GENERAL OBLIGATIONS OF W-A
12.1W-A shall during the period of this Agreement:
12.1.1 comply at all times with all applicable
Directives, laws and regulations pertaining to the
marketing and promotion of the Product in the
Territory;
12.1.2 employ or otherwise engage at its own
expense sufficient trained and qualified personnel
and maintain adequate facilities for the efficient
promotion and sale of the Product throughout the
Territory;
12.1.3 in marketing the Product, not make any
statement, representations, warranties or guarantees
concerning the Product except as are expressly
authorised pursuant to the marketing authorisation
for the Product;
12.1.4 submit through the Operating Committee all
advertising and promotional schemes and material
(including copy and artwork) relating to the
promotion of the Product for the approval of TLC
prior to publication or distribution;
12.1.5 keep the Operating Committee regularly
informed of full details concerning the marketing of
the Product in the Territory, including but not
limited to prospects, competitive activity etc.,
which information shall be recorded in Operating
Committee meeting minutes. W-A will also promptly
inform the Operating Committee of any other
information which it now has or which it may receive
in the future which is likely to be of interest,
benefit or use to TLC in relation to its sale of the
Products in the Territory and elsewhere and in
particular, but without limitation, full details of
new and prospective customers and will supply TLC
with any other information requested by TLC, relevant
to the performance by W-A of its obligations under
this Agreement;
12.1.6 keep TLC fully informed of any change in
Control of W-A in accordance with Section 20.2;
12.1.7 in all correspondence and other dealings relating
directly or indirectly to the promotion of the
Product clearly indicate that it is acting on its own
account as principal and will not represent itself
impliedly or expressly to be the agent of TLC nor
incur any contractual or other liability on behalf of
TLC nor in any way purport to pledge TLC's credit;
and
12.1.8 In this clause, "Employee" means an employee
employed by TLC immediately prior to the Effective
Date:
12.1.8.1TLC shall indemnify W-A against all costs,
expenses, damages, compensation, fines and
other liabilities arising out of or in
connection with:
12.1.8.1.1 any
claim by an Employee arising from
his/her employment with TLC or the
termination of that employment; and
12.1.8.1.2 any
claim by an Employee arising from
the termination of his/her
employment with W-A (howsoever
arising) and which is calculated by
reference to the length of his/her
continuous employment (as defined
in and determined in accordance
with the Employment Rights Act 1996
(the "ERA")), provided that this
indemnity shall only apply in
relation to any termination which
takes effect within five (5) years
of the Effective Date and so that
TLC's liability shall be limited to
the amount of any such claim
calculated by reference to the
period of the Employee's continuous
employment with TLC or any
Associated Employer (as defined in
the ERA) of TLC.
12.1.8.2Subject to the provisions of Section
12.1.8.1, W-A hereby agrees to pay to TLC by
way of contribution towards the costs,
including costs to cancel auto leases, mobile
telphone contracts, and all other such
peripheral costs of termination, incurred by
TLC in terminating the contracts of
employment of the Director, Clinical
Marketing, Sales Co-ordinator, and five (5)
Clinical Marketing Managers, up to the sum of
one hundred forty-eight thousand British
pounds (148,000) within thirty (30) days of
receipt of invoices from TLC for any such
costs.
12.2W-A shall notify TLC, in writing, within twenty-four (24)
hours following receipt of any notice from any governmental
agency or public authority of any action to be taken by such
agency or authority which may affect the Product.
12.3W-A shall during the period of this Agreement carry out its
obligations hereunder in the following manner:
12.3.1 in a manner which shows the skill,
diligence, prudence and foresight which would
reasonably and ordinarily be expected from a skilled
and experienced person engaged in the same type of
undertaking under the same or similar circumstances;
12.3.2 in a manner which meets the highest
professional and ethical standards;
12.3.3 in a manner free from dishonesty and
corruption; and
12.3.4 in a manner which shall enhance the image
and reputation of TLC and its Affiliates, but for the
avoidance of doubt it is declared and agreed that
this Agreement confers no right on W-A to use the
name or logo of TLC, except as otherwise stipulated
in this Agreement.
12.4 W-A affirms that it is familiar with the Foreign Corrupt
Practices Act of 1977 of the United States of America, as
amended by the Foreign Corrupt Practices Act Amendments of
1988 and as may be further amended and supplemented from
time to time ("FCPA"). W-A further warrants, covenants,
represents and agrees with TLC that, in connection with the
performance of this Agreement or with the sale of any
Product, neither W-A nor any of its principals, employees or
agents will perform, to the best of its knowledge and
belief, any act which would constitute a violation of the
FCPA or which would cause TLC to be in violation of the
FCPA. W-A shall certify the accuracy and veracity of the
foregoing representation and warranty from time to time as
TLC shall request. W-A will enforce the foregoing
obligation in accordance with the extract from its Code of
Conduct, attached as Schedule 5 and made a part hereof.
13. ADVERSE REACTION REPORTING
13.1During the term of this Agreement each Party will report
adverse reactions reported to it in respect of the Product
to the other Party and to the appropriate regulatory
authorities in accordance with all relevant laws and
regulations.
13.2During the term of this Agreement, W-A will report all
serious adverse reactions from any source to TLC's Affiliate
in the United Kingdom for regulatory reporting to the
Medicines Control Agency (the "MCA") and W-A Global Safety
Group within 24 hours of receipt. TLC will duly copy W-A's
Affiliate in the United Kingdom on any reports made to the
MCA marked "reported." All other non-serious reactions will
be reported by W-A's Affiliate in the United Kingdom to TLC
and W-A Global Safety Group on a monthly basis. TLC will
provide W-A with the MCA drug analysis and product analysis
prints upon request and will provide copies of any
anonymised reports received from the MCA.
13.3The central safety department of each Party will report to
the central safety department of the other Party all adverse
reactions reported to it in respect of the Product as
follows:
13.3.1 fatal unexpected and life-threatening
unexpected adverse reactions by telephone or
facsimile within three (3) working days of receipt by
the central safety department;
13.3.2 all other serious adverse reactions in
writing within fifteen (15) working days of receipt
by the central safety department; and
13.3.3 a summary of all adverse reactions, serious
and non-serious, in writing on a six-month basis for
the first two years and thereafter on a yearly basis,
indicating those cases which have previously been
reported to the other Party.
Further information received on any serious adverse reaction
(or any information which changes an adverse reaction from
non-serious to serious) will also be reported to the other
Party within three (3) or fifteen (15) working days of
receipt by the central safety department, according to the
above criteria.
13.4An adverse reaction will be considered "serious" if it is
any one or more of the following; namely, fatal, life
threatening, disabling or incapacitating, results in
hospitalisation or prolongation of hospitalisation, a
congenital abnormality, a carcinoma, or an overdose. In
addition, any adverse reaction which suggests a significant
hazard, contraindication, side effect or precaution that may
be associated with the use of the Product will be considered
a serious adverse reaction.
14. GRANT OF RIGHTS
14.1TLC hereby grants W-A the exclusive right to promote the
Product in the Territory under the TLC Trade Marks, subject
to Section 15 herein.
15. INTELLECTUAL PROPERTY
15.1TLC represents, warrants and undertakes that to the best of
its knowledge and belief at the Effective Date:
15.1.1 TLC or a TLC Affiliate owns the TLC Trade
Marks within the Territory;
15.1.2 the TLC Trade Marks are duly registered and
subsisting in the Territory and all renewal fees have
been duly paid;
15.1.3 nothing has been done within the Territory
to diminish or otherwise adversely affect the
reputation of the TLC Trade Marks;
15.1.4 TLC is not aware of any infringement by any
third party in the Territory of the TLC Trade Marks;
15.1.5 TLC or a TLC Affiliate owns the TLC Patents within the
Territory;
15.1.6 the TLC Patents are duly issued and
subsisting in the Territory, and all annuities have
been duly paid and shall when due be duly paid;
15.1.7 there is no pending or threatened claim,
proceeding or litigation relating to the TLC Trade
Marks or the TLC Patents that could adversely affect
the ability of W-A to market and sell the Product in
the Territory; and
15.1.8 there is no pending or threatened claim,
proceeding or litigation alleging that the sale or
use of the Product in the Territory would infringe a
patent, trademark or other intellectual property
right of a third party.
15.2During the period of this Agreement TLC shall carry out at
its own expense and with sole discretion any and all
activities required in the Territory in relation to TLC
Trade Marks or any TLC Patents, including prosecution,
maintenance, enforcement and defence of any of the same.
15.3Except as otherwise stipulated in this Agreement W-A
acknowledges that it has no right, title or interest in or
to the Product nor in the TLC Patents, the TLC Trade Marks,
or in any trade secrets, copyrights, design rights, database
rights, moral rights or other intellectual property rights
applicable to the Product. To the extent and in the manner
requested by TLC, W-A shall place patent, trade xxxx and
copyright notices and similar proprietary legends on all
Product and packaging materials in order to preserve the
proprietary rights of TLC or its Affiliates.
15.4W-A shall give TLC notice of any infringement within the
Territory of the TLC Trade Marks or the TLC Patents coming
to its attention. TLC shall have the right to have sole
conduct of any proceedings necessary, including full
authority to settle such proceedings. Prior to any such
settlement TLC shall consult with W-A on the impact of any
such settlement on W-A's interests. In the case of any
proceedings within the Territory, TLC shall be entitled to
join W-A as a co-plaintiff who shall provide all reasonable
assistance in relation to such proceedings at its own cost
and expense. If in any such proceedings, whether at trial
or by way of settlement, TLC is successful, it shall be
entitled to retain any award of costs and damages made in
such proceedings or settlement, but TLC shall remit to W-A
only to the extent of such recovery by TLC the reasonable
out-of-pocket costs, legal fees and expenses expended by W-A
in providing such assistance to TLC. In the case that TLC
informs W-A in writing that TLC has elected not to pursue
such infringement proceedings, W-A may initiate and pursue
such proceedings either on its own or as a joint plaintiff
with TLC, if TLC so desires, provided that W-A has obtained
TLC's written consent, which shall not be unreasonably
withheld. In the event that W-A shall bring proceedings on
its own, W-A shall be entitled to retain 100% of any award
of costs and damages awarded in such proceedings or
settlement monies paid in connection therewith, but W-A
shall remit to TLC only to the extent of such recovery by W-
A the reasonable out-of-pocket costs, legal fees and
expenses expended by TLC in providing assistance to W-A.
15.5If during the period of this Agreement either Party shall
receive any notice, claim or proceedings from any third
party alleging infringement of such third party's
intellectual property rights by reason of W-A's marketing or
sale of the Product in the Territory, such Party shall
forthwith notify the other Party of any such notice, claims
or proceedings and:
15.5.1 TLC shall be responsible at its own cost and
expense for dealing with any such notice, claim or
proceedings, and W-A shall co-operate in TLC's
handling and defence thereof; and
15.5.2 TLC shall have conduct of and sole authority
to defend or settle such claims or proceedings. In
order to resolve any such claims or proceedings, TLC
may agree to take a license from the owner of the
patent, trademark or other intellectual property
right in question, but if such license cannot be
obtained on terms that are acceptable to TLC, it may,
following consultation with W-A, elect to discontinue
marketing of the Product in the Territory, in which
case this Agreement shall be terminated, unless W-A
agrees to pay all or a portion of the license fees or
royalties necessary to obtain a license therefor.
The foregoing is without prejudice to any rights or
claims that W-A may have by reason of any breach by
TLC of the representations, warranties and/or
undertakings contained in Sections 15.1.1 through
15.1.8 hereof, except that the termination of this
Agreement by TLC in accordance with the terms of this
Section only shall not in itself constitute any
breach of TLC's obligations hereunder.
15.5.3 TLC shall indemnify and hold W-A free and
harmless from any payment of royalties or damages to
third parties as a consequence of any judgement,
award or settlement arising from a claim of patent or
trademark infringement, or infringement of other
intellectual property rights, based on W-A's use or
sale of the Product in the Territory under the TLC
Trade Marks and TLC Patents in accordance with the
terms of this Agreement, except as provided in
Section 15.5.2, and except for any claim based on
marketing or promotional materials created by,
packaging or labelling produced by, Product
modifications made by, or other acts done by, W-A,
its agents, employees or customers.
16. SALES TARGETS
16.1In the event that in any one year of the term of this
Agreement the Agreed Minimum Sales Targets are not achieved,
notwithstanding the provision and delivery of adequate
levels of stock of the Product to the market by TLC and by
TLC's distributor, then, subject to the saving clause
provided hereunder, TLC shall have the following options:
16.1.1 to terminate this Agreement or
16.1.2 to co-operate in improving the marketing of the
Product.
16.2For the purposes of Section 16.1.1, W-A may, at its option,
aggregate the Agreed Minimum Sales Targets in any two (2)
years of the term of this Agreement and take the average
thereof in order to meet such targets. If TLC wishes to
exercise the option set out in Section 16.1.1, it shall
notify W-A to this effect in writing within thirty (30) days
of receiving notice that any particular Agreed Minimum Sales
Target has not been met and thereupon the relevant
provisions of Sections 19 and 20 shall apply. However, the
Parties will agree on revised targets if the Agreed Minimum
Sales Targets are not achieved due to unforeseeable events
beyond W-A's reasonable control, such as actions of
governmental or regulatory authorities or any failure on the
part of TLC or its distributor to effect the sale of the
Product in circumstances envisaged in Section 10.8 of this
Agreement. Any failure by TLC to give notice of termination
within the thirty-day period will not constitute a waiver of
its right to terminate under Section 16.1.1 if additional
time is needed to enable TLC to determine the cause of such
failure to meet targets, to allow the Parties to negotiate
revised targets, or to calculate two-year averaged targets.
16.3TLC's failure to terminate this Agreement pursuant to the
provisions of Section 16.1.1 in any one year shall not
prejudice TLC's right to exercise this option in any of the
following years.
16.4If in any one year TLC wishes to exercise the option set out
in Section 16.1.2, TLC will convene a meeting of the
Operating Committee to determine a new plan for the
marketing and sale of the Product in the Territory (the "New
Marketing Plan").
16.5Upon being so convened, the Operating Committee shall
prepare the first year of the New Marketing Plan, and such
New Marketing Plan will contain:
16.5.1 an estimate of marketing/promotional budget
and selling expenses required for the Product in the
Territory during such year;
16.5.2 the target audiences for the Product in the
Territory; and
16.5.3 the marketing/promotional budget and selling
expenses and the projected number of details to be
shared by TLC or its Affiliate and W-A in the
Territory to all target audiences during such Year.
Such determination of budget and the number of
details shall be made considering factors including
the number of physicians in each target audience,
their geographic distribution, the elapsed time since
product launch, and the frequency of detailing visits
to each target audience which is customary in
pharmaceutical sales practice in the Territory for
products of similar nature to the Product, provided
always that W-A shall be required to perform a
guaranteed number of the projected details, such
number to be defined by the Operating Committee. In
no event shall such number of projected details by W-
A or TLC be less than thirty percent (30%) of total
projected details.
16.6In the event of a New Marketing Plan, and not later than
three (3) months prior to the beginning of any year, a New
Marketing Plan for the following year shall be prepared by
the Operating Committee covering the same issues as set out
in Section 16.5.
16.7During any year of the New Marketing Plan TLC or its
Affiliate and W-A shall supply each other on a regular,
monthly basis with copies of sales call reports in order to
ascertain the actual number of details undertaken by both
Parties. Such call reports will be treated as Confidential
Information under Section 17 and will be provided only to
employees of the Parties who are members of the Operating
Committee or who are responsible for calculating payments
hereunder.
16.8In the event that TLC or its Affiliate co-operates in the
marketing of the Product, it shall be entitled to a credit
against amounts owed to W-A calculated as the sum of A and
B, where
(I) For the first one million three hundred
thousand British pounds (1,300,000) of in-the-market
sales during each Contract Year:
DTLC
A = NS x 40% x ____________
DTLC + DE
DE
B = ET x ____________
DTLC + DE
and
(II) For all subsequent in-the-market sales during any
Contract Year:
DTLC
A = NS x 50% x ____________
DTLC + DE
DE
B = ET x ____________
DTLC + DE
and
NS = Net Sales for the three (3) months ending on
the day before each Quarter Day;
DTLC = The number of sales calls undertaken by TLC
and its Affiliates for the Product in the three (3)
months ending on the day before each Quarter Day;
DE = The number of sales calls undertaken by W-A
and its Affiliates for the Product in the three (3)
months ending on the day before each Quarter Day; and
ET = The expenses incurred by TLC and its
Affiliates in support of the Product in the
Territory, other than personnel-related expenses, in
the three (3) months ending on the day before each
Quarter Day.
Such credits shall be taken against payments due to W-A in
accordance with Section 10.1 herein. For the purpose of
making the foregoing calculation, W-A undertakes to inform
TLC of the applicable number of sales calls within five (5)
days after each of the Quarter Days.
17. CONFIDENTIALITY
17.1The Parties each undertake and agree to:
17.1.1 keep the Confidential Information secret and
confidential and not directly or indirectly to
disclose or permit to be disclosed the same to any
third party, other than its Affiliates, consultants
or other advisors, for any reason without the prior
written consent of the other Party;
17.1.2 ensure that only those of its officers and
employees and those of its Affiliates who are
directly concerned with the carrying out of this
Agreement have access to the Confidential Information
on a strictly applied "need to know" basis and are
informed of the secret and confidential nature of it;
17.1.3 ensure that the Confidential Information is
not covered by any fixed or floating charge entered
into at any time by it and not otherwise to establish
a lien over or in any other way encumber, the same;
and
17.1.4 not copy, reproduce or otherwise replicate
for any purpose or in any manner whatsoever any
documents, discs, CD-ROM or any other media upon
which Confidential Information can be permanently
stored containing the Confidential Information.
17.2The obligations of confidence referred to in this Section 17
shall not extend to any Confidential Information which:
17.2.1 is or shall be generally available to the
public otherwise than by reason of breach by the
recipient or its Affiliate of the provisions of this
Section;
17.2.2 in the case of Confidential Information
disclosed or made available to a Party ("Recipient
Party") or its Affiliate directly or indirectly by
the other Party:
(a) is known to the
Recipient Party and is at its free disposal
(having been generated independently by the
Recipient Party or a third party in
circumstances where it has not been derived
directly or indirectly from the other Party's
Confidential Information) prior to its receipt
from the other provided that evidence of such
knowledge is furnished by the Recipient Party
within twenty-eight (28) days of receipt of that
Confidential Information; or
(b) is subsequently
disclosed to the Recipient Party without
obligations of confidence by a third party owing
no such obligations in respect of that
Confidential Information;
17.2.3 is required by law to be disclosed
(including as part of any regulatory submission or
approval process) and then only when prompt written
notice of this requirement has been given to the
other Party so that the other Party may, if so
advised, seek appropriate relief to prevent such
disclosure, provided always that in such
circumstances such disclosure shall be only to the
extent so required and shall be subject to prior
consultation with the other Party with a view to
agreeing on the timing and content of such
disclosure.
17.3Subject to the provisions of Section 17.2.3, all
Confidential Information disclosed by one Party to the other
shall remain the intellectual property or property of the
disclosing Party. In the event of a court, nominee or
supervisor for composition in satisfaction of debts,
liquidator, trustee, receiver, administrative receiver,
receiver and manager, interim receiver, custodian
sequestrator or similar officer ("Officer") assumes partial
or complete Control over the assets of a Party based on the
insolvency or bankruptcy of that Party, that Party shall:
17.3.1 promptly notify the court or Officer:
(a) that Confidential
Information received from the other Party under
this Agreement remains the property of the other
Party unless expressly assigned;
(b) of the
confidentiality and security obligations
under this Agreement; and
17.3.2 to the extent permitted by law, take all
steps necessary or desirable to maintain the
confidentiality and security of the other Party's
Confidential Information and to ensure that the court
or Officer maintains that Confidential Information in
confidence and that Confidential Material is kept
secure in accordance with this Agreement.
17.4The terms and conditions of this Agreement shall be treated
as Confidential Information by both Parties. If either
Party desires to issue a press release regarding this
Agreement, it shall submit the proposed text of such press
release to the other Party and shall thereafter issue it
only if the other Party does not object to the proposed text
within forty-eight hours after receiving it. The Party
proposing to issue the press release will make reasonable
efforts to incorporate the other Party's comments and will
not issue any press release regarding this Agreement over
the other Party's objection except as provided in Section
17.2.3.
17.5The obligations of the Parties under Sections 17.1 to 17.4
shall survive the expiration or termination of this
Agreement for whatever reason and continue for a period of
five (5) years.
17.6The Parties understand and agree that remedies at law may be
inadequate to protect against any breach of any of the
provisions of this Section 17 by either Party or their
employees, agents, officers or directors or any other person
acting in concert with it or on its behalf. Accordingly,
each Party shall be entitled to seek the granting of
injunctive relief by a court of competent jurisdiction
against any action that constitutes any breach of this
Section 17. It is understood that injunctive relief is
intended solely as provisional relief pending resolution of
the dispute.
18. LIABILITY/INDEMNITY
18.1Subject to the provisions of Section 18.3, TLC shall
indemnify, defend and hold harmless W-A, its officers,
agents, employees and Affiliates from any and all liability,
loss, damage, cost and expense (including court costs and
reasonable attorney's fees) incurred or sustained by W-A or
its Affiliates as a result of any claim or demand of any
party arising out of or connected with the negligence of TLC
in the preparation of a clinical trial protocol and/or with
any defect which may arise from failure to meet product
specifications as approved by the Competent Authorities of
the Territory, including for such purposes manufacturing
defects arising out of the Product not complying with the
Specifications; provided however that TLC and its Affiliates
shall have no liability for any loss, damage, cost or
expense which directly results from:
18.1.1 failure of W-A, its officers, agents,
employees or Affiliates to adhere to the term of a
clinical trial protocol, TLC's instructions relative
to the use of the relevant Product or any term or
provision of this Agreement;
18.1.2 failure of W-A, its officers, agents,
employees or Affiliates to comply with any applicable
governmental or regulatory requirements; or
18.1.3 negligence or wilful malfeasance by W-A, its
officers, agents, employees and/or Affiliates, but
only to the extent that such loss, damage, cost or
expense are due to the negligence or wilful
malfeasance of W-A, its officers, agents, employees
and/or Affiliates.
18.2W-A shall indemnify, defend and hold harmless TLC, its
Affiliates, and their respective officers, agents and
employees from any and all liability, loss, damage, cost and
expense (including court costs and reasonable attorney fees)
incurred or sustained by any of them as a result of any
claim or demand of any party arising out of or connected
with:
18.2.1 failure of W-A, its officers, agents,
employees or Affiliates to adhere to the term of a
clinical trial protocol, TLC's written instructions
relative to the use of the relevant products or any
term or provision of this Agreement;
18.2.2 failure of W-A, its officers, agents,
employees or Affiliates to comply with any applicable
governmental or regulatory requirements; or
18.2.3 negligence or wilful malfeasance by W-A, its
officers, agents, employees and/or Affiliates.
18.3Neither Party shall be liable in an action for breach of
contract or in tort brought by one against the other whether
under the indemnity set out in Section 18.1 or 18.2 or
otherwise for special, indirect or consequential damages
resulting from such action or claim arising out of this
Agreement including without limitation loss of turnover,
profits, goodwill or business interruption however the same
may be caused.
18.4Each Party's agreement to indemnify and hold the other
harmless pursuant to this Section 18 is conditional upon the
indemnified party:
18.4.1 providing written notice to the indemnifying
party of any claim or demand arising out of the
indemnified activities within thirty (30) days after
the indemnified party has knowledge of such claim or
demand;
18.4.2 permitting the indemnifying party to assume
full responsibility to investigate, prepare for and
defend against any such claim or demand including the
right to compromise or settle the same; and
18.4.3 not compromising or settling such claim or
demand without the indemnifying party's written
consent.
Each Party agrees that any settlement made by an
indemnifying party shall not impose an obligation or
restriction on any indemnified party without such
indemnified party's written consent.
19. TERM
19.1Subject to the provisions for early termination contained
herein, this Agreement shall take effect from the Effective
Date and shall continue until the fifth anniversary thereof
(the "Initial Term"). Provided that the Agreed Minimum
Sales Targets are achieved, as modified by Section 16.2,
during the Initial Term or during any subsequent period of
five (5) Contract Years (a "Renewal Term"), W-A shall have
the right to market the Product for an additional Renewal
Term, subject to good faith agreement between the Parties
regarding the Agreed Minimum Sales Targets for the Renewal
Term. In the event that the Parties are unable to agree,
then TLC agrees that it shall market the Product to the
exclusion of any other third party.
19.2In the event that the Parties are unable to agree on renewal
terms after the Initial Term or any Renewal Term, TLC will
make payments to W-A in the amount of fifteen percent (15%)
of the Net Sales of Product sold in the Territory by TLC or
its Affiliate in the first year following termination of
this Agreement, or, if the Product is marketed by an
independent distributor, fifteen percent (15%) of the
revenue received by TLC or its Affiliate from such
distributor on account of Product shipped to the distributor
during the first year following termination of this
Agreement; and seven and one-half percent (7.5%) of the Net
Sales of Product sold in the Territory by TLC or its
Affiliate in the second year following termination of this
Agreement, or, if the Product is marketed by an independent
distributor, seven and one-half percent (7.5%) of the
revenue received by TLC or its Affiliate from such
distributor on account of Product shipped to the distributor
during the second year following termination of this
Agreement. No such payments will be required if the reason
for nonrenewal is a failure to meet Agreed Minimum Sales
Targets during the Initial Term or any Renewal Term.
19.3In the event that the Agreement is terminated prior to the
expiration of the Initial Term due to TLC's material breach,
then TLC agrees to make payments to W-A representing
compensation to W-A equal to seven and one-half percent
(7.5%) of Net Sales for each year which W-A would otherwise
have had marketing rights but for the termination, based on
the Net Sales for the immediately preceding twelve (12)
months prior to the effective date of termination.
20. TERMINATION
20.1Each Party shall have the right to terminate this Agreement
upon giving ninety (90) days written notice thereof to the
other Party upon the occurrence of the following events at
any time during the term of this Agreement:
20.1.1 if the other Party commits a material breach
of this Agreement, which in the case of a breach
capable of remedy shall not have been remedied within
thirty (30) days of the receipt by it of a notice
identifying the breach and requiring its remedy;
20.1.2 any Party shall suspend payment of its debts
or cease or threaten to cease to carry on its
business or become bankrupt or insolvent;
20.1.3 a proposal is made or a nominee or
supervisor is appointed for a composition in
satisfaction of the debts of any Party or a scheme or
arrangement of its affairs in relation thereto or any
Party commences negotiations with one or more of its
bankers with a view to the general readjustment or
rescheduling of all or part of its indebtedness or
enters into any composition or arrangement for the
benefit of its creditors or proceedings are commenced
in relation to any Party under any law, regulation or
procedure relating to the re-construction or re-
adjustment of debts (including where a petition is
filed or proceedings commenced seeking any
reorganisation, arrangement, composition or
readjustment under any applicable bankruptcy,
insolvency, moratorium, reorganisation or other
similar law affecting creditor's rights or where a
Party consents to, or acquiesces in, the filing of
such a petition);
20.1.4 an application is made to the courts for an
administrative order under the bankruptcy laws or any
statutory modification or re-enactment thereof with
respect to any Party;
20.1.5 any Party takes, without the consent of the
other Party (such consent not to be unreasonably
withheld), any action, or any legal proceedings are
started or other steps taken by a third party, with a
view to:
(a) the winding up or dissolution of such Party
(other than for the re-construction of a solvent
company); or
(b) the appointment of a liquidator, trustee,
receiver, administrative receiver, receiver and
manager, interim receiver custodian, sequestrator
or similar officer of such Party against the
Party or a substantial part of the assets of the
Party; or
20.1.6 the pricing authorisation imposed by the
Competent Authority is below the minimum price
provided under Section 5.1.
20.2TLC shall have the right to terminate this Agreement upon
giving thirty (30) days written notice thereof to W-A in the
event that a third party unrelated to W-A's current
shareholders acquires Control of W-A and such party is
engaged directly or indirectly in the manufacture or sale of
lipid products.
20.3Upon termination of this Agreement for any reason W-A shall
forthwith:
20.3.1 discontinue making any representations
regarding its status as a provider of promotion
services for TLC;
20.3.2 cease conducting any activities with respect
to the marketing or sale of the Product in the
Territory;
20.3.3 return to TLC technical sales or promotional
and sales training material and any other material of
TLC then in its possession including without
limitation all Confidential Information and all
clinical data concerning the Product;
20.3.4 refrain from using the TLC Trade Marks; and
20.3.5 if so requested by TLC and at TLC's expense
take all actions reasonably requested by TLC to
transfer to TLC or its designee any registration,
approval or other regulatory licence or permission
granted to W-A by a Competent Authority in the
Territory for the Product.
20.4Except for sums otherwise owing upon termination of this
Agreement or thereafter becoming due and payable neither
Party should be required to pay the other Party any
termination damages or special, incidental or consequential
damages of any kind arising out of the termination
(including without limitation labour claims and loss of
profits, investments or goodwill), and W-A hereby waives and
disclaims any such claims whether arising under local law or
otherwise.
20.5Upon termination of this Agreement howsoever arising the
rights of each Party against the other which have accrued at
the date of termination shall not be affected.
21. ASSIGNMENT
21.1Except as provided in Section 21.2, the obligations and
rights provided in this Agreement shall not be assigned,
transferred or sub-contracted by any Party unless agreed
upon in writing by the other. Subject to the foregoing, the
rights and obligations of the Parties hereunder shall inure
to the benefit of and bind their respective successors and
assignees.
21.2Subject to the prior written consent of TLC, which consent
shall not be unreasonably withheld, W-A shall be entitled to
assign its rights and obligations under this Agreement to
any wholly or majority owned Affiliate of W-A. TLC may
assign in whole or in part its obligations and rights in
this Agreement to a TLC Affiliate at any time at its
discretion.
22. FORCE MAJEURE
22.1If a Party ("the Non-Performing Party") shall be unable to
carry out any of its obligations under this Agreement due to
Force Majeure, this Agreement shall remain in effect but
for:
22.1.1 the Non-Performing Party's relevant
obligations; and
22.1.2 the relevant obligations of the other Party
("the Innocent Party") owed to the Non-Performing
Party under this Agreement shall be suspended for a
period equal to the circumstance of Force Majeure or
three (3) months, whichever is the shorter, provided
that:
22.1.2.1 the suspension of
performance is of no greater scope than is
required by the Force Majeure;
22.1.2.2 the Non-Performing
Party gives the Innocent Party prompt
notice describing the circumstance of Force
Majeure, including the nature of the
occurrence and its expected duration, and
continues to furnish regular reports with
respect thereto during the period of Force
Majeure;
22.1.2.3 the Non-Performing Party uses
all reasonable efforts to remedy its
inability to perform and to mitigate the
effects of the circumstance of Force
Majeure; and
22.1.2.4 as soon as practicable after
the event which constitutes Force Majeure,
the Parties shall discuss how best to
continue their operations as far as
possible in accordance with this Agreement.
22.2If Force Majeure is continuing at the expiry of the said
period of three (3) months the Innocent Party shall have the
right to terminate this Agreement forthwith upon notice in
writing to the Non-Performing Party.
23. WAIVER
23.1No Party shall be deemed to have waived any of its rights or
remedies whatsoever unless such waiver is made in writing
and signed by a duly authorised representative of that
Party. In particular, no delay or failure of either Party
in exercising or enforcing any of its rights or remedies
whatsoever shall operate as a waiver thereof or so as to
preclude or impair the exercise or enforcement thereof nor
shall any partial exercise or enforcement of any such right
or remedy by a Party preclude or impair any other exercise
or enforcement thereof by such Party.
24. SEVERANCE OF TERMS
24.1If the whole or any part of this Agreement is or shall
become or be declared illegal, invalid or unenforceable in
any jurisdiction for any reason whatsoever (including both
by reason of the provisions of any legislation or by reason
of any decision of any court or Competent Authority either
having jurisdiction over this Agreement or having
jurisdiction over either of the Parties to this Agreement)
then:
24.1.1 in the case of the illegality, invalidity or
unenforceability of the whole of this Agreement, it
shall terminate in relation to the jurisdiction in
question; or
24.1.2 in the case of the illegality, invalidity or
unenforceability of part of this Agreement, such part
shall be severed from this Agreement in the
jurisdiction in question and such illegality,
invalidity or unenforceability shall not in any way
whatsoever prejudice or affect the remaining parts of
this Agreement which shall continue in full force and
effect provided always that if in the reasonable
opinion of any Party any such severance materially
affects the commercial basis of this Agreement, such
Party shall have the right to terminate this
Agreement with immediate effect upon giving ninety
(90) days written notice to the other Party
containing the reason(s) why the commercial basis of
this Agreement has been materially affected by such
severance.
25. ENTIRE AGREEMENT/VARIATIONS
25.1 This Agreement constitutes the entire agreement and
understanding between the Parties and supersedes all prior
oral or written understandings, arrangements,
representations or agreements between them relating to the
subject matter of this Agreement. No director, employee or
agent of either Party is authorised to make any
representation or warranty to the other Party not contained
in this Agreement, and each Party acknowledges that it has
not relied on any such oral or written representations or
warranties.
25.2No variation, amendments, modification or supplement to this
Agreement shall be valid unless made in writing in the
English language and signed by a duly authorised
representative of each Party.
26. NOTICES
26.1Save as otherwise expressly provided in this Agreement, any
notice or other communication to be given by any person to
any other person pursuant to this Agreement shall be in
writing and in the English language and shall be given by
letter delivered by hand or sent by courier or facsimile and
shall be addressed to the recipient and sent to the address
or facsimile number of the recipient set out in Schedule 3
hereto marked for the attention of the representative set
out in Schedule 3 or to such other address and/or facsimile
number or marked for such other attention as such recipient
may from time to time specify by notice given in accordance
with this Section 26.1 to the Party giving the relevant
notice or other communication to it and shall be deemed to
have been received:
26.1.1 in the case of delivery by hand or by
courier, when delivered; or
26.1.2 in the case of facsimile, on acknowledgement
by the recipient facsimile receiving equipment on a
Business Day provided that such acknowledgement
occurs before 1700 hours local time of the recipient
on the Business Day of acknowledgement and in any
other case on the Business Day next following the
Business Day of acknowledgement.
26.2In the case of notices other than orders for goods given by
fax written confirmation should be sent by recorded mail
within 48 hours.
27. COSTS
27.1Each Party shall bear its own legal fees and expenses and
any other expenses incurred in the preparation and execution
of this Agreement.
28. GOVERNING LAW
28.1The interpretation, validity, construction and performance
of this Agreement shall be governed by the laws of the State
of New York, as the same may be in effect at the time of any
legal proceeding pursuant to Section 29.
29. JURISDICTION
29.1Any dispute between the Parties regarding the
interpretation, construction or performance of this
Agreement that cannot be resolved through amicable
negotiations shall be finally resolved by submission to the
exclusive jurisdiction of the United States Federal Courts
for the Southern District of New York. Solely for the
purposes of this Agreement, each of the Parties hereto does
hereby irrevocably submit to the exclusive jurisdiction of
the United States Federal Courts sitting in the Southern
District of New York.
30. NO PARTNERSHIP OR AGENCY CREATED
30.1Nothing in this Agreement shall constitute or be deemed to
constitute a partnership between TLC or its Affiliates and W-
A or constitute or be deemed to constitute W-A as agent of
TLC or its Affiliates or to contract in the name of or to
create a liability against TLC or its affiliates in any way
or for any purpose.
AS WITNESS whereto the respective signatures have been given on
behalf of the Parties hereto on the day and year first above
written.
Wyeth-Ayerst International Inc. The Liposome
Company, Inc.
By: By:
Name: Beat X. Xxxxx Name: Xxxxxxx XxXxxxx
Title: Vice President, Title: Vice President, General
Business Development Counsel & Secretary
Date: Date:
L:\LEGALDPT\LEGAL\DISTRIB\WYAY_UK6.DOC
SCHEDULE 1
AGREED MINIMUM SALES TARGETS
Year 1 817,410 British pounds (100mg vials)
156,293 British pounds (50mg vials) *
Year 2 1,022,420 British pounds
Year 3 1,073,540 British pounds
Year 4 1,073,540 British pounds
Year 5 1,073,540 British pounds
_______________
* Assuming April 1, 1999 launch of 50mg vials:
525 packs of 50mg vials (This number can be amended on a pro
rata basis if the launch date goes beyond April 1, 1999)
SCHEDULE 2
SPECIFICATIONS
ABELCET
(Amphotericin B Lipid Complex or ABLC)
Supplied as suspension in vials containing 20ml (100mg of
amphotericin B) or 10ml (50mg of amphotericin B).
Each ml contains:
Amphotericin B USP 5.0mg
L-a-Dimyristoylphosphatidylcholine (DMPC) 3.4mg
L-a-Dimyristoylphosphatidylglycerol (DMPG) 1.5mg
(as sodium and ammonium salts)
Sodium Chloride 9.0mg
Water for injection, q.s. ad 1.0ml
SCHEDULE 3
NOTICES
To TLC: The Liposome Company, Inc.
Xxx Xxxxxxxx Xxx
Xxxxxxxxx Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Facsimile: 000-000-0000
Attention: Chief Executive Officer
To W-A: Wyeth-Ayerst International Inc.
000 Xxxxxx-Xxxxxxx Xxxx
Xx. Xxxxxx, XX 00000
Facsimile: 000-000-0000
Attention: Mr. Beat X. Xxxxx
SCHEDULE 4
LIST PRICE
The List Price is as follows:
ABELCET (100mg X 10 vials) 860 British pounds
ABELCET (50mg X 10 vials) 500 British pounds
SCHEDULE 5
EXTRACT FROM WYETH-AYERST CODE OF CONDUCT
SCHEDULE 6
TLC PATENTS
(EP) 0282405
(EP) 0394265
(EP) 0270460
SCHEDULE 7
MEDICAL INFORMATION PROCEDURES
Schedule 7
Provision of Medical Information & Handling of Customer
Complaints.
1. Provision of Medical Information
1.1 Date of Handover of Inquiries
W-A shall have responsibility for the provision of Medical
Information from the Effective Date.
1.2 Stability Inquiries
W-A will handle stability inquiries as per the guidelines
below
TLC will provide guidelines (for consideration and agreement
by W-A) as to which stability inquiries W-A will handle and
where these would need to be answered in conjunction with
TLC.
1.3 Medical Information Enquiries
Answering of all Medical Information inquiries is the
responsibility of W-A.
TLC to provide copies of the following to enable W-A to
handle the above:
Abelcet Database
Copies of all Clinical Papers
Copies of all Standard Letter / Texts
Breakdown of changes to SmPC
TLC to provide back-up should W-A be unable to answer any
questions.
1.4 XXXX & BNF Entries
W-A's responsibility.
2.0 Customer Complaints
These remain the responsibility of TLC, and any complaints
will be directed care of Xxxxx Xxxxx @ TLC
