MEDTECH PRODUCTS, INC. AND PHARMACARE LIMITED AND PRESTIGE BRANDS HOLDINGS, INC. AND ASPEN PHARMACARE HOLDINGS LIMITED Exclusive Supply Agreement
EXHIBIT
10.2
MEDTECH
PRODUCTS, INC.
AND
PHARMACARE
LIMITED
AND
PRESTIGE
BRANDS HOLDINGS, INC.
AND
ASPEN
PHARMACARE HOLDINGS LIMITED
____________________________________________
____________________________________________
Table
of Contents
1. | PARTIES ....................................................................................................................................................................................................... |
1
|
2. | RECITAL ....................................................................................................................................................................................................... |
1
|
3. | INTERPRETATION................................................................................................................................................................................................ |
1
|
4. | PREREQUISITE CONDITIONS............................................................................................................................................................................ |
11
|
5. | FACILITY ..................................................................................................................................................................................................... |
12
|
6. | INTERIM PERIOD AND ALTAIRE....................................................................................................................................................................... |
12
|
7. | MATERIAL TERMS OF THE SUPPLY AGREEMENT......................................................................................................................................... |
14
|
7.1 | Supply....................................................................................................................................................................................................... |
14
|
7.2 | Right of First Refusal............................................................................................................................................................................... |
14
|
7.3 | Purchase price/s....................................................................................................................................................................................... |
15
|
7.4 | Forecasts/Firm Orders............................................................................................................................................................................. |
17
|
7.5 | Quantities of Supply and Exclusive Purchase.......................................................................................................................................... |
18
|
7.6 | Delivery.................................................................................................................................................................................................... |
19
|
7.7 | Specifications........................................................................................................................................................................................... |
19
|
7.8 | Acceptance of Delivery............................................................................................................................................................................ |
20
|
7.9 | Terms of Sale............................................................................................................................................................................................ |
21
|
7.10 | Medtech's Intellectual Property............................................................................................................................................................... |
22
|
7.11
|
Manufacturing Issues............................................................................................................................................................................... |
23
|
7.12 | Product Optimization and Line Extensions............................................................................................................................................. |
24
|
7.13 | Adverse Drug Reaction, Competent Authorities and Product Recall...................................................................................................... |
25
|
7.14 | Delivery of Know-How and Intellectual Property................................................................................................................................... |
25
|
7.15 | Warranties by Medtech............................................................................................................................................................................ |
26
|
7.16 | Strategic Plan........................................................................................................................................................................................... |
27
|
7.17 | Regulatory Support.................................................................................................................................................................................. |
27
|
7.18 | Liability.................................................................................................................................................................................................... |
28
|
7.19 | Remedies................................................................................................................................................................................................... |
29
|
7.20 | Subcontracting......................................................................................................................................................................................... |
33
|
7.21 | Sale of Business by Medtech..................................................................................................................................................................... |
33
|
8. | EFFECT OF TERMINATION OR EXPIRATION.................................................................................................................................................. |
33
|
9. | CONFIDENTIALITY.............................................................................................................................................................................................. |
34
|
10. | RELATIONSHIP OF PARTIES.............................................................................................................................................................................. |
35
|
11. | ASSIGNMENT........................................................................................................................................................................................................ |
35
|
12. | FORCE MAJEURE.................................................................................................................................................................................................. |
35
|
13. | GOVERNING LAW AND JURISDICTION........................................................................................................................................................... |
36
|
14. | NOTICES................................................................................................................................................................................................................ |
36
|
15. | ANNOUNCEMENT............................................................................................................................................................................................... |
37
|
16. | PRESTIGE SURETYSHIP....................................................................................................................................................................................... |
37
|
17. | ASPEN SURETYSHIP............................................................................................................................................................................................ |
38
|
18. | AFFILIATES............................................................................................................................................................................................................ |
40
|
19. | COSTS..................................................................................................................................................................................................................... |
40
|
EXHIBIT A | - Primary Packaging Schedules |
42
|
EXHIBIT B | - Products, Territory and Delivery Destination |
43
|
EXHIBIT C | - Quality Agreement |
44
|
EXHIBIT D | - Purchase Price/s |
00
|
XXXXXXXX XX0 | - Product Names, Strengths and Sizes |
53
|
1. |
PARTIES
|
1.1. |
Medtech
Products, Inc., a Delaware Corporation having its principal place
of
business at 00 Xxxxx Xxxxxxxx, Xxxxxxxxx, Xxx Xxxx, 00000, Xxxxxx
Xxxxxx of America (“Medtech”);
|
1.2. |
Pharmacare
Limited, a company registered and incorporated in the Republic of
South
Africa having its principal place of business at Xxxxxxxx 0 Xxxxxxxxxx
Xxxx, Xxxxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxxxx, Xxxxxxxx of South
Africa
(“Pharmacare”);
|
1.3. |
Prestige
Brands Holdings, Inc., a Delaware Corporation having its principal
office
at 00 Xxxxx Xxxxxxxx, Xxxxxxxxx, Xxx Xxxx 00000, Xxxxxx Xxxxxx of
America
(“Prestige”);
|
1.4. |
Aspen
Pharmacare Holdings Limited, a company registered and incorporated
in the
Republic of South Africa having its principal place of business at
Xxxxxxxx 0 Xxxxxxxxxx Xxxx, Xxxxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxxxx,
Xxxxxxxx of South Africa (“Aspen”).
|
2. |
RECITAL
|
2.1. |
Medtech
and
Pharmacare are entering into this supply agreement with regard to
the
manufacture and supply by Pharmacare of the products (as defined
below) to
Medtech and certain ancillary issues.
This supply agreement is intended to be exclusive in the United States
and
Canada except as specifically provided herein. This supply agreement
is
not intended to be exclusive outside the United States and Canada
unless
specifically provided herein.
|
2.2. |
Pharmacare
is a wholly owned subsidiary of
Aspen.
|
2.3. |
Medtech
is a wholly owned subsidiary of
Prestige.
|
3. |
INTERPRETATION
|
In this Supply Agreement -
3.1.
|
4
clause
headings are for convenience and shall not be used in its interpretation
unless the context clearly indicates a contrary intention
-
|
3.1.1. |
an
expression which denotes the singular includes the plural and vice
versa;
|
3.1.2. |
the
following expressions bear the meanings assigned to them below and
cognate
expressions bear corresponding meanings
-
|
3.1.2.1. |
“this
agreement”
means this agreement and its Exhibits, as amended, from time to
time;
|
3.1.2.2. |
“adverse
event”
means any untoward medical occurrence that may present during treatment
with a medicine, but which does not necessarily have a causal relationship
with this treatment;
|
3.1.2.3. |
“affiliate/s”
means an entity, (whether or not incorporated and including without
any
limitation, a company, corporation, trust, partnership, joint venture
or
other association of persons) which, presently or in the
future -
|
3.1.2.3.1. |
is
owned or controlled by a party hereto by way of ownership, directly
or
indirectly, of 20% or more of such entity’s share capital or otherwise,
and such an entity shall continue to be deemed an affiliate only
as long
as such ownership or control continues;
or
|
3.1.2.3.2. |
owns
or controls a party hereto by way of ownership, directly or indirectly,
of
20% or more of such party’s share capital or otherwise, and such an entity
shall continue to be an affiliate only for so long as such ownership
or
control continues;
|
3.1.2.4. |
“Altaire”
means Altaire Pharmaceuticals Inc., a Delaware Corporation having
its
principal place of business at 00-0 Xxxxx Xxxxx, Xxxxxxxx, Xxx Xxxx
00000,
Voice 000-000-0000; Fax
000-000-0000;
|
5 |
3.1.2.5. |
“applicable
laws”
means in relation to any person or entity, all or any laws compliance
with
which is mandatory for that person or
entity;
|
3.1.2.6. |
“bulks”
means bulk batches of the manufactured products prior to their primary
packaging;
|
3.1.2.7. |
“current
good manufacturing practice or cGMP’s”
means the regulatory and other standards of good manufacturing practice
relating to the manufacture of medicinal products as directed in
the Code
of Federal Regulations 21 CFR, Parts 210 and 211 and the Guidance
for
Industry: cGMP’s;
|
3.1.2.8. |
“commission/commissioned”
means the stage at which government or regulatory authority has been
granted and the facility is capable of commencing manufacture of
the
products;
|
3.1.2.9. |
“confidential
information”
means information of a confidential and proprietary nature as defined
in
clause
9;
|
3.1.2.10. |
“effective
date”means
the date upon which this agreement is signed by the party which signs
it
last in time;
|
3.1.2.11. |
“exclusive
supply term”
means the period commencing on 1 January 2009 and terminating on 31
December 2013 and the extended period/s (if
any);
|
3.1.2.12. |
“extended
period/s”
has the meaning given to that term in clause
3.1.2.44;
|
3.1.2.13. |
“ex-works”
means ex-works as determined in accordance with INCOTERMS
2000;
|
3.1.2.14. |
“facility”
means the eye drop manufacturing facility which is in the process
of being
constructed by Pharmacare in Xxxx Xxxxxxxxx, Xxxxxxxx xx Xxxxx Xxxxxx,
for
the purposes of, inter
alia,
manufacturing the products;
|
6 |
3.1.2.15. |
“FDA”
means the United States Department of Health and Human Services,
Food and
Drug Administration;
|
3.1.2.16. |
“firm
order”has
the meaning given to that term in clause
7.4;
|
3.1.2.17. |
“firm
order period”
has the meaning given to that term in clause
7.4;
|
3.1.2.18. |
“force
majeure event”
means an event which interferes with the ability of a party to perform
its
obligations or duties under the supply agreement which is not within
the
reasonable control of the party affected, not due to malfeasance,
and
which could not with the exercise of due diligence have been avoided,
including fire, accident, labour difficulty, strike, riot, civil
commotion, act of God, delay or change in
law;
|
3.1.2.19. |
“governmental
or regulatory authority”
means any court, tribunal, arbitrator, agency, commission, official,
department, inspectorate, ministry, parliament or public or statutory
person or other instrumentality of any relevant country, state, province,
county, city or other political subdivision having jurisdiction over
any
of the activities contemplated by the supply agreement and for the
avoidance of doubt shall include the
FDA;
|
3.1.2.20. |
“interim
period”
means the period from the effective date until 31 December
2008;
|
3.1.2.21. |
“intellectual
property”
means the body of technical information that is secret and substantial
and
comprises the formulae, specific manufacturing and packaging instructions
(including but not limited to information, formulations, instructions,
specifications and methods of quality control) but excluding the
trademarks and patents;
|
3.1.2.22. |
“inventory”
means raw materials and packaging components for the
products;
|
7 |
3.1.2.23. |
“know-how”
means the scientific and technical practices developed or owned by
Medtech
that are secret and substantial as well as any knowledge or the right
to
have the knowledge relating to the intellectual property imparted
and
comprises techniques and processes which are inherent and necessary
to
manufacture the products so as to enable Pharmacare to so manufacture
the
products;
|
3.1.2.24. |
“laws”
means all laws, statutes, rules, regulations, ordinances, guidelines
and
other pronouncements having the effect of law of any relevant governmental
or regulatory authority;
|
3.1.2.25. |
“latent
defect”
means a defect (a) existing at the time of receipt of the products
by
Medtech which is not discovered by visual inspection of the products
by
Medtech (or could not have been discovered by visual inspection in
accordance with clause
7.8.1
of
this agreement); but excluding (b) (i) a defect arising after the
transfer
of risk in the products including a defect resulting from the storage,
handling or transport of the products following the transfer of risk;
and
(ii) a defect which is attributable to any specifications or instructions
received from Medtech;
|
3.1.2.26. |
“manufacture”means
all the activities relating to the production of each product spanning
from purchasing the inventory to production, quality control and
assurance, filling, labelling, packaging and finishing, release,
holding
and storage and the tests and analyses conducted in connection
therewith;
|
3.1.2.27. |
“manufacturing
authorisation”
means the authorisation to manufacture the products as granted by
the
relevant governmental or regulatory
authorities;
|
3.1.2.28. |
“marketing
authorisation”
means those product licences and product authorisations relating
to the
products which enable the sale of the products in any part of the
territory as granted by the relevant governmental or regulatory
authorities;
|
8 |
3.1.2.29. |
“Medtech’s
requirements of the products”
means the total volume of the products which Medtech and/or its
affiliates, directly or indirectly, market, distribute and/or sell
in the
territory;
|
3.1.2.30. |
“party”
means either Medtech or Pharmacare and “parties”
shall mean both Medtech and
Pharmacare;
|
3.1.2.31. |
“patents”means
any unexpired and otherwise valid patent issued by the United States
Patent and trademark Office licensed, owned or applied for by Medtech
or
its affiliates pertaining to the products and used in their
manufacture;
|
3.1.2.32. |
“primary
packaging”
means the packaging that constitutes the final packed individual
product
unit in a form suitable for sale to retailers which, as at the effective
date, consist of the packaging specifications set out in
Exhibit
A;
|
3.1.2.33. |
“prime
rate”
means the minimum overdraft rate (percent per annum, compounded monthly)
from time to time published by the Standard Bank of South Africa
Limited
as being its minimum overdraft rate to its prime customers in the
private
sector, as certified by any manager of that bank, whose designation
need
not be proved;
|
3.1.2.34 |
“product”means
the products described in column
1
of
Exhibit
B;
|
3.1.2.35. |
“quality
agreement”means
the quality agreement which stands to be executed between the parties
in
relation to the delineation of technical and quality assurance
responsibilities of the parties, which agreement will be substantially
in
accordance with the pro-forma quality agreement, annexed hereto marked
Exhibit
C;
|
3.1.2.36. |
“regulatory
support”
means the allocation, in the Republic of South Africa, of one suitably
qualified representative of Pharmacare to assist Medtech in undertaking
the compliance activities and processes relating to the maintenance
and
updating
|
9 |
of the marketing authorisations in so far as the activities relate to the purchasing of inventory, production, quality control and assurance, filling, labelling, packaging and finishing, release, holding and storage of the products; under the direct supervision, instruction and control and at the risk of Medtech and which includes the grant of the rights of use to Medtech of Pharmacare’s equipment and consumables incidental thereto; |
3.1.2.37. |
“rolling
forecast”
has the meaning given to that term in clause
7.4.1;
|
3.1.2.38. |
“secondary
packaging”
means the packaging that constitutes the outer packaging (including
but
not limited to shrink wrap and pallets) used to transport and store
the
products;
|
3.1.2.39. |
“serious
adverse event”
means any untoward medical occurrence that at any
dose:
|
3.1.2.39.1. |
results
in death;
|
3.1.2.39.2. |
is
life-threatening, in that the patient is at risk of death at any
time of
the event;
|
3.1.2.39.3. |
requires
patient hospitalisation or prolongation of existing
hospitalisation;
|
3.1.2.39.4. |
results
in persistent or significant disability/incapacity;
or
|
3.1.2.39.5. |
results
in a congenital abnormality/birth
defect;
|
3.1.2.40. |
“specifications”
means the specifications applicable to the products as recorded in
their
respective marketing
authorisations;
|
3.1.2.41. |
“stability
services”
means all activities and processes necessary to validate the products
shelf life in accordance with the stability protocol recorded in
the
technical agreement;
|
10 |
3.1.2.42. |
“strategic
plan”
means the strategic plan referred to in clause
7.16;
|
3.1.2.43. |
“territory”
means the United States and Canada. The territory may be expanded
or
contracted from time to time by written agreement between the
parties;
|
3.1.2.44. |
“term”
means the period commencing on the effective date and terminating
on 31
December 2013 (“the initial period”) which agreement will be automatically
extended for consecutive periods of 5 (five) years each (“the extended
periods”) on the same terms and subject to the same conditions set out in
the supply agreement unless either party gives the other party written
notice of its intention to terminate the supply agreement, which
notice
shall be given at least 18 (eighteen) months prior to the expiry
of the
initial period or any of the extended periods (as the case may
be);
|
3.1.2.45. |
“trademarks”
means Medtech’s name and logo and other trademarks (including but not
limited to Murine and Clear Eyes) it wishes to include on the
products;
|
3.1.2.46. |
“validation/validated”
means the process of establishing documented evidence which produces
a
high degree of assurance that a specific process will consistently
produce
the bulks in a form which will meet their pre-determined specifications
and quality attributes.
|
4. |
PREREQUISITE
CONDITIONS
|
4.1. |
This
agreement (other than 1, 2, 3, this 4 and 9 to 19, by which the parties
shall immediately be bound) is subject to fulfilment of the prerequisite
antecedent conditions that by no later than midnight (South African
time)
on 21 September 2006 -
|
4.1.1. |
the
board of directors of Aspen approves the transaction contemplated
in this
agreement; and
|
11 |
4.1.2. |
the
board of directors of Prestige approves the transaction contemplated
in
this agreement.
|
4.2. |
Each
of the parties shall, insofar as may be applicable, use all reasonable
commercial endeavours to procure the fulfilment of the prerequisite
conditions.
|
4.3. |
Each
of the prerequisite conditions are expressed to be for the benefit
of both
parties and may be waived only by unanimous written agreement between
the
parties at any time prior to the date for the fulfilment thereof,
provided
that such waiver is competent in terms of the applicable
laws.
|
4.4. |
The
parties shall be entitled to extend the time period for the fulfilment
of
any of the prerequisite conditions by written agreement prior to
the
expiry of any time period for fulfilment of any of the unfulfilled
prerequisite condition/s, provided that such extension of time is
competent in terms of the applicable
laws.
|
4.5. |
If
any prerequisite condition is validly waived, it shall be deemed
to have
been fulfilled.
|
4.6. |
If
any prerequisite condition is not fulfilled for any reason other
than as a
result of a breach of 4.2 -
|
4.6.1. |
the
whole of this agreement (other than 1, 2, 3, this 4 and 9 to 19 by
which
the parties shall continue to be bound) shall have no force or effect;
and
|
4.6.2. |
no
party shall have any claim against any other in terms of this agreement
except for such claims, if any, as may arise from a breach of any
provision of this agreement by which the parties remain bound.
|
5. |
FACILITY
|
5.1. |
Pharmacare
will construct and commission the facility so as to enable Pharmacare
to
manufacture the products in accordance with the terms and subject
to the
conditions set out in this
agreement.
|
5.2. |
Pharmacare
undertakes to use its best endeavours to procure
that:
|
12 |
5.2.1. |
by
1 January 2008, the facility will be capable of commencing the process
of
validating the bulks;
|
5.2.2. |
by
1 July 2008, the bulks will be validated;
and
|
5.2.3. |
by
1 January 2009, the facility will be commissioned and capable of
manufacturing the products in those quantities set out in clause
7.5.1.
|
5.3. |
Notwithstanding
the aforesaid, Pharmacare will use its best endeavours to commence
manufacturing the products as early as is practically
possible.
|
6. |
INTERIM
PERIOD AND ALTAIRE
|
6.1. |
Medtech
acknowledges that it is unlikely that Pharmacare will be capable
of:
|
6.1.1. |
manufacturing
the products for commercial sale prior to 1 July 2008;
and
|
6.1.2. |
meeting
all of Medtech’s requirements for the products prior to 1 January
2009.
|
6.2. |
Accordingly,
Medtech will be obliged to secure its own supply of the products
during
the interim period, this by:
|
6.2.1. |
attending
to a stock build-up of the products and extending the products shelf
life;
and/or
|
6.2.2. |
purchasing
the products from Altaire or another
supplier.
|
6.3. |
During
the interim period, Medtech may elect to purchase certain of its
requirements of the products from Pharmacare, on the terms and subject
to
the conditions set out in this agreement, to the extent agreed between
the
parties, in writing, from time to time. During the interim period
Medtech
shall not be required to purchase its requirements from Pharmacare
if such
purchase would violate the terms of any agreement with Altaire or
another
supplier.
|
6.4 | Pharmacare shall contribute the maximum sum of US$250,000.00 (two hundred and fifty thousand United States Dollars) towards Altaire's process validation |
13 |
costs
in relation to the products so as to facilitate Altaire's ability
to act
as a back-up supplier in accordance with the provisions of clause
6.6.2 and thereafter during the entire term. The aforesaid
sum of US$250,000.00 (two hundred and fifty thouseand United States
Dollars) shall constitute the maximum amount payable by Pharmacare
to
Medtech in reimbursement of such costs and such payment shall be
subject
to -
|
6.4.1.
Altaire's costs being reasonable, necessary and directly in relation to the
process validation of the products by Altaire; and
6.4.2.
Medtech issuing a valid invoice on Pharmacare and providing Pharmacare with
copies of documents in support of the relevant costs and evidencing
the
successful process validation of the products by Altaire.
6.5
Medtech
undertakes to maintain
Altaire, or other suitable vendor as its back-up supplier of the Products during
the entire term.
14 |
7. |
MATERIAL
TERMS OF THE SUPPLY
AGREEMENT
|
7.1. |
Supply
|
7.1.1. |
Subject
to clauses
7.5
and/or 7.19.1,
during the exclusive supply term and the extended period/s (if any),
Pharmacare will exclusively sell and supply the products to Medtech,
which
will exclusively purchase all of Medtech and its affiliates’ requirements
of the products for the territory from Pharmacare on the terms and
subject
to the conditions set out
hereunder.
|
7.1.2. |
For
clarification purposes it is recorded that neither party has any
rights
and/or obligations against the other party in relation to
-
|
7.1.2.1. |
the
manufacture, supply and/or purchase of any products which will be
marketed, distributed and/or sold in any geographical area, other
than the
territory (unless the territory is expanded by written agreement
between
the parties); and/or
|
7.1.2.2. |
any
products, other than the products as defined (unless Pharmacare exercises
its rights of first refusal in terms of clause
7.2).
|
7.2. |
Right
of First Refusal
|
7.2.1. |
Should
Medtech and/or its affiliates at any time during the term
-
|
7.2.1.1. |
intend
to market, distribute and/or sell additional sterile liquid eye care
products or extensions to the products anywhere in the territory
(“the
new
products”);
and/or
|
7.2.1.2. |
require
the manufacture of the products and/or new products for marketing,
distribution and/or sale outside of the territory (“the external
territory”)
|
then Medtech shall give notice, in writing (“the offer
notice”)
to
Pharmacare of it and/or its affiliates intention to so develop, market,
15
distribute and/or sell the new products and/or its requirements for the products
in relation to the external territory.
7.2.2. |
The
offer notice shall -
|
7.2.2.1. |
set
out the precise specifications of the new products and their primary
packaging and/or the intended jurisdiction of their sale;
and
|
7.2.2.2. |
state
the price at which Medtech proposes to purchase the new products
and/or
the products in relation to the external
territory.
|
7.2.3. |
For
a period of 90 (ninety) days from the receipt of the offer notice,
Pharmacare shall have the irrevocable right and option to elect to
manufacture, supply and sell the new products and/or the products
in
relation to the external territory at the price set out in the offer
notice read together with the terms and conditions set out in this
agreement.
|
7.2.4. |
In
the event of Pharmacare not accepting its irrevocable right and option
set
out in the offer notice within the aforesaid period of 90 (ninety)
days,
it shall be deemed to have declined the same and Medtech and/or its
affiliates shall then have the right to purchase the new products
and/or
the products in relation to the external territory from a third party
of
its choice, provided that the price thereof shall not be higher than
the
price set out in the offer notice.
|
7.2.5. |
The
provisions of this clause
7
shall not apply in circumstances where Medtech and/or its affiliates
do
not have the legal and/or contractual competence to procure the
manufacture of the new products and/or the manufacture of the products
for
marketing, distribution and/or sale in the external territory by
Pharmacare. Medtech hereby undertakes to Pharmacare to use its best
endeavours, in all circumstances, to obtain such legal and/or contractual
competence.
|
7.3. |
Purchase
price/s
|
7.3.1. |
Medtech
shall purchase the products from Pharmacare at the purchase price/s
(“the
purchase
price/s”)
set out in Exhibit
D.
|
16 |
7.3.2. |
The
purchase price/s are ex-works.
|
7.3.3. |
The
purchase price/s shall -
|
7.3.3.1. |
include
|
7.3.3.1.1. |
the
costs of conversion as set out in Exhibit
D
as
adjusted, from time to time, in accordance with the provisions of
clauses
7.3.4
and/or 7.3.5;
|
7.3.3.1.2. |
the
costs of primary packaging;
|
7.3.3.1.3. |
the
costs of raw material;
|
7.3.3.1.4. |
the
costs of providing stability services;
and
|
7.3.3.1.5. |
the
costs of providing the regulatory
support;
|
7.3.3.2. |
exclude
|
7.3.3.2.1. |
the
costs of secondary packaging; and
|
7.3.3.2.2. |
the
costs of delivery.
|
7.3.4. |
The
purchase price/s shall be increased -
|
7.3.4.1. |
in
relation to the costs of conversion on 1 January 2010 and on 1 January
of
each succeeding year taking into account price affecting factors,
such as
variations in Pharmacare’s costs of labour, energy, increases in taxes and
all other relevant factors affecting Pharmacare’s conversion costs in
manufacturing the products;
|
7.3.4.2. |
in
relation to the costs of all other components as set out in clauses
7.3.3.1.2, 7.3.3.1.3, 7.3.3.1.4 and 7.3.3.1.5
on
the earlier of 1 January 2009 or the date of first supply of the
products
to Medtech and on 1 January of each succeeding year taking into
|
17 |
account the actual increase in Pharmacare's costs of procuring and/or rendering the same. |
7.3.5. |
No
later than 60 (sixty) days prior to each purchase price increase,
Pharmacare shall submit reasonable documentary proof of the factors
affecting such increases to Medtech and enter into consultations
with
Medtech in relation thereto.
|
7.3.6. |
Notwithstanding
the provisions of clause
7.3.4
increases in the purchase price/s shall be moderated (“the moderation”) by
-
|
7.3.6.1. |
manufacturing
process improvements achieved, from time to time, by Pharmacare in
relation to the manufacture of the products. Pharmacare undertakes
to use
its best endeavours to achieve such improvements;
and
|
7.3.6.2. |
those
cost efficiencies which will accrue to Pharmacare in the event of
Medtech
purchasing more than 28 000 000 (twenty eight million) units of
the products from Pharmacare during any calendar year of the
term.
|
The
moderation will be tabled by Pharmacare on an annual basis and determined in
consultation with Medtech.
7.3.7 |
No
price increase shall be effective unless and until Pharmacare has
provided
at least 60 days notice in writing to
Medtech.
|
7.4. |
Forecasts/Firm
Orders
|
7.4.1. |
Unless
otherwise agreed in writing by the parties, Medtech shall on a monthly
basis provide Pharmacare with a rolling forecast of its requirements
for
the products for an 18 (eighteen) month period (the “rolling
forecast”).
All rolling forecasts and any updates to such rolling forecasts shall
be
updated on a monthly basis and provided to Pharmacare by the 10 (tenth)
business day of each month, for the 18 (eighteen) month period commencing
on the first day of the immediately following
month.
|
18 |
7.4.2. |
Medtech’s
requirements of the products during the first 3 (three) months of
the
rolling forecast (“the
firm order period”)
shall be considered a firm order (in that Medtech will be required
to
purchase and Pharmacare shall be required to supply the products)
(the
“firm
order”)
unless agreed otherwise by the parties in writing. Firm orders each
month
shall be in accordance with the multiple order quantity of that product’s
manufacture batch size (that is, in whole multiple manufacture batch
sizes
and not fractions thereof).
|
7.4.3. |
Pharmacare
shall order sufficient quantities of the inventory to enable it to
manufacture the products in accordance with Medtech’s requirements for
firm orders.
|
7.5. |
Quantities
of Supply and Exclusive
Purchase
|
7.5.1. |
Notwithstanding
any other provisions of this agreement during each calendar year
Pharmacare shall not be obliged to supply more than 30 000 000
(thirty million) units of the products and, in any event, not more
than
-
|
7.5.1.1. |
9 000 000
(nine million) units of the products which are 0.2 (nought point
two)
ounces and/or 10 (ten) millilitres in
size;
|
7.5.1.2. |
3 000 0000
(three million) units of the products which are 1 (one) ounce in
size;
|
7.5.1.3.
|
24 000 000
(twenty four million) units of the products which are 0.5 (nought
point
five) ounces in size.
|
7.5.2. |
Subject
to clauses
7.5
and 7.19.1,
Medtech shall, during the exclusive supply term and the extended
period/s
(if any), be obliged to purchase all of Medtech and its affiliates’
requirements of the products for the territory exclusively from Pharmacare
on the terms and subject to the conditions set out in this
agreement.
|
7.5.3. |
Notwithstanding
any other provision of this agreement, should Medtech require in
excess of
30 000 000 (thirty million) units of the products during
|
19 |
any
calendar year and/or products in excess of the threshold set out
in
clause
7.5.1
(“the additional
products”),
then Medtech shall give notice, in writing (theinvitation
notice”)
to Pharmacare of its requirements for the additional products and
Pharmacare shall, for a period of 30 (thirty) days from the date
of
receipt of the invitation notice, have the irrevocable right and
option to
elect to manufacture, sell and supply the additional products to
Medtech
on the terms and subject to the conditions set out in this agreement.
In
the event of Pharmacare failing to accept the irrevocable right and
option
set out in the invitation notice, then it shall be deemed to have
declined
the same and Medtech shall be entitled to purchase the additional
products
from a third party of its choice.
|
7.6. |
Delivery
|
7.6.1. |
Pharmacare
shall deliver each firm order of each product in the quantities and
within
the delivery dates directed by Medtech as specified in the firm order,
at
Medtech’s expense. A firm order will be considered complete if it is
within a tolerance of + or - 5% (five percent) of the ordered quantity.
Any deviation greater than + or - 5% (five percent) needs to be agreed
in
writing between the parties.
|
7.6.2. |
Pharmacare
shall ensure that all products supplied under this agreement, other
than
validation batches, shall have their relevant registered shelf-life,
less
a maximum of 90 (ninety) days, at the date of delivery thereof (ex-works)
unless otherwise agreed in writing between the
parties.
|
7.6.3. |
Delivery
will be considered on time if the products are delivered (as determined
in
accordance with INCOTERM ex-works) at anytime during the month for
delivery.
|
7.6.4. |
Pharmacare
shall arrange the delivery of each order of the product to the location
as
agreed, in writing, between the
parties.
|
7.7. |
Specifications
|
7.7.1. |
Changes
may be made in the specifications as required to maintain the product
for
sale in the territory, subject to written agreement between the
|
20 |
parties
and compliance with cGMP’s. Medtech shall notify Pharmacare as far in
advance as is practicable prior to the effectiveness of such amendment
or
change and Pharmacare shall promptly notify Medtech of the implementation
of any such amendment or change. To the extent that such amendment
or
change results in an increase or reduction in the cost of manufacturing
a
product, the parties shall jointly examine and mutually agree upon
the
consequences thereof and shall make appropriate adjustments to the
purchase price/s, save as otherwise agreed in writing any such increase
in
the purchase price/s shall be borne by
Medtech.
|
7.7.2. |
Changes
in the specifications requested by Medtech in relation to product
improvements and the like shall require Pharmacare’s prior written
consent, which consent shall not be unreasonably withheld. To the
extent
that such changes result in an increase or reduction in the costs
of
manufacturing a product, the parties shall jointly examine and mutually
agree upon the consequences thereof and shall make appropriate adjustments
to the purchase price/s. Save as is otherwise agreed in writing any
such
increase in purchase price/s shall be borne by Medtech. Medtech shall
also
be liable for and shall pay for the costs of amending the know-how
and/or
intellectual property as a consequence of such changes to the
specifications, including but not limited to validation and
stability.
|
7.7.3. |
Medtech
and Pharmacare shall cooperate to ensure that the specifications
and other
instructions provided by Medtech are and shall, at all times, be
in
accordance with the marketing authorisations for each product.
Notwithstanding the aforesaid, Medtech shall be solely responsible
for
ensuring that the specifications and all instructions given to Pharmacare
are, at all times, in accordance with the marketing authorisation
for each
product and the applicable laws. Medtech shall be solely liable for
any
omissions and/or shortcomings in relation to the marketing authorisations
for each product.
|
7.8. |
Acceptance
of Delivery
|
7.8.1. |
Medtech
shall, within a period of 30 (thirty) business days of receipt of
products
delivered to it (or its nominee) by Pharmacare have the right to
|
21 |
reject
any such products as a consequence of them being defective or where
the
products delivered are outside the quantity tolerance specified in
clause
7.6.1.
If Medtech does not notify Pharmacare of its election to reject the
products within the aforesaid period of 30 (thirty) business days,
then
the products delivered will be deemed to have been accepted by Medtech
unless the defect is latent.
|
7.8.2. |
In
addition to the rights to return defective products in clause
7.8.1,
following the date of delivery of a product to Medtech (or its nominee),
Medtech shall be entitled to return products still in the possession
or
under the control of Medtech in the event that latent defects in
such
products later become evident.
|
7.8.3. |
Any
quantities of the products which are properly rejected and/or returned
by
Medtech in accordance with the provisions of this agreement shall
be
returned to Pharmacare at Pharmacare’s expense and at Pharmacare’s
option:
|
7.8.3.1. |
the
products shall be replaced by Pharmacare as quickly as possible at
Pharmacare’s sole expense; or
|
7.8.3.2. |
Pharmacare
shall refund the purchase price/s then paid to it by Medtech in respect
of
those products.
|
7.9. |
Terms
of Sale
|
7.9.1. |
The
products shall be delivered ex-works and accordingly the purchase
price/s
therefor excludes the costs and expenses associated with delivery
and
secondary packaging. The parties undertake to co-operate to do all
things
reasonably practicable to ensure the reliable and economic delivery
of the
products to Medtech.
|
7.9.2. |
Unless
otherwise agreed by the parties in writing, Pharmacare shall be
responsible for making the delivery arrangements on behalf of Medtech.
The
parties shall annually in advance (or at such other times as agreed)
agree
delivery arrangements for the supply during that year (or other relevant
following period).
|
22 |
7.9.3. |
All
or any direct costs and expenses incurred by Pharmacare in respect
of the
actual delivery of the products and in relation to secondary packaging
shall be reimbursed by Medtech to Pharmacare simultaneously with
the
payment of the purchase price/s for the products in
question.
|
7.9.4. |
Pharmacare
shall issue an invoice with each delivery of product in respect of
the
purchase price/s of such products which invoice will include the
costs and
expenses of delivery and/or secondary packaging referred to in
clause
7.9.3
above and Medtech agrees to pay such invoice by wire transfer arranged
through an United States bank, payable within 60 (sixty) days from
the
issue of the invoice.
|
7.9.5. |
All
payments of the purchase price/s or other sums payable by Medtech
shall be
made without any set-off in a timely fashion. Any amount due to Pharmacare
and not paid within the required period shall be subject to interest
charged at the prime rate (both before and after any judgement) calculated
from the date the payment of the relevant sum was due to the date
it is
paid in full (inclusive).
|
7.9.6. |
The
risk of loss, damage, destruction of products shall pass to Medtech
when
the products are delivered (as determined in accordance with the
INCOTERM
ex-works).
|
7.9.7. |
The
legal and beneficial title to the products shall transfer to Medtech
on
the date Pharmacare has received payment in full and in cleared funds
of
the purchase price/s for the
products.
|
7.10. |
Medtech’s
Intellectual Property
|
In
order
to avoid the infringement of Medtech’s intellectual property and solely for the
purposes of Pharmacare manufacturing the products for Medtech, Medtech grants
to
Pharmacare non-transferable, royalty-free, non-exclusive license to use
the:
7.10.1. |
trademarks;
and
|
7.10.2. |
the
intellectual property.
|
23 |
7.11. |
Manufacturing
Issues
|
7.11.1. |
If
it is necessary for the purposes of compliance with any applicable
laws
for Pharmacare to make any change to the manufacturing process, procedures
or facilities including changes in or replacement of equipment it
shall so
notify Medtech and Medtech shall as soon as possible make all such
changes
to the marketing authorisation, through application to the relevant
governmental or regulatory authority and Pharmacare shall, at Medtech’s
cost and expense (which costs and expenses shall be paid for by Medtech
and/or reimbursed to Pharmacare by Medtech against demand), supply
data
which Medtech reasonably requires for such
purpose.
|
7.11.2. |
Pharmacare
warrants to Medtech that it will manufacture each product in compliance
with the specifications for such product and in accordance with good
manufacturing practices, the marketing authorisations and the provisions
of the technical agreement.
|
7.11.3. |
Pharmacare
will, at its cost and expense, maintain all necessary manufacturing
authorisations to manufacture the
products.
|
7.11.4. |
Pharmacare
will be responsible for creating and retaining all records relating
to the
manufacture of the product as required by the applicable laws and
confirmed in the technical
agreement.
|
7.11.5. |
Pharmacare
shall, at its cost and expense, conduct all necessary validation
and
routine maintenance stability studies in respect of the
products.
|
7.11.6. |
Pharmacare
shall be responsible for procuring all inventory for each product.
All
inventory procured by Pharmacare and used in the products shall be
tested
(by Pharmacare or the supplier thereof) to assure that they meet
the
specifications and quality
standards.
|
7.11.7. |
Pharmacare
shall supply products bearing the trademarks and Medtech’s marketing
authorisation number and Medtech shall be responsible for determining
the
contents and appearance of the product containers,
|
24 |
labels, inserts and packaging materials in relation to the primary packaging. |
7.11.8. |
Pharmacare
shall make changes to the appearance of the primary packaging as
requested
by Medtech from time to time. Pharmacare will make no change to the
primary packaging without the prior written approval of Medtech.
All
increases in costs associated with changes to the primary packaging,
including but not limited to stability tests to support such changes,
shall be added to and incorporated into the purchase price/s of the
products.
|
7.11.9. |
In
order that Pharmacare can make the necessary preparations for the
commencement of manufacture of each product (and primary packaging)
bearing Medtech’s name and logo Medtech shall provide Pharmacare with
copies of the necessary artwork, materials and other information
required
by Pharmacare a reasonable period prior to the commencement of their
production in accordance with Pharmacare’s reasonable
lead-times.
|
7.12. |
Product
Optimisation and Line
Extensions
|
7.12.1. |
The
parties will meet twice annually in order to evaluate Medtech’s
requirements for the development of product optimisations and line
extensions (“the development
work”)
for the ensuing 12 (twelve) month period. The meeting site will alternate
between Port Xxxxxxxxx, South Africa and Irvington, New
York.
|
7.12.2. |
Within
30 (thirty) days of Medtech’s requirements for the development work having
been determined, Pharmacare shall have the right to submit a quote
to
Medtech to undertake the whole or part of the development work and
simultaneously therewith Pharmacare shall give to Medtech the anticipated
date/s by which Pharmacare will be in a position to complete the
same.
|
7.12.3. |
In
the event of Medtech and Pharmacare failing to reach agreement on
any
issue relevant to the development work and/or Pharmacare failing
to timely
submit its proposals to Medtech in that regard, Medtech shall be
|
25 |
entitled to engage a third party of its choice to undertake the development work without recourse to or from Pharmacare. |
7.13. |
Adverse
Drug Reaction, Competent Authorities and Product
Recall
|
7.13.1. |
Medtech
will be responsible for reporting any adverse event in particular,
without
limiting the generality of the aforegoing, any serious adverse event
unless otherwise agreed, in writing, between the
parties.
|
7.13.2. |
Pharmacare
shall, immediately upon receipt of any communication from any governmental
or regulatory authority relating to each product, forward a copy
or
description of the same to Medtech and respond to all inquiries by
Medtech
relating thereto. If Pharmacare must communicate with any governmental
or
regulatory authority, then Pharmacare shall so advise Medtech immediately,
and, unless prohibited by the applicable law, provide Medtech in
advance
with a copy of any proposed written communication and comply with
any and
all reasonable direction of Medtech concerning any meeting or written
or
oral communication with any governmental or regulatory
authority.
|
7.13.3. |
Medtech
shall have sole responsibility for and shall make all decisions with
respect to any complaint, recall, market withdrawals or any other
corrective action related to the
products.
|
7.14. |
Delivery
of Know-How and Intellectual
Property
|
The
parties shall agree, in the strategic plan, the process
and timing of the delivery of the know-how and intellectual property
by
Medtech to Pharmacare which know-how and intellectual property shall
include but not be limited to a technical data pack in respect of
each of
the products containing at least the vendor details, specifications
and
test methods for active pharmaceutical ingredients and excipients,
vendor
details, specifications and test methods for primary packaging, detailed
requirements of printed primary packaging, detailed manufacturing
and
primary packing instructions, secondary packaging instructions, validation
parameters and previous reports, finished product specifications
and test
methods, validations and/or system suitability data, stability
|
26
protocols
and results of previous stability tests, complete batch manufacturing records
for past batches and product samples.
7.15. |
Warranties
by Medtech
|
Medtech
warrant to
Pharmacare that -
7.15.1. |
the
know-how and/or knowledge relating to the intellectual property will
be
disclosed and/or imparted to Pharmacare on the date/s set out in
the
strategic plan and will be sufficient, without the necessity of Pharmacare
undertaking further work thereon other than process validation and
expiration dating, to manufacture the products in accordance with
the
manufacturing authorisations, the marketing authorisations and the
applicable laws;
|
7.15.2. |
neither
the trademarks or the primary packaging will, throughout the term,
infringe the rights, including the intellectual property rights,
of any
person or entity when delivered to Medtech for sale in the
territory;
|
7.15.3. |
the
transfer of the know-how and intellectual property to Pharmacare
will not
infringe the rights, including the intellectual property rights,
of any
person or entity and it will, throughout the term, have the exclusive
legal and beneficial interest in the know-how and related
information;
|
7.15.4. |
provided
that the products have been manufactured by Pharmacare in compliance
with
their specifications and in accordance with good manufacturing practices
and all applicable laws will not whether, by their use or administration
or otherwise, cause any adverse event and, in particular, without
limiting
the generality of the aforegoing, any serious adverse event;
and
|
7.15.5. |
it
will purchase from Pharmacare no less than those quantities of the
products as set out in clause
7.5.2.
|
27 |
7.16. |
Strategic
Plan
|
7.16.1. |
As
soon as is practicably possible after the effective date, the parties
will
meet and do all things necessary, in good faith, to develop a strategic
plan in relation to, inter
alia
-
|
7.16.1.1. |
the
method and timing of the delivery and transfer of the know-how and
intellectual property to
Pharmacare;
|
7.16.1.2. |
the
transitional plan incorporating the supply of the products by Pharmacare
to Medtech during the interim period and the transfer of the manufacture
of the products from Xxxxxx Laboratories Inc. to Pharmacare and where
necessary Altaire;
|
7.16.1.3. |
the
method and timing of the commissioning of the facility and each part
of
that facility;
|
7.16.1.4. |
the
method and timing of the validation and the proposed order of such
validation; and
|
7.16.1.5. |
the
arrangements for the delivery of the products to the locations agreed,
in
writing, between the parties.
|
7.16.2. |
The
parties shall be obliged to allocate and dedicate, at their respective
cost and expense, sufficient resources and skilled personnel to ensure
that the strategic plan promotes and establishes a sound and enduring
business relationship between the parties on the terms and subject
to the
conditions set out in this
agreement.
|
7.17. |
Regulatory
Support
|
7.17.1. |
Notwithstanding
the purchase price/s being inclusive of regulatory support, Medtech
shall,
at all times, and without limitation be solely responsible to ensure
that
all activities and processes relating to the maintenance and updating
of
the marketing authorisations are timely and comprehensively undertaken
in
accordance with the applicable
laws.
|
28 |
7.17.2. |
Pharmacare’s
obligations in relation to regulatory support shall include allocation,
in
the Republic of South Africa, of one of its suitably qualified
representatives to assist Medtech in undertaking the compliance activities
and processes relating to the maintenance and updating of the marketing
authorisations in so far as the activities relate to the purchasing
of
inventory, production, quality control and assurance, filling, labelling,
packaging and finishing, release, holding and storage of the products;
under the direct supervision, instruction and control and at the
risk of
Medtech and which includes the grant of the rights of use to Medtech
of
Pharmacare’s equipment and consumables incidental thereto. In no event
shall Pharmacare be liable in contract, tort (including negligence)
or
breach of statutory duty or otherwise, including pursuant to an indemnity
for any loss or damage of whatever nature whatsoever arising out
of or in
connection with the failure to maintain and/or update the marketing
authorisations in accordance with the applicable
laws.
|
7.17.3. |
Medtech
hereby indemnifies Pharmacare against any liability for loss (excluding
economic loss), damage or injury (including death) whether direct,
indirect or consequential suffered by any person or entity not being
a
party to this agreement resulting from or arising out of the failure
to
maintain and/or update the marketing authorisations in accordance
with the
applicable laws.
|
7.17.4. |
Pharmacare
hereby indemnifies Medtech against any liability for loss (excluding
economic loss), damage or injury (including death) whether direct,
indirect or consequential suffered by any person or entity not being
a
party to this agreement resulting from or arising out of the failure
of
Pharmacare to meet specifications or to follow the requirements of
cGMP’s.
|
7.18. |
Liability
|
In
no
event shall Medtech or Pharmacare be liable to each other in contract, tort
(including negligence), breach of statutory duty, under any indemnity or
otherwise for:
29 |
7.18.1. |
any
indirect or consequential loss of or damage of any nature whatsoever;
or
|
7.18.2. |
save
as is expressly provided for in clauses
7.19.2,
any loss of profit, pure economic loss, depletion of goodwill, loss
of
business or like loss (whether direct or indirect);
or
|
7.18.3. |
any
claim/s by the other party (inclusive of indemnities by either party)
irrespective of the nature or cause of such claim/s which alone or
in
aggregate exceed US$50,000,000.00 (fifty million United States
Dollars),
|
arising
out of or in connection with this agreement.
7.19. |
Remedies
|
7.19.1. |
Provided
that Pharmacare has used its best endeavours to timeously deliver
the
products to Medtech on the terms and subject to the conditions set
out in
this agreement, then Medtech shall have no claims against Pharmacare
arising out of or flowing from such non-delivery. In all instances
where
Pharmacare fails to timeously deliver any of the products to Medtech
(“the
undelivered
products”),
Medtech shall be obliged to use its best endeavours (for so long
as
Pharmacare remains in breach of its obligations to so supply the
products), to purchase the undelivered products from Altaire and/or
another supplier of its choice.
|
7.19.2. |
Subject
to clause
7.19.4,
in the event of Medtech failing to purchase all of Medtech and its
affiliates’ requirements of the products exclusively from Pharmacare
-
|
7.19.2.1. |
during
the 12 (twelve) month period commencing on 1 January 2009 and terminating
on 31 December 2009, then Medtech shall pay
to Pharmacare
a compensation fee in the sum of US$5,000,000.00 (five million United
States Dollars);
|
7.19.2.2. |
during
the 12 (twelve) month period commencing on 1 January 2010 and terminating
on 31 December 2010, then Medtech shall
|
30 |
pay to Pharmacare a compensation fee in the sum of US$4,000,000.00 (four million United States Dollars); |
7.19.2.3. |
during
the 12 (twelve) month period commencing on 1 January 2011 and terminating
on 31 December 2011, then Medtech shall pay to Pharmacare a compensation
fee in the sum of US$4,000,000.00 (four million United States
Dollars);
|
7.19.2.4. |
during
the 12 (twelve) month period commencing on 1 January 2012 and terminating
on 31 December 2012, then Medtech shall pay to Pharmacare a compensation
fee in the sum of US$3,000,000.00 (three million United States
Dollars);
|
7.19.2.5. |
during
the 12 (twelve) month period commencing on 1 January 2013 and terminating
on 31 December 2013, then Medtech shall pay to Pharmacare a compensation
fee in the sum of US$3,000,000.00 (three million United States
Dollars).
|
7.19.3. |
The
compensation fee/s referred to in clause
7.19.2.1
to
clause
7.19.2.5
shall be jointly and/or individually referred to as “the Pharmacare
compensation fee/s”.
Medtech agrees that the Pharmacare compensation fee/s is in consideration
for, amongst other things, the construction of the facility by Pharmacare
in order to supply the products to Medtech on the terms and subject
to the
conditions set out in this
agreement.
|
7.19.4. |
The
Pharmacare compensation fee/s shall not be payable
-
|
7.19.4.1. |
should
Medtech and/or its affiliates have purchased 30,000,000 (thirty million)
units of the products from Pharmacare during any of the relevant
calendar
years or such greater volumes as may have been agreed to between
the
parties, from time to time; and/or
|
7.19.4.2. |
in
circumstances where Pharmacare is not able to supply the relevant
products
to Medtech.
|
31 |
7.19.5. |
The
Pharmacare compensation fee shall be due, owing and payable by Medtech
to
Pharmacare within 30 (thirty) days of the date of Medtech and/or
its
affiliates’ breach of the provisions of clause
7.19.2
and shall be payable without demand, deduction or
set-off.
|
7.19.6. |
In
the event of Pharmacare not being able to fulfil its obligations
to
Medtech in terms of this agreement as a consequence of Pharmacare
allocating the manufacturing capacity of the facility for the purposes
of
manufacturing products for any third party
-
|
7.19.6.1. |
during
the 12 (twelve) month period commencing on 1 January 2009 and terminating
on 31 December 2009, then Pharmacare shall pay to Medtech a compensation
fee in the sum of US$5,000,000.00 (five million United States
Dollars);
|
7.19.6.2. |
during
the 12 (twelve) month period commencing on 1 January 2010 and terminating
on 31 December 2010, then Pharmacare shall pay to Medtech a compensation
fee in the sum of US$4,000,000.00 (four million United States
Dollars);
|
7.19.6.3. |
during
the 12 (twelve) month period commencing on 1 January 2011 and terminating
on 31 December 2011, then Pharmacare shall pay to Medtech a compensation
fee in the sum of US$4,000,000.00 (four million United States
Dollars);
|
7.19.6.4. |
during
the 12 (twelve) month period commencing on 1 January 2012 and terminating
on 31 December 2012, then Pharmacare shall pay to Medtech a compensation
fee in the sum of US$3,000,000.00 (three million United States
Dollars);
|
7.19.6.5. |
.during
the 12 (twelve) month period commencing on 1 January 2013 and terminating
on 31 December 2013, then Pharmacare shall pay to Medtech a compensation
fee in the sum of US$3,000,000.00 (three million United States
Dollars).
|
32 |
7.19.7. |
The
compensation fee/s payable by Pharmacare to Medtech in terms of
clause
7.19.6
shall jointly and/or individually be referred to as “the Medtech
compensation fee/s”.
|
7.19.8. |
The
Medtech compensation fee shall be due, owing and payable by Pharmacare
to
Medtech within 30 (thirty) days of the date of Pharmacare breaching
the
provisions of clause
7.19.6
and shall be payable without demand, deduction or
set-off.
|
7.19.9. |
In
the event of Medtech failing to pay the full purchase price/s for
the
products and/or the Pharmacare compensation to Pharmacare on due
date,
then Pharmacare shall be entitled to immediately suspend the further
supply of the products (“the suspended
products”)
to Medtech, on written notice to Medtech, this until such time as
the
outstanding purchase price/s and/or the Pharmacare compensation,
together
with accrued interest thereon, has been paid in full. The failure
by
Pharmacare to deliver the suspended products shall not give rise
to a
breach of this agreement by
Pharmacare.
|
7.19.10. |
Any
amounts which are due by one party to the other party in terms of
this
agreement which are not paid on due date shall accrue interest at
the
prime rate, calculated from due date to date of payment
(inclusive).
|
7.19.11. |
A
failure by either party to perform or observe any of their remaining
obligations set out in this agreement shall entitle the other party
to
only claim specific performance and damages (subject to the limitations
set out in clause
7.18)
and the parties hereby waive and abandon all or any other rights
and
remedies against the other party not expressly set out in this
clause
7.19.
|
33 |
7.20. |
Subcontracting
|
Pharmacare
may subcontract its obligations to any third party provided that such
subcontracting does not cause a breach of any applicable laws, and provided
that
Pharmacare remains responsible for and liable for the acts, errors and omissions
of its subcontractor. Any intention to subcontract shall be noticed to Medtech,
in writing, not less than 90 days in advance.
7.21. |
Sale
of Business by
Medtech
|
In
the
event of Medtech, at any time during the term, selling, disposing of or
otherwise alienating its business of marketing, selling and/or distributing
the
products, it will procure that the third party acquirer of that business takes
assignment of this agreement and Medtech will, notwithstanding such sale,
alienation or other disposal, bind itself in favour of Pharmacare as surety
for
and co-principal debtor in solidum with the third party for the due and punctual
payment and performance by the third party of all of the assigned obligations
and for the payment of any damages which Pharmacare may suffer as a result
of,
or in connection with, any breach by the third party of any provisions of this
agreement.
8. |
EFFECT
OF TERMINATION OR
EXPIRATION
|
8.1. |
Upon
expiration or prior termination of this agreement, for any reason,
it
shall not release either party from any liability which at the said
time
it has already incurred to the other party nor affect in any way
the
survival of any rights, duties or obligations of either
party.
|
8.2. |
Upon
earlier termination of this agreement, Pharmacare shall supply to
Medtech
and Medtech shall purchase the finished products at their purchase
price/s
and any inventory then in Pharmacare’s possession (or on order by
Pharmacare), this at the cost price/s
thereof.
|
8.3. |
Medtech
shall be liable to pay Pharmacare the purchase price/s for the finished
products and the cost price of the inventory within 14 (fourteen)
days
of
the date of expiration or earlier termination of this agreement or
in
respect of part termination.
|
34 |
8.4. |
Delivery
of the finished products and inventory pursuant to the provisions
of this
clause
8
shall be made ex-works.
|
8.5. |
Pharmacare’s
non-transferable, royalty-free, non-exclusive license to use the
trademarks and the intellectual property shall immediately terminate
and
Pharmacare shall have no further rights, title or interest in and
to the
said trademarks or intellectual property and it shall immediately
cease
exercising any rights in relation
thereto.
|
9. |
CONFIDENTIALITY
|
9.1. |
All
confidential and/or proprietary information of Pharmacare disclosed
to
Medtech and all confidential and/or proprietary information of Medtech
disclosed to Pharmacare including, but not limited to, information
relating to any product or the business affairs or finances of either
party, information contained in the know-how and the terms of this
agreement and/or the supply agreement known hereafter as the “confidential
information”
shall be held in confidence and not disclosed by the other party
to any
third party or used, for any reason whatsoever, outside the scope
of this
agreement and/or the supply agreement; provided, that the definition
of
“confidential
information”
and the obligation of confidentiality assumed by Medtech and Pharmacare
hereunder shall not apply to any confidential or proprietary information
which was or becomes available to Medtech or Pharmacare, as the case
may
be, on a non-confidential basis from a source that is not under an
obligation (whether contractual, legal or fiduciary) to the other
party to
keep such information confidential. If the party receiving information
of
the other party (the “receiving
party”)
is requested in any judicial or administrative proceeding or by any
governmental or regulatory authority to disclose any information
of the
other party (the “disclosing
party”),
the receiving party shall give the disclosing party prompt notice
of such
request so that the disclosing party may seek an appropriate protective
order. The receiving party shall cooperate fully with the disclosing
party
in obtaining such an order. If in the absence of a protective order
the
receiving party is nonetheless compelled to disclose confidential
information of the disclosing party, the receiving party may make
such
disclosure without liability hereunder, provided that the receiving
party
gives the disclosing party written notice of the confidential information
to be disclosed as far in advance of its disclosure as is practicable
and,
upon the disclosing party’s request and at its expense, the receiving
party will use its best
|
35 |
efforts to obtain reasonable assurances that confidential treatment will be accorded to such confidential information. |
9.2. |
This
clause
9
shall survive the expiration or termination of this agreement for
a period
of five (5) years.
|
10. |
RELATIONSHIP
OF PARTIES
|
The
parties shall be considered independent contractors, and neither the conclusion
of this agreement nor the performance of any of the provisions hereof shall
be
construed to make either party an agent, employee or legal representative of
the
other, nor shall this agreement be deemed to establish a joint venture or
partnership.
11. |
ASSIGNMENT
|
Neither
party shall cede its rights or assign its obligations under this agreement
without the prior written consent of the other party (such consent not to be
unreasonably withheld).
12. |
FORCE
MAJEURE
|
The
occurrence of a force majeure event shall not excuse a party from the
performance of its obligations or duties under this agreement, but shall merely
suspend such performance during the continuation of force majeure event. The
party prevented from performing its obligations or duties because of force
majeure shall promptly notify the other party hereto (the “other
party”)
of the
occurrence and particulars of such force majeure event and shall provide the
other party, from time to time, with its best estimate of the duration of such
force majeure event and with notice of the termination thereof. The party so
affected shall use its best efforts to avoid or remove such causes of
non-performance. Upon termination of the force majeure event, the performance
of
any suspended obligation or duty shall promptly recommence. Neither party shall
be liable to the other party for any direct, indirect, consequential,
incidental, special, punitive or exemplary damages arising out of or relating
to
the suspension or termination of any of its obligations or duties under this
agreement by reason of the occurrence of force majeure event. In the event
that
force majeure event has occurred and is
36 |
continuing for a period of at least 6 (six) months, the other party shall have the right to terminate this agreement upon 30 (thirty) days written notice. |
13. |
GOVERNING
LAW AND JURISDICTION
|
13.1. |
The
construction, validity and performance of this agreement shall be
governed
by the laws of the State of New York, United States of
America.
|
13.2. |
It
is irrevocably agreed that the State and Federal courts located in
the
State of New York, United States of America, are to have non-exclusive
jurisdiction to settle any disputes which may arise out of or in
connection with this agreement and accordingly that any action or
proceeding so arising may be brought in such
courts.
|
14. |
NOTICES
|
14.1. |
Any
notice to be given under this agreement shall be in writing and delivered
personally or sent by first class recorded delivery post or facsimile
to
the address for service of the other party as set out in clause
13.4,
or such other address as may have been notified in writing to the
other
party.
|
14.2. |
A
notice shall be deemed to have been served as follows if personally
delivered, at the time of delivery; if posted, at the expiration
of 96
(ninety six) hours after the envelope containing the same was delivered
into the custody of the postal authorities; or if sent by facsimile
at the
expiration of 24 (twenty four) hours after the same was
transmitted.
|
14.3. |
In
proving service of a notice: by delivery by hand: it shall be sufficient
to show that delivery by hand was made; by post: it shall be sufficient
to
show the envelope containing the communication was properly sent
by first
class recorded delivery post; by facsimile transmission: it shall
be
sufficient to show that the facsimile was despatched and a confirmatory
transmission report received.
|
37 |
14.4. |
Addresses
for service:
|
Pharmacare and Aspen:
Xxxxxxxx 0 Xxxxxxxxxx Xxxx
Xxxxxxxxx Xxxxx
Xxxxxxxx
XXXXXXXXXXXX
Telefax No. (011) 2396100
With copy to:
Aspen Pharmacare Holdings Limited
0xx
Xxxxx Xxxxx Xxxxx
Xxxxx Xxxx
00 Xxxxxxxxx Xxxxxx
Xx Xxxxx Xxxxx
Xxxxxx
Telefax No. (031) 5808640
Marked for the attention of The
Deputy
Group Chief Executive
|
Medtech:
Medtech Products, Inc.
Attn: CEO
00 Xxxxx Xxxxxxxx
Xxxxxxxxx, Xxx Xxxx 00000
Telefax (No 001) 000-000-0000
With a copy to:
Prestige Brands Holdings, Inc.
Attn: General Counsel
00 Xxxxx Xxxxxxxx
Xxxxxxxxx, Xxx Xxxx 00000
Telefax (No. 001) 000-000-0000
|
15. |
ANNOUNCEMENT
|
Neither
party shall issue or make any public statement with respect to this agreement
without the prior consent of the other party, which consent shall not be
unreasonably withheld or delayed. No approval shall be required to the extent
disclosure may be required by the applicable law.
16. |
PRESTIGE
SURETYSHIP
|
16.1. |
By
its signature hereto, Prestige hereby binds itself in favour of Pharmacare
as surety for and co-principal debtor in
solidum
with Medtech for the due and punctual payment and performance by
Medtech
of all of its obligations pursuant to this agreement and/or any suretyship
which Medtech may exercise in favour of Pharmacare in accordance
with the
provisions of clause
7.21
and, without restricting the generality of the aforegoing -
|
16.1.1. |
for
any claim/s under any indemnity given by Medtech to
Pharmacare;
|
16.1.2. |
for
the payment of the Pharmacare compensation (clause
7.19.2);
and/or
|
16.1.3. |
for
the payment of any damages which Pharmacare may suffer as a result
of, or
in connection with any breach by Medtech of any provisions of this
agreement and/or any suretyship which may be given by Medtech in
|
38 |
favour of Pharmacare in accordance with the provision of clause 7.21. |
16.2. |
The
suretyship referred to in clause
16.1
shall remain of full force and effect and fully binding notwithstanding
-
|
16.2.1. |
any
amendment/s to this agreement and/or any other agreement from time
to time
subsisting between the parties;
|
16.2.2. |
any
indulgence, concession, leniency or extension of time which may be
shown
or given by Pharmacare to Medtech;
|
16.2.3. |
the
receipt by Pharmacare of any dividends, or other benefits in any
liquidation, judicial management or other similar disability of
Medtech;
|
16.2.4. |
any
additional suretyships, guarantees, securities or indemnities acquired
by
Pharmacare in connection with the obligations of Medtech;
and
|
16.2.5. |
the
liquidation, judicial management or deregistration of Medtech or
any
compromise by Medtech with its creditors
generally.
|
16.3. |
Prestige
hereby renounces the benefits of the legal exceptions “non
causa debiti”,
“errore
calculi”,
“excussion”, “division”, “no value received”, and “revision of accounts”,
with the meaning and effect of all of which it declares itself to
be fully
acquainted.
|
16.4. |
Prestige
hereby warrants that it has a material interest in binding itself
as
aforesaid in favour of Pharmacare.
|
17. |
ASPEN
SURETYSHIP
|
17.1. |
By
its signature hereto, Aspen hereby binds itself in favour of Medtech
as
surety for and co-principal debtor in
solidum
with Pharmacare for the due and punctual payment and performance
by
Pharmacare of all of its obligations pursuant to this agreement and
without restricting the generality of the aforegoing
-
|
39 |
17.1.1. |
for
any claim/s under any indemnity given by Pharmacare to
Medtech;
|
17.1.2. |
for
the payment of the Medtech compensation (clause
7.19.5);
and/or
|
17.1.3. |
for
the payment of any damages which Medtech may suffer as a result of,
or in
connection with any breach by Pharmacare of any provisions of this
agreement.
|
17.2. |
The
suretyship referred to in clause
17.1
shall remain of full force and effect and fully binding notwithstanding
-
|
17.2.1. |
any
amendment/s to this agreement and/or any other agreement from time
to time
subsisting between the parties;
|
17.2.2. |
any
indulgence, concession, leniency or extension of time which may be
shown
or given by Medtech to Pharmacare;
|
17.2.3. |
the
receipt by Medtech of any dividends, or other benefits in any liquidation,
judicial management or other similar disability of
Pharmacare;
|
17.2.4. |
any
additional suretyships, guarantees, securities or indemnities acquired
by
Medtech in connection with the obligations of Pharmacare;
and
|
17.2.5. |
the
liquidation, judicial management or deregistration of Pharmacare
or any
compromise by Pharmacare with its creditors
generally.
|
17.3. |
Aspen
hereby renounces the benefits of the legal exceptions “non
causa debiti”,
“errore
calculi”,
“excussion”, “division”, “no value received”, and “revision of accounts”,
with the meaning and effect of all of which it declares itself to
be fully
acquainted.
|
17.4. |
Aspen
hereby warrants that it has a material interest in binding itself
as
aforesaid in favour of Medtech.
|
40 |
18. |
AFFILIATES
|
18.1. |
Medtech
undertakes to Pharmacare that it shall procure that all of its affiliates
are bound by and that they comply with the provisions of this
agreement.
|
18.2. |
Prestige
undertakes to Pharmacare that it shall procure that all of its affiliates
are bound by and that they comply with the provisions of this
agreement.
|
19. |
COSTS
|
Each
party shall be liable for its own costs incurred in relation to the negotiation,
preparation and execution of this agreement.
[The
remainder of this page deliberately left blank]
SIGNED
by Pharmacare at …………………………… on this 18th day of
September, 2006
For
and on behalf of PHARMACARE
LIMITED
|
||
/s/
Xxxxxxx Xxxxxxx Xxxx
|
||
XXXXXXX
XXXXXXX SAAD, Group
Chief
|
||
Executive,
he warranting by his
signature
|
||
that
he is duly authorised hereto
|
||
SIGNED by Medtech at Irvington, on this 18th day of September,
2006
For and on behalf of MEDTECH
PRODUCTS, INC.
|
||
/s/ Xxxxx X. Xxxx | ||
XXXXX X. XXXX, President, he warranting | ||
by his signature that he is duly authorised | ||
hereto | ||
SIGNED by
Prestige at
Irvington, New York on this 18th day of September, 2006
For and on behalf of PRESTIGE BRANDS
HOLDINGS, INC.
|
||
/s/ Xxxxx X. Xxxx | ||
XXXXX X. XXXX, Chief Executive Officer, | ||
he warranting by his signature that he is duly | ||
authorized hereto | ||
42
SIGNED
BY Aspen at
................................ on this 18th day of
September, 2006
|
||
For and on behalf of ASPEN
PHARMACARE HOLDINGS LIMITED
|
||
/s/ Xxxxxxx Xxxxxxx Xxxx | ||
XXXXXXX XXXXXXX SAAD, Group Chief
Executive, he warranting by his signature that he is duly authorised
hereto
|
||