Exhibit 10.17(d)
Dated 27th November 2000
CEPHALON (UK) LIMITED
- and -
NOVARTIS PHARMACEUTICALS UK LIMITED
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DISTRIBUTION AGREEMENT
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CMS Xxxxxxx XxXxxxx
Xxxxx Xxxxx
000 Xxxxxxxxxx Xxxxxx
Xxxxxx XX0X 0XX
T+44(0)20 7367 3000
F+44(0)20 7367 2000
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
THIS AGREEMENT is made the 27th day of November 2000
BETWEEN:
(1) CEPHALON (UK) LIMITED (Registered no 3207745) a company incorporated in
England and Wales whose registered office is at 11/13 Xxxxxxxxx Xxxxxxx
Road, Surrey Xxxxxxxx Xxxx, Xxxxxxxxx, Xxxxxx XX0 0XX ("Cephalon"); and
(2) NOVARTIS PHARMACEUTICALS UK LIMITED ( Registered no 119006), a company
incorporated in England and Wales whose registered office is at Xxxxxxx
Xxxxxxxx Xxxx, Xxxxxxx, Xxxxxxxxx, Xxxxxx XX00 0XX ("Novartis").
WHEREAS:
Cephalon wishes to appoint Novartis to distribute and sell Products (as
hereinafter defined) in the Territory (as hereinafter defined) and
Novartis wishes to accept such appointment on the terms and conditions of
this Agreement.
NOW IT IS HEREBY AGREED as follows:
1. Interpretation
1.1 Unless the context otherwise requires the following definitions shall
apply throughout this Agreement:
"Adverse Reaction" means a response to a substance that is noxious and
unintended and which occurs at doses normally used in man for prophylaxis,
diagnosis and therapy;
"Affiliate" means any company, partnership or other entity which directly
or indirectly Controls, is Controlled by or is under common Control with
the Party in question including as a Subsidiary or Holding Company;
"Agreement" means this agreement including the Schedules hereto as may be
varied from time to time in accordance with the provisions of this
agreement;
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**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
"Commencement Date" means 1 January 2001;
"Control" means the ownership (direct or indirect) of more than 50% of the
issued share capital, or the legal power to direct or cause the direction
of the general management and policies of the Party in question and
"Controlled" and "Controller" shall be construed accordingly;
"End Users" means customers who are not reselling the Products to third
parties;
"Force Majeure" means in relation to any Party any event or circumstance
which is beyond the reasonable control of that Party which event that
Party could not reasonably be expected to have taken into account at the
date of this Agreement including acts of God, war, riot, civil commotion,
any overriding emergency, fire, flood, storm and industrial dispute (other
than industrial dispute affecting only the employees of the Party
suffering the event of force majeure or any of its agents or
subcontractors);
"Good Distribution Practice" or "GDP" means the regulatory standards and
principles and guidelines of good distribution practice as in force from
time to time relating to the warehousing, storage and physical
distribution of medicinal products established by the applicable
Governmental or Regulatory Authority including, without limitation, the
Guidelines on Good Distribution Practice of Medicinal Products for Human
Use published by the European Commission, as the same may be amended from
time to time;
"Good Manufacturing Practice" or "GMP" means the regulatory standards and
principles and guidelines of good manufacturing practice as in effect from
time to time relating to the manufacture of medicinal products including,
without limitation, standards for equipment, facilities, production and
quality control established by the applicable Governmental or Regulatory
Authority;
"Governmental or Regulatory Authority" means any local or national agency,
authority, department, court, tribunal, arbitrator, inspectorate,
minister, ministry official or public or statutory person (whether
autonomous or not) of, or of any
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**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
government of, any country having jurisdiction over this Agreement or any
of the Parties or in respect of the regulation of medicinal products in
the Territory including the European Commission and the European Court of
Justice;
"Insolvency Event" in relation to any Party, means any one of the
following:
(a) a notice shall have been issued to convene a meeting for the purpose
of passing a resolution to wind up that Party or such a resolution
shall have been passed other than a resolution for the solvent
reconstruction or reorganisation of that Party; or
(b) a resolution (other than a resolution for the solvent reconstruction
or reorganisation of a Party) shall have been passed by that Party's
directors to seek a winding up or administration order or a petition
for a winding up or administration order shall have been presented
against that Party or such an order shall have been made; or
(c) a receiver, administrative receiver, receiver and manager, interim
receiver, custodian, sequestrator or similar officer is appointed in
respect of that Party or over a substantial part of its assets or
any third party takes steps to appoint such an officer in respect of
that Party or an encumbrancer takes steps to enforce or enforces its
security; or
(d) a proposal for a voluntary arrangement shall have been made in
relation to that Party under Part I Insolvency Xxx 0000; or
(e) a step or event shall have been taken or arisen outside the
Territory which is similar or analogous to any of the steps or
events listed at (a) to (d) above; or
(f) that Party suspends or threatens to suspend making payments to all
or some of that Party's creditors or the Party submits to any type
of voluntary arrangement; or
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**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
(g) where that Party is resident in the Territory it is deemed to be
unable to pay its debts within the meaning of Xxxxxxx 000 Xxxxxxxxxx
Xxx 0000;
"Managed Services Agreement" means the Managed Services Agreement of even
date entered into between the Parties;
"Party" means Cephalon or Novartis (or their respective successors) and
"Parties" shall mean both of them;
"Product" means the Product listed in the Schedule together with such
additions as the Parties may agree in writing from time to time;
"Product Licence" means the authorisation for the sale and marketing of a
Product in the Territory granted by a Governmental or Regulatory Authority
as may be varied from time to time by Cephalon or Novartis as the case may
be;
"Rights" means all or any copyright, design right, trademarks, trade
names, patents, know-how, trade secrets and other intellectual property or
other proprietary rights in respect of or relating to the Products which
may at any time subsist throughout all or any part of the world (whether
registered or otherwise) including without limitation the Trademark, and
all extensions and renewals thereof;
"Sale" means the transfer of title in the Products for consideration; and
"sell" and "selling" shall be construed accordingly;
"SKU" means a single stock keeping unit of Product;
"Specification" means the specification for a Product set out in the
Product Licence;
"Supply Price" means the price for each SKU as set out in Schedule 1A;
"Term" means the period of ten years from the Commencement Date;
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**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
"Territory" means the United Kingdom together with the Republic of Ireland
or as may be agreed between the parties from time to time;
"Trademark" means the registered trademark for the Product set out in the
Schedule;
"Working Day" means a day other than a Saturday, Sunday, bank or other
public holiday in England and Wales;
1.2 In this Agreement:-
1.2.1 unless the context otherwise requires all references to a particular
Clause, Schedule or paragraph shall be a reference to that Clause,
Schedule or paragraph, in or to this Agreement as it may be amended
from time to time pursuant to this Agreement;
1.2.2 the table of contents and headings are inserted for convenience only
and shall be ignored in construing this Agreement;
1.2.3 unless the contrary intention appears words importing the masculine
gender shall include the feminine and vice versa and words in the
singular include the plural and vice versa;
1.2.4 unless the contrary intention appears words denoting persons shall
include any individual, partnership, company, corporation, joint
venture, trust, association (incorporated or unincorporated),
organisation or other entity, in each case whether or not having
separate legal personality;
1.2.5 reference to any statute or regulation includes any modification or
re-enactment of that statute or regulation; and
1.2.6 reference to the words "include" or "including" are to be construed
without limitation to the generality of the preceding words.
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
2. Appointment and Term
2.1 Cephalon hereby appoints Novartis with effect from the Commencement Date
as its distributor of the Product in the Territory on and subject to the
terms and conditions of this Agreement. For the avoidance of doubt
Cephalon reserves the right to distribute the Product in all territories
outside the Territory.
2.2 This Agreement shall commence on the Commencement Date and continue for
the Term or until terminated by mutual agreement between the Parties,
provided that the provisions of Clause 2.3 and 3.13 shall expire on the
fifth anniversary of the Commencement Date unless renewed by specific
agreement between the Parties.
2.3 Cephalon will not appoint in the Territory any other distributor or
reseller of the Product nor will it directly supply for its own account
the Product to distributors, resellers or End Users located within the
Territory.
3. General Undertakings by Novartis
3.1 Novartis shall perform its obligations hereunder as principal. Except as
provided in this Agreement, it shall not otherwise dispose of the Product
within the Territory, and shall not sell the Product within the Territory
on behalf of, or in the name of, Cephalon.
3.2 Novartis agrees that the only remuneration it shall receive directly as a
result of distributing the Product under this Agreement shall be any
margin it receives on the resale of the Product. Novartis shall be
responsible for obtaining payment in respect of all sales made of the
Product in the Territory.
3.3 Novartis shall provide Cephalon at least twice weekly with an estimate of
sales achieved and shipped.
3.4 Novartis shall not during the Term:
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
(a) actively canvass or solicit orders for the Product outside the
Territory; or
(b) open branches for the sale of the Product outside the Territory;
or
(c) maintain distribution depots for the Product outside the
Territory.
3.5 Novartis shall not during the Term do anything which may prevent the sale,
or interfere with the development of, sales of the Product in the
Territory or which may adversely affect the quality of the Product.
3.6 Novartis shall sell and distribute the Product only in accordance with the
Product Licence and all applicable laws, rules and regulations in the
Territory.
3.7 Novartis shall maintain sufficient resources (either its own employees or
through permitted subcontracts) to carry out its obligations hereunder in
respect of the Product throughout the Territory and to perform in a timely
and satisfactory manner Novartis' obligations under this Agreement.
3.8 Novartis agrees during the Term to comply with, and not to take any action
which would be subject to penalty under, all laws, rules and regulations
applicable to this Agreement in the Territory, and to conduct its business
in accordance with all applicable ethical business practices and Good
Distribution Practice.
3.9 Novartis shall obtain and maintain at its own cost and expense all
necessary permissions, consents and licences to enable it to carry out its
obligations hereunder in the Territory and to ensure the full and legal
operation of this Agreement (other than the Product Licence).
3.10 Novartis shall keep Cephalon informed in writing in respect of any
complaint, claim, demand or dispute concerning the Product.
3.11 Novartis shall advise Cephalon within 48 hours of any reported Adverse
Reaction occurring in the Territory and reported to Novartis in respect of
the Product. Cephalon shall have sole responsibility for reporting Adverse
Reactions to the
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
Medicines Control Agency and will conduct all communication relating to
safety issues.
3.12 Novartis undertakes during the Term to store the Product in accordance
with the terms of the Product Licence and GDP under conditions that will
prevent deterioration of the Product and under any special conditions as
may be notified to Novartis by Cephalon from time to time. Novartis agrees
to allow Cephalon or its authorised representative to inspect the Product
when in storage under the control of Novartis from time to time upon
reasonable notice.
3.13 Novartis undertakes during the Term that it will not copy, produce, make,
modify or manufacture or assist any other party to copy, produce, make or
manufacture the Product or any part thereof for use, sale, or any other
purpose whether inside or outside the Territory.
3.14 In the event of any Product recall, revocation of the Product Licence or
any other event affecting the Product, Novartis shall:
3.14.1 immediately cease all distribution of the Product;
3.14.2 comply at Cephalon's cost with all Cephalon's reasonable
instructions regarding collection of recalled Product, such
collection to be at Cephalon's expense, unless such recall is
caused by the acts or omission of Novartis, other than when
Novartis is acting on Cephalon's instructions, provided
however that Novartis shall use all reasonable endeavours to
minimise such costs and expenses;
3.14.3 provide such other assistance as may be reasonably requested
by Cephalon.
4. General Undertakings by Cephalon
4.1 Cephalon shall, and shall procure that its Affiliates shall, during the
Term promptly refer to Novartis (or as Novartis shall direct) all
enquiries it receives for the Product for sale or ultimate delivery within
the Territory.
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**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
4.2 Cephalon shall, and shall procure that its Affiliates shall, use all
reasonable endeavours so far as permitted by law to safeguard the
exclusive rights hereby granted to Novartis including the taking of such
steps as may be available to prevent the infringement of any Rights it may
have in respect of the Product within the Territory.
4.3 Cephalon shall supply the Product in accordance with Specification and in
packaging which incorporates any information that may be required by the
Product Licence, any Governmental or Regulatory Authority or any
applicable law, rule or regulation from time to time.
4.4 Cephalon shall be responsible for reporting any Adverse Reactions relating
to the Product to the health authorities in the Territory in accordance
with the applicable legal requirements.
4.5 Cephalon shall provide Novartis with copies of the periodic safety update
reports (if any) on Adverse Reactions and update requirements and
recommendations as to the best use of the Product.
4.6 Cephalon shall be responsible for entering all Adverse Reactions to the
Product into its global Adverse Reaction database. This information will
be available for analysis and comment if required in relation to any
emerging safety issue in relation to the Product.
4.7 Cephalon agrees to inform Novartis and keep it informed within 48 hours of
notification of any action by, or notification or other information which
it receives (directly or indirectly) from any Governmental or Regulatory
Authority, which (a) raises any material concerns regarding the safety or
efficacy of any Product, (b) which indicates or suggests a potential
material liability for either Party to third parties arising in connection
with the Product, or (c) which is reasonably, likely to lead to a recall
of the Product, including in all cases, but not limited to:
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
(i) Governmental or Regulatory Authority inspections of manufacturing,
distribution of other related facilities, in which the Product is
manufactured, stored or otherwise present;
(ii) receipt of a warning letter from any Governmental or Regulatory
Authority relating to the Product; or
(iii) on initiation of any Governmental or Regulatory Authority
investigations, detention, seizure or injunction concerning the
Product.
5. Supply and Purchase of Product
5.1 Novartis shall purchase from Cephalon such amount of Product for sale in
the Territory as shall be agreed from time to time, ready packaged from
Cephalon or an Affiliate of Cephalon and shall not alter or amend the
packaging of any Product so supplied. The minimum order quantity shall
represent no less than three months' supply based on average sales during
the previous two months.
5.2 All orders issued by Novartis to Cephalon for the Product shall be
processed by Cephalon and delivered at Novartis' expense to the warehouse
of Healthcare Logistics Limited at Iver, Buckinghamshire, or such other
address as shall be stipulated by Novartis. Cephalon shall use all
reasonable endeavours to ensure delivery of Product takes place on the
delivery date specified in the order issued by Novartis.
5.3 Cephalon shall be entitled at any time during the Term to make such
alterations to the Specification as it may reasonably think fit without
giving Novartis prior notice of such alterations.
5.4 Without prejudice to the provisions of Clause 9. Novartis shall carefully
examine all quantities of Product supplied by Cephalon on receipt thereof
and notify Cephalon within 5 (five) Working Days in writing of any defects
reasonably discoverable on careful examination. Cephalon shall replace or,
at its option, refund the Supply Price paid for any such quantities found
to be so defective but shall not
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
be under any other liability to Novartis in relation to such defects. If
Cephalon does not receive a notice as referred to in this Clause, it shall
be discharged from all liability (whether arising in negligence or
otherwise) arising from such defects and such quantities shall be deemed
to have been accepted by Novartis.
6. Stock
Novartis shall at all times during the Term carry a minimum of three (3)
months' stock of the Product calculated by reference to the average sales
of Product during the previous two months.
7. Pricing and Payment
7.1 Novartis shall pay the Supply Price to Cephalon for all quantities of
Product supplied to Novartis hereunder, within [**] of receipt of invoice
in respect of batch orders of [**] supply or more and [**] where such
orders [**] supply or more.
7.2 Payment for each order of Product made hereunder shall be made by
telegraphic transfer to such bank account as Cephalon shall notify to
Novartis from time to time.
7.3 The currency for all payments under Clause 7.2 shall be in(pound)sterling.
7.4 Risk on the Products shall pass to Novartis upon delivery. Title in the
Products shall not pass to Novartis until Cephalon has received cleared
funds in full payment of the Supply Price including, without limitation,
VAT, if applicable.
7.5 If Novartis fails to pay the Supply Price for any Product supplied by
Cephalon hereunder:
7.5.1 within [**] as the case may be after the date of the invoice
therefor Cephalon shall be entitled (without prejudice to any
other right or remedy it may have) to charge Novartis interest
on the price (which shall accrue from day to day after as well
as before judgement) at the rate of [**] per
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
annum above National Westminster plc's base rate from time to
time in force from the date the payment became due until
actual payment is made, compounded monthly; and
7.5.2 then after [**] from expiry of the relevant credit term as set
out in clause 7.1 Cephalon shall be entitled (without
prejudice to any other right or remedy it may have) to:
(a) cancel or suspend any further delivery to Novartis under
any order; and
(b) sell or otherwise dispose of any Products which are the
subject of any order by Novartis, whether or not appropriated
thereto, and apply the proceeds of sale to the overdue
payment.
7.6 All payments to be made by Novartis to Cephalon hereunder are exclusive of
value added tax which shall be payable if applicable to do so in addition
at the rate and in the manner for the time being prescribed by law.
8. Marketing, Advertising and Promotion
Cephalon shall carry out all marketing, advertising and promotion of the
Product in the Territory in accordance with the Managed Services
Agreement.
9. Trademark and Rights
9.1 Without implying any warranty or undertaking on the part of Cephalon
(other than as set out in Clause 10, the Trademark and all the Rights
shall belong to and remain vested in Cephalon.
9.2 Novartis may use such of Cephalon's Rights as Cephalon from time to time
authorises in writing and on and subject to such terms and conditions as
Cephalon may require. Novartis shall:
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
9.2.1 use the Trademark and the Rights exclusively in performing its
duties under this Agreement; and
9.2.2 not gain any title to the Trademark or the Rights; and
9.2.3 not take any action which may prejudice or adversely affect
the Trademark the Rights or Cephalon's title to and rights in
them; and
9.2.4 not use in relation to the Products any trademarks other than
the Trademark without obtaining the prior written consent of
Cephalon.
9.3 Novartis shall not use the Trademark or any of the Rights in connection
with any other trademarks, logos, distinguishing marks or corporate names
(including, without limitation, as part of any corporate, business or
trading name or style of Novartis or any other person) without the prior
written consent of Cephalon. In particular (but without limitation to the
generality of the foregoing), Novartis shall not make any use of the
Trademark such that confusion may arise between the Products bearing the
Trademark and other products.
9.4 Novartis shall promptly notify Cephalon of any infringement of the
Trademark or the Rights or Confidential Information in the Territory, and
of any claim that the sale of the Products in the Territory infringes any
person's rights, of which it may become aware and shall at the request and
expense of Cephalon take such action in respect of such infringement or
claim, as Cephalon may request.
9.5 The provisions of this Clause 9 shall remain in full force and effect
after the expiry or termination of this Agreement for any reason.
10. Warranties and Indemnity
10.1 Each party warrants to the other that it is entitled to enter into this
Distribution Agreement and grant the Rights described herein.
10.2 Cephalon warrants to Novartis that:
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
10.2.1 so far as it is aware the Sale of Products under the Trademark
does not infringe the trademark rights or other Rights of any
third party; and
10.2.2 it shall supply Product which meets the Specification and
which is manufactured in accordance with Good Manufacturing
Practice and shall be responsible for creating and retaining
manufacturing, analytical and distribution records, testing
and releasing materials, undertaking product and quality
controls, including in-process controls and all necessary
stability studies, and analysis relating to the Product all in
accordance with such Specification and Good Manufacturing
Practice.
10.3 Save as is expressly stated in this Agreement no representation, condition
or warranty whatsoever is made or given by or on behalf of either Party
and all conditions and warranties implied by operation of law or otherwise
are hereby expressly excluded.
10.4 If any claim against Novartis, its Affiliates, recognised distributors or
agents (the "Indemnified Party") is brought by reason of the fact that any
Product has caused illness, death or bodily injury, then unless such claim
is a result of the gross negligence or misconduct of the Indemnified
Party, Cephalon shall indemnify Novartis and its Affiliates for any and
all liabilities, claims, damages and costs incurred or suffered by the
other Novartis or its Affiliates or recognised distributors, and for any
and all other liabilities, claims, damages and costs suffered by Novartis
or its Affiliates, as a result of any associated Product recall, final
packaging and similar costs associated with such Product. Such indemnity
will include the reimbursement of the legal expenses reasonably incurred
in contesting or defending such claim.
10.5 Novartis shall give Cephalon prompt written notice of any claim or threat
of claim it receives with respect to any matter for which it or its
Affiliates may be entitled to indemnification, and Cephalon shall
thereafter defend or settle any such claim at its sole expense, and with
counsel selected by the Cephalon and reasonably acceptable to the
Indemnified Party. In the defence or settlement of any such claim, the
Indemnified Party shall cooperate with and assist Cephalon to the extent
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
reasonably possible, but Cephalon shall bear and pay any and all expenses
incurred by the Indemnified Party in providing such cooperation and
assistance, either directly or upon request of the Indemnified Party who
has incurred such expense. Failure to give notice shall not constitute a
defence, in whole or in part, to any claim by the Indemnified Party
hereunder except to the extent the rights of the indemnifying Party are
materially prejudiced by such failure to give notice.
11. Subcontractors
11.1 Novartis may subcontract the performance of some or all of its obligations
hereunder to third parties, provided always that Novartis shall remain
responsible for ensuring such obligations are complied with in accordance
with the terms of this Agreement
11.2 If Cephalon shall be dissatisfied with the performance of services by
Novartis' sub-contractors, the parties shall in good faith consider
measures to address the causes of such dissatisfaction. If notwithstanding
such measures (or if no measures are appropriate), Novartis will terminate
the services of such subcontractor forthwith upon being required to do so
by Cephalon and shall appoint a replacement sub-contractor nominated by
Cephalon.
12. Termination
12.1 Either party may terminate this Agreement on [**] written notice to the
other if Control of the other or any of that Party's Controllers shall
pass from the present shareholders or owners or Controllers to other
persons.
12.2 Without prejudice to any right or remedy that either Party may have
against the other for breach or non-performance of this Agreement, either
Party shall have the right to terminate the Agreement immediately:
(a) on the other party committing a breach of any of the provisions
of any of the Agreement providing that (where the breach is capable
of rectification) the Party in breach has been advised in writing of
the
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
breach and has not rectified in within 30 (thirty) days of receipt
of such advice, or
(b) if an Insolvency Event occurs in relation to the other Party.
12.3 Upon termination of this Agreement:
12.3.1 Novartis shall continue to distribute the Product on the terms
and conditions herein for a period of [**] or until such time
as Cephalon has appointed an alternative distributor and that
distributor is ready to commence the distribution of the
Product. Thereafter, Novartis shall cease distributing the
Product and shall at the request of Cephalon promptly return
to Cephalon all documentation of any nature whatsoever and all
Confidential Information in its possession or control relating
to the Product or to Cephalon and to the activities of
Novartis in relation to the Product or Cephalon (other than
correspondence between Novartis and Cephalon which does not
relate to technical matters); and
12.3.2 Novartis shall transfer or procure the transfer of all stock
of Product held by it or its subcontractor to Cephalon or to
the replacement Distributor appointed under Clause 12.3.1 as
Cephalon shall direct; and
12.3.3 Novartis shall cease distributing and selling the Product and
using the Trademark or any of the Rights and shall at the
request of Cephalon promptly return to Cephalon all
documentation of any nature whatsoever and all Confidential
Information in its possession or control relating to the
Product or to Cephalon (other than correspondence between
Novartis and Cephalon which does not relate to technical
matters); and
12.3.4 Novartis shall (if so required by Cephalon) supply Cephalon
with a list of Novartis' customers for the Product in the
Territory; and
12.3.5 All unshipped orders placed by Novartis with Cephalon even if
previously accepted, shall be cancelled without liability to
either Party; and
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confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
12.3.6 Cephalon shall repurchase the Product then owned by Novartis
at a price equal to the Supply Price less (a) any sums owed by
Novartis to Cephalon and (b) any sums attributable to any
damage to Product caused by Novartis; and
12.3.7 Novartis shall allow Cephalon access to the storage facilities
of Novartis or its subcontractor to enable Cephalon or its
representative to determine the state of the Product Cephalon
will repurchase; and
12.3.8 If, in the reasonable opinion of Cephalon or its
representative, any of the Product owned by Novartis has
become unsaleable, it shall be disposed of by Novartis in
accordance with directions given by Cephalon, at Novartis'
expense where the Product has become unsaleable as a result of
its act or omission and otherwise at Cephalon's expense and in
accordance with applicable law; and
12.3.9 Novartis shall promptly pack and ship, to such destination as
Cephalon may direct, Product which Cephalon has repurchased.
12.4 During the period of [**] prior to the termination of this Agreement
Novartis shall allow any person notified by Cephalon as being the
successor to Novartis for the distribution and sale of the Products in
Territory to make himself known to Novartis' customers so as to be able to
do business as Cephalon's distributor from the day after the expiry or
earlier termination of this Agreement.
12.5 For the three months following termination of this Agreement, Novartis
shall refer any customers to the distributor appointed to succeed it or to
Cephalon's nearest other distributor or to Cephalon itself as Cephalon
shall direct.
12.6 Termination of this Agreement shall not affect the accrued rights of the
Parties arising in any way out of this Agreement as at the date of
termination including without limitation the right to recover damages
against the other and all provisions which are expressed to survive this
Agreement shall remain in full force and effect.
17
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
13. Force Majeure
13.1 If a Party (the "Non-Performing Party") is unable to carry out any of its
obligations under this Agreement due to Force Majeure this Agreement shall
remain in effect but:-
13.1.1 the Non-Performing Party's relevant obligations under this
Agreement; and
13.1.2 the relevant obligations of the other Party ("the Innocent
Party") under this Agreement, shall be suspended for a period
equal to the circumstance of Force Majeure or 3 months
whichever is the shorter provided that:-
(a) the suspension of performance is of no greater scope than
is required by the Force Majeure;
(b) 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 during the period of
Force Majeure;
(c) 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
(d) a soon as practicable after the event which constitutes
Force Majeure the Parties discuss how best to continue their
operations as far as possible in accordance with this
Agreement.
14. Notices
14.1 Any notice to be given in connection with this Agreement shall be in
writing and shall be deemed duly served if delivered personally or sent by
first class or recorded delivery post or by facsimile to the Company
Secretary at the address of the Party concerned which is set out in this
Agreement or as may be notified to the other
18
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
Party in accordance with the provisions of this Clause. Any notices which
are sent by e-mail shall not be valid unless and until confirmed by
personal delivery, first class or recorded delivery post or by facsimile.
14.2 Any such notice shall be deemed to be served:
14.2.1 if delivered personally, on the day on which it is delivered;
14.2.2 if sent by post, 5 Working Days after the time of posting;
14.2.3 if sent by facsimile, on acknowledgement by the recipient's
facsimile receiving equipment on a Working Day if the
acknowledgement occurs before 1700 hours local time of the
recipient and in any other case on the following Working Day.
15. Relationship of Parties
15.1 This Agreement shall not operate so as to create any of the following
relationships between the Parties:
15.1.1 partnership;
15.1.2 agency;
15.1.3 joint venture; or
15.1.4 employer/ employee.
15.2 This Agreement shall not permit or authorise either Party to:
15.2.1 incur any expenses on behalf of the other Party;
15.2.2 enter into any commitment or make any representation or
warranty on behalf of the other Party;
15.2.3 pledge the credit of, or otherwise bind or oblige the other
Party; or
19
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
15.2.4 commit the other Party in any way whatsoever without in each
case obtaining the other Party's prior written consent.
16. Waiver
In no event shall any delay failure or omission on the part of any Party
in enforcing exercising or pursuing any right, power, privilege, claim or
remedy, which is conferred by this Agreement, or arises under this
Agreement, or arises from any breach by the other Party to this Agreement
of any of its obligations under this Agreement, be deemed to be or be
construed as:
16.1.1 a waiver thereof, or of any other such right power privilege
claim or remedy, in respect of the particular circumstances in
question; or
16.1.2 operate so as to bar the enforcement or exercise thereof, or
of any other such right, power, privilege, claim or remedy, in
any other instance at any time or times afterwards.
17. Severability
Any provision of this Agreement which is held invalid or unenforceable in
any jurisdiction shall be ineffective to the extent of such invalidity or
unenforceability without invalidating or rendering unenforceable the
remaining provisions hereof, and any such invalidity or unenforceability
in any jurisdiction shall not invalidate or render unenforceable such
provisions in any other jurisdiction
18. Third Party Rights
Nothing in this Agreement is intended to confer on any person any right to
enforce any term of this Agreement which that person would not have had
but for the Contracts (Rights of Third Parties) Xxx 0000.
20
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
19. Governing Law
This Agreement is governed by and shall be construed in accordance with
the laws of England and the Parties hereby submit to the non-exclusive
jurisdiction of the English Courts .
20. Transmission of Rights
Neither Party shall assign the benefit and/or the burden of this Agreement
to any third party without the prior written consent of the other.
21. Variations
Except as provided herein, this Agreement may not be amended, varied or
modified except in writing signed by a duly authorised officer or
representative of each of the Parties.
22. Counterparts
This Agreement may be executed in any number of counterparts and by the
Parties on separate counterparts, each of which when so executed shall be
an original of this Agreement, and all of which shall together constitute
one and the same instrument. Complete sets of counterparts shall be lodged
with each Party.
IN WITNESS WHEREOF the parties hereto have executed this Agreement on the day
and year first before written.
21
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
SIGNED by )
for and on behalf of ) J. Xxxxx Xxxxx
CEPHALON (UK) LIMITED )
in the presence of: )
Xxxx Xxx Xxxx
SIGNED by )
for and on behalf of ) Xxxxxx Xxxxx
NOVARTIS PHARMACEUTICALS )
UK LIMITED )
in the presence of: )
Xxxxx X Xxxxxxxxx
22
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
Schedule
The Products
Brand Name/Active Pack Size (SKU) Supply Price
Ingredient
PROVIGIL/modafanil 30 x 100mg [**]
tablets
Trademarks
Product Territory Class Registered Valid until
number
PROVIGIL UK 5 GB1566855 2005
23
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
