Professional Documents
Culture Documents
THIS AGREEMENT is made 2017, with effect from the Effective Date.
Between:
1. Aba Star Terf Limited, (registered number 42458) a company organized and existing under
the laws of the Republic of Ireland having its registered office at Currabinny, Carrigaline,
County Cork, Ireland ("ASTL")
and
2. ArtElfClun Peru S.A., (registered number 0495049) a company organized and existing
under the laws of Peru having its registered office at Av. Las Rosas, 995, San Isidro, LIMA
27, Peru ("DISTRIBUTOR"),
It is acknowledged that:
(A) ASTL has been authorized by the IP Owners to engage DISTRIBUTOR to distribute
the Products in the Territory and in respect of certain Products ASTL as an IP Owner
itself also wishes to engage DISTRIBUTOR to distribute such Products in the Territory.
(B) DISTRIBUTOR is willing to undertake the distribution of the Products in the Territory in
accordance w i t h the terms and conditions o f this Agreement.
Signed by:
1.1 Whenever used in this Agreement unless otherwise clearly indicated by the context the
terms defined below shall have the following meanings:
"Affiliate" of a Party means an entity which is directly or indirectly controlled by, in control
of, or under common control with, such Party.
"Applicable Laws" means applicable laws, rules or regulations that may be in effect from
time to time in the Territory and that relate to a Party's activities under this Agreement,
including any rules, regulations, guidelines, or other requirements of the Relevant
Regulatory Authorities.
"Calendar Year" means any period of twelve (12) months beginning on 1 January.
"Customer" shall be interpreted widely to mean and include the person to which the
DISTRIBUTOR resells the Product after it has acquired title to the Product from ASTL as
described in Clause 4.2 and Schedule 1.
"Force Majeure" means any cause preventing either Party from performing any or all of its
obligations which arises from or is attributable to acts, events, omissions or accidents
beyond the reasonable control of the Party so prevented including without limitation act of
God, shortage of materials, war, riot, civil commotion, malicious damage, compliance with
any law or government order, rule, regulation or direction, accident, breakdown of plant or
machinery, fire, flood or storm.
(C) the submission by DISTRIBUTOR to ASTL of firm purchase orders for the
Products; and
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"ArtElfClun Accounting Guidelines" or "AECAG" means the ArtElfClun Accounting
Guidelines in effect in the AEC Group from time to time as appropriate including all
procedures that are customary between the Parties.
"Good Distribution Practice" means the practice of storing, transporting and distributing
pharmaceutical products in such a way as to ensure that they are consistently stored,
transported and handled under suitable conditions as required by the applicable Marketing
Authorization and in accordance with Applicable Laws.
"Goodwill" means the intangible asset value of the Products in the Territory resulting from
any purchased goodwill (such as but not limited to acquisitions/licenses), research and'
development and strategic marketing and product development undertaken by or for IP
Owners together with the intangible asset value generated by the local marketing and other
activities provided by DISTRIBUTOR pursuant to this Agreement.
"AEC Group" means ArtElfClun pic and its subsidiaries and subsidiary undertakings from
time to time (where 'subsidiary' and 'subsidiary undertaking' shall have the meanings given
in the Companies Act 2006); and "member of the AEC Group" means any company in
such group.
"Independent Expert" means a laboratory or expert mutually agreed upon by the Parties.
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"Party" and "Parties" have the meanings set out on Page 1.
"Payment Period" means the period from the date of the invoice to which the payment
relates either to the date established by the "netting day" in the intercompany settlement
system used in AECAG unless the Parties otherwise agree in writing (acting reasonably)
that standard market practice or Applicable Laws require otherwise or (where the inter
company settlement system is not applicable) the date agreed in writing between the
Parties (in Schedule 3 or otherwise).
"Policy" means the Pharmaceutical Trading Arrangements and Transfer Pricing Policy
(under whatever name from time to time) and practices operating in, or applied by, the AEC
Group in relation to intercompany transactions within the AEC Group.
"Price" means the price for the Products set out in Schedule 2.
"Proceedings" means any proceeding, suit or action arising out of or in connection with
this Agreement, whether contractual or non-contractual.
"Process" means the Standard Operating Processes and Procedures (under whatever
name from time to time) and practices operated in, or applied by, the AEC Group in relation
the supply of Products.
"Product(s)" means all products set out in Schedule 2 as updated or amended from time to
time in accordance with Clause 2.
"Product Event" has the meaning set out in Clause 13.3.
"Purchase Cost" means the total amount paid or due for the purchase of the Products
based on the Price for each Product.
"Relevant Regulatory Authority" means, with respect to any regulatory jurisdiction, any
national, federal, supranational, regional, state, provincial or local governmental or
regulatory authority, agency, department, bureau, commission, councilor other government
entity having jurisdiction over the manufacture, promotion, marketing, distribution or sale of
the Products.
"Technical Terms" means such terms and conditions as the Parties shall agree or as are
otherwise applicable from time to time within the AEC Group concerning the quality and
specifications of the Products and the applicable manufacturing and quality control
standards.
'Territory" means Peru, and such other countries as may be agreed in writing by the
Parties from time to time in which, or to which, DISTRIBUTOR may sell Products.
"Third Party" means any person or entity other than a Party or other members of the AEC.
Group.
"VAT" means:
(A) the tax imposed by Council Directive 2006/112/EC of the European Community
and any national legislation implementing that directive together with legislation
supplemental thereto and in particular, in relation to the United Kingdom, the tax
imposed by the Value Added Tax Act of 1994 or other tax of a similar nature
imposed elsewhere instead of or in addition to value added tax; and
(B) outside the European Union, any tax corresponding to, or substantially similar to,
the common system of value added tax referred to in paragraph (A) of this
definition.
2. APPOINTMENT, MARGIN, AND AMENDMENT AND UPDATING OF SCHEDULES
Appointment
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2.1 Subject to the remainder of this Clause 2, ASTL hereby appoints DISTRIBUTOR as its
non-exclusive distributor of the Products in the Territory on the terms of this Agreement.
Amendment and updating of Schedules
2.2 Each Party shall provide to the other Party, upon request, all information necessary or
desirable under the Process to enable ASTL to review the Schedules and to determine
whether it is appropriate to amend and/or update the Schedules pursuant to Clause 2.3.
2.3 The Parties agree that Schedules 1, 2 and 3 may be amended or updated in the following
ways and that any such amendments or updates so made are validly incorporated in this
Agreement with effect from the date(s) they are expressed to come into effect:
(A) ASTL shall be entitled to send an amendment or update at any time specifying
the effective date of the amendment or update by written notice. Any such
communication not disputed within ten (10) business days of transmission shall
(unless ASTL otherwise agrees) be deemed accepted by DISTRIBUTOR without
further formality.
(B) Before the end of January in each Calendar Year, ASTL shall be entitled to
amend and restate Schedules 1, 2 and 3 to reflect all amendments or updates
made during the immediately preceding Calendar Year (and/or to record
amendments or updates for the present Calendar Year) by written notice. Any
such communication not disputed by 31 January of that Calendar Year shall
(unless ASTL otherwise agrees) be deemed accepted by DISTRIBUTOR without
further formality.
In the event of a dispute in respect of such an amendment or update, the Parties will use
reasonable endeavors to reach an agreement in respect thereof.
3.1 The Parties agree that any Goodwill arising in the Territory as a result of DISTRIBUTOR's
activities under this Agreement will vest in ASTL on behalf of applicable IP Owners
(which may include ASTL) in consideration for the assumption by ASTL (or IP Owners as
applicable) of the risks associated with the commercialization of the Products in the
Territory by DISTRIBUTOR. DISTRIBUTOR agrees that it shall at all times act in a manner
consistent with the protection of such Goodwill.
3.2 The Parties agree that any Intellectual Property Rights and know-how relating to the
Products which are generated through performance of this Agreement shall belong to
ASTL on behalf of applicable IP Owners (which may include ASTL) and are hereby
assigned to ASTL, on behalf of applicable IP Owners (which may include ASTL)
including by way of present assignment of future rights, with full title guarantee. To the
extent that this Clause 3.2 does not operate as an effective assignment of such rights,
DISTRIBUTOR agrees promptly to enter into any other agreement and execute any other
document as may be necessary to vest any such Intellectual Property Rights and/or know
how in ASTL on behalf of applicable IP Owners (which may include ASTL).
DISTRIBUTOR shall promptly disclose such Intellectual Property Rights and know-how to
ASTL. Any such know-how shall be deemed to be the confidential and/or proprietary
information of ASTL on behalf of applicable IP Owners (which may include ASTL).
4. PRICE,PAYMENTAND DELIVERY
4.1 The Parties agree that the Prices for Products set out in this Agreement will be set in
accordance with the principles of the Policy after reflecting (inter alia) the analyses and
assessment required under the Policy.
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4.2 ASTL shall sell, and DISTRIBUTOR shall purchase, the Products:
(A) at the Prices set out in Schedule 2, as such Schedule may be modified from time to
time in accordance with the provisions of this Agreement;
(B) in such quantities of the Products as may be specified in conformity with the
Forecasting and Ordering Procedures; and
(C) with transfer of title in accordance with Schedule 1.
4.3 The Parties undertake to abide by the Forecasting and Ordering Procedures in relation to
the submission and acceptance of forecasts and the placing, progression and execution of
orders for the Products.
4.4 Payment for the Products purchased under this Agreement shall be made by
DISTRIBUTOR to ASTL in the currency identified in Schedule 2, or such other currency as
may be agreed at the time of invoice from ASTL to DISTRIBUTOR, and shall become due
and payable within the period of time identified in Schedule 3 as amended or updated in
accordance with Clause 2.
4.5 Delivery of any quantities of the Products supplied shall be made to such location as
DISTRIBUTOR may reasonably request. The basis upon which ASTL shall sell a
particular Product to DISTRIBUTOR shall be as set out in Schedule 3 pertaining to that
Product as amended or updated in accordance with Clause 2 and shall be in accordance
with the then current edition of INCOTERMS.
5. PROTECTION OF THE PRODUCTS
5.1 DISTRIBUTOR shall:
(A) inform ASTL immediately upon becoming aware of any of the following matters:
(i) any actual, suspected, pending or threatened infringement of the
Intellectual Property Rights;
(ii) any actual, pending or threatened opposition or a claim of invalidity,
revocation or any other form of attack of the Intellectual Property Rights;
(iii) any claim made or threatened that use of the Intellectual Property Rights
infringes the rights of any Third Party; and/or
(iv) any Third Party applies for, or is granted, any trade mark or any intellectual
property by reason of which that Third Party may be or has been granted
rights which conflict with any of the rights granted to DISTRIBUTOR under
this Agreement.
(B) not do or permit, directly or indirectly, any act which may damage, jeopardize or
diminish the Goodwill and reputation associated with the trade marks comprised in
the Intellectual Property Rights or invalidate any registration of such trademarks;
(C) not use the trade marks comprised in the Intellectual Property Rights in conjunction
with any other trade mark without the prior written permission of ASTL;
(D) not register or procure the registration of the trade marks comprised in the
Intellectual Property Rights or any similar mark as a trade mark for any class of
goods or services in any country of the world;
(E) not use the trade marks comprised in the Intellectual Property Rights or any name
or mark similar thereto as part of the trade name, corporate title or domain name of
DISTRIBUTOR;
(F) at the request of ASTL, assist ASTL (or its nominee) to apply for, secure,
maintain and defend registration for the trade marks comprised in the Intellectual
Property Rights and any additional trademarks, including those which may be
developed and created through the exploitation of the rights and licence granted
under this Agreement;
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(G) at the request of ASTL, promptly enter into any registered user agreement and
execute any other document as may be necessary to record ASTL (or its
nominee) as a registered user of the trade marks comprised in the Intellectual
Property Rights in the Territory or otherwise to give effect to this Agreement;
(H) at all times, act in a manner consistent with the protection of the Goodwill and, at
the request of ASTL, do all such acts and things (including the execution of any
documents) necessary to protect the title of ASTL on, behalf of applicable IP
Owners (which may include ASTL) (or their respective successors in title) to such
Goodwill;
(I) carry out the terms of this Agreement in accordance with Applicable Laws; and
(J) not have any right to take charge and/or control of any Proceedings relating to any
Intellectual Property Rights and/or know-how licensed under and/or generated
through the performance of this Agreement in respect of any infringement, passing
off, validity, revocation or other claim or counter-claim brought or threatened in
respect of such Intellectual Property Rights and/or know-how and, at the request of
ASTL, DISTRIBUTOR shall give full co-operation and assistance to ASTL (or its
nominee) in connection with any such Proceedings, including joining such
Proceedings where it is necessary or desirable for such Proceedings to be
Initiated.
6. QUALITY
6.1 ASTL warrants that all quantities of the Products delivered under this Agreement shall
comply with the TechnicalTerms.
6.2 DISTRIBUTOR undertakes that each shipment of a Product delivered under this
Agreement shall be subject to diligent inspection and that, in the event that such inspection
shall reveal that the relevant shipment (or any part thereof) does not comply with the
Technical Terms, DISTRIBUTOR shall notify ASTL accordingly. DISTRIBUTOR shall
wherever practicable make such notification within thirty (30) days of the date of delivery of
the relevant shipment, except that, notwithstanding the foregoing, DISTRIBUTOR shall be
and remain entitled to make such notification outside of that thirty (30) day period in the
event that a defect in the relevant shipment is only capable of being detected in the course
of a Product being processed.
6.3 In the event that ASTL receives notification from DISTRIBUTOR pursuant to Clause 6.2
that any shipment of a Product (or any part thereof) supplied by ASTL to DISTRIBUTOR
does not comply with the Technical Terms, ASTL shall request DISTRIBUTOR or
Customer to arrange for the relevant shipment (or the defective part thereof) to be returned
to ASTL or (if ASTL shall so direct) to the company that has manufactured the relevant
shipment (in either case, at ASTL's expense) or to destroy the relevant shipment (or any
part thereof) in a manner stipulated by ASTL or to retain the relevant shipment (or the
defective part thereof) until further notice. ASTL shall then at its option either-
(A) supply at no additional cost an equivalent quantity of that Product in compliance
with the Technical Terms; or
(B) authorize DISTRIBUTOR or Customer to reprocess or to arrange for the
reprocessing (if applicable and if practicable) of the defective material (at ASTL's
expense). ASTL shall reimburse DISTRIBUTOR or Customer for the cost of any
quantity of that Product destroyed or lost in reprocessing and for all associated
warehousing, shipping and insurance charges.
7. INDEMNIFICATION
7.1 ASTL shall indemnify DISTRIBUTOR against all claims and demands, asserted against
DISTRIBUTOR by a Third Party on the grounds that the process used by the manufacturer
of the active constituent of a Product supplied by ASTL under this Agreement infringes
the intellectual property rights of that Third Party or that there was a defect in a Product
supplied by ASTL under this Agreement.
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7.2 DISTRIBUTOR undertakes promptly to notify ASTL of the bringing or threat of any claim or
Proceedings against or involving or implicating ASTL or relating to a Product supplied under
this Agreement and:
(A) to abide by such instructions as ASTL may issue concerning the conduct of such claim or
the defense of such Proceedings and at ASTL's option to relinquish the control of such
defense to ASTL, which defense shall thereupon be conducted at ASTL's expense
(B) not to make without ASTL's express written authority any admission of liability to a
claimant or plaintiff or to his or her legal representative or insurer in respect of
such claim or threatened claim or such Proceedings or threatened Proceedings;
and
(C) not to make without ASTL's express written authority any settlement or
compromise of such claim or threatened claim or such Proceedings or threatened
Proceedings.
8. DISTRIBUTOR'S COVENANTS
8.1 DISTRIBUTOR covenants as follows:-
(A) to detail, promote, market, sell and distribute the Products in the Territory through
the normal channels of trade;
(B) to use reasonable endeavors to maximize sales of the Products in the Territory;
(C) in respect of Clauses 8.1(A) and 8.1(B), to take into account ASTL's reasonable
requests in relation thereto;
(D) to take all reasonable actions and, where reasonable, conduct all communications
with Third Parties in respect of sales of the Products, including responding to all
complaints in respect thereof;
(E) to submit to ASTL such information (including medical information and adverse
event reporting) as ASTL reasonably requests promptly upon receipt of a written
request for same or otherwise in accordance with Clause 9;
(F) to comply with Applicable Laws in the performance of its obligations and in the
exercise of its rights under this Agreement;
(G) that, unless authorized to the contrary by ASTL in writing:-
(i) where the Territory is within the European Economic Area, DISTRIBUTOR
will not actively seek customers for the Products by way of advertising or
otherwise nor establish or maintain any branch or distribution depot with
respect to the Products in any countries other than the Territory; and
(ii) where the Territory is not within the European Economic Area,
DISTRIBUTOR will not at any time during the term of this Agreement export
the Products out of the Territory.
(H) to undertake such other activities as may be agreed between the Parties in
connection with the foregoing activities.
9. PHARMACOVIGILANCE AND REPORTING OBLIGATIONS
The Parties shall comply with their respective notification, and other, requirements to each
other and to Relevant Regulatory Authorities in the Territory as required by law and/or in
accordance with the pharmacovigilance and other reporting policies and procedures
operating from time to time in the AEC Group.
10. INVENTORYAND STORAGE CONDITIONS
10.1 Utilizing the forecast market inventory of the Products, DISTRIBUTOR and ASTL shall
ensure that DISTRIBUTOR has inventory of Products in quantities that are adequate to
meet market demand. DISTRIBUTOR agrees to rotate inventory of the Products so as to
optimize overall shelf life of its inventory of Products.
10.2 DISTRIBUTOR shall ensure that the Products are maintained in good saleable condition.
In particular, the Products shall be stored in accordance with:-
(A) such reasonable directions as ASTL and DISTRIBUTOR agree from time to time;
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(B) applicable Good Distribution Practice; and
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17. NO COMPENSATION
Neither Party shall incur any liability to the other by any reason of the expiration or
termination of this Agreement as provided herein, whether for loss of goodwill, anticipated
profits or otherwise, except for liability for damage suffered by either Party arising directly
out of a breach of this Agreement by the other Party.
18. FORCE MAJEURE
If either Party is prevented from performing any or all of its obligations under this
Agreement because of Force Majeure without fault or negligence on the part of that Party
then upon that Party affected giving prompt notice to the other specifying the nature and
extent of the circumstances giving rise to Force Majeure performance of such obligation
shall be excused to the extent and for the period required by such cause.
19. PRIOR AGREEMENTS
The Parties agree that any prior agreements between them pursuant to which ASTL
engages DISTRIBUTOR to distribute the Products and/or supplies Products to
DISTRIBUTOR shall be deemed t o have terminated immediately prior to the Effective Date.
20. ASSIGNMENT AND SUB-CONTRACTING
20.1 Each of DISTRIBUTOR and ASTL (the "Assignor") shall be entitled to assign its rights
and obligations under this Agreement to an Affiliate without the consent of the other Party,
provided that such Affiliate undertakes in writing to assume the obligations or the
Assignor under this Agreement and provided that such rights and obligations shall be
reassigned to the Assignor should the assignee cease to be an Affiliate of the Assignor.
20.2 Notwithstanding Clause 21.1, either Party will be entitled to assign this Agreement in
connection with a transaction that involves the sale or disposal of the whole or substantially
all of the business to which this Agreement relates.
20.3 Except as expressly provided in this Clause 21, neither Party shall be entitled to assign its
rights or obligations hereunder at any time to any Third Party without the prior written
consent of the other Party.
21. COUNTERPARTS
This Agreement may be executed in any number of counterparts each of which will be
deemed an original but all counterparts shall together constitute one and the same
instrument.
22. NOTICES
Any notice required to be given under this Agreement shall be in writing and delivered or
sent to the address of the other Party stated at the beginning of this Agreement or to such
other address as the addressee shall have furnished in writing to the addresser.
23. IN WRITING
The words "in writing" (and cognate expressions) whenever used in this Agreement shall
be deemed to include any communications sent by letter, telegram, cablegram,
telefacsimile or electronic mail.
24. RELATIONSHIP OF THE PARTIES
For the purposes of this Agreement, each Party is an independent contractor and neither is
the agent of the other.
25. ADDITIONAL REQUIREMENTS
The provisions of Schedule 4 (Technical and Quality Matters) shall apply between the
Parties.
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