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Purchasing conditions
•
Purchasing conditions
Special
terms of the purchasing conditions
• Raw materials for
routine manufacturing - Annex A2.A
• Raw materials for
Research and Development Projects - Annex A2.B
• Services
- Annex A2.C
• IT services
- Annex A2.D
• Analytical Services
- Annex A2.E
Purchasing Conditions
Purchasing Policy COP043 Annex 2 - 17.Oct.2007
1. General
The Hovione Purchasing Conditions are an integral part of the
Purchase Order (PO), scheduling agreements, quality and value
contracted, that Hovione places with the Vendor. The PO is the
document that defines the purchase contract: if required the
PO will state the references of other documents and correspondence
which was the basis of the negotiation leading up to the agreement
contained in the PO and is deemed to be made part of the agreement.
Both parties agree that in case of dispute the terms written
by Hovione in Hovione documents known to the Vendor always take
precedence. It is the responsibility of the Vendor to verify
it has a complete and clear understanding of what is Hovione’s
request as defined in the PO.
2. Hovione responsibilities
In relation to all merchantable goods to be supplied to Hovione,
it is Hovione responsibility to provide Vendor with complete,
accurate and timely information requested to the proper execution
of the work as well as all the information relating to any regulations
to which Hovione is bound to, namely related to quality, health
safety and environment. Vendor will not be responsible for any
consequences which may arise from any delay or failure to do
so and these may also result in additional fees for which invoices
will be raised.
All critical issues, whether given as oral or telephone instructions,
or decisions taken at meetings shall always be reduced in writing,
ideally in the form of minutes prepared by Vendor and approved
by both parties.
3. Purchase Order
The PO shall clearly set the agreed value of the contract. The
currency, the payment terms and the key time commitments shall
be clearly expressed together with the accurate general description
of the object of the contract. Additional technical data shall
be provided to define the purchased object.
Vendor is requested to inform Hovione on the acceptance of the
PO and all its content.
The PO defines the approved conditions and any changes must
be previously authorised. It is the responsibility of the Vendor
to inform Hovione of any changes to the conditions stated in
the PO, namely value, delivery date and characteristics of the
merchantable goods or any consequence of it. Hovione reserves
the right to cancel the PO if any condition herein stated is
not accomplished.
The PO shall be signed by the Hovione representative within
the policy in force at Hovione.
4. Warranties of suitability for the
purpose and as to quality
and durability
Hovione is a manufacturer of fine chemicals /APIs – Active
Pharmaceutical Ingredients for the pharmaceutical industry and
operates in a highly regulated environment.
The Hovione facilities and laboratories operate under the appropriate
strictest standards of GMP and ISO. Hovione manufactures goods
for human consumption. APIs are produced under conditions that
involve hazardous (flammable, explosive, corrosive) conditions.
Hovione will therefore always advise of the specific conditions,
these must therefore be identified and addressed to ensure a
complete understanding of suitability of the merchantable goods.
These merchantable goods will be used in a pharmaceutical process
and as such, the merchantable goods to be supplied shall be
adequate to it (for example free of contamination) and shall
be manufactured or executed under a system that should meet
Quality and HSE (Health, Safety and Environment) applicable
legislation and other requirements as ISO9000, ISO14001, OHSAS
18001, cGMP standards (as understood by FDA and ICH Q7a) and
ATEX directive 94/9/EC and 99/9/EC.
Any change to the merchantable goods that impacts or may impact
in the quality or regulatory fillings (e.g. its manufacturing
process) needs to be previously assessed by Hovione to evaluate
its impact in Hovione’s process. It is the responsibility
of the Vendor to inform Hovione in writing and get Hovione’s
authorization prior to the implementation of the change.
In the process of defining what is the substance matter of the
PO, Hovione has been careful to explain to the Vendor what is
the purpose that the purchased merchantable goods is destined
to serve.
To the extent that Hovione has been careful to explain in detail
the reason for acquiring the merchantable goods, Vendor has
a general duty to ensure that to the extent of his professional
activity and the competencies it has represented to Hovione
to have is obligated to deliver a merchantable goods that will
substantially achieve the purpose desired by Hovione to a reasonable
extent and thus meet Hovione’s expectations. It is under
this assumption that Hovione has contracted with the Vendor
and has agreed to the price.
The Vendor provides Hovione with warranties over the good quality
of materials, building and craftsmanship which will ensure the
sound operation of the purchased object for the intended purpose.
Such warranties will last for a period of at least 18 months
from date of delivery (defined as per the shipping receipt when
the purchased object left the Vendor’s premises) or one
year from start-up or handing-over. The Vendor will take full
responsibility for the quality and reliability of all parts
of the equipment that make up the order, including those parts
or services supplied by a third-party Vendor or sub contractor.
Environment
The protection of the environment is an imperative and strategic
objective for the company business. Hovione has subscribed the
“Responsible Care Program”. All the company employees
in their work follow those guidelines: - respect for the environment
is an imperative in all Hovione activities; - follows the current
legislation and are continuously searching for new opportunities
to optimize it and to recycle; - a management Waste Policy that
is integrated, clear and autonomous.
The Hovione’s Health, Safety and Environment (HSE) Policy
is known by all our Vendors, being also a part of Hovione Purchasing
Conditions. If the merchantable goods supplied have a significant
impact in terms of HSE, a risk assessment shall be made prior
to the acquisition.
5. Hovione’s Policies on Quality,
Health, Safety and Environment and Code of Ethics
Hovione’s Policies are described in Hovione Purchasing
Policies. Vendor is aware of it and accomplish with it, whenever
it is applicable to the merchantable goods to be supplied to
Hovione.
Vendor agrees that is aware that Hovione operates in a highly
regulated environment. Vendor shall ensure that Vendor’s
work is performed to standards and guidelines that strengthen
positively Hovione’s business. Vendor is also aware of
Hovione’s policies and agrees that Vendor’s work
shall be aligned with such policies and regulations in force.
Specific Environmental requirements should be evaluated during
the negotiation phase and mentioned in the PO (for instance,
noise level, identification and instructions in English and
in the official language of the site to which it is intended
for). Vendor is engaged to comply with all applicable legislation/regulations.
6. Payment
A Vendor invoice is only eligible for payment if there are no
differences with the PO, if it refers the delivery date of the
merchantable goods, if the date of issue is within the period
of 5 days of the goods receipt and if states a PO number.
Sending invoices with the goods delivered is acceptable, but,
an original invoice shall be sent by mail to the attention of
Hovione Accounting Department.
Hovione shall only pay in advance monies which clearly correspond
to the value of the merchantable goods that need to be acquired
for the fabrication of the purchased goods. For each advanced
monies the supplier has to issue a Bank Guarantee opened with
a first class bank for the total advanced value, prevailing
until the complete delivery of the goods. The cost of any rental
or trials shall be deducted from the final order. Hovione reserves
the rights to open a letter of credit instead of effecting advanced
payments.
Payments are effective fortnight by e-banking and monthly by
other means. If Vendors wish to be advised when a payment is
made, please kindly send key contact person e-mail address to
finance@hovione.com.
Invoices are payable based on the purchase ledger system in
place at Hovione, after the merchantable goods has been approved
for use and based on the payment terms agreed in the purchase
order or contract signed between Hovione and Vendor.
7. Retention of Monies
Hovione reserves the right to request from the Vendor to retain
up to 15% of the agreed purchase price as security. These retention
monies shall be released in full within 12 months of delivery
to Hovione of the merchantable goods purchased. Hovione will
accept to release part or all the funds in exchange for a suitable
bank guarantee that the Vendor will provide Hovione with, and
after successful start-up as evidenced by a handing over document.
8. Fines for late delivery
The PO placed with the Vendor will usually be part of a wider
number of POs which aims to complete a system, to be incorporated
into a new installation or a manufacturing campaign. The scheduling
of such a project will therefore involve multiple parties and
key dates. It is imperative that the Vendor respects the time
commitments which the PO will define clearly. Should the Vendor
fail to observe such time commitments Hovione reserves the right
to deduct "fines for late delivery" from the purchase
price.
The fine shall be up to 0.5% per week of delay, limited to 5%
of the agreed purchase price, from the agreed delivery date
of the object which is delayed and where such delay clearly
affects negatively the management of the overall project.
9. Drawings and operating instructions
The Vendor shall ensure that complete (relevant and sufficient
in detail and covering all aspects of the purchased object)
execution drawings (to be followed by definitive, correct as-built
drawings) shall be promptly forwarded to Hovione as soon as
available. These can be sent by mail or electronic means, in
the form of paper as well as magnetic or other format that may
be used more efficiently by Hovione. The Vendor shall supply
two copies of all the commissioning and operating instructions,
parts list and user’s manual in a language understood
by the intended users at Hovione.
The Vendor shall supply Hovione with additional copies upon
request, at no further cost, at any time during at least the
expected life of the purchased object.
10. Retention of files
In absence of any alternative instructions from Hovione, Vendor
will retain records related to the merchantable goods supplied
to Hovione, at least, for ten years after the supply date.
11. Insurance and Transport
Hovione has in place an insurance policy to cover the transport
from warehouse to warehouse, including cover for accidents during
erection and start-up. The Vendor will ensure that Hovione is
duly notified of the readiness to ship, and of the shipping
details. All necessary documents shall be provided to Hovione
by fax or/and electronic mail as soon as available. Unless specified
in the negotiation documentation the Vendor is obliged to provide
at no cost to Hovione suitable export packing. Every shipment
shall be marked with: Name of Vendor, PO number, Hovione. Suitable
markings such as "fragile", shall be prominently displayed.
12. Confidentiality
Hovione operates in a very competitive environment, its activities
and manufacturing processes involve proprietary technologies.
Hovione’s know-how is very valuable and a key competitive
advantage. It is only made available to the Vendor to assist
him in carrying out his business and best serve Hovione’s
needs. The Vendor agrees to respect the confidentiality of all
the information it receives from Hovione, this shall be held
in trust by the Vendor and is to be used solely to the benefit
of Hovione through the supply of the purchased merchantable
goods.
Vendor also recognize that Hovione has much proprietary confidential
information belonging to both Hovione and to Hovione’s
customers which Hovione holds in trust for the customers whilst
performing services for them. If ever, during the performance
of Vendors duties, Vendor becomes exposed to such information;
Vendor agrees to respect its confidential nature and not to
disclose it to any third party. Furthermore Vendor confirms
that all its employees that are involved in Hovione business
are also under a similar personal obligation of confidentiality,
and accept the responsibility for any breach by them.
Hovione needs to share some confidential information to Vendor
to allow that the supplies of goods and services, parties now
wish to establish a contractual framework that shall protect
their respective proprietary information and longer term interests.
Vendor shall observe the highest standards of confidentiality
over Confidential Information provided to it by Hovione as such
data includes information that Hovione itself has received on
trust and under strict obligations of confidentiality to its
customers. In the course of these communications and activities,
Hovione and Vendor may disclose or deliver to each other certain
Confidential Information (defined below).
“Confidential Information”
means any scientific, technical trade or business information
possessed or obtained by, developed for or given to the disclosing
party which is treated by the disclosing party as confidential
or proprietary including, without limitation, Research Materials
(defined below), gene sequences and loci, formulations, techniques,
methodology assay systems, formulae, procedures, tests equipment,
data computer software (including, without limitation, object
code and source code), documentation, reports, know-how, sources
of supply, patent positioning, technical, engineering, financial
and commercial information, architecture works, flow diagrams,
layout drawings, equipment details, calculations, drawings graphs,
blueprints, tables, photographs, copyright material, trade secrets,
unpatented inventions, relationships with consultants and employees,
business plans and business developments, information concerning
the existence, scope or activities of any research, development,
manufacturing, marketing or other projects of the disclosing
party, and any other confidential information about or belonging
to the disclosing party’s Vendors, licensors, licensees,
partners, affiliates, customers, potential customers or others.
The Parties will use commercially reasonable efforts consistent
with reasonable practices to:
- Label or identify as “CONFIDENTIAL” at the time
of disclosure or, by written notice to the other party, within
thirty (30) days following such disclosure, Confidential Information
which is disclosed in writing or other tangible form:
- all confidential information shall be disclosed in writing
or electronically and marked confidential or if disclosed orally
or visually or gained by visiting plants/labs and shall include
any tangibles such as strains and product samples or in any
other way, shall be summarized and identified as confidential
by the disclosing party in writing with 30 days of the disclosure.
- Vendor shall receive the Confidential Information in the strictest
confidence and in good faith, and shall not at any time without
the prior written consent of Hovione use the Confidential Information,
or any knowledge or information which Vendor may acquire as
a result of receiving the Confidential Information, in any way
which is in furtherance of competition with Hovione, or otherwise
directly or indirectly detrimental to the interest of Hovione,
or any purpose whatever other than for the purpose of the project
under an agreement and or contract with Hovione.
“Confidential
Information” does not include information which:
a) was known to the receiving party
at the time it was disclosed, other than by previous disclosure
by the disclosing party, as evidenced by the receiving party’s
written records at the time of disclosure;
b) is at the time of disclosure or later becomes publicly known
under circumstances involving no breach of a specific agreement;
c) is lawfully and in good faith made available to the receiving
party by a third party who did not derive it, directly or indirectly,
from the disclosing party;
d) is independently developed by a receiving party without the
use of the disclosing party’s Confidential Information.
Research Materials include,
without limitation, all reagents, chemical compounds, together
with all related impurities, intermediates, raw-material or
other materials – as well as the analytical, engineering
and process chemistry know-how to produce such Research Materials
and all regulatory documentation necessary to obtain authorization
to sell by a health authority.
Affiliated Companies shall
mean:
- any corporation, company or other business entity, which is
owned directly or indirectly by Vendor or by Hovione;
- any corporation, company or other business entity, which owns
directly or indirectly fifty per cent (50%) or more of the voting
stock of Vendor or Hovione;
- any corporation, company or other business entity under the
direct or indirect control of a corporation, company or other
business entity described in the above paragraphs of this chapter.
Ownership: Hovione and Vendor
shall at all times remain the sole owner of their respective
Confidential Information. However any inventions that may arise
as a result of a specific collaboration shall belong to Hovione
and should any invention give rise to an opportunity to patent,
parties shall collaborate so that, at Hovione’s expense,
one or more patents are applied for and assigned to Hovione
or to any 3rd Party Hovione shall direct.
Nondisclosure of Confidential Information:
Hovione and Vendor shall not, directly or indirectly, publish,
disseminate or otherwise disclose, deliver or make available
to any person outside its organization any of the other party’s
Confidential Information. Hovione and Vendor may disclose the
other party’s confidential Information to persons within
their respective organizations and to their respective affiliates
and collaborators who/which have a need to receive such Confidential
Information in order to further the supply of the purchased
merchantable goods and who/which are bound to protect the confidentiality
of such Confidential Information, as set forth below. It is
the responsibility of the Vendor to ensure that all its employees
that may have access to Hovione’s information are under
an obligation not to disclose to third parties such confidential
information (for example: name of Hovione as a client, name
of Hovione’s clients, nature of merchantable goods to
Hovione, nature of business). Vendor shall not disclose to any
party the existence of an agreement with Hovione. Hovione shall
however have the right to disclose the identity of the Vendor
to the customer for whom it is supplying if this is being done
on an exclusive basis.
Required Disclosure: If required,
Hovione and Vendor may disclose the other party’s Confidential
Information to a governmental authority or by order of a court
of competent jurisdiction, provided that such disclosure is
subject to all applicable governmental or judicial protection
available for like information and reasonable advance notice
is given to the other party.
Use of Confidential Information:
Hovione and Vendor shall use the other party’s Confidential
Information solely for the purpose to the merchantable goods
or for such other purposes as may be approved by the other party
in writing, nor will it disclose such Confidential Information
to any third party (other than to its employees and consultants
whose duties justify the need to know such Confidential Information
and who have agreed to be bound by the terms of this conditions).
Expiration; Termination
Expiration; Return of Research Materials
and Other Confidential Information: Confidential Information
obligations will expire ten (10) years from the last date of
disclosure of any confidential information. Upon expiration,
or sooner upon disclosing party’s request, the receiving
party shall promptly return to the disclosing party all Research
Materials and any other tangible Confidential Information.
Termination for Breach: Prior
to expiration, however, either party may terminate this Agreement
immediately upon written notice to the other party if it determines
that the other party has breached its confidentiality obligations.
In this event, the party in breach shall promptly return to
the other all Confidential Information and its confidentiality
obligations will continue indefinitely.
Agreements with Personnel and Affiliates
Hovione and Vendor have or shall obtain agreements with all
parties who are permitted access to the other party’s
Confidential Information under this Agreement which impose comparable
confidentiality obligations on such parties.
13. Promotion
Vendor shall not list, feature or mention Hovione or the supplied
merchantable goods as a reference in its documentation or client
list. On a case-by-case basis, Hovione may make exceptions to
this rule, but any and every authorization to make a specific
disclosure shall require a specific written consent by Hovione.
14. Auditing
Vendor accepts to be audited by Hovione’s to verify compliance
with these Purchasing Conditions and or any other contract and
agreement signed. Such audits can be carried out by a consultant
acceptable to Hovione.
15. Public Liability Disclaimer
When visiting Hovione’s premises, Vendor and its employees
shall be subject to Hovione’s’ badge and pass requirements
in effect at the site visited. Vendor and its employees agree
to be bound by all orders, rules, and regulations of Hovione
pertaining to the use of Hovione facilities. Hovione shall not
be liable under any circumstances for any personal or property
injury or damage done or suffered by Vendor or its employees
on Hovione premises and Vendor shall assume all such risk of
injury or damage.
Any and all damages or harm caused by Vendor to Hovione’s
installation and employees or those of subcontractors, Vendors,
clients and independent workers is the sole and entire responsibility
of the Vendor.
16. Conflicts of Interest and Non-Compete
Clause
Vendor accepts not to seek to hire anyone employed by Hovione,
similarly Hovione accepts mirror like obligations. Vendor accepts
the obligation to disclose to Hovione any work that Vendor do
for others which could present a conflict of interests. Vendor
declares that it will not compete and or create competition
to Hovione, directly or indirectly via third parties on the
business of any API and or any relevant raw material, intermediates,
building blocks and impurities which are used in the manufacturing
process of Hovione APIs.
17. Subcontractors
Vendor shall not make use of subcontractors in any activity
directly related to the merchantable goods supplied/to be supplied
to Hovione, except with the Hovione’s written authorization.
In the event that a subcontractor is chosen, the responsibility
of the totality of the works performed to Hovione will lie exclusively
in the Vendor, whatever the executor of the work may have been.
18. Gifts and benefits
It is Hovione’s Policy that all its employees and their
family members are not allowed to solicit or accept any money,
valuables gifts or benefits from Hovione customers or Vendors.
Hovione believes that giving and accepting of any valuable gifts
are unnecessary and may even be detrimental to the development
of business relationships. Received gifts will be remitted to
Hovione Human Resources to be used for the Hovione Christmas
party’s lucky draw.
19. Nota Bene
Hovione Purchasing Conditions shall in no way reduce any rights
that Hovione may have under the Law of the country where the
merchantable good was sold and/or may benefit from the general
terms of sale of the Vendor; they are to be construed as applicable
to all purchases that Hovione may make and are therefore to
be interpreted so as to suitably defend Hovione’s rights;
these Purchasing Conditions are subordinated to the terms in
the actual PO which are specific to the purchased object. Herein,
“merchantable good” is deemed to include raw material,
product, equipment and material or service or know-how or a
combination thereof.
20. No License
Nothing contained herein shall be construed to grant Vendor
any immunity or license under any Hovione intellectual property
right.
21. No Violation
Hovione and Vendor represents that its compliance with the terms
of these Conditions will not violate any duty which such party
may have to any other person or entity, including obligations
concerning providing services to others, confidentiality of
proprietary information.
22. Law and Jurisdiction
These terms of business (a) may not be assigned or transferred
by Vendor without Hovione’s prior consent (b) shall be
governed by and construed in accordance with the laws of Switzerland
without regard to any choice of law principle that would dictate
the application of the law of another jurisdiction, and in case
of questions and or dispute arising in connection with or relating
to the execution, the implementation, the interpretation of
any clause contained in these Conditions, which cannot be amicably
settled by the Parties through negotiations in good faith within
sixty (60) days from the first notice of such dispute , controversy
or claim, Parties accepting to submit to the jurisdiction of
the Rules of Arbitration and Conciliation of the International
Chamber of Commerce (Paris) to be held in Zurich in the English
language and may be executed by facsimile, which will be deemed
an original.
23. Hovione Policies and Rules
23.1- Quality Policy:
We, at Hovione, are committed to Quality. A demanding quality,
which is adjusted to satisfy our Customers and Health Authorities.
| • |
Our Quality System assures
that we are in compliance with current GMP and regulatory
requirements. |
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Following the rules is very
important because the products we make save lives. |
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Quality is designed-in and
built-in, it is a team effort, and everyone’s individual
work is very important. |
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We do it right first time,
and we improve all the time. |
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In order to improve change
is encouraged, but all changes are controlled. |
| • |
Deviations and complaints
are recorded and investigated. |
| • |
Corrective and preventive
actions are implemented through changes to controlled
documentation and training. |
| • |
Traceability enables the
identification of non-conformities, deviations and the
trend that determines when change is appropriate. |
| • |
To do good work YOU
| - |
must first understand what is expected
of you, |
| - |
then you must be well trained and finally, you
must do your best. You should listen to your colleagues
and, when appropriate, you should inform the Customer
before making changes. |
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23.2 - Health, Safety and Environment
Policy:
The protection of people, facilities and the environment is
a strategic imperative for development and is a constant source
of concern for Hovione FarmaCiencia SA, relying on the following
principles:
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We comply with the applicable legislation
and other requirements that the company subscribes to; |
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We design facilities, processes and
operations in agreement with principles that assure safety,
health and the environment; |
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We evaluate and prevent risks to health
and safety and the impact on the environment of all areas
of Company activity; |
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We adopt adequate policies for the management
of waste, emissions and natural resources that prevent
pollution and are, whenever possible, integrated and autonomous; |
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We inform and train our employees and
demand that they act responsibly in the defence of health,
safety and the environment using common sense and in alignment
with the business; |
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We investigate and record all non-compliance
situations and implement corrective/preventive actions
to avoid recurrences; communicate them promptly and effectively
to all Company staff and all on-site sub-contractors,
whenever appropriate. |
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We maintain a cordial and constructive
relationship with the community and other interested parties
based on a spirit of mutual respect and dialogue, and
aim to continuous improvement in Health, Safety and Environment
matters, evaluating regularly our performance in order
to reach the established objectives. |
23.3- The Hovione Code of Ethics
Fundamental Principles
Since its foundation, Hovione’s activity has been governed
by ethical values that have been transmitted down form more
than four decades. Hovione believes that the respect for these
values is the basic principle for the healthy growth of the
Company, permeating and guiding its business conduct and human
relations. This behavior is based on Compliance with the Law,
Honesty, Loyalty, Courtesy, Respect, Diligence and a Sense of
Responsibility.
The Hovione Code of Ethics establishes fundamental rules of
conduct which govern relationships between the Company and the
Staff, Clients, Suppliers, Competitors, Shareholders, Public
Authorities and the Community. Hovione’s ethical principles
aim to establish and develop Trust in all of its relationships.
While the Company strives to defend and promote its scientific,
industrial, commercial and financial interests, Truth and Honesty
shall prevail above all.
Hovione is dedicated to serving the Pharmaceutical Industry
with products that save human lives and improve quality of life
– the mission of our Company and the nature of our activities
implies great responsibility in our work, not only in the quest
for sound science but also in achieving a constant state of
compliance with the regulations and best practices in the industry.
Our daily activity is further based on observing our obligations
towards confidentiality and protecting the valuable know-how
and information of the Company and that of our Clients.
Hovione operates in three continents and represents a multitude
of different cultures, races, nationalities and religions. A
written document describing certain fundamental rules of conduct
which reflect the values we have always held is now necessary.
This document applies to all members of the Company; it also
applies to persons who are conducting business on behalf of
Hovione and who are seen by third parties as representing the
Company. Hovione expects from all members of its staff, irrespective
of their level of responsibility, a conduct in accordance with
these principles and rules of conduct. In case of doubt in the
application of any of the present rules, it is each one’s
responsibility to seek advice from his or her hierarchical head
or from Human Resources.
This Code of Ethics is a set of principles. Local Hovione companies
will use them to develop additional internal procedures if required
by their own laws, regulations and local custom or business.
Rules of Conduct - Summary
Dealing with our business partners
1.1 The prosperity and future of Hovione is based on serving
our clients to their satisfaction and best expectations.
1.2 We treat clients with honesty, professionalism and openness.
1.3 We endeavour to supply products and services as agreed,
namely in terms of quantity, quality, price, and delivery date,
always confirming to specification and to the regulations.
1.4 We inform clients of any relevant or unexpected deviation
from the agreed terms, conditions and specifications, whether
technical, scientific or commercial.
1.5 We promote with our customers and other business partners
long lasting partnerships, which are based on trust and are
mutually beneficial.
1.6 We select our suppliers through an objective evaluation
of competence, price, quality, delivery dates, payment terms,
shared values and other due diligence issues, according to our
requirements and interests.
1.7 Loyal competition is essential to establish a level playing
field for all participants in the industry and for its sound
development and we will work to uphold and preserve it.
1.8 We will not obtain or acquire information about competitors
in an illegal or irregular manner; we will not denigrate their
reputation but endeavour to make objective comparisons.
1.9 We will not undertake any unethical business practices to
attract a client to the detriment of a competitor.
1.10 We will not increase profits by any illegal or dishonest
means. We will not accept any personal presents or personal
favors, which are intended to influence the business relationship
with the Company.
1.11 We work with our business partners under contractual obligations
of confidentiality. We protect and keep confidential all scientific,
industrial and business information obtained under that relationship,
in the present and for the future.
1.12 We never promise what we cannot keep or what is not ours
to guarantee, as our promises bind the Company.
1.13 We investigate and respond to all complaints, striving
to give each one equal attention, irrespective of origin.
Respecting and obeying laws and regulations
2.1 We respect the Law. We observe the truth; act honestly and
in accordance with Industry regulations.
2.2 When we become aware of any instance of non-compliance with
these rules or with this Code of Ethics, we will inform the
Company of any such instance.
2.3 We report our activities to Authorities as required by law.
Hovione and the Community
3.1 Hovione strives to maintain good and stable neighborly relations
within its Community and takes an interest in its needs.
3.2 Hovione encourages dialogue and informs the public in a
clear and accessible language of its activity and undertakings,
opening its doors regularly to the Community, Authorities, Press,
Academia and the Public in general.
3.3 Hovione organizes plant visits for schools, students or
other parties with and educational intent.
3.4 Hovione strives to constantly improve the conditions of
its facilities and its performance in terms of safety, health
and environmental protection and communicates its performance
to the public.
3.5 Hovione takes all necessary measures within its possibilities
to prevent or reduce environmental, material or personal damage.
3.6 Hovione will offer help to Authorities in case of an incident
outside the Company in the field of its expertise and available
means.
3.7 Hovione collaborates with Authorities in issues relating
to safety and environmental protection.
3.8 Partisan politics shall not take place within the Company.
23.4 – Basic access rules to
Hovione facilities
Vehicles without a flameproof device are not allowed to enter
Hovione's industrial facilities. Drivers are responsible to
place the flameproof device during the time they are inside
the facilities. Vehicles already having another type of security
device flameproof must show it. If the exhaust pipes or the
exhaust silencers of the vehicles are damaged, they will not
be allowed to enter Hovione areas.
The vehicles will be inspected when leaving Hovione facilities.
This action is part of a rigorous system of security rules for
entrance and exit control of materials and equipments with or
without delivery notes. This inspection is compulsory and therefore
we ask for your understanding.
Photocopies can only be taken and original removed from premises
with prior authorization. Access to our internal computer system
is not allowed, unless controlled by Hovione personnel. Other
security rules:
• SMOKING is not allowed. There are duly identified areas
where smoking is allowed;
• Speed Limit in the facilities is 20km/h;
• Please switch off your mobile phone. For security reasons,
mobile phones can only be used in administrative areas.
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Raw materials for routine manufacturing
Annex A2.A
POs are issued based on a planning methodology that gives a
month detail (for delivery dates after two months). Based on
this, re-scheduling of the delivery dates can occur and the
Vendor is aware of it, without any impact on the order conditions.
Final delivery dates must be confirmed on before 15 days of
the delivery date.
The purpose of the purchase is for use in a pharmaceutical process/plant
and as such, the product to be supplied by Vendor should fit
this purpose – free of contaminations. If any changes
occurred that may have impact in the quality of the product
to be supplied, Vendor should notify Hovione in writing.
If no instruction in contrary, the merchantable good shall be
delivered to the Hovione warehouse from 8:00 am to 3:00 pm and
the condition to access Hovione premises stated on Hovione Purchasing
Conditions shall be observed.
At the time of goods receipt, the validity should be equal or
superior to 2/3 of the total validity of the product.
Vendor hereby warrants and guaranties to Hovione that all changes
brought upon any area related to the preparation of any product
for Hovione, and especially the products listed in the PO, shall
only be implemented after they are duly disclosed to Hovione,
their impact is duly understood and Hovione authorizes such
changes to be implemented – such Hovione authorization
must be in writing and must be received by Vendor before any
such changes are authorized for implementation.
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Raw materials for Research
and Development Projects
Annex A2.B
Hovione is involved in a large number of drug discovery programs
as provider of API's. Vendors are well aware that many of those
projects may fail in the clinic studies and that only few products
shall reach routine commercial manufacture.
For products to be used in one of these projects, it is agreed
by Hovione and Vendor that:
| • |
All remaining quantities
of the supplied product will be returned to the Vendor,
after Hovione production campaign is completed; |
| • |
The total quantity of product
ordered and received by Hovione will be returned to the
Vendor in the case that Hovione production campaign is
cancelled; |
| • |
The returns are credited
at the purchased value and the relevant expenses with
the return supported by Hovione; |
| • |
Some packages maybe opened
for sampling/quality testing purposes or partial consumption. |
The purpose of the purchase is for use in a pharmaceutical process/plant
and as such, the product to be supplied by Vendor should fit
this purpose – free of contaminations. If any changes
occurred that may have impact in the quality of the product
to be supplied, Vendor should notify Hovione in writing.
If no instruction in contrary, the merchantable good shall be
delivered to the Hovione warehouse from 8:00 am to 3:00 pm and
the condition to access Hovione premises stated on Hovione Purchasing
Conditions shall be observed.
At the time of goods receipt, the validity should be equal or
superior to 2/3 of the product shelf life.
Vendor hereby warrants and guaranties to Hovione that all changes
brought upon any area related to the preparation of any product
for Hovione, and especially the products listed in the PO, shall
only be implemented after they are duly disclosed to Hovione,
their impact is duly understood and Hovione authorizes such
changes to be implemented – such Hovione authorization
must be in writing and must be received by Vendor before any
such changes are authorized for implementation.
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Services
Annex A2.C
- Scope of Work
Vendor shall provide the nature of work in relation to a specific
mentioned Hovione company, within the Hovione Group. In relation
to any merchantable goods, Vendor will ensure that this is sufficiently
comprehensive and of a high standard, free of any negligence
or poor diligence. In relation to all work done it is the Vendor’s
responsibility to provide Hovione with complete, accurate and
timely information requested to the proper execution of the
work as well as all the information relating to quality, health,
safety and environment regulations to which Hovione is bound
to. Vendor will be prompt and flexible and understand that in
today’s business environment success depends on being
aligned with Hovione interest. Vendor confirm that in consideration
for the fees paid or for the amounts received in the invoices
Hovione receives good and final title, with no exception, for
all the products, services and any intellectual property whether
patentable, copyrightable or not and, Hovione has full rights
to make use it wishes.
If the service is totally or partially performed at Hovione’s
facilities, Vendor shall be previously aware of the specific
rules defined for the presence of its employee, such as safety
rules and assure that they will be accomplished. Please refer
to Hovione’s manual reference HQ.MAN.HSE004.
- Billable work
Vendor is aware of the purchasing procedures in place at Hovione.
Billable work must have a PO. Hovione PO shall indicate clearly:
- An approved price. This may be fixed price deal, or a unit
rate deal. In all cases any change must refer to a pre-approved
unit rates that will enable any deviation to be calculated fairly.
Any deviation shall have to be formally approved in writing.
- A timetable setting out the agreed dates, as well as fines
for late delivery – if specified in the PO or contract
celebrated between Vendor and Hovione.
- An appropriately detailed and completely described brief setting
out the work that Hovione wishes to purchase from Vendor.
- Key People
Vendor must identify the employees specialized and qualified
to the success of the project. Whenever applicable or requested,
Vendor should provide Hovione with the necessary qualification
evidence. Vendor agrees that changes of staff may hurt the good
progress of the project, and commits to avoid staff changes
during the period of the project covered in a PO.
- Fees
Service fees are described in the PO. Unless agreement is reached
to the contrary, Vendor fees may be based on the number and
seniority of staff required, the degree of skill and responsibility
involved and the resources required to perform the required
service contracted. Any fee budget agreed is necessarily based
on the assumption that the information required for the Vendor
work is made available in accordance with agreed timetables.
If delays or other unanticipated problems which are beyond the
Vendor’s control occur, this may result in additional
fees for which invoices will be raised on the above basis. Vendor
shall advise Hovione of delays as they occur and will estimate
their effect, Vendor shall seek Hovione approval before going
ahead with such extra work.
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IT services
Annex A2.D
Considering the specificity involving Information Technology
(IT) services to be supplied, Hovione requires that the Vendors
with whom Hovione established business relationships comply,
within the contracted scope, with the following terms as part
of the Hovione Purchasing Conditions:
The development, configuration, parameterization and design
of any information system should be carried out in order to
enable its operation, maintenance and development by Hovione’s
IT internal resources, therefore reducing the dependence from
external Vendors after the service has been handed over to Hovione.
When these objectives or functionalities are not possible to
achieve with simple solutions and using standard technologies
it must be reach to an agreement with Hovione representative,
before its implementation.
Any IT services implementation which will be carried out for
over 1 week*men must have a technical hand-over and a closing
session, as follows:
The technical hand-over session should provide Hovione’s
IT staff with all necessary information to meet the conditions
above mentioned. This session should be formal, independently
from a gradual transfer of know-how that should occur during
the implementation and will be resumed with a meeting minutes.
The closing session will take place upon completion of the services.
The sign off will be done by the IT Director or his/her delegate
as appropriate to assure the compliance with the previously
specified user requirements and to identify possible deviations,
pending issues, as well as negative and positive aspects verified
during the services supply which may contribute to the continuous
improvement process at Hovione.
The payment of invoices for the supply of IT services may be
suspended until the above mentioned sessions take place, unless
otherwise specified in the Purchase Order, but taking always
into account what is established under the Hovione Purchasing
Conditions.
The adjudication of any IT system or application assumes, in
case that is not clearly defined in the Purchase Order or in
the "User Requirements", the existence of reports
and/or tools for creation of reports, enabling Hovione to access
Business Intelligence information in these systems or applications,
in an autonomous, simple and flexible way, without having to
support additional expenses.
Due to the nature of Hovione’s business activity and considering
the high dependence on IT systems, IT security should be taken
into consideration in all circumstances and be a part of every
development, installation or configuration that has been performed.
More specifically, unless otherwise authorized, it is strictly
forbidden to any IT Vendor and in addition stated under the
Confidentiality chapter of Hovione Purchasing Conditions, to
disclose:
| • |
Any Hovione commercial,
technical, industrial, scientific or organizational information,
as well as rules and internal procedures |
| • |
Any Hovione information
regarding third parties, namely clients, Vendors, other
partners or organizations, obtained within the IT services
supply scope, regardless of whether or not confidentiality
agreements have been signed. |
| • |
The access or use of Hovione’s
IT systems, via local or remote access, for purposes not
specifically agreed, such as product demonstration to
other clients, training, tests or others. |
| • |
The access or use of these systems outside
the duration of the services supply, regardless of its
purpose. |
Hovione is a multinational company with facilities in different
countries therefore, the adjudication of IT systems, particularly
the ones of application nature, requires always a "multi-site"
mode, also known as "multi-company", without a significant
change of that system’s structure.The definition of IT
services include, non-exclusively:
• IT consulting services;
• Installation and configuration
of IT applications
• Installation and configuration
of hardware and communication equipments;
• Development of applications.
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Analytical Services
Annex A2.E
Hovione operates in a highly regulated market. The performance
of the analytical testing should comply with appropriate GMP
requirements as understood by FDA and ICH Q7a. It also should
comply with the Hovione requirements, as stated in the PO. Specific
requirements are listed below.
Equipment: The equipment used
for the analytical testing should be qualified, calibrated and
maintained at appropriate intervals. These procedures and records
should be maintained.
Software: Electronic records
should not allow the elimination of previous records, should
record who/when data was changed, should be easily available
and should be maintained. Access to the software should be controlled.
Backup and restore of these records should be periodically performed
as well as periodic review of its validations status.
Personnel qualification: analysts
and supervisor of the work should have appropriate training,
which should be dully recorded.
Traceability: Records should
include identification of the Vendor, batch and validity of
the reagents, solutions and standards used. The internal code,
Vendor and serial number of the equipment used should also be
recorded.
Records: Log books should be
inviolable. Additional paper data (for example, chromatograms)
should be signed in all pages by the analyst. Records should
be maintained and easily available.
Analytical methods: System
suitability should be performed before initiating the sample
testing, by testing five replicates of a standard with acceptance
criteria of 5%, whenever applicable. Non conforming test results
should be evaluated according to an Out Of Specification test
procedure and all records should be maintained. Hovione should
be informed of any OOS within two (2) working days. Measures
of avoiding Cross Contamination should be implemented.
Change control: Changes related
to the work performed to Hovione need to be assed in terms of
the impact for Hovione and should not be implemented without
previous Hovione’s authorisation.
Calculations: Verification
of conformity with a specification limit should be done for
the individual test results and not only for the average. Rounding
of test results should only be done to the final test result.
All calculations should be recorded unless performed by validated
software.
Report: It should include date
of the testing, name of the analyst, name/code of sample, test
method reference and operational conditions, standards used
and their traceability, reagents and equipment identification,
test results, Out Of Specification test results and when applicable,
molecular structure and uncertainty of the test result.
For further information please contact
Chemical Suppliers:
Other Suppliers:
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