General Terms and Conditions

ARTICLE 1 – DEFINITIONS

The following terms, when the first letter is capitalized, shall have the meanings defined hereunder:

“Affiliated Company(ies)”                          means any company which directly or indirectly controls, is controlled by or is under common control with Sanofi. For the purposes hereof, control shall mean the direct or indirect ownership of more than fifty per cent (50%) of the equity or more than fifty per cent (50%) of the voting rights.

“Agreement”                                                  means this document together with the applicable Purchase Order specifying the contractual terms and conditions applicable to goods and/or services ordered by CLIENT to PROVIDER.

 

“CLIENT”                                                          means Sanofi-Aventis South Africa Proprietary Limited, with company registration number 1996/010381/07, a private company duly incorporated in accordance with the company laws of the Republic of South Africa, with its registered business address at Floor 5, Building I, Hertford Office Park, 90 Bekker Road, Midrand, 2196

                                                                          OR Sanofi Industries South Africa Proprietary Limited, with company registration number 1931/002901/07, a private company duly incorporated in accordance with the company laws of the Republic of South Africa, with its registered business address at Floor 5, Building I, Hertford Office Park, 90 Bekker Road, Midrand, 2196;

                                                                        OR Opella Healthcare South Africa Proprietary Limited, with company registration number 2020176440/07, a private company duly incorporated in accordance with the company laws of the Republic of South Africa, with its registered business address at Floor 4, Building I, Hertford Office Park, 90 Bekker Road, Midrand, 2196;

                                                                        (each individually the “Client”, acting severally not jointly, under each respective Purchase Order).

 

“Effective date”                                             shall have the meaning given in Clause 12.1.

 

“Force Majeure”                                           means an external, unpredictable and irresistible event such as, without this list being limitative, acts of God (the elements), acts of authorities, war (whether declared or not), riot, blockage, embargo, invasion, mob violence, lock-outs, epidemics, quarantine, natural disaster (volcanic eruptions, floods, earthquakes, hurricanes) or strikes.

“Intellectual Property Rights (IPR)”        shall mean any right arising out of or relating to patents (including the rights to patentable or non-patentable inventions, discoveries, know-how trade secrets and other confidential information), designs, trademarks, domain names, databases, copyrights, any registration or application to register, renew and/or extend any of these rights and all other IPR and equivalent or similar forms of protection existing in any country.

“Party(ies)”                                                     means individually or collectively the PROVIDER and/or the CLIENT.

“PROVIDER”                                                   means any company bound by an agreement with CLIENT for the provision of any goods, services and/or deliverables.

 

“Purchase Order (PO)”                                means any purchase request of specific goods and/or services to PROVIDER, which upon acceptance of the latter shall become the agreement between CLIENT and PROVIDER.

 

“Sanofi”                                                           means collectively the Sanofi parent company with its headquarters in France and Sanofi Affiliates which include any corporation or legal entity, that directly or indirectly controls, is controlled or is under common control with the Sanofi parent company.

 

“Third Party”                                                  means any company, individual or entity other than CLIENT, the Affiliated Companies or PROVIDER.

ARTICLE 2 – PURPOSE

The following General Terms and Conditions (General T&Cs) shall apply to the relationship between any supplier of goods and/or provider of services (the PROVIDER) and the company issuing the Purchase Order (PO) (the CLIENT) and shall establish the contractual framework for the delivery of goods and/or the performance of services.

It is recorded that these General T&Cs are incorporated by reference into all POs. Acceptance of the PO by PROVIDER shall entail acceptance by the latter of these General T&Cs. The General T&Cs and the applicable PO shall together form and be understood as the Agreement.

Deviations from these General T&Cs may only be made in the context of special conditions concluded in writing. Such deviation shall be valid only for the PO in question, without PROVIDER being able to invoke it for other orders.

Any terms and conditions of PROVIDER’s general terms and conditions of sale shall not be applicable even if CLIENT does not expressly object to them.

In the event of any conflict between the General T&Cs and the PO, the following order of priority will govern:

a)            first, any special conditions applicable which may be appended to these General T&Cs;

b)            second, the General T&Cs;

c)             third, the provisions of the applicable PO.

ARTICLE 3 – TERM

Notwithstanding the date set out on the face of this Agreement, this Agreement may not exceed 36 (thirty-six) months. In the event it does, the agreement shall terminate automatically 3 (three) years from signature date.

The Agreement may not be tacitly renewed and may be extended only by means of a written amendment signed by mutual agreement of the Parties.

ARTICLE 4 – TERMINATION

Each Party may terminate the Agreement immediately, as of right, without notice and without prejudice to any other rights or remedies, after sending a registered letter with acknowledgement of receipt:

a)            in case of breach or failure by a Party to perform one or more of its obligations under the Agreement, fifteen (15) days after the receipt of a formal notice to correct the situation, remained without effect,

b)            in the event of a cessation of activity, a recovery or a judicial liquidation plan of one of the Parties, subject to the legal provisions in force,

c)            in case of the occurrence of an event of Force Majeure under the conditions of “Force Majeure” Clause.

CLIENT may terminate the Agreement immediately, as of right, without notice and without prejudice to any other rights or remedies, after sending a registered letter with acknowledgement of receipt:

a)         in the event of repeated delays by PROVIDER in the delivery of the goods and/or the services,

b)         in the event of material and/or repeated breaches in connection with the quality of the goods and/or the services and which may in particular generate a major security risk,

c)         in case of non-compliance by PROVIDER with the following articles: “Confidentiality” Clause, “Personal data protection” Clause, “Requirements pursuant to social regulation” Clause, “Environment” Clause, “Conflict of interest” Clause, “Information security and quality measures” Clause, “Ethics and business integrity” Clause and “Pharmacovigilance” Clause.

            

             CLIENT may terminate the Agreement at any time for convenience by providing PROVIDER with a written notice of 7 (seven) days.

In case of an operation with a Third Party resulting in the change of control of PROVIDER, it shall immediately notify CLIENT by registered letter with acknowledgement of receipt. In this case, CLIENT reserves the right to terminate the Agreement in its entirety by providing a one (1) month notice from the date of PROVIDER’s notification. Change of control means any organizational change of PROVIDER resulting in: (i) either the main shareholder of the Party in question at the time of signing of the Agreement no longer having effective control of the Party; or (ii) any significant change in the shareholding structure of said Party, affecting its control.

In the case of expiration or termination of the Agreement, CLIENT shall only be required to pay to PROVIDER the sums corresponding to compliant goods or services delivered and not yet invoiced up to the effective date of termination, no other amounts being due from CLIENT to PROVIDER. PROVIDER shall reimburse the advance payment received for goods or services not delivered.

In case of expiration or termination of the Agreement, PROVIDER shall return to CLIENT any and all information, documents and materials (and all copies thereof) and all data provided by CLIENT under this Agreement and/or in connection with the delivery of the goods and/or services.

ARTICLE 5 - FINANCIAL CONDITIONS

5.1 Prices

The prices agreed between CLIENT and PROVIDER are fixed prices and are exclusive of taxes.

5.2 Invoicing

Invoices shall be made out in the currency indicated in the PO.

All invoices shall at least contain the following information:

a)            the PO number;

b)            detailed supporting documentation regarding the goods and/or services delivered;

c)             the applicable taxes;

d)            the PROVIDER’s account references for payment; and

e)            the requestor of the goods and/or services.            

 

All invoices shall be transmitted via e-mail to the accounting department of CLIENT and to the contact person as reflected on the PO

Should PROVIDER not be able to e-mail the invoice, a hard copy of the invoice shall be delivered or sent via registered post to the following address:

Floor 5, Building I,

Hertford Office Park,

90 Bekker Road,

Midrand,

2196

 

CLIENT reserves the right to refuse any invoice that is not established in accordance with the provisions of this Clause.

5.3 Payment terms

Unless the Parties have agreed on other payment terms and subject that the goods and/or services are properly received, the deadline for payment of amounts due from CLIENT to PROVIDER for the provision of services and/or the delivery of goods is set at 60 (sixty) days after the invoice date, provided that the invoice is in full compliance with the applicable legislative and regulatory rules and with the above-mentioned requirements.

Payment shall be made for undisputed invoices and disputed invoices may be withheld and will not accrue interest until such time as the dispute is resolved.

Payment shall be made by bank transfer.

Failure to pay by the deadline indicated above for a reason solely attributable to CLIENT shall result in the application of late-payment interest equal to the prime interest rate in South Africa. This interest begins accruing from the day after the payment deadline until the day of payment.

In the event of expiration or termination of the Agreement, CLIENT shall pay SUPPLIER for the compliant goods delivered and/or the services provided until the end of the notice period. All deposits or pre-payments paid by CLIENT for goods and/or services not delivered shall be reimbursed by PROVIDER.

ARTICLE 6 – LIABILITY

The delivery or goods or the provision of services are carried out under the full liability of PROVIDER. In this respect, PROVIDER is liable for any type of injury, damage and/or loss, whether direct or indirect, resulting from the breach of its contractual commitments to CLIENT, or from error, negligence, omission or fault on the part of its staff or potential subcontractors that it may use for the execution of Services suffered by CLIENT (including its personnel, representatives and Affiliates), its customers and/or any Third Party related to CLIENT.

CLIENT and PROVIDER shall be responsible, each as applies to them, for all direct or indirect financial consequences resulting from the civil liability they assume for any physical, environmental, material or immaterial damage caused to a Third Party during execution of the Agreement.

ARTICLE 7 – INSURANCE

PROVIDER represents that it holds insurance policies underwritten by an insurance company known to be solvent and covering the financial consequences for which it would be liable for damages that it may cause to CLIENT or a Third Party while performing the Agreement.

PROVIDER agrees to present, upon the signing of the Agreement and on request of CLIENT during the Services, the proof of insurance taken out in accordance with this article, and to prove the payment of insurance premiums at the first request of CLIENT.

PROVIDER agrees to maintain this coverage throughout the duration of the Agreement.

All these insurance policies must be taken out by PROVIDER to allow PROVIDER to notify CLIENT with advance notice of at least thirty (30) days, of any cancellation of modification of these insurance policies.

ARTICLE 8 - FORCE MAJEURE

The Parties shall not be held responsible for any shortcomings or delays in performance of their obligations that may be due to Force Majeure, understood as an external, unpredictable and irresistible event which make it impossible for a Party to fulfill its obligations under this Agreement.

Should a case of Force Majeure affect the Agreement, the affected Party shall immediately notify the other Party, by registered letter (or via e-mail) with acknowledgement of receipt, of the occurrence of said event setting forth its estimated duration.

In this case, the Parties must promptly come together and make their best efforts to reduce the effects of the case of Force Majeure.

At the end of the event of Force Majeure and its effects, the performance of the obligations that were suspended for the duration of the event shall resume as soon as possible. Each Party will bear its own costs and expenses incurred in connection with the event of Force Majeure.

Should the Parties fail to agree on the measures required and should the case of Force Majeure exceed a period of one (1) month from the notification of its occurrence, either Party may immediately terminate the Agreement as of right, without any compensation to be claimed for this purpose.

ARTICLE 9 – AUDIT

The Parties agree that CLIENT may at any time during the term of the Agreement and for a period of 5 (five) years after its termination or expiration, carry out an audit or have an audit carried out by an independent body appointed by CLIENT in order to assess the compliance of PROVIDER and PROVIDER’s subcontractors with their obligations under the Agreement and any applicable laws and regulations.

CLIENT shall give a 15 (fifteen) days’ prior notice to PROVIDER before conducting such audit which shall take place during normal business hours.

For the purpose of this audit, PROVIDER agrees to facilitate access to auditors of PROVIDER’s or PROVIDER’s sub-contractors site, to cooperate fully with them and to provide them all necessary information. PROVIDER will allow the designated auditors to access all facilities, information and documents necessary to carry out the audit.

The audit shall be paid by CLIENT unless the audit demonstrated a breach of the Agreement by PROVIDER or PROVIDER’s subcontractors in which case, PROVIDER shall reimburse the totality of the cost of the audit.

A copy of the audit report will be provided free of charge by CLIENT to PROVIDER upon request. The results of the conducted audit shall be considered as confidential information by both Parties.

Should the audit detect non-compliance with the obligations of PROVIDER referred to in the Agreement and/or any applicable laws and regulations or if CLIENT, following the audit, voices recommendations or reservations, PROVIDER shall take, at its sole expense, all appropriate measures to implement any corrective or preventive action or any CLIENT’s recommendation as soon as possible. Any failure to remediate shall be deemed as a breach and shall allow CLIENT to terminate the Agreement for breach.

The Parties agree that the implementation or lack thereof of the audit procedure shall in no way exonerate PROVIDER from meeting its contractual obligations.

Should a competent authority or authority with an interest in the activities of PROVIDER carry out or intend to carry out an audit, inspection and/or investigation of PROVIDER’s files, operations and facilities, or of the systems and/or the procedures that are related to the Agreement or liable to affect the ability of PROVIDER to deliver the goods and/or provide the services as agreed under the Agreement, PROVIDER will inform the CLIENT in detail as soon as possible of the measures taken or proposed. CLIENT shall be allowed on site and have the right to review the audit report and any requested submission to the authority.

ARTICLE 10 – CONFIDENTIALITY

Each Party shall treat as strictly confidential all information obtained from the other Party either directly or indirectly, in written, oral, electronic or any other form, whether or not labelled as confidential, that relates or refers to the Agreement.

The Parties shall not divulge any confidential information to any Third Party without the other Party’s prior written consent. However, a Party may disclose confidential information in the event that it is required to do so by law or pursuant to a court decision, on condition that such Party immediately notifies the other Party in writing so as to enable the other Party to take any form of appropriate protective measures.

This Clause shall not extend to information which:

a)            was rightfully in the possession of such Party prior to its disclosure;

b)            is already public knowledge or becomes so at a future date (otherwise than as a result of a breach of this Clause); or

c)             is trivial or obvious.

 

The Parties shall take all necessary measures to protect the confidential information they have in their possession. More specifically, each Party shall protect the confidential information received from the other Party with at least the same degree of care as the one used when dealing with its own confidential information.

The confidential information shared by one Party to the other Party may not be used for any purpose other than the performance of the Agreement. The confidential information shall thus be used by the Parties solely as necessary to perform the obligations under the Agreement and only for the duration of the performance of the Agreement.

PROVIDER undertakes to limit the access to the confidential information to its personnel and authorized subcontractors solely for the purpose of completing the delivery of goods and/or the performance of services. PROVIDER warrants that its employees and authorized subcontractors shall not disclose or use the confidential information at any time or for any manner not authorized under this Clause. In any event, should the obligation of confidentiality be breached, PROVIDER shall be held fully liable for such breach to CLIENT.

CLIENT shall be allowed to freely communicate, through all means of communications, on the Agreement, the goods and/or services to deliver and the business relationship between the Parties.

Unless prior written consent is obtained from CLIENT, PROVIDER shall refrain from mentioning the existence and/or the content of this Agreement in its promotional materials and/or campaigns, as well as in any usage of CLIENT’s logo, any citation of CLIENT or its Affiliated Companies or any other communication with Third Parties that relates to the business relationship PROVIDER has with CLIENT.

The Parties expressly acknowledge that whenever confidential information is shared by one Party to another within the context of the Agreement, it shall remain the exclusive property of the disclosing Party. The return or the destruction of confidential information shall be organized upon termination of the Agreement and at any time upon CLIENT’s request. 

The provisions of this Clause shall survive the termination or expiry of this Agreement for a period of 10 (ten) years. 

ARTICLE 11 - INTELLECTUAL PROPERTY

Each Party shall retain full ownership of the IPR of any of its pre-existing elements, which shall be understood as any element created by a Party or licensed to it by a Third Party before or completely independently from the performance of the Agreement.

PROVIDER shall transfer to CLIENT, with all the associated legal and factual guarantees, exclusive ownership or license of all IPR in the deliverables resulting from the performance of the Agreement, regardless of the form, nature and state of completion, which shall include any outcome, document, study, report, any technical creation, created and/or developed by PROVIDER under the Agreement (including improvement and/or modification to CLIENT’s pre-existing elements).

Following the above-mentioned transfer, PROVIDER cedes and/or assigns to CLIENT the right, without this list being limitative, to publish, circulate, reproduce, process and otherwise exploit all of the ideas, concepts, drafts and designs, which were developed on behalf of CLIENT by PROVIDER. This right extends to all types of use, including, but not limited to, print advertising and multimedia exploitation.

This transfer shall be irrevocable, shall be (sub)licensable, shall apply worldwide and shall be valid for the entire duration of the protection of the rights under applicable current legislation.

Payment by CLIENT for the goods delivered and/or services performed shall constitute satisfaction in full for the acquisition of the above mentioned rights.

PROVIDER guarantees to CLIENT and its Affiliated Companies the peaceful enjoyment of the assigned rights. In this respect, PROVIDER warrants that nothing provided under the Agreement violates IPR belonging to any Third Party. To this end, PROVIDER shall indemnify, substitute in court proceedings and hold CLIENT and Affiliated Companies harmless against any claim from any Third Party relating to said rights.

ARTICLE 12 - SPECIFIC PROVISIONS RELATED TO ORDER

12.1 Order formalization – Order acceptance – Order changes

Unless otherwise agreed in writing in advance, the written PO issued by CLIENT is the only document PROVIDER may accept in order to perform services or deliver goods. The acceptance of the PO is established by the return to CLIENT of a signed version of the PO, which constitutes its acceptance without any reservation.

The Agreement shall be effective once the PO signed by PROVIDER has been received by CLIENT. In the event that PROVIDER does not return a signed PO to CLIENT but nevertheless delivers goods and/or performs services, the Agreement shall become effective on the date CLIENT has issued a PO to PROVIDER (“Effective Date”).

PROVIDER must notify CLIENT expressly in writing if it accepts an order on terms which are different from those stipulated in the original PO issued by CLIENT. In this event, the Agreement between PROVIDER and CLIENT shall not take effect until CLIENT has consented to those different terms in writing.

Any variations or modifications to this Agreement, to the goods being delivered or services being rendered, must be in writing and signed by the authorised representatives of the Parties or through a new PO.

12.2 Order performance

PROVIDER shall carry out the delivery of goods and/or the performance of services continuously and diligently, to the satisfaction of CLIENT and in accordance with the terms and conditions of the PO, applicable laws, professional standards and good industry practices.

PROVIDER represents, warrants, undertakes and agrees that it has the required skills, capacity and equipment to perform its obligations under the PO and that it shall deliver the goods and/or perform the services in a professional manner using qualified and competent personnel.

PROVIDER states and warrants that it holds the administrative authorizations or approvals required by applicable regulations to deliver goods and/or provide services and agrees to provide at CLIENT’s request the related supporting document and immediately inform CLIENT of the loss, withdrawal or non-renewal of any authorization or approval necessary for the provision of the goods and/or services.

PROVIDER guarantees that its subcontractors, if any, shall comply with the same obligations as listed above.

With reference to CLIENT’s absolute social and patient responsibility as a pharmaceutical industry, any interruption or suspension of order performance by PROVIDER may have critical adverse consequences for CLIENT, notably for the continuity of its business. As a result, PROVIDER undertakes to continue at all times the performance of the order by all possible means (including by maintaining an up-to-date business continuity and disaster recovery plan as necessary).

12.3 Acceptance of Goods and/or Services

Any delivery of goods/services shall be subject to their approval by CLIENT. Final acceptance of the goods and/or services implies the lifting of any reservations. It discharges PROVIDER from its contractual delivery obligations without releasing it from its legal responsibilities.

CLIENT shall inspect the goods and/or services for defects without delay after receipt of such goods and/or services.

CLIENT shall be entitled to give notice of defects to PROVIDER within a time limit of 7 (seven) calendar days from the date the necessary inspection of the goods and/or services is concluded. In the case of perishable goods, CLIENT shall be obliged to give notice without delay.

Where defects are hidden, notice of defects shall be given by CLIENT upon discovery of such defects.

If defects in the goods and/or services make a more extensive examination of the goods and/or services necessary, then the costs of same shall be borne by PROVIDER.

PROVIDER’s liability for defects shall not be affected by the acceptance of the goods and/or services by CLIENT.

12.4 Planning – Delays – Penalties

The delivery and/or performance date specified in the PO shall be binding. The relevant date for determining whether the goods and/or services have been delivered and/or performed on time shall be the date the goods arrive at the agreed destination and/or the services are performed as per the dates indicated in the PO.

If PROVIDER is unable to provide CLIENT with a binding delivery and/or performance date, PROVIDER shall be obliged to specify the earliest and latest possible delivery and/or performance dates.

Any delay, for whatever reason, occurring during the execution of the PO, must be reported immediately by PROVIDER to CLIENT in writing.

CLIENT reserves the right to cancel the PO in the event of non-compliance with the delivery date of the goods or the performance of the service.

In case of delay in the delivery of the goods or in the execution of the service, the PO may provide for penalties for delay, these penalties never representing a lump-sum compensation for the damage suffered by CLIENT. The payment of these penalties shall be made by offsetting the amount of PROVIDER's invoices.

Furthermore, in the event of partial delivery or performance, CLIENT reserves the right to cancel the PO, retaining the goods already delivered or the part of the service already performed against payment of the corresponding part of the price.

12.5 Information security and quality measures

PROVIDER shall comply and shall procure that each of PROVIDER's Personnel and permitted subcontractors shall comply at a minimum with the information security and quality measures provisions currently set out in https://suppliers.sanofi.com/en/standards-and-procedures as amended by CLIENT from time to time.

Such terms are hereby incorporated herein by reference and the Parties expressly commit to comply with them.

12.6 Pharmacovigilance

Where the PO is related to a CLIENT product, specific pharmacovigilance requirements will apply. In this case, PROVIDER and CLIENT shall comply with the terms of the applicable pharmacovigilance clause currently available at https://suppliers.sanofi.com/en/standards-and-procedures as amended by CLIENT from time to time.

Such terms are hereby incorporated herein by reference and the Parties expressly commit to comply with them.

12.7 Warranties

In accordance with the PO, PROVIDER shall guarantee the quality and conformity of the goods and/or services which shall be free from any defects and will be of quality suitable for the purpose for which the goods and/or services are required.

In accordance with Clause 12.5, at CLIENT’s sole choice and discretion and without prejudice to any other rights or remedies CLIENT may have under the order and applicable law, PROVIDER shall:

a)            either correct/complement/replace the defective or non-conforming goods/deliverables or services; or

b)            return such for full credit.

 

PROVIDER warrants to CLIENT a step-in right in order to allow the latter to carry out the performance of the PO by itself or by any Third Party chosen by CLIENT after any breach of the PO by PROVIDER, at any time, with PROVIDER’s cooperation and assistance, and without prejudice to any other rights or remedies CLIENT may have under the PO and applicable law.

 

PROVIDER shall bear all costs incurred by the implementation of the chosen remedy, which could include, without this list being limitative, the transportation costs between CLIENT’s and PROVIDER’s site or the step-in costs.

 

12.8 Delivery – Transfer of ownership and risks

The PO will specify the appropriate Incoterm applicable to the Agreement. Where no agreement regarding delivery has been made, delivery shall be made for free to the agreed destination.

The transfer of ownership and risks shall be governed by the agreed Incoterms Rules for Any Mode of Transport as provided for in the International Chamber of Commerce’s Incoterms® 2010 English Edition.

12.9 Rules applicable in the event of on-site activities

PROVIDER undertakes to comply and fully cause its employees to comply with the access, hygiene, safety, environmental (including waste management) instructions, rules and regulations in force on CLIENT’s Site regardless of their form.

PROVIDER agrees to report any accident suffered by a member of its staff, and any incident whose consequences could be harmful to the safety of staff, equipment and/or the environment, as soon as they are known. This report will be done to the contact person designated by CLIENT for the performance of the Agreement or any person who may take their place.

PROVIDER warrants that its work will not cause any difficulties for other contractors working simultaneously on CLIENT’s Site, and in particular, that it will not cause any damage to facilities, equipment or machines belonging to them, existing structures or those under construction.

CLIENT reserves the right to require PROVIDER to proceed with the immediate eviction of any employee or subcontractor who does not respect the access, health, environmental protection and safety instructions applicable on the Site and/or whose behavior could jeopardize the proper delivery of goods and/or performance of the services. Any request for eviction formulated by CLIENT will be made in writing.

The breach of PROVIDER’s personnel and subcontractors to comply with the access, hygiene, safety, environmental instructions, rules and regulations in force on CLIENT’s site shall entitle the latter to terminate the PO.

 

ARTICLE 13 - ADDITIONAL PROVISIONS

13.1 Personal Data protection

Under this Clause, the Parties agree that the terms “Personal Information”, “Responsible Party”, “Operator”, “Processing”, “Applicable Data Protection Law”, “Services” and “Purchase Order” shall have the meaning assigned to them in the Data Processing Agreement (if applicable) or otherwise the meaning assigned to them in these General T&Cs or, as the case may be, in the applicable law.

Each Party shall, with regards to its own respective Processing activities for which it acts as a Responsible Party, comply with its own obligations under Applicable Data Protection Law.

The Parties agree that, for the purposes of performing the PO under these General T&Cs, PROVIDER does not process Personal Information on behalf of CLIENT.

However, to the extent that PROVIDER processes any Personal Information on CLIENT’s behalf within the scope of the PO or should PROVIDER identify the fact that, during the performance of the PO, PROVIDER is processing Personal Information on CLIENT’s behalf (in such case, PROVIDER shall immediately inform CLIENT thereof), such Processing shall be governed by the terms of the Data Processing Agreement currently available at the following address and as amended by CLIENT from time to time:

www.sanofi.co.za

Such terms are hereby incorporated herein by reference and the Parties expressly commit to comply with them.

Where the performance of the PO under the General T&Cs benefits affiliates of CLIENT, either directly or through the signature of any relevant documentation (e.g. statement of work, purchase order, etc.), the Parties expressly agree that each CLIENT affiliate shall be regarded as a Responsible Party independently in its own right.

For the purpose of this Agreement, Personal Information shall have the meaning ascribed to it in the Protection of Personal Information Act 4 of 2013 ("POPIA") which means information relating to an identifiable, living, natural person and an identifiable existing juristic person, where applicable, as further described in section 1 of POPIA. Applicable Data Protection Law shall mean POPIA as well as the personal data protection laws, rules and regulations applicable in the country where all or part of the Services are performed where these are performed in full or in part outside of South Africa.  

In accordance with POPIA, the Parties undertake, with respect to Processing any Personal information, to:

  1. ensure compliance with POPIA including but not limited to Processing all Personal Information in accordance with at least one of the lawful grounds for Processing Personal Information set out in section 11 of POPIA; and
  2. ensure compliance with all 8 (eight) processing conditions provided in POPIA,

for the avoidance of doubt, this includes taking reasonable steps when collecting Personal Information to notify the person to whom the Personal Information relates to in order to ensure that the person is aware of the information being collected, the name and address of the party Processing the information, the purpose for which the information is being collected, whether the supply of the information is voluntary or mandatory, the consequences of failure to provide the information, any applicable law authorizing or requiring the collection of the information, the fact that the party Processing the information intends on transferring the information to a third country or international organization (including the level of protection afforded in respect of the transferred information); and any further information as described in section 18 of POPIA.

The Parties undertake to take appropriate, reasonable technical and organizational measures to secure the integrity and confidentiality of Personal Information in its possession or under its control. Each Party undertakes to notify the other Party where there are reasonable grounds to believe that any Personal Information has been accessed or acquired by any unauthorized person and may affect the other Party.

The CLIENT may at any time carry out an audit, having provided the PROVIDER with reasonable notice of such audit, to verify compliance with the Provider's obligations as set forth in this clause.

In the event of a breach by the PROVIDER of its obligations, the CLIENT reserves the right to immediately and automatically terminate this Agreement, without prejudice to any other claims the CLIENT may have.

13.2 Global Compact – Anti-Corruption – Conflict of Interest – Transparency – Restricted Parties Screening – Conflict Minerals

Global Compact. Sanofi is a member of the Global Compact established by the United Nations (https://www.unglobalcompact.org) and has undertaken to support and apply certain fundamental principles in the fields of human rights, working conditions, the environment and anti-corruption. Relations with CLIENT at the time of any PO are contingent upon PROVIDER’s respect for this same principles as well any specific code of conduct implementing such principles by CLIENT such as the Sanofi Supplier Code of Conduct (https://suppliers.sanofi.com/-/media/Project/OneSanofi-Web/Websites/Global/Sanofi-Suppliers-COM/fr/Sanofi-Supplier-code-of-conduct.pdf) and the Sanofi Code of Ethics (http://www.codeofethics.sanofi/). PROVIDER undertakes to respect these principles and/or codes of conduct during the performance of the PO and set up sufficient internal procedures, tools and measurement indicators necessary to guarantee compliance with these principles. It authorizes CLIENT to assess the effectiveness of these, itself or through a third part approved by the two Parties.

Anti-Corruption. PROVIDER undertakes to comply with all applicable national and international laws and regulations regarding the prevention of and fight against corruption and influence peddling. This commitment must be extended by PROVIDER to all the third parties to whom PROVIDER may subcontract all or part of the PO. PROVIDER undertakes to never propose to Sanofi employees any sum of money, gifts, loans, rebates or valuable objects.

Conflict of interests. PROVIDER declares that on the proof of receipt date of the Order Form formalizing the PO, no conflict of interests (hereinafter the “Conflict of Interests”) exists to affect or that is likely to affect the performance of the service(s) or the supplying of the goods due to these interests conflicting with their proper realization to the detriment of CLIENT’s interests. In addition, PROVIDER undertakes to declare any Conflict of Interest arising during performance of the PO. In this event, CLIENT shall have the right to exercise its right of termination under the conditions provided for in the General T&Cs.

Transparency. In the event applicable to PROVIDER, CLIENT shall make public the existence of this PO together with any amounts of costs paid within the framework of the PO in accordance with the prevailing legal and regulatory provisions relating to the transparency of personal connections.

Restricted Parties Screening. PROVIDER shall comply with any and all applicable trade regulations (including but not limited to those on embargo and embargoed countries) and shall take all the necessary measures not to work with entities or individuals who are on any (national or international) sanctions and similar restrictions lists.

Conflict Minerals. PROVIDER shall not use, and shall not allow to be used, any (a) cassiterite, columbite-tantalite, gold, wolframite, or the derivatives tantalum, tin or tungsten (“Initial Conflict Minerals”) that originated in the Democratic Republic of Congo (“DRC”) or an adjoining country, or (b) any other mineral or its derivatives determined by the Secretary of State to be financing conflict pursuant to Section 13p of the Securities and Exchange Act of 1934 (“Additional Conflict Minerals”, and together with the Initial Conflict Minerals, “Conflict Minerals”), in the manufacturing of any Product that is implied in the performance of the PO. Notwithstanding the foregoing, if PROVIDER uses, or determines that it has used, a Conflict Mineral in the manufacturing of any such Product(s), PROVIDER shall immediately notify CLIENT, which notice shall contain a written description of the use of the Conflict Mineral, including, without limitation, whether the Conflict Mineral appears in any amount in the Product(s) (including trace amounts) and a valid and verifiable certificate of origin of the Conflict Mineral used. PROVIDER must be able to demonstrate that it undertook a reasonable country of origin inquiry and due diligence process in connection with its preparation and delivery of the certificate of origin.

13.3 Requirements pursuant to social regulation

PROVIDER certifies and attests that the goods and/or services ordered will be performed by employees who are regularly employed with respect to applicable labor legislation and declares that it has fulfilled its corresponding social and fiscal obligations.

PROVIDER alone determines the composition of its team providing the goods and/or services, maintaining it at the level required by the particular nature of said goods and/or services. It must ensure the team is properly informed and authorized and that it is sufficient in number to perform the Services under the best working and safety conditions.

PROVIDER alone provides the monitoring and management of its staff. The officers, agents, temporary workers or employees hired by PROVIDER for performing the Agreement remain under its sole control and its sole management. The staff of PROVIDER shall not under any circumstances be considered subordinates of CLIENT.

PROVIDER will defend and hold CLIENT harmless for any claim in this regard.

13.4 Environment

PROVIDER shall comply with all applicable environmental protection rules and regulations and health and safety provisions relating notably to chemicals and classified facilities including, where applicable, REACH Regulation (EC 1907/2006), CLP Regulation (EC 1272/2008), BPR Regulation (EU 528/2012) and IED Directive (2010/75/EU).

Recognizing the corporate social responsibility of CLIENT, PROVIDER shall accept evaluation by CLIENT of PROVIDER’s environmental and industrial safety standards.

ARTICLE 14 - MISCELLANEOUS

14.1 Transfer – Assignment

PROVIDER acknowledges that it has been chosen by CLIENT on the basis of its expertise and skills. Consequently, PROVIDER shall not transfer/assign all or part of the rights and obligations it holds as a result of the Agreement without the prior written authorization of CLIENT. In any event, when CLIENT has consented to the transfer/assignment, PROVIDER remains jointly and severally liable with the transferee/assignee.

CLIENT shall be free to assign or transfer all or part of its rights and obligations under the Agreement to its Affiliated Companies, subsidiaries and successors in interest and to any Third Party without PROVIDER’s prior authorization.

14.2 Subcontracting

PROVIDER shall not subcontract all or part of the Services to anyone without the prior written approval of CLIENT.

In any case, it is agreed that, if CLIENT were to give such consent, PROVIDER shall remain personally liable vis-à-vis CLIENT for the complete and perfect performance of this Agreement by its subcontractors.

14.3 Language

The Parties hereto confirm that it is their wish that this Agreement as well as all other documents relating hereto, including notices, have been and shall be drawn up in the English language only.

ARTICLE 15 - GOVERNING LAW AND DISPUTE RESOLUTION

15.1 Governing law

All legal relations between PROVIDER and CLIENT, including but not limited to any disputes, claims, controversies, disagreements, actions and proceedings arising out of or in connection with the Agreement shall be governed by South African law.

Any applicable conflict of law rules shall be expressly excluded. If relevant, the application of the United Nations Convention on the International Sale of Goods (“CISG”) of 11 April 1980 shall be expressly excluded.

15.2 Dispute resolution

Any dispute as to the interpretation or performance of the Agreement that cannot be resolved amicably shall be brought before a competent South African Court, to which the Parties attribute exclusive territorial jurisdiction, notwithstanding multiple defendants, summary proceedings or third-party claims.

GENERAL TERMS AND CONDITIONS

ARTICLE 1 – DEFINITIONS

The following terms, when the first letter is capitalized, shall have the meanings defined hereunder:

“Affiliated Company(ies)”                          means any company which directly or indirectly controls, is controlled by or is under common control with Sanofi. For the purposes hereof, control shall mean the direct or indirect ownership of more than fifty per cent (50%) of the equity or more than fifty per cent (50%) of the voting rights.

“Agreement”                                                  means this document together with the applicable Purchase Order specifying the contractual terms and conditions applicable to goods and/or services ordered by CLIENT to PROVIDER.

 

“CLIENT”                                                          means Sanofi-Aventis South Africa Proprietary Limited, with company registration number 1996/010381/07, a private company duly incorporated in accordance with the company laws of the Republic of South Africa, with its registered business address at Floor 5, Building I, Hertford Office Park, 90 Bekker Road, Midrand, 2196

                                                                          OR Sanofi Industries South Africa Proprietary Limited, with company registration number 1931/002901/07, a private company duly incorporated in accordance with the company laws of the Republic of South Africa, with its registered business address at Floor 5, Building I, Hertford Office Park, 90 Bekker Road, Midrand, 2196;

                                                                        OR Opella Healthcare South Africa Proprietary Limited, with company registration number 2020176440/07, a private company duly incorporated in accordance with the company laws of the Republic of South Africa, with its registered business address at Floor 4, Building I, Hertford Office Park, 90 Bekker Road, Midrand, 2196;

                                                                        (each individually the “Client”, acting severally not jointly, under each respective Purchase Order).

 

“Effective date”                                             shall have the meaning given in Clause 12.1.

 

“Force Majeure”                                           means an external, unpredictable and irresistible event such as, without this list being limitative, acts of God (the elements), acts of authorities, war (whether declared or not), riot, blockage, embargo, invasion, mob violence, lock-outs, epidemics, quarantine, natural disaster (volcanic eruptions, floods, earthquakes, hurricanes) or strikes.

“Intellectual Property Rights (IPR)”        shall mean any right arising out of or relating to patents (including the rights to patentable or non-patentable inventions, discoveries, know-how trade secrets and other confidential information), designs, trademarks, domain names, databases, copyrights, any registration or application to register, renew and/or extend any of these rights and all other IPR and equivalent or similar forms of protection existing in any country.

“Party(ies)”                                                     means individually or collectively the PROVIDER and/or the CLIENT.

“PROVIDER”                                                   means any company bound by an agreement with CLIENT for the provision of any goods, services and/or deliverables.

 

“Purchase Order (PO)”                                means any purchase request of specific goods and/or services to PROVIDER, which upon acceptance of the latter shall become the agreement between CLIENT and PROVIDER.

 

“Sanofi”                                                           means collectively the Sanofi parent company with its headquarters in France and Sanofi Affiliates which include any corporation or legal entity, that directly or indirectly controls, is controlled or is under common control with the Sanofi parent company.

 

“Third Party”                                                  means any company, individual or entity other than CLIENT, the Affiliated Companies or PROVIDER.

ARTICLE 2 – PURPOSE

The following General Terms and Conditions (General T&Cs) shall apply to the relationship between any supplier of goods and/or provider of services (the PROVIDER) and the company issuing the Purchase Order (PO) (the CLIENT) and shall establish the contractual framework for the delivery of goods and/or the performance of services.

It is recorded that these General T&Cs are incorporated by reference into all POs. Acceptance of the PO by PROVIDER shall entail acceptance by the latter of these General T&Cs. The General T&Cs and the applicable PO shall together form and be understood as the Agreement.

Deviations from these General T&Cs may only be made in the context of special conditions concluded in writing. Such deviation shall be valid only for the PO in question, without PROVIDER being able to invoke it for other orders.

Any terms and conditions of PROVIDER’s general terms and conditions of sale shall not be applicable even if CLIENT does not expressly object to them.

In the event of any conflict between the General T&Cs and the PO, the following order of priority will govern:

a)            first, any special conditions applicable which may be appended to these General T&Cs;

b)            second, the General T&Cs;

c)             third, the provisions of the applicable PO.

ARTICLE 3 – TERM

Notwithstanding the date set out on the face of this Agreement, this Agreement may not exceed 36 (thirty-six) months. In the event it does, the agreement shall terminate automatically 3 (three) years from signature date.

The Agreement may not be tacitly renewed and may be extended only by means of a written amendment signed by mutual agreement of the Parties.

ARTICLE 4 – TERMINATION

Each Party may terminate the Agreement immediately, as of right, without notice and without prejudice to any other rights or remedies, after sending a registered letter with acknowledgement of receipt:

a)            in case of breach or failure by a Party to perform one or more of its obligations under the Agreement, fifteen (15) days after the receipt of a formal notice to correct the situation, remained without effect,

b)            in the event of a cessation of activity, a recovery or a judicial liquidation plan of one of the Parties, subject to the legal provisions in force,

c)            in case of the occurrence of an event of Force Majeure under the conditions of “Force Majeure” Clause.

CLIENT may terminate the Agreement immediately, as of right, without notice and without prejudice to any other rights or remedies, after sending a registered letter with acknowledgement of receipt:

a)         in the event of repeated delays by PROVIDER in the delivery of the goods and/or the services,

b)         in the event of material and/or repeated breaches in connection with the quality of the goods and/or the services and which may in particular generate a major security risk,

c)         in case of non-compliance by PROVIDER with the following articles: “Confidentiality” Clause, “Personal data protection” Clause, “Requirements pursuant to social regulation” Clause, “Environment” Clause, “Conflict of interest” Clause, “Information security and quality measures” Clause, “Ethics and business integrity” Clause and “Pharmacovigilance” Clause.

            

             CLIENT may terminate the Agreement at any time for convenience by providing PROVIDER with a written notice of 7 (seven) days.

In case of an operation with a Third Party resulting in the change of control of PROVIDER, it shall immediately notify CLIENT by registered letter with acknowledgement of receipt. In this case, CLIENT reserves the right to terminate the Agreement in its entirety by providing a one (1) month notice from the date of PROVIDER’s notification. Change of control means any organizational change of PROVIDER resulting in: (i) either the main shareholder of the Party in question at the time of signing of the Agreement no longer having effective control of the Party; or (ii) any significant change in the shareholding structure of said Party, affecting its control.

In the case of expiration or termination of the Agreement, CLIENT shall only be required to pay to PROVIDER the sums corresponding to compliant goods or services delivered and not yet invoiced up to the effective date of termination, no other amounts being due from CLIENT to PROVIDER. PROVIDER shall reimburse the advance payment received for goods or services not delivered.

In case of expiration or termination of the Agreement, PROVIDER shall return to CLIENT any and all information, documents and materials (and all copies thereof) and all data provided by CLIENT under this Agreement and/or in connection with the delivery of the goods and/or services.

ARTICLE 5 - FINANCIAL CONDITIONS

5.1 Prices

The prices agreed between CLIENT and PROVIDER are fixed prices and are exclusive of taxes.

5.2 Invoicing

Invoices shall be made out in the currency indicated in the PO.

All invoices shall at least contain the following information:

a)            the PO number;

b)            detailed supporting documentation regarding the goods and/or services delivered;

c)             the applicable taxes;

d)            the PROVIDER’s account references for payment; and

e)            the requestor of the goods and/or services.            

 

All invoices shall be transmitted via e-mail to the accounting department of CLIENT and to the contact person as reflected on the PO

Should PROVIDER not be able to e-mail the invoice, a hard copy of the invoice shall be delivered or sent via registered post to the following address:

Floor 5, Building I,

Hertford Office Park,

90 Bekker Road,

Midrand,

2196

 

CLIENT reserves the right to refuse any invoice that is not established in accordance with the provisions of this Clause.

5.3 Payment terms

Unless the Parties have agreed on other payment terms and subject that the goods and/or services are properly received, the deadline for payment of amounts due from CLIENT to PROVIDER for the provision of services and/or the delivery of goods is set at 60 (sixty) days after the invoice date, provided that the invoice is in full compliance with the applicable legislative and regulatory rules and with the above-mentioned requirements.

Payment shall be made for undisputed invoices and disputed invoices may be withheld and will not accrue interest until such time as the dispute is resolved.

Payment shall be made by bank transfer.

Failure to pay by the deadline indicated above for a reason solely attributable to CLIENT shall result in the application of late-payment interest equal to the prime interest rate in South Africa. This interest begins accruing from the day after the payment deadline until the day of payment.

In the event of expiration or termination of the Agreement, CLIENT shall pay SUPPLIER for the compliant goods delivered and/or the services provided until the end of the notice period. All deposits or pre-payments paid by CLIENT for goods and/or services not delivered shall be reimbursed by PROVIDER.

ARTICLE 6 – LIABILITY

The delivery or goods or the provision of services are carried out under the full liability of PROVIDER. In this respect, PROVIDER is liable for any type of injury, damage and/or loss, whether direct or indirect, resulting from the breach of its contractual commitments to CLIENT, or from error, negligence, omission or fault on the part of its staff or potential subcontractors that it may use for the execution of Services suffered by CLIENT (including its personnel, representatives and Affiliates), its customers and/or any Third Party related to CLIENT.

CLIENT and PROVIDER shall be responsible, each as applies to them, for all direct or indirect financial consequences resulting from the civil liability they assume for any physical, environmental, material or immaterial damage caused to a Third Party during execution of the Agreement.

ARTICLE 7 – INSURANCE

PROVIDER represents that it holds insurance policies underwritten by an insurance company known to be solvent and covering the financial consequences for which it would be liable for damages that it may cause to CLIENT or a Third Party while performing the Agreement.

PROVIDER agrees to present, upon the signing of the Agreement and on request of CLIENT during the Services, the proof of insurance taken out in accordance with this article, and to prove the payment of insurance premiums at the first request of CLIENT.

PROVIDER agrees to maintain this coverage throughout the duration of the Agreement.

All these insurance policies must be taken out by PROVIDER to allow PROVIDER to notify CLIENT with advance notice of at least thirty (30) days, of any cancellation of modification of these insurance policies.

ARTICLE 8 - FORCE MAJEURE

The Parties shall not be held responsible for any shortcomings or delays in performance of their obligations that may be due to Force Majeure, understood as an external, unpredictable and irresistible event which make it impossible for a Party to fulfill its obligations under this Agreement.

Should a case of Force Majeure affect the Agreement, the affected Party shall immediately notify the other Party, by registered letter (or via e-mail) with acknowledgement of receipt, of the occurrence of said event setting forth its estimated duration.

In this case, the Parties must promptly come together and make their best efforts to reduce the effects of the case of Force Majeure.

At the end of the event of Force Majeure and its effects, the performance of the obligations that were suspended for the duration of the event shall resume as soon as possible. Each Party will bear its own costs and expenses incurred in connection with the event of Force Majeure.

Should the Parties fail to agree on the measures required and should the case of Force Majeure exceed a period of one (1) month from the notification of its occurrence, either Party may immediately terminate the Agreement as of right, without any compensation to be claimed for this purpose.

ARTICLE 9 – AUDIT

The Parties agree that CLIENT may at any time during the term of the Agreement and for a period of 5 (five) years after its termination or expiration, carry out an audit or have an audit carried out by an independent body appointed by CLIENT in order to assess the compliance of PROVIDER and PROVIDER’s subcontractors with their obligations under the Agreement and any applicable laws and regulations.

CLIENT shall give a 15 (fifteen) days’ prior notice to PROVIDER before conducting such audit which shall take place during normal business hours.

For the purpose of this audit, PROVIDER agrees to facilitate access to auditors of PROVIDER’s or PROVIDER’s sub-contractors site, to cooperate fully with them and to provide them all necessary information. PROVIDER will allow the designated auditors to access all facilities, information and documents necessary to carry out the audit.

The audit shall be paid by CLIENT unless the audit demonstrated a breach of the Agreement by PROVIDER or PROVIDER’s subcontractors in which case, PROVIDER shall reimburse the totality of the cost of the audit.

A copy of the audit report will be provided free of charge by CLIENT to PROVIDER upon request. The results of the conducted audit shall be considered as confidential information by both Parties.

Should the audit detect non-compliance with the obligations of PROVIDER referred to in the Agreement and/or any applicable laws and regulations or if CLIENT, following the audit, voices recommendations or reservations, PROVIDER shall take, at its sole expense, all appropriate measures to implement any corrective or preventive action or any CLIENT’s recommendation as soon as possible. Any failure to remediate shall be deemed as a breach and shall allow CLIENT to terminate the Agreement for breach.

The Parties agree that the implementation or lack thereof of the audit procedure shall in no way exonerate PROVIDER from meeting its contractual obligations.

Should a competent authority or authority with an interest in the activities of PROVIDER carry out or intend to carry out an audit, inspection and/or investigation of PROVIDER’s files, operations and facilities, or of the systems and/or the procedures that are related to the Agreement or liable to affect the ability of PROVIDER to deliver the goods and/or provide the services as agreed under the Agreement, PROVIDER will inform the CLIENT in detail as soon as possible of the measures taken or proposed. CLIENT shall be allowed on site and have the right to review the audit report and any requested submission to the authority.

ARTICLE 10 – CONFIDENTIALITY

Each Party shall treat as strictly confidential all information obtained from the other Party either directly or indirectly, in written, oral, electronic or any other form, whether or not labelled as confidential, that relates or refers to the Agreement.

The Parties shall not divulge any confidential information to any Third Party without the other Party’s prior written consent. However, a Party may disclose confidential information in the event that it is required to do so by law or pursuant to a court decision, on condition that such Party immediately notifies the other Party in writing so as to enable the other Party to take any form of appropriate protective measures.

This Clause shall not extend to information which:

a)            was rightfully in the possession of such Party prior to its disclosure;

b)            is already public knowledge or becomes so at a future date (otherwise than as a result of a breach of this Clause); or

c)             is trivial or obvious.

 

The Parties shall take all necessary measures to protect the confidential information they have in their possession. More specifically, each Party shall protect the confidential information received from the other Party with at least the same degree of care as the one used when dealing with its own confidential information.

The confidential information shared by one Party to the other Party may not be used for any purpose other than the performance of the Agreement. The confidential information shall thus be used by the Parties solely as necessary to perform the obligations under the Agreement and only for the duration of the performance of the Agreement.

PROVIDER undertakes to limit the access to the confidential information to its personnel and authorized subcontractors solely for the purpose of completing the delivery of goods and/or the performance of services. PROVIDER warrants that its employees and authorized subcontractors shall not disclose or use the confidential information at any time or for any manner not authorized under this Clause. In any event, should the obligation of confidentiality be breached, PROVIDER shall be held fully liable for such breach to CLIENT.

CLIENT shall be allowed to freely communicate, through all means of communications, on the Agreement, the goods and/or services to deliver and the business relationship between the Parties.

Unless prior written consent is obtained from CLIENT, PROVIDER shall refrain from mentioning the existence and/or the content of this Agreement in its promotional materials and/or campaigns, as well as in any usage of CLIENT’s logo, any citation of CLIENT or its Affiliated Companies or any other communication with Third Parties that relates to the business relationship PROVIDER has with CLIENT.

The Parties expressly acknowledge that whenever confidential information is shared by one Party to another within the context of the Agreement, it shall remain the exclusive property of the disclosing Party. The return or the destruction of confidential information shall be organized upon termination of the Agreement and at any time upon CLIENT’s request. 

The provisions of this Clause shall survive the termination or expiry of this Agreement for a period of 10 (ten) years. 

ARTICLE 11 - INTELLECTUAL PROPERTY

Each Party shall retain full ownership of the IPR of any of its pre-existing elements, which shall be understood as any element created by a Party or licensed to it by a Third Party before or completely independently from the performance of the Agreement.

PROVIDER shall transfer to CLIENT, with all the associated legal and factual guarantees, exclusive ownership or license of all IPR in the deliverables resulting from the performance of the Agreement, regardless of the form, nature and state of completion, which shall include any outcome, document, study, report, any technical creation, created and/or developed by PROVIDER under the Agreement (including improvement and/or modification to CLIENT’s pre-existing elements).

Following the above-mentioned transfer, PROVIDER cedes and/or assigns to CLIENT the right, without this list being limitative, to publish, circulate, reproduce, process and otherwise exploit all of the ideas, concepts, drafts and designs, which were developed on behalf of CLIENT by PROVIDER. This right extends to all types of use, including, but not limited to, print advertising and multimedia exploitation.

This transfer shall be irrevocable, shall be (sub)licensable, shall apply worldwide and shall be valid for the entire duration of the protection of the rights under applicable current legislation.

Payment by CLIENT for the goods delivered and/or services performed shall constitute satisfaction in full for the acquisition of the above mentioned rights.

PROVIDER guarantees to CLIENT and its Affiliated Companies the peaceful enjoyment of the assigned rights. In this respect, PROVIDER warrants that nothing provided under the Agreement violates IPR belonging to any Third Party. To this end, PROVIDER shall indemnify, substitute in court proceedings and hold CLIENT and Affiliated Companies harmless against any claim from any Third Party relating to said rights.

ARTICLE 12 - SPECIFIC PROVISIONS RELATED TO ORDER

12.1 Order formalization – Order acceptance – Order changes

Unless otherwise agreed in writing in advance, the written PO issued by CLIENT is the only document PROVIDER may accept in order to perform services or deliver goods. The acceptance of the PO is established by the return to CLIENT of a signed version of the PO, which constitutes its acceptance without any reservation.

The Agreement shall be effective once the PO signed by PROVIDER has been received by CLIENT. In the event that PROVIDER does not return a signed PO to CLIENT but nevertheless delivers goods and/or performs services, the Agreement shall become effective on the date CLIENT has issued a PO to PROVIDER (“Effective Date”).

PROVIDER must notify CLIENT expressly in writing if it accepts an order on terms which are different from those stipulated in the original PO issued by CLIENT. In this event, the Agreement between PROVIDER and CLIENT shall not take effect until CLIENT has consented to those different terms in writing.

Any variations or modifications to this Agreement, to the goods being delivered or services being rendered, must be in writing and signed by the authorised representatives of the Parties or through a new PO.

12.2 Order performance

PROVIDER shall carry out the delivery of goods and/or the performance of services continuously and diligently, to the satisfaction of CLIENT and in accordance with the terms and conditions of the PO, applicable laws, professional standards and good industry practices.

PROVIDER represents, warrants, undertakes and agrees that it has the required skills, capacity and equipment to perform its obligations under the PO and that it shall deliver the goods and/or perform the services in a professional manner using qualified and competent personnel.

PROVIDER states and warrants that it holds the administrative authorizations or approvals required by applicable regulations to deliver goods and/or provide services and agrees to provide at CLIENT’s request the related supporting document and immediately inform CLIENT of the loss, withdrawal or non-renewal of any authorization or approval necessary for the provision of the goods and/or services.

PROVIDER guarantees that its subcontractors, if any, shall comply with the same obligations as listed above.

With reference to CLIENT’s absolute social and patient responsibility as a pharmaceutical industry, any interruption or suspension of order performance by PROVIDER may have critical adverse consequences for CLIENT, notably for the continuity of its business. As a result, PROVIDER undertakes to continue at all times the performance of the order by all possible means (including by maintaining an up-to-date business continuity and disaster recovery plan as necessary).

12.3 Acceptance of Goods and/or Services

Any delivery of goods/services shall be subject to their approval by CLIENT. Final acceptance of the goods and/or services implies the lifting of any reservations. It discharges PROVIDER from its contractual delivery obligations without releasing it from its legal responsibilities.

CLIENT shall inspect the goods and/or services for defects without delay after receipt of such goods and/or services.

CLIENT shall be entitled to give notice of defects to PROVIDER within a time limit of 7 (seven) calendar days from the date the necessary inspection of the goods and/or services is concluded. In the case of perishable goods, CLIENT shall be obliged to give notice without delay.

Where defects are hidden, notice of defects shall be given by CLIENT upon discovery of such defects.

If defects in the goods and/or services make a more extensive examination of the goods and/or services necessary, then the costs of same shall be borne by PROVIDER.

PROVIDER’s liability for defects shall not be affected by the acceptance of the goods and/or services by CLIENT.

12.4 Planning – Delays – Penalties

The delivery and/or performance date specified in the PO shall be binding. The relevant date for determining whether the goods and/or services have been delivered and/or performed on time shall be the date the goods arrive at the agreed destination and/or the services are performed as per the dates indicated in the PO.

If PROVIDER is unable to provide CLIENT with a binding delivery and/or performance date, PROVIDER shall be obliged to specify the earliest and latest possible delivery and/or performance dates.

Any delay, for whatever reason, occurring during the execution of the PO, must be reported immediately by PROVIDER to CLIENT in writing.

CLIENT reserves the right to cancel the PO in the event of non-compliance with the delivery date of the goods or the performance of the service.

In case of delay in the delivery of the goods or in the execution of the service, the PO may provide for penalties for delay, these penalties never representing a lump-sum compensation for the damage suffered by CLIENT. The payment of these penalties shall be made by offsetting the amount of PROVIDER's invoices.

Furthermore, in the event of partial delivery or performance, CLIENT reserves the right to cancel the PO, retaining the goods already delivered or the part of the service already performed against payment of the corresponding part of the price.

12.5 Information security and quality measures

PROVIDER shall comply and shall procure that each of PROVIDER's Personnel and permitted subcontractors shall comply at a minimum with the information security and quality measures provisions currently set out in https://suppliers.sanofi.com/en/standards-and-procedures as amended by CLIENT from time to time.

Such terms are hereby incorporated herein by reference and the Parties expressly commit to comply with them.

12.6 Pharmacovigilance

Where the PO is related to a CLIENT product, specific pharmacovigilance requirements will apply. In this case, PROVIDER and CLIENT shall comply with the terms of the applicable pharmacovigilance clause currently available at https://suppliers.sanofi.com/en/standards-and-procedures as amended by CLIENT from time to time.

Such terms are hereby incorporated herein by reference and the Parties expressly commit to comply with them.

12.7 Warranties

In accordance with the PO, PROVIDER shall guarantee the quality and conformity of the goods and/or services which shall be free from any defects and will be of quality suitable for the purpose for which the goods and/or services are required.

In accordance with Clause 12.5, at CLIENT’s sole choice and discretion and without prejudice to any other rights or remedies CLIENT may have under the order and applicable law, PROVIDER shall:

a)            either correct/complement/replace the defective or non-conforming goods/deliverables or services; or

b)            return such for full credit.

 

PROVIDER warrants to CLIENT a step-in right in order to allow the latter to carry out the performance of the PO by itself or by any Third Party chosen by CLIENT after any breach of the PO by PROVIDER, at any time, with PROVIDER’s cooperation and assistance, and without prejudice to any other rights or remedies CLIENT may have under the PO and applicable law.

 

PROVIDER shall bear all costs incurred by the implementation of the chosen remedy, which could include, without this list being limitative, the transportation costs between CLIENT’s and PROVIDER’s site or the step-in costs.

 

12.8 Delivery – Transfer of ownership and risks

The PO will specify the appropriate Incoterm applicable to the Agreement. Where no agreement regarding delivery has been made, delivery shall be made for free to the agreed destination.

The transfer of ownership and risks shall be governed by the agreed Incoterms Rules for Any Mode of Transport as provided for in the International Chamber of Commerce’s Incoterms® 2010 English Edition.

12.9 Rules applicable in the event of on-site activities

PROVIDER undertakes to comply and fully cause its employees to comply with the access, hygiene, safety, environmental (including waste management) instructions, rules and regulations in force on CLIENT’s Site regardless of their form.

PROVIDER agrees to report any accident suffered by a member of its staff, and any incident whose consequences could be harmful to the safety of staff, equipment and/or the environment, as soon as they are known. This report will be done to the contact person designated by CLIENT for the performance of the Agreement or any person who may take their place.

PROVIDER warrants that its work will not cause any difficulties for other contractors working simultaneously on CLIENT’s Site, and in particular, that it will not cause any damage to facilities, equipment or machines belonging to them, existing structures or those under construction.

CLIENT reserves the right to require PROVIDER to proceed with the immediate eviction of any employee or subcontractor who does not respect the access, health, environmental protection and safety instructions applicable on the Site and/or whose behavior could jeopardize the proper delivery of goods and/or performance of the services. Any request for eviction formulated by CLIENT will be made in writing.

The breach of PROVIDER’s personnel and subcontractors to comply with the access, hygiene, safety, environmental instructions, rules and regulations in force on CLIENT’s site shall entitle the latter to terminate the PO.

 

ARTICLE 13 - ADDITIONAL PROVISIONS

13.1 Personal Data protection

Under this Clause, the Parties agree that the terms “Personal Information”, “Responsible Party”, “Operator”, “Processing”, “Applicable Data Protection Law”, “Services” and “Purchase Order” shall have the meaning assigned to them in the Data Processing Agreement (if applicable) or otherwise the meaning assigned to them in these General T&Cs or, as the case may be, in the applicable law.

Each Party shall, with regards to its own respective Processing activities for which it acts as a Responsible Party, comply with its own obligations under Applicable Data Protection Law.

The Parties agree that, for the purposes of performing the PO under these General T&Cs, PROVIDER does not process Personal Information on behalf of CLIENT.

However, to the extent that PROVIDER processes any Personal Information on CLIENT’s behalf within the scope of the PO or should PROVIDER identify the fact that, during the performance of the PO, PROVIDER is processing Personal Information on CLIENT’s behalf (in such case, PROVIDER shall immediately inform CLIENT thereof), such Processing shall be governed by the terms of the Data Processing Agreement currently available at the following address and as amended by CLIENT from time to time:

www.sanofi.co.za

Such terms are hereby incorporated herein by reference and the Parties expressly commit to comply with them.

Where the performance of the PO under the General T&Cs benefits affiliates of CLIENT, either directly or through the signature of any relevant documentation (e.g. statement of work, purchase order, etc.), the Parties expressly agree that each CLIENT affiliate shall be regarded as a Responsible Party independently in its own right.

For the purpose of this Agreement, Personal Information shall have the meaning ascribed to it in the Protection of Personal Information Act 4 of 2013 ("POPIA") which means information relating to an identifiable, living, natural person and an identifiable existing juristic person, where applicable, as further described in section 1 of POPIA. Applicable Data Protection Law shall mean POPIA as well as the personal data protection laws, rules and regulations applicable in the country where all or part of the Services are performed where these are performed in full or in part outside of South Africa.  

In accordance with POPIA, the Parties undertake, with respect to Processing any Personal information, to:

  1. ensure compliance with POPIA including but not limited to Processing all Personal Information in accordance with at least one of the lawful grounds for Processing Personal Information set out in section 11 of POPIA; and
  2. ensure compliance with all 8 (eight) processing conditions provided in POPIA,

for the avoidance of doubt, this includes taking reasonable steps when collecting Personal Information to notify the person to whom the Personal Information relates to in order to ensure that the person is aware of the information being collected, the name and address of the party Processing the information, the purpose for which the information is being collected, whether the supply of the information is voluntary or mandatory, the consequences of failure to provide the information, any applicable law authorizing or requiring the collection of the information, the fact that the party Processing the information intends on transferring the information to a third country or international organization (including the level of protection afforded in respect of the transferred information); and any further information as described in section 18 of POPIA.

The Parties undertake to take appropriate, reasonable technical and organizational measures to secure the integrity and confidentiality of Personal Information in its possession or under its control. Each Party undertakes to notify the other Party where there are reasonable grounds to believe that any Personal Information has been accessed or acquired by any unauthorized person and may affect the other Party.

The CLIENT may at any time carry out an audit, having provided the PROVIDER with reasonable notice of such audit, to verify compliance with the Provider's obligations as set forth in this clause.

In the event of a breach by the PROVIDER of its obligations, the CLIENT reserves the right to immediately and automatically terminate this Agreement, without prejudice to any other claims the CLIENT may have.

13.2 Global Compact – Anti-Corruption – Conflict of Interest – Transparency – Restricted Parties Screening – Conflict Minerals

Global Compact. Sanofi is a member of the Global Compact established by the United Nations (https://www.unglobalcompact.org) and has undertaken to support and apply certain fundamental principles in the fields of human rights, working conditions, the environment and anti-corruption. Relations with CLIENT at the time of any PO are contingent upon PROVIDER’s respect for this same principles as well any specific code of conduct implementing such principles by CLIENT such as the Sanofi Supplier Code of Conduct (https://suppliers.sanofi.com/-/media/Project/OneSanofi-Web/Websites/Global/Sanofi-Suppliers-COM/fr/Sanofi-Supplier-code-of-conduct.pdf) and the Sanofi Code of Ethics (http://www.codeofethics.sanofi/). PROVIDER undertakes to respect these principles and/or codes of conduct during the performance of the PO and set up sufficient internal procedures, tools and measurement indicators necessary to guarantee compliance with these principles. It authorizes CLIENT to assess the effectiveness of these, itself or through a third part approved by the two Parties.

Anti-Corruption. PROVIDER undertakes to comply with all applicable national and international laws and regulations regarding the prevention of and fight against corruption and influence peddling. This commitment must be extended by PROVIDER to all the third parties to whom PROVIDER may subcontract all or part of the PO. PROVIDER undertakes to never propose to Sanofi employees any sum of money, gifts, loans, rebates or valuable objects.

Conflict of interests. PROVIDER declares that on the proof of receipt date of the Order Form formalizing the PO, no conflict of interests (hereinafter the “Conflict of Interests”) exists to affect or that is likely to affect the performance of the service(s) or the supplying of the goods due to these interests conflicting with their proper realization to the detriment of CLIENT’s interests. In addition, PROVIDER undertakes to declare any Conflict of Interest arising during performance of the PO. In this event, CLIENT shall have the right to exercise its right of termination under the conditions provided for in the General T&Cs.

Transparency. In the event applicable to PROVIDER, CLIENT shall make public the existence of this PO together with any amounts of costs paid within the framework of the PO in accordance with the prevailing legal and regulatory provisions relating to the transparency of personal connections.

Restricted Parties Screening. PROVIDER shall comply with any and all applicable trade regulations (including but not limited to those on embargo and embargoed countries) and shall take all the necessary measures not to work with entities or individuals who are on any (national or international) sanctions and similar restrictions lists.

Conflict Minerals. PROVIDER shall not use, and shall not allow to be used, any (a) cassiterite, columbite-tantalite, gold, wolframite, or the derivatives tantalum, tin or tungsten (“Initial Conflict Minerals”) that originated in the Democratic Republic of Congo (“DRC”) or an adjoining country, or (b) any other mineral or its derivatives determined by the Secretary of State to be financing conflict pursuant to Section 13p of the Securities and Exchange Act of 1934 (“Additional Conflict Minerals”, and together with the Initial Conflict Minerals, “Conflict Minerals”), in the manufacturing of any Product that is implied in the performance of the PO. Notwithstanding the foregoing, if PROVIDER uses, or determines that it has used, a Conflict Mineral in the manufacturing of any such Product(s), PROVIDER shall immediately notify CLIENT, which notice shall contain a written description of the use of the Conflict Mineral, including, without limitation, whether the Conflict Mineral appears in any amount in the Product(s) (including trace amounts) and a valid and verifiable certificate of origin of the Conflict Mineral used. PROVIDER must be able to demonstrate that it undertook a reasonable country of origin inquiry and due diligence process in connection with its preparation and delivery of the certificate of origin.

13.3 Requirements pursuant to social regulation

PROVIDER certifies and attests that the goods and/or services ordered will be performed by employees who are regularly employed with respect to applicable labor legislation and declares that it has fulfilled its corresponding social and fiscal obligations.

PROVIDER alone determines the composition of its team providing the goods and/or services, maintaining it at the level required by the particular nature of said goods and/or services. It must ensure the team is properly informed and authorized and that it is sufficient in number to perform the Services under the best working and safety conditions.

PROVIDER alone provides the monitoring and management of its staff. The officers, agents, temporary workers or employees hired by PROVIDER for performing the Agreement remain under its sole control and its sole management. The staff of PROVIDER shall not under any circumstances be considered subordinates of CLIENT.

PROVIDER will defend and hold CLIENT harmless for any claim in this regard.

13.4 Environment

PROVIDER shall comply with all applicable environmental protection rules and regulations and health and safety provisions relating notably to chemicals and classified facilities including, where applicable, REACH Regulation (EC 1907/2006), CLP Regulation (EC 1272/2008), BPR Regulation (EU 528/2012) and IED Directive (2010/75/EU).

Recognizing the corporate social responsibility of CLIENT, PROVIDER shall accept evaluation by CLIENT of PROVIDER’s environmental and industrial safety standards.

ARTICLE 14 - MISCELLANEOUS

14.1 Transfer – Assignment

PROVIDER acknowledges that it has been chosen by CLIENT on the basis of its expertise and skills. Consequently, PROVIDER shall not transfer/assign all or part of the rights and obligations it holds as a result of the Agreement without the prior written authorization of CLIENT. In any event, when CLIENT has consented to the transfer/assignment, PROVIDER remains jointly and severally liable with the transferee/assignee.

CLIENT shall be free to assign or transfer all or part of its rights and obligations under the Agreement to its Affiliated Companies, subsidiaries and successors in interest and to any Third Party without PROVIDER’s prior authorization.

14.2 Subcontracting

PROVIDER shall not subcontract all or part of the Services to anyone without the prior written approval of CLIENT.

In any case, it is agreed that, if CLIENT were to give such consent, PROVIDER shall remain personally liable vis-à-vis CLIENT for the complete and perfect performance of this Agreement by its subcontractors.

14.3 Language

The Parties hereto confirm that it is their wish that this Agreement as well as all other documents relating hereto, including notices, have been and shall be drawn up in the English language only.

ARTICLE 15 - GOVERNING LAW AND DISPUTE RESOLUTION

15.1 Governing law

All legal relations between PROVIDER and CLIENT, including but not limited to any disputes, claims, controversies, disagreements, actions and proceedings arising out of or in connection with the Agreement shall be governed by South African law.

Any applicable conflict of law rules shall be expressly excluded. If relevant, the application of the United Nations Convention on the International Sale of Goods (“CISG”) of 11 April 1980 shall be expressly excluded.

15.2 Dispute resolution

Any dispute as to the interpretation or performance of the Agreement that cannot be resolved amicably shall be brought before a competent South African Court, to which the Parties attribute exclusive territorial jurisdiction, notwithstanding multiple defendants, summary proceedings or third-party claims.