TENAX ENTERPRISES (PTY) LTD
STANDARD TERMS AND CONDITIONS OF SERVICE
Effective Date: 01 April 2025
1. DEFINITIONS
In these Terms:
“Company” means Tenax Enterprises (Pty) Ltd (Registration No. 2025/256733/07), including all subsidiaries, divisions, agents, and authorised representatives.
“Client” means any person or entity engaging the Company for professional services.
“Services” include, but are not limited to, regulatory affairs, quality assurance, compliance, audit, pharmacovigilance, dossier compilation, medical writing, data management, quality management systems, training, and related consultancy services.
“Deliverables” refer to any reports, documentation, data, or outputs produced by the Company under a Service Agreement.
“Agreement” means the contractual relationship between the Company and the Client incorporating these Terms, any quotation, proposal, or statement of work.
2. ACCEPTANCE AND APPLICATION
2.1 Engagement of the Company constitutes acceptance of these Terms.
2.2 These Terms apply to all services rendered by the Company, regardless of any conflicting terms proposed by the Client, unless expressly agreed in writing by a duly authorised representative of the Company.
2.3 Amendments or deviations must be in writing and signed by both parties.
3. REGULATORY FRAMEWORK AND COMPLIANCE
3.1 The Company operates in accordance with all applicable South African and international legislation and standards governing pharmaceutical, medical, and life sciences operations, including but not limited to:
Medicines and Related Substances Act (Act 101 of 1965) and associated SAHPRA Guidelines;
Medical Device Regulations and In Vitro Diagnostic Medical Device Regulations under the same Act;
Pharmacy Act (Act 53 of 1974) and South African Pharmacy Council (SAPC) directives;
National Health Act (Act 61 of 2003) and National Department of Health (NDoH) policies;
Occupational Health and Safety Act (Act 85 of 1993);
Hazardous Substances Act (Act 15 of 1973);
Basic Conditions of Employment Act (Act 75 of 1997) and Labour Relations Act (Act 66 of 1995);
Companies Act (Act 71 of 2008);
Protection of Personal Information Act (POPIA, Act 4 of 2013); and
Electronic Communications and Transactions Act (ECTA, Act 25 of 2002).
3.2 International and quality management frameworks adhered to include:
ISO 13485:2016 (Medical Devices),
ISO 9001:2015 (Quality Management Systems),
Good Manufacturing Practice (GMP),
Good Distribution Practice (GDP),
Good Vigilance Practice (GVP),
Good Clinical Practice (GCP),
WHO, EMA, PIC/S, and ICH harmonised guidelines.
3.3 The Client undertakes to cooperate with all reasonable requests necessary for the fulfilment of regulatory or quality obligations by the Company.
4. FEES, QUOTATIONS, AND PAYMENT
4.1 Fees are expressed in South African Rand (ZAR) unless stated otherwise.
4.2 All invoices are payable within 30 (thirty) days of invoice date unless otherwise stipulated.
4.3 Overdue balances accrue interest at the prime lending rate plus 13% per annum.
4.4 All prices are exclusive of VAT unless explicitly noted.
4.5 The Company reserves the right to suspend Services for overdue or unpaid accounts.
5. CONFIDENTIALITY
5.1 Both parties shall maintain the confidentiality of all proprietary, regulatory, or personal information exchanged in the course of the engagement.
5.2 Confidentiality obligations survive termination of this Agreement.
5.3 The Company may disclose information only when legally required, to regulatory authorities, or when necessary for regulatory submissions or audits.
6. INTELLECTUAL PROPERTY RIGHTS
6.1 All intellectual property, methodologies, templates, and know-how developed by the Company remain its sole property.
6.2 The Client retains ownership of pre-existing data or proprietary materials supplied to the Company.
6.3 Deliverables are licensed for the Client’s internal regulatory and operational use only, unless otherwise agreed in writing.
7. DATA PROTECTION AND PRIVACY (POPIA)
7.1 The Company collects and processes personal information strictly in accordance with POPIA.
7.2 The Client consents to such processing and confirms that all information provided has been lawfully obtained.
7.3 The Company implements appropriate technical and organisational security measures to ensure data confidentiality and integrity.
8. WARRANTIES AND DISCLAIMERS
8.1 The Company warrants that Services shall be executed with due professional care, skill, and diligence.
8.2 Regulatory outcomes (e.g., SAHPRA approval) are influenced by external factors and are beyond the Company’s control.
8.3 Except as expressly stated, the Company provides no further warranties, express or implied.
9. LIMITATION OF LIABILITY
9.1 The Company shall not be liable for indirect or consequential losses, including but not limited to loss of profit, revenue, goodwill, or anticipated savings.
9.2 Liability, if any, shall be limited to the total professional fees paid for the specific Service giving rise to the claim.
9.3 The Company shall not be liable for delays caused by force majeure, regulatory backlogs, or third-party actions.
10. BANKING DETAILS & FRAUD PREVENTION
10.1 Tenax Enterprises (Pty) Ltd will never change its banking details via e-mail.
10.2 Any communication suggesting otherwise must be reported immediately to our Finance Department.
10.3 Always verify payment details verbally and in writing before effecting any transfer.
10.4 The Company disclaims liability for payments made into unauthorised or fraudulent accounts.
11. FORCE MAJEURE
The Company shall not be held liable for failure to perform obligations where such failure is due to events beyond its reasonable control, including but not limited to natural disasters, pandemics, acts of government, cyber incidents, or industrial action.
12. TERMINATION
12.1 Either party may terminate this Agreement with 30 days’ written notice.
12.2 The Company may terminate immediately upon breach, insolvency, or unethical conduct by the Client.
12.3 Upon termination, all outstanding invoices become immediately payable.
13. GOVERNING LAW AND JURISDICTION
This Agreement is governed by the laws of the Republic of South Africa, and any dispute shall fall under the exclusive jurisdiction of the High Court of South Africa, Gauteng Division (Pretoria).
14. ENTIRE AGREEMENT
This document, together with any quotation, proposal, or engagement letter, constitutes the full understanding between the parties and supersedes all prior discussions, agreements, or representations.
15. CONTACT DETAILS
Tenax Enterprises (Pty) Ltd
70 Vergelegen, Road, Equestria 0184
Email: info@tenaxenterprises.com | Website: www.tenaxenterprises.com