Brightwake Ltd - Terms and Conditions of Purchase - 2024

1. Interpretation

In these conditions:

‘Company’ means Brightwake Ltd of Lowmoor Business Park, Kirkby-in-Ashfield, Nottinghamshire, England 

‘Conditions’  means the standard terms and conditions of purchase set out in this document together with any special terms, conditions or amendments to those standard terms and conditions specified on the Order or which, prior to the date of the Order, the Supplier and the Company specifically agreed in Writing would apply to that Order;

‘Confidential Information’ means all information which would be regarded as confidential by a reasonable business person (however recorded or preserved) concerning the Company’s business, customers, suppliers, market opportunities, operations, processes, product information, or know-how - including, but not limited to, the Supplied Information.

‘Contract’ means the contract for the purchase and sale of the Products and/or the Services by the Company from the Supplier, which is comprised solely of the Order, the Conditions, and any other documents (or parts thereof) specified in the Conditions. Should there be any inconsistency between the documents comprising the Contract, then the Order shall have precedence.

‘Delivery’ means delivery of the Products or provision of the Services to or at the Delivery Address; and ‘Deliver’, and ‘Delivered’ shall be construed accordingly;

‘Delivery Address’ means the Company’s warehouse at Prospect Close, Kirkby-in-Ashfield Nottinghamshire, England, or such other address or addresses for delivery of the Products and/or provision of the Services (as appropriate) specified on the Order or subsequently agreed in Writing by the parties.

‘Delivery Date’ means the time of actual Delivery of the Products or completion of provision of the Services;

‘IP Rights’ means know-how, patents, design rights, copyright and all other intellectual property rights which may exist or be applied for anywhere in the world.

‘Order’ means an acceptance by the Company, in the form of a Purchase Order, of an offer or quotation of the Supplier.

‘Products’ means the products (if any) referred to in the Order as being required to be supplied to the Company by the Supplier;

‘Purchase Order’ means either (i) an official order form or (ii) another Written document signed or sent by an authorised signatory of the Company.

‘Raw Material Specification’ means the specifications for the composition, product safety assurance, manufacture, packaging, and/or quality control of the Raw Materials. Component means any raw material, substance, piece, part, software, firmware, labelling, or assembly which is intended to be included as part of the finished, packaged, and labelled device.

‘Services’ means any services (if any) referred to in the Order as being required to be supplied to the Company by the Supplier;

‘Specification’ means (i) all manufacturing, testing and packing specifications specified in the Conditions (or, if no specifications are expressly specified, the Supplier’s published specifications) for the Products and Services concerned; and (ii) all relevant laws and regulations); 

‘Supplied Information’ means any and all specifications, plans, drawings, process information, documents or designs supplied by the Company to the Supplier, or drawn up by the Supplier at the request of, or using information supplied by, the Company;

‘Supplier’ means any person, partnership, unincorporated business or incorporated company to whom the Order is addressed;

‘Writing’ includes facsimile transmission, electronic mail and comparable means of communication, and the term ‘Written’ shall be interpreted accordingly.

2.  Supply of Products and Services

2.1 The Supplier shall deliver all Products together with such documents relating to their manufacture as the Company may reasonably require. 

2.2 The supply of all Products and Services shall be exclusively in accordance with the Contract, and commencement of Delivery shall be deemed conclusive evidence of the Supplier’s acceptance of the Conditions.

3. Cancellation

No Order may be cancelled by the Supplier except with the agreement in Writing of the Company and on terms that the Supplier shall indemnify the Company in full against all loss (including loss of profit), costs (including the cost of all labour, materials and subcontractors), damages, charges and expenses incurred by the Company as a result of such cancellation. 

4. Intellectual Property and Confidentiality

4.1 All IP Rights arising from any work undertaken by the Supplier in performance of its obligations under the Contract shall automatically vest in the Company and the Supplier agrees to communicate promptly to the Company full details of them and to do everything necessary to enable the Company to obtain the maximum benefit of this Clause.  The Supplier waives all moral rights in respect of any goods or material generated as a result of the provision of the Services.

4.2 The Supplied Information shall remain the property of the Company and the Supplier shall return it to the Company immediately upon the earlier of the fulfilment or termination of the Contract, completion of the relevant Service, or the Company’s request. 

4.3 The Supplier shall not, without the Company’s prior Written consent, use all or any of the Confidential Information for any purpose (except as is strictly necessary to perform its obligations under the Contract); or divulge all or any of it to any third party, other than on a need-to-know basis to those employees or agents of the Supplier who, at the time of disclosure, are bound by obligations of confidentiality no less onerous than those contained within the Conditions. 

4.4 The Supplier shall use all reasonably commercial endeavours to protect the Confidential Information from loss, damage or inappropriate disclosure, providing at least the same degree of protection it affords its own commercially sensitive data and materials

4.5 The Supplier shall not, without the Company’s prior Written consent, mention the Company’s name in connection with the Contract, or disclose the existence of the Contract in any publicity material or other communication to third parties.

5. Delivery

5.1 Unless otherwise specified in the Order, the quoted price of any Products is Delivered, Duty Paid (DDP) to the Delivery Address. 

5.2 Delivery of the Products and Services shall take place at the time stated on the Order or as otherwise agreed between the parties.  In the event that the Contract does not specify a required date for Delivery, the Supplier shall ensure that Delivery is effected within a reasonable time after the date of the Order.

5.3  The Supplier shall ensure that:

                (a)  The products supplied are appropriately packed to ensure that the quality and integrity is retained during transportation and handling. Where relevant, special packaging requirement may be specified in the Raw Material Specification

                (b)  each delivery of the Products is accompanied by a delivery note which shows the date of the Order, the Order number (if any), the type and quantity of the Products (including the code number of the Products, where applicable), special storage instructions (if any) and, if the Products are being delivered by instalments, the outstanding balance of Products remaining to be delivered; 

(c) Labelling

Each primary package shall be clearly labelled, where applicable, showing the following information: 

1. Name and address of Supplier
2. Name and address of the Company (Brightwake Ltd)
3. Description and item number
4. Batch number (if any)
5. Quantity
6. Carton number and total number of cartons
7. Expiry dates if applicable.
8. Other relevant information

                (d)  if the Supplier requires the Company to return any packaging material to the Supplier, that fact is clearly stated on the delivery note.  Any such packaging material shall be returned to the Supplier at the cost of the Supplier.

5.4  If the Supplier:

                (a)  delivers less than 90% of the quantity of Products ordered, the Company may reject the Products; or

                (b)  delivers more than 110% of the quantity of Products ordered, the Company may at its discretion reject the Products or the excess Products and any rejected Products shall be returnable at the Supplier’s risk and expense.  If the Supplier delivers more or less than the quantity of Products ordered, and the Company accepts the delivery, a pro rate adjustment shall be made to the invoice for the Products.

5.5  The Supplier shall not deliver the Products in instalments without the Company’s prior written consent.  

5.6 Goods Inwards Inspection

Acceptance Requirement

All materials for manufacturing will be subjected to Brightwake Ltd Quality Assurance Incoming Inspection for conformance with the requirements of the respective Raw Material Specification prior to disposition.

Material accepted by QA Incoming Inspection may subsequently be rejected if found to be defective during processing or in manufactured products due to faulty material and/or poor workmanship traceable to the supplier.

6. Risk and Property

Title and risk in the Products shall pass to the Company upon the Delivery Date. 

7. Prices and Payment

7.1  Unless otherwise agreed in Writing by the Company, all prices quoted in the Order are fixed and are fully inclusive of all charges, taxes, levies and other sums due to the Supplier with the exception of Value Added Tax at the current rate, which (where applicable) shall be shown on the relevant invoice as a net extra charge.

7.2  The Supplier shall be entitled to invoice the Company for Products and Services which it supplies to the Company in accordance with the Order, and payment shall be due within 60 days of the Delivery Date, or as otherwise stated on the Order. 

7.3  Any invoice issued pursuant to Condition 7.2 shall clearly state the Company PO number. The Company will be under no obligation to pay any invoices that do not include this information. 

7.4   To ensure prompt payment in accordance with Condition 7.2, where the Company has outstanding or recently paid invoices from the Supplier in relation to other transactions, the Supplier will provide a statement of account to the Company on a monthly basis.

8. Warranties

8.1 All Products (including any packaging) supplied, and all Services performed, shall be of good and satisfactory quality, fit for their purpose, and (in the case of Products, for whichever is the longer of their shelf life and 12 months from the Delivery Date,) comply in all respects with the Specification.

8.2 The Supplier shall supply the Products and carry out the Services applying due care, skill and diligence in accordance with best practices in the Supplier’s industry including (where applicable) cGMP and cGLP.  

8.3  The Supplier warrants that neither the Company’s use or sale of all or any of the Products, nor its use or sale of any information, design, object or other deliverable arising from the delivery of the Services (in either case, in accordance with the Contract,) will infringe the IP Rights of either the Supplier or any third party.

8.4 The Company shall not be deemed to have accepted any Products or Services as complying with the Specification if it notifies the Supplier of any perceived failure of the Products or Services to conform with the Specification within 30 days of the later of (a) the Delivery Date and (b) the earliest reasonable date upon which any non-conformance with the Specification could have been determined.   

8.5 The Supplier represents and warrants that: (i) any minerals that it supplies to the Company are from socially and environmentally responsible sources that do not directly or indirectly contribute to conflict and that do not benefit or finance armed groups in the Democratic Republic of Congo or any adjoining country; (ii) it has adopted conflict mineral policies and management systems; and (iii) it requires its own suppliers to adopt similar policies and systems.

9. Indemnity and Insurance

9.1 The Supplier shall indemnify the Company and hold it harmless from and against any and all expenses (including reasonable attorneys' fees), costs, claims, losses and damages incurred by the Company which, in whole or in part and whether directly or indirectly, are based upon or arise out of any breach by the Supplier of the Conditions, or any negligent act or omission or wilful misconduct of the Supplier, or its employees, agents or sub-contractors.

9.2 The Supplier shall maintain Product Liability Insurance covering its liabilities set out above, with a reputable insurance carrier, and with minimum limits of five million pounds sterling.  Upon demand, the Supplier shall provide the Company with a certificate of insurance evidencing the coverage, endorsements and limits of such insurance. 

10. Termination by the Company

The Company may, without prejudice to any of its other rights, terminate the Contract immediately by notice if:

10.1 the Supplier commits a material breach or persistently breaches the Contract and fails to remedy any such breach within 14 days of the Company’s Written request to do so, or

10.2 any change occurs in the ownership, control or financial status of the Supplier which the Company reasonably believes will prejudice the Company’s interests. 

Where the Company terminates the Contract under the provisions of Condition 10.1 above, then (again, without prejudice to any other rights which it may have,) it shall be entitled to a refund (which the Supplier shall promptly pay,) of any fees previously paid by the Company to the Supplier in respect of the relevant Services and/or Products. 

11. Labour Standards Compliance. 

11.1 The Company is committed to ensuring that its operations (including its supply chains) are free from any practices associated with modern slavery and human trafficking. The Company also expects its suppliers to take all necessary steps to “know and show” that their own operations and supply chains are free of human trafficking and modern slavery.

The Supplier represents and warrants that the Supplier, and its subcontractors and suppliers involved in the provision of Goods and Services, comply with all applicable labour and employment laws, regulations, standards and conventions from time to time in force, including, but not limited to those:

•  prohibiting any form of slavery or human trafficking, child labour or other exploitation of children and discrimination on the basis of race, religion, ethnicity, gender and other similar characteristics,
•  mandating safe and sanitary workplaces, equal remuneration or compensation for equal work, and equal employment opportunities, and
•  prohibiting interference with or discrimination against workers engaged in union or other organizing activities and requiring collective bargaining with labor organizations if applicable. 

        11.2 Without limiting the generality of the foregoing, the Supplier represents and warrants that: 

• it knows, understands and abides by the provisions of the Modern Slavery Act (2015) (the “Act”) and the United Nations Guiding Principles on Business and Human Rights (“UN Principles”); and 
• to the extent applicable,  the Supplier, and its subcontractors and suppliers, involved in the provision of Products hereunder, comply with International Labor Organization’s Conventions (the “ILOC’s), available at http://www.ilo.org/dyn/normlex/en/f?p=NORMLEXPUB:12000:0::NO.
• neither the Supplier nor any of its officers, employees or other persons associated with the supply of the Goods and/or Services has been convicted of any offence involving slavery and human trafficking nor has been or is the subject of any investigation, inquiry or enforcement proceedings by any governmental, administrative or regulatory body regarding any offence or alleged offence of or in connection with slavery and human trafficking
  
  11.3 The Supplier shall notify the Company immediately should it become aware of: (i) any breach, or potential breach, of the labour standards provisions set forth in this Agreement; or (ii) any actual or suspected slavery or human trafficking in a supply chain which has a connection with this Agreement.

         11.4 The Supplier hereby certifies, and shall further certify from time to time upon request that: 

• it has not used forced or indentured labour or child labour (as defined by local law, or if not defined by local law anyone under the age of 16) in the manufacture or production of Goods or Services furnished to the Company hereunder;
•  
• it does not know or have reasonable basis to believe that any of the Supplier’s subcontractors, suppliers or sub-suppliers have used forced or indentured labour or child labour (as defined by local law, or if not defined by local law anyone under the age of 16) in the manufacture or production of Products and Services furnished to the Company; and
• all materials incorporated into Products were sourced, processed and manufactured in compliance with the human trafficking and slavery laws of the country or countries in which it operates.

11.5  The Supplier represents and warrants that it complies with a social accountability guideline pursuant to which it disqualifies any supplier or subcontractor that uses or permits unacceptable labour practices, such as child labour, forced labour or trafficking in persons, or unsafe or unsanitary working conditions. the Supplier further represents and warrants that:

• it includes in its contracts with its subcontractors and anti-slavery and human trafficking provisions; and
• undertakes or arranges for periodic inspections of any subcontractor and supplier involved in the provision of Products and Services to ensure compliance with the foregoing.

11.6 To the extent necessary to enable the Customer to satisfy its obligations to customers, and as otherwise required by law, the Supplier agrees that upon reasonable advance notice from the Company, the Company has the right to undertake or arrange for the inspections of the Supplier’s facilities and an examination of such of the Supplier’s records (including any audit records related to the Supplier’s subcontractors' and suppliers') as are required to verify compliance with the Supplier’s representations and warranties set forth above. 

11.7 The Company may terminate any Contract with immediate effect by giving written notice to the Supplier if the Supplier is found to have violated any of the labour standards provisions referred to above or any of the labour and employment laws, regulations, standards or conventions then in effect (including, but not limited to the Act, the UN Principals and the ILOC’s).

12. Quality System Compliance . 

12.1 Complaint Handling

When nonconformity is identified by Brightwake Ltd after the receipt of the Supplier product or service, due to customer complaints, or other relevant sources Brightwake Ltd may initiate a Supplier Corrective Action Request (SCAR). This section:

1. Requires Brightwake Ltd to notify the Supplier using an official SCAR form
2. Requires the Supplier to respond in a timely manner with a corrective action plan 
3. Requires the Supplier:
4. To complete the SCAR form with the corrective action plan
5. Sign, date, and return the SCAR form to Brightwake Ltd
6. Requires the Supplier to provide a project timeline schedule if the corrective action plan cannot be implemented or completed in a timely manner
7. Requires the Supplier to provide an updated status report on the corrective action plan
8. Requires the Supplier’s corrective action plan:

1. To determine the causes of the nonconformity
2. To evaluate the need for action to ensure the nonconformity does not   
3. recurrence
4. To determine the action needed to prevent recurrence
5. To implement the action needed to prevent recurrence
6. To review the effectiveness of the corrective action
7. Requires that records or reports for these types of activities are defined, maintained, and made available upon request
8. Requires supplier to replace in parts that has been rejected or issue a credit to Brightwake Ltd      for the non-conformity, not limited to part price only

12.2 Audit

Suppliers shall agree to allow Brightwake Notified Bodies to perform unannounced audits or inspections of the Supplier’s facilities, systems, documentation and other requirements. 

This requirement applies to critical suppliers whose goods or services are integrated into Brightwake devices that are CE marked.

Suppliers agree to allow Brightwake Regulatory bodies to perform planned audits or inspections of the Supplier’s facilities, systems, documentation, and other requirements.

Supplier agrees to share audit results with Brightwake when the findings relate to products/ processes/services provided to Brightwake.

The supplier shall provide to Brightwake its operating hours to facilitate the Notified Body in planning for unannounced audits.

12.3 Changes

The Supplier must notify Brightwake Ltd at a minimum 90 days (depending on the impact of the change) prior to change implementation for the following: 

Type of Change

Change in FDA registration status  -If applicable 

Change in ISO certification status

Third party supplier changes

Material/product design and drawing changes

Production processes

Raw materials used

Vendor part changes

Production facility changes

Test or manufacturing equipment

The Supplier agrees to only use approved materials and/or specifications without alteration or substitution and that they will not introduce any changes requiring approval without having first obtained the written approval of Brightwake. If Brightwake discovers changes made by the Supplier without the written agreement of Brightwake, the Supplier will be held liable for damages incurred by Brightwake as a result of the changes.

13. Miscellaneous

13.1 Any notice required to be given under these Conditions shall be in Writing and sent to the other party at its registered office or principle place of business.  Notices are deemed to have been received on the first working day after the date of posting or, where delivery is by hand or via email, upon delivery.

13.2 The Supplier shall not be entitled to assign or sub-contract the whole or any part of the Contract without the prior Written consent of the Company. 

13.3 No waiver by the Company of any breach of the Contract by the Supplier shall be considered as a waiver of any subsequent breach of the same or any other provision.

13.4 If any provision of these Conditions is held by any competent authority to be invalid or unenforceable in whole or in part then it will be automatically replaced by a valid and enforceable provision which achieves, so far as is legally permissible, the commercial effect of the original provision.

13.5 The Contract shall constitute the entire agreement between the Supplier and the Company in relation to the supply of the Products and Services provided that nothing in this Condition will prejudice