DB ORTHODONTICS LIMITED
STANDARD TERMS AND CONDITIONS OF PURCHASE
THIS AGREEMENT is made on receipt of the purchase request.
(1) DB ORTHODONTICS LIMITED whose registered office is at Ryefield Way, Silsden, Keighley, BD20 0EF (the “Legal Manufacturer”); and,
(2) The “Supplier” often referred as the Original Equipment Manufacturer (OEM)).
BACKGROUND TO THIS AGREEMENT (and where applicable)
(A) DB Orthodontics is in the business of the design, development, manufacture and supply of orthodontic medical devices and wishes to secure from the supply the supply of certain products to meet its business requirements, to be placed on the market under the responsibility of DB Orthodontics.
(B) The supplier will manufacture and supply DB Orthodontics, as per the agreed product specification. The supplier has CE Marked the devices in accordance with the Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC.
(C) DB Orthodontics will pack and label these devices, and place them on the market under DB Orthodontics brand and CE Mark. DB Orthodontics does not carry out any further processing of the devices.
(D) The supplier has represented to DB Orthodontics that it has the capability to manufacture and supply high quality, CE Marked devices to meet DB Orthodontics requirements.
(E) DB Orthodontics and the supplier have agreed to enter into this Agreement to set out the basis of their working relationship and the terms and conditions upon which the supplier will manufacture and supply CE Marked devices to DB Orthodontics.
IT IS AGREED as follows: -
1.1 In this Agreement, the words and expressions set out below shall have the meanings set out opposite (unless the context otherwise requires):
“Change of Control” means this Agreement together with all Schedules to this agreement means if during the period of this Agreement either the suppliers or the business presently conducted by the supplier comes under the ownership or control different from the ownership or control in being at the date of this Agreement
“Confidential Information” means the Intellectual Property Rights, the new Intellectual Property Rights the terms of this Agreement and any secret or confidential commercial, financial, marketing, technical or other information that is of value to DB Orthodontics in any form or medium whether disclosed orally or in writing before or after the date of an Order, together with any reproductions of such information in any form or medium or any part of such information.
"Delivery Address" means such address as DB Orthodontics notifies in writing to the supplier from time to time.
"Effective Date" Purchase Order Date
"Medical Devices Directive" means Directive 93/42/EEC.
"Products" means the products provided to DB Orthodontics by the supplier, detailed in Schedule 1; together with all modified versions thereof or such other products as the parties may agree from time to time shall be covered by this Agreement.
“Intellectual Property Rights”
“New Intellectual Property Rights” means any patents, registered designs, trade-marks and service marks (whether registered or not), domain names, and any applications for any of the foregoing and the right to apply therefore in any part of the world, copyright, design rights, know-how and all other intellectual or industrial property rights subsisting in any part of the world, means all rights in relation to any Intellectual Property Rights of whatsoever nature generated or created by, or arising in the course of this Agreement including without limitation any improvements.
"Price" means the price payable by DB Orthodontics for the Products determined in accordance with Clause 8 and Schedule 1 (if applicable).
"Field Safety Corrective Action" as defined in Clause 11.1.
Order Form” means DB Orthodontics’ standard Template Order Form.
"Order" means a Purchase Order made by DB Orthodontics to the supplier for the supply of Products.
"Specification(s)" means the detailed description including technical specification of the Products as detailed in Schedules 1 & 2.
1.2 All references to any statute or statutory provision shall be deemed to include references to any statute or statutory provision which amends, extends consolidates or replaces the same and shall include any orders, regulations, codes of practice, instruments or other subordinate legislation made thereunder and any conditions attaching thereto.
1.3 Any headings to Clauses, Paragraphs and/ or Schedules are for convenience only and shall not affect the meaning of this Agreement.
1.4 In this Agreement, general words are not to be given a restrictive meaning where they are followed by examples intended to be included within the general words.
1.5 In this Agreement, words importing any particular gender include all other genders and words importing the singular shall include the plural and vice versa.
2. REGULATORY RESPONSIBILITIES
2.1 DB Orthodontics shall be responsible for the regulatory compliance of the products described in Schedule 1, in respect of the placing of these Products on the market, under the DB Orthodontics brand. DB Orthodontics are responsible for ensuring that the finished Products comply with the relevant requirements of the Medical Devices Directive and DB Orthodontics shall affix the CE Mark to the labelling of the products to indicate this compliance.
2.2 The supplier shall be considered a sub-contract manufacturer to DB Orthodontics, in respect of the products described in Schedule 1, when these Products are placed on the market under the DB Orthodontics brand.
2.3 The supplier shall be responsible for the regulatory compliance of the products described in Schedule 1, in respect of their supply in a non-sterile condition to DB Orthodontics.
2.4 The supplier (who holds the rights to the design) will provide fully un-redacted technical documentation upon request to DB Orthodontics or its Notified Body, without the requirement for further contractual actions between the Notified Body and supplier such as non-disclosure agreements.
2.5 Full details of the regulatory responsibilities of each party under this Agreement are defined in Schedule 3 to this Agreement.
3. SUPPLY OF PRODUCTS & SERVICES
3.1 The supplier shall supply Products to DB Orthodontics on the terms and conditions set out in this Agreement.
3.2 The terms and conditions contained in this Agreement shall apply to all supplies of the Products or Services between the supplier and DB Orthodontics and no Order shall be capable of acceptance by the supplier unless it is on an Order form. For the avoidance of doubt, each Order for supply of Products shall incorporate the terms and conditions of this Agreement and no other terms and conditions whosoever shall apply to supply of Products or Services by the supplier to DB Orthodontics unless such terms and conditions are agreed in writing by an authorised representative of DB Orthodontics.
3.3 The supplier shall notify DB Orthodontics in writing within seven (7) business days of receipt of an Order if it is unable to meet the Order.
3.4 When requested by DB Orthodontics, a valid Certificate of Conformity will be supplied to DB Orthodontics with each batch of Product, stating that the Product complies with the Medical Devices Directive, EN ISO 13485 and any additional requirements stated in the DB Orthodontics Specification.
3.5 The supplier shall always act
3.5.1 In accordance with all relevant laws, regulations and good industry practice;
3.5.2 in good faith;
3.5.3 In accordance with all the terms of this Agreement; and
3.5.4 in an effective, timely and efficient manner.
4. ORDERING AND DELIVERY
4.1 The supplier shall deliver the Products to the Delivery Address unless otherwise directed by DB Orthodontics.
4.2 Unless otherwise agreed in writing, time for delivery by the supplier shall be of the essence and shall be in accordance with the agreed lead times stated on the Order.
4.3 The Supplier agrees to comply with any terms and conditions relating to delivery which are contained in the confirmation of an Order, including:
4.3.1 A packing/delivery note quoting DB Orthodontics order number, part number and lot number to accompany each delivery or consignment of the Products; and
4.3.2 The Products to be properly packed and secured in such a manner as to reach their destination in an undamaged condition.
5 TITLE AND RISK
5.1 Subject to Clause 5.2 the title, risk of loss, destruction and damage will be considered according to DAP (DB Orthodontics, Silsden, U.K.) Incoterms 2010.
5.2 If DB Orthodontics has paid for the Products to be supplied prior to delivery or a subsequent return for modification or repair:
5.2.1 Title in those Products shall pass to DB Orthodontics immediately; and
5.2.2 The Supplier shall keep those Products separate from the goods owned by the Supplier or belonging to third parties and shall mark those Products as the property of DB Orthodontics.
5.2.3 The Supplier becomes the owner of property in Products if DB Orthodontics is not paying for the goods in the period of time specified in the paragraph 8.2
6.1 The supplier warrants that:
6.1.1 The Products will comply in every way with the terms and conditions hereof and the Specification and any other requirements communicated in writing to the supplier at the time of Order;
6.1.2 The Products will be free from defects in materials or workmanship and shall be fit for purpose and of satisfactory quality and shall conform to samples supplied to DB Orthodontics;
6.1.3 The Products will not infringe any Intellectual Property Rights of any third party;
6.1.4 The Products and their labelling and packaging shall comply with all applicable legislation and regulations applicable at the time of delivery and as set out in this Agreement; and
6.1.5 It is under no obligation to any third party that would interfere with its obligations under this Agreement.
7. REJECTION OF PRODUCTS
7.1 DB Orthodontics may upon delivery or at any time after delivery reject the Products or any part thereof if, in the opinion of DB Orthodontics, acting reasonably, the Products are not supplied in accordance with the provisions of this Agreement.
7.2 If DB Orthodontics rejects a delivery of Products and DB Orthodontics has not already paid the supplier for those Products, the supplier shall not be entitled to claim payment for such Products. If DB Orthodontics rejects a delivery of Products and DB Orthodontics has already paid the supplier or those Products, Clause 7.5 below shall apply.
7.3 If DB Orthodontics selects not to reject the Products where it would otherwise have the right to reject, then it may (at its discretion), upon delivery or at any time after delivery, require the supplier at its sole cost to replace or repair the Products so that they conform to the Order and Specification within a reasonable time and may delay payment until the requirements of the Order and Specification have been entirely fulfilled.
7.4 If DB Orthodontics rejects a delivery (in accordance with Clause 7.1), it will notify the supplier of such rejection. The supplier shall collect the rejected delivery within fourteen (14) days of such notice or such other period as the parties may agree. If the supplier fails to collect the rejected Products within this time period, DB Orthodontics will be entitled to store or destroy the Products and the supplier shall reimburse DB Orthodontics the reasonable costs incurred by DB Orthodontics in relation to the storage or destruction of the Products.
7.5 The supplier shall pay DB Orthodontics within thirty (30) days of DB Orthodontics demand:
7.5.1 Any money paid by DB Orthodontics to the supplier in respect of any rejected Products which the supplier does not replace or re-work; and
7.5.2 Any additional expenditure over and above the price specified in the Order reasonably incurred by DB Orthodontics in obtaining other Products in replacement of any rejected Products or at DB Orthodontics sole option such amount shall be deducted from any amounts owing by DB Orthodontics to the supplier or any amounts payable by DB Orthodontics in respect of any future Orders.
7.6 DB Orthodontics shall notify the supplier within thirty (30) days of the date of delivery of any shortfall in the quantities of Products delivered and supplier shall, at DB Orthodontics option, either make good the shortfall or, if an invoice has been delivered to DB Orthodontics in respect of those Products issued to DB Orthodontics a credit note in respect of the Price of the shortfall of the Products.
8. PRICE AND PAYMENT
8.1 The Price for the Products, which are to be supplied, may not be changed except upon the written agreement of both parties and with a minimum of three months advance notice. In no event shall any price change be applicable to the products covered by a [firm purchase] Order delivered to DB Orthodontics by the Supplier prior to the effective date of the agreed price change.
8.2 Unless otherwise specified in the Order, DB Orthodontics shall pay each invoice within sixty (60) days of the end of the month in which DB Orthodontics receives a valid and correct invoice.
8.3 The parties may, acting in good faith, re-negotiate a decrease in the price of Products from time to time to reflect a volume discount dependent on the volume of Products ordered by DB Orthodontics.
8.4 If the products are not delivered by the agreed delivery date then DB Orthodontics shall without prejudice to any other rights and remedies it may have be entitled to delay delivery until required.
9.1 The supplier shall maintain in force with a legitimate insurer such insurance policies with such levels of cover and against such risks as are appropriate and adequate having regard to its obligations under this Agreement and the supplier shall (at DB Orthodontics request) provide such evidence of such insurance policies as DB Orthodontics shall require from time to time.
10.1 The supplier accepts unlimited liability for:
10.1.1 Any indemnity given by the supplier under this Agreement;
10.1.2 Death or personal injury caused by the negligence of the supplier;
10.1.3 Fraud or fraudulent misrepresentation committed by or on behalf of the supplier; and
10.1.4 Any other matter for which it would be unlawful for the supplier to exclude liability or purport to exclude liability by operation of law.
10.2 The supplier acknowledges that DB Orthodontics places particular reliance upon the provisions of this Agreement and, in addition to any other remedy available DB Orthodontics, the supplier agrees to indemnify DB Orthodontics and keep DB Orthodontics fully and effectively indemnified in full and on demand from and against all claims, demands, actions, proceedings and all damages, liabilities, losses, costs and expenses (including legal and other professional advisers’ fees) which are suffered or incurred by DB Orthodontics directly and indirectly as a result of:
10.2.1 The supplier’s breach or failure to comply with any of the terms of this Agreement;
10.2.2 As a result of any act or omission of the supplier which is committed in bad faith including a breach of confidentiality;
10.2.3 Any infringement of DB Orthodontics Intellectual Property Rights or the New Intellectual Property Rights; and
10.2.4 Any liability DB Orthodontics incurs to a third party to the extent contributed or caused to by the OEM.
11 PRODUCT DEFECTS
11.1 If either party becomes aware of any defect in the Products previously delivered to DB Orthodontics at any time or any error or omission in the instructions for the use and/or care of the Products (whether or not any such defect, error or omission represents a breach of any provision of this Agreement) which exposes or may reasonably be expected to expose customers or consumers to any risk of death, injury or damage to property it shall immediately notify the other party of such defect (with all relevant information relating to the defect) (a "Field Safety Corrective Action" or “FSCA”).
11.2 Following the issue of a FSCA, DB Orthodontics may at its discretion and at the supplier’s cost if the defect is due to the OEM:
11.2.1 Recall any Products already sold by DB Orthodontics to its customers or require the supplier to arrange for the recall of any Products already sold by DB Orthodontics to its customers (whether for repair, refund, credit or replacement which shall in each case be undertaken by the supplier at DB Orthodontics option); and/or
11.2.2 Issue any notification whether in writing or otherwise to its customers about the manner of use or operation of any Products.
11.3 The supplier shall indemnify DB Orthodontics in full and keep DB Orthodontics fully and effectively indemnified on demand from and against all claims, demands, actions, proceedings and all damages, liabilities, losses, costs and expenses suffered or incurred arising in relation to from any recall of the Products by DB Orthodontics where such recall is attributable to the fault of the supplier.
11.4 The provisions of clauses 11.2 and 11.3 shall not apply in respect of any defects that arise solely from the repackaging operations performed by DB Orthodontics on Products supplied by the supplier, or from the failure of DB Orthodontics to comply with the requirements of the Medical Devices Directive in respect of Products placed on the market; under DB Orthodontics brand and CE Mark.
12 DURATION AND TERMINATION
12.1 This Agreement shall come into force immediately and, subject to the following provisions of this clause 12 shall continue in force for an initial period of 5 years and thereafter unless or until terminated by either party giving to the other party not less than 12 months written notice to expire at any time on or after the end of that initial period.
12.2 Notwithstanding Clause 12.1 above, DB Orthodontics reserves the right to terminate the Agreement immediately where the ownership of the majority of the voting rights in supplier is transferred with the effect that the supplier comes under the control of a party who is, in the reasonable opinion of DB Orthodontics, a competitor of DB Orthodontics or where the supplier is otherwise subject to a Change of Control.
12.3 Either party shall be entitled forthwith to terminate this Agreement by giving written notice to the other if:
12.3.1 The other party commits any continuing or material breach of any of the provisions of this Agreement and, in the case of such a breach which is capable of remedy, fails to remedy the breach within 30 days after receipt of a written notice giving full particulars of the breach and requiring it to be remedied;
12.3.2 An encumbrancer takes possession or a receiver is appointed over any of the property or assets of the other party;
12.3.3 The other party makes any composition or voluntary arrangement with its creditors or enters into administration, or a moratorium comes into force in respect of the other party (within the meaning of the Insolvency Act 1986);
12.3.4 The other party goes into liquidation (except for the purposes of an amalgamation, reconstruction or other reorganisation and in such manner, that the company resulting from the reorganisation effectively agrees to be bound by or to assume the obligations imposed on that other party under this Agreement); or
12.3.5 The other party goes into liquidation (except for the purposes of an amalgamation, reconstruction or other reorganisation and in such a manner that the company resulting from the re organisation effectively agrees to be bound by or to assume the obligations imposed on the other party under this Agreement); or
12.3.6 The other party ceases, or threatens to cease, to carry on business.
12.4 For the purpose of clause 12.3.1, a breach shall be considered capable of remedy if the party in breach can comply with the provision in question in all respects other than as to the time of performance (provided that time of performance is not of the essence).
12.5 Any waiver by either party of a breach of any provision of this Agreement shall not be considered as a waiver of any subsequent breach of the same or any other provision.
12.6 The rights to terminate this Agreement given by this clause shall not prejudice any other right or remedy of either party in respect of the breach concerned (if any) or any other breach.
12.7 On the termination of this Agreement for any reason, the supplier shall offer to sell to DB Orthodontics all Products which have been manufactured by the supplier but not delivered to DB Orthodontics at the date of termination, and all usable but unused stocks of labelling and packaging for the Products bearing any of DB Orthodontics trademarks, at a price equal to their cost to the supplier.
12.8 Subject to clause 12.7, on the termination of this Agreement for any reason the supplier shall:
12.8.1 Subject to clause 14.2, cease to manufacture and sell the Products or to use, either directly or indirectly, any of the Intellectual Property Rights or New Intellectual Property Rights and forthwith return to DB Orthodontics any documents in its possession or control which contain or record any part of any of that Intellectual Property Rights or New Intellectual Property Rights; and
12.8.2 Cease to use any of the Intellectual Property Rights or New Intellectual Property Rights and, subject as provided in this clause and except in respect of any accrued rights, neither party shall have any further obligation to the other.
12.9 The provisions of clause 12 shall continue in force in accordance with its terms, notwithstanding termination of this Agreement for any reason.
12.10 For the avoidance of doubt the supplier hall is required to continue its obligations to supply Products subject to Orders under this Agreement from the period of receipt of notice to terminate until the effective date of such termination.
13 ASSIGNMENT AND SUB-CONTRACTING
13.1 This Agreement is personal to the supplier and the supplier shall not assign transfer or sub-contract any of its rights arising under this Agreement without the prior written consent of DB Orthodontics.
14.1 Both parties shall keep and procure to be kept secret and confidential all Confidential Information and shall not use nor disclose the Confidential Information save as permitted by this Agreement. Where disclosure is made to any employee, director, consultant, agent or contractor whose duties cannot be fulfilled without such disclosure, it shall be done subject to obligations equivalent to those set out in this Clause 14 and both parties shall use its best efforts to procure that any such employee, consultant or agent complies with such obligations.
14.2 The obligations of confidentiality in this Clause 14 shall not extend to any matter which either party can show:
14.2.1 is in or becomes part of the public domain other than as a result of a breach of the obligations of confidentiality under this Agreement;
14.2.2 was in its written records prior to the date of disclosure of the same by either party under this Agreement;
14.2.3 Was independently disclosed to it by a third party entitled to disclose the same; and/or
14.2.4 Is required to be disclosed under any applicable law or by order of a court or governmental body or authority of competent jurisdiction.
14.3 The supplier shall immediately upon receipt of a request in writing from DB Orthodontics to do so, deliver up to DB Orthodontics to its order all written Confidential Information (including any copies, analyses, memoranda or other notes on or concerning the Confidential Information made by the supplier or in the supplier’s possession or under the supplier’s custody and control) and so far as is practicable to do so, remove any Confidential Information from any computer, word processor or other device in the supplier’s possession or under the supplier’s custody and control.
14.4 The supplier shall not publicise or otherwise make any commercial use of the connection established between the supplier and DB Orthodontics without the prior written consent of DB Orthodontics.
15. INTELLECTUAL PROPERTY
15.1 DB Orthodontics hereby grants to the supplier for the term of this Agreement a non-exclusive licence of DB Orthodontics Intellectual Property Rights for the sole purpose of enabling the supplier to perform its obligations under this Agreement.
15.2 DB Orthodontics shall retain ownership of (DB Orthodontics Intellectual Property Rights (which the supplier hereby acknowledges) and nothing in this Agreement shall be deemed to grant to the supplier any right, title or interest whatsoever in DB Orthodontics Intellectual Property Rights except such rights as are granted pursuant to Clause 15.1.
15.3 The supplier agrees not to make any financial claim associated with the Intellectual Property or the New Intellectual Property Rights and shall indemnify DB Orthodontics forthwith on demand from and against any costs, claims, demands, damages, losses, liabilities or expenses which DB Orthodontics may suffer or incur as a result of any financial claim made in relation to the Intellectual Property or the New Intellectual Property Rights by the supplier or any of its employees or sub-contractors.
15.4 For the avoidance of doubt, title to and all New Intellectual Property Rights shall belong to DB Orthodontics.
15.5 The supplier undertakes to do all such acts, deeds, documents and things as DB Orthodontics may reasonably require to assign or procure the assignment to DB Orthodontics of all such New Intellectual Property Rights which may vest in the supplier or any reason. The supplier shall procure that any persons who may have or acquire any moral rights in the New Intellectual Property Rights shall waive the same (if any) to the fullest extent permitted by law.
16.1 For quality control purposes, DB Orthodontics (or its authorised representatives) shall be entitled at any time to enter into any premises used for the manufacture of Products or the performance of any of the supplier's obligations under this Agreement in order to:
16.1.1 Check the compliance of the supplier with the terms of this Agreement; and/or
16.1.2 Inspect the records of the supplier insofar as such records relate to the supplier’s performance of its obligations under this Agreement and to take such copies of those records as it deems appropriate.
16.2 The supplier under the terms of the Agreement will allow DB Orthodontics Notified Body on-site to perform unannounced audits; these costs will be borne by DB Orthodontics.
16.2.1 In the event that the supplier (or a critical subcontractor to the supplier) refuses the unannounced audit; it must be assumed that the device may be noncompliant and suspension of DB Orthodontics certification for the concerned devices is a possible consequence. In this instance, DB Orthodontics will seek to recover; from the supplier, any costs incurred.
16.2.2 It is the responsibility of the supplier to inform DB Orthodontics of any shutdowns; (including shutdowns relating to the critical sub-contractors).
16.2.3 It is the responsibility of DB Orthodontics to inform their Notified Body of any shutdowns (including shutdowns related to the supplier and / or the supplier’s critical sub-contractors).
17.1 Any provision of this Agreement which is or may be void or unenforceable shall to the extent of its invalidity be deemed severable and shall not affect any other provision of this Agreement.
17.2 Any notices to be served on either of the parties by the other shall be in writing and sent by pre-paid or registered post to the address of the other party or such other address as is notified by that party or by facsimile transmission marked for the attention of a senior representative of that party. Such notice shall be deemed to have been received by the addressee within 72 (seventy-two) hours of posting or 24 (twenty-four) hours if sent by facsimile transmission where sent to the correct address or facsimile number of the addressee and where applicable evidence of posting and/or transmission is retained.
17.3 This Agreement (together with any documents referred to in it) supersedes all previous understandings and negotiations in respect of the parties' obligations as provided in this Agreement and each party acknowledges that this Agreement represents the entire agreement between the parties in relation to the supply of the Products by the supplier.
17.4 Any variation to this Agreement must be agreed in writing by both parties.
17.5 A person who is not a party to this Agreement shall have no rights pursuant to the Contracts (Rights of Third parties) Act 1999 to enforce any term of this Agreement.
17.6 The failure by any party to insist upon the strict performance of any provision, term or condition of this Agreement or to exercise any right or remedy consequent upon the breach thereof shall not constitute a waiver of any such breach of any subsequent breach of such provision, term or condition.
17.7 The supplier shall execute and deliver any other documents or deeds and take any other steps as shall be reasonably required by DB Orthodontics to give DB Orthodontics the full benefit of this Agreement. This clause shall survive termination of this Agreement.
17.8 Neither of the parties shall be liable for any failure or delay in performing obligations in this Agreement if such failure or delay is due to natural disasters or other causes reasonably beyond their control.
17.9 Nothing in this Agreement shall constitute or create or be deemed to constitute or create between the parties hereto, a partnership, joint venture, association, agency, employment or master and servant relationship.
17.10 The supplier warrants and represents to DB Orthodontics that it is an independent contractor and, as such, bears the sole responsibility for the payment of all tax or social security obligations which may be found due from it or any of its employees in relation to any payments or arrangements made under this Agreement and, further agrees to indemnify DB Orthodontics in respect of all tax or social security obligations which may be found due from DB Orthodontics in any payments or arrangements made under this Agreement together with any interest or penalties.
17.11 Each of the parties shall pay its own costs of and incidental to the negotiation preparation and completion of this Agreement and all other agreements referred to herein.
18 GOVERNING LAW AND JURISDICTION
18.1 All matters or disputes arising out of or in connection with this Agreement and which the parties are unable to settle amicably shall be subject to the non-exclusive jurisdiction of the courts of England or to the non-exclusive jurisdiction of the courts of the Country in which supplier is located, depending on which party is undertaking the action.