Execution Version
FRAME OWN BRANDING AGREEMENT
This Own Branding Agreement (this “Agreement”) is made as of this 1stday of April, 2014 (the “Effective Date”) by and between A company, a corporation organized under the laws of the district / country , with an address at A address (“OEM Manufacturer”) and B company, together with its affiliate[s], which is incorporated under the laws of district / country, having a place of business at B address (together, \Own Brander\
Recitals
A. OEM Manufacturer is engaged in and/or has rights related to the development, manufacture and/or sale of Active Implantable medical devices and related supplies and services, including with regard to the CE-marked Product Name , Model: ***.
B. Own Brander is experienced with the promotion, distribution and sale of medical devices and related supplies and services and desires to become an authorized Own Brander of OEM Manufacturer medical products.
C. OEM Manufacturer desires to appoint **** as its Own Brander for its Products, subject to the terms set forth below.
Agreement
In consideration of the matters stated in the Recitals hereto and the mutual covenants contained in this Agreement, the parties agree as follows:
1.0 DEFINITIONS
When used in this Agreement, each of the following terms shall have the definition set out below:
Agreement: “Agreement” means this agreement, together with Exhibits A, which are attached hereto and which are an integral part hereof.
Complaint: “Complaint” means any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a Device after it is released for distribution.
Term: the period of twelve (12) months following the Effective Date, and any renewal period mutually agreed between the parties hereto.
2.0 APPOINTMENT AS OWN BRANDER 1
2.1 The OEM Manufacturer appoints ** as authorized non-exclusive Own Brander to market and distribute the Device under the name of Own brander. From time to time, OEM Manufacturer and Own Brander may enter into a specific agreement, setting forth the terms and conditions upon which, Own Brander will market Devices into certain territories, to be mutually agreed. Such specific agreement will be subject to the terms herein.
2.2 The Device manufactured by the OEM Manufacturer (including material, packaging, instructions for use and labeling) will be distributed by the Own brander in his own responsibility under his own name. Therefore the Own brander is considered the manufacturer according to the directive AIMD 90/385/EEC.
2.3The OEM Manufacturer will provide to the Own brander copy of the valid CE certificate in place and ISO 13485 to allow applying the CE Mark on the Device and to distribute the Device in the European Union.
2.4 The OEM Manufacturer will provide to Own Brander a written declaration that the supplied Devices are exactly the same product as covered by the CE certificate and is produced on the same production location under identical conditions except for the OBL details on the product labeling. 2.5 This confirmation allows the Own brander to refer to the technical documentation, manufacturing and final inspection of the OEM Manufacturer, which are in the responsibility of the OEM Manufacturer. 2.6 The Notified Body of each party will have the right to perform audits at the other party or request information from him if needed.
2.7 The Own Brander will have the right to audit the OEM Manufacturer or any of its subcontractors at any time upon reasonable prior notice.
3 OWN BRANDER OBLIGATIONS
3.1 In addition and not by way of limitation of the other duties and obligations of Own Brander set forth in this Agreement, at all times during the Term the Own Brander shall: (a) Use its best efforts to promote and sell the Device and to represent the interests of OEM
Manufacturer at all times to end-user customers in the Own Brander Territory. Own Brander agrees to act in a sales capacity in accordance with the direction of OEM Manufacturer’s sales manager or other designated manager;
(b) Maintain a local sales force of adequate size, qualification,and attention to represent and
promote the sale of the Device. The sales force shall be employees or authorized agents of Own Brander. Sales force must complete requisite training to level of competency to be defined by OEM Manufacturerprior to representation, sales, service and maintenance of customer base where Device are sold;The expenses associated with hiring, employing and training the above mentioned sales force will be paid by the OEM Manufacturer.
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(c)
Promptly following receipt or becoming aware of a Complaint as defined in Section 1.0 concerning the Device,notify OEM Manufacturerof any information of which Own Brander becomes aware that suggests that any of the Devices may have been associated with a complaint, and refer to OEM Manufacturer any inquiry (other than a purchase order or potential purchase order) from the public, any governmental authority, any trade association or any news media, publication or reporter concerning the Products or OEM Manufacturer so that OEM Manufacturer may coordinate a response to such inquiry with Own Brander;
use its best efforts to promote and sell the Products within the Territory, including but not limited, to (i) presenting the Products at exhibitions and Own Brander’s website, (ii)
sending physicians of the hospitals and clinics with whom it works to courses run by Own Brander from time to time, (iii) including a link on the Own Brander’s website to OEM Manufacturer’s website, (iv) translating and printing OEM Manufacturer’s promotional and operational material related to the Products if required, provided that the text, format, content and circulation of such translations shall be subject to OEM Manufacturer’s prior written approval (for the avoidance of any doubt, the Own Brander acknowledges that all rights, title and interests in such translations shall remain vested in OEM Manufacturer);
(d)
(e)
Continuously provide OEM Manufacturer with timely feedback and updates on its actions and any other information which becomes available to Own Brander and is relevant to the marketing of the Product in the territory, as request; and
4 OEM MANUFACTURER OBLIGATIONS.
OEM Manufacturer agrees to:
(a) Provide sales training for new products, samples of marketing material and publications, and appropriate competitive information for use in the normal course of sales. Expenses for large quantities of this material for use in Own Brandermarketing programs will be charged to Own Brander. Expenses related to travel and accommodation of any person for the purpose of appropriate clinical, technical or sales training, in the Own Brander Territory or outside it, shall be the direct responsibility of the Own Branderbut will be reimbursed to Own Brander by OEM Manufacturer.
(b) ProvideOwn Brander reasonable advance notice, no more than 90 days, if OEM Manufacturer discontinues production of any of its Products.
(c) InformOwn Brander of material Product Complaints that are in OEM Manufacturer's reasonable judgment, of medical significance to all patients implanted with such Product.
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(d) maintain complete end user account information for each product sold or otherwise distributed, including name, address and phone number of such end-user, details about the product and all other protocols necessary to account for and trace all products implanted or sold, and make this information available to either an independent auditor in a case of audit, or to Own Brander if requested by Own Brander or instructed by regulatory body such as the FDA or court of law;
(e) To reimburse all expenses incurred by Own Brander in connection with this Agreement, as set forth in Exhibit A of this Agreement.
5 REGULATORY COMPLIANCE AND APPROVAL
5.1 Obligations of the Own Brander
5.1.1 Own Brander shall be responsible for complying with any laws, regulations or rules, which may
be applicable to the marketing, selling, technically supporting or servicing of the Product. Specifically, but without limitation, Own Brander shall be responsible for any applications, licenses, or other submittals or approvals required by laws, regulations or rules related to the marketing or use or selling of the Product and Own Brander shall comply with such laws,
regulations or rules, the cost of which will be covered and paid by the OEM Manufacturer. Own Brander shall retain a copy of any document and communicationrelated to any of the applications, licenses, or other submittals or approvals, and Own Brander shall provide any of these copies to OEM Manufacturer at the request of OEM Manufacturer. OEM Manufacturer shall provide Own Brander with all regulatory documentation requested by Own Brander and which are available to OEM Manufacturer, in order to assist Own Brander in the process of obtaining such approvals.
5.1.2 Registration of the Product in each relevant jurisdiction shall be completed by the Own Brander in
the name of OEM Manufacturer, where applicable. Similarly, Own Brander shall make efforts to obtain reimbursement coverage for the Product and for the related therapy and procedures. The cost of registration and any otherevaluation, applicationand documentation shall be paid for by the OEM Manufacturer.
5.1.3 The declaration of conformity prepared by the Own Brander will be based on the OEM
declaration of conformity and valid CE certificates issued by a recognized notified body.
5.1.4 The Own brander will inform the OEM Manufacturer in writing promptly of all safety-related
complaint, incident or potential incident.
5.1.5 The Own brander shall promptly forward to the OEM Manufacturer copies of any and all written
requests, notification and /or orders of competent authorities. The OEM Manufacturer will 4
prepare all answers and relevant records for the competent authorities for the devices with the OBL labeling.
5.1.6 The Own brander is obligated to maintain a traceability system for each lot / Serial number, which
will be maintained by the OEM manufacturer
5.2 Obligations of the OEM Manufacturer
5.2.1 OEM Manufacturer will ensure that the design and production of the Product conform to
the laws and regulations required for obtaining the CE mark, and that the Product will carry the CE mark.
5.2.2 The OEM Manufacturer will make available to the Own brander the Declaration of
Conformity of the OEM Manufacturer as the basis for the Own branders own Declaration of Conformity. The OEM Manufacturer declares that the product/material is of the same specifications as the product/material of the Own brander. 5.2.3 The OEM Manufacturer, will update the Own Brander of any relevant information
regarding the status of the CE and ISO 13485 certificates on a regular basis (at least once a year) and immediately in case of withdrawal / suspension of the certificates by the OEMs' notified body. 5.2.4 The OEM Manufacturer is obligated to maintain a full quality assurance system. The
OEM Manufacturer is obligated to maintain the certification of the system / products by a recognized Notified Body.
5.2.5 The OEM Manufacturer will perform validations of any processes as necessary, including
sterilization, and maintain controlled production conditions for manufacturing, testing, storage and delivery, as per the product specifications.
5.2.6 The OEM Manufacturer will keep available the technical documentation, which allows the
assessment of the conformity of the Device with the requirements of the Directive. The documentation will be kept for the contract supply period and at least 15 years thereafter. 5.2.7 The maintenance of the technical documentation will be performed by the OEM
Manufacturer. The OEM Manufacturer shall promptly inform the Own brander about significant changes to the technical document of the Device in order to inform the Own brander Notified Body about these changes. 5.2.8 The OEM Manufacturer will make available on request to the Own brander Competent
Authority/Notified Body and to the OBL in duly substantial cases the above mentioned technical documentation. 5.2.9 According to the Own brander’s directions, the OEM Manufacturer will apply the CE
Mark on the Own branders products. The CE Mark will be accompanied with the Notified Body number of the Own brander. 5