DRAFT Attachment 2 COOPERATION AGREEMENT Regarding Endoscopic Training Center (ETC) between and ________________________________________ (hereafter referred to as ”CENTER”) Preamble: WHEREAS, the named above wish to cooperate in the realization an maintenance of an ”ENDOSCOPIC TRAINING CENTER” (herinafter ”ETC”) in ____________ where research and practical training in the area of endoscopic surgery shall be provided to interested medical doctors, nurses and other medical personnel (hereinafter ”Users”). WHEREAS, XXX provides endoscopic instruments of its own manufacture to the ETC as well as basic instructions and in-training for ETC personnel and Users. WHEREAS, the CENTER provides the necessary infrastructure to the ETC such as premises and personnel as well as scientific research support. WHEREAS, the parties wish to define their mutual rights and obligations with regard to the functioning of the ETC by the terms of this Agreement. NOW, THEREFORE, the parties agree as follows: Page 1/9 DRAFT ARTICLE 1: SETTING UP OF AN ”ETC” 1.1 Both parties shall, to the best of their abilities, cooperate in developing minimal invasive surgery techniques by utilizing and promoting endoscopic treatment methods in the here above-mentioned ETC. 1.2 To this effect, they shall work closely together for making available to medical doctors, nurses and other medical persons, an ETC equipped with adequate schooling and training facilities for all endoscopic treatments mentioned in Attachment 1 (hereinafter ”Exclusive Treatments”). By mutual agreement, the list of Exclusive treatments covered by the ETC may be amended and/or changed at any time. If deemed useful, the parties shall execute a revised form of Attachment 1. 1.3 The ETC shall organize medical and endoscopic workshops. It shall assist Users and potential Users in the most general manner to become acquainted with and improve their knowledge on Exclusive Treatments with XXX endoscopes and other XXX instruments. 1.4 XXX and the CENTER shall each appoint one or more persons responsible for the work of the ETC (hereinafter ”ETC Supervising Body”). The ETC Supervising Body shall supervise the activities of the ETC and shall make all efforts to jointly optimize the goals of the parties involved. ARTICLE 2: CONTRIBUTIONS BY THE PARTIES Subject to the general terms and conditions of this Agreement, XXX’ contributions to the ETC shall consist of the following: 2.1 assisting the CENTER in procuring the instruments at subsidized prices. organizing with the assistance of its local representative(s) and employee(s) consultation service for correct selection of endoscopic instruments and equipment as well as for training medical personnel on how to properly store, use, sterilize and maintain endoscopic instruments and equipment. making available at the discretion of XXX any additional equipment required to conduct training programs/workshops. Subject to the general terms and conditions of this Agreement, the CENTER’s contributions shall be the following: o making available, free of charge, necessary infrastructure (personnel and premises) to the ETC for organizing and performing, on a continuous basis, all activities mentioned in Article 1.2 and 1.3 above. In particular, this includes the duty to make available to the ETC sufficient manpower, a permanent showroom, a training center, a liaison person for congresses, and, from time to time, operation facilities for conducting workshops, or a congress hall for making conferences and seminars; day to day supervision of the ETC staff according to directions received from the ETC Supervising Body; Page 2/9 DRAFT assisting the ETC staff scientifically by providing specialists of high qualifications to conduct courses, training, workshops, seminars, congresses and the like at the ETC; offering to XXX participation of specialists designated by XXX in all the activities organized by the CENTER; supervising the safe and proper storage and care by ETC personnel of XXX instruments and equipment provided to the ETC; safeguarding that operation and training methods at the ETC are performed in strict conformity with national legislation and safety regulations applicable to the existing law of India; to conduct training for times a year with max. 10 participants out of which 80 % should be undergoing training for the first time. ARTICLE 3: EXCLUSIVITY o During the lifetime of this Agreement, the CENTER and the ETC commit themselves not to use, in the field of Exclusive Treatments, endoscopes or medical instruments other than manufactured by XXX. o The CENTER and the ETC also commit themselves to solely demonstrate and recommend to Users equipment of XXX. ARTICLE 4: TERM o This Agreement comes into effect upon signing by both parties for an initial period of _____ years. o Upon the end of the initial period and thereafter, this Agreement shall renew automatically for an additional one (1) year period, unless it is terminated by either party by giving at least 6 months written advance notice to the other party by registered mail or confirmed telefax. o Notwithstanding Art. 4.1 and 4.2 hereinabove, this Agreement may be terminated by written notice of one party with immediate effect and without observing any notice periods, if: one party commits a material breach of this Agreement amounting to valid reasons for immediate terminations; the ability to perform the obligations of one party under this Agreement is endangered or becomes unreasonable due to financial difficulties of one of the parties, as a result of force majeure, or for political and economical changes in the country where the ETC is located Page 3/9 DRAFT ARTICLE 5: LIABILITY o Each party shall be personally liable for its contributions to the ETC and for its duties defined in this Agreement. o XXX shall, however, not be liable for any damage created to third parties because of improper use of XXX devices by the CENTER, by ETC staff, or by any USER, or because of faulty advice or incorrect training by any of the aforementioned parties. ARTICLE 6: MISCELLANEOUS o Without prior written consent of the other party, this Agreement as a whole or in part shall not be assigned or transferred. o If any part of this Agreement should be invalid in any jurisdiction under applicable law, the legality and enforceability of the remaining parts thereof shall not in any way be affected or impaired thereby. o This Agreement contains the entire mutual consent between the parties with respect to its subject matter and supercedes all prior agreement and undertakings between the parties in connection with it. o The parties must mutually agree upon all publicity, information, programs, posters and audio-visual material concerning the ETC. XXX reserves the right to mention the ETC on its list of Referral Centers. ARTICLE 7: GOVERNING LAW / ARBITRATION CLAUSE o This Agreement and all agreements ensuing there from shall be subject to, construed in compliance with, and interpreted according to the Indian laws. o All disputes arising out of or in connection with this Agreement and any agreements ensuing there from including disputes on the conclusion, binding effect, amendment and termination of this Agreement, or of any ensuing agreements, shall be resolved to the exclusion of the ordinary courts of ___________________________. The Arbitration proceeding shall be held in ___________________________. Made in two (2) copies, each party declares to have received one copy. _________________________________ ___________________________ KARL XXX GmbH & Co.KG,Tuttlingen Endoscopic Training Center (ETC) Page 4/9 DRAFT ATTACHMENT 3: Exemplary Training Program ”Hands-on” Basic Training Course Course Faculty: National & international faculty with expertise in Minimally invasive Gynaecology & Surgery. in Minimally Invasive Gynaecology (MIG) at ________ Hospital in _____________ by ETC Training Dates: April ________, 2005 July ________, 2005 October _______, 2005 Organizer and Sponsor: KARL XXX GmbH & Co.KG A certificate will be issued by the ETC. Course Director: Dr. __________________ For inquiries please contact: ________________ ________________ Phone: ________________ Fax: __________________ Aimed at: Consultant Gynaecologists, Practising Gynaecologists, Registrars and Post-graduates with little or no experience in video-endoscopy. Course objectives: To improve knowledge of anatomical and surgical principles of gynaecological surgery. To develop & enhance surgical skills in videoendoscopic surgery (laparoscopic & hysteroscopic) and vaginal surgery. To enable easier transference of the acquired endoscopic skills to clinical situations. To facilitate use of minimally invasive techniques for management of gynaecological diseases. Course contents: Surgical anatomy of the pelvis. Basic surgical techniques and elctro-surgical principles. Principles of minimally invasive gynaecology including hand-eye-coordination in videolaparoscopy & video-hysteroscopy with practical exercises. Equipment, instrumentation & documentation. Clinical techniques & applications of MIG. Endosuturing techniques. Teaching style: Individualised ”hands-on” Pelvi-Trainer & Hystero-Trainer simulator sessions for each participant. Extensive independent practising facilities with personalised training. Laparoscopic & hysteroscopic dissection on animate tissue. Simulated hands-on experience in specific laparoscopic & hysteroscopic procedures. Didactic lectures using video & slide presentations. Informal discussion groups & interactive sessions. Observing & assisting in surgery from within the operating room. Fees: ________________________ Venue: ________________________ Closing date for application exactly one month before the first day of the respective course. Places on the courses will be allocated after the closing date for applications and will ordinarily be on a firstcome-first-served basis. Page 5/9 DRAFT ATTACHMENT 3: Exemplary Course Schedule Day 1: Lectures and Hands-on Endotraining at the ETC in ________________________ 08.30-09.30 09.00-10.00 10.00-11.00 11.00-11.30 11.30-12.30 12.30-01.30 01.30-04.30 Day 2: Introduction to the course & minimally invasive gynaecology Instrumentation & documentation Safe use of electrosurgery Coffee break Simple hand-eye-coordination exercises on Pelvi-Trainer and HysteroTrainer Lunch Principles of basic surgical techniques including knotting and suturing skills Lectures and Hands-on Endotraining at the ETC in ________________________ 08.00-09.00 09.00-10.00 10.00-11.00 05.00-07.00 Surgical anatomy of the pelvis Hysteroscopy in clinical situations Principles of minimally invasive gynaecology and transferring learnt skills to surgical practice Coffee break Practical hands-on endotraining and endosuturing with 1 hour break for lunch Complications of laparoscopic / hysteroscopic surgeries Day 3: Operating Theatre Sessions 11.00-11.30 11.30-05.00 at _________________ hospital in ____________________. 09.30 onwards In the operating theatre with interactive sessions, demonstrating basic and various surgical video-laparoscopic, video-hysteroscopic and vaginal techniques (the variety being subject to availability of cases). Page 6/9 DRAFT ATTACHMENT 3: List of ETCs and their Equipment Name of Doctor Place Medical Field Available KARL XXX Equipment Endotrainer Units (camera, monitor, light source, insuffl., pump, HF-unit) Telescopes Trocars Instruments Add. Instruments Telemed. Equipment Dr. Dr. Dr. Dr. Dr. India India India India India X X X X X X X X X X X X X X X X X X X X X X X X X Dr. Malaysia X X X X X Page 7/9 DRAFT ATTACHMENT 4: Time Schedule Name of Doctor Place Will be equipped until end of Dr. Page 8/9 DRAFT ATTACHMENT 5: Confirmation We hereby confirm that, as part of the PPP measure "Expansion of training capacity in existing endoscopic training centers (ETCs), as well as the foundation of new ETCs in order to enable a larger number of Indian doctors to be trained in minimally invasive surgery in India", we have made the contractually agreed contribution in the scope defined below: a) Creation of suitable training capacity in new ETCs and expansion of training capacity in existing ETCs by providing the necessary training equipment/instruments at subsidized prices. b) Conclusion of cooperation agreements with the sponsored ETCs as per attachment 2. c) Development of training schedules. d) Implementation of at least three training courses in minimally invasive surgery per year at each training center with a maximum of 10 participants (1st interim report). e) Concluding report with information on the continuation of the program (final report). ________________________ Company ________________________ Place and date ________________________ Signature Page 9/9
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