MINIMED and ELAN shall promptly inform the other in writing of any alleged infringement of which it shall become aware by a third party of any patents within the ELAN PATENTS or ELAN IMPROVEMENTS and provide such other with any available evidence of infringement.
MINIMED shall inform ELAN in a timely fashion of its intent to seek patent protection on a MINIMED SYSTEM Improvement developed solely by MiniMed. At ELAN's request, MINIMED shall cooperate with ELAN's patent counsel to seek concurrent patent protection for a MINIMED SYSTEM IMPROVEMENT as it relates to the Product and System and such an improvement as it relates to ELAN's developments outside the scope of this Agreement. The parties will cooperate to seek such concurrent protection so that neither party shall be the owner of any patent, application or publication that may be used as prior art against the other, or otherwise be a bar to the other in obtaining patent protection for such improvement as it relates to the MINIMED SYSTEM Improvements.
MINIMED at its option, shall be entitled to institute ENFORCEMENT PROCEEDINGS in respect of any infringement or unauthorised use of the MINIMED SYSTEM IMPROVEMENTS or MINIMED INFUSION SYSTEM BACKGROUND TECHNOLOGY at its own expense and for its own benefit. ELAN agrees to provide all reasonable co-operation and assistance to MINIMED in relation to any such ENFORCEMENT PROCEEDINGS and agrees to be named as a party in any ENFORCEMENT PROCEEDINGS, as necessary, instituted by MINIMED hereunder.
MINIMED and ELAN hereby confirm that each shall undertake its respective part of the PROJECT as a collaborative effort and that the provisions of this Agreement requires that each Party diligently carries out those tasks assigned to it under the PROJECT and as otherwise agreed during the course of the PROJECT. Each Party shall co-operate with the other in good faith particularly with respect to unknown problems or contingencies and shall perform its obligations in good faith and in a commercially reasonable, diligent and workmanlike manner. CLAUSE 6 - FACILITY, EQUIPMENT & MATERIALS
MINIMED undertakes that it shall exercise all commercially reasonable efforts to establish and validate, on or before the PRODUCTION COMMENCEMENT DATE, a manual production line at the FACILITY which has the capacity to manufacture in routine production a minimum of * units of the CONTINUOUS SYSTEM per calendar month which are in accordance with the CONTINUOUS SYSTEM SPECIFICATIONS. Thereafter, MINIMED undertakes that it shall exercise commercially reasonable efforts to enable production capacities at the levels and in accordance with the schedule set forth below: Months From PRODUCTION COMMENCEMENT DATE Units per Month * * * * Confidential portion omitted and filed separately with the Commission.
MINIMED undertakes that it shall * to establish and validate a fully automated production line at the FACILITY to enable production capacities of the CONTINUOUS SYSTEM in accordance with the CONTINUOUS SYSTEM SPECIFICATIONS at the levels and in accordance with the schedule set forth below: Months From Completion of Section II of Technology Transfer Units per Month --------------------------------- --------------- * * * * * * The PROJECT TEAM shall agree upon a date for completion of Section II of the technology transfer. Such validation of the fully automated production line shall be performed in accordance with the instructions of the PROJECT TEAM. MINIMED shall construct the fully automated production line for the 24 CONTINUOUS SYSTEM in a cost efficient manner which will allow such production line to be expanded to satisfy, in a commercially reasonable fashion, any increased capacity requirements for the CONTINUOUS SYSTEM. Notwithstanding anything to the contrary contained herein, it is acknowledged and agreed that production of a new medical device technology and the technology transfer contemplated by Clause 5 of this Agreement each involve inherent risks in terms of outcomes and timing, and the obligation of MINIMED hereunder shall be expressly limited to a covenant to exercise commercially reasonable efforts in connection therewith. Pursuant to Clause 2.1.2.(1), until such time MIMIMED has established the fully automated production line in accordance with this paragraph, ELAN shall be free to manufacture such amounts of the CONTINUOUS SYSTEM as may be required by ELAN or its LICENSEES in excess of the amount which MINIMED has the capacity to manufacture and supply to ELAN.
MINIMED warrants that it shall only use equipment, tools, machinery and MATERIALS in the manufacture of the CONTINUOUS SYSTEM which are in accordance with the CONTINUOUS SYSTEM SPECIFICATIONS and PACKAGING SPECIFICATIONS for the CONTINUOUS SYSTEM and all applicable laws, rules and regulations.
MINIMED is duly and validly existing in the jurisdiction of its incorporation and each other jurisdiction in which the conduct of its business requires such qualification (except where such failure to so qualify shall not have a material adverse affect on the business and assets of MINIMED), and is in material compliance with all applicable laws, rules, regulations or orders relating to its business and assets;
MINIMED has full corporate authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby; this Agreement has been duly executed and delivered by MINIMED and constitutes the legal and valid obligations of MINIMED and is enforceable 38 against MINIMED in accordance with its terms and the execution, delivery and performance of this Agreement and the transactions contemplated hereby and will not violate or result in a default under or creation of lien or encumbrance under MINIMED's bylaws and certificate of association or any material agreement or instrument binding upon or affecting MINIMED or its properties or assets or any applicable laws, rules, regulations or orders affecting MINIMED or its properties or assets;
MINIMED further represents and warrants that, MINIMED shall manufacture and package the CONTINUOUS SYSTEM in accordance with the 39 instructions furnished by ELAN to MINIMED, which are reasonably acceptable to MINIMED, the REGULATORY APPLICATION and any granted REGULATORY APPROVALS. and all applicable regulations and requirements of the RHAs in the TERRITORY including the then cGMP regulations which apply to the manufacture and supply of the CONTINUOUS SYSTEM.
