AGREEMENT BETWEEN NATIONAL INSTITUTE OF PREVENTIVE MEDICINE, DEPATRMENT OF HEALTH, EXECUTIVE YUAN, REPUBLIC OF CHINA AND STATENS SERUMINSTITUT, DENMARK (AD.1994.02.16)-1

AGREEMENT PREAMBLE This Agreement between National Institute of Preventive Medicine, Department of Health, Executive Yuan, Republic of China (here-inafter referred to as Party A) and Statens Seruminstitut, Denm-ark (hereinafter referred to as Party B) is based on agreements made during meetings at Statens Seruminstitut July 1992 and dis-cussed in detail during meetings at National Institute of Preve-ntive Medicine February 1993. RECITALS WHEREAS, The parties in the Memorandum of Understanding of 31 J-uly 1992 stipulate that a broad collaboration will be establish-ed between the Parties for the benefits of the populations in t-he Republic of China and Denmark as well as other relevant coun-tries. WHEREAS, Party B as a gesture of good faith is willing to provi-de to Party A tuberculin bulk solutions for the purpose of prep-arations of finished tuberculin products by Party A at its faci-lities to fulfill the needs of the products in the Republic of China. WHEREAS, This agreement is the first step of the action plan ag-reed by the parties to develop said broad collaboration. WHEREAS, Party A desires to receive from Party B the tuberculin bulk solution, and Party B is willing to provide to Party A saidproduct. THEREFORE Party A and Party B agree as follows: 1.Tuberculin bulk soltions: Tuberculin PPD RT23 1TU/O.lml (here- inafter referred to as the PPD). 2.Quantity: Party B agrees to sell to Party A, on a long-term a- nd steady basis, the PPD in quantities from 500,000 to 1,000,0 00 doses each time and twice a year , for Party A to produce the final products to be distributed only within the Republic of China. The procedure for ordering the PPD is described in Annex A. 3.Price: Party B shall sell the PPD to Party A at a price of DKK 0.35 per dose (1TU/O.lml) delivered CIP Taipei C.K.S. Interna- tional Airport (Incoterms 1990). To compensate for Party A’s wastage and necessary overfilling, each shipment shall contain 20% more than the quantity actually ordered and the extra part shall be free of charge to Party A. The selling price of the PPD shall not be changed within the first two years of this a- greement. Any price increase following this period shall be r- easonably and should be based on exchange rates developments, market conditions, and actual increases in productions costs by Party B. 4.Date of Delivery: Party B shall deliver the PPD to Party A in accordance with the procedure set forth in Annex A. 5.Terms of Payment: Party A shall pay 50% of the total price of the PPD upon ordering and pay the rest within two months after the PPD are delivered by Party B and pass the inspection arra- nged by Party A. 6.Guaranty: Party B warrants that the PPD delivered to Party A meets the specifications set forth by Party B and agreed upon by party A. 1) If non-conformity should exist, either because the temperatu- re monitoring at the time of delivery does not meet the spec- ifications or the PPD does not pass the inspection and analy- sis arranged by Party A, Party A shall immediately inform Pa- rty B to solve the problems. 2) In any case of non-conformity caused by Party B, Party B sha- ll refund the payment for the PPD made by Party A, and Party A shall return the PPD to Party B. 3) In any case of non-conformity, whether or not it is caused by Party B, Party A shall have the right to order for new PPD to be delivered within 4 months to ensure that Party A at all t- ime will be in a position to cover the needs for the finished products in R.O.C. 7.Penal Provisions: 1) If Party B can not deliver the PPD on the date of delivery, it has to pay 0.3% of the total price for each day past the agreed due date. It is agreed, however, that the maximum pen- alty is 50% of the total price. 2) The above penalty provision shall also apply to orders for P- PD as a result of non-conformity as set forth in section 6 a- bove. 3) Party B shall not be liable for the delay of the delivery of goods as a result of failing to fulfill the entire or part of the Agreement because of force majeure, including Act of God, earthquake, war, blockades, rebellions, storms, fire, flood, strike (excluding internal strikes within an individual fact- ory), embargo, explosion, government or international organi- zations orders or restrictions, etc. Nonetheless, any party affected by any event resulted from the above mentioned force majeure shall do its best to eliminate, recover and overcome the hardships and fulfill its obligations in the Agreement in due course. 8.The Parties shall have the right to terminate this agreement with 9 months notice to expire by the end of a calendar year. However, termination of this agreement can take effect no ear- lier than by the end of the calendar year of 1995. It is stip- ulated by the parties that this agreement shall be in force on a long-term basis as part of the expected broad collaboration between the parties. 9.If any dispute should arise between the Parties concerning the subject matters of this agreement, the Parties shall settle t- he dispute amicably through good faith negotiations. If the d- ispute can not be settled amicably, it shall be finally settl- ed arbitrally under the rules of The International Chamber of Commerce. The arbitral procedure shall take place in Singapore . The language to be used shall be English. The English versi- on of the agreement is the governing version. 10.This Agreement is made in duplicate, with four identical cop- ies, signed by both parties. Party A shall hold one original together with four copies and Party B shall hold the other o- riginal for reference and filing respectively. IN WITNESS WHEREOF, this Agreement is signed on , 1994. National Institute of Preventive Medicine, Department of Health, Executive Yuan, Republic of China (Party A) [Signed] Name : Dr. Chi-Byi Horng Title :Director Jan.14,1994 Statens Seruminstitut, Denmark (Party B) [Signed] Name : Dr. Lars Pallesen Title : Executive Director, CEO Feb. 16, 1994 Witness [Signed] Name :Prof. Stephan Hus Title :Representative, Republic of China on Taiwan Feb.23, 1994 ANNEX A General and commercial specifications: 1) The Parties have appointed the following two persons to be i- nch arge of and act as liaison officers on matters of general and commercial nature: Party A: Dr. M. Y. Liau Head, Division of Biological Products Party B: Mr. Michael A. Olsen Department of Corporate Planning 2) Ordering: The procedure for submitting orders for the PPD shall be as follows: (1) Party A shall inform Party B about its intentions for purch- ase the PPD in each calendar year no later than November the foregoing year. (2) The first delivery in each calendar year shall be no earlier than March, unless Party A has notified Party B 4 months be- fore delivery date. (3) Submission ofdnal orders shall be made no later than 3 month before delivery date. Technical Specifications: 1) The Parties have appointed the fellowing two persons to be incharge of and to act as liaison omcers on matters conce- rning quality control/quality assurance. Party A: Dr. Cheng-hasiung Lu Head, Division of Biological Quality Control. Party B: Mrs. Birgitte W. Knudsen Head, Department of Quality Assurance 2) There should be a temperature monitor card and ice-packs installed in each packed box. 3) There should be information regarding the manufacturing d- ate, the delivering batch code, the valid period and the producer’s name on the outer surface of each packed box. 4) The valid period shall not be less than one year and three months starting from the date of delivery. 5) Party B shall provide Party A with all reasonably necessa- ry information for the application of the production lice- nse for the PPD. 6) Party B shall provide Party A 6 weeks in advance with eno- ugh quantity of reference standard and sensitizing agent ( the vald period shall be more than 6 months) to facilitate the measurement oft;he potency of the PPD. For each batch of bulk solution, the following reagents are requested: 1.Sensitizer 20mg 2.Reference PPD A) 5 TU/O.lml 30ml B) 0.5 TU/O.lml 30ml 7) Party B shall provide Party A with the reference standard in testing the additive of the PPD, Potassium hydroxychin- oline sulphate. 8) Party B shall provide Party A with the complete protocol of batch file and the testing report for each shipment of the PPD. 9) To ensure the quality of the end products made from the P- PD hulk solution produced by Party A, if it is necessary, Party A may Bend the final products to Party B for testing . Party B shall conduct the said testing in due course and free of charge. 10) Party B shall be responsible for the training of Party A’s personnels to enable then to understand the standard oper- ation procedure of dispensing and packing the PPD, the qu- ality control and the quality assurance at Party B’s expe- nse. However , Party B shall be responsible for the trave- lling, lodging and boarding expenses of the trainees.

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