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1 AGREEMENTPREAMBLEThis 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 agreementsmade during meetings at Statens Seruminstitut July 1992 and dis-cussed in detail during meetings at National Institute of Preve-ntive Medicine February 1993.RECITALSWHEREAS, 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 tuberculinbulk 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 1,000,000 doses each time and twice a year , for Party A to producethe final products to be distributed only within the Republicof China. The procedure for ordering the PPD is described inAnnex A.3.Price: Party B shall sell the PPD to Party A at a price of DKK0.35 per dose (1TU/O.lml) delivered CIP Taipei C.K.S. Interna-tional Airport (Incoterms 1990). To compensate for Party A'swastage and necessary overfilling, each shipment shall contain20% more than the quantity actually ordered and the extra partshall be free of charge to Party A. The selling price of thePPD 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 costsby Party B.4.Date of Delivery: Party B shall deliver the PPD to Party A inaccordance with the procedure set forth in Annex A.5.Terms of Payment: Party A shall pay 50% of the total price ofthe PPD upon ordering and pay the rest within two months afterthe 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 Ameets the specifications set forth by Party B and agreed uponby 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 PartyA shall return the PPD to Party B.3) In any case of non-conformity, whether or not it is caused byParty B, Party A shall have the right to order for new PPD tobe delivered within 4 months to ensure that Party A at all t-ime will be in a position to cover the needs for the finishedproducts 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 theagreed 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 ofgoods as a result of failing to fulfill the entire or part ofthe 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 partyaffected by any event resulted from the above mentioned forcemajeure shall do its best to eliminate, recover and overcomethe hardships and fulfill its obligations in the Agreement indue course.8.The Parties shall have the right to terminate this agreementwith 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 ona long-term basis as part of the expected broad collaborationbetween the parties.9.If any dispute should arise between the Parties concerning thesubject 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 ofCommerce. 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 originaltogether 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 HorngTitle :DirectorJan.14,1994Statens Seruminstitut, Denmark (Party B)[Signed]Name : Dr. Lars PallesenTitle : Executive Director, CEOFeb. 16, 1994Witness[Signed]Name :Prof. Stephan HusTitle :Representative, Republic of China on TaiwanFeb.23, 1994ANNEX AGeneral 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 generaland commercial nature:Party A:Dr. M. Y. LiauHead, Division of Biological ProductsParty B:Mr. Michael A. OlsenDepartment of Corporate Planning2) Ordering:The procedure for submitting orders for the PPD shall be asfollows:(1) Party A shall inform Party B about its intentions for purch-ase the PPD in each calendar year no later than November theforegoing year.(2) The first delivery in each calendar year shall be no earlierthan 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 monthbefore delivery date.Technical Specifications:1) The Parties have appointed the fellowing two persons to beincharge of and to act as liaison omcers on matters conce-rning quality control/quality assurance.Party A:Dr. Cheng-hasiung LuHead, Division of Biological Quality Control.Party B:Mrs. Birgitte W. KnudsenHead, Department of Quality Assurance2) There should be a temperature monitor card and ice-packsinstalled in each packed box.3) There should be information regarding the manufacturing d-ate, the delivering batch code, the valid period and theproducer's name on the outer surface of each packed box.4) The valid period shall not be less than one year and threemonths 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 facilitatethe measurement oft;he potency of the PPD. For each batchof bulk solution, the following reagents are requested:1.Sensitizer 20mg2.Reference PPDA) 5 TU/O.lml 30mlB) 0.5 TU/O.lml 30ml7) Party B shall provide Party A with the reference standardin testing the additive of the PPD, Potassium hydroxychin-oline sulphate.8) Party B shall provide Party A with the complete protocolof batch file and the testing report for each shipment ofthe 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 andfree of charge.10) Party B shall be responsible for the training of Party A'spersonnels 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.