CONSIDERING that Mikah has a new drug application (“ANDA”) for the product, Actavis LLC has exclusive rights to market and sell. On the basis of a possible merger between Actavis LLC (“Actavis”) and Teva Pharmaceutical Industries Ltd., Actavis wishes to terminate the contract with Mikah under the terms of Appendix 1; 6.2 The distributor may not sell or market the product in another country or in other regions, except for the area specified in this Agreement. If the distributor intends to expand to other regions beyond the territory, a separate written agreement must be signed between the distributor and CASI. 1.9 “RFN Party” means that certain third parties with whom SuperGen has granted the right to discuss for the first time all pharmaceutical compounds granted by SuperGen are held and/or developed pursuant to a written agreement. The parties ensure that all global and local pharmacovigilance obligations are met, that pharmacovigilance officers are appointed, that all pharmacovigilance personnel have the required skills, and that an operational pharmacovigilance system is in place on both parties. 7.3 Product recall. If one of the contracting parties finds that an event, incident or circumstance may require a recall or other removal of a product or another of the product from the U.S. market or within the territory, that party is notified of the other party and the parties are consulted on it. SuperGen has sole responsibility to decide whether a recall or other removal of this product has been initiated in the United States and whether it has not occurred, and the sole responsibility for the handling and adoption of such a product in the territory. Such a recall or any other distance by one of the contracting parties is carried out according to a procedure to be defined by SuperGen by entering EuroGen. unless, as noted below, when a product (or a lot or part of it) is recalled or removed from the market, the cost and expense of such a recall or its removal; including, but not limited to costs and other costs or obligations incurred by third parties, the costs and costs of notifying customers, and the costs and expenses associated with the shipment of the recalled product, as well as the costs and costs of destroying the product withdrawn from the market, unless, as noted below, the costs and expenses are borne by SuperGen, to the extent that these costs and expenses are borne by the United States and borne by EuroGen to the extent that these costs and expenses are borne by the national territory.