Company: MDCXW
Filing Date: 2025-03-28
Form Type: 253G2
Source: 0001062993-25-006502
Chunk: 59

Company: Medicus Pharma Ltd.
Filing Date: 2025-03-28
Form: 253G2
Chunk 59
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 manufacturers might only be required to conduct a relatively inexpensive study to show that their product has the same active ingredient(s), dosage form, strength, route of administration, conditions of use, or labeling as our product candidate and that the generic product is bioequivalent to us, meaning it is absorbed in the body at the same rate and to the same extent as the Product. These generic equivalents, which must meet the same quality standards as branded pharmaceuticals, would be significantly less costly than ours to bring to market and companies that produce generic equivalents are generally able to offer their products at lower prices. Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product is typically lost to the generic product. Accordingly, competition from generic equivalents to our products would materially adversely impact our ability to successfully commercialize the Product. A variety of risks associated with potential international business relationships could materially adversely affect our business. We may enter into agreements with third parties for the development and commercialization of the Product in international markets. If we do so, we would be subject to additional risks related to entering into international business relationships, including: ● differing regulatory requirements in other countries including, among others, marketing approval, pricing, reimbursement and sales and marketing practices; ● potentially reduced protection for intellectual property rights; 48 ● potential for so-called parallel importing, which is when a local seller, faced with higher local prices, opts to import goods from a foreign market with lower prices, rather than buying them locally; ● unexpected changes in tariffs, trade barriers and regulatory requirements, including the imposition of new tariffs by the U.S. government on imports to the U.S. and/or the imposition of retaliatory tariffs by foreign countries; ● economic weakness, including inflation, or political instability in foreign economies and markets; ● compliance with tax, employment, immigration and labor laws for employees traveling and working abroad; ● foreign taxes; ● foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other risks incident to doing business in another country; ● workforce uncertainty in countries where labor unrest is more common than in Canada or the United States; ● production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad or supply chain disruptions; and ● business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods, tsunamis, hurricanes and fires. These and other risks may materially adversely affect our ability to develop and commercialize products in international markets and may harm