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In relation to our generic pharmaceutical business, at times, companies in this business may seek approvals<br />

to market generic products before the expiration of applicable patents, based upon the belief that such<br />

patents are invalid, unenforceable, or would not be infringed by such company's products. As a result, such<br />

a company may face the risk of significant patent litigation. Depending upon a complex analysis of a<br />

variety of legal and commercial factors, if such company wins a lower court decision in such patent<br />

litigation, it may, in certain circumstances, elect to market a generic product even though an appeal of the<br />

lower court decision is pending. While it is not our current policy to launch a generic product on such “at<br />

risk” basis, should we or our marketing partner elect to proceed in this manner in the future based on<br />

scientific analysis or business judgment, we could face the risk of incurring substantial patent liability<br />

damages in the future.<br />

Our management team and other key personnel are critical to our operations. If we are unable to<br />

continue to attract and retain such personnel, our operations could be negatively affected.<br />

We are dependent on members of our senior management team as well as members of our scientific,<br />

technical and business staff and our employees for the smooth operation of our business. These personnel<br />

possess technical and business capabilities that are difficult to replace. The loss of any of these principal<br />

members of our scientific or management staff, or failure to attract or retain other key scientific, technical<br />

and business employees, could prevent us from pursuing our business objectives or developing and<br />

commercialising our products. Recruiting and retaining qualified scientific personnel to perform research<br />

and development work are critical to our success. Qualified personnel are difficult to attract and retain. We<br />

may not be able to continuously attract or retain such personnel, or retain them on acceptable terms, given<br />

the demand for such personnel among pharmaceutical and healthcare companies, universities and nonprofit<br />

research institutions. Although we believe we enjoy good relations with our staff and employees, no<br />

assurance can be given that relations will not be disrupted either as a result of disputes or negative external<br />

factors.<br />

Our operations are subject to environmental, employee, health and safety laws and regulations.<br />

Our operations are subject to various national and state environmental laws and regulations relating to<br />

environmental protection in the various locations in India and internationally where we operate. For<br />

example, the discharge or emission of chemicals, dust or other pollutants into the air, soil or water that<br />

exceed permitted levels and cause damage to others may give rise to liabilities to the government and third<br />

parties, and may result in our incurring costs to remedy any such discharge or emissions. See also “ – The<br />

manufacture and storage of pharmaceutical and chemical products is subject to environmental regulation<br />

and risk”. There can be no assurance that compliance with such environmental laws and regulations will<br />

not result in a curtailment of production or a material increase in the costs of production or otherwise have<br />

a material adverse effect on our financial condition and results of operations. Environmental laws and<br />

regulations in India have become increasingly stringent, and it is possible that they will become<br />

significantly more stringent in the future. If any of our plants or operations are shut down, we may<br />

continue to incur costs in complying with regulations, appealing any decision to close our facilities,<br />

maintaining production at our existing facilities and continuing to pay labour and other costs<br />

notwithstanding the closure of any such plant or operation. Stricter laws and regulations, or stricter<br />

interpretation of the existing laws and regulations may impose new liabilities on us or result in the need for<br />

additional investment in environmental protection equipment, either of which could affect our business,<br />

financial condition or prospects.<br />

We are also subject to laws and regulations of the countries in which we operate that govern relationships<br />

with employees in such areas as minimum wage and maximum working hours, overtime, working<br />

conditions, hiring and terminating of employees, contract labour and work permits. Furthermore, the<br />

success of our business is contingent upon, among other things, receipt of all required licenses, permits and<br />

authorizations, including local land use permits, manufacturing permits, building and zoning permits and<br />

environmental, health and safety permits. Changes or concessions required by regulatory authorities could<br />

also involve significant costs and delay or prevent completion of the construction or opening of a plant or<br />

could result in the loss of an existing license. Inability to renew expired licenses and approvals, failure to<br />

comply with applicable regulatory requirements and/or failure to comply with the conditions of our licenses<br />

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