34 Even if we are ablel to commercializ l e any n product candid d at d es t ,s such productst may a become subject to unfav f orablel pricing regu e lations,s third-par - ty reimbursement practices or health l care refo e rm initiativ t es,s which wouldl harm our busine i ss. Drug r pricing and access policies in the United States and internationally may change and negatively impact the commercial viability of our produc d t candidates. Proposed policy changes, including the potential for Medicare to negotiate with drug r manufact f ur t ers under the Inflation Reduction Act of 2022, or the IRA, R may limit our ability to competitively price our product candidates, if approved. Further, commercial insurers may limit patient access to our product candidates, if approved and other branded therapies. The regulations that govern marketing approvals, pricing and reimbursement for new drugs r vary widely from country to country. In the United States, recently enacted legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug r before it can be marketed. In many countries, the pricing review period begins afte f r marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subj u ect to continuing governmental control even afte f r initial approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then be subj u ect to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenue we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if any product candidates we may develop obtain marketing approval. Our ability to successful f ly commercialize any products that we may develop also will depend in part on the extent to which reimbursement for these products and related treatments will be availabl a e from government health administration authorities, private health insurers, and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establ a ish reimbursement levels. A primary r trend in the U.S. healthcare industry r and elsewhere is cost containment. Government authorities and third- party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Government authorities currently impose mandatory discounts for certain patient groups, such as Medicare, Medicaid and Veterans Affa f irs, or VA, hospitals, and may seek to increase such discounts at any time. Future regulation may negatively impact the price of our products, if approved. Increasingly, third-party payors are requiring that drug r companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that reimbursement will be availabl a e for any product candidate that we commercialize and, if reimbursement is availabl a e, that the level of reimbursement will be sufficient. Reimbursement may impact the demand for, or the price of,f any product candidate for which we obtain marketing approval. In order to get reimbursement, physicians may need to show that patients have supe u rior treatment outcomes with our products compared to standard of care drugs r , including lower-priced generic versions of standard of care drugs r . If reimbursement is not availabl a e or is availabl a e only at limited levels, we may not be able to successful f ly commercialize any product candidate for which we obtain marketing approval. In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors and coverage and reimbursement levels for products can differ significantly from payor to payor. As a result, the coverage determination process is ofte f n a time consuming and costly process that may require us to provide scientific f and clinical suppor u t for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. There may be significant delays in obtaining reimbursement for newly approved drugs r , and coverage may be more limited than the purpos r es for which the medicine is approved by the FDA, EMA or other comparable foreign regulatory r authorities. Moreover, eligibility for reimbursement does not imply that any drug r will be paid for in all cases or at a rate that covers our costs, including research, development, manufact f ur t e, sale, and distribution. Interim reimbursement levels for new drugs r , if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug r and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs r and may be incorporated into existing payments for other services. Net prices for drugs r may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs r from countries where they may be sold at lower prices than in the United States. Third-party payors ofte f n rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Further, coverage policies and third-party payor reimbursement rates may change at any time. Therefor f e, even if favorable coverage and reimbursement status t is attained, less favorable coverage policies and reimbursement rates may be implemented in the future. Our inability to promptly obtain and maintain coverage and profita f bl a e payment rates from both government-funded and private payors for any approved products we may develop could have a material adverse effe f ct on our operating results, our ability to raise capital needed to commercialize product candidates, and our overall financial condition.