Represents non-capitalizable upfront or development milestone based payments under certain license arrangements. Milestone payments prior to FDA approval of a product are expensed as. The amounts incurred during fiscal are primarily associated with our acquisition of Cadence and Questcor.
The incremental expense represents the difference between fair value and the manufactured cost of the inventory. Summary Historical Financial Data of Ikaria. The information set forth below is only a summary that you should read together with the historical audited consolidated financial statements of Ikaria, Inc. Historical results are not necessarily indicative of any results to be expected in the future. Sales to related parties.
Total revenues. Selling, general and administrative. Research and development. Amortization of acquired intangibles. Merger transaction costs and expenses. Other operating expense income , net. Total operating costs and expenses. Income loss from operations. Loss on extinguishment of debt. Income loss before income taxes. These items, if applicable, include: discontinued operations; other income, net; separation costs; restructuring charges, net; immediately expensed up-front and milestone payments; acquisition-related costs; loss on extinguishment of debt; share-based compensation; non-cash impairment charges and certain other non-recurring items.
Loss on extinguishment of debt 1. Acquisition-related expenses 2. Cost of sales inventory step-up 3. Summary Historical Financial Data of Target. The following selected historical consolidated financial data is derived from Compound Holdings II, Inc. The information set forth below is only a summary that you should read together with the historical audited consolidated financial statements of Compounds Holdings II, Inc.
Selling and marketing. Other operating income, net. Loss from operations. Loss before income taxes. Income tax benefit. Net loss. These items, if applicable, include: discontinued operations; other income, net; separation costs; restructuring charges, net; immediately expensed up-front and milestone payments; acquisition-related costs; share-based compensation; other non-recurring items; and non-cash impairment charges.
Cost of sales inventory step-up 1. Risks Related to the Ikaria Acquisition. While the Ikaria Acquisition is pending, Mallinckrodt and Ikaria will be subject to business uncertainties that could adversely affect their businesses. Uncertainty about the effect of the Ikaria Acquisition on employees, customers and suppliers may have an adverse effect on Ikaria and Mallinckrodt. Employee retention may be challenging during the pendency of the Ikaria Acquisition, as certain employees may experience uncertainty about their future roles.
If key employees depart because of issues related to the uncertainty and difficulty of integration or a desire not to remain with the businesses, the business of the combined company following the Ikaria Acquisition could be seriously harmed. In addition, the Ikaria Purchase Agreement restricts Ikaria from taking specified actions until the Ikaria Acquisition occurs without the consent of Mallinckrodt. These restrictions may prevent Ikaria from pursuing attractive business opportunities that may arise prior to the completion of the Ikaria Acquisition.
Risks Related to the Business of the Combined Company. Mallinckrodt and Ikaria may fail to realize all of the anticipated benefits of the Ikaria Acquisition or those benefits may take longer to realize than expected. The combined company may also encounter significant difficulties in integrating the two businesses.
The combination of two independent businesses is a complex, costly and time-consuming process. As a result, Mallinckrodt and Ikaria will be required to devote significant management attention and resources to integrating their business practices and operations. The integration process may disrupt the businesses and, if implemented ineffectively, would restrict the realization of the full-expected benefits. The failure to meet the challenges involved in integrating the two businesses and to realize the anticipated benefits of the transaction could cause an interruption of or a loss of momentum in, the activities of the combined company and could adversely affect the results of operations of the combined company.
The difficulties of combining the operations of the companies include, among others:. In addition, even if the operations of the businesses of Mallinckrodt and Ikaria are integrated successfully, the full benefits of the transaction may not be realized, including the synergies, cost savings or sales or growth opportunities that are expected. These benefits may not be achieved within the anticipated time frame, or at all.
Further, additional unanticipated costs may be incurred in the integration of the businesses of Mallinckrodt and Ikaria. As a result, we cannot assure you that the combination of Mallinckrodt and Ikaria will result in the realization of the full benefits anticipated from the transaction.
Mallinckrodt entered into the Ikaria Purchase Agreement because it believes that the Ikaria Acquisition will be beneficial to it and its shareholders and that combining the businesses of Mallinckrodt and Ikaria will produce benefits and cost savings.
If Mallinckrodt is not able to successfully combine the businesses of Mallinckrodt and Ikaria in an efficient and effective manner, the anticipated benefits and cost savings of the Ikaria Acquisition may not be realized fully, or at all, or may take longer to realize than expected, and the value of the notes may be affected adversely.
In addition, the actual integration may result in additional and unforeseen expenses, and the anticipated benefits of the integration plan may not be realized. Actual synergies, if achieved, may be lower than what Mallinckrodt expects and may take longer to achieve than anticipated.
Mallinckrodt and Ikaria will incur direct and indirect costs as a result of the Ikaria Acquisition. Mallinckrodt and Ikaria will incur substantial expenses in connection with completing the Ikaria Acquisition, and Mallinckrodt also expects to incur substantial expenses in connection with coordinating the businesses, operations, policies and procedures of Mallinckrodt and Ikaria over a period of time following the completion of the Ikaria Acquisition.
Many of the expenses that will be incurred, by their nature, are difficult to estimate accurately. These expenses may exceed the costs historically borne by Mallinckrodt and Ikaria. Mallinckrodt expects that, following the completion of the Ikaria Acquisition, Mallinckrodt will have significantly less cash on hand than the sum of cash on hand of Mallinckrodt and Ikaria prior to the completion of the Ikaria Acquisition. Additionally, Mallinckrodt expects that, following completion of the Ikaria Acquisition, Mallinckrodt will have significantly less availability under its Revolver than Mallinckrodt and Ikaria, respectively, had under their revolving credit facilities prior to the consummation of the Ikaria Acquisition.
Although the management of Mallinckrodt believes that it will have access to cash sufficient to meet. In the event that Mallinckrodt does not have adequate capital to maintain or develop its business, additional capital may not be available to Mallinckrodt on a timely basis, on favorable terms, or at all. The pro forma financial information has been derived from the audited and unaudited historical financial statements of Mallinckrodt and Ikaria and certain adjustments and assumptions have been made regarding the combined company after giving effect to the transaction.
The assets and liabilities of Ikaria have been measured at fair value based on various preliminary estimates using assumptions that Mallinckrodt management believes are reasonable utilizing information currently available. The process for estimating the fair value of acquired assets and assumed liabilities requires the use of judgment in determining the appropriate assumptions and estimates. These estimates may be revised as additional information becomes available and as additional analyses are performed.
Any material variance from the pro forma financial information may cause significant variations in the value of the notes. Risks Related to Ikaria. Our near-term prospects, including our ability to finance our company, develop our product candidates and make acquisitions of additional products and product candidates, will depend heavily on the continued successful commercialization of INOMAX Total Care.
Any adverse developments with respect to the sale or use of INOMAX Total Care could significantly reduce our revenues and have a material adverse effect on our ability to generate net income and positive cash flow from operations and to achieve our business plan. Certain key U. Certain key patents owned by MGH related to the use of therapeutic nitric oxide for treating or preventing bronchoconstriction or reversible pulmonary vasoconstriction expired in Prior to their expiration, we depended, in part, upon these patents to provide us with exclusive marketing rights for our product for some period of time.
Ikaria has obtained new patents on methods of identifying patients at risk of serious adverse events when nitric oxide was administered to patients with particular heart conditions which the FDA has approved for inclusion on the INOMAX warning label, and that may have the effect of inhibiting development of competitive generic products.
However, the expiration of these key patents owned by MGH increases the risk that others could introduce and commercialize competitive nitric oxide therapies. If we do not receive approval to market INOMAX for additional uses, our ability to grow revenues and achieve our business plan may be materially adversely affected.
In order to market INOMAX for any other indications, we will need to conduct appropriate clinical trials, obtain positive results from those trials, and obtain regulatory approval for such proposed indications. Obtaining regulatory approval is uncertain, time consuming and expensive. Even well-conducted studies of effective drugs will sometimes appear to be negative in either safety or efficacy results.
The regulatory review and approval process to obtain marketing approval for a new indication can take many years, often requires multiple clinical trials and requires the expenditure of substantial resources. This process can vary substantially based on the type, complexity, novelty and indication of the product candidate involved.
The FDA and other regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that any data submitted is insufficient for approval and require additional studies or clinical trials. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent regulatory approval of a new indication for a product candidate. Our key product candidate currently in development is exclusively licensed from other companies.
If the licensors terminate the licenses, or fail to maintain or enforce the underlying patents, our competitive position and market share will be harmed. If we fail to use commercially reasonable efforts to develop, market, commercialize and sell terlipressin, Orphan has the right to terminate the agreement if we fail to use such efforts during the six months following notice from Orphan.
Orphan also has the right to terminate the agreement after notice and a cure period. If the agreement is terminated, our exclusive rights from Orphan will terminate and Orphan will have the right to reacquire rights to terlipressin from us, on pre-agreed terms. We are likely to enter into additional license agreements as part of the development of our business in the future. Our licensors may not successfully prosecute certain patent applications under which we are licensed and on which our business depends.
Even if patents issue from these applications, our licensors may fail to maintain these patents, may decide not to pursue litigation against third-party infringers, may fail to prove infringement, or may fail to defend against counterclaims of patent invalidity or unenforceability.
If these in-licenses are terminated, or if the underlying patents fail to provide the intended market exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, products identical to ours. This could have a material adverse effect on our competitive business position and our business prospects. The FDA and other foreign regulatory authorities approve drugs and medical devices for the treatment of specific indications, and products may only be promoted or marketed for the indications for which they have been approved.
While physicians are free to prescribe approved products for unapproved uses, it is unlawful for drug and device manufacturers to market or promote a product for an unapproved use. INOMAX is currently approved, and therefore we are permitted to market it in the United States, for only one use: the treatment of term and near-term infants with HRF associated with pulmonary hypertension.
Based on the information collected in this survey, we believe that sales of INOMAX for unapproved uses relate to conditions for which we are not currently planning to seek FDA approval. The laws and regulations relating to the promotion of products for unapproved uses are complex and subject to substantial interpretation by the FDA and other government agencies. Promotion of a product for unapproved use is prohibited; however, certain activities that we and others in the pharmaceutical industry engage in are permitted by the FDA.
For example, we provide medical. We have put in place compliance and training programs designed to ensure that our sales and marketing practices comply with applicable regulations. Notwithstanding these programs, the FDA or other government agencies may allege or find that our current or prior practices constitute prohibited promotion of INOMAX for unapproved uses.
We also cannot be sure that our employees will comply with company policies and applicable regulations regarding the promotion of products for unapproved uses. Over the past several years, a significant number of pharmaceutical and biotechnology companies have been the target of inquiries and investigations by various federal and state regulatory, investigative, prosecutorial and administrative entities in connection with the promotion of products for unapproved uses and other sales practices, including the Department of Justice and various U.
Under the False Claims Act, any individual can bring a claim on behalf of the government alleging that a person or entity has presented a false claim, or caused a false claim to be submitted, to the government for payment. The person bringing a qui tam suit is entitled to a share of any recovery or settlement.
In a qui tam suit, the government must decide whether to intervene and prosecute the case. If the government declines to intervene and prosecute the case, the individual may pursue the case alone. From time to time, employees and former employees of ours have alleged that certain of our practices were not in compliance with applicable law. In each such case, we have reviewed the allegations and concluded they were without merit. We have been the subject of one qui tam suit brought in by a former employee which alleged, among other things, that Ikaria had a practice of encouraging unproven off-label use of our products, and that this usage had the effect of increasing billings to government programs; this case was voluntarily dismissed in after the Department of Justice investigated and declined to intervene.
Because qui tam suits are filed under seal, it is possible that we are the subject of one or more additional qui tam actions of which we are unaware. If the FDA or any other governmental agency initiates an enforcement action against us or if we are the subject of a qui tam suit and it is determined that we violated prohibitions relating to the promotion of products for unapproved uses in connection with past or future activities, we could be subject to substantial civil or criminal fines or damage awards and other sanctions such as consent decrees and corporate integrity agreements pursuant to which our activities would be subject to ongoing scrutiny and monitoring to ensure compliance with applicable laws and regulations.
Any such fines, awards or other sanctions would have an adverse effect on our revenue, business, financial prospects and reputation. Any inquiry or investigation into our promotion practices, even if resolved in our favor, would be costly and could divert the attention of our management, damage our reputation and have an adverse effect on our business.
Because of the broad scope and complexity of these laws and regulations, the high degree of prosecutorial resources and attention being devoted to the sales practices of pharmaceutical companies by law enforcement authorities, and the risk of potential exclusion from federal government reimbursement programs, numerous companies have determined that it is highly advisable that they.
Companies that have chosen to settle these alleged violations have typically paid multi-million dollar fines to the government and agreed to abide by consent decrees or corporate integrity agreements. Any inquiry or investigation into our promotion practices, whether in the United States or by a foreign regulatory authority, even if resolved in our favor, would be costly and could divert the attention of our management, damage our reputation and have an adverse effect on our business.
We develop and manufacture INOMAX at our facility in Port Allen, Louisiana, which, other than our backup production facility, is the only FDA inspected site for manufacturing pharmaceutical-grade nitric oxide in the world.
Our Port Allen facility is subject to the risks of a natural disaster or other business disruption. The Coppell facility, which is capable of producing INOMAX from our supply of a concentrated pre-mix, which we manufacture at our Port Allen facility, would only be capable of serving as a backup facility for as long as our supply of concentrated pre-mix lasts, which we currently estimate to be about one year.
In addition, because the manufacture of a pharmaceutical gas requires specialized equipment and expertise, there are few, if any, third-party manufacturers to whom we could contract this work in a short period of time. The INOcal product is considered a device.
Manufacturing this product required Port Allen to comply with device manufacturing regulations and become ISO certified. Our Coppell facility is not certified for manufacture of INOcal. There can be no assurance that we would be able to meet our requirements for INOcal if there were a catastrophic event or failure of our current manufacturing system in the Port Allen facility. If we are required to produce INOcal at our Coppell facility, or change or add a new manufacturer or supplier, the process would likely require prior certification and would be very time consuming.
Our drug-delivery systems are sophisticated electro-mechanical devices comprised of components that may deteriorate over time. If we experience problems with, failure of, or delays in obtaining such components, our ability to provide our customers with INOMAX Total Care would be adversely affected.
Because our drug-delivery systems are sophisticated electro-mechanical devices, the parts which comprise the devices are subject to wear and tear, which may result in decreased function or failure of those parts over time. Although we perform scheduled, preventive maintenance on all of our drug delivery systems to limit device failures, and additional maintenance as needed whenever a customer reports a device malfunction, components of our devices may fail.
Our future growth depends, in part, on our ability to penetrate foreign markets, where we are subject to additional regulatory burdens and other risks and uncertainties. Our future profitability will depend, in part, on our ability to grow and ultimately maintain our sales in foreign markets. However, we have limited experience in marketing, servicing, and distributing our products in countries other than the United States, Mexico and Canada and rely on third parties to support our foreign operations.
Our foreign operations and any foreign operations we establish in the future subject us to additional risks and uncertainties, including:. Foreign sales of our products could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions, changes in tariffs, and difficulties in staffing and managing foreign operations. Other companies may develop competitive products that could negatively affect our sales of INOMAX and related products and services.
As a result, we must make significant investments in research and development, manufacturing and sales and marketing. If we are unable to continue to develop and sell innovative new products with attractive margins or if other companies infringe on our intellectual property, our ability to maintain a competitive advantage could be negatively affected and our financial condition and operating results could be materially adversely affected.
Our financial condition and operating results depend substantially on our ability to continually improve INOMAX and related products and services and to maintain therapeutic and functional advantages. There can be no assurance that we will be able to continue to provide products and services that compete effectively. For example, physicians use other drugs, such as Flolan, Ventavis, Primacor and Revatio, to treat acute pulmonary hypertension. In addition, we are aware that neonatologists, surgeons and other physicians have and may continue to experiment with.
In the past, 12th Man Technologies approached several INOMAX customers with an offer to develop and sell nitric oxide and a nitric oxide delivery system. Air Liquide Healthcare America Corporation, or Air Liquide, currently manufactures and sells a nitric oxide mixture in a pressurized canister in the European Union.
Other companies, including industrial gas companies may attempt to produce a traditional generic version of INOMAX, may attempt to provide a device to deliver nitric oxide, or may contract with a third-party manufacturer to produce the pharmaceutical nitric oxide or the device to deliver nitric oxide. Our partnership and distribution arrangements limit our ability to operate in certain geographic markets or develop certain products, which may limit our future growth. We are party to a number of commercial and license agreements with third parties and related parties that limit our ability to sell our products in certain geographic markets, require us to sell our products exclusively to a distributor of our products in certain geographic markets, or that limit our ability to develop or commercialize certain uses of our products or new drug candidates.
We may have received better terms from unaffiliated third parties than the terms we received in our agreements with related parties. We have entered into license and commercial agreements with Linde AG, a current shareholder of Seller and former shareholder of Ikaria, governing, among other things, the exclusive sale of our products and services to affiliates of Linde AG in Europe and certain South American territories.
From until , during which time certain of these agreements were negotiated, a representative of Linde AG was a member of the board of Ikaria. The terms of the agreements we negotiated in the context of our separation related to, among other things, allocation of assets, liabilities, rights, indemnifications and other obligations among the spun-out business and us.
Third parties may seek to hold us responsible for liabilities that we transferred in the spin-out. In connection with the spin-out of certain businesses and assets in February , we transferred to the spun-out business all liabilities related to the spun-out business and assets. Third parties may. Under our agreements with the spun-out business, it has agreed to indemnify us for claims and losses relating to these transferred liabilities.
However, if those liabilities are significant and we are ultimately liable for them, we cannot assure you that we will be able to recover the full amount of our losses from the spun-out business, particularly since the spun-out business is a growth stage company with minimal or no income.
Any disputes that arise between us and the spun-out business with respect to our past and ongoing relationships could harm our business operations. Disputes may arise between us and the spin-out business in a number of areas relating to our past and ongoing relationships, including:.
We may not be able to resolve any potential conflicts, and even if we do, the resolution may be less favorable than if we were dealing with an unaffiliated party. Risks Related to Government Regulation of Ikaria. The design, development, manufacture, supply, and distribution of our products are highly regulated and technically complex.
The design, development, manufacture, supply, and distribution of pharmaceutical products and medical devices, both inside and outside the U. We, along with our third-party providers, must comply with all applicable regulatory requirements of the FDA and foreign authorities. In addition, the facilities used to manufacture, store, and distribute our products are subject to inspection by regulatory authorities at any time to determine compliance with applicable regulations.
The manufacturing techniques and facilities used for the manufacture and supply of our products must be operated in conformity with current Good Manufacturing Practices, or cGMP, regulations promulgated by the FDA. In complying with cGMP requirements, we, along with our suppliers, must continually expend time, money and effort in production, record keeping, and quality assurance and control to ensure that our products meet applicable specifications and other requirements for safety, efficacy and quality.
In addition, we, along with our suppliers, are subject to unannounced inspections by the FDA and other regulatory authorities. Any failure to comply with regulatory and other legal requirements applicable to the manufacture, supply and distribution of our products could lead to remedial action such as recalls , civil and criminal penalties and delays in manufacture, supply and distribution of our products. In addition, we may from time to time be forced to delay the launch of new products or carry out voluntary recalls to address unforeseen design difficulties or defects, which could result in an adverse effect on our revenue and operating results.
We must comply with federal, state and foreign laws and regulations relating to the healthcare business, and, if we do not fully comply with such laws and regulations, we could face substantial penalties and other negative impacts on our business. We and our suppliers and customers are subject to extensive regulation by the federal government, and the governments of the states and foreign countries in which we may conduct our business.
If our operations are found to be in violation of any of the laws and regulations to which we or our customers are or will be subject, we may be subject to civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the curtailment or restructuring of our operations. Similarly, if our customers are found to be non-compliant with applicable laws, they may be subject to sanctions, which could also have a negative impact on us.
Any penalties, damages, fines, curtailment or restructuring of our operations would adversely affect our ability to operate our business and our financial results. If we fail to comply with the extensive regulatory requirements to which we and our products are subject, our products could be subject to restrictions or withdrawal from the market and we could be subject to penalties.
The testing, manufacturing, labeling, safety, advertising, promotion, storage, sales, distribution, export and marketing, among other things, of our products, both before and after approval, are subject to extensive regulation by governmental authorities in the United States, Canada, Mexico and elsewhere throughout the world where we sell our products and services.
Both before and after approval of a product, quality control and manufacturing procedures must conform to cGMP. Regulatory authorities, including the FDA, periodically inspect manufacturing facilities to assess compliance with cGMP. Our failure or the failure of our contract manufacturers to comply with the laws administered by the FDA or other governmental authorities could result in, among other things, any of the following:. We may incur significant costs complying with environmental laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities.
Certain aspects of our business are subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, distribution, storage, handling, treatment and disposal of materials. For example, high-pressure gas cylinders can be regarded as hazardous materials. Although we believe our safety procedures for handling and disposing of these materials and waste products comply with these laws and regulations, we cannot eliminate the risk of accidental.
In the event of contamination or injury, or failure to comply with environmental, occupational health and safety and export control laws and regulations, we could be held liable for any resulting damages and any such liability could exceed our assets and resources. Failure to comply with the U. Foreign Corrupt Practices Act could subject us to penalties and other adverse consequences. We are subject to the U. Foreign Corrupt Practices Act which generally prohibits U. We can make no assurance that our employees or other agents, including third party distributors, will not engage in prohibited conduct under our policies and procedures and the Foreign Corrupt Practices Act for which we might be held responsible.
If our employees or other agents are found to have engaged in such practices, we could suffer severe penalties and other consequences that may have a material adverse effect on our business, financial condition and results of operations.
Governments may impose price controls, which may adversely affect our future profitability. We are subject to rules and regulations in jurisdictions outside the U. In some foreign countries, particularly in the European Union, the pricing of prescription pharmaceuticals and biologics is subject to governmental control.
In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product candidate. If reimbursement of our future products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability. We may be unsuccessful in our efforts to develop and obtain regulatory approval for new products, which may significantly impair our growth and ability to remain profitable.
Our long-term prospects depend, in large part, on successful development, or acquisition or licensing, and commercialization of our product candidates, including Terlivaz. Our product candidates are in various stages of development. Before we commercialize any product candidate, we will need to develop the product candidate by completing successful clinical trials, submit an NDA or supplemental NDA that is accepted by the FDA and receive FDA approval to market the product candidate.
Ikaria currently is in discussions with the FDA to determine its regulatory strategy. Clinical trials of product candidates are expensive and time consuming, and the results of these trials are uncertain. Before we can obtain regulatory approvals to market any product for a particular indication, we will be required to complete preclinical studies and extensive clinical trials in humans to demonstrate the safety and efficacy of such product for such indication.
Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. Furthermore, there are few drugs that have been approved in critical care indications. It is often difficult to design and carry out clinical trials for critical care indications for a number of reasons, including ethical concerns with conducting placebo-controlled studies in critically ill patients, the difficulty in meeting endpoints tied to mortality and the heterogeneity of underlying conditions.
For the foregoing reasons, we may not be able to develop clinical trials for some of our product candidates that will be acceptable to the FDA. Success in preclinical testing or early clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results. An unexpected result in one or more of our clinical trials can occur at any stage of testing due to drug effect or trial design.
Even well-conducted studies of effective drugs will sometimes appear to be negative. We may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent us from receiving regulatory approval or commercializing our products, including:. The rate of completion of clinical trials depends, in part, upon the rate of enrollment of patients.
Patient enrollment is a function of many factors, including the size of the patient population, the eligibility criteria for the trial, the existence of competing clinical trials and the availability of alternative or new treatments. In particular, the patient population targeted by some of our clinical trials may be small. Delays in patient enrollment in any of our current or future clinical trials may result in increased costs and program delays. Administering any pharmacologically active product candidate to humans may produce undesirable side effects.
As a result, our clinical trials could be suspended at any time for safety-related reasons. We may voluntarily suspend or terminate our clinical trials if at any time we believe that our product candidates present an unacceptable risk to the clinical trial subjects. In addition, institutional review boards or regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe that the clinical trials present an unacceptable safety risk to patients.
The FDA may accept the labeling recommendations made in the labeling supplement, it may reject the recommended changes, or it may require other changes to the labeling. We are unable to accurately predict when or if any of our product candidates will prove effective or safe in humans or will receive regulatory approval.
If the effects of our product candidates include undesirable side effects or have characteristics that are unexpected, we may need to abandon our development of those product candidates. In the case of INOMAX, ongoing clinical trials for new indications could uncover safety concerns that impact our existing business. If we are unable to expand our sales and marketing capabilities, the commercial opportunity for our product and product candidates may be diminished.
We plan to expand our team of sales professionals as we prepare to support continued growth of INOMAX Total Care and, over time, the expected commercial launch of other products in development, such as Terlivaz, if and when such products receive required regulatory approvals. We may not be able to attract, hire, train and retain qualified sales and marketing professionals to augment our existing capabilities in the manner or on the timeframe that we are currently planning.
If we are not successful in our efforts to expand our sales team and marketing capabilities, our ability to independently market and sell INOMAX and related products and services and any product candidates that we successfully bring to market will be impaired. In such an event, we would likely need to establish a collaboration, co-promotion, distribution, or other similar arrangement to market and sell the product candidate.
However, we might not be able to enter into such an arrangement on terms that are favorable to us, or at all. The biotechnology and pharmaceutical industry is characterized by rapid technological developments and a high degree of competition. As a result, our products could become obsolete.
Our industry is highly competitive. Potential competitors in the U. Many of our competitors have substantially greater capital resources, research and development staffs, and facilities than we have. In addition, many of our competitors also have substantially greater experience in conducting clinical trials, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products and medical devices.
These entities represent significant. Competition and innovation from these or other sources, including advances in current treatment methods, could potentially affect sales of our products negatively or make our products obsolete. Furthermore, we may be at a competitive marketing disadvantage against companies that have broader product lines and whose sales personnel are able to offer more complementary products than we can.
Any failure to maintain our competitive position could adversely affect our business and results of operations. In addition, as we lose patent protection or marketing exclusivity on our products over time, we will likely have to compete with generic versions of our products. If Terlivaz is approved by the FDA, we expect that it will compete with a combination of midodrine, a vasopressor, and octreotide, a vasodilation inhibitor.
If we fail to attract and retain senior management and key scientific and engineering personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates.
Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, clinical, scientific, equipment service, operations and engineering personnel. We are highly dependent upon the contributions of our executive officers, as well as our most senior clinicians and scientists. The loss of services of any key employees could delay or prevent the successful development of our product pipeline, completion of our planned clinical trials or the commercialization of our product candidates.
Although we have entered into employment agreements with these individuals, setting forth certain salary, severance and other terms, the agreements do not require continued employment and we or the employee may terminate the relationship at any time. Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with manufacturing standards we have established, to comply with federal and state healthcare fraud and abuse laws and regulations, to report financial information or data accurately, to disclose unauthorized activities to us or to comply with our Code of Business Conduct and Ethics for Officers and Employees.
In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, false claims, inappropriate promotion, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible for our chief compliance officer, who works to ensure that we and our employees are in compliance with applicable rules, regulations and company policies, to identify and deter employee misconduct.
The precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.
Ikaria conducted an extensive investigation and eventually sued the former employees. Ikaria continues to pursue its rights in this matter. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates. We face an inherent risk of product liability as a result of the clinical testing of our product candidates and face an even greater risk with respect to our commercialized products.
We may be sued if INOMAX or any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. In addition, we may be sued if our drug-delivery systems malfunction or are alleged to have malfunctioned. We have been, and may in the future be, sued based on allegations that our drug-delivery system fails to provide adequate warnings.
For example, although no suits have been brought to date, it is possible that a suit could be brought as a result of issues relating to our recalls. A suit may also be brought against us if our drug-delivery system is alleged to fail to adequately monitor for nitrogen dioxide, which forms when nitric oxide mixes with oxygen in the air.
Elevated levels of nitrogen dioxide can be toxic and lead to decreased pulmonary function, chronic bronchitis, chest pain and pulmonary edema. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumer protection acts.
If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:. Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop.
Any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
As our product is used commercially, unintended side effects, adverse reactions or incidents of misuse may occur that could result in additional regulatory controls, changes to product labeling, adverse publicity and reduced sales of our products. During research and development, the use of pharmaceutical products, such as ours, is limited principally to clinical trial patients under controlled conditions and under the care of expert physicians.
The widespread commercial use of INOMAX or other products that we may develop could uncover undesirable or unintended side effects that were not exhibited in our clinical trials or the commercial use as of the filing date of this prospectus. We train healthcare professionals on the proper use of our drug and drug-delivery systems. However, healthcare professionals from time to time operate our drug-delivery systems incorrectly.
These events, among others, could result in adverse publicity that harms the commercial prospects of INOMAX or other products we may develop or lead to additional regulatory controls that could limit the circumstances under which the product is prescribed or used or even lead to the withdrawal of the product from the market. Reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our products profitably.
Market acceptance and sales of our product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for any of our product candidates and may be affected by existing and future healthcare reform measures. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs they will pay for and establish reimbursement levels.
Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to the payor. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement.
We cannot be sure that coverage or adequate reimbursement will be available for any of our product candidates. Also, we cannot be sure that reimbursement amounts will not reduce the demand for, or the price of, our products. If reimbursement is not available or is available only to limited levels, we may not be able to commercialize certain of our products.
In the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system that could impact our ability to sell our products profitably. In particular, the Medicare Modernization Act of revised the payment methodology for many products under Medicare.
This has resulted in lower rates of reimbursement. There have been numerous other federal and state initiatives designed to reduce payment for pharmaceuticals. As a result of legislative proposals and the trend towards managed healthcare in the United States, third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs.
They may also refuse to provide any coverage of approved products for medical conditions other than those for which the FDA has granted market approvals. As a result, significant uncertainty exists as to whether and how much third-party payors will reimburse patients for their use of newly approved drugs, which in turn will put pressure on the pricing of drugs.
We expect to experience pricing pressures in connection with the sale of our products due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, additional legislative proposals, as well as national, regional or local healthcare budget limitations. We rely on third parties for important aspects of our commercialization infrastructure for INOMAX and related services and failure of these third parties to fulfill these functions would disrupt our business.
We have entered into agreements with local third-party providers to provide warehousing, distribution, and service centers in certain markets in which we sell our products. Our third-party providers may not be able to warehouse, distribute, or service our products without interruption, or may not comply with their other contractual obligations to us.
Any failure of any of those third-party providers to fully and timely perform their obligations may result in an interruption in the supply of INOMAX and related products and services in the affected geographic area. Also, we may not have adequate remedies for any breach of our agreements with such third-party providers.
Furthermore, if any of our third-party distributors ceases doing business with us or materially reduces the amount of services they perform for us, and we cannot enter into agreements with replacement service providers on commercially reasonable terms, we might not be able to effectively distribute our products to all geographic locations we currently serve. For starters, working in a small family office meant that there was way more interaction with my co-workers.
I was able to talk and ask about a wide range of different things, and as a result, I learned not only about finance but also about Hong Kong! In addition, with regards to the working environment, working in the buy-side meant that my co-workers really took ownership of their investments.
I personally noticed that they performed an exceptionally wide range of analyses, ranging from top-down to bottom-up fundamental analysis, talking to sell-side equity researchers, and having meetings with people in the industry, in order to make sure that their analyses were accurate. In conclusion, my internship at Ikaria Capital was indeed a very fruitful experience. My workspace. With Aaron, the Research Analyst. With Henry, the co-founder of Ikaria Capital.
Facebook Twitter Weibo. Share this Story. Internship Experience.
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|Krutchik alan n&md investment corp||He also co-founded Ikaria Capital Limited, a company focusing on late-stage technology investments. In addition, we may be subject to allegations of trade secret strategi trading forex tanpa indikator ekonomi and other claims. Obtaining ikaria investments limited and reimbursement approval for a product from a government or ikaria investments limited third-party payor is a time consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to the payor. These restrictions may prevent Ikaria from pursuing attractive business opportunities that may arise prior to the completion of the Ikaria Acquisition. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.|
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|Investment banking investment management logos software||To that end, we must be able to manage our development efforts and clinical trials effectively ikaria investments limited hire, train and integrate additional management, administrative and sales and marketing personnel. Qui tam suits, also commonly referred to as ikaria investments limited suits," are often brought by current or former employees. Other expense incomenet 1. We may incur charges to earnings related to our efforts to consummate transactions. The data provided below were based on, and should be read in conjunction with, the historical consolidated financial statements and related notes of each of Mallinckrodt, Questcor and Cadence for the applicable periods, which are incorporated herein by reference, and the historical financial statements and related notes of Target and Ikaria included in this offering circular.|
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