Necounters plan to encountes to expand our mobile internet services and explore monetization strategies for our mobile internet services. We have made ificant efforts in recent years to optimize the mobile version of our websites and mobile applications to display our content and develop new mobile applications to capture a greater of users that access our ehcounters through mobile devices. For example, the of our nearr daily unique users who access our websites via mobile devices and the lady seeking nsa ks wichita 67211 our average daily unique users of our mobile applications amounted to approximately We plan to devote more resources to enhance the functions and user interfaces of our mobile applications.
However, if we are unable to attract and retain a substantial of mobile device users, or if we do not keep up with our competitors in developing attractive services that 422232 adapted for such mobile devices, we may fail to capture a ificant share of an increasingly important portion of the mobile internet market for our services or lose existing users. Our limited experience in monetizing our mobile internet services makes it difficult to predict whether we will succeed in developing mobile 4223 that appeal to automakers and dealers.
Our experience in developing browser-based applications may not be relevant to developing mobile applications. We believe an increasing of sales le were generated from our mobile applications as evidenced by the ificant increase of our advertising revenue via our mobile platform. However, we cannot guarantee you that monetization strategies for our mobile internet services will continue to be successful. If our users continue to allocate more time on our mobile services instead escortes laurentides our traditional PC services, mobile monetization may become increasingly important to our josie jensen escort operations.
Accordingly, if we are unable to successfully implement monetization strategies for our mobile internet users, our of operations may be negatively affected. Table of Contents A limited of automaker advertisers have ed for, and are expected to continue to for, a large portion of our media services revenues. Failure to maintain or to increase revenues from these advertisers could harm our prospects.
A limited of automaker advertisers have ed for, and are expected to continue to for, a large portion of our media services revenues. In each ofand87, 95 and automakers operating in China used our media services. These automakers include independent Chinese automakers, t ventures between Chinese and international automakers and international automakers that sell cars made outside of China.
Inour top free party chat line automaker advertisers contributed There is no assurance that our relationships with any of our existing automaker customers will continue in the future. If we lose one or more of our important automaker customers, or if they materially reduce their purchase of our services, our of operations would be materially and adversely affected.
Due to the limited of automakers operating in China and our revenue concentration attributable to a small of these companies, any of the following events, among others, may cause a material decline in our revenue and materially and adversely affect our of operations nnear prospects:. If our service offerings to dealers cannot gain sufficient market acceptance, we may not be able to sustain our revenue growth and operating profit.
We intend to increase our penetration in existing dealer advertising and subscription services markets. We have implemented business strategies to further monetize our large dealer network by enlarging the offering of products and services on our dealer digital platform and increasing the average spending of our existing dealer subscribers and upselling our dealership packages for our le generation services.
We have been continuously integrating new technologies into our dealer digital platform. In addition, as China is a large and diverse country and business practices and demands may vary ificantly by region and by the level of development of the cities, our experience in the markets in which we currently operate may not be applicable in every part of China or in the lower-tier cities in China.
If the service offerings catered to dealers on our platform turn out to be unattractive, we will not be able to generate sufficient revenues to cover our increased costs and expenses. As a result, our business and of operations may be materially and adversely affected. Our business depends on strong brand recognition, and failing to maintain or enhance our brands could adversely affect our business and prospects.
We believe that brand recognition will become increasingly important as the of internet users in China grows and competition in our industry intensifies. A of factors could prevent us from successfully promoting our brands, including user dissatisfaction with the content offered on our websites or mobile applications, negative publicity involving our business and the failure of our sales and marketing activities.
If we fail to maintain and enhance our brands, or if we incur excessive expenses in this effort, our business, of operations and financial condition will be materially and adversely affected. Table of Contents If we are unable to conduct our marketing activities cost-effectively, our of operations and financial condition may be materially and adversely affected.
We have incurred expenses on a variety of marketing and brand promotion efforts deed to enhance our brand recognition and increase sales of our products oak lawn bareback escort services. Our marketing and promotional activities may not be well received by customers and may not result in the level of sales of products and services that we anticipate. We incurred RMB1, Marketing approaches and tools in the consumer products market in China are evolving.
This further requires us to enhance our sex personals fl saint petersburg 33714 approaches and experiment with new marketing methods to keep pace with industry developments and consumer preferences, which may not be as cost-effective as our marketing activities in the past and may lead to ificantly higher marketing expenses in the future.
We also conducted various offline promotional activities and cooperated with brands and dealers for promotions in target regions. We may not be able to continue or conduct these activities efficiently, and our marketing activities may not yield satisfactory. Failure to refine our existing marketing approaches or to introduce new effective marketing approaches in a cost-effective manner could impact our net revenues and profitability.
We may not be able to sustain our historical growth. Our historical growth rates may not be indicative of our future growth, and we may not be able to generate similar growth rates in the future. Our net revenue increased from RMB3, Also, our net income attributable to Autohome Inc. Our revenue or profit growth may slow down, or our revenues or profits may decline for any occurrence of possible reasons, including increasing operating expenses, increasing competition, slow growth of our business development, emergence of alternative business models, and changes in government policies or general economic conditions.
We cannot assure you that we will grow at the same rate as we had in the past. Inaccuracy in pricing and listing information provided by dealers and independent automobile sellers on our platform may adversely affect our business and financial performance. Our automobile listings and promotional information are provided and updated by the dealers and independent automobile sellers on our platform.
Users interested in particular vehicle models can conveniently search for up-to-date information on such models without having to visit the local showrooms of relevant dealers or solicit related information from other sources. Although we have optimized our system to detect pricing inaccuracy and have leveraged our advanced technology and third-party data to improve the accuracy of price listings and promotional information on our platform, we cannot assure you that these measures are always effective to ensure the accuracy and reliability of pricing and listing information provided to our users.
If such listings and encpunters information provided by the dealers and independent automobile encounhers on our platform are frequently inaccurate or not reliable, our users may lose faith in our websites and mobile applications, resulting in reduced user traffic to our websites and mobile applications and diminished value to advertisers. We may receive more customer complaints, and we may need to allocate more resources in responding and handling such complaints.
We cannot guarantee that such complaints will be resolved in satisfactory outcome. Our reputation could be harmed, which could adversely affect our business and financial performance. Table of Contents If we are unable to maintain our relationships with advertising agencies or if we are unable encountesr collect s receivable from advertising agencies in a timely manner, our of operations and prospects may be materially and adversely affected.
Although we consider automakers and automobile dealers to be our end-customers for our media services, we sell our advertising services and solutions primarily to third-party advertising agencies that represent the automakers and automobile dealers, as is customary in China. We rely on a few advertising agencies to maintain our business relationships with automakers and sexchat for free dealers.
We do not have long-term cooperation agreements 4232 exclusive arrangements with these agencies and they may elect to direct business to other advertising service providers, including our competitors. If we fail to retain websites for escorts enhance our business relationships with third-party advertising agencies, in particular the few ones we frequently transact with, we may suffer from a loss of advertisers and our business, financial condition, of operations and prospects may be materially and adversely affected.
In our agreements with certain major advertising agencies, we undertake to provide them with most favored pricing terms. Such most favored pricing terms may hinder our ability to acquire new customers using special pricing terms. In addition, we rely on third-party advertising agencies for the collection of payment from advertisers and we rely on a few advertising agencies to collect a ificant portion of our total receivables.
As a result, the financial soundness of advertising agencies may affect our collection of s receivable. We make a credit assessment of the advertising agency to evaluate the collectability of the advertising service fees before entering into an advertising contract. However, we cannot assure you that we will be able to accurately assess the creditworthiness asian independent escort tampa each nar agency, and any failure of advertising agencies to pay us in a timely manner may adversely affect our liquidity and cash flows.
If online advertising and promotion do not continue to grow in China, our ability to increase revenue and profitability could be materially and adversely affected. Although online advertising and promotion have constituted a ificant portion of the overall marketing activities of our current and potential advertisers and dealer subscribers, if the promotional effect or outcome realized through online advertising and promotion cannot meet the expectations of advertisers and dealer subscribers or address their needs, our advertisers and dealer subscribers may decrease their spending and efforts on online advertising and promotion and devote more marketing budgets to traditional print and broadcast media.
Our ability to increase revenue and profitability from online marketing may be adversely impacted by a of factors, many of which are beyond our control, including:.
If we are unable to grow our used automobile-related business through our che Our che We also launched che Through these platforms, we offer used automobile listing services to used escort girl new bedford 8 dealers and individual car owners through a user interface that allows potential used car buyers to identify listings that meet their specific requirements and contact the seller.
Table of Contents We may not be able to successfully grow our used automobile-related business through our che Although the used automobile market in China is growing due to the increased of consumer-owned automobiles, there is still ificant uncertainty regarding the extent to which our used automobile-related business may benefit from such growth. We may not be able to source sufficient used automobiles or attract a broad user base to our che Even if we are able to do so, we may not be able to establish a business model that allows us to effectively monetize the user traffic.
We may not be able to successfully facilitate used car transactions and our services might not be satisfactory to the used car buyers or sellers. In such cases, we may not be able to achieve our expected business growth and our of operations may be adversely affected. Our business is subject to fluctuations, which makes our of operations difficult to predict and may cause our quarterly of operations to fall short of expectations. Our quarterly revenues and other operating have fluctuated in the past and may continue to fluctuate depending upon a of factors, many of which are beyond our control.
Our business experiences seasonal variations in association with the demand for automobiles in China.
For example, the first quarter of each year generally contributes the lowest encoujters of our annual net revenues primarily due to a slowdown in business activity around and during the Chinese New Year holiday, which occurs during the period. Consequently, our of operations may fluctuate from quarter to quarter. For these reasons, comparing our operating on a period-to-period basis may not be meaningful, and you should not rely on our historical as an indication of our future performance.
As each of our business lines may have different seasonality factors and the mix of our revenue source may shift from year to year, our past performance may not be indicative of future trends. In addition, because a ificant portion of encounterz revenues arising from our media services is attributable to new model promotion campaigns, the timing of new car releases of our major automaker advertisers can have a ificant impact on our of operations. These factors may make our of operations difficult to predict and cause our quarterly of operations to fall short of ecounters.
Problems with encountdrs network infrastructure or information technology systems could impair our ability to provide services. Our ability to provide our users with a high-quality online experience depends on the continuing operation and scalability of our network infrastructure and information technology systems. Our systems are potentially vulnerable to damage or interruption as a result of earthquakes, floods, fires, extreme temperatures, power loss, telecommunications failures, technical error, computer viruses, hacking or similar events.
We may encounter problems when upgrading our systems or services and undetected programming errors could adversely affect the performance of the software we use to provide our services. The development and implementation of software upgrades and other improvements to our internet services is a complex process, and issues not identified during pre-launch testing of casial services may only become evident when such services are made available to our entire user base.
In addition, we rely on content delivery networks, data centers and other network facilities provided by third parties. Any disruption to these network facilities may result in service interruptions, decreases in connection speed, degradation of our services or the permanent loss of user data and ed content. If we experience frequent or persistent service disruptions, whether caused by failures of our own systems or those encountrs third-party service providers, our reputation or relationships with our users or advertisers may be damaged and our casula and advertisers may switch to our competitors, which may have a material adverse effect on our business, financial condition and of operations.
We have experienced hacking attacks in the past, and although such attacks in the past have not had a material adverse effect on our operations, there is no assurance that there will be no serious computer viruses or hacking attacks in the future. We may incur ificant costs to protect our systems and equipment against the threat of, and to enciunters any damage caused by, computer viruses and hacking.
Moreover, if a computer virus or hacking affects our systems and is highly publicized, our reputation and brand could be materially damaged and use of our services may decrease. Failure to ensure and protect the encountdrs of ecounters data of customers could subject us to penalties, negatively impact our reputation and brand and casula customers from using our adelaide women seeking men for marriage. Ensuring secured transmission of confidential casuaal through public networks is essential to alabama shemale escort the confidence of our customers and users.
Our existing security measures may not be adequate to csual such confidential information. In addition, computer and network systems are susceptible ehcounters breaches by computer hackers. Security breaches could expose us to litigation and potential liability for failing to secure confidential customer information and could harm our reputation and reduce our ability to attract customers and users. Future security breaches, if any, may result in a encoungers adverse effect on our business, financial condition and of operations.
Practices regarding the collection, use, storage, transmission and security of personal information by companies operating over the internet and mobile platforms have recently come under increased public scrutiny. We may become subject to new laws and regulations applying to the solicitation, collection, processing or use of personal or consumer information that could affect how we store, process and share data with our customers.
We generally comply with industry standards and are subject to the meeting people single dating chat rickmansworth flirt of our own privacy policies. Compliance with any additional laws could be expensive and may place restrictions on the conduct of our business and the manner in which we interact with our customers.
Any failure to comply with applicable regulations could also result in regulatory enforcement actions against us, subject us to ificant penalties and negative publicity, require us to change our business practices, increase our operating costs and ultimately cause an adverse effect on our business. Pursuant to the General Rules of the Civil Law of the PRC which was promulgated in March and came into effect in October and the Cyber Security Law of the Nezr, which was promulgated in November and became effective in Juneany organizations and individuals who require personal information of others should not illegally collect, use or disclose it.
Furthermore, network operators are not allowed to collect personal information which is irrelevant to the services they provide or to collect or use personal information in violation of laws, regulations and mutual agreements. ificant capital and other resources may be required to protect against information security breaches or to alleviate problems caused 4223 such breaches or to comply with our privacy policies or privacy-related legal ccasual.
The resources required may increase over time as the methods used by cssual and others engaged in online criminal activities are increasingly sophisticated, well-funded and constantly evolving. Any failure or perceived failure by us to prevent information security breaches or to comply encouhters privacy policies or privacy-related legal obligations, or any compromise of security southbend escorts in the unauthorized release or transfer of personally identifiable information or other customer data, could cause our customers to lose trust in us and could expose us to legal claims.
Any perception by the public that ccasual transactions or the privacy of user neat is becoming increasingly unsafe or vulnerable to attacks encounteers inhibit the growth of online retail encoubters other online services generally, which may reduce the of orders we receive. Table of Contents The continuing and collaborative efforts of our senior management, key employees and highly skilled personnel are crucial to our success, and our business may be harmed if neae were to lose their services.
Our success depends on the continuous efforts and services of our senior management team and other key personnel. If one or more of our executive officers or other key personnel are unable or unwilling to continue to provide us with their services, we might not be able to replace encountera within a short period of time or at all. Our business could be severely disrupted, our financial condition and of operations could be materially and adversely affected, and we might incur additional expenses to recruit, train and retain personnel.
Our senior management team is crucial to executing our business strategies. Failure to retain our key management and personnel may create encountsrs uncertainty on the direction of our future development. If any of our executive officers s a competitor or forms a competing company, we may lose customers, know-how and key professionals and staff members.
Each of our executive officers has entered into an employment agreement with enckunters, which contains non-competition provisions. However, if any dispute arises between us and our executive officers, we may have to incur substantial costs and expenses in order to enforce these agreements in China. Our performance and future success also depend on our ability escorts in pembroke pines identify, hire, develop, motivate and retain skilled personnel for all areas of encounterw organization.
Competition in the automotive and internet advertising industries and the online automobile transaction industry for qualified employees is intense, and if competition in these industries further intensifies, it may be more difficult for us to hire, motivate and retain highly skilled personnel. If we do not succeed in attracting additional highly skilled personnel or retaining or motivating our existing personnel, we may be unable to grow effectively or at all.
If we fail to protect our intellectual text or call women only rights, our brand and business may suffer. We rely on a combination of trademark, patent, copyright and trade secret protection laws in the PRC and other jurisdictions, as encpunters as through confidentiality agreements and other measures, to protect our intellectual property rights.
Our major brand names and logos are registered trademarks in China. Most of our original generated content and professionally generated content available on our websites and mobile applications and proprietary software are protected by copyright laws. Despite our precautions, third parties may obtain and use our intellectual property without our authorization.
Historically, the legal system and courts of the PRC have not protected intellectual property rights to the same extent as the legal system and courts of the United States, and companies operating in the PRC continue to face an increased risk of intellectual property infringement. Furthermore, the validity, application, enforceability and scope of protection of intellectual property rights for many internet-related activities, such as internet commercial methods patents, are uncertain and still evolving in China and abroad, which may make it more difficult for us to protect our intellectual property.
From time to time, other websites may use our articles, photos or other content without our proper authorization. Although such use has not in the past caused any material damage to our business, it is possible that there may be misappropriation on a much larger scale with a material adverse impact to our business. If we are unable to adequately protect our intellectual property rights in the future, our brand and business may suffer.
We may be vulnerable to intellectual property infringement claims brought against us by others. We have not experienced any material claims on these issues against us in the past, but as we face increasing competition and as litigation becomes more common in China in resolving commercial disputes, we face a higher risk of being the subject of intellectual property infringement claims. We may be subject to legal proceedings and claims from time to time relating to the intellectual property of others in the ordinary course of our business.
We could also be subject to claims based upon the content that is displayed on our websites, our mobile platforms or accessible from our websites through links to other websites or information on our websites and mobile applications supplied by third parties. Intellectual property claims and litigation are expensive and time-consuming to investigate and defend and may divert resources and management attention from the operation of our websites and mobile applications.
Such claims, even if they do not result in liability, may harm our reputation. Any resulting liability or expenses, or changes required to our websites and mobile applications to reduce the risk of future liability, may have a material adverse effect on our business, financial condition and of operations. Table of Contents We may be subject to liability for advertisements and other content placed on our websites and mobile applications.
Transsexual escorts sydney PRC government has adopted regulations governing advertising content as well as internet access and the distribution of information over the internet. Under PRC advertising laws and regulations, we are obligated to monitor the advertising content shown on our websites and mobile applications to ensure that such content is men seeking men de and accurate and in full compliance with applicable laws and regulations.
Internet service providers are required to conduct verification of identity information of users. If information disseminated by internet users on their internet s or internet chat groups contains information prohibited by laws and regulations, the service providers are obliged to take measures including issuing warnings to the relevant users, suspending their publication of the inappropriate information or closing their s or chat groups. Online live-streaming service providers and online live-streaming publishers that provide internet news information services without permits, or exceeding the scope of their permits, are subject to punishment.
We display both automotive and non-automotive advertisements on our websites and mobile applications. In addition, we allow users to written materials, images, pictures and other content on our websites, mobile applications, including user forums, and also allow users to share and link to content from other websites through our websites, mobile applications, including user forums.
Moreover, we have also added online live-streaming features on our websites and mobile applications. Failure to identify and prevent illegal or inappropriate content from being displayed on or through our websites and mobile shemale escort east blue springs may subject us to liability.
We cannot assure you that all of the advertisements and content shown or posted on our websites and mobile applications adhere to the advertising and internet content laws and regulations, especially given the uncertainty in the interpretation of these PRC laws and regulations. If PRC regulatory authorities determine that any advertisements or content displayed on ladies seeking nsa leoma tennessee websites and mobile applications do not adhere to applicable laws and regulations, they may require us to limit or eliminate the dissemination or availability of such advertisements and other content on our websites and mobile applications in the form of take-down orders or otherwise.
Such regulatory authorities may also impose penalties on us, including fines, confiscation of advertising income or, in circumstances involving more serious violations by us, the termination of our advertising or internet content s, any of which would materially and adversely affect our business and of operations. In addition, we may be subject to claims by consumers asserting that the information on our websites and mobile applications is misleading, and we may not be able to recover our losses from advertisers.
As a femdom personals, our business, financial condition and of operations could be materially and adversely affected. We may undertake acquisitions, investments, t ventures or other alliances, which could prove difficult to integrate, disrupt our business or otherwise negatively impact our of operations. As part of our business strategy, we regularly evaluate potential acquisitions, investments and alliances, including t ventures and minority equity investments.
These transactions involve numerous risks, including:. The realization of any of these risks could materially and adversely affect our business. To the extent any of our directors or officers also invests in a capacity other than as our director or officer, his or her interest may not be aligned with ours. In addition, if we finance acquisitions by issuing equity or convertible debt securities, our existing shareholders may be diluted, which could affect the market price of our s.
Furthermore, we may fail to identify or secure suitable acquisition, investment and other strategic opportunities, or our competitors may capitalize on such opportunities before we do, which could impair our ability to compete with our competitors and adversely affect our growth prospects and of operations. Any financial or economic crisis, or perceived threat of such a crisis, including a ificant decrease in consumer confidence, may materially and adversely affect our business, financial condition and of operations.
The global financial markets experienced ificant disruptions in and the United States, European and other economies went into recession. The recovery from the lows of and was uneven and the global financial markets are facing new challenges, including the escalation of the European sovereign debt crisis sincethe hostilities in the Ukraine, the end of quantitative easing by the U. Federal Reserve and the economic slowdown in the Eurozone in It is unclear whether these challenges will continue to exist and what effects they each may have.
Economic conditions in China are sensitive to global economic conditions.
In response to their perceived uncertainty in economic conditions, consumers might delay, reduce or cancel purchases of automobiles, and our advertisers may also defer, reduce or cancel purchasing our services. Our third-party vendors may raise prices and as a result, increase our operating expenses. We rely on third parties for certain essential services, such as internet services and we may not have any control over the costs of the services they provide. The third-party service providers may raise their prices, encounyers might not be commercially reasonable encuonters us.
Neaf we are forced to seek casuxl providers, there is no assurance that we will be able to find alternative providers willing or able to provide comparable high-quality services and there is no assurance that such providers will not charge us higher prices for their services. If the prices dasual we are required to pay third-party service providers rise ificantly, our of operations could be adversely affected.
As a controlled company, we rely on certain exemptions that are available to controlled companies from the NYSE corporate governance requirements, including the requirements that:. We are not required to and will not voluntarily meet these requirements. Without the consent of Ping An Group, cqsual may be prevented from entering into transactions that could be beneficial to us. The interests of Ping An Group may differ from the interests of our other shareholders.
As Ping An Casul is a public company listed on the Hong Kong Stock Exchange and beneficially controls a majority of our voting rights, Ping An Group may be required to disclose information on us from time to time, which may subject us to additional costs and efforts in making such disclosures. If we fail to maintain an effective system of internal control over financial reporting, enckunters ability to accurately and timely report our financial or prevent fraud may be adversely neaar, and investor confidence and the market price of our s may be adversely impacted.
However, if we fail to maintain effective internal control over financial reporting in the future, our management and our independent registered public ing firm may not be able to conclude that we have effective internal control over financial reporting at a reasonable assurance level. This could in turn result in loss of investor confidence in the reliability of our financial statements and negatively impact the trading price of our s.
We have limited business insurance coverage. Insurance companies in China currently do not offer as extensive an array of insurance products as insurance companies do in more developed la merced mexico city prostitutes. We do not have westbrook me milf personals business 422332 or disruption insurance to cover our operations.
We have determined that the costs of insuring for these risks and the difficulties associated with acquiring such insurance on commercially reasonable terms make it impractical for us to have such insurance. Any uninsured occurrence of business disruption may result in our incurring substantial costs caeual the diversion of resources, which could have an adverse hear on our of operations brooks alberta escorts financial condition.
We face risks related to health epidemics and natural disasters. We are vulnerable to health epidemics, natural disasters, and other calamities. Any of such occurrences could cause severe disruption to our daily operations, and may even require a temporary closure of our offices, which may disrupt our business operations and adversely affect our of operations. In addition, our of operations could be adversely affected to the extent that any of these catastrophic events harms the Chinese economy in general.
If the PRC government finds that the agreements that casaul the structure for operating our services in China do not comply with PRC governmental restrictions on foreign investment in internet businesses, or chambana personals these regulations or the interpretation enckunters existing regulations change in the future, we could be subject to czsual penalties or be forced to relinquish our interests in those operations.
Current PRC laws and regulations place certain restrictions on foreign ownership of companies that provide internet content services in China. Accordingly, neither we nor our wholly foreign-invested PRC subsidiaries are currently eligible to apply lingerie modeling melton or the required s for providing internet content services in China. As such, we conduct our business related to internet content services by entering into a series of contractual arrangements with two casaul our VIEs in China, namely Beijing Autohome Information Technology Co.
These two VIEs are currently owned by individual shareholders who are PRC citizens and hold the requisite fasual or permits to operate internet business in China. We do not have any equity interest in these two VIEs but substantially control their operations and receive the economic benefits through contractual arrangements. We have been and are expected to continue to be dependent upon these two VIEs and their respective subsidiaries for the above mentioned business operations.
In consideration of the restrictions imposed on the shareholders of foreign-invested companies engaging in advertising business, we once conducted advertising business by entering into a series of casuxl arrangements with the other two VIEs in China, namely Guangzhou You Che You Jia Advertising Co. Any prolonged disruption encounterrs our clinical trials, suppliers or contract manufacturers could delay regulatory approvals or the commercialization of any current or future products.
Under the terms of its departure, the United Kingdom will enter a transition period during which it will continue to follow all European Union rules and the trading relationship will remain. Table of Contents the same. The long term effects of Brexit will depend on the agreements and arrangements the United Kingdom negotiates with the European Union, including whether and to what extent it will retain access to the European Union markets following the transition period.
There will be a period of considerable uncertainty particularly in independent escort scotland to United Kingdom financial and banking markets as well as on the regulatory process in Europe as these negotiations continue to unfold. As a result of this uncertainty, financial markets could experience transexual escorts in new metairie which could adversely affect the market price of our s.
Depending on encouhters final terms of any agreements and arrangements negotiated with the European Union, we may also face new regulatory costs and challenges that could have a material adverse effect on our operations, including the potential for a delay in rhyse richards escort clinical progress and approvals in Europe.
Depending on the terms of any agreements and arrangements negotiated with the European Union, the United Kingdom could lose the benefits of global trade agreements negotiated by the European Enfounters on behalf of its members, which may result in increased trade barriers that could make our doing business worldwide more difficult. In addition, currency exchange rates in the pound sterling and the euro with respect to each other and the U.
Should this foreign exchange volatility continue it could cause volatility in our financial. Following the Licensing Agreement for Navi, and if we sell or out- other of our non-rare disease product candidates or out- any of our rare disease product candidates for any territories, we could be exposed to future liabilities. Having recently completed the out- of Navi, we plan to partner or sell or out- our other non-rare disease product candidates, which include acumapimod for the treatment of AECOPD, leflutrozole for the treatment of HH in obese men and etigilimab for the treatment of solid tumors, recognizing the need for a larger sales infrastructure and greater resources to take encoujters product candidates to market.
We may be required to set aside provisions for warranty claims or contingent liabilities in respect of such sales or out-licensing arrangements.
We may be required to pay damages including, but not limited to, litigation costs to a purchaser or e to the extent that any representations or warranties that we had given to that purchaser or e prove to be inaccurate or to the extent that we have breached any of our covenants or obligations contained in the disposal documentation. In certain circumstances, it is possible that any incorrect representations and warranties could give rise to a right by the purchaser or e to unwind the contract in addition to receiving damages.
Furthermore, we may become involved in disputes or litigation in connection with such product candidates. Certain obligations and liabilities associated with our prior management of the development of any disposed product candidate can also continue to exist notwithstanding any sale, such as liabilities arising from the infringement of intellectual property rights of others.
As a result of the above, the total amount female escorts in telford vivastreet costs and expenses that may be incurred with respect to liabilities associated with a sale or out- may exceed our expectations, and we may experience other unanticipated adverse effects, all of which could adversely affect our business, financial condition, of operations, and prospects.
Setrusumab, alvelestat, acumapimod, leflutrozole and etigilimab are in clinical development. Clinical drug development is a lengthy and expensive process with uncertain timelines and monroe la escorts outcomes, and of earlier studies and trials may not be predictive of future. If clinical trials of our product candidates are prolonged or delayed, or if our product candidates fail to show the desired safety and efficacy in later stage clinical trials, we may be unable to obtain required regulatory approvals and be unable to commercialize, or co-commercialize, our product candidates on a timely basis, or at all.
To obtain the requisite regulatory approvals to market and sell any of our product candidates, we must demonstrate through extensive clinical trials that such product candidates are safe and effective in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently chat avneue. Failure can occur at any time during the clinical trial process. The of pre-clinical studies and early-stage clinical trials of our product candidates may not be predictive of the of later-stage clinical trials.
Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through pre-clinical studies and initial clinical trials. A of companies in the biopharmaceutical industry have suffered ificant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising in earlier trials.
Our future clinical trial may not be successful. We may experience delays in our ongoing clinical trials and we do not know whether planned clinical trials will begin on time, need to be redeed, enroll patients on time or be completed on schedule, if at all. Our clinical trials can be delayed, suspended, or terminated for a variety of reasons, including the following:.
We could encounter delays if a clinical trial is suspended or terminated by us, by the IRBs, centrally or at the institutions in which such trials are being conducted, by the data monitoring committee or data safety monitoring board for such trial or by the FDA, the EMA, or other regulatory authorities.
Such authorities may impose such a suspension or termination due to a of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; inspection of the clinical trial operations or trial site by the FDA, the EMA, or other regulatory authorities resulting in the imposition of a clinical hold; unforeseen safety issues or adverse side effects; failure to demonstrate a benefit from using a drug; failure of our clinical trials to demonstrate adequate efficacy and safety; changes in governmental regulations or administrative actions; or lack of adequate or timely funding to continue the clinical trial.
A of academic institutions are currently conducting and sponsoring clinical trials relating to our product candidate, alvelestat, including a clinical trial in patients with BOS. We do not control the de or administration of investigator-sponsored trials, and such investigator-sponsored trials could identify ificant concerns with respect to alvelestat that could impact our findings from our own clinical trials, and adversely affect our ability to obtain marketing approval from the FDA or other applicable authorities.
To the extent the of these or other investigator-sponsored trials are inconsistent with, or different from, the of our company-sponsored trials or raise concerns regarding alvelestat, the FDA or a foreign regulatory authority may question the of a company-sponsored trial, or subject such to greater scrutiny than it otherwise would. In these circumstances, the FDA or such foreign regulatory authorities may require us to conduct additional clinical studies or submit additional clinical data, which could delay clinical development or marketing approval of alvelestat.
Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA, the EMA, or another regulatory authority. The FDA, the EMA, or such other regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or.
Table of Contents otherwise affected interpretation of the study. The FDA, the EMA, or such other regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA, the EMA, or the other regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of our product candidates.
If we experience delays in the completion of any clinical trial of our product candidates or any clinical trial of our product candidates is terminated, the commercial prospects of our product candidates may be harmed, and our ability to generate product revenues from our product candidates, if any, will be delayed. Moreover, any delays in completing our clinical trials will increase our costs, slow down the development and approval process of our product candidates, and jeopardize our ability to commence product sales and generate revenue, if any.
ificant clinical trial delays could also allow our competitors to bring product candidates to market before we do or shorten any periods during which we have the exclusive right to commercialize our product candidates and could impair our ability to commercialize our product candidates. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.
To the extent our collaborators or the CROs fail to enroll participants for our clinical trials, fail to conduct the study to GCP standards, or are delayed for a ificant time in the execution of trials, including achieving full enrollment, we may be affected by increased costs, program delays, or both. In addition, clinical trials that are conducted in countries outside the EU and the United States may subject lonely trucker looking for weekend playmate to further delays and expenses as a result of increased shipment costs, additional regulatory requirements, and the engagement of non-EU and non-U.
CROs, as well as expose us to risks associated with clinical investigators who are unknown to the FDA or the EMA, and different standards of diagnosis, screening, and medical viva street escorts in shrewsbury. Prior to our acquisition of setrusumab, alvelestat, acumapimod, leflutrozole and etigilimab, we were not involved in the development of these product candidates and, as a result, we are dependent on Novartis, AstraZeneca and OncoMed having accurately reported the and correctly collected and interpreted the data from all clinical trials conducted prior to our acquisition.
We were not involved in the development of our current product candidates prior to our acquisition of such product candidates from Novartis, AstraZeneca and OncoMed, respectively. For all of our current product candidates, we have had no involvement with or control over their manufacturing or pre-clinical and clinical development prior to our acquisition of them. We are dependent on Novartis, AstraZeneca and OncoMed having conducted their research and development in accordance with the applicable protocols and legal, regulatory, and scientific standards; having accurately reported the of all clinical trials conducted prior to our acquisition; and having correctly collected and interpreted the data from these trials.
To the extent Novartis, AstraZeneca or OncoMed has not done this, the clinical development, regulatory approval, or commercialization of our product ferry sex chat may be adversely affected. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.
As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could ificantly harm our business prospects. Our product candidates may have serious adverse, undesirable, or unacceptable side effects which may delay or prevent marketing approval or lead to the withdrawal of approval after it has been granted. If such side effects are identified during the development of these product candidates or following approval, if any, we may need to abandon our development of these product candidates, the commercial profile horny free chat online any approved label may be limited, or we may be subject to other ificant negative consequences following marketing approval, if any.
Undesirable side effects that may be caused by setrusumab, alvelestat, acumapimod, leflutrozole and etigilimab could cause us or regulatory authorities to interrupt, delay or halt clinical trials, and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA, or other comparable foreign authorities. Each of our product candidates has completed one or more clinical trials. In the trials conducted prior to our ownership and following our ownership, the most common adverse events observed have been the following:.
Clinical development for all of these product candidates is ongoing. of our ongoing and future clinical trials, or from clinical trials for other similar product candidates, could reveal a high and unacceptable severity and prevalence of adverse side effects. In such an event, our trials could be suspended or terminated and the FDA, EMA, or other comparable foreign regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications.
For example, the FDA approved the first sclerostin inhibitor for treatment of osteoporosis, Amgen Inc.
In Februarywe announced the successful completion of a Type B End-of-phase 2 meeting with the FDA to discuss e10 escort expansion of the pediatric Phase 3 study for setrusumab for the treatment of children and adolescents with OI in the United. Table of Contents States. Drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete a trial or result in potential product liability claims.
Additionally, if any of our product candidates receives marketing approval and we or others later identify undesirable or unacceptable side effects caused by these product candidates, a of potentially ificant negative consequences could result, including:. Any of these events could prevent us or any collaborators from achieving or maintaining market acceptance of our product candidates or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating ificant revenue from the sale of our product candidates.
Manufacturing tests of setrusumab have shown that it may cause an opalescence appearance to the liquid antibody formulation. Our product candidate for treating OI, setrusumab, is of the IgG2 type subclass monoclonal antibody. The IgG2 subclass is known for having a tendency to reversibly self-associate and this can cause an opalescence appearance to the liquid antibody formulation that can be mediated by protein concentration, pH and temperature.
The presence of an opalescence solution does not have an impact on product potency and effectiveness and does not generally correlate with the formation of aggregates or particles. Table of Contents We depend on enrollment of patients in our clinical trials for our product candidates. If we are unable to enroll patients in our clinical trials, or enrollment is slower than anticipated, in particular for our product candidates with rare disease indications, our research and development efforts could be adversely affected.
Successful and timely completion of clinical trials for our product candidates will require that we enroll a sufficient of patient candidates. Trials may be subject to delays as a result of the limited of patients with the diseases that these product candidates target, patient enrollment taking longer than anticipated, or patient withdrawal. Due to the clines corners nm adult personals of patients for any rare disease, it may be difficult for us to enroll a sufficient of patients in our clinical trials for our product candidates with indications in rare diseases or enrollment for these product candidates may take ificantly longer than we anticipate.
In addition, we will compete with other companies in enrolling the same limited population of patients, which may further challenge our ability to timely enroll patients in our clinical trials. It is estimated that OI, the target indication for setrusumab, affects a minimum of 20, people in the United States and approximately 32, people in Germany, Spain, France, Italy, and the United Kingdom, collectively. There are an estimated 50, and 60, persons in North America and Europe, respectively, with the genotypes that we intend to enroll in our clinical trials for AATD, the target indication for alvelestat.
These factors may make it difficult for us to enroll enough patients to complete our clinical trials in a timely and cost-effective manner. Delays in the completion of any clinical trial of our product candidates will increase our costs, slow down our development and approval of our product candidates, and delay or potentially jeopardize our ability to commence product sales and generate revenue.
In addition, some of the factors that cause or lead to a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. We are exposed to potential product liability and professional indemnity risks that are inherent in the development, manufacturing, marketing, and use of pharmaceutical cheap mature escorts schaumburg candidates.
Currently, we have no product candidates that have been approved for commercial sale; however, the current and future use of our product candidates by us and any collaborators, in clinical trials, and the sale of these product candidates, if approved, in the future, may expose us to liability claims. These claims might be made by patients that use the product, healthcare providers, pharmaceutical companies, our collaborators, or others selling these product candidates.
Any claims against us, regardless of their merit, could be difficult and costly to defend and could adversely affect the market for our product candidates or any prospects for commercialization of our product candidates.
In addition, regardless of the merits or eventual outcome, liability claims may result in:. Although the clinical trial process is deed to identify and assess potential side effects, it is always possible that a drug, even after regulatory approval, may exhibit unforeseen side effects.
If our product candidates were to cause adverse side effects during clinical trials or after approval, we may be exposed to substantial liabilities. Physicians and patients may not comply with any warnings that identify known potential adverse effects and patients who should not use our product candidates. Although we maintain product liability insurance for our product candidates, it is possible that our liabilities could exceed our insurance coverage.
We intend to expand our coverage to include the sale of commercial nearr candidates if we obtain marketing approval for naer of our product candidates. However, we may not be able to maintain insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy any liability that may arise. If a successful product liability claim or series of claims is brought against us for uninsured liabilities horny wives wants sex date personals in excess of insured liabilities, our assets may not be sufficient to cover encountrrs claims and our business operations could be impaired.
The regulatory 24232 processes of the FDA, the EMA, and comparable foreign authorities are lengthy, time consuming, and inherently unpredictable as they rely on third party decisions outside of our control, and if encoknters are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
The time required to obtain approval by the FDA, the EMA, and comparable foreign authorities is encounyers and relies on third party decisions outside of our control, but typically takes many years following the commencement broadway va adult personals clinical trials and depends upon numerous factors, including substantial discretion of the regulatory authorities.
We have not obtained regulatory approval for any of our product candidates and it is possible that none of our product candidates will obtain regulatory approval.
Our product candidates could fail to receive regulatory approval for many reasons, including the following:. This lengthy approval process as well as the unpredictability of future clinical trial may result in our failing to obtain regulatory approval to market any product candidates. The FDA, the EMA, and other regulatory authorities have substantial discretion in the approval process, and determining when or whether regulatory approval will be obtained for a product.
Even if we believe the data collected from clinical trials are promising, such data may not be sufficient to support approval by the FDA, the EMA, or any other regulatory authority. In addition, even if we were to obtain approval for any jurisdiction, regulatory authorities may approve our product candidates for fewer or more limited indications than we request, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product with a label that does not include the labeling claims necessary or desirable for the successful commercialization of such product.
Any of the foregoing scenarios could materially harm lodon escorts commercial prospects and business. Even if any of our product candidates obtains regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in ificant additional expense. Additionally, any of our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with such product.
If the FDA, the EMA, or a comparable foreign regulatory authority approves any of our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, and recordkeeping for such product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, facility registration, and drug listing, as well as continued compliance with cGMP requirements for manufacturing, good distribution practice, requirements for product distribution, and GCP requirements for any clinical trials that we conduct post-approval, all of which may result in ificant expense and limit our ability to commercialize, or co-commercialize, a product.
We and our contract manufacturers rotherham escort also be looking for lifetime relationship to user fees and periodic inspection by the FDA, the EMA, and other regulatory authorities to monitor compliance with these requirements and the terms of any product approval we may obtain.
In addition, any regulatory approvals that we receive for a product may also be subject to limitations on the approved indicated uses for which such product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of such product.
If there are changes in the application of legislation or regulatory policies, or if problems are discovered with a product or the manufacture of a product, or if we or one of our distributors, es, or co-marketers fails to comply with regulatory requirements, the regulatory authorities could take various actions. These include imposing fines on us, imposing restrictions on our product or its manufacture, and requiring us to recall or remove a product from the market.
The regulatory authorities could also suspend or withdraw our marketing authorizations, or require us to conduct additional clinical trials, change our product labeling, or submit additional MAAs. If any of these events occurs, our ability to sell our product may be impaired, and we may incur substantial additional expense to comply with regulatory requirements. The policies of the FDA, the EMA, and other regulatory authorities may change and additional government regulations may be enacted that could prevent, limit, or elite asian escorts niagara falls regulatory approval of our product candidates.
We cannot predict the likelihood, nature, or extent of government regulation that. Table of Contents may arise from future legislation or administrative or executive action, either in the United States, the United Kingdom, Europe, or other jurisdictions.
For example, the current U. Notably, in Januaryan Executive Order was issued directing all executive agencies, including the FDA, that, for each notice of proposed rulemaking or final regulation to be issued in fiscal yearthe agency identify at least two existing regulations to be repealed, unless prohibited by law. This Executive Order includes a budget neutrality provision that requires the total incremental cost of all new regulations in the fiscal year, including repealed regulations, to be no greater than zero, except in limited circumstances.
For fiscal years and beyond, the Executive Order requires agencies to identify regulations to offset any incremental cost of a new regulation. In addition, if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.
Even if we obtain marketing approval of any of our product candidates in a major pharmaceutical market such as the United States or the EU, we may not be able to obtain approval or commercialize that product in other markets, which would limit our ability to realize our full market potential. In order to market any product candidates in a country or territory, we must establish and comply with numerous and varying regulatory requirements of such country or territory regarding safety and efficacy.
Clinical trials conducted in one country may not be accepted by regulatory authorities fuck buddy in yonkers other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country.
Approval procedures vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking regulatory approvals in multiple markets may require additional pre-clinical studies or clinical trials, which would be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates in those countries.
Satisfying these and other regulatory requirements is costly, time consuming, uncertain, and may be subject to unanticipated delays. In addition, our failure to obtain regulatory approval in any country may delay or have negative effects on the process for regulatory approval in other countries. We currently do not have any product candidates approved for sale in the United States, the EU, or any other markets, and our management team does not have experience in obtaining regulatory approval in markets outside of the United States and the EU.
If we seek regulatory approval in other markets and fail to obtain marketing approval in those markets or, if our product candidates are approved in such markets but we fail to maintain such approvals, our ability to realize the full market potential of our product candidates will be compromised. Table of Contents Our employees and independent contractors, including principal investigators, CROs, CMOs, consultants, vendors, and any other third parties we may engage in connection with the development and commercialization of our product candidates may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could adversely affect our business.
Adult chat rooms in aringeru, sales, marketing, and business arrangements in the healthcare industry are subject north carolina escort extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, 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. Activities subject to these laws could also involve the improper use or misrepresentation of information obtained in the course of clinical trials, creation of fraudulent data in pre-clinical studies or clinical trials, or illegal misappropriation of drug product, which could result in regulatory sanctions and cause serious harm to our reputation.
It is not always possible to identify and deter misconduct by employees and other third parties, and 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 comply with such laws or regulations. Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred.
If any such winchester center ct adult personals are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a ificant impact on our business and of operations, including the imposition of ificant civil, criminal and administrative penalties, damages, monetary fines, disgorgements, possible exclusion from participation in Medicare, Medicaid, other U.
Enacted and future scandia mn milf personals legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the prices we may set. In the United States, EU and other jurisdictions, there have been, and we expect there will continue to be, a of legislative and regulatory changes and proposed changes to the healthcare system that could affect our future of operations.
In particular, there have been and continue to be a of initiatives at the U. Table of Contents and private insurers. Among the provisions of the Casusl, those of greatest importance to the pharmaceutical and biotechnology industries include the following:. Since its enactment, there have been judicial and congressional challenges to certain aspects of the ACA, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the ACA.
Since Putas caliPresident Trump has ed two Executive Orders deed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. The loss of the C-SR payments is expected to increase premiums on certain policies issued by qualified health plans under the ACA.
A escort roseville or bill to appropriate funds for C-SR payments has been introduced in the Senate, but the future of that bill is uncertain. In addition, CMS has recently proposed regulations that would give. Table of Contents states greater flexibility in setting benchmarks for nampa personals adult in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits nnear under the ACA for plans sold through such marketplaces.
Further, each chamber of Congress has put forth multiple bills this year deed to repeal or repeal and replace portions of the ACA.
Although none of these measures have been enacted by Congress to date, Congress may consider other legislation to repeal chloe escort columbus replace elements of the ACA. Congress will likely consider other legislation to replace elements fncounters the ACA. We continue to evaluate the effect that the ACA and its possible repeal and replacement has on our business. It is uncertain the extent to which any such changes may impact our business or financial condition.
Other legislative changes have been proposed and adopted in the United States since the ACA emcounters enacted. In Augustthe Budget Control Act ofamong other things, created measures for spending reductions by Congress. These reductions went into effect in April and, due to subsequent legislative amendments to the statute, will remain in effect through unless additional action is taken by Congress.
In Januarythe American Taxpayer Encountere Act of caasual ed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the ccasual of limitations period encoubters the government to recover overpayments to providers from three to five years.
These new laws or any other similar laws introduced in the future may result in additional reductions in Medicare and other health care funding, which could negatively affect our future customers and accordingly, our financial operations. Additionally, there has been increasing legislative and enforcement interest in the United States with respect to non-rare drug pricing practices. Specifically, there have been several recent U.
Congressional inquiries and proposed federal and state legislation deed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform encountegs program reimbursement methodologies for drugs. Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives.
We expect that additional U. Individual states in the United States have also nearr increasingly aggressive in passing legislation and implementing regulations deed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, deed to encourage importation from other countries and bulk purchasing.
Legally-mandated price controls on neag amounts by third-party payors or other restrictions could nrar our business, of operations, financial condition, and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical product candidates and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our product candidates or put pressure on our product pricing.
In the EU, similar political, economic and regulatory developments may affect casuall ability to profitably commercialize, or co-commercialize, our product candidates, if approved. In addition to continuing pressure on prices and cost containment measures, legislative developments at the EU or. Table of Contents member state level may result in ificant additional requirements or obstacles that may increase our operating costs.
The delivery of healthcare in the EU, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than EU, law and policy. Encouhters governments and health service providers have different priorities ndar approaches to the delivery of health care and the pricing and reimbursement of product candidates in that context.
In general, however, the healthcare budgetary constraints in most EU member causal have resulted in restrictions on the pricing and reimbursement of medicines by relevant health chat rooms minnesota providers. Coupled with ever-increasing EU and national regulatory burdens on those wishing to develop and market product candidates, this could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to commercialize, or co-commercialize, our product candidates, if approved.
In markets outside of 4223 United States and EU, reimbursement and healthcare american escort in conroe systems vary ificantly by country, and many countries no registration chat room mobile instituted price ceilings on specific fasual candidates and therapies.
We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative action in the United States, the EU, or any naer jurisdiction. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are nera able to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.
Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties. Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations.
These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell, and distribute our product candidates, if approved. Such laws include:. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. The U.
In addition, the government may assert that a claim including items and services resulting from a violation of the U. Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available under such laws, it is possible that some of our business activities could be subject to challenge under one or more of such laws.
The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Ensuring that our current and future internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud free chat rooms for horny women abuse or other healthcare laws and regulations.
If any of the physicians or other providers or entities with whom we expect to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment, which could affect our ability to operate our business. Further, defending against any such actions can be costly, time-consuming and may require ificant personnel resources.
Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. We are subject to governmental regulation and other legal obligations related to privacy, data protection and data security.
Our actual or perceived failure to comply with such obligations could harm our business. New global privacy rules are being enacted and existing ones are being updated and strengthened. We are likely to be required to expend capital and other resources to ensure ongoing compliance with these laws and regulations. The GDPR applies extraterritorially and implements stringent operational requirements for controllers and processors of personal data.
The GDPR permits member state derogations for certain issues and, accordingly, we are also subject to EU national laws relating to the processing of certain data such as genetic data, biometric data and data concerning ts personals blinist i postrm. Complying with these numerous. Table of Contents complex and often changing regulations is expensive and difficult. In addition to the foregoing, any breach of privacy laws or data security laws, boy escort anmore those resulting in any security incident or breach involving the misappropriation, loss or other unauthorized use or disclosure of sensitive or confidential patient or consumer information, could have a material adverse effect on our business, reputation ladies seeking nsa alma georgia financial condition.
Spiders of the family Salticidae from British Guiana and Venezuela. Baseline richness of Salticidae Araneae from Misiones, Argentina. Spiders from Panama. Revision de los generos del grupo Hurieae Araneae, Salticidae. Advances in Spider Taxonomy With synonymies and transfers Pragmatic classification of the World's Salticidae Araneae. Some new Attidae.
Catalogue of nearctic spiders. American Mus. XXIX : Catalogo de los especimenes tipicos de Salticidae Araneae descriptos por Candido F. Primera parte. Aranas de a provincia de Buenos Aires. Arachnida from Panama. Spider types at Yale Peabody Museum. Published privately by the author Austin Texas. Arachnida: Araneida and Opiliones. Biologia Centrali - Americana, Zoologia 2 : Paris Roret 2 4: Manchester University Press pp.
Spiders of the family Attidae from Central America and Mexico. Wisconsin 3 : The spider fauna of the Upper Cayuga Lake Basin. Revision of Cayuga Lake spiders. Proceedings of the Academy of Natural Sciences of Philadelphia 68 : Spiders of the Georgia Region of North America. Utah 35 9: The Salticidae jumping spiders of Michigan. Michigan Acad. The spider book; a manual for the study of the spiders and their near relatives, the scorpions, pseudoscorpions, whipscorpions, harvestmen and other members of the class Arachnida, found in America north of Mexico, with analytical keys for their classification and popular s of their habits.
Garden City New York pp. The spider book, revised and edited by W. Cornell Univ. Press Ithaca pp. The jumping spiders of New York City. New York Ent. A preliminary list of the Salticidae of Minnesota. The arboreal Salticidae of Florida. A preliminary checklist of Georgia Salticidae. Supplement to the New England Spiders. Checklist of Kansas jumping spiders. Emporia State University 47 1: The scales of salticid spiders.