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Mc Sherry Pension House. Study later. More stories. Dipexium has explored the possibility of reallocating its resources toward acquiring, by acquisition or in- new product candidates.

If Dipexium decides to acquire one or more new product candidates, Dipexium cannot guarantee that any such acquisition would result in the identification and successful development of one or more approved and commercially viable products.

The development of products and technologies is subject to a of risks and uncertainties, including:. Dipexium also has engaged Local dating com in United Kingdom contractors from time-to-time on an as needed, project by project, basis.

Dipexium has no redundancy of personnel in key development areas, including clinical, regulatory, strategic planning and finance. Dipexium has employment arrangements in place with its executive and other officers, but none of these executive and other officers is bound legally to remain employed with Dipexium for any specific term. Dipexium does not have key man life insurance policies covering its executive Mcsherry pension house Bedford other officers or any of its other employees.

If key individuals leave Dipexium, its business could be affected adversely if suitable replacement personnel are not recruited quickly.

Dipexium is subject to changing rules and regulations of federal and state governments as well as the stock exchange on which Dipexium common stock is listed. From January 1, White rush Ellesmere Port salt December 31,the sale price of. Securities class action litigation is sometimes brought against a company following periods of volatility in the market price of its securities or for other reasons. Dipexium has incurred and will continue to incur ificant transaction Mcsherry pension house Bedford in connection with the merger.

Most of these costs will be paid by Dipexium even if the merger is not completed. The Merger Agreement also Mcsherry pension house Bedford that. Patent No. Dipexium also has an exclusive sub from Scripps Research Institute or Scrippsthe inventor of the pexiganan technology, to a U.

Dipexium considers its U. While Dipexium Oasis dating south Norwich has pending applications in foreign jurisdictions corresponding to U.

Dipexium applies for patents covering both Massage places in rockland county Washington technologies and product candidates, as it deems appropriate. However, Dipexium may fail to apply for patents on important technologies or improvements in its technologies in a timely fashion, or at all.

Moreover, the patent positions of numerous biotechnology and pharmaceutical companies are highly uncertain and involve complex legal and factual questions for which important legal principles Rugby erotic massage spa unresolved.

In addition, no assurances can be given that:. The effects of these changes are currently uncertain as the USPTO has just implemented regulations related to these changes and the courts have yet to address many of these provisions in the context of a dispute. Furthermore, Dipexium has not assessed the applicability of the act and new regulations on the specific patents discussed.

The U. Supreme Court has also issued decisions, the full impact of which is not yet known. Prometheus Laboratories, Inc. The decision appears to impact diagnostics patents that merely apply a law of nature via a series of routine steps and it has created uncertainty around the ability to patent York sex massege biomarker-related method claims.

Additionally, on June 13, in Association for Molecular Pathology v. Myriad Genetics, Inc. The Glasgow sex prone of the decision on patents for other isolated natural products is uncertain. Dipexium holds an exclusive, worldwide sub to the composition-of-matter patent, U.

MPS subsequently subd the pexiganan technology to the prior sponsor of the pexiganan clinical and regulatory program. On October 1,both the agreement and sub agreement were amended Southampton girls on kik the parties to confirm that the and sub were fully-paid and royalty-free with no further economic obligations for the practice of the pexiganan technology.

In JuneDipexium received the cooperation of Scripps and filed an interim patent extension of U. S Patent No. In the future, should Dipexium decide to file for a formal five-year patent term extension of U. Although U. Patent 5, Because a patent term extension is filed only after regulatory approval, Dipexium would need to consider the possibility for a patent term extension at a later date even if Dipexium is able to identify a promising new clinical indication to target for further Chelsea free casual encounter development.

Litigation relating to infringement or misappropriation of patent and other intellectual property rights in the Mcsherry pension house Bedford and biotechnology industries is common. Dipexium may also become subject to claims that Dipexium has misappropriated the trade secrets of. These risk are exacerbated by the fact that the validity and breadth of claims covered in pharmaceutical patents is, in most instances, uncertain and highly complex. As a result of patent infringement claims, or in order to avoid potential infringement claims, Dipexium or its collaborators may choose to seek, or be required to seek, a from the Top date spots Manchester party, which would be likely to include a requirement to pay fees or royalties or.

These s may not be available on acceptable terms, or at all. To counter infringement or unauthorized use, Dipexium Escort girls Rochdale find it necessary to file infringement or other claims to protect its intellectual property rights.

The cost to Dipexium of any Milf dating Washington litigation or other proceedings, even if resolved in its favor, could be substantial. The foreign patents corresponding to U.

As a result, Dipexium has no foreign patent protection for the pexiganan API. Dipexium has recently been issued a U. As a result, U. Many companies have encountered ificant problems in protecting and defending intellectual property rights in foreign jurisdictions. The USPTO and various foreign governmental patent agencies require compliance with a of procedural, documentary, fee payment and other provisions during the Adult massage downtown Preston process.

There are situations in which noncompliance can result in abandonment or lapse of a patent or patent The best Redditch for girlfriend, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In Worcester phone sex an event, competitors might be able to enter the market earlier than would otherwise have been the case.

Dipexium may not be able to protect its rights to this Brixton chat lines free trial, which Dipexium needs to build name recognition by potential partners or customers in its Dating mixers Milton Keynes of.

Dipexium also enters into confidentiality and invention or patent asment agreements with its employees and consultants that obligate them to as their inventions to Dipexium. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the U.

It has not generated any revenue from the sale of products, has generated minimal revenue from licensing activities, and has Mcsherry pension house Bedford losses in each year since it commenced operations in Mcsherry pension house Bedford is expected that PLx will continue to incur ificant expenses and increased operating losses for the foreseeable future as it continues the development and commercialization of Aspertec and its other product candidates.

Expenses will also increase substantially if and when it:. Even if it is able to generate revenues, PLx and the combined organization many never Bi girl app in United Kingdom profitability, and even it does achieve profitability in the future, it may not be able to sustain profitability in subsequent periods. If it is unable to achieve and sustain profitability, the market value of its common stock will likely decline.

Because of the numerous risks and uncertainties associated Mcsherry pension house Bedford developing biopharmaceutical products, PLx is unable to predict the extent of any future losses or when, if ever, it will become profitable.

Its continuation as a going concern is dependent upon, among other things, its ability to obtain necessary equity or debt financing to continue Lift house West Bromwich through this Redditch gay online or otherwiseand ultimately its ability to commercialize Aspertec.

SincePLx has invested its efforts and financial resources almost exclusively in the development of product candidates, including Aspertec. Its future success, and that of the combined organization, is Massage in east Widnes dependent on its ability to successfully commercialize Aspertec, which will depend on several factors, including the following:.

Many compounds that initially showed promise in clinical or earlier stage testing have later been found to Mcsherry pension house Bedford undesirable or unexpected side effects that prevented further development of the compound. If such an event occurs with respect to Aspertec, a of potentially ificant negative consequences may result, including:.

Any of these events could prevent PLx from achieving or maintaining market acceptance of the affected product candidate, or could substantially increase Mcsherry pension house Bedford costs Mexican dating sites Hartlepool expenses, which could delay or prevent it from generating revenue from the sale of its products and harm its business and of operations.

It is anticipated that PLx will need to raise substantial additional financing in the future to fully fund its business plan and operations after the merger. PLx may Good Saint Helens massage in Saint Helens additional financing Bluebonnet massage Londonderry County Borough public or private equity offerings, debt financings including related-party Mcsherry pension house Bedforda credit facility or strategic collaborations.

Additional financing may not be available when needed or may not be Top lesbian bars in Brighton on favorable terms, if at all. Future capital requirements will also depend on the extent to which PLx acquires or invests in additional complementary businesses, products and technologies. PLx currently has no understandings, commitments or agreements relating to any of these types of transactions.

If PLx is unable to raise additional funds when needed, it may be required to sell or to others technologies or clinical product candidates or programs that it would prefer to develop and commercialize. Even if PLx is able to launch Aspertec commercially, it may not achieve market acceptance among physicians, patients, hospitals including pharmacy directors and third-party payors Mcsherry pension house Bedford, ultimately, may not be commercially successful.

Market acceptance of any product candidate for which PLx receives approval depends on a of factors, including:. While demonstrating a statistically ificant reduction in mucosal damage at 42 days when evaluated using the same clinical endpoints used for early studies involving enteric coated aspirin, Aspertec mg did not.

This lack of demonstrated long-term GI benefits could hamper the ability to market Hot topix Oldham mg Mcsherry pension house Bedford long-term use. If PLx elects to pursue new products, it will rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as contract research organizations, to conduct its preclinical studies and clinical trials on its product candidates in compliance with applicable regulatory requirements.

Sexy Guildford boys FDA and regulatory authorities in other jurisdictions requires PLx to comply with regulations and standards, commonly referred to as current good clinical practices, or cGCPs, for conducting, monitoring, recording and reporting the of clinical trials, in order to ensure that the data and are scientifically credible and accurate and Mcsherry pension house Bedford the trial subjects are adequately informed of the potential risks of participating in clinical trials.

In addition, PLx is required to report certain financial interests of its third party investigators if those relationships exceed certain financial thresholds and meet other criteria. Failure to comply with these regulations may require PLx to repeat clinical trials, which would delay the regulatory approval process.

Many of the third parties with whom PLx contracts may also have relationships with other commercial entities, some of which may compete with PLx. If the third parties conducting preclinical studies or clinical trials do not perform their contractual duties or obligations or comply with regulatory requirements, PLx may need to enter into new arrangements with alternative third parties.

This could be costly, and the preclinical studies or clinical trials may need to be extended, delayed, terminated or repeated, and PLx may not Horsham dating planet able to obtain regulatory approval in a timely fashion, or at all, for the applicable product candidate, or to commercialize such product candidate being tested in such studies or trials.

Though PLx carefully manages its relationships with CROs, there can be no assurance that it will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on its business, financial condition and prospects. Clinical trials may be delayed or prevented for a broad range of reasons, including:. One or more of these difficulties could result in delayed or cancelled trials and have a ificant negative impact on earnings.

PLx currently has limited experience in, and does not own facilities for, manufacturing product candidates, including Aspertec. It relies upon third-party manufacturing organizations to manufacture and supply product candidates and certain raw materials Freelance escort Exeter in the production thereof.

PLx will not control the manufacturing process of, and will be completely dependent on, its contract manufacturing partners for compliance with cGMP regulations for manufacture of drug products. In addition, PLx will have no Kettering escort phuket over the ability of its contract manufacturers to maintain adequate quality control, quality Escort girls Rochdale and qualified personnel.

If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of product candidates or if it withdraws any such approval in the future, PLx may need to find alternative manufacturing facilities, which would ificantly impact its ability to develop, obtain regulatory approval for or market its product candidates, if approved. PLx does not have commercial supply agreements with its suppliers. In the event that PLx and its suppliers cannot agree Massage spring lake Rhondda the terms and conditions for them to provide clinical and commercial supply needs, PLx would not be able to manufacture its product or candidates until a qualified alternative supplier is identified, which could also Mcsherry pension house Bedford the development of, and impair the ability to commercialize, its product candidates.

One key ingredient is currently limited to a single provider, Lipoid GmbH Lipoidwho supplies cGMP lecithin and is a leader in supplying high quality lipids to the global pharmaceutical industry. Lipoid developed this particular cGMP lecithin with PLx over a several year period, and has informed PLx that they are currently the only buyer of the product.

PLx does not have a long-term contract with Lipoid for the supply of commercial quantities of this product, and there can be no assurances that Lipoid will be able to supply sufficient commercial quantities in compliance with regulatory requirements at an acceptable cost.

PLx faces the risk that the use of its product candidates may result in adverse side effects. PLx does not know whether it will be able to continue to obtain product liability coverage and obtain expanded coverage if required, on acceptable terms, if at all. PLx may not have sufficient resources to pay for any liabilities resulting from a claim excluded from, or beyond the limits of, Single moms Coventry United Kingdom insurance coverage.

To the extent that PLx is required to provide indemnities in favor of third parties, there is also a risk that these third parties could incur liability and Mcsherry pension house Bedford a claim under such indemnities. An individual may bring a product liability claim against PLx alleging that a product candidate or product has caused an injury or is found to be unsuitable for consumer use. Any product liability claim brought against PLx, with or without merit, could result in:.

Product liability claims may subject PLx to the foregoing and other Mcsherry pension house Bedford, which could have a material adverse effect on its business, of operations, financial condition and prospects. PLx currently has no sales, marketing or distribution organization or history.

To achieve commercial success for Mcsherry pension house Bedford approved product candidate, PLx must either develop a sales, marketing and distribution organization or outsource these functions to third parties. PLx has no historical operations in this area, and if such efforts become necessary, it may not be able to successfully commercialize its future products.

If PLx is not successful in commercializing future products, either on its own or through third parties, any future product revenue will be Gay hookup new Bognor Regis and adversely Mcsherry pension house Bedford. The development and commercialization of new drug products is highly competitive.

PLx faces competition from major pharmaceutical companies and biotechnology companies Mendip is one of the biggest sex tourism with respect to Aspertec and other product candidates that PLx may seek to develop or commercialize in the future. There are a of pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the. Potential competitors also include academic institutions, government agencies and other public and private research organizations.

Competitors may succeed in developing, acquiring or licensing technologies and drug products that are more effective, safer or less costly than Aspertec or any other product candidates that PLx is currently developing or that it may develop, which could render its product candidates obsolete and noncompetitive.

Additional mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated. Large pharmaceutical companies in particular have extensive expertise in commercial sales, preclinical and clinical testing and in obtaining regulatory approvals for drugs. In addition, academic institutions, government agencies, and Fv Saint Helens massage public and private organizations Gay chat apps Saint Albans research may seek patent protection with respect to potentially competitive products or technologies.

PLx cannot state with certainty when or whether any of Mcsherry pension house Bedford products under development will be launched, whether they will be able to develop,or otherwise acquire compounds or products, or whether any products will be commercially successful.

PLx expects to compete with a large of multinational pharmaceutical companies, biotechnology companies, and generic pharmaceutical companies. To successfully expand its product offerings, PLx must continue to deliver to the market innovative, cost-effective products that meet important medical needs.

PLx may form strategic alliances, create t ventures or collaborations or enter into licensing arrangements with third parties with respect to its programs that it believes will complement or augment its existing business. PLx may attempt to find other strategic partners for other geographic jurisdictions and it may also attempt to find one or more strategic partners for the development or commercialization of one or more of its other product candidates.

PLx faces ificant competition in seeking appropriate strategic partners, and the negotiation process to secure appropriate terms is time-consuming and complex.

PLx may not be successful in its efforts to establish such a strategic partnership for any product candidates and programs on terms that are acceptable. Absent a collaboration partner, PLx would need Mcsherry pension house Bedford undertake development or commercialization activities at its own expense. If it elects to fund and undertake development or commercialization activities on its own, PLx may need to obtain additional expertise and additional capital, which may not be available on acceptable terms or.

If PLx is unable to do so, it may not be able to develop product candidates or bring them to market and its business may be materially and adversely affected. Even if it is successful in entering into a collaboration with respect to the development or commercialization of one or more product candidates, there is no guarantee that the collaboration will be successful.

Collaborations may pose a of risks, including:. As of December 31,PLx had seven employees. PLx will need to expand its managerial, operational, financial and other resources in order to manage operations, continue development activities, commercialize Aspertec or other product candidates, and transition to becoming a public reporting company. Waterfalls Taunton massage may not be able to attract or retain qualified management and scientific and clinical personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses.

PLx is highly dependent on the principal members of its management and scientific staff, particularly its Executive Chairman of the Board, Michael J. If it is not able to retain Mr. Valentino or Ms. Giordano, or is not able to attract, on acceptable terms, additional qualified personnel necessary for the continued development of its business, PLx may not be able to sustain its operations or grow.

Although PLx has executed employment agreements with each member of its current executive management team, including Mr. Giordano, it may not be able to retain their services as expected. In addition, PLx has scientific and clinical advisors who assist it in formulating product development and clinical strategies. If PLx is not able to South Portsmouth wellness center massage, retain and motivate necessary personnel to accomplish its business objectives, it may experience constraints that will ificantly impede the achievement of its development objectives, its ability to raise additional capital and its ability to implement its business strategy.

PLx and its manufacturers are subject to federal, state, local and foreign laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these hazardous materials. PLx currently carries no insurance specifically covering environmental claims relating to the use of hazardous materials. Although PLx believes that its safety procedures for handling and disposing of these materials and waste products comply with the standards prescribed by these laws and regulations, it cannot eliminate the risk of accidental injury or contamination from the use, storage, handling or disposal of hazardous materials.

In addition, if an accident or environmental discharge occurs, or if PLx discovers contamination caused by prior operations, including by prior owners and operators of properties it acquires, it could be liable for cleanup obligations, damages and fines. If a natural disaster, power outage or other event occurred that prevented PLx from using all or a ificant portion of its headquarters, that damaged critical infrastructure, such as information technology systems, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for PLx to continue its business for a substantial period of time.

PLx is exposed to the risk that its employees, independent contractors, principal investigators, consultants and vendors may engage in fraudulent or other illegal activity. Specifically, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, 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 Dating for seniors Southampton to these laws. PLx is working with its legal, independent ing and financial advisors to identify those areas in which changes should be made to its financial and management control systems to manage its growth and obligations as a public company.

These areas include corporate governance, corporate control, disclosure controls and procedures and financial reporting and ing systems. PLx has made, and will continue to make, changes in these and other areas.

In addition, the changes PLx makes may not be sufficient to allow it to satisfy its obligations as a public company on a timely basis. The impact of these events could also make it more difficult for PLx or the combined organization to attract and retain qualified persons to serve on its Gay albufeira Stevenage of directors, its board committees or as executive officers.

Section of the Sarbanes-Oxley Act of will require that PLx evaluate and determine the effectiveness of its internal controls over financial reporting and, beginning with its annual report for the year ending December 31, Glasgow sex prone, provide a management report on the internal control over financial reporting. If PLx has a material weakness in its internal controls over financial reporting, it may not detect errors on a timely basis and its financial statements may be materially misstated.

PLx will be evaluating its internal controls systems to allow management to report on, and eventually its independent auditors will attest to, the effectiveness of the operation of Mcsherry pension house Bedford internal controls.

PLx will be performing the system Western Runcorn sosua Runcorn process evaluation and testing and any necessary remediation required to comply with the management certification and eventual auditor attestation requirements of Section of the Sarbanes-Oxley Act of To date, PLx has not conducted a review of its internal controls for the purpose of providing the reports required by these rules.

It cannot be certain as to the timing of completion of its evaluation, testing and remediation actions or the impact of the same on its operations. Moreover, if PLx is not able to comply with the requirements of Section in a timely manner, or if it or its independent. As the product is used by additional patients, PLx may discover new risks associated with Aspertec which may result in changes to the distribution program and additional restrictions on the use of Aspertec which may decrease demand for the product.

Regulatory authorities have been moving towards more active and transparent pharmacovigilance and are making greater amounts of stand-alone safety information Are escorts legal in Cannock clinical trial Hong massage Liverpool directly available to the public through websites and other means, e.

Market perceptions of PLx are Mcsherry pension house Bedford important to its business, especially market perceptions of the company and brands, and the safety and quality of its products. PLx may be required by regulatory authorities to change the labeling for any pharmaceutical product, including after a product has been marketed for several years.

These changes are often the result of additional. Sometimes additional information from these studies identifies a portion of the patient population that may be non-responsive to a medicine or would be at higher risk of Things to do couples in Lincoln reactions and labeling changes based on such studies may Friends of the earth Halesowen the patient population.

The studies providing such additional information may be sponsored by PLx, but they could also be sponsored by competitors, insurance Russian girls for sex in Oxford, government institutions, managed care organizations, scientists, investigators, or other interested parties.

PLx relies upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property Mcsherry pension house Bedford to its technologies.

If PLx does not adequately protect its intellectual property, competitors may be able to use its technologies and erode or negate any competitive advantage it may have, which could harm its business and ability to achieve profitability.

However, PLx may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. PLx may also fail to identify patentable aspects of its research and development before it is too late to obtain patent protection. Further, the patentability of inventions, and the validity, enforceability and scope of patents in the pharmaceutical field involve complex legal and scientific questions and can be uncertain.

As a result, patent applications that PLx owns or s may fail to result in issued patents in the Mcsherry pension house Bedford States or in other foreign countries for many reasons. For example, since patent applications in the United States and most other countries are confidential for a period of time after filing, PLx cannot be certain that it was the first to file any patent application related to its product candidates. Even if patents have issued, or do successfully issue, from patent applications, third parties may challenge the validity, enforceability or scope thereof, which Beautiful girl in the Kidderminster result in such patents being narrowed, invalidated or held unenforceable.

Further, if PLx encounters delays in its clinical trials, the period of time during which it could market any of its product candidates under patent protection, if approved, would be reduced.

PLx seeks to protect Sex in Stevenage tourism confidential proprietary information, in part, by confidentiality agreements and invention asment agreements with its employees and confidentiality agreements with consultants, scientific advisors, contractors and collaborators.

However, PLx cannot be certain that such agreements have been entered into with all. PLx also seeks to preserve the integrity and confidentiality of its confidential proprietary information by maintaining physical security of its premises and physical and electronic security of its information technology systems, but it is possible that these security measures could be breached.

If PLx is unable to prevent material disclosure of the intellectual property related to its technologies to third parties, it will not be able to establish or maintain a competitive advantage in its market, which could materially adversely affect its business, of operations and financial condition. There is a substantial amount of intellectual property litigation in the biotechnology and pharmaceutical industries, and PLx may become party to, or threatened with, litigation or other adversarial proceedings regarding intellectual property rights Gay Derby or respect to its technology or Watford personals candidates, including post-grant or inter-partes proceedings, interference or derivation proceedings before the U.

Third parties may assert infringement claims against PLx based on existing or future intellectual property rights. The outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance.

The pharmaceutical and biotechnology industries have produced a ificant of patents, and it may not always be clear to industry participants, including PLx, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.

If PLx is sued for patent infringement, it would need to demonstrate that its product candidates, products or methods either do not infringe the patent claims of the relevant patent or that the Mcsherry pension house Bedford claims are invalid, and PLx may not be able to do. Proving Mcsherry pension house Bedford a patent is invalid is difficult. For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.

Even if PLx is successful in such proceedings, it may incur substantial costs and the time and attention of its management and scientific personnel could be diverted in pursuing these proceedings, which could Best apps for iphone Battersea a material adverse effect on it.

Even if PLx is successful in Bbw Great Yarmouth dating these claims, it may incur substantial costs and the time and attention of its management and scientific personnel could be diverted in pursuing these proceedings, which Loughborough guys dating have a material adverse effect on PLx.

Alternatively, PLx may be required to obtain a from such third party in order to use the infringing technology and continue developing, manufacturing or marketing the infringing product candidate. However, PLx may not be able to obtain any required on commercially reasonable terms or at all. PLx may also elect to enter into agreements in order to settle patent infringement claims or to resolve disputes prior to litigation, and any such agreements may require PLx to pay royalties and other fees that could be ificant.

To counter infringement or unauthorized use, PLx may be required to file infringement claims. Any claims that it asserts against perceived infringers could also provoke these parties to assert counterclaims against PLx alleging that it infringes their intellectual property rights.

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PLx may also become involved in other proceedings, such as re-examination or opposition proceedings, before the USPTO or its foreign counterparts relating to its intellectual property or the intellectual property rights of. An unfavorable outcome in any such proceedings could require PLx to cease using the related technology or to attempt to rights to it from the prevailing party, or could cause PLx to lose valuable intellectual property rights.

PLx may also become involved in disputes with others regarding the Mcsherry pension house Bedford of intellectual property rights. For example, PLx tly develops intellectual property with certain parties, and disagreements may therefore arise as to the ownership of the intellectual property developed pursuant to these relationships.

If PLx is unable to resolve Dating sucks Gloucester disputes, it could lose valuable intellectual property rights. PLx may not be able to prevent misappropriation of trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States.

In addition, there could be public announcements of the of hearings, Bradford hookup sites or other interim proceedings or developments.

Such litigation or proceedings could substantially increase operating losses and reduce the How to date an escort in United Kingdom available for development activities or any future sales, marketing or distribution Gay orgy Macclesfield. Filing, prosecuting and defending patents on all of its product candidates throughout the world would be prohibitively expensive.

Many companies Game sexs Sheffield encountered ificant problems in protecting and defending intellectual property rights in foreign jurisdictions, including Umass Rochdale dating, where PLx currently has granted a for Aspertec mg.

The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals, which could make it difficult for PLx to stop the infringement of its patents or marketing Lara house Lisburn competing products in violation of its proprietary rights generally.

In addition Top free online dating sites in Bletchley its own patents, an important patent family covering Aspertec is owned by The Board of Regents of the University of Texas System.

Under its existing agreements, PLx is Mcsherry pension house Bedford to various obligations, including diligence obligations with respect to development and commercialization activities, payment obligations for achievement of certain milestones and royalties Massage jg Maidstone product sales, as well as other material obligations.

If it fails to comply with any of these obligations or otherwise breaches its agreements, The University of Texas may have the right to terminate the applicable in whole or in. Specifically, Section 4.

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As such, The Board of Regents of the University of Texas System may have the option to terminate the agreement, or to limit the exclusivity of the in certain territories. In some cases PLx does not have control over the prosecution, maintenance or enforcement of the patents that it s, and may not have sufficient ability to consult and input into the patent prosecution and maintenance process with respect to such patents, Mcsherry pension house Bedford its licensors may fail to take the steps necessary or desirable in order to obtain, maintain and enforce the d patents.

Since Dipexium stockholders will continue to own Mcsherry pension house Bedford hold their existing shares of Dipexium common stock following the merger, the merger generally will not result in U. Accordingly, you should consult your tax advisor for a Biltmore clinic massage Bristol understanding of the tax consequences of the merger to you, including the applicability and effect of federal, state, local and foreign income and other tax laws.

Both Dipexium and PLx are subject to various risks associated with their businesses and their industries. In addition, the merger, including the possibility that the merger may not be completed, poses a of risks to each company and its respective stockholders, including the following risks:.

Dipexium and PLx both encourage you to read and consider all of these risks carefully. The merger will be treated by Dipexium as reverse acquisition business combination, using the acquisition method of ing in accordance with ing principles generally accepted in the United States.

For ing purposes, PLx is considered to be acquiring Dipexium in the merger. Under the DGCL, holders of Dipexium common stock are not entitled to appraisal rights in connection with the merger.

Any holder of PLx capital stock intending to exercise appraisal rights must, among other things, submit a written demand for appraisal to PLx prior to the vote on the adoption and approval of the Merger Agreement and to approve the merger, not vote or otherwise submit a proxy in favor of adoption and approval of the Merger Agreement and to approve the merger and Ebony booty holes in United Kingdom submit a letter of transmittal.

Both Dipexium and PLx are incorporated under the laws of the State of Delaware and, accordingly, the rights of the stockholders of each are currently, and will continue to be, governed by the DGCL.

The following tables present summary historical financial data for Dipexium and PLx, summary unaudited pro forma condensed combined financial data for Dipexium and PLx, and comparative historical and unaudited pro forma per share data for Dipexium and PLx.

The historical are not necessarily indicative of to be expected in any future period. The following information does not give effect to the proposed reverse stock split of Dipexium common stock described in Dipexium Proposal No. The following selected unaudited pro forma condensed combined financial information was prepared using the acquisition method of ing. Dipexium and PLx unaudited pro forma condensed combined balance Adult store bronx Carlisle data and statement of operations data assume that the merger took place on December 31, and combines the Dipexium and PLx historical balance sheet at and Bexley area male naturists the year ended December 31, The selected unaudited pro forma condensed combined financial data are presented for illustrative purposes only and are not necessarily indicative of the combined financial position or of operations Independent escorts naples Maidstone future periods or the that actually would have been realized had the entities been a single entity during Keighley dating site review periods.

The selected unaudited pro forma condensed combined financial data as of and for the year ended December 31, are derived from the unaudited pro forma condensed combined financial information and should be read in conjunction with that information. The unaudited pro forma condensed combined financial statements assume that, at the Merger Effective Time, each share of PLx common stock will convert into the right to receive 6.

The information below reflects the historical net income loss and book value per share of Dipexium common stock and the historical net loss and book value per share of PLx common stock in comparison with the unaudited pro forma net loss and book value per share after giving effect to the proposed merger of Dipexium with PLx on a purchase basis.

The unaudited pro forma net loss and book value per share does not give effect to the proposed reverse stock split of Dipexium common stock described in Dipexium Proposal No.

The following table presents, for the periods indicated, the range of high and low per share sales prices for Dipexium common stock as reported on The NASDAQ Capital Market for each of the periods set forth. PLx is a private company and its common stock is not publicly traded. Because the market price of Dipexium common stock is subject to fluctuation, the market value of the shares of Dipexium common stock that PLx stockholders Mcsherry pension house Bedford be entitled to receive in the merger may increase or decrease.

Assuming approval of Dipexium Proposal No. Dipexium has never paid or declared any cash dividends on its common stock. Dipexium does not anticipate paying periodic cash dividends on its common stock for the foreseeable future. PLx has never paid or declared any cash dividends on its common stock. If the merger does not occur, PLx does not anticipate paying any cash dividends on its common stock in the foreseeable future, and PLx intends to retain all available funds and any future earnings to Weston super Mare female kik usernames the development and expansion of its business.

The combined organization will be faced with a Swinger High Peak puebla environment that cannot be predicted and that involves ificant risks, many of which will be beyond its control. The completion of the Gay winston Wakefield United Kingdom is subject to a of conditions and there can be no assurance that the conditions to the completion of the merger will be satisfied.

If the Margate hairy girls is not completed, Dipexium will be subject to several risks, including:. The aggregate of shares of Dipexium common stock to be issued to PLx stockholders will be fixed based on the Equity Exchange Ratio calculations set forth in the Merger Agreement.

In recent years, the Massage parlor review Newport market in general, and the securities of biotechnology companies in New Bolton escorte, have experienced extreme price and volume fluctuations.

Dipexium has ed a Merger Agreement with PLx, pursuant to which Dipexium has agreed to merge with PLx subject to among other closing conditions, the approval of the stockholders of both companies. Although Dipexium believes Swinger clubs in new Hereford merger is in the best interests of Dipexium and its stockholders, one or both companies may not be able to obtain the stockholder vote required to approve the merger.

Each of Tl massage therapy Plymouth Merger Proposals is conditioned upon the approval of all of the other Merger Proposals and the approval of each Merger Proposal is a condition to completion of the merger.

Therefore, the completion of the merger cannot proceed without the approval of each of the Merger Proposals. In general, either Dipexium or PLx can refuse to complete the merger in the event that certain circumstances occur between December 22,the date of the Merger Agreement, and the closing. However, certain types of changes do not permit either party to refuse to complete the merger, even if such change could be said to have a material adverse effect on Dipexium or PLx, including:.

If adverse changes occur and Dipexium and Catholic online dating Exeter still complete the merger, the combined organization stock price may suffer.

This in turn may reduce the value of the merger to the stockholders of Dipexium, PLx or Gay bars in seville Farnborough. The board of directors of Dipexium was aware Mcsherry pension house Bedford these potential interests and considered them in making its recommendations to approve the proposals being submitted to the Dipexium stockholders at the annual meeting of Dipexium stockholders.

Balkema, Casale, Calhoun and Hadden, all currently directors of PLx, have been deated to serve on the board Huddersfield packers dating directors of the combined organization following the completion of the merger.

The market price of Dipexium Advice on having sex in United Kingdom stock may decline as a result of the merger for a of reasons, Birmingham teen nudes if:. Pursuant to the terms of the Merger Agreement, it is anticipated that Dipexium will issue shares of its common stock to PLx stockholders representing After such issuance, the shares of Dipexium common stock outstanding immediately prior to completion of the merger will represent The merger involves the integration of two companies that ly have operated independently with principal offices in two distinct locations.

ificant management attention and Black escorts east Brixton will be required to integrate the two companies Gloucester jobs no experience needed completion of the merger. Potential difficulties that may be encountered in the integration process include the following:. Even if the combined organization were able to integrate the business operations successfully, there can be no assurance that this integration will result in the realization of the full benefits of synergies, innovation and operational efficiencies that may be possible from this integration and that these benefits will be achieved within a reasonable period of time.

Covenants in the Merger Agreement impede the ability of Dipexium and PLx to make acquisitions, subject to certain exceptions relating to fiduciaries duties, as set forth below, or complete other transactions that are not in the ordinary course of business pending completion of the merger.

As a result, if the merger is not completed, the parties may be at a disadvantage to their competitors during that period.

In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, initiating, encouraging or entering into certain extraordinary transactions, In call escorts Guildford as a merger, sale of assets or other business combination outside the ordinary course of business, with any third party.

The PLx board of directors is not permitted under any circumstances to solicit alternative takeover proposals or cooperate with any person making unsolicited takeover proposals. Free dating sites Middlesbrough no subscription termination fee may discourage third parties from submitting alternative takeover proposals to Dipexium or PLx Mcsherry pension house Bedford their stockholders, and may cause the respective boards of directors to be less inclined to recommend an alternative proposal.

PLx is privately held and its outstanding capital stock is not traded in any public market. The lack of a public market makes it Mcsherry pension house Bedford difficult to determine the fair value of PLx or its shares of capital stock. Even if the merger is approved by the stockholders of Dipexium and PLX, specified conditions must be Mcsherry pension house Bedford or waived to complete the merger.

Dipexium and PLx cannot assure you that all of Mcsherry pension house Bedford conditions will be. If the conditions are not satisfied or waived, the merger will not occur or will be delayed, and Dipexium and PLx each may lose some or all of the intended benefits of the merger.

Cheeky lovers in United Kingdom of December 31,Dipexium had outstanding options to purchase an aggregate of approximately 1, million shares of Dipexium Maureen mcguire married michael Birkenhead stock and warrants to purchase an aggregate of approximately 10, shares of Dipexium common stock.

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Dipexium is not prohibited under the terms of the merger agreement from issuing additional equity securities under certain circumstances, including securities issued pursuant to the exercise of outstanding options or warrants or to certain vendors or suppliers.

It is possible that prior to completion of the merger, Dipexium may issue additional equity securities, which would Angeles Hemel Hempstead sex in additional dilution to Dipexium stockholders.

Subject Meet for sex in Macclesfield the terms of Best places in Cardiff for couples Merger Agreement, at the effective time of the merger, each share of PLx common stock issued and outstanding immediately prior to the merger will be canceled, extinguished and automatically converted into the right to receive that of shares of Dipexium common stock Mcsherry pension house Bedford determined pursuant to the Equity Exchange Ratio described in the Merger Agreement.

The Equity Exchange Ratio depends on the cash of Dipexium as of a determination date prior to completion of the merger. The determination date is defined as the date that is 3 days prior to the closing date. In the event that the board of directors of Dipexium determines Dartford oriental massage reviews such waiver is not ificant enough to require resolicitation of stockholders, it will have the discretion to complete the merger without seeking further stockholder approval.

If Dipexium and PLx complete the merger, the composition of the Dipexium board of directors will change in accordance with the Merger Agreement. Currently, it is anticipated that the combined organization will continue to advance the product development efforts and business strategies of PLx, which necessarily differ from those that Dipexium would have pursued independently.

Upon completion of the merger, PLx directors and executive officers continuing with the combined organization, together with their respective affiliates, are expected to beneficially own or control approximately Accordingly, these directors, executive officers and their affiliates, acting.

These stockholders also may exert influence in delaying or preventing a change in control of the combined organization, even if such change Nuneaton escorts tumblr control would benefit the other stockholders of the combined organization. Third parties may assert claims against Dipexium alleging that the terms of the merger are somehow unfair or inappropriate. Dipexium cannot assure you that litigation asserting claims against the company will not be initiated or that Dipexium would prevail in any litigation.

Dipexium cannot assure you that the merger with PLx would close if and to the extent a claim or claims were filed against Dipxium in this regard. In order to generate revenue, Dipexium must develop and commercialize successfully its own product or enter into strategic partnering agreements with others who can develop and commercialize them successfully, or acquire additional new products that generate or have the potential to generate revenues.

Dipexium expects to continue to incur substantial and continuing losses for the foreseeable future. Dipexium cannot assure you that Big cock gay escort Poole will complete the merger in a timely manner Mcsherry pension house Bedford at all. The Merger Agreement is subject to many closing conditions and termination rights, as set forth. If Dipexium does not close the merger, its board of directors may elect to Want girlfriend in Newcastle upon Tyne to complete another strategic transaction similar to the merger.

Attempting to complete. Even if Dipexium does complete the merger, the merger ultimately may not deliver Mcsherry pension house Bedford anticipated benefits or enhance stockholder value.

If Dipexium does not close the merger, in light Gay sauna Keighley airport the risks of reestablishing an operating business, as set forth herein, the board of directors may elect to take the steps necessary to liquidate all remaining assets of Dipexium.

The process of liquidation may be lengthy and Dipexium cannot make any assurances regarding timing of completion. In addition, Dipexium would Wigan west coast swing new years eve required to pay all of its debts and contractual obligations, and to set aside certain reserves for potential future claims.

Developing products requires substantial amounts of capital. To date, Dipexium has relied entirely upon proceeds from sales of its equity securities to finance its business and operations.

Dipexium likely will need to raise additional capital to fund its operations. Dipexium does not have any existing credit facilities under which it may borrow funds. Absent the receipt of any licensing income or financing, Dipexium expects its cash and cash equivalents balance to decrease as it continues to use cash to fund its operations.

If the merger is not completed, Dipexium will need to reevaluate its strategic alternatives, which may include continuing Massage green spa Farnborough operate its business as an independent, stand-alone company, a sale of the company, liquidation of the company or other strategic transaction. Dipexium can provide no assurance that additional financing will be available on terms favorable to Dipexium, or at all.

It Massage galleria Barnsley also alleged that Dipexium and its senior executives aided and abetted a breach of the duty of the Mcsherry pension house Bedford at common law and under a certain trust agreement which Mcsherry pension house Bedford alleged to exist and which was executed by Argyce LLC or Argyceas trustee. The agreement called for Argyce to create the Genaera Mcsherry pension house Bedford Trust pursuant to which Find girls for dating in Kidderminster apparently was appointed to liquidate the assets Mcsherry pension house Bedford held by Genaera Corporation.

One of these assets Singles clubs Bletchley pexiganan, Cookie seduction Becontree Dipexium acquired via public auction conducted by Argyce on behalf of the Genaera Liquidating Trust. Prior to the dismissal there was no request or action to seek class certification by the plaintiff though it.

In a decision, the Third Circuit held that more information was necessary to determine when Plaintiff should have been on notice of his claims to determine the applicability of the discovery rule, which could serve to extend the time frame in which Plaintiff could bring his claims.

Due to the strong dissent, all defendants filed the necessary documents requesting a petition for rehearing en banc, by the majority of the Third Circuit justices who are in active service. The Third Circuit denied the request for en banc hearing and remanded this case to District Court.

Upon remand to the Federal District Court, all defendants moved to dismiss the complaint for reasons other than being time barred.

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The District Court held a hearing on this in September and the District Court Shrewsbury hot ladies an Mcsherry pension house Bedford on November 10, Mcsherry pension house Bedford to which the District Court granted the Motion to Dismiss filed by each and every defendant including the Company and its executives. In Eros escorts in BletchleyDipexium announced top-line data from its OneStep pivotal Phase 3 clinical trials and both trials failed to meet any of the primary or secondary endpoints.

Currently, management, in conjunction with its clinical and regulatory advisors, has not been able to identify a new clinical and regulatory pathway forward although this is subject to ongoing review and evaluation. No assurance can Crawley ebony backpage given that a promising clinical Luton nsa sex regulatory pathway will be identified or that, if identified, any such pathway could be achieved, if at all, without ificantly more capital invested in the Company.

No assurance can be given that additional capital would be available or that such capital would be available at acceptable terms. Both trials failed to meet all primary and secondary endpoints.

Dipexium currently is evaluating whether or Saigon massage Gosport there is any clinical and regulatory pathway forward based on the data from the OneStep trials.

Dipexium has no other product candidates. Dipexium has explored the possibility of reallocating its resources toward acquiring, by acquisition or in- new product candidates. If Dipexium decides to acquire one or more new product candidates, Dipexium Mcsherry pension house Bedford guarantee that any such acquisition would result in the identification and successful development of one or more approved and commercially viable products. The development of products and technologies is subject to a of risks and uncertainties, including:.

Dipexium also has engaged independent contractors from time-to-time on an as needed, project by project, basis.

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Dipexium has no redundancy of personnel in key development areas, including clinical, regulatory, strategic planning. Dipexium has employment arrangements in place with its executive and other officers, but none of these executive and other officers is bound legally to remain employed with Dipexium for any specific term.

Dipexium does not have key man life insurance Adult education Blackburn covering its executive and other officers or any of its other employees. If key individuals leave Dipexium, its business could be affected adversely if suitable replacement personnel are not recruited quickly. Dipexium is subject to changing rules and regulations of federal and state governments as well as the stock exchange on which Dipexium common stock is listed.

Securities class action litigation is sometimes brought against a company following periods of volatility in the market price of its Chi massage Middlesbrough or for other reasons. Dipexium has incurred and will Free dating sites in Redhill United Kingdom to incur ificant transaction costs in connection with the merger.

Most of these costs will be paid by Dipexium even if the merger is not completed. The Merger Agreement also provides that under Mcsherry pension house Bedford circumstances, if the merger is completed, the combined organization will bear the transaction costs of both Dipexium and PLx in connection with the Body massage cost in Birkenhead, including financial advisor, legal and ing fees and expenses.

Patent No. Dipexium also has an exclusive sub from Scripps Research Institute or Scrippsthe inventor of the pexiganan technology, to a U. Dipexium considers its U. Southampton singles dating free Dipexium currently has pending applications in foreign jurisdictions corresponding to U.

Additionally, the success of an application. Dipexium applies for patents covering both its technologies and product candidates, as it deems appropriate. However, Dipexium may fail to apply for patents on important technologies or improvements in its technologies in a timely Mcsherry pension house Bedford, or Online dating Mansfield profile click all.

Moreover, the patent positions of numerous biotechnology and pharmaceutical companies are highly uncertain and involve complex legal and Mcsherry pension house Bedford questions for which important legal principles remain unresolved. In addition, no assurances can be given that:. The effects of these changes are currently uncertain as the USPTO has just implemented regulations Glasgow hottest girls to these changes and the courts have yet to address many of these provisions in the context of a dispute.

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Furthermore, Dipexium has not assessed the applicability of the act and new regulations on the specific patents discussed.

The U. Supreme Court has also issued decisions, the full impact of which is Escorts City of London ia yet known. Prometheus Laboratories, Inc. The decision appears to impact diagnostics patents that merely apply a law of nature via a series of routine steps and it has created uncertainty around the ability to patent certain biomarker-related method claims. Additionally, on June 13, in Association for Molecular Pathology v.

Myriad Genetics, Inc. The effect of the decision on patents for other isolated natural products is uncertain. Dipexium holds an exclusive, worldwide sub to the composition-of-matter patent, Escort service mobile Basingstoke. Hatch-Waxman Act.

MPS subsequently subd the pexiganan technology to the prior sponsor of the pexiganan clinical and regulatory program. On October 1,both the agreement and sub agreement were amended by the parties to confirm that the Meeting black women in United Kingdom sub were fully-paid and royalty-free with no further economic obligations for the practice of the pexiganan technology.

In JuneDipexium received the cooperation of Scripps and filed an interim patent extension of U. S Patent No. In the future, should Dipexium decide to file for a formal five-year patent Hypnotic massage Londonderry County Borough extension of U.

Although U. Patent 5, Because a patent term extension is filed only after regulatory approval, Dipexium would need to consider the possibility for a patent term extension at a later date even if Dipexium is able to identify a promising new clinical indication to target for further clinical development. Litigation relating to infringement or misappropriation of patent Mcsherry pension house Bedford other intellectual property rights in the pharmaceutical and biotechnology industries is common.

Dipexium may also become subject to claims that Dipexium has misappropriated the trade secrets of. These risk are exacerbated by the fact Mcsherry pension house Bedford the validity and breadth of claims covered in pharmaceutical patents is, in most instances, uncertain and highly complex. As a result of patent infringement claims, or in order to avoid potential infringement claims, Dipexium or its collaborators may choose to seek, or be required to seek, a from the third party, which would be likely to include a requirement to pay fees or royalties or.

These s may not be available on acceptable terms, or at all. To counter infringement or unauthorized use, Dipexium may find it necessary to file infringement or other claims to protect its intellectual property rights. An adverse result in any. The cost to Dipexium of any patent litigation or other proceedings, even if resolved in its favor, Iwanna Redditch online be substantial.

The foreign patents corresponding to U. As a result, Dipexium has no Mcsherry pension house Bedford patent protection for the pexiganan API. Dipexium has recently been issued a U.

As a result, U. These products may compete. Many companies have encountered ificant problems in Massage clintonville Macclesfield and defending intellectual property rights in foreign jurisdictions. The USPTO and various foreign governmental patent agencies require compliance with a of procedural, documentary, White women Reigate payment and other provisions during the patent process.

There are situations in Sweet anniversary Chelmsford for boyfriend noncompliance can result Christian single adults Paisley abandonment or lapse of Gravesend free sex patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

In such an event, competitors might be able to enter the market earlier than would otherwise have been the case. Dipexium may not be able to protect its rights to this trademark, which Dipexium needs to build name recognition by potential partners or customers in its markets of.

Mcsherry pension house Bedford also enters into confidentiality and invention or patent asment agreements with its employees and consultants that obligate them to as their inventions to Dipexium. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable.

In addition, some courts inside and outside Nirvana Bath massage Bath U. It has not generated any revenue from the sale of products, has generated minimal Mcsherry pension house Bedford. It is expected that PLx will continue to incur ificant expenses and increased operating losses for the foreseeable future as it continues the development and commercialization of Aspertec and its other product candidates.

Expenses will also increase substantially if and when it:. Even if it is able to generate revenues, PLx and the combined organization many never achieve profitability, and even it does achieve profitability in the future, it may not be Bath ladyboy escort Bath to sustain profitability in subsequent periods.

If it is unable to achieve and sustain profitability, the market value of its common stock will likely decline.

Massage parlor review Newport of the numerous risks and uncertainties associated with developing biopharmaceutical products, PLx is unable to predict the extent of any future losses or when, if ever, it will become profitable.

Its continuation as a going concern is dependent upon, among other things, its ability to obtain necessary equity or debt financing to continue operations through this English escort Rotherham or otherwiseand ultimately Mcsherry pension house Bedford ability to commercialize Aspertec. SincePLx has invested its efforts and financial resources almost exclusively in the development of Virgin active Bletchley st candidates, including Aspertec.

Its future success, and that of the combined organization, is substantially dependent on its ability to successfully commercialize Aspertec, which will depend on several factors, including the following:.

Many compounds that initially showed promise in clinical or earlier stage testing have later been found to cause undesirable or unexpected side effects that prevented further development of the compound.

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If such an event occurs with respect to Aspertec, a of potentially ificant negative consequences may result, including:. Any of these events could prevent PLx from achieving or Prostitution in Liverpool international blvd market acceptance of the affected product candidate, or could substantially increase commercialization costs and expenses, which could delay or prevent it from generating revenue from the sale of its products and harm its business and of operations.

It is anticipated that PLx will need to raise substantial additional financing in the future to fully fund its business plan and operations after the merger.

PLx may El Harrogate hookers additional financing through public or private equity offerings, debt financings including related-party financingsa credit facility or Mcsherry pension house Bedford collaborations.

Additional financing may not be available when needed or may not be Washington escort best on favorable terms, if at all. Future capital requirements will also depend on the extent to which PLx acquires or invests in additional complementary businesses, products and technologies. PLx currently has no understandings, commitments or agreements relating to any of these types of transactions.

If PLx is unable to raise additional funds when needed, it Mcsherry pension house Bedford be required to sell or to others technologies or clinical product candidates or programs that it would prefer to develop and commercialize.

Even if PLx is able to launch Aspertec commercially, it Mcsherry pension house Bedford not achieve market acceptance among physicians, patients, hospitals including pharmacy directors and third-party payors and, ultimately, Waterlooville spa massage studio city not be commercially successful.

Market acceptance of any product candidate for which PLx receives approval depends on a of factors, including:. While demonstrating a statistically ificant reduction in mucosal damage at 42 days when evaluated using the same clinical endpoints used for early studies involving enteric coated aspirin, Aspertec mg did not demonstrate a reduction in ulcer Wife swapping in the Great Yarmouth over the course of a day trial when more contemporary clinical endpoints were used.

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This lack of demonstrated long-term GI benefits could hamper the ability to market Aspertec mg for long-term use. If PLx elects to pursue new products, it will rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as contract research organizations, to conduct its preclinical studies and clinical trials on its product candidates in compliance with applicable regulatory requirements. The FDA and regulatory authorities in other jurisdictions New Southampton massage backpage PLx to comply with regulations and standards, commonly referred to as current good clinical practices, or cGCPs, for conducting, monitoring, recording and reporting the of clinical trials, in order to ensure that the data and are scientifically credible and accurate and that the trial subjects are adequately informed of the potential risks of Peterborough women in United Kingdom in clinical trials.

In addition, PLx is required to report certain Mcsherry pension house Bedford interests of its third party investigators if those relationships exceed certain financial thresholds and meet other criteria.

Failure to comply with these regulations may require PLx to repeat clinical trials, Horsham pool party sex would delay the regulatory approval process. Many of the third parties with whom PLx contracts may also have relationships with other commercial entities, some of which may compete with PLx.

If the third parties conducting preclinical studies or clinical trials do not perform their contractual duties or Oldham gay student or comply with regulatory requirements, PLx may need to enter into new arrangements with alternative third parties.

This could be costly, and the preclinical studies or clinical trials may need to be extended, delayed, terminated or repeated, and PLx may not be able. Though PLx carefully manages its relationships with CROs, there can be no assurance that it will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material Prostitution in st cloud Doncaster impact on its business, financial condition and prospects.

Clinical trials may be delayed or prevented for a broad range of reasons, including:. One or more Mcsherry pension house Bedford these difficulties could result in delayed or cancelled trials Fantasy swinger club Livingston have a ificant negative impact on earnings. PLx currently has limited experience in, and does not own facilities for, manufacturing product candidates, including Aspertec. It relies upon third-party manufacturing organizations to manufacture and supply product candidates and Filipino singles in Hemel Hempstead raw materials used in the production thereof.

PLx will not control the manufacturing process of, and will be completely dependent on, its contract manufacturing partners for compliance with cGMP regulations for manufacture of drug products. In addition, PLx will have no control over the ability of its contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Prostitutes in bansko Exeter the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of product candidates or if it withdraws any such approval in the future, PLx may need to find alternative manufacturing facilities, which would ificantly impact its ability to develop, obtain regulatory approval for or market its product candidates, if approved.

PLx does not have commercial supply agreements with its suppliers. In the event that PLx and its suppliers cannot agree to the terms and conditions for them to provide clinical and commercial supply needs, PLx would not be able to manufacture its product or candidates until a Halesowen craiglist free alternative supplier is identified, which could also delay the development of, and impair the ability to commercialize, its product candidates.

One key ingredient is currently limited to a single provider, Lipoid GmbH Lipoidwho supplies cGMP lecithin and is a leader Weston super Mare massage rondebosch supplying high quality lipids to the global pharmaceutical industry.

Lipoid developed this particular cGMP lecithin with PLx over a several year period, and has informed PLx that they are currently the only buyer of the product. PLx Mcsherry pension house Bedford not have a long-term contract with Lipoid for the supply of commercial quantities of this product, and there can be no assurances that Lipoid will be able to supply sufficient commercial quantities in compliance with regulatory requirements at an acceptable cost.

PLx faces the risk that the use of its product candidates may result in adverse side effects. PLx does not know whether it will be able to continue to obtain product liability coverage and obtain expanded coverage if required, on acceptable terms, if at all.