Item 8.01
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Other Information
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On November 23, 2016, the Company provided an update as set
forth below to the Companys intellectual property matters.
Intellectual Property
We have filed patent applications directed to Resunab, compositions and methods for treating disease using Resunab. If granted, the resulting
patents would expire on dates ranging from 2030 to 2034, subject to extension under certain circumstances. The patent application filings are directed to:
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Compositions including an improved ultrapure version of Resunab and uses of the compositions for the treatment of fibrotic conditions and inflammatory conditions;
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The use of Resunab in the treatment of fibrotic diseases; and
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Resunab formulations and uses of the formulations for the treatment of disease.
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We do not
have any issued patents for Resunab for the treatment of cystic fibrosis, systemic sclerosis, dermatomyositis, SLE or any other indications for which we are currently seeking commercial approval.
Resunab has been granted Orphan Drug Designation for both cystic fibrosis and systemic sclerosis in the U.S. and for Cystic Fibrosis in the
European Union. We will be seeking orphan drug status for Resunab in systemic sclerosis in Europe. For dermatomyositis and possibly other orphan inflammatory diseases we will be seeking orphan drug status from the U.S. Food and Drug Administration
and in Europe. Orphan drug status provides seven years of market exclusivity in the U.S. and ten years in Europe beginning on the date of drug approval.
Our commercial success depends in part on our ability to obtain and maintain patent and other proprietary protection for Resunab and to
operate without infringing the proprietary right of others and to prevent others from infringing our proprietary rights. We strive to protect our intellectual property through a combination of patents and trademarks as well as through the
confidentiality provisions in our contracts. With respect to Resunab, we endeavor to obtain and maintain patent protection in the U.S. and internationally on all patentable aspects of the drug. We cannot be sure that the patents will be granted with
respect to any patent applications we may own or license in the future, nor can we be sure that any patents issued or licensed to us in the future will be useful in protecting our technology. For this and more comprehensive risks related to our
intellectual property, please see Risk FactorsRisks Relating to Our Intellectual Property Rights in this current report on Form 8-K and in our most recently filed annual report on Form 10-K and subsequently filed reports with the
SEC.
In addition to patent protection, we rely on trade secrets and know-how to develop and maintain our competitive position. For
example, aspects of our proprietary technology platform are based on unpatented trade secrets and know-how related to the manufacturing of Resunab. Trade secrets and know-how can be difficult to protect. We seek to protect our proprietary technology
and processes, in part, by confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and commercial partners. These agreements are designed to protect our proprietary information
and, in the case of the invention assignment agreements, to grant us ownership of technologies that are developed through a relationship with a third party. We also seek to preserve the integrity and confidentiality of our data and trade secrets by
maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached, and
we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our contractors use intellectual property owned by others in their work for
us, disputes may arise as to the rights in related or resulting know-how and inventions.
We also plan to seek trademark protection in the
U.S. and outside of the U.S. where available and when appropriate. We intend to use these registered marks in connection with our pharmaceutical research and development as well as our product candidates.
Risks Relating to Our Intellectual Property Rights
It is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights.
Our commercial success will depend, in part, on obtaining and maintaining patent protection for our technologies, products and processes,
successfully defending these patents against third-party challenges and successfully enforcing these patents against third party competitors. The patent positions of
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pharmaceutical companies can be highly uncertain and involve complex legal, scientific and factual questions for which important legal principles remain unresolved. Changes in either the patent
laws or in interpretations of patent laws may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be allowable in our pending applications or, if we obtain patents from our applications,
enforceable. Our pending patent applications for Resunab and its uses may never be approved by U.S. or foreign patent offices and the existing patent applications relating to Resunab and related technologies may be challenged, invalidated or
circumvented by third parties and might not protect us against competitors with similar products or technologies. We do not have any issued patents for Resunab for the treatment of cystic fibrosis, systemic sclerosis, dermatomyositis, SLE or any
other indications for which we are currently seeking commercial approval.
The degree of future protection for our proprietary rights is
uncertain, because legal means afford only limited protection and may not adequately protect our rights, permit us to gain or keep our competitive advantage, or provide us with any competitive advantage at all. For example, others have filed, and in
the future are likely to file, patent applications covering products and technologies that are similar, identical or competitive to Resunab, or important to our business. We cannot be certain that any patent application owned by a third party will
not have priority over patent applications filed by us, or that we will not be involved in interference, opposition or invalidity proceedings before U.S. or foreign patent offices.
We also rely on trade secrets to protect technology, especially in cases when we believe patent protection is not appropriate or obtainable.
However, trade secrets are difficult to protect. While we require employees, academic collaborators, consultants and other contractors to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or other
proprietary or licensed information. Typically, research collaborators and scientific advisors have rights to publish data and information in which we may have rights. If we cannot maintain the confidentiality of our proprietary technology and other
confidential information, our ability to receive patent protection and our ability to protect valuable information owned by us may be imperiled. Enforcing a claim that a third-party entity illegally obtained and is using any of our trade secrets is
expensive and time consuming, and the outcome is unpredictable. In addition, courts are sometimes less willing to protect trade secrets than patents. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
If we fail to obtain or maintain patent protection or trade secret protection for Resunab or our technologies, third parties could use
our proprietary information, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and attain profitability.
We may also rely on the trademarks we may develop to distinguish our products from the products of our competitors. We cannot guarantee that
any trademark applications filed by us or our business partners will be approved. Third parties may also oppose such trademark applications, or otherwise challenge our use of the trademarks. In the event that the trademarks we use are successfully
challenged, we could be forced to rebrand our products, which could result in loss of brand recognition, and could require us to devote resources to advertising and marketing new brands. Further, we cannot provide assurance that competitors will not
infringe the trademarks we use, or that we will have adequate resources to enforce these trademarks.