Rompolas, P., Mesa, K. R. & Greco, V. Spatial organization within a niche as a determinant of stem-cell fate. Nature 502, 513–519 (2013).

BioTime Inc. (OTCBB: BTIM ) BioTime, headquartered in Alameda, California, develops blood plasma volume expanders, blood replacement solutions for hypothermic (low temperature) surgery, organ preservation solutions, and technology for use in surgery, emergency trauma treatment and other applications. BioTime’s lead product Hextend is manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements.

        In addition to the protection afforded by patents, we also rely on trade secret protection for certain aspects of our intellectual property. For example, a majority of the patents underlying our proprietary peptide chemistry technology expire by 2022. As a result, we anticipate that we will rely on trade secrets as the primary protection for the know-how behind our proprietary platform. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, consultants, independent contractors, advisors, contract manufacturers, suppliers and other third parties. We also enter into confidentiality and invention or patent assignment agreements with employees and certain consultants. Any party with whom we have executed such an agreement may breach that agreement and disclose our proprietary

        A certification that the new product will not infringe the already approved product’s listed patents or that such patents are invalid or unenforceable is called a Paragraph IV certification. If the applicant does not challenge the listed patents or indicates that it is not seeking approval of a patented method of use, the ANDA application will not be approved until all the listed patents claiming the referenced product have expired (other than method of use patents involving indications for which the ANDA applicant is not seeking approval).

        The Company recorded no current or deferred tax expense for federal and state purposes and no current foreign tax expense for the years ended December 31, 2018 and 2017. A foreign deferred tax benefit of approximately $19,000 has been recorded for both the years ended December 31, 2018 and 2017.

        2.     Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

We may be required to initiate litigation to enforce our rights or defend our activities in response to alleged infringement of a third-party. In addition, we may be sued by others who hold intellectual property rights and who claim that their rights are infringed by Aramchol or any of our future products or product candidates. These lawsuits can be very time consuming and costly. There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries generally.

In the early 1980s, localized drug delivery was another novel concept pursued with PLG polymers. One program, funded by the US Army Institute of Dental Research, focused on the local delivery of antibiotics to treat battle wounds (12). The concept was for a soldier to apply a powder of controlled-release PLG/antibiotic microparticles directly into a wound. The microparticles would then slowly release the antibiotic and maintain a high level of drug at the wound site for 14 or 21 days to achieve efficacy without requiring daily, oral dosing.

Well the EDQM has now added their word to the debate of contaminantshttps://www.edqm.eu/en/news/update-edqm-review-cep-applications-sartan-substances-4-february-2019

During 2018, when the Company determined that the achievement of its first milestone was probable, it included the variable consideration of $1.5 million as a part of the transaction price allocated to the combined performance obligation including the delivery of the license and completion of the ARREST study. The Company will re-evaluate the transaction price in each reporting period when events whose outcomes are resolved or other changes in circumstances occur that would indicate it is appropriate to recognize variable consideration as revenue.

Frohlich, E. D. & Susic, D. Pressure overload. Heart Fail Clin 8, 21–32, 10.1016/j.hfc.2011.08.005 (2012).

Stilli, D. et al. Myocardial remodeling and arrhythmogenesis in moderate cardiac hypertrophy in rats. Am J Physiol Heart Circ Physiol 280, H142–50 (2001).