Upon the signing of the Samil Agreement, Samil paid the Company a gross upfront fee of approximately $2.1 million and in September], 2018, we received a milestone payment of $1.5 million. Samil has also agreed to pay additional clinical and regulatory-based milestone payments, which may aggregate to an additional $4.5 million, as well as tiered, double-digit royalties payable on sales (lower if sales of a generic equivalent commence in the Territory).

These factors and any corresponding price fluctuations may materially and adversely affect the market price and trading volume of our ordinary shares and result in substantial losses by our investors.

        We expect to enter into additional collaborations for the development and commercialization of certain of our product candidates. If we enter into such collaborations, we will have limited control over the amount and timing of resources that our collaborators will dedicate to the development or commercialization of our product candidates. Our ability to generate revenues from these arrangements will depend on any future collaborators’ abilities to successfully perform the functions assigned to them in these arrangements. In addition, any future collaborators may have the right to abandon research or development projects and terminate applicable agreements, including funding obligations, prior to or upon the expiration of the agreed upon terms.

Low-temperature batch to continuous processes The conversion of low-temperature batch reactions to continuous processes is attractive because in many cases higher temperatures can be used to achieve equal or better results. For example, scientists from Eisai report the continuous production of eribulin mesylate via the diisobutylaluminum hydride reduction of an ester followed by n-butyllithium-mediated coupling of the resultant aldehyde to a sulfone fragment to afford a sulfone-diol as a key intermediate, all without the need for cryogenic conditions (11). The reduction was run at -50 °C instead of -70 °C, yet a better selectivity and yield were obtained, while the butyllithium-mediated coupling when run under flow conditions at 10 °C proceeded with a better conversion rate than the batch reaction when performed at -70 °C.

Our reporting currency and financial currency is the U.S. dollar. In this annual report, “NIS” means New Israeli Shekel, and “$,” “US$” and “U.S. dollars” mean United States dollars.

        The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance

My guess (based on disagreement among experts) is that there are individuals for whom a great deal of high intensity exercise is beneficial, and there are others who damage their cardiovascular systems by pushing too far.  Doctors may be able to tell you if you have a heart condition that makes exercise hazardous.  My hope (based on personal experience with yoga) is that we might develop a sensitivity to our bodies, so that we can distinguish the pain of damage from the pain and resistance that always accompanies a strenuous workout.

On another note, i am not a fan of CR i believe IF is far superior. This is based on the fact that IF continues to drive down insulin where CR does lower insulin levels it does plateau.

The Company determined that the transaction price at contract inception was $2.1 million consisting of the upfront, non-refundable payment. None of the clinical or regulatory milestones were included in the transaction price upon inception, as all milestone amounts were fully constrained. Management assessed that the likelihood of occurrence of the other performance obligations in the Agreement was remote upon contract inception. As such, the stand-alone value of such performance obligations was deemed de minimis and none of the transaction price was allocated to those obligations. Any consideration related to sales-based milestones and royalties will be recognized when the related sales occur, and therefore have also been excluded from the transaction price.

As of January 1, 2014, dividends paid out of income attributed to a Preferred Enterprise or to a Special Preferred Enterprise are generally subject to withholding tax at source at the rate of 20% unless a lower tax rate is provided under an applicable tax treaty (subject to the receipt in advance of a valid certificate from the Israel Tax Authority allowing for a reduced tax rate). However, if such dividends are paid to an Israeli company, no tax is required to be withheld (although, if such dividends are subsequently distributed to individuals or a non-Israeli company, withholding tax at a rate of 20% or such lower rate as may be provided in an applicable tax treaty will apply). In 2017-2019 dividends paid out of preferred income attributed to a Special Preferred Enterprise, directly to a foreign parent company, are subject to withholding tax at source at the rate of 5% (temporary provisions).

(A) RNA was isolated in kidneys from P311+/+ (n = 6) and P311−/− (n = 6) mice 7 days after UUO or sham operation. TGF-β1 mRNA expression was determined by real-time PCR. (B) Representative photomicrographs of TGF-β1-specific immunohistochemical staining of UUO kidneys from P311+/+ and P311−/−mice on day 7. Black arrowhead indicates the TGF-β1-positive region. Bottom panel: negative controls for the immunohistochemical staining of TGF-β1 on the obstructed kidneys from both P311+/+ and P311−/− mice. (C) TGF-β1-positive region was quantified in stained sections from P311+/+ (n = 6) and P311−/− (n = 6) mice 7 days after UUO. (D) Western blot analysis of TGF-β1 protein levels. TGF-β1 protein levels in each treatment group (n = 3 per group) were quantified. A-D are representative of at least three similar experiments. Scale bar: 100μm. Data are presented as the mean ± SD. *P < 0.05; **P < 0.01.

We face potential product and other liability exposure, and, if claims are brought against us, we may incur substantial liability.