We are exposed to the risk that our employees, independent contractors, consultants, collaborators and contract research organizations may engage in fraudulent conduct or other illegal activity. Misconduct by those parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates: (1) FDA regulations or similar regulations of comparable non-U.S. regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities, (2) manufacturing standards, (3) federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable non-U.S. regulatory authorities, and (4) laws that require the reporting of financial information or data accurately. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws, standards or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations,
In this case, the valsartan recall was originally traced back to a problem with the material from Zhejiang Huahai Pharmaceuticals. That’s the Chinese manufacturer who made the API itself. There were originally two generic companies whose tablets included the ZHP material, Teva and Prinston. But the Teva material was sold by Major Pharmaceuticals and also by Actavis, while the Prinston was sold by Solco Healthcare – there are those three layers of API production, pill manufacturing, and repackaging. It turned out that there were nine more repackagers of the Teva and Prinston tablets, so valsartan packages under those other names were added to the recall list. But not all of them. To add the confusion, some of the packages from those companies were still OK, because they’d bought the tablets from more than one manufacturer. The recall had to be done by batch number. Meanwhile, Torrent Pharmaceuticals also emerged as a company who had bought the original valsartan API from Zhejiang Huahai, so their products went on the list as well.
We have exclusively licensed one patent family directed to an in vitro translation system for incorporating unnatural amino acids from Dr. A. C. Forster. This family, which covers certain rights related to our Extreme Diversity platform, includes five granted patents, including one in the U.S. and four in foreign jurisdictions, including Australia, Canada, Europe, and Japan. Patents in this family are generally expected to expire in 2022, subject to possible patent term extensions. This license may be terminated if we fail to make payments thereunder, if we commit a material breach of our obligations thereunder, or if we make an assignment for benefit of creditors or have a petition in bankruptcy filed; also, we may terminate the license for any reason upon 30 days’ prior written notice. As of the date of this Annual Report on Form 10-K, we have paid an aggregate amount of approximately $280,000 under this license. In connection with the execution of this license, we paid an issue fee of approximately $175,000, and annual maintenance fees are approximately $15,000. In addition, we issued equity in the amount of approximately 8,500 shares of common stock in connection with this license. The license provides for running royalties equal to 0.25% of net sales of licensed products thereunder, payable on a country-by-country and licensed product-by-licensed product basis until the expiration of the last valid claim covering such product in such country.
HIF-dependent gene regulation was performed by a dual reporter gene assay, using a firefly luciferase construct and a reference Renilla luciferase construct pRL-TK (Promega, Madison, WI). A putative promoter of miR-322 containing the consensus sequence of the HRE was constructed by PCR from rat genomic DNA by using the primers: 5- CCG CTC GAG TAC TTA GTT TAA CTA CAG ACT C -3 (forward) and 5- CGA CGC GTG GGG CCG CTC TGG GGT ACC TGC -3 (reverse). Luciferase activity was measured in cell extracts with a Lumat LB9508 luminometer (Berthold, Bad Wildbad, Germany).
I’ve often thought that one of the brain’s greatest abilities is the ability to forget. Hence I would be quite surprised a rejuvenated brain would have any difficulty adapting to existing in a rejuvenated body.
In addition, we rely on the protection of our trade secrets and proprietary know-how. Although we have taken steps to protect our trade secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidential information and inventions agreements with employees, consultants and advisors, we cannot provide any assurances that all such agreements have been duly executed, and third parties may still obtain this information or may come upon this or similar information independently. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating its trade secrets. If any of these events occurs or if we otherwise lose protection for our trade secrets or proprietary know-how, our business may be harmed.
For example a standardized product may contain Willow (bark) 500 mg Willow (bark) Extract standardized to 15% salicin (60 mg) 400 mg
Bachem is continuously expanding and updating its extensive range of products for your research purposes. We are pleased to present our latest product additions, which include several Pro-VGF-derived peptides, osteoblast activating peptides, and two deuterium-labelled API analogs. A number of pro
Pursuant to the Companies Law, an external director is required to have either financial and accounting expertise or professional qualifications according to criteria set forth in regulations promulgated under the Companies Law, provided that at least one of the external directors has financial and accounting expertise. However, if at least one of our other directors (1) meets the independence requirements of the Exchange Act, (2) meets the Nasdaq requirements for membership on the audit committee and (3) has financial and accounting expertise as defined in the Companies Law and applicable regulations, then neither of our external directors is required to possess financial and accounting expertise as long as both possess other requisite professional qualifications as required under the Companies Law and regulations promulgated thereunder.
Thanks Akshay, yes indeed there are other ways to get rid of iron and/or chelate it. I’m just pointing out one of aspirin’s likely other mechanisms. Yes also that willow bark could and probably does have other components that are important. Some research concluded that the salicylate in willow couldn’t possibly account for all of its painkilling ability since there’s too little compared to aspirin.
For those who like gossip.The above you tube video features Leonard Guarente, whom I have known and interviewed since 2006. As he begins his lecture he refers to two students of his at MIT, Brian Kennedy and Nic Astriaco. I have interviewed both of them. Nic left his fellowship in the UK in the 90’s after 9 months and entered the priesthood. He now teaches genetics at Providence College and also consults on the ethical issues brought up by research. His long ago partner, Brian Kennedy, was actually his mentor when he returned to research after being ordained. Kennedy recounted that first meeting “Nic came in with his clerical collar and his bible and we trashed it out, argued our positions” – all done in understatement. Guarente explained that when he told his colleagues about Nic entering the seminary, their reaction was “worse than if he had died.” Lenny and Brian have clashed over their dueling genes, srituins and mtor, on and off for years.
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.
Steps Closer to the Adoption of Continuous Processing | Terlipressin Acetate Gmp Manufacturer Related Video:
Our pursuit and company goal is to "Always satisfy our customer requirements". We continue to develop and design superior quality products for both our old and new customers and achieve a win-win prospect for our clients as well as us for Lanreotide Acetate Provider, Liraglutide Acetate, Aviptadil Acetate Exporter, We expect to provide products and services to more users in global aftermarket markets; we launched our global branding strategy by providing our excellent products all over the world by virtue of our well reputed partners letting global users keep pace with technology innovation and achievements with us.