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Figure 2. MGL inhibitors specifically suppress cannabinoid-sensitive synaptic transmissions in a CB1-dependent manner. A, B, Two representative experiments showing the effects of bath-applied MAFP 0.1 M ; on cannabinoid-sensitive IPSCs. The IPSC traces acquired at the indicated time points a c ; top ; and the IPSC amplitudes plotted as a function of time bottom ; are shown. The IPSC amplitude declined slowly A ; or rapidly B ; after MAFP application and recovered to the initial level after addition of the CB1 antagonist AM281 0.3 M ; . C, Effect of bath-applied MAFP 0.1 M ; on cannabinoid-insensitive IPSCs. Examples of IPSC traces before and 5 min after the initiation of MAFP application top ; and averaged data for the time course of IPSC amplitude bottom; n 4 ; are shown. D, Effects of bath-applied MAFP 0.1 M ; on EPSCs. Examples of EPSC traces before and 5 min after the initiation of MAFP application top ; and averaged data for the time course of EPSC amplitude bottom; n 9 ; are shown. E, From left to right, Averaged data showing percentage changes in the amplitudes of cannabinoidsensitive IPSCs, cannabinoid-insensitive IPSCs, and EPSCs by application of indicated drugs. Numbers of tested cells are indicated in parentheses. * p 0.05; * p 0.01; * p 0.001 by paired t test.
Exhibit 12 i ; CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER CERTIFICATIONS I, Israel Makov, certify that: 1. 2. I have reviewed this annual report on Form 20-F of Teva Pharmaceutical Industries Limited; 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; Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report; The company's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures as defined in Exchange Act Rules 13a-15 e ; and 15d-15 e for the company and have: a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; evaluated the effectiveness of the company's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and disclosed in this report any change in the company's internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company's internal control over financial reporting; and, for example, prescribing information.
Being candid with the FDA about problems and setbacks will signal the developer's good faith and interest in working with the regulatory agency. Risk management begins early in the development process and continues after the filing of the application. The FDA in recent years has had a great interest in risk management. It is smart these days to build a risk-management plan into the application because the FDA will often ask for it. This can make the difference between receiving an approvable letter and an approval letter. "The most important audience is the FDA" says Donald McLearn, senior VP of Ruder Finn Inc. ruderfinn ; , a communications, counseling, and services agency. Mr. McLearn spent many years at the FDA, where he served as the deputy associate commissioner for public affairs. "Even when a company is going before an advisory committee meeting, it has remember that the FDA set up the questions to ask the advisory committee. And the questions and answers can be make or break for a company. The companies cannot ever believe that the FDA doesn't stage manage that whole process." 10. Being too eager to disclose to the public The price of a pharmaceutical company's stock can fluctuate significantly based on financial reports and the outcome of new drug applications. Pharmaceutical developers need to pay close attention to the timing and contents of disclosures and announcements to investors and the public. The companies that tend to be eager about their announcements are the biotechnology companies, which want to stimulate the price of their stock. "I don't know what the motive is, " Mr. McLearn told R&D Directions. "They tend to announce everything too quickly, sometimes embarrassing themselves, because then it's public to the world that they've been turned down." Mr. McLearn has some advice for these companies: "Don't announce to the world everything too fast. Be strategic about announcing to the world when you're going in with an application to the FDA." Most major companies that have had experience in this area tend to wait until they have good news to announce. Many lawsuits have been filed during the past year against pharmaceutical companies for misrepresenting product potential and issuing misleading financial reports to inflate stock prices. Federal and state securities laws oblige public corporations to disclose accurately, completely, and promptly all material information that could affect investment prices to investors. Knowing or reckless misrepresentation or non-disclosure is actionable under the federal securities laws. In spite of the strict requirements concerning disclosure, inexperienced companies can hurt themselves by poorly timing disclosures or announcing every detail of a clinical development program in the hopes of boosting the price of the stock. 11. Not Thinking Globally Pharmaceutical companies can avoid dossier planning and compilation nightmares if they consider preparing the new drug application in a global format. In July 2003, the common technical document is going to be mandatory in Europe and Japan. "The FDA strongly expects it, " Ms. Shibley told R&D Directions. "Companies could save a lot of time in submitting applications in different regions if they start out with that common technical document format.
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The following forms need to be completed and returned to the DYF by the indicated due date: Family Information Form Family Health History Form Request for Financial Assistance Bruno or Chip application - if applicable Payment Plan Form - if applicable PAYING REGISTRATION FEES & FINANCIAL ASSISTANCE There are three ways to pay for camp and transportation fees: 1. 2. 3. Pay the full camp fee in one payment at least two weeks prior to the start of the session. You may pay with a check, debit, or credit card. Pay the full camp fee through monthly payments. Pay the portion of camp fees you can afford and request a scholarship for the balance. He synthesis of -chiral amines using the catalytic asymmetric addition of diorganozinc reagents has produced very exciting results in recent years 13 ; . This very important subunit is commonly found in many pharmaceuticals and other biologically important compounds. Some specific examples include Flomax antihypertensive ; and Mezitil antiarrhythmics ; Fig. 1 ; 4 ; . The most important methodologies developed to prepare -chiral amines in enantiomerically pure form rely on either chemical resolution or on the use of readily available chiral synthons as building blocks. More recently, the development of efficient chiral auxiliaries has led to the extensive use of chiral imines as precursors to -chiral amines by alkylation chemistry 59 ; or hydrogenation 10 ; . Catalytic asymmetric nucleophilic addition reactions of organometallic reagents to imines have been reported with Ntosylimines 11, 12 ; , N-arylimines 1315 ; , and N-acylimines 16, 17 ; as amine precursors. The cleavage of the protecting group leads to the -chiral amine; however, in the former two cases, harsh conditions are usually necessary [N-tosyl, SmI2; N-aryl, ceric ammonium nitrate or PhI OAc ; 2; N-formyl, H3O , heat]. Furthermore, the reactions usually require excess of the diorganozinc reagent, and in a number of cases, the addition of dimethylzinc is unsuccessful or affords to the amine in much lower yields and enantiomeric excesses ee ; . Recently, we reported that the copper-catalyzed addition of diorganozinc reagents to N-phosphinoylarylimines proceeds in high yields and enantioselectivities in the presence of a catalytic amount of the novel Me-DuPHOS monoxide [ R, R ; -BozPHOS] chiral ligand Scheme 1 ; 18, 19 ; . In addition to being readily available, this hemilabile bidentate ligand offers superb catalytic activity, broad substrate generality, and mild reaction conditions. Furthermore, the increase in imine electrophilicity imparted by the N-phosphinoyl protecting group, combined with its ease of cleavage under mildly acidic conditions, makes this method very attractive to prepare -chiral amines. The one major limitation of this methodology is our inability to prepare alkylaldehyde-derived N-phosphinoylimines bearing -enolizable protons in reasonable yields. This has been a limitation not only in diorganozinc addition chemistry 2025 ; , but also in catalytic asymmetric nitro-Mannich 26 ; , Mannich 27 ; , and Strecker 28 ; processes that use similar electrophilic precursors. This inherent limitation is also present in the preparation of N-acylimines, and several strategies have been developed to circumvent this problem. The in situ generation of and micardis. Monitoring of mexitil® plasma levels is recommended during such concurrent use to avoid ineffective therapy. Simply press the buy button and order mexitil online and telmisartan.

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13 prevent monopolists from buying off would-be rivals by the simple device of sharing monopoly profits with them. Review of this error is urgently needed because the ruling below could seriously impede the Commission's law enforcement efforts on behalf of consumers nationwide. In light of the large number of leading drugs that are the subject of patent challenges, the economic stakes for the American consumer in this issue are staggering. The court of appeals' reversal of the Commission's factual findings regarding the Upsher agreement also warrants review, because it departs so drastically from the established standard of appellate review. This issue does not, however, affect the court of appeals' analysis of the ESI agreement, which independently warrants the grant of certiorari on Question 1. I. THE COURT OF APPEALS ERRED IN RULING THAT AGREEMENTS BETWEEN COMPETITORS ARE LAWFUL IF WITHIN THE "POTENTIAL" REACH OF A PATENT CLAIM. 1. The starting point for this case, as the court of appeals recognized, is that an agreement between competitors in which one pays the other to stay out of a market is "clearly anticompetitive, " and hence unlawful unless excused by the lawful exercise of patent rights. Pet. App. 13a. This Court has repeatedly dealt with analogous situations. See, e.g., United States v. Masonite Corp., 316 U.S. 265, 274 1942 Ethyl Gasoline Corp. v. United States, 309 U.S. 436, 455 1940 ; . In such cases, the overarching principle is clearly established: that "[t]he owner of a patent cannot extend his statutory grant by contract or agreement." Masonite, 316 U.S. at 277; Ethyl, 309 U.S. at 456; United States v. Line Material Co., 333 U.S. 287, 308 1948 ; , even if the agreement takes the form of a litigation settlement. See United States v. Singer Mfg. Co., 374 U.S. 174, 197-200 1963 ; White, J., concurring ; competitors' collusive and prazosin. This increase was observed at the first test point which was the second day after starting mexitil®.

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