Sentences with phrase «regarding submissions made»

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Earlier today the Greater Vancouver Board of Trade made its formal submission to government regarding proposed tax changes for controlled private corporations.

This government has failed in that process by leaving stakeholders with less than two months - a large portion of which was over Christmas - to make submissions regarding legislation that substantially affects their lives.

We can all agree she can not really KO / TKO, or at least has not shown anything in that regard, and if all starts align and the opponent make silly mistakes and she also remembers the instructions etc. she may get a submission.

INEC, initially, made its position clear regarding Akko Federal Constituency of Gombe State to the National Chairman of APC that the submission of the name of a new candidate for the court - ordered election is «not acceptable» because «the period for nomination of candidate for the election has since elapsed,» but failed to follow it through to a logical conclusion.

Access to this material will let the editors put the results in the submission in the proper context and make the best decision regarding the submitted manuscript.

Participation in Contest and acceptance of prize constitutes each winner's and each entrant's permission for Sponsor to use his / her name, address (city and state), likeness, photograph, picture, portrait, voice, biographical information, Submission and / or any statements made by each winner or entrant regarding the Contest or Sponsor for advertising and promotional purposes without notice or additional compensation, except where prohibited by law.

Call out models, including preferential, rotational and seniority were researched, and members were asked to make submissions on call out models and the issues regarding retired teachers working as TTOCs.

For now, Amazon has not had a lot of concern regarding potential fraudulent short stories, as many of the stories in their catalog are submitted by well - respected and published writers; in many cases, it is not the author who makes the submission, but the publishing company who owns the rights to the work.

We understand the needs of a college student regarding the submission of their Cryptography assignment, and make sure each of our clients receives the best possible writing assistance which would help them score an A + grade.

With us, you won't face any issues regarding the late submission of the academic papers as we stay true to our deadlines and make sure to deliver you the document as fast as possible.

* Juror guidelines state that consideration must be made for submissions by non-native English speakers regarding issues of spelling, punctuation, and sentence structure.

If you look below you'll see I made a submission to EECA (Energy Efficiency and Conservation Authority) in regard to CFLs (compact fluorescent lamps).

«Failure to remove [the passive house proposal] will entail the consideration, by the Minister, of the use of the powers available to him under Section 31 of the Planning Act to ensure the overall coherence of the plan as regards housing supply and housing standards components,» the submission, made by a senior civil servant on behalf of Minister Kelly, states.

[As regards the fourth submission Mr Nathan relies on another dictum of Potter LJ in Downing where he said: «The burden of proving that any of the grounds in s. 9 (4) has been made out lies upon the claimant and, if the defendant can raise an arguable case in favour of validity, a stay should be granted: Hume v AA Mutual International Insurance Co Ltd [1996] LRLR 19.»]

Nonetheless, the ARO invited the parties to make further submissions regarding the thresholds to apply regarding whether the re-employment obligations applied to the employer.

«If the applicant seeks leave to commence a future application involving the University regarding the matter of her official transcript or makes a request to add the University to another application in relation to the official transcript, written submissions must be included with her materials outlining why the application or the request is intended as a legitimate assertion of her Code rights, is not intended to vex the University or its representatives, and will not result in an abuse of process.»

Furthermore, the applicant did not comply with the order for evidence submission with regard to cost within thirty days of the decision made on Mar 21, 2014.

I recommend that the Municipal Conflict of Interest Act be amended to include a provision stating explicitly that nothing in the Act prevents a member of council from making submissions regarding a finding in a report by the integrity commissioner or regarding the imposition of a penalty under a municipal code of conduct.

That being said, having regard to the submissions delivered by counsel and the admissions made by the Claimant and his counsel and my own findings that the Claimant does have some residual earning capacity, which may or may not translate into income depending on what the Claimant does vocationally, I find there is a 50 % contingency of the likelihood that his CPP payments will continue in the future and in this regard 50 % of the net present value of the future payments should be deducted from the award.

Over and all, always remember to submit your documents on time, once you do end up submitting, make sure you have had the time to follow up with the person regarding the status of the submission.

Ever changing and new federal laws, such as HIPAA, and those regarding electronic claims submission make it a bit more difficult to take medical billing work home.

[8] The right to negotiate contemplates the giving of notice of proposed mining future acts to native title parties pursuant to section 29 NTA («section 29 notices»), providing the opportunity to make submissions to the Government party regarding the proposed future act and negotiations in good faith between native title parties, mining parties and the Government party regarding the doing of the act or the doing of the act subject to conditions.

No notice was given to the representative bodies of the Northern Territory Government's intention to apply the future act regime in this manner, nor were they given an opportunity to make submissions regarding the matter.

In addition, the following paragraph also appears on the Competition Tribunals website regarding the recent decision: «The specific terms of the Tribunal's order will be determined after the parties have provided written submissions addressing this issue of remedy and have had an opportunity to make oral submissions on that issue.»

Jack Lane, president of the London and St. Thomas Association of Realtors (LSTAR), recently appeared before the province's Standing Committee on Finance and Economic Affairs during public hearings in London to make the case for two recommendations outlined in the Ontario Real Estate Association's Pre-Budget Submission regarding personal real estate corporations and brownfields remediation.

26 DOS 99 Matter of DOS v. Bronson - failure to pay judgment; DOS fails its burden of proof; failure to appear at hearing; ex parte hearing may proceed upon proof of proper service; DOS fails its burden of proof to establish broker made false statement with intent to deceive regarding property conditions; broker negligently makes misstatement to buyer; failure to pay judgment demonstrates untrustworthiness unless broker presents valid evidence of inability to pay; broker fails to appear to provide evidence; submission of unverified written answer is insufficient evidence to prove inability to pay judgment; broker's license suspended until broker submits proof he has fully paid judgment