Sentences with phrase «exemptions under article»

Exemptions under Article 8 (1)(c) based on establishing clinical superiority of a second product over an approved orphan product would be wholly in conflict with the basis on which generic products obtain approval, viz. relying on the reference product's clinical safety and efficacy.

It makes it easy to assess which businesses fall within that definition, and which can benefit from the liability exemptions under Article 12 (1).

Nonetheless, this provision is strictly interpreted by the Court and the case discussed here exemplifies that only goods intended for specifically military purposes qualify for the exemption under article 346 TFEU.

The first and probably most compelling reason is that operators of open wireless networks, although they benefit from the liability exemption under Article 12 (1) E-Commerce Directive, can still incur the costs for an injunction ordered against them.

As the Directive itself does not list any further criteria, and other language versions of the Directive do not suggest another interpretation, the CJEU concluded, in order to safeguard a uniform interpretation and application of the Directive, that no further requirements beyond that of providing access to a communication network are necessary to qualify for an exemption under Article 12 (1)(paras 52 - 53).

Not exact matches

In an article for Bloomberg View published shortly after the election, Cass Sunstein, administrator of the White House Office of Information and Regulatory Affairs under President Obama, called the idea «pretty dumb» and said it would be extremely difficult to implement and require so many exemptions as to leave its scope narrow.

«Under the new... overtime threshold,» Collins and Perez write in their article, «universities, teaching hospitals, and other institutions that employ postdocs have a choice: they can carefully track their fellows» hours and pay overtime, or they can raise their salaries to levels above the threshold and thereby qualify them for exemption [from the need to pay overtime].

HSI's delegation to the 64th annual meeting of the International Whaling Commission, held in Panama City, Panama, called upon conservation nations of the IWC to challenge Korea's plans to go whaling under Article VIII scientific exemption clause.

Teva concluded that since the approval of nilotinib was based upon an exemption granted under Article 8 (3) with regard to the first orphan product (imatinib), it should not be entitled to same scope of orphan exclusivity as imatinib and thus should not be considered a hurdle towards the approval of generics referencing imatinib.

Nevertheless, the CJEU, siding with the EMA, held that neither the statutory text nor the underlying goal of the Orphan Drug Regulation aimed at granting exclusivity to all the eligible medicinal products dictate the denial of orphan exclusivity to medicinal products approved under exemptions provided by Article 8 (3).

Article IV of chapter 1 of Part the Second of the Constitution is hereby amended by inserting after the words «and to impose and levy proportional and reasonable assessments, rates and taxes, upon all the inhabitants of, and persons resident, and estates lying, within said Commonwealth» the words: -, except that, in addition to the powers conferred under Articles XLI and XCIX of the Amendments, the general court may classify real property according to its use in no more than four classes and to assess, rate and tax such property differently in the classes so established, but proportionately in the same class, and except that reasonable exemptions may be granted.