Data exclusivity period

ROYALTY TERM shall mean, with respect to each country in which Product is sold the period of time equal to the longer of (i) ten (10) years from the date of first sale of the Product in such country, (ii) the expiration of the last-to-expire Licensed Patent listed in EXHIBIT A in such country that claims such Product, or (iii) the period of time equal to the Data Exclusivity Period in such country. 

The relevant data exclusivity periods for each approved drug product, as well as any applicable patents on the product or its use, are listed in the Orange Book , which is published by the FDA and also available electronically on the FDA s web site. 

In the US, a manufacturer may not submit an application that relies on data from an approved submission for a period of 5 years after the reference product was authorised, unless the owner of the original data has granted a right of reference. The FDA may not approve an application that relies on data submitted as a supplement (e.g. new therapeutic indication) to an authorised drug for a period of 3 years after approval ofthe supplement. These exclusivity periods will be extended by 6 months if the reference submissions contain paediatric data. The FDA will also not... 

In addition the EU law also allows for one year of additional data exclusivity for the whole compound if additional indications of significant overall therapeutic value are approved within the eight-year period (Towse 2004). 

Structural characterizations of the immobilized bilayer assemblies are essential for the molecular design of the functional materials. On the bases of the systematic crystallographic investigation of single crystals of double-chain ammonium amphiphiles [9], Okuyama wrote a computer simulation program for the calculation of bilayer structures in cast bilayer films and bilayer thicknesses estimated from the repeating period in the X-ray diffraction data have been exclusively used for structural discussions [10,11]. 

Our data suggests that hematopoiesis can be sustained for prolong cultivation periods in the presence of feeder layer cells or condition media supported culture models. Prolonged support of primitive hematopoietic cells (undifferentiated cells such as promyelocytes, myelocytes and metamyelocytes) and their clonogenic capacity and functional characteristics in feeder layer positive cultures, indicates that diffusible factors are sufficient and that direct cell-to-cell contacts may not be exclusively required for successful long term in K/fro hematopoiesis. 

Based upon these features another learning machine was constructed for the year 1982, describing the situation with exclusion of the months Septanber till December when the weather was in general too unstable. Fran that period 36 situations have been selected where conplaints were registered for at least two consecutive hours. These data were ccmpleted by another 36 situations without conplaints, selected exactly 24 hours before or after a period with complaints. 

The data do not establish, however, whether even more appropriate patent challenges might have been brought if the period of generic market exclusivity was longer than 180 days. 

The general effect of the latter provision is to afford the holder of the first marketing authorisation a period of marketing exclusivity for 6 or 10 years, irrespective of the patent position, during which time the second applicant cannot make an MA application and enter the market unless he produces the full data required under Directive 2001/83/EEC. 

With respect to the edge exclusion, orbital tools differ from other CMP tools because during use virtually the entire pad is in compression. In contrast, rotational tools periodically compress and then release the pad as it passes under the carrier and rotates around the tool. Very little data is publicly available regarding the fundamental properties of pads, so the significance of this difference between tool types is not well understood. 

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