Paragraph III Certification definition

Paragraph III Certification means a certification described in section 505(j)(2)(A)(vii)(III) and 505(b)(2)(A)(iii) of the U.S Food, Drugs and Cosmetics Act.
Sample 1Sample 2Sample 3
Paragraph III Certification means a certification that a generic applicant seeks FDA approval of its ANDA as of the date a patent listed in the Orange Book for a relevant NDA expires.
Sample 1Sample 2
Paragraph III Certification has the meaning given to such term in the Sublicence
Sample 1Sample 2

Examples of Paragraph III Certification in a sentence

  • The Joint Office reached its maximum number of personnel, 10, toward the end of 1968.

  • Rather, it is a vehicle for Teva to try to deprive its competitor Ranbaxy of the statutory exclusivity period to which Ranbaxy is entitled under the Hatch-Waxman Act, burdening the district court and Eisai in the process.Teva claims that it matters not that the first-filer in Caraco had filed Paragraph IV Certifications as to all Orange Book Patents, whereas Ranbaxy here did not (filing instead a Paragraph III Certification to the ’841 patent, which is the basic compound patent).

  • Ranbaxy (and twelve other generic companies) must wait until the ’841 patent expires by virtue of its Paragraph III Certification with regard to that patent.Rather than respect the patent as Ranbaxy and the others did by filing a Paragraph III Certification with regard to the ’841 patent, Teva concocted an obviousness defense (which Teva changed completely and then withdrew as it became challenged in litigation) so that Teva could become a shared first-filer.

  • Those companies recognize that they have no good-faith defense of eithernon-infringement or invalidity with regard to the ’841 basic compound patent; eachhas filed a Paragraph III Certification as to that patent and accepted that it has to await the expiration of the ’841 patent to introduce generic versions of donepezil.

  • Notice Requirements Of Generic Applicants If the generic drug applicant submits a Paragraph III Certification to any of the patents listed in the Orange Book for the RLD, the FDA cannot approve the ANDA until the expiration of that patent.

  • However, an exception applies to an ANDA holder that after filing its ANDA with the original patent statements, including a Paragraph IV Certification to at least one Listed Patent and a Paragraph III Certification to another Listed Patent changes its previously submitted Paragraph III patent certification to a Paragraph IV Certification.

Related to Paragraph III Certification

  • Back-Up Certification As defined in Section 13.06.

  • Income Certification means a Tenant Income Certification and a Tenant Income Certification Questionnaire in the form attached as Exhibit B hereto or in such other comparable form as may be provided by the Issuer to the Owner, or as otherwise approved by the Issuer.

  • Sxxxxxxx-Xxxxx Certification As defined in Section 11.09.

  • Final Certification As defined in Section 2.02(a) hereof.

  • Initial Certification As defined in Section 2.02(a) hereof.

  • Xxxxxxxx-Xxxxx Certification As defined in Section 11.05.

  • Interim Certification As defined in Section 2.02.

  • Certification period means the period for which an individual is certified eligible for a program.

  • Class R-III Certificate Any one of the Class R-III Certificates executed by the Trustee and authenticated by the Certificate Registrar substantially in the form annexed hereto as Exhibit D and evidencing an interest designated as a "residual interest" in REMIC III for purposes of the REMIC Provisions.

  • REMIC III Certificate Any Regular Certificate or Class R Certificate.

  • CEC Certification and Verification means that the CEC has certified (or, with respect to periods before the Project has commenced commercial operation (as such term is defined by and according to the CEC), that the CEC has pre-certified) that the Project is an ERR for purposes of the California Renewables Portfolio Standard and that all Energy produced by the Project qualifies as generation from an ERR for purposes of the Project.

  • NRSRO Certification A certification executed by a NRSRO in favor of the Issuer and the Information Agent that states that such NRSRO has provided the Issuer with the appropriate certifications under Exchange Act Rule 17g-5(a)(3)(iii)(B) and that such NRSRO has access to the 17g-5 Website.

  • Class A-5 Certificate Any one of the Certificates executed by the Trustee and authenticated by the Trustee or the Authenticating Agent in substantially the form set forth in Exhibit A-5 and Exhibit C hereto. Class A-5 Certificateholder: The registered holder of a Class A-5 Certificate.

  • Form 10-K Certification As defined in Section 4.03(e).

  • Class R-II Certificate Any one of the Class R-II Certificates executed by the Trustee and authenticated by the Certificate Registrar substantially in the form annexed hereto as Exhibit D and evidencing an interest designated as a "residual interest" in REMIC II for purposes of the REMIC Provisions.

  • Servicer Certification As defined in Section 3.22(b) hereof.

  • REMIC II Certificate Any Regular Certificate or Class R Certificate.

  • Class A-V Certificate Any one of the Certificates designated as a Class A-V Certificate, including any Subclass thereof.

  • Class A-8 Certificate Any one of the Certificates executed by the Trustee and authenticated by the Trustee or the Authenticating Agent in substantially the form set forth in Exhibit A-8 and Exhibit C hereto.

  • Tax Certification Forms means any forms or other documentation as may be issued or required by a Tax Authority or by us from time to time to confirm your tax status [or the tax status of a Connected Person].

  • Class G Certificate Any one of the Certificates with a “Class G” designation on the face thereof, substantially in the form of Exhibit A-1 attached hereto, and evidencing a portion of a class of “regular interests” in REMIC III for purposes of the REMIC Provisions.

  • Class R-I Certificate Any one of the Class R-I Certificates executed by the Trustee and authenticated by the Certificate Registrar substantially in the form annexed hereto as Exhibit D and evidencing an interest designated as a "residual interest" in REMIC I for purposes of the REMIC Provisions.

  • Class R-1 Certificate Any Certificate designated a “Class R-1 Certificate” on the face thereof, in the form set forth in Exhibit A-5 hereto, evidencing the Residual Interest in REMIC I and representing the right to the Percentage Interest of distributions provided for the Class R-1 Certificates as set forth herein.

  • Class A-7 Certificate Any one of the Certificates executed by the Trustee and authenticated by the Trustee or the Authenticating Agent in substantially the form set forth in Exhibit A-7 and Exhibit C hereto.

  • Class A-6 Certificate Any one of the Certificates executed by the Trustee and authenticated by the Trustee or the Authenticating Agent in substantially the form set forth in Exhibit A-6 and Exhibit C hereto.

  • Class B-5 Certificate Any one of the Certificates executed by the Trustee and authenticated by the Trustee or the Authenticating Agent in substantially the form set forth in Exhibit B-5 and Exhibit C hereto. Class B-5 Certificateholder: The registered holder of a Class B-5 Certificate.