Common use of Food and Drug Administration Clause in Contracts

Food and Drug Administration. (a) Pursuant to 21 C.F.R. § 314.94(a)(12)(v), and within 10 business days after the Commencement Date, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, a statement that IMPAX has been granted a license with respect to the Purdue Patents with respect to the IMPAX Product, pursuant to the terms of this Supplemental License Agreement. (b) Pursuant to 21 C.F.R. § 314.94(a)(12)(viii)(A), and within 10 business days of the Supplemental License Termination Date, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, an amendment to IMPAX’s certifications in the IMPAX ANDA with respect to the Purdue Patents, changing those certifications to certifications under 21 C.F.R. § 314.94(a)(12)(i)(A)(3) and requesting that the FDA promptly change the IMPAX ANDA approval from an effective approval to a tentative approval. In the event the Terminal Date (as defined in the Settlement Agreement) has occurred prior to the date upon which IMPAX would otherwise be required to amend, pursuant to the terms of this Section 3(b), IMPAX’s certifications in the IMPAX ANDA, then IMPAX shall not be required to amend such certifications with respect to the IMPAX Product. From and after the Terminal Date, nothing herein will prohibit IMPAX from filing or maintaining with respect to the IMPAX Product a certification, including but not limited to a certification based on invalidity or unenforceability pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4); provided, however, if there is a vacatur, reversal or settlement of the type referred to in paragraph 19(x) or (y) of the Settlement Agreement then within ten (10) days of the issuance of such reversal or vacatur or within ten (10) days after being notified in writing by the Purdue Companies of such settlement, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, an amendment to IMPAX’s certifications and requests to the FDA specified in this Section 3(b).

Food and Drug Administration. (a) Pursuant to 21 C.F.R. § 314.94(a)(12)(v), and within 10 business days after the Commencement Signing Date, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, a statement that IMPAX has been granted a license with respect to the Purdue Patents with respect to the IMPAX Product, pursuant to the terms of this Supplemental Patent License Agreement. (b) Pursuant to 21 C.F.R. § 314.94(a)(12)(viii)(A314.107(e), and within 10 business days of entry of the Consent Judgment, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, a copy of such Consent Judgment. (c) Pursuant to 21 C.F.R. § 314.94(a)(12)(viii)(A), and upon the earliest to occur of (i) the Supplemental License Termination DateDate (as defined in the Supplemental License Agreement), (ii) the date that is five business days following any termination of this Patent License Agreement by the Purdue Companies for a material breach by IMPAX under Section 10 of this Patent License Agreement, and (iii) November 30, 2007, if the Supplemental License Agreement has not been entered into, other than as a result of the breach by the Purdue Companies of their obligations under Section 1.1(e) hereof, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, an amendment to IMPAX’s certifications in the IMPAX ANDA with respect to the Purdue Patents, changing those certifications to certifications under 21 C.F.R. § 314.94(a)(12)(i)(A)(3) and requesting that the FDA promptly change the IMPAX ANDA approval from an effective approval to a tentative approval. In the event the Terminal Date (as defined in the Settlement Agreement) has occurred prior to the date upon which IMPAX would otherwise be required to amend, pursuant to the terms of this Section 3(b3(c), IMPAX’s certifications in the IMPAX ANDA, then IMPAX shall not be required to amend such certifications with respect to the IMPAX Product. From and after the Terminal Date, nothing herein will prohibit IMPAX from filing or maintaining with respect to the IMPAX Product a certification, including but not limited to a certification based on invalidity or unenforceability unenforceability, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4); provided, however, if there is a vacatur, reversal or settlement of the type referred to in paragraph 19(x) or (y) of the Settlement Agreement Agreement, then within ten (10) days of the issuance of such reversal or vacatur or within ten (10) days after being notified in writing by the Purdue Companies of such settlement, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, an amendment to IMPAX’s certifications and requests to the FDA specified in the first sentence of this Section 3(b3(c).

Food and Drug Administration. (a) Pursuant to 21 C.F.R. § 314.94(a)(12)(v), and within 10 business days after the Commencement Date, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, a statement that IMPAX has been granted a license with respect to the Purdue Patents with respect to the IMPAX Product, pursuant to the terms of this Supplemental License Agreement. (b) Pursuant to 21 C.F.R. § 314.94(a)(12)(viii)(A), and within 10 business days of the Supplemental License Termination Date, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, an amendment to IMPAX’s certifications in the IMPAX ANDA with respect to the Purdue Patents, changing those certifications to certifications under 21 C.F.R. § 314.94(a)(12)(i)(A)(3) and requesting that the FDA promptly change the IMPAX ANDA approval from an effective approval to a tentative approval. In the event the Terminal Date (as defined in the Settlement Agreement) has occurred prior to the date upon which IMPAX would otherwise be required to amend, pursuant to the terms of this Section 3(b), IMPAX’s certifications in the IMPAX ANDA, then IMPAX shall not be required to amend such certifications with respect to the IMPAX Product. From and after the Terminal Date, nothing herein will prohibit IMPAX from filing or maintaining with respect to the IMPAX Product a certification, including but not limited to a certification based on invalidity or unenforceability pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4); provided, however, if there is a vacatur, reversal or settlement of the type referred to in paragraph 19(x) or (y) of the Settlement Agreement then within ten (10) days of the issuance of such reversal or vacatur or within ten (10) days after being notified in writing by the Purdue Companies of such settlementXXXXX, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, an amendment to IMPAX’s certifications and requests to the FDA specified in this Section 3(b)XXXXX.

Food and Drug Administration. (a) Pursuant to 21 C.F.R. § 314.94(a)(12)(v), and within 10 business days after the Commencement Signing Date, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, a statement that IMPAX has been granted a license with respect to the Purdue Patents with respect to the IMPAX Product, pursuant to the terms of this Supplemental Patent License Agreement. (b) Pursuant to 21 C.F.R. § 314.94(a)(12)(viii)(A314.107(e), and within 10 business days of entry of the Consent Judgment, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, a copy of such Consent Judgment. (c) Pursuant to 21 C.F.R. § 314.94(a)(12)(viii)(A), and upon the earliest to occur of (i) the Supplemental License Termination DateDate (as defined in the Supplemental License Agreement), (ii) the date that is five business days following any termination of this Patent License Agreement by the Purdue Companies for a material breach by IMPAX under Section 10 of this Patent License Agreement, and (iii) November 30, 2007, if the Supplemental License Agreement has not been entered into, other than as a result of the breach by the Purdue Companies of their obligations under Section 1.1(e) hereof, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, an amendment to IMPAX’s certifications in the IMPAX ANDA with respect to the Purdue Patents, changing those certifications to certifications under 21 C.F.R. § 314.94(a)(12)(i)(A)(3) and requesting that the FDA promptly change the IMPAX ANDA approval from an effective approval to a tentative approval. In the event the Terminal Date (as defined in the Settlement Agreement) has occurred prior to the date upon which IMPAX would otherwise be required to amend, pursuant to the terms of this Section 3(b3(c), IMPAX’s certifications in the IMPAX ANDA, then IMPAX shall not be required to amend such certifications with respect to the IMPAX Product. From and after the Terminal Date, nothing herein will prohibit IMPAX from filing or maintaining with respect to the IMPAX Product a certification, including but not limited to a certification based on invalidity or unenforceability unenforceability, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4); provided, however, if there is a vacatur, reversal or settlement of the type referred to in paragraph 19(x) or (y) of the Settlement Agreement then within ten (10) days of the issuance of such reversal or vacatur or within ten (10) days after being notified in writing by the Purdue Companies of such settlementXXXXX, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, an amendment to IMPAX’s certifications and requests to the FDA specified in this Section 3(b)XXXXX.

Food and Drug Administration. (a) Pursuant to 21 C.F.R. § 314.94(a)(12)(v), and within 10 business days after of the Commencement Patent License Effective Date, IMPAX the Endo Companies shall submit to the United States Food and Drug Administration (the “FDA”), with a copy to the Purdue Companies, a statement that the Endo Companies have been granted a license with respect to the Purdue Patents with respect to the product covered by the Endo ANDA, pursuant to the terms of this Patent License Agreement. (b) Pursuant to § 314.107(e), within 10 business days of entry of the Consent Judgment, the Endo Companies shall submit to the FDA, with a copy to the Purdue Companies, a statement copy of that IMPAX has been granted a license with respect to the Purdue Patents with respect to the IMPAX Product, pursuant to the terms of this Supplemental License AgreementConsent Judgment. (bc) Pursuant to 21 C.F.R. § 314.94(a)(12)(viii)(A), and within 10 business days of the Supplemental License Termination Date, IMPAX the Endo Companies shall submit to the FDA, with a copy to the Purdue Companies, an amendment to IMPAX’s the Endo Companies’ certifications in the IMPAX Endo ANDA with respect to the Purdue Patents, changing those certifications to certifications under 21 C.F.R. § 314.94(a)(12)(i)(A)(3) and requesting that the FDA promptly change the IMPAX Endo ANDA approval from an effective approval to a tentative approval. In Nothing in this paragraph 3 shall prohibit the event Endo Companies from requesting and obtaining final approval of the Terminal Date Endo ANDA from the FDA in order to make, use, sell, offer to sell, import or otherwise distribute (as defined in or authorize others to make, use, sell, offer to sell, import or distribute) any controlled-release oxycodone products covered by the Settlement Agreement) has occurred prior to the date upon which IMPAX would otherwise be required to amend, Endo ANDA pursuant to the terms of this Section 3(b), IMPAX’s certifications in the IMPAX ANDA, then IMPAX shall not be required to amend such certifications with respect to the IMPAX Product. From and after the Terminal Date, nothing herein will prohibit IMPAX from filing or maintaining with respect to the IMPAX Product a certification, including but not limited to a certification based on invalidity or unenforceability pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4); provided, however, if there is a vacatur, reversal or settlement of the type referred to in paragraph 19(x) or (y) Paragraph 5 of the Settlement Agreement then within ten (10) days of the issuance of such reversal or vacatur or within ten (10) days after being notified in writing by the Purdue Companies of such settlement, IMPAX shall submit to the FDA, with a copy to the Purdue Companies, an amendment to IMPAX’s certifications and requests to the FDA specified in this Section 3(b)Agreement.