Common use of Regulatory Developments Clause in Contracts

Regulatory Developments. (a) All Products and all Required Permits as of the Effective Date are listed on Schedule 5.11, and Borrower has delivered to Agent a copy of all Required Permits to the extent requested by Agent; (b) Without limiting the generality of Section 5.6 above, with respect to any Product being tested or manufactured by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, (ii) Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower of (A) any material deficiency or violation of Laws and/or the Required Permits related to the manufacture of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; and (c) Without limiting the generality of Section 5.6 above, with respect to any Product marketed or sold by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, (ii) Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower of (A) any material deficiency or violation of Laws and/or the Required Permits related to the marketing or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace.

Regulatory Developments. (a) All Products and all Required Permits as of the Effective Date are listed on Schedule 5.115.11 (as updated from time to time pursuant to Section 6.2(d)), and Borrower has delivered to Agent a copy of all Required Permits to the extent requested by AgentAgent pursuant to Section 6.2(d); (b) Without limiting the generality of Section 5.6 above, with respect to any Product being tested or manufactured by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; and; (c) Without limiting the generality of Section 5.6 above, with respect to any Product marketed or sold by Borrower, (i) Borrower has shall have received, and such Product is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) any material deficiency such Required Permit or violation of Laws and/or the Required Permits related to the marketing approval or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; (d) Without limiting the generality of Section 5.6 above, (i) there have been no adverse clinical test results which could cause a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market; and (e) Borrower has not (since the Effective Date) experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower in accordance with all specifications thereof and the required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month.

Regulatory Developments. (a) All Products and all Required Permits as of the Effective Date are listed on Schedule 5.115.11 (as updated from time to time pursuant to Section 6.2(e)), and Borrower has delivered to Agent a copy of all Required Permits in effect as of the date hereof and to the extent requested by Agent;Agent pursuant to Section 6.2(e). (b) Without limiting the generality of Section 5.6 above, with respect to any Product being tested or manufactured by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (Ai) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the manufacture of such Product, or (Bii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; and. (c) Without limiting the generality of Section 5.6 above, with respect to any Product marketed or sold by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) any material deficiency such Required Permit or violation of Laws and/or the Required Permits related to the marketing approval or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace. (d) Without limiting the generality of Section 5.6 above, (i) there have been no adverse clinical test results which have or could reasonably be expected to cause a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market. (e) Borrower has not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower in accordance with all specifications thereof and the required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month.

Regulatory Developments. (a) All Products and all Required Permits as of the Effective Date are listed on Schedule 5.115.11 (as updated from time to time pursuant to Section 6.2(e)), and Borrower has delivered to Agent a copy of all Required Permits to the extent requested by AgentAgent pursuant to Section 6.2(e); (b) Without limiting the generality of Section 5.6 above, with respect to any Product being tested or manufactured by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; and; (c) Without limiting the generality of Section 5.6 above, with respect to any Product marketed or sold by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) any material deficiency such Required Permit or violation of Laws and/or the Required Permits related to the marketing approval or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; (d) Without limiting the generality of Section 5.6 above, (i) there have been no adverse clinical test results which have or could reasonably be expected to cause a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market; and (e) Borrower has not (since the Effective Date) experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower in accordance with all specifications thereof and the required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month.

Regulatory Developments. (a) All Products and all Required Permits as of the Effective Date are listed on Schedule 5.115.11 (as updated from time to time pursuant to Section 6.2(e)), and Borrower has delivered to Agent a copy of all Required Permits to the extent requested by Agent;Agent pursuant to Section 6.2(e). (b) Without limiting the generality of Section 5.6 above, with respect to any Product being tested or manufactured by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (Ai) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the manufacture of such Product, or (Bii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; and. (c) Without limiting the generality of Section 5.6 above, with respect to any Product marketed or sold by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) any material deficiency such Required Permit or violation of Laws and/or the Required Permits related to the marketing approval or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace. (d) Without limiting the generality of Section 5.6 above, (i) there have been no adverse clinical test results which have or could reasonably be expected to cause a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market. (e) Borrower has not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower in accordance with all specifications thereof and the required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month.

Regulatory Developments. (a) All Products and all material Required Permits as of the Effective Date are listed on Schedule 5.115.11 (as updated from time to time pursuant to Section 6.2(e)), and Borrower has delivered to Agent a copy of all material Required Permits as of the date hereof and to the extent requested by Agent;Agent pursuant to Section 6.2(e). (b) Without limiting the generality of Section 5.6 above, except as disclosed in writing to Agent from time to time, with respect to any Product being tested or manufactured by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (Ai) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the manufacture of such Product, or (Bii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; and. (c) Without limiting the generality of Section 5.6 above, except as disclosed in writing to Agent from time to time, with respect to any Product marketed or sold by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) any material deficiency such Required Permit or violation of Laws and/or the Required Permits related to the marketing approval or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace. (d) Without limiting the generality of Section 5.6 above, (i) there have been no adverse clinical test results which have or could reasonably be expected to cause a Material Adverse Change, and (ii) except as disclosed in writing to Agent from time to time, there have been no Product recalls or voluntary Product withdrawals from any market.

Regulatory Developments. (a) All Products and all Required Permits as of the Effective Date are listed on Schedule 5.115.11 (as updated from time to time pursuant to Section 6.2(e)), and Borrower has delivered to Agent a copy of all Required Permits as of the date hereof and to the extent requested by Agent;Agent pursuant to Section 6.2(e). (b) Without limiting the generality of Section 5.6 above, with respect to any Product being tested Development Compound or manufactured by Sale Compound of Borrower, (i) Borrower has received, received and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of and/or manufacture, as applicable, with respect to such Product as such testing is currently being conducted by or on behalf of BorrowerBorrower with respect to Development Compounds or Sale Compounds, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (Ai) Borrower’s manufacturing facilities and processes for any Sale Compound which have disclosed any material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the manufacture of such ProductSale Compound, or (Bii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that the development, testing and/or of such Development Compound or manufacturing of such Product Sale Compound by Borrower should cease; and. (c) Without limiting the generality of Section 5.6 above, with respect to any Product Sale Compound that may be marketed or sold by Borrower, (i) Borrower has received, and such Product Sale Compound is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being Sale Compound that may be marketed or sold by Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) any material deficiency such Required Permit or violation of Laws and/or the Required Permits related to the marketing approval or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product Sale Compound cease or that such Product Sale Compound be withdrawn from the marketplace. (d) Without limiting the generality of Section 5.6 above, there have been no serious adverse clinical test results related to the safety or efficacy of Development Compounds resulting in the termination of all clinical studies for such Development Compound or recalls of Sale Compounds (whether voluntary or involuntary), in each case which have resulted in or could reasonably be expected to result in a Material Adverse Change. (e) Borrower has not experienced any material failures in its manufacturing of any Sale Compound such that the amount of such Sale Compound successfully manufactured by Borrower in accordance with all specifications thereof and the required payments related thereto in any month shall decrease significantly with respect to the quantities of such Sale Compound produced in the prior month, which such decrease has resulted in or could reasonably be expected to result in a Material Adverse Change.

Regulatory Developments. (a) All Products and all Required Permits as of the Effective Date are listed on Schedule 5.115.11 (as updated from time to time pursuant to Section 6.2(e)), and Borrower has delivered to Agent a copy of all Required Permits as of the date hereof and to the extent requested by Agent;Agent pursuant to Section 6.2(e). (b) Without limiting the generality of Section 5.6 above, with respect to any Product being tested or manufactured by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (Ai) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the manufacture of such Product, or (Bii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; and. (c) Without limiting the generality of Section 5.6 above, with respect to any Product marketed or sold by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) any material deficiency such Required Permit or violation of Laws and/or the Required Permits related to the marketing approval or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace. (d) Without limiting the generality of Section 5.6 above, (i) there have been no adverse clinical test results which have or could reasonably be expected to cause a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market. (e) Borrower has not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower in accordance with all specifications thereof and the required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month.

Regulatory Developments. (a) All Products and all Required Permits as of the Effective Date are listed on Schedule 5.115.11 (as updated from time to time pursuant to Section 6.2(e)), and Borrower has delivered to Agent a copy of all Required Permits as of the date hereof and to the extent requested by Agent;Agent pursuant to Section 6.2(e). (b) Without limiting the generality of Section 5.6 above, with respect to any Product being tested or manufactured by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDAFDA and Health Canada, notifying Borrower that such Governmental Authority is conducting an investigation or review (other than a normal routine scheduled inspection) of (Ai) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the manufacture of such Product, or (Bii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; and. (c) Without limiting the generality of Section 5.6 above, with respect to any Product marketed or sold by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDAFDA and Health Canada, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) any material deficiency such Required Permit or violation of Laws and/or the Required Permits related to the marketing approval or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace. (d) Without limiting the generality of Section 5.6 above, (i) there have been no adverse clinical test results which have or could reasonably be expected to cause a Material Adverse Change in respect of any Product since the date on which Borrower acquired rights to such Product, and (ii) there have been no product recalls or voluntary product withdrawals from any market in respect of any Product since the date on which Borrower acquired rights to such Product other than as set out in Schedule 5.11(d)(ii). (e) Borrower has not experienced any significant failures in its manufacturing of any Product which caused any reduction in Products sold.

Regulatory Developments. (a) All Products and all Required Permits as of the Effective Date are listed on Schedule 5.115.11 (as updated from time to time pursuant to Section 6.2(e)), and Borrower has delivered to Agent a copy of all Required Permits as of the date hereof and to the extent requested by Agent;Agent pursuant to Section 6.2(e). (b) Without limiting the generality of Section 5.6 above, with respect to any Product being tested Development Compound or manufactured by Sale Compound of Borrower, (i) Borrower has received, received and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of and/or manufacture, as applicable, with respect to such Product as such testing is currently being conducted by or on behalf of BorrowerBorrower with respect to Development Compounds or Sale Compounds, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (Ai) Borrower's manufacturing facilities and processes for any Sale Compound which have disclosed any material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the manufacture of such ProductSale Compound, or (Bii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that the development, testing and/or of such Development Compound or manufacturing of such Product Sale Compound by Borrower should cease; and. (c) Without limiting the generality of Section 5.6 above, with respect to any Product Sale Compound that may be marketed or sold by Borrower, (i) Borrower has received, and such Product Sale Compound is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being Sale Compound that may be marketed or sold by Borrower, (ii) and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) any material deficiency such Required Permit or violation of Laws and/or the Required Permits related to the marketing approval or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product Sale Compound cease or that such Product Sale Compound be withdrawn from the marketplace. (d) Without limiting the generality of Section 5.6 above, there have been no serious adverse clinical test results related to the safety or efficacy of Development Compounds resulting in the termination of all clinical studies for such Development Compound or recalls of Sale Compounds (whether voluntary or involuntary), in each case which have resulted in or could reasonably be expected to result in a Material Adverse Change. (e) Borrower has not experienced any material failures in its manufacturing of any Sale Compound such that the amount of such Sale Compound successfully manufactured by Borrower in accordance with all specifications thereof and the required payments related thereto in any month shall decrease significantly with respect to the quantities of such Sale Compound produced in the prior month, which such decrease has resulted in or could reasonably be expected to result in a Material Adverse Change.

Regulatory Developments. (a) All Products sold, marketed, manufactured and commercialized and all Required Permits as of the Effective Date relating to such Products are listed on Schedule 5.115.11 (as updated from time to time pursuant to Section 6.2(e)), and and, Borrower has delivered to Agent a copy of all such Required Permits requested by Agent as of the date of this Agreement or thereafter, including to the extent requested by Agent;Agent pursuant to Section 6.2(e). (b) Without limiting the generality of Section 5.6 aboveabove and except as set forth in Schedule 5.11, with respect to any Product being tested or manufactured by Borrower, (i) Borrower has applied for or received, and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such Product Product, and except as such testing is currently being conducted by or on behalf of Borrowerreported to Agent and Lenders in accordance with Section 6.2(f), (ii) Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (Ai) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the manufacture of such Product, or (Bii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; and. As of the Closing Date, no such notices have been received by Borrower, except as set forth in Schedule 5.11. (c) Without limiting the generality of Section 5.6 aboveabove and except as set forth in Schedule 5.11, with respect to any Product marketed or sold by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, (ii) and, except for those reported to Agent in accordance with Section 6.2(f), Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower that such Governmental Authority is conducting an investigation or review of (A) any such Required Permit or approval due to material deficiency deficiencies or violation violations of Laws and/or the Required Permits related to the marketing or sale of such ProductPermits, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no nor has any such Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace. As of the Closing Date, no such notices have been received by Borrower and no such orders have been issued by any Governmental Authority, except as set forth in Schedule 5.11. (d) Without limiting the generality of Section 5.6 above, (i) there have been no adverse clinical test results which have or could reasonably be expected to cause a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market which have or could reasonably be expected to cause a Material Adverse Change. (e) Except as set forth in Schedule 5.11, Borrower has not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower in accordance with all specifications thereof and the required payments related thereto in any month shall decrease in a manner resulting in a Material Adverse Change.