Common use of Regulatory Status Clause in Contracts

Regulatory Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d)), and Borrower has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d). (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market. (E) As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d)), and Borrower has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d). (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1i) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2ii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (CB) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace. (DC) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results in connection with a Product which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market. (ED) As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d)), and Borrower each Credit Party has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d). (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower each Credit Party and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrowersuch Credit Party, and Borrower and no Credit Party or its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1) Borrowersuch Credit Party’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower any Credit Party or its Subsidiaries, Borrower the Credit Parties and its their Subsidiaries 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 the Credit Parties or its their Subsidiaries, and Borrower the Credit Parties and its their Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market, other than recalls or withdrawals that relate only to a specific lot or batch of a Product. (E) As of the date of this Agreement The Credit Parties and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its their Subsidiaries have not experienced any significant failures in its manufacturing of any Product material to the business of the Credit Parties such that the amount of such Product successfully manufactured by Borrower any Credit Party or its Subsidiaries 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 monthsignificantly.

Regulatory Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d)), and Borrower has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or and to the extent requested by Agent or such Lender pursuant to Section 8.1(d). (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1i) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2ii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market. (E) As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d)), and Borrower has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d). (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower or its Subsidiaries, except as disclosed on the ONSOLIS Disclosure Schedule, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, above (i) and except as disclosed in the SEC Filings made prior to the Closing Date, there have been no adverse clinical test results conducted by Borrower, or to Borrower’s knowledge, conducted by other Persons which have or could reasonably be expected to result in a Material Adverse Change, and (ii) except as disclosed on the ONSOLIS Disclosure Schedule, there have been no Product recalls or voluntary Product withdrawals from any market. (E) As of Except as disclosed on the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remadeONSOLIS Disclosure Schedule, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d)), and Borrower has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d).. ​ (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease.. ​ (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product ​ ​ MidCap / Ocular / 4th A&R Credit Agreement ​ withdrawals from any market.. ​ (E) As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d)), and Borrower has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d). (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market. (E) As of On the Closing Date and the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remadeCredit Extension, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d)), and Borrower Xxxxxxxx has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d). (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower or its Subsidiaries, except as disclosed on the ONSOLIS Disclosure Schedule, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, above (i) and except as disclosed in the SEC Filings made prior to the Closing Date, there have been no adverse clinical test results conducted by Borrower, or to Borrower’s knowledge, conducted by other Persons which have or could reasonably be expected to result in a Material Adverse Change, and (ii) except as disclosed on the ONSOLIS Disclosure Schedule, there have been no Product recalls or voluntary Product withdrawals from any market. (E) As of Except as disclosed on the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remadeONSOLIS Disclosure Schedule, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower which has caused or its Subsidiaries in accordance with all specifications thereof and the required payments related thereto in any month shall decrease significantly with respect is reasonably likely to the quantities of such Product produced in the prior monthcause a Material Adverse Change.

Regulatory Status. (Aa) All of Borrower’s material Products and all material Regulatory Required Permits (limited to those Regulatory Required Permits the loss of which would reasonably be expected to result in a Material Adverse Change) are listed on the Products Schedule to the Disclosure Letter and Required Permits Schedule to the Disclosure Letter, respectively (as updated from time to time pursuant to Section 8.1(d)6.14), and Borrower has delivered to Agent and each Lender a copy of all Regulatory Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d6.16. (b) None of the Borrowers or any Subsidiary thereof are in violation of any Healthcare Law, except where any such violation could not reasonably be expected to result in a Material Adverse Change. (c) None of the Borrower’s or its Subsidiaries’ officers, directors, employees, shareholders, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (Bd) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with With respect to any Product being tested or manufacturedeach Product, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing testing, manufacture, marketing or manufacture sale of such Product as such testing or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower have provided Agent and its Subsidiaries have not received any notice from any applicable Governmental Authorityeach Lender with all notices and other information required by Section 6.16, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1ii) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any is being tested, manufactured, marketed or sold, as the case may be, in material deficiencies or violations of compliance with all applicable Laws and/or the and Regulatory Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should ceasePermits. (Ce) Without limiting the generality of Section 8.1 above, as As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remadeClosing Date, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any marketRegulatory Reporting Events. (E) As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (A) All Products and all Required Permits for the Product of the Closing Date, are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d))Schedule, and Borrower has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d)Lender. (B) Without limiting the generality of Section 8.1 above, except as may be disclosed on the Disclosure Schedule, as of the date of this Agreement Closing Date (and on each subsequent date that the representations and warranties in this Agreement are brought down or remaderemade pursuant to Section 8.2 solely with respect to a new Product), with respect to any Product being tested or manufacturedthe Product, Borrower and its Subsidiaries have received, and such the Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such the Product as such testing or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such the Product or Pipeline Assets which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Productthe Product that would reasonably be expected to result in a Material Adverse Change, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such the Product should cease, in each case, that would reasonably be expected to result in a Material Adverse Change. (C) Without limiting the generality of Section 8.1 above, except as may be disclosed on the Disclosure Schedule, as of the date of this Agreement Closing Date (and on each subsequent date that the representations and warranties in this Agreement are brought down or remaderemade pursuant to Section 8.2 solely with respect to a new Product), with respect to any the Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries have received, and such the Product is the subject of, all material Required Permits needed in connection with the marketing and sales of such the Product as currently being marketed or sold by Borrower or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental AuthorityAuthority in the United States, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such the Product cease in the United States or that such the Product be withdrawn from the marketplacemarketplace in the United States. (D) Without limiting the generality of Section 8.1 above, except as may be disclosed on the Disclosure Schedule, as of the date of this Agreement Closing Date (and on each subsequent date that the representations and warranties in this Agreement are brought down or remaderemade pursuant to Section 8.2 solely with respect to a new Product), (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls recalls, Product regulatory action by any government authority or voluntary Product withdrawals from any marketmarket that would reasonably be expected to ​ ​ result in a Material Adverse Change. (E) As of the date of this Agreement (and on each subsequent date that the representations and warranties in this Agreement are brought down or remaderemade pursuant to Section 8.2 solely with respect to a new Product), Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries which would reasonably be expected to result 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 montha Material Adverse Change.

Regulatory Status. (Aa) All of Borrower’s material Products and all material Regulatory Required Permits (limited to those Regulatory Required Permits the loss of which would reasonably be expected to result in a Material Adverse Change) are listed on the Products Schedule to the Disclosure Letter and Required Permits Schedule to the Disclosure Letter, respectively (as updated from time to time pursuant to Section 8.1(d)6.14), and Borrower has delivered to Agent and each Lender a copy of all Regulatory Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d6.16. (b) None of the Borrowers or any Subsidiary thereof are in violation of any Healthcare Law, except where any such violation could not reasonably be expected to result in a Material Adverse Change. (c) None of the Borrower’s or its Subsidiaries’ officers, directors, employees, shareholders, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (Bd) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with With respect to any Product being tested or manufacturedeach Product, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing testing, manufacture, marketing or manufacture sale of such Product as such testing or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower have provided Agent and its Subsidiaries have not received any notice from any applicable Governmental Authorityeach Lender with all notices and other information required by Section 6.16, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1ii) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries have received, and such Product is the subject ofbeing tested, all Required Permits needed in connection with the marketing and sales of such Product as currently being manufactured, marketed or sold by Borrower or its Subsidiariessold, as the case may be, in material compliance with all applicable Laws and Borrower Regulatory Required Permits. Midcap / MannKind / Credit and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace.Security Agreement (De) Without limiting the generality of Section 8.1 above, as As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remadeClosing Date, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any marketRegulatory Reporting Events. (E) As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (Aa) All of Borrower’s Products and all material Regulatory Required Permits are listed on the Products Schedule and Required Permits Schedule Schedule, respectively (as updated from time to time pursuant to Section 8.1(d)6.14), and Borrower has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as to (b) None of the date hereof Borrower or any of its Subsidiaries are in violation of any Healthcare Law, except where any such violation could not reasonably be expected to result in a Material Adverse Change. (c) None of the Borrower’s or its Subsidiaries’ officers, directors, employees or their agents or, to Borrower’s knowledge, any of its shareholders or affiliates has made an untrue statement of material fact or fraudulent statement to the extent requested by Agent FDA or such Lender pursuant failed to Section 8.1(ddisclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (Bd) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with With respect to any Product being tested or manufacturedeach Product, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing testing, manufacture, marketing or manufacture sale of such Product as such testing or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower have provided Agent and its Subsidiaries have not received any notice from any applicable Governmental Authorityeach Lender with all material notices and other material information required by Section 6.16, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1ii) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any is being tested, manufactured, marketed or sold, as the case may be, in material deficiencies or violations of compliance with all applicable Laws and/or the and Regulatory Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should ceasePermits. (Ce) Without limiting the generality of Section 8.1 above, as As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remadeClosing Date, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any marketRegulatory Reporting Events. (E) As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d)), and Borrower each Credit Party has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d). (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower each Credit Party and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrowersuch Credit Party, and Borrower each Credit Party and its Subsidiaries have not received any written notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1) Borrowersuch Credit Party’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower any Credit Party or its Subsidiaries, Borrower such Credit Party and its Subsidiaries 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 such Credit Party or its Subsidiaries, and Borrower each Credit Party and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market, other than recalls or withdrawals (x) in a single jurisdiction that does not account for a material portion of the Credit Parties’ revenue or (y) that relate only to specific lots or batches of a Product. (E) As No Credit Party or any Subsidiary of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not a Credit Party has experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower such Credit Party or its Subsidiaries in accordance with all specifications thereof and the required payments related thereto in any month shall decrease significantly with respect except to the quantities of extent that such Product produced failures do not and or could reasonably be expected to result in the prior montha Material Adverse Change.

Regulatory Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule (as updated from time to time pursuant to Section 8.1(d)), and Borrower has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d). (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market. (E) As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (A) All Products and all Required Permits are listed on the Products Schedule and Required Permits Schedule attached hereto (as updated from time to time pursuant to Section 8.1(d)), and Borrower has delivered to Agent and each Lender a copy of all Required Permits requested by Agent and such Lender as of the date hereof or and to the extent requested by Agent or such Lender pursuant to Section 8.1(d). (B) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product being tested or manufactured, Borrower and its Subsidiaries have 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 or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1i) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws and/or the Required Permits related to the manufacture of such Product, or (2ii) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease. (C) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results in connection with a Product which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any market. (E) As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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 Status. (Aa) All of Borrower’s Products and all Regulatory Required Permits are listed on Schedule 5.8(a) and Schedule 5.8(b) of the Products Schedule and Required Permits Schedule Disclosure Letter, respectively (as updated from time to time pursuant to Section 8.1(d)6.14), and Borrower has delivered to Agent and each Lender a copy of all Regulatory Required Permits requested by Agent and such Lender as of the date hereof or to the extent requested by Agent or such Lender pursuant to Section 8.1(d6.16. (b) None of the Borrowers or any Subsidiary thereof are in violation of any Healthcare Law, except where any such violation could not reasonably be expected to result in a Material Adverse Change. (c) None of the Borrower’s or its Subsidiaries’ officers, directors, employees, shareholders, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (Bd) Without limiting the generality of Section 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, with With respect to any Product being tested or manufacturedeach Product, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing testing, manufacture, marketing or manufacture sale of such Product as such testing or manufacturing is currently being conducted by or on behalf of Borrower, and Borrower have provided Agent and its Subsidiaries have not received any notice from any applicable Governmental Authorityeach Lender with all notices and other information required by Section 6.16, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (1ii) Borrower’s or such Subsidiary’s manufacturing facilities and processes for such Product which have disclosed any is being tested, manufactured, marketed or sold, as the case may be, in material deficiencies or violations of compliance with all applicable Laws and/or the and Regulatory Required Permits related to the manufacture of such Product, or (2) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should ceasePermits. (Ce) Without limiting the generality of Section 8.1 above, as As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remadeClosing Date, with respect to any Product marketed or sold by Borrower or its Subsidiaries, Borrower and its Subsidiaries 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 or its Subsidiaries, and Borrower and its Subsidiaries have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority 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 8.1 above, as of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, (i) there have been no adverse clinical test results which have or could reasonably be expected to result in a Material Adverse Change, and (ii) there have been no Product recalls or voluntary Product withdrawals from any marketRegulatory Reporting Events. (E) As of the date of this Agreement and on each subsequent date that the representations and warranties in this Agreement are brought down or remade, Borrower and its Subsidiaries have not experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Borrower or its Subsidiaries 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.