Regulatory Required Permits. (1) With respect to any Product, (x) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and have provided Agent and each Lender with all notices and other information required by Section 4.17 and (y) such Product is being tested, manufactured, marketed or sold, as the case may be, in material compliance with all applicable Laws and Regulatory Required Permits. (2) Except as set forth on Schedule 8.2(c) or as disclosed to the Agent and Lenders after the Closing Date pursuant to Section 4.17 (i) Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, that (x) such Governmental Authority is conducting an investigation or review of (A) any such Regulatory Required Permit or approval or that any such Regulatory Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace or (B) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws (including Healthcare Laws) and/or the Regulatory Required Permits related to the manufacture of such Product, or (C) any such Regulatory Required Permit or (y) any such Regulatory Required Permit has been revoked or withdrawn, (ii) no Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease, in each case to the extent not reasonably likely to result in a Material Adverse Effect.
Appears in 2 contracts
Samples: Credit and Security Agreement (Ellipse Technologies Inc), Credit and Security Agreement (Ellipse Technologies Inc)
Regulatory Required Permits. (1) With respect to any ProductProduct or service, (xi) Borrower and its Subsidiaries have received, and such Product or service is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product or conduct of such service as currently being conducted by or on behalf of BorrowerBorrowers, and have provided Agent and each Lender with all notices and other information required by Section 4.17 4.17, and no Borrower has received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting a material investigation or review of any such Regulatory Required Permit or approval or that any such Regulatory Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any final and binding order or recommendation stating that such marketing or sales of such Product or conduct of such service cease or that such Product or service be withdrawn from the marketplace, and (yii) such Product is being tested, manufactured, marketed or sold, as the case may be, in material compliance with all applicable Laws and Regulatory Required Permits.
(2) Except as set forth on Schedule 8.2(c) or as disclosed to the Agent , and Lenders after the Closing Date pursuant to Section 4.17 (i) Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, that (x) such Governmental Authority is conducting an a material investigation or review of (A) any such Regulatory Required Permit or approval or that any such Regulatory 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 or (B) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws (including Healthcare Laws) and/or the Regulatory Required Permits related to the manufacture of such Product, or (CB) any such Regulatory Required Permit or (y) that any such Regulatory Required Permit has been revoked or withdrawn, (ii) 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, in each case to the extent not reasonably likely to result in a Material Adverse Effect.
Appears in 2 contracts
Samples: Credit and Security Agreement (Revolving Loan) (Novadaq Technologies Inc), Credit and Security Agreement (Term Loan) (Novadaq Technologies Inc)
Regulatory Required Permits. (1) With respect to any ProductProduct or service, (xi) Borrower and its Subsidiaries have received, and such Product or service is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product or conduct of such service as currently being conducted by or on behalf of BorrowerBorrowers, and have provided Agent and each Lender with all notices and other information required by Section 4.17 4.17, and no Borrower has received any written notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting a material investigation of any such Regulatory Required Permit or approval or that any such Regulatory Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any final and binding order or recommendation stating that such marketing or sales of such Product or conduct of such service cease or that such Product or service be withdrawn from the marketplace, and (yii) such Product is being tested, manufactured, marketed or sold, as the case may be, in material compliance with all applicable Laws and Regulatory Required Permits.
(2) Except as set forth on Schedule 8.2(c) or as disclosed to the Agent , and Lenders after the Closing Date pursuant to Section 4.17 (i) Borrower has not received any written notice from any applicable Governmental Authority, specifically including the FDA, that (x) such Governmental Authority is conducting an a material investigation or review of (A) any such Regulatory Required Permit or approval or that any such Regulatory 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 or (B) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws (including Healthcare Laws) and/or the Regulatory Required Permits related to the manufacture of such Product, or (CB) any such Regulatory Required Permit or (y) that any such Regulatory Required Permit has been revoked or withdrawn, (ii) 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, in each case to the extent not reasonably likely to result in a Material Adverse Effect.
Appears in 2 contracts
Samples: Credit and Security Agreement (Revolving Loan) (Invuity, Inc.), Credit and Security Agreement (Term Loan) (Invuity, Inc.)
Regulatory Required Permits. (1) With respect to any Product, (xi) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of BorrowerProduct, and have provided Agent and each Lender with all notices and other information required by Section 4.17 4.17, and (y) such Product is being tested, manufactured, marketed or sold, as the case may be, in material compliance with all applicable Laws and Regulatory Required Permits.
(2) Except as set forth on Schedule 8.2(c) or as disclosed to the Agent and Lenders after the Closing Date pursuant to Section 4.17 (i) no Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, that (x) such Governmental Authority is conducting an investigation or review of (A) any such Regulatory Required Permit or approval or that any such Regulatory 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 (ii) such Product is being tested, manufactured, marketed or sold, as the case may be, in material compliance with all applicable Laws and Regulatory Required Permits, and Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (BA) Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws (including Healthcare Laws) and/or the Regulatory Required Permits related to the manufacture of such Product, or (CB) any such Regulatory Required Permit or (y) that any such Regulatory Required Permit has been revoked or withdrawn, (ii) 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, in each case to the extent not reasonably likely to result in a Material Adverse Effect.
Appears in 2 contracts
Samples: Term Credit and Security Agreement (Spectranetics Corp), Revolving Credit and Security Agreement (Spectranetics Corp)
Regulatory Required Permits. (1) With respect to any ProductProduct or service, (xi) the Borrower and its Subsidiaries have has received, and such Product or service is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product or conduct of such service as currently being conducted by or on behalf of BorrowerBorrowers, and have provided Agent and each Lender with all notices and other information required by Section 4.17 6.17, and (y) such Product is being tested, manufactured, marketed or sold, as the case may be, in material compliance with all applicable Laws and Regulatory Required Permits.
(2) Except as set forth on Schedule 8.2(c) or as disclosed to the Agent and Lenders after the Closing Date pursuant to Section 4.17 (i) Borrower has not received any written notice from any applicable Governmental Authority, specifically including the FDA, that (x) such Governmental Authority is conducting an investigation or review of (A) any such Regulatory Required Permit or approval or that any such Regulatory 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 or conduct of such service cease or that such Product or service be withdrawn from the marketplace (ii) such Product is being tested, manufactured, marketed or sold, as the case may be, in material compliance with all applicable Laws and Regulatory Required Permits, and Borrower has 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 (BA) the Borrower’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws (including Healthcare Laws) and/or the Regulatory Required Permits related to the manufacture of such Product, except where noncompliance would not have a Material Adverse Effect, or (CB) any such Regulatory Required Permit or (y) that any such Regulatory Required Permit has been revoked or withdrawn, (ii) 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, except where failure to be in each case such compliance or for a Permit to the extent be valid and in full force and effect would not reasonably likely to result in have a Material Adverse Effect.
Appears in 1 contract