Intellectual Property and Products. (a) Schedule 6.18(a) (as updated from time to time in accordance with Section 7.1.2 hereof) accurately and completely lists all of Australian Borrower’s and each Subsidiary’s Registered Intellectual Property. Each of Australian Borrower and each Subsidiary owns and possesses or has a license or other right to use all Intellectual Property as is necessary for the conduct of the business of each Borrower and the other Loan Parties, without any infringement upon the intellectual property rights of others. (b) Schedule 6.18(b) (as updated from time to time in accordance with Section 7.1.2 hereof) accurately and completely lists all Products and all Required Permits, and each Borrower and each other Loan Party has delivered to Agent a copy of all Required Permits as of the date hereof and to the extent requested by Agent from time to time in its discretion. (i) With respect to any Product being tested, manufactured, marketed and/or sold by any Borrower or any other Loan Party, such Borrower or such Loan Party has received (or the applicable, authorized third parties have received), and such Product is the subject of, all Required Permits needed in connection with the testing, manufacture, marketing and/or sale of such Product by or on behalf of such Borrower or such Loan Party. No Borrower or any other Loan Party has received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review (other than a normal routine scheduled inspection) of such Borrower’s or such other Loan Party’s manufacturing facilities, the processes for such Product or any related sales or marketing activities and/or the Required Permits related to such Product. There are no material deficiencies or violations of applicable laws in relation to the manufacturing, processes, sales or marketing of such Product and/or the Required Permits related to such Product, no Required Permit has been revoked or withdrawn, nor, to the best of each Borrower’s and each other Loan Party’s knowledge, has any such Governmental Authority issued any order or recommendation stating that the development, testing, manufacturing, sales and/or marketing of such Product by or on behalf of such Borrower or such other Loan Party should cease or be withdrawn from the marketplace, as applicable. (ii) Except as set forth on Schedule 6.18(b), (A) there have been no adverse clinical test results in respect of any Product since the date on which such Borrower or such other Loan Party acquired rights to such Product, and (B) there have been no product recalls or voluntary product withdrawals from any market in respect of any Product since the date on which such Borrower or such other Loan Party acquired rights to such Product. (iii) No Borrower or any other Loan Party has experienced any significant failures in its manufacturing of any Product which caused any reduction in Products sold.
Appears in 4 contracts
Samples: Credit Agreement (SWK Holdings Corp), Credit Agreement (Parnell Pharmaceuticals Holdings Pty LTD), Credit Agreement (Parnell Pharmaceuticals Holdings Pty LTD)
Intellectual Property and Products. (a) Schedule 6.18(a5.18(a) (as updated from time to time in accordance with Section 7.1.2 6.1.2 hereof) accurately and completely lists all of Australian Borrower’s and each Subsidiary’s Registered Intellectual Property. Each of Australian Borrower and each Subsidiary owns and possesses or has a license or other right to use all Intellectual Property as is necessary for the conduct of the business of each Borrower and the other Loan Parties, without any infringement upon the intellectual property rights of others.
(b) Schedule 6.18(b5.18(b) (as updated from time to time in accordance with Section 7.1.2 6.1.2 hereof) accurately and completely lists all Products and all Required Permits, and each Borrower and each other Loan Party has delivered to Agent a copy of all Required Permits as of the date hereof and to the extent requested by Agent from time to time in its discretion.
(i) With respect to any Product being tested, manufactured, marketed and/or sold by any Borrower, Borrower or any other Loan Party, such Borrower or such Loan Party has received (or the applicable, authorized third parties have received), and such Product is the subject of, all Required Permits needed in connection with the testing, manufacture, marketing and/or sale of such Product by or on behalf of such Borrower. Borrower or such Loan Party. No Borrower or any other Loan Party has not received any notice from any applicable Governmental Authority, specifically including the FDAFDA and Health Canada, that such Governmental Authority is conducting an investigation or review (other than a normal routine scheduled inspection) of such Borrower’s or such other Loan Party’s manufacturing facilities, the processes for such Product or any related sales or marketing activities and/or the Required Permits related to such Product. There are no material deficiencies or violations of applicable laws in relation to the manufacturing, processes, sales or marketing of such Product and/or the Required Permits related to such Product, no Required Permit has been revoked or withdrawn, nor, to the best of each Borrower’s and each other Loan Party’s knowledge, has any such Governmental Authority issued any order or recommendation stating that the development, testing, manufacturing, sales and/or marketing of such Product by or on behalf of such Borrower or such other Loan Party should cease or be withdrawn from the marketplace, as applicable. CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL TREATMENT AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
(ii) Except as set forth on Schedule 6.18(b5.18(b), (A) there have been no adverse clinical test results in respect of any Product since the date on which such Borrower or such other Loan Party acquired rights to such Product, and (B) there have been no product recalls or voluntary product withdrawals from any market in respect of any Product since the date on which such Borrower or such other Loan Party acquired rights to such Product.
(iii) No Borrower or any other Loan Party has not experienced any significant failures in its manufacturing of any Product which caused any reduction in Products sold.
Appears in 3 contracts
Samples: Credit Agreement (Aralez Pharmaceuticals Inc.), Credit Agreement (Aralez Pharmaceuticals Inc.), Credit Agreement (Aralez Pharmaceuticals Inc.)
Intellectual Property and Products. (a) Schedule 6.18(a5.18(a) (as updated from time to time in accordance with Section 7.1.2 6.1.2 hereof) accurately and completely lists all of Australian Borrower’s and each Subsidiary’s Registered Intellectual Property. Each of Australian Borrower and each Subsidiary owns and possesses or has a license or other right to use all Intellectual Property as is necessary for the conduct of the business of each Borrower and the other Loan Parties, without any infringement upon the intellectual property rights of others.
(b) Schedule 6.18(b5.18(b) (as updated from time to time in accordance with Section 7.1.2 6.1.2 hereof) accurately and completely lists all Products and all Required Permits, and each Borrower and each other Loan Party has delivered to Agent a copy of all Required Permits as of the date hereof and to the extent requested by Agent from time to time in its discretion.
(i) With respect to any Product being tested, manufactured, marketed and/or sold by any Borrower, Borrower or any other Loan Party, such Borrower or such Loan Party has received (or the applicable, authorized third parties have received), and such Product is the subject of, all Required Permits needed in connection with the testing, manufacture, marketing and/or sale of such Product by or on behalf of such Borrower. Borrower or such Loan Party. No Borrower or any other Loan Party has not received any notice from any applicable Governmental Authority, specifically including the FDAFDA and Health Canada, that such Governmental Authority is conducting an investigation or review (other than a normal routine scheduled inspection) of such Borrower’s or such other Loan Party’s manufacturing facilities, the processes for such Product or any related sales or marketing activities and/or the Required Permits related to such Product. There are no material deficiencies or violations of applicable laws in relation to the manufacturing, processes, sales or marketing of such Product and/or the Required Permits related to such Product, no Required Permit has been revoked or withdrawn, nor, to the best of each Borrower’s and each other Loan Party’s 's knowledge, has any such Governmental Authority issued any order or recommendation stating that the development, testing, manufacturing, sales and/or marketing of such Product by or on behalf of such Borrower or such other Loan Party should cease or be withdrawn from the marketplace, as applicable. CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL TREATMENT AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
(ii) Except as set forth on Schedule 6.18(b5.18(b), (A) there have been no adverse clinical test results in respect of any Product since the date on which such Borrower or such other Loan Party acquired rights to such Product, and (B) there have been no product recalls or voluntary product withdrawals from any market in respect of any Product since the date on which such Borrower or such other Loan Party acquired rights to such Product.
(iii) No Borrower or any other Loan Party has not experienced any significant failures in its manufacturing of any Product which caused any reduction in Products sold.
Appears in 1 contract
Samples: Credit Agreement (Tribute Pharmaceuticals Canada Inc.)