Common use of Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc Clause in Contracts

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, of any Safety Notices with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Product; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property developed or controlled by such Loan Party or any of its respective Subsidiaries; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any claim by any Person that the conduct of such Loan Party’s or such Subsidiary’s business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that Person.

Appears in 5 contracts

Samples: Credit Agreement (Societal CDMO, Inc.), Credit Agreement (Societal CDMO, Inc.), Credit Agreement (Recro Pharma, Inc.)

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Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Borrower and each of the Subsidiaries will (i) maintain in full force and effect all Material material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative AgentLender, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices material product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party the Borrower or its respective Subsidiariesany of the Subsidiaries and all Material Agreements, excluding the maintenance of Intellectual Property that except in the commercially reasonable business judgment of event that the Borrower is determines in its reasonable commercial judgment not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productto do so; (viiiv) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any material Infringement or other violation by any Person of its Material Intellectual PropertyProperty and aggressively pursue any such Infringement or other violation except in any specific circumstances where the Borrower or any of the Subsidiaries determines that it is not commercially reasonable to do so; (viiiv) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material Intellectual Property Property, including Patents, developed or controlled by such Loan Party the Borrower or any of the Subsidiaries, except in the event that the Borrower determines in its respective Subsidiariesreasonable commercial judgment not to do so; and (ixvi) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any material claim by any Person that the conduct of such Loan Partythe Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes in any material respect any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except when the Borrower determines in its reasonable commercial judgment not to do so.

Appears in 4 contracts

Samples: Credit Agreement (Natera, Inc.), Credit Agreement (Natera, Inc.), Credit Agreement (Natera, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Borrower and each of the Subsidiaries will: (i) maintain in full force and effect all Material material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative AgentLender, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, marketpromote, import, distribute and distribute manufacture (or use reasonable best efforts to cause their respective suppliers to manufacture, as the case may be) all Products in compliance in all material respects with QSRs, the FD&C Act and other applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate (or use reasonable best efforts to cause their respective suppliers to operate, as the case may be) all manufacturing facilities in compliance in all material compliance respects with QSRs and all other applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party the Borrower or its respective Subsidiariesany of the Subsidiaries and all Material Agreements, excluding the maintenance of Intellectual Property that except in the commercially reasonable business judgment of event that the Borrower is determines in its reasonable commercial judgment not necessary or material for either to do so, and all Key Contracts (x) other than the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Endoform Development and Commercialization Activities associated with any ProductAgreement #1); (vii) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material Intellectual PropertyProperty and use commercially reasonable efforts to pursue any such Infringement or other violation except in any specific circumstances where both (A) the Borrower or any of the Subsidiaries are able to demonstrate that it is not commercially reasonable to do so and (B) where not doing so does not materially adversely affect any Product; (viii) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material Intellectual Property Property, including Patents, developed or controlled by such Loan Party the Borrower or any of its respective the Subsidiaries; and (ix) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has the Borrower obtains knowledge thereof, of any claim by any Person that the conduct of such Loan Partythe Borrower’s or such Subsidiary’s any of the Subsidiaries’ or any of their respective suppliers’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so.

Appears in 2 contracts

Samples: Credit Agreement (TELA Bio, Inc.), Credit Agreement (TELA Bio, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Borrower and each of the Subsidiaries will (i) in all material respects maintain in full force and effect all Material material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative AgentLender, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) in all material respects design, manufacture, store, transport, label, sell, marketpromote, import and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCAFD&C Act, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectand other applicable laws, rules and regulations; (iv) in all material respects conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Lawslaws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development rules and Commercialization Activitiesregulations; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activitiesall other applicable laws, rules and regulations; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material material Intellectual Property owned or controlled by such Loan Party the Borrower or its respective Subsidiariesany of the Subsidiaries and all Material Agreements, excluding the maintenance of Intellectual Property that except in the commercially reasonable business judgment of event that the Borrower is determines in its reasonable commercial judgment not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productto do so; (vii) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has having knowledge thereof, of any material Infringement or other violation by any Person of its Material material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material material Intellectual Property Property, including Patents, developed or controlled by such Loan Party the Borrower or any of the Subsidiaries, except in the event that the Borrower determines in its respective Subsidiariesreasonable commercial judgment not to do so; and (ix) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan Partythe Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so.

Appears in 2 contracts

Samples: Credit Agreement (Avedro Inc), Credit Agreement (Avedro Inc)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Borrower and each of the Subsidiaries will (i) in all material respects maintain in full force and effect all Material material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and in all material respects comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative AgentLender, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices material product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) in all material respects design, manufacture, store, transport, label, sell, marketpromote, import and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCAFD&C Act, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectand other applicable Laws; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products in all material respects in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with cGMPs, and all other applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material material Intellectual Property owned or controlled by such Loan Party the Borrower or its respective Subsidiariesany of the Subsidiaries and all Material Agreements, excluding the maintenance of Intellectual Property that except in the commercially reasonable business judgment of event that the Borrower is determines in its reasonable commercial judgment not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productto do so; (vii) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any material Infringement or other violation by any Person of its Material material Intellectual PropertyProperty and aggressively pursue any such Infringement or other violation except in any specific circumstances where both (x) the Borrower or any Subsidiary is able to demonstrate that it is not commercially reasonable to do so and (y) where not doing so does not materially adversely affect any material Product; (viii) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material material Intellectual Property Property, including material Patents, developed or controlled by such Loan Party the Borrower or any of its respective the Subsidiaries, except in any specific circumstances where both (x) the Borrower or any Subsidiary is able to demonstrate that it is not commercially reasonable to do so and (y) where not doing so does not materially adversely affect any material Product; and (ix) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any material claim by any Person that the conduct of such Loan Partythe Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes in any material respect any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so; and (x) notify the Lender, promptly after learning thereof, of any application or registration relating to any material item of its Intellectual Property which may, in the Borrower’s or such Subsidiary’s reasonable commercial judgment, become abandoned or dedicated to the public or placed in the public domain or invalid or unenforceable, or of any adverse determination or development (including the institution of, or any such determination or development in, any proceeding in the United States Patent and Trademark Office, the United States Copyright Office or any foreign counterpart thereof or any court) regarding the Borrower’s or such Subsidiary’s ownership of any of its Intellectual Property, its right to register the same or to keep and maintain and enforce the same.

Appears in 2 contracts

Samples: Credit Agreement (TransMedics Group, Inc.), Credit Agreement (TransMedics Group, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of Holdings, the Borrower and each of the Subsidiaries will: (i) maintain in full force and effect all Material material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights Authorizations necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has Holdings obtains knowledge thereof, of any Safety Notices product recalls, safety alerts, clinical holds, corrections, withdrawals, marketing suspensions, removals or the like conducted, undertaken or issued, whether or not at the request, demand or order of any Governmental Authority or otherwise, with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective Subsidiaries, or any basis for undertaking or issuing any such action or itemProduct, in each case, that could would reasonably be expected to have a an adverse impact on the business of Holdings, the Borrower and the Subsidiaries in any material effect on any Product Development and Commercialization Activitiesrespect; (iii) designdevelop, manufacturetest, store, transport, label, sell, marketpromote, import, export, distribute and distribute manufacture all Products in compliance in all material respects with GMPs, the FD&C Act, the PHSA and other applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all preclinical studies, tests and clinical trials relating to the Products in accordance in all material respects with all cGCPsGLPs, GCPs and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with GMPs and all other applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that Agreements (except in the commercially reasonable business judgment of event that the Borrower is determines in its reasonable commercial judgment not necessary or material for either (xto do so) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productall Key Contracts; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has Holdings obtains knowledge thereof, of any material Infringement or other violation by any Person of its Material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material Intellectual Property Property, including Patents, developed or controlled by such Loan Party Holdings, the Borrower or any of the Subsidiaries, except in the event that the Borrower determines in its respective Subsidiariesreasonable commercial judgment that failure to so pursue such action will not be adverse to the interests of Holdings, the Borrower and the Subsidiaries in any material respects; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has Holdings obtains knowledge thereof, of any claim by any Person that the conduct of such Loan Party’s business of Holdings, the Borrower or such Subsidiary’s business any of the Subsidiaries (including the development, manufacture, use, sale or other commercialization of any Product) materially Infringes any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so.

Appears in 2 contracts

Samples: Credit Agreement (Valneva SE), Credit Agreement (Valneva SE)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Borrower and each of the Subsidiaries will: (i) maintain in full force and effect all Material material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, marketpromote, import, distribute and distribute manufacture all Products in material compliance with QSRs, the FD&C Act and other applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with QSRs and all other applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material material Intellectual Property owned or controlled by such Loan Party the Borrower or its respective Subsidiariesany of the Subsidiaries and all Material Agreements, excluding the maintenance of Intellectual Property that except in the commercially reasonable business judgment of event that the Borrower is determines in its reasonable commercial judgment not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productto do so; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material Intellectual PropertyProperty and aggressively pursue any such Infringement or other violation except in any specific circumstances where both (A) the Borrower or any of the Subsidiaries has determined that it is not commercially reasonable to do so and (B) where not doing so does not materially adversely affect any Product; (viii) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material material Intellectual Property Property, including Patents, developed or controlled by such Loan Party the Borrower or any of its respective the Subsidiaries; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan Partythe Borrower’s or such Subsidiary’s any of the Subsidiaries’ business or any of their respective suppliers’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so.

Appears in 2 contracts

Samples: Credit Agreement (Acutus Medical, Inc.), Pledge and Security Agreement (Acutus Medical, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each Credit Party will, and will cause each of its Subsidiaries to, (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices Product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued by such Credit Party, such Subsidiary or its respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may beeffect, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled Controlled by such Loan Credit Party or its respective Subsidiariessuch Subsidiary and all Material Agreements, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Product; (viiiv) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement infringement or other violation by any Person of its Material Intellectual Property; Property and aggressively pursue any such infringement or other violation except in any specific circumstances where both (viiix) such Credit Party or such Subsidiary is able to demonstrate that it is not commercially reasonable to do so and (y) not doing so does not materially adversely affect any Product, (v) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material new Intellectual Property developed or controlled Controlled by such Loan Credit Party or any of its respective Subsidiaries; and such Subsidiary, (ixvi) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of (x) any claim by any Person that the conduct of such Loan Credit Party’s or such Subsidiary’s business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes infringes any Intellectual Property of such Credit Party or such Subsidiary and, if requested by the Agent, use commercially reasonable efforts to resolve such claim, or (y) any event, circumstance, act or omission that Personcould reasonably be expected to cause any representation or warranty contained in Section 6.19 to be incorrect in any material respect if such representation or warranty was to be made at the time such Credit Party or such Subsidiary learned of such event, circumstance, act or omission and (vii) notify the Agent, promptly after learning thereof, if any Patents constituting Material Intellectual Property are challenged or found invalid by any relevant Governmental Authority.

Appears in 2 contracts

Samples: Credit Agreement and Guaranty (Adma Biologics, Inc.), Credit Agreement and Guaranty (Adma Biologics, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Borrower and each of its Subsidiaries will (i) maintain in full force and effect all Material material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative AgentLender, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices material product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material material Intellectual Property owned or controlled by such Loan Party the Borrower or its respective any of the Subsidiaries, excluding the maintenance of Intellectual Property that except, in the commercially reasonable business judgment of event that the Borrower is determines in its reasonable commercial judgment not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productto do so; (viiiv) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any material Infringement or other violation by any Person of its Material material Intellectual PropertyProperty and aggressively pursue any such Infringement or other violation except in any specific circumstances where the Borrower or any of its Subsidiaries determines that it is not commercially reasonable to do so; (viiiv) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (for, and protect against Infringement with respect to, all material Intellectual Property, including Patents, owned or controlled by the Borrower or any of the Subsidiaries, except as in the event that the Borrower may otherwise determine determines in its reasonable business judgment) for all Material Intellectual Property developed or controlled by such Loan Party or any of its respective Subsidiariescommercial judgment not to do so; and (ixvi) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any material claim by any Person that the conduct of such Loan Partythe Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes in any material respect any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except when the Borrower determines in its reasonable commercial judgment not to do so.

Appears in 2 contracts

Samples: Credit Agreement (Natera, Inc.), Credit Agreement (Natera, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With a)With respect to the Products, (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of the business of Super Holdings and its businessSubsidiaries, and comply with the terms and conditions applicable to the foregoingforegoing excluding the maintenance of the Regulatory Authorizations that in the commercially reasonable business judgment of the Credit Parties are not necessary or material for the conduct of the business of Super Holdings and its Subsidiaries; (ii) promptly notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, Agent of any Safety Notices Notice conducted, to be undertaken or issued, by such Credit Party, its respective Subsidiaries or its respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Credit Party or its their respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectmaterial adverse effect on any Product Development and Commercialization Activities; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material adverse effect on any Product Development and Commercialization Activities; and (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material adverse effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Product; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property developed or controlled by such Loan Party or any of its respective Subsidiaries; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any claim by any Person that the conduct of such Loan Party’s or such Subsidiary’s business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that Person.

Appears in 1 contract

Samples: Note Purchase Agreement (RVL Pharmaceuticals PLC)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, (i) maintain maintain, either directly or through its Product Distributors, as applicable, in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its businessthe business of the Loan Parties and their Subsidiaries and relevant Product Distributors, and comply with the terms and conditions applicable to the foregoing, except where failure to do so could not reasonably be expected to have a material adverse effect on any Product Development and Commercialization Activities; (ii) promptly notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, Agent (for further distribution to the Lenders) of any Safety Notices Notice conducted, to be undertaken or issued, by such Loan Party, its respective Subsidiaries or its respective Product Distributors or suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility Facility owned or operated by any Loan Party or its their respective SubsidiariesSubsidiaries or any Product Distributor (as relating to Products), or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material adverse effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, FDCA and the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectmaterial adverse effect on any Product Development and Commercialization Activities; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; and (v) operate all manufacturing facilities Facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material adverse effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Product; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property developed or controlled by such Loan Party or any of its respective Subsidiaries; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any claim by any Person that the conduct of such Loan Party’s or such Subsidiary’s business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that Person.

Appears in 1 contract

Samples: Credit Agreement (Zevra Therapeutics, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Parent, the Borrower and each Subsidiary will (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse EffectKey Permits, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, of any Safety Notices with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Owned Intellectual Property owned or controlled by such Loan Party or its respective Subsidiariesand all Material Agreements, excluding the maintenance of Intellectual Property that except in the commercially reasonable business judgment of event that the Borrower is determines in its reasonable commercial judgment not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productto do so; (viiiii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material any Owned Intellectual PropertyProperty which is material to the Parent’s and the Borrower’s business and pursue any such Infringement to the extent, and in the manner, the Parent, the Borrower or any of the Subsidiaries determine in their reasonable judgment it is commercially reasonable to do so; (viiiiv) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material material Intellectual Property Property, including Patents, developed or controlled by such Loan Party the Parent, the Borrower or any of its respective the Subsidiaries, except as permitted under Section 8.8(vi) or as agreed to by Administrative Agent in advance in writing; and (ixv) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan Partythe Parent’s, the Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so; (vi) maintain an appropriate information security program with organizational, physical, administrative and technical measures consistent with generally accepted standards for the industry in which the Parent, the Borrower or any Subsidiary operates to protect the operation, confidentiality, integrity, and security of all Confidential Business Information, Personal Data and IT Assets (including, for clarity, all information and transactions stored or contained therein or transmitted thereby) against unauthorized access, acquisition, interruption, alteration, modification, or use; and (vii) notify the Administrative Agent, promptly after learning thereof, of any product recalls, safety alerts, corrections, removals, withdrawals, marketing suspensions, removals or the Signature Page to Credit Agreement like conducted, to be undertaken or issued, by the Parent, the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product, or any basis for undertaking or issuing any such action or item.

Appears in 1 contract

Samples: Credit Agreement (TriSalus Life Sciences, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of Holdings, the Borrower and each of the Subsidiaries will (i) maintain in full force and effect all Material Regulatory Authorizations (including the Product Authorizations), and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the Products and the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative AgentLender, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by Holdings, the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material GCA Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any ProductProperty; (viiiv) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material Intellectual PropertyProperty and pursue any such Infringement or other violation except where Holdings, the Borrower or any of the Subsidiaries determine that it is not commercially reasonable to do so; (viiiv) use commercially reasonable efforts to pursue, enforce, and maintain in full force and effect pursue legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material new Intellectual Property developed or controlled by such Loan Party Holdings, the Borrower or any of its respective the Subsidiaries; and (ixvi) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan PartyHoldings’, the Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and, if requested by the Lender, use commercially reasonable efforts to resolve such claim.

Appears in 1 contract

Samples: Credit Agreement (GC Aesthetics PLC)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of the business of Super Holdings and its businessSubsidiaries, and comply with the terms and conditions applicable to the foregoingforegoing excluding the maintenance of the Regulatory Authorizations that in the commercially reasonable business judgment of the Credit Parties are not necessary or material for the conduct of the business of Super Holdings and its Subsidiaries; (ii) promptly notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, Agent of any Safety Notices Notice conducted, to be undertaken or issued, by such Credit Party, its respective Subsidiaries or its respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Credit Party or its their respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectmaterial adverse effect on any Product Development and Commercialization Activities; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material adverse effect on any Product Development and Commercialization Activities; and (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material adverse effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Product; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property developed or controlled by such Loan Party or any of its respective Subsidiaries; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any claim by any Person that the conduct of such Loan Party’s or such Subsidiary’s business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that Person.

Appears in 1 contract

Samples: Note Purchase Agreement (Osmotica Pharmaceuticals PLC)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Borrower and each of the Subsidiaries will (i) maintain in full force and effect all Material Regulatory AuthorizationsKey Permits, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices product recalls, safety alerts, corrections, manufacturing interruptions or suspensions, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by the Borrower or any Loan Party or its respective of the Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, marketpromote, import and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCAFD&C Act, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectand other applicable Laws in all material respects; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a Laws in all material effect on any Product Development and Commercialization Activitiesrespects; (v) use commercially reasonable efforts to cause its suppliers to operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a and all other applicable Laws in all material effect on any Product Development and Commercialization Activitiesrespects; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Owned Intellectual Property owned or controlled by such Loan Party or its respective Subsidiariesand all Material Agreements, excluding the maintenance of Intellectual Property that except in the commercially reasonable business judgment of event that the Borrower is determines in its reasonable commercial judgment not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productto do so; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material any Owned Intellectual PropertyProperty and diligently pursue any such Infringement or other violation except in any specific circumstances where both (x) the Borrower or any of the Subsidiaries are able to demonstrate that it is not commercially reasonable to do so and (y) where not doing so does not materially adversely affect any Product; (viii) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material Intellectual Property Property, including Patents, developed or controlled by such Loan Party the Borrower or any of the Subsidiaries, except in the event that the Borrower determines in its respective Subsidiariesreasonable commercial judgment not to do so; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan Partythe Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so; and (x) maintain a commercially reasonable information security program with organizational, physical, administrative and technical measures designed to protect the operation, confidentiality, integrity, and security of all Confidential Business Information, IT Assets and Personal Data against unauthorized access, acquisition, interruption, alteration, modification, or use.

Appears in 1 contract

Samples: Credit Agreement (Verrica Pharmaceuticals Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Borrower and each of the Subsidiaries will: (i) maintain in full force and effect all Material material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, marketpromote, import, distribute and distribute manufacture all Products in material compliance with QSRs, the FD&C Act and other applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with QSRs and all other applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full fiill force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material material Intellectual Property owned or controlled by such Loan Party the Borrower or its respective Subsidiariesany of the Subsidiaries and all Material Agreements, excluding the maintenance of Intellectual Property that except in the commercially reasonable business judgment of event that the Borrower is determines in its reasonable commercial judgment not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productto do so; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material Intellectual PropertyProperty and aggressively pursue any such Infringement or other violation except in any specific circumstances where both (A) the Borrower or any of the Subsidiaries has determined that it is not commercially reasonable to do so and (B) where not doing so does not materially adversely affect any Product; (viii) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full hill force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material material Intellectual Property Property, including Patents, developed or controlled by such Loan Party the Borrower or any of its respective the Subsidiaries; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan Partythe Borrower’s or such Subsidiary’s any of the Subsidiaries’ business or any of then- respective suppliers’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so.

Appears in 1 contract

Samples: Credit Agreement (Acutus Medical, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of Holdings, the Borrower and each of the Subsidiaries will (i) except as would not reasonably be expected to result in a Material Adverse Effect, maintain in full force and effect all Material Regulatory Authorizations, Key Permits and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with including filing any notice or registration required in order to design, manufacture, store, label, sell, promote, import or distribute the terms and conditions applicable to the foregoingProducts; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices material Product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by Holdings, the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by Holdings, the Borrower or any Loan Party or its respective of the Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could ; (iii) except as would not reasonably be expected to have result in a material effect on any Product Development and Commercialization Activities; (iii) Material Adverse Effect, design, manufacture, store, transport, label, sell, marketpromote, import and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCAFD&C Act, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectand other applicable laws, rules and regulations; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance accordance, in all material respects, with all cGCPs, and other applicable Lawslaws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development rules and Commercialization Activitiesregulations; (v) operate and use commercially reasonable efforts to cause its suppliers to operate all manufacturing facilities in all material respects in compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activitiesall other applicable Laws, rules and regulations; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Owned Intellectual Property, all Key Contracts and all Material Intellectual Property owned or controlled by such Loan Party or its respective SubsidiariesAgreements, excluding the maintenance of Intellectual Property that except, in each case, in the commercially event that the Borrower determines in its reasonable business judgment of (as determined by the Borrower is in good faith) not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productto do so; (vii) notify the Administrative Agent, reasonably promptly after any Responsible Officer of any Loan Party has obtaining knowledge thereofthereof (and to the extent permitted by applicable Law), of any material Infringement or other material violation of any Owned Intellectual Property and pursue any such Infringement or other violation by any Person of as Borrower determines in its Material Intellectual Propertyreasonable commercial judgment; (viii) use commercially reasonable efforts efforts, and subject to pursueBorrower’s reasonable business judgment, enforce, to pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material material respects for, and protect against material Infringement with respect to, all Owned Intellectual Property developed or controlled by such Loan Party or any of its respective SubsidiariesProperty, including Patents; and (ix) notify the Administrative Agent, reasonably promptly after any Responsible Officer of any Loan Party has obtaining knowledge thereofthereof (and to the extent permitted by applicable Law), of any material claim by any Person that the conduct of such Loan PartyHoldings’, the Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so.

Appears in 1 contract

Samples: Credit Agreement (Harmony Biosciences Holdings, Inc.)

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Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of the business of the Borrower and its businessSubsidiaries, and comply with the terms and conditions applicable to the foregoingforegoing excluding the maintenance of the Regulatory Authorizations that in the commercially reasonable business judgment of the Loan Parties are not necessary or material for the conduct of the business of the Borrower and its Subsidiaries; (ii) promptly notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, Agent of any Safety Notices Notice conducted, to be undertaken or issued, by such Loan Party, its respective Subsidiaries or, to the knowledge of the Borrower, its respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its their respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse EffectEffect or a material adverse effect on any Product Development and Commercialization Activities; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; and (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Product; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property developed or controlled by such Loan Party or any of its respective Subsidiaries; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any claim by any Person that the conduct of such Loan Party’s or such Subsidiary’s business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that Person.

Appears in 1 contract

Samples: Credit Agreement (Kala Pharmaceuticals, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of Parent and each Subsidiary will (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse EffectKey Permits, all other contract rights, authorizations or other rights necessary or material for the operations operation of the business of Parent and its businessSubsidiaries, and comply with the terms and conditions applicable to the foregoingtaken as a whole, except where not doing so does not materially adversely affect any material Product; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, of any Safety Notices with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) all Owned Intellectual Property and all Material Agreements (other than Key Contracts), except in the conduct of event that the business of any Loan Party or Borrower determines in its Subsidiaries or reasonable commercial judgment not to do so, and (y) any material Product Development and Commercialization Activities associated with any Productall Key Contracts; (viiiii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material any Owned Intellectual PropertyProperty and aggressively pursue any such Infringement except in any specific circumstances where both (x) Parent or any of the Subsidiaries are able to demonstrate that it is not commercially reasonable to do so and (y) where not doing so does not materially adversely affect any material Product; (viiiiv) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material Intellectual Property Property, including Patents, developed or controlled by such Loan Party Parent or any of the Subsidiaries, except in the event that the Borrower determines in its respective Subsidiariesreasonable commercial judgment not to do so; and (ixv) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan PartyParent’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so; (vi) maintain an appropriate information security program with organizational, physical, administrative and technical measures consistent with generally accepted standards for the industry in which Parent or any Subsidiary operates to protect the operation, confidentiality, integrity, and security of all Confidential Business Information, Personal Data and IT Assets (including, for clarity, all information and transactions stored or contained therein or transmitted thereby) against unauthorized access, acquisition, interruption, alteration, modification, or use; and (vii) notify the Administrative Agent, promptly after learning thereof, of any product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by Parent, any of the Subsidiaries or their respective material suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product, or any basis for undertaking or issuing any such action or item.

Appears in 1 contract

Samples: Credit Agreement (MDxHealth SA)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Borrower and each Subsidiary will (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse EffectKey Permits, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, of any Safety Notices with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) all Owned Intellectual Property and all Material Agreements (other than Key Contracts), except in the conduct of event that the business of any Loan Party or Borrower determines in its Subsidiaries or reasonable commercial judgment not to do so, and (y) any material Product Development and Commercialization Activities associated with any Productall Key Contracts; (viiiii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material any Owned Intellectual PropertyProperty and aggressively pursue any such Infringement except in any specific circumstances where both (x) the Borrower or any of the Subsidiaries are able to demonstrate that it is not commercially reasonable to do so and (y) where not doing so does not materially adversely affect any Product; (viiiiv) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for for, and protect against Infringement with respect to, all Material Intellectual Property Property, including Patents, developed or controlled by such Loan Party the Borrower or any of its respective the Subsidiaries; and (ixv) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan Partythe Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so; (vi) maintain an appropriate information security program with organizational, physical, administrative and technical measures consistent with generally accepted standards for the industry in which the Borrower or any Subsidiary operates to protect the operation, confidentiality, integrity, and security of all Confidential Business Information, Personal Data and IT Assets (including, for clarity, all information and transactions stored or contained therein or transmitted thereby) against unauthorized access, acquisition, interruption, alteration, modification, or use; and (vii) notify the Administrative Agent, promptly after learning thereof, of any product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product, or any basis for undertaking or issuing any such action or item.

Appears in 1 contract

Samples: Credit Agreement (AVITA Medical, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, the Borrower and each of its Subsidiaries will (i) maintain in full force and effect all Material material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (ii) notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices material product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued by the Borrower or any of its Subsidiaries or its respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may beeffect, and pay all costs and expenses relating to, all Material material Intellectual Property owned or controlled Controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not or any of its Subsidiaries and all material agreements necessary or material customary for either (x) the conduct operation of the business of the Borrower or any Loan Party or its Subsidiaries or of the Subsidiaries, (y) any material Product Development and Commercialization Activities associated with any Product; (viiiv) notify the Administrative Agent, promptly within five (5) Business Days after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement infringement or other violation by any Person of its Material Intellectual Property; Property and aggressively pursue any such infringement or other violation except in any specific circumstances where both (viiix) the Borrower or any of its Subsidiaries is able to demonstrate that it is not commercially reasonable to do so and (y) where not doing so does not materially adversely affect any Product, (v) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material new material Intellectual Property developed or controlled Controlled by such Loan Party the Borrower or any of its respective Subsidiaries; Subsidiaries necessary or customary for the operation of the business of the Borrower or any of the Subsidiaries and (ixvi) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of (x) any material claim by any Person that the conduct of such Loan Partythe Borrower’s or such Subsidiary’s any of its Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes infringes any Intellectual Property of the Borrower or any of its Subsidiaries and, if requested by the Agent, use commercially reasonable efforts to resolve such claim, or (y) any event, circumstance, act or omission that Personcould reasonably be expected to cause any representation or warranty contained in Section 6.17 to be incorrect in any material respect if such representation or warranty was to be made at the time the Borrower or any of its Subsidiaries learned of such event, circumstance, act or omission.

Appears in 1 contract

Samples: Credit Agreement (Avadim Health, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of Holdings, the Borrower and each of the Subsidiaries will (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or and material for the operations of its business, and comply with the terms and conditions applicable to the foregoingforegoing excluding the maintenance of Regulatory Authorizations that in the commercially reasonable business judgment of the Borrower are not necessary or material for the conduct of the business of Holdings, the Borrower or any Subsidiary; (ii) notify the Administrative AgentLender, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices product recalls, safety alerts, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by Holdings, the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, store and distribute label all Products in compliance in all material respects with cGMP, QSRs and other applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products sponsored by Borrower in accordance in all material respects with all cGCPsIDEs, current good clinical practices, current good laboratory practices, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect effect, not permit to expire, lapse, be forfeited, be lost, be cancelled or be abandoned prior to the maximum expect legal life of, or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party Holdings, the Borrower or its respective Subsidiariesany of the Subsidiaries and all Material Agreements, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of Holdings, the Borrower or any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any ProductSubsidiary; (viivi) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viiivii) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property Property, including Patents, developed or controlled by such Loan Party Holdings, the Borrower or any of its respective the Subsidiaries; and (ixviii) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan PartyHoldings’, the Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and, if requested by the Lender, use commercially reasonable efforts to resolve such claim. Exhibit 10.1 CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO RULE 24b-2 Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.

Appears in 1 contract

Samples: Acknowledgement and Agreement (Unilife Corp)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of the Loan Parties and their respective Subsidiaries will (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or and material for the operations of its business, and comply with the terms and conditions applicable to the foregoingforegoing excluding the maintenance of the Regulatory Authorizations that in the commercially reasonable business judgment of the Loan Parties are not necessary or material for the conduct of the business of the Loan Parties; (ii) notify the Administrative AgentLender, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by such Loan Party, its respective Subsidiaries or its respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCAFD&C Act, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectand other applicable laws, rules and regulations; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Lawslaws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development rules and Commercialization Activitiesregulations; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activitiesall other applicable laws, rules and regulations; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or and its respective Subsidiaries, Subsidiaries and all Material Agreements excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Productas would be commercially reasonable; (vii) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property Property, including Patents, developed or controlled by such Loan Party or any of its respective Subsidiaries; and (ix) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan Party’s or any such Loan Party’s Subsidiary’s business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and, if requested by the Lender, use commercially reasonable efforts to resolve such claim.

Appears in 1 contract

Samples: Credit Agreement (Recro Pharma, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, (i) maintain in full force and effect all Material Key Permits and other Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of the business of the Borrower and its businessSubsidiaries, and comply with the terms and conditions applicable to the foregoingforegoing excluding the maintenance of the Regulatory Authorizations that in the commercially reasonable business judgment of the Loan Parties are not necessary or material for the conduct of the business of the Borrower and its Subsidiaries and promptly provide evidence of any Key Permit upon request of the Administrative Agent; (ii) promptly notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, Agent of any Safety Notices Notice conducted, to be undertaken or issued, by such Loan Party, its respective Subsidiaries or, to the knowledge of the Borrower, its respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its their respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectmaterial adverse effect on any Product Development and Commercialization Activities; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; and (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material adverse effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Product; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property developed or controlled by such Loan Party or any of its respective Subsidiaries; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any claim by any Person that the conduct of such Loan Party’s or such Subsidiary’s business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that Person.

Appears in 1 contract

Samples: Credit Agreement (Dermira, Inc.)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, each of Holdings, the Borrower and each of the Subsidiaries will (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or and material for the operations of its business, and comply with the terms and conditions applicable to the foregoingforegoing excluding the maintenance of Regulatory Authorizations that in the commercially reasonable business judgment of the Borrower are not necessary or material for the conduct of the business of Holdings, the Borrower or any Subsidiary; (ii) notify the Administrative AgentLender, promptly after a Responsible Officer of any Loan Party has knowledge learning thereof, of any Safety Notices product recalls, safety alerts, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by Holdings, the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its respective SubsidiariesProduct, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, store and distribute label all Products in compliance in all material respects with cGMP, QSRs and other applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products sponsored by Borrower in accordance in all material respects with all cGCPsIDEs, current good clinical practices, current good laboratory practices, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect effect, not permit to expire, lapse, be forfeited, be lost, be cancelled or be abandoned prior to the maximum expect legal life of, or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party Holdings, the Borrower or its respective Subsidiariesany of the Subsidiaries and all Material Agreements, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of Holdings, the Borrower or any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any ProductSubsidiary; (viivi) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viiivii) use commercially reasonable efforts to pursue, enforce, pursue and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property Property, including Patents, developed or controlled by such Loan Party Holdings, the Borrower or any of its respective the Subsidiaries; and (ixviii) notify the Administrative AgentLender, promptly after any Responsible Officer of any Loan Party has knowledge learning thereof, of any claim by any Person that the conduct of such Loan PartyHoldings’, the Borrower’s or such Subsidiary’s any of the Subsidiaries’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that PersonPerson and, if requested by the Lender, use commercially reasonable efforts to resolve such claim.

Appears in 1 contract

Samples: Acknowledgement and Agreement (Unilife Corp)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Products, (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of the business of the Borrower and its businessSubsidiaries, and comply with the terms and conditions applicable to the foregoingforegoing excluding the maintenance of the Regulatory Authorizations that in the commercially reasonable business judgment of the Loan Parties (and subject to the consent of the Required Lenders) are not necessary or material for the conduct of the business of the Borrower and its Subsidiaries; (ii) promptly notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, Agent of any Safety Notices Notice conducted, to be undertaken or issued, by such Loan Party, its respective Subsidiaries or its respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product or manufacturing facility owned or operated by any Loan Party or its their respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectmaterial adverse effect on any Product Development and Commercialization Activities; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material adverse effect on any Product Development and Commercialization Activities; and (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material adverse effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Product; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property developed or controlled by such Loan Party or any of its respective Subsidiaries; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any claim by any Person that the conduct of such Loan Party’s or such Subsidiary’s business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that Person.

Appears in 1 contract

Samples: Credit Agreement (RVL Pharmaceuticals PLC)

Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc. (a) With respect to the Material Products, (i) maintain in full force and effect all Material Regulatory Authorizations, and except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, all other contract rights, authorizations or other rights necessary or material for the operations of the business of the Issuer and its businessSubsidiaries, and comply with the terms and conditions applicable to the foregoingforegoing excluding the maintenance of the Regulatory Authorizations that in the commercially reasonable business judgment of the Credit Parties are not necessary or material for the conduct of the business of the Issuer and its Subsidiaries; (ii) promptly notify the Administrative Agent, promptly after a Responsible Officer of any Loan Party has knowledge thereof, Agent of any Safety Notices Notice conducted, to be undertaken or issued, by such Credit Party, its respective Subsidiaries or its respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Material Product or manufacturing facility owned or operated by any Loan Credit Party or its their respective Subsidiaries, or any basis for undertaking or issuing any such action or item, in each case, that could reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (iii) design, manufacture, store, transport, label, sell, market, and distribute all Material Products in compliance with applicable Laws, including without limitation, cGMPs, the FDCA, the PHSA, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a Material Adverse Effectmaterial adverse effect on any Product Development and Commercialization Activities; (iv) conduct all studies, tests and preclinical and clinical trials relating to the Material Products in accordance with all cGCPs, and other applicable Laws, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; and (v) operate all manufacturing facilities in material compliance with applicable Laws, including without limitation, cGMPs, the Controlled Substances Act, except where the failure to do so could not reasonably be expected to have a material effect on any Product Development and Commercialization Activities; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Material Intellectual Property owned or controlled by such Loan Party or its respective Subsidiaries, excluding the maintenance of Intellectual Property that in the commercially reasonable business judgment of the Borrower is not necessary or material for either (x) the conduct of the business of any Loan Party or its Subsidiaries or (y) any material Product Development and Commercialization Activities associated with any Product; (vii) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any Infringement or other violation by any Person of its Material Intellectual Property; (viii) use commercially reasonable efforts to pursue, enforce, and maintain in full force and effect legal protection (except as Borrower may otherwise determine in its reasonable business judgment) for all Material Intellectual Property developed or controlled by such Loan Party or any of its respective Subsidiaries; and (ix) notify the Administrative Agent, promptly after any Responsible Officer of any Loan Party has knowledge thereof, of any claim by any Person that the conduct of such Loan Party’s or such Subsidiary’s business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that Person.

Appears in 1 contract

Samples: Note Purchase Agreement (Puma Biotechnology, Inc.)

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