Compliance with Laws; Manufacturing Sample Clauses

Compliance with Laws; Manufacturing. (a) Kamada shall comply in all material respects with all applicable laws, rules and regulations applicable to the design, manufacture, labeling, packaging, storage and handling of the Product in the Xxxxxx Territory, including maintaining qualified manufacturing and quality facilities and/or procedures. The content of the labeling or any packaging inserts shall remain the responsibility of Xxxxxx as provided in Sections 4.3, 6.1 and 6.2. Kamada shall ensure that all third party manufacturers of any raw materials for the Product comply in all material respects with all laws, rules and regulations applicable to the design, manufacture, labeling and packaging of the Product in the Xxxxxx Territory. Without limiting the generality of the foregoing, Kamada (and all third party manufacturers of any raw materials for Product) shall implement such quality control systems and procedures as shall be appropriate to ensure compliance with the requirements of cGMP and ICH that are applicable to Kamada (or any third party manufacturer) as the manufacturer and supplier of the Product. Kamada shall allow reasonable access to its records, manufacturing facilities, and its third party manufacturers’ manufacturing facilities and records (if applicable) to allow Xxxxxx and any Regulatory Authority to conduct full compliance audits or inspections relating to the Product. Further, the Parties shall make Commercially Reasonable Efforts to, within sixty (60) days following the Effective Date but in any event prior to the sale of any Product by Xxxxxx to third parties, enter into a Quality Agreement in accordance with applicable cGMP and ICH requirements and regulations, which shall include, without limitation, a Complaint management process, storage and shipment conditions and controls, product release and environmental, temperature and humidity conditions and controls, as well as roles and responsibilities in the change control process, each, as applicable. Kamada and any third party manufacturer engaged by Kamada shall ensure that the Products are manufactured in strict compliance with the Specifications. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.
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Compliance with Laws; Manufacturing. INNOCOLL shall comply in all material respects with all laws, rules and regulations applicable to the design, manufacture, labeling, packaging, storage and handling of the Product in the Territory, including maintaining qualified manufacturing and quality facilities and/or procedures. INNOCOLL shall ensure that all third-party manufacturers of any raw materials for the Product comply in all material respects with all laws, rules and regulations applicable to the design, manufacture, labeling and packaging of the Product in the Territory. Without limiting the generality of the foregoing, INNOCOLL (and all third-party manufacturers of any raw materials for Product) shall implement such quality control systems and procedures as shall be appropriate to ensure compliance with the requirements of ISO and cGMP/QSR, that are applicable to INNOCOLL or such third-party manufacturer as the manufacturer and supplier of the Product. INNOCOLL shall allow reasonable access to its records, manufacturing facilities, and its third-party manufacturers’ manufacturing facilities and records (if applicable) to allow any Regulatory Authority to conduct full compliance audits or inspections relating to the Product. Further, the parties shall make Commercially Reasonable Efforts to, within sixty (60) days following the Effective Date but in any event prior to the sale of any Product by BIOMET to third parties, enter into a Quality Agreement in accordance with applicable ISO and cGMP/QSR requirements and regulations, which shall include, without limitation, a joint complaint management process, storage and shipment conditions and controls, product release and environmental, temperature and humidity conditions and controls, as applicable. INNOCOLL and any third party manufacturer shall ensure that the Products are manufactured in strict compliance with the Specifications.
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Compliance with Laws; Manufacturing. Kamada shall comply in all material respects with all Applicable Laws and Guidelines applicable to the design, manufacture, labeling, packaging, storage, testing, release, shipping and handling of the Product in the Territory, including maintaining qualified manufacturing and quality facilities and/or procedures in accordance with EU cGMP pharmaceutical standards. Further, the Parties shall, within [*****] following the execution of this Agreement, enter into a Quality Agreement in accordance with Applicable Laws and Guidelines, which shall include, without limitation, a complaint management process, storage, and shipment conditions and controls, product release and environmental, temperature and humidity conditions and controls, as well as roles and responsibilities in the change control process, each, as applicable. Kamada and any Third Party manufacturer engaged by Kamada shall ensure that the Products are manufactured in strict compliance with the Specifications. Following receipt of the EU Centralized Approval, the Parties will review and if necessary, amend, such Quality Agreement. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.
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Compliance with Laws; Manufacturing. Ivivi (and all third-party manufacturers of the Product) shall comply in all material respects with all laws, rules and regulations applicable to the manufacture, labeling and packaging of the Product in the Marketing Territory, including maintaining qualified manufacturing and quality facilities and/or procedures. Without limiting the generality of the foregoing, Ivivi (and all third-party manufacturers of the Product) shall implement such quality control systems and procedures as shall be appropriate to (a) ensure compliance with the requirements of the International Standards Organization ("ISO") and Quality Systems Regulations ("QSR"), as applicable to Ivivi or such third-party manufacturer as the manufacturer and supplier of the Product, and (b) place the XX xxxxx on the Product in accordance with applicable law. Furthermore, Ivivi (and its third-party manufacturers of the Product) shall comply with all processes dictated by approval processes and regulations in any country in which the Product is approved for sale, including, but not limited to, FDA manufacturing, storage and handling requirements, and other government requirements. In addition, Ivivi shall allow reasonable access to its records, manufacturing facilities, and its third-party manufacturers' manufacturing facilities and records (if applicable) to allow any Government Heath Authority to conduct full compliance audits or inspections relating to the Product. Further, the parties shall make reasonable commercial efforts to, within sixty (60) days following the Effective Date but in any event prior to the sale of any Product to third parties, enter into a Quality Agreement in accordance with QSR regulations which shall include, without limitation, a joint complaint management process; storage and shipment conditions and controls; environmental, temperature and humidity conditions and controls, as applicable; a requirement to provide Allergan written documentation of Product compliance and monitoring records demonstrating continuous compliance with Product storage and shipment in accordance with Product labeling; and such other provisions as requested by Allergan or required or suggested by regulatory guidance or Allergan World Wide Quality Assurance requirements.
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Compliance with Laws; Manufacturing. (a) GeneLink shall comply in all material respects with all laws, rules and regulations applicable to the manufacture, labeling and packaging of the Products in the Territory, including maintaining qualified manufacturing and quality facilities and/or procedures. Without limiting the generality of the foregoing, GeneLink shall implement such quality control systems and procedures as shall be appropriate to ensure compliance with the requirements of ISO and GMP/QSR, as applicable to GeneLink or such third-party manufacturer as the manufacturer and supplier of the Products. Furthermore, GeneLink shall comply with all processes dictated by regulations in any country in the Territory, including, but not limited to, FDA manufacturing, storage and handling requirements, and other government requirements. In addition, GeneLink shall allow reasonable access to its records, manufacturing facilities, and shall cause any third-party manufactures to provide reasonable access to such third-party manufacturers’ manufacturing facilities and records (if applicable) to allow Licensee, the FDA and/or any government health authority in other countries in the Territory to conduct full compliance audits or inspections relating to the Products.
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Related to Compliance with Laws; Manufacturing

  • COMPLIANCE WITH LAWS IN GENERAL Company, Shareholders and Company's licensed professional employees, and the conduct of the Business and use of the Assets, have complied with all applicable laws, rules, regulations and licensing requirements, including, without limitation, the Federal Environmental Protection Act, the Occupational Safety and Health Act, the Americans with Disabilities Act and any environmental laws and medical waste laws, and there exist no violations by Company, any Shareholder or any licensed professional employee of Company of any Federal, state or local law or regulation. Company and Shareholders have not received any notice of a violation of any Federal, state and local laws, regulations and ordinances relating to the operations of the Business and Assets and no notice of any pending inspection or violation of any such law, regulation or ordinance has been received by Company.

  • Compliance with Laws, Etc Comply, and cause each of its Subsidiaries to comply with all applicable laws, rules, regulations and orders, such compliance to include, without limitation, compliance with ERISA and Environmental Laws, except where the failure to do so, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.

  • Compliance With Laws; Anti-Terrorism Laws (a) Each Credit Party is in compliance with the requirements of all applicable Laws, except for such Laws the noncompliance with which could not reasonably be expected to have a Material Adverse Effect.

  • Compliance with Laws and Policies Employee agrees that he will at all times comply with all applicable laws and all current and future lawful policies of the Company, not inconsistent with the intent of this agreement.

  • Compliance with Laws; Use The Premises shall be used for the Permitted Use and for no other use whatsoever. Tenant shall comply with all statutes, codes, ordinances, orders, rules and regulations of any municipal or governmental entity whether in effect now or later, including the Americans with Disabilities Act (“Law(s)”), regarding the operation of Tenant’s business and the use, condition, configuration and occupancy of the Premises. In addition, Tenant shall, at its sole cost and expense, promptly comply with any Laws that relate to the “Base Building” (defined below), but only to the extent such obligations are triggered by Tenant’s use of the Premises, other than for general office use, or Alterations or improvements in the Premises performed or requested by Tenant. “

  • Compliance with Law, Etc No Loan Party or any of its Subsidiaries is in violation of (i) any of its Governing Documents, (ii) any Requirement of Law, or (iii) any material term of any Contractual Obligation (including, without limitation, any Material Contract) binding on or otherwise affecting it or any of its properties, and no default or event of default has occurred and is continuing thereunder.

  • Compliance with Laws and Orders Buyer is not in violation of or in default under any Law or order applicable to Buyer or its Assets the effect of which, in the aggregate, would reasonably be expected to hinder, prevent or delay Buyer from performing its obligations hereunder.

  • Compliance with Law The Company shall make reasonable efforts to comply with all applicable federal and state securities laws; provided, however, notwithstanding any other provision of the Plan and this Agreement, the Company shall not be obligated to issue any Common Stock pursuant to this Agreement if the issuance thereof would result in a violation of any such law.

  • Compliance with Laws; Licenses (i) The businesses of each of the Company and its Subsidiaries since the Applicable Date have not been, and are not being, conducted in violation of any applicable federal, state, local, foreign or transnational law, statute or ordinance, common law, or any rule or regulation (collectively, “Laws”) or any order, judgment, injunction, ruling, writ, award or decree of any Governmental Entity (collectively, “Order”), except for such violations that would not, individually or in the aggregate, reasonably be likely to have a Company Material Adverse Effect. No investigation or review by any Governmental Entity with respect to the Company or any of its Subsidiaries is pending or, to the Knowledge of the Company, threatened, nor has any Governmental Entity indicated an intention to conduct the same, except for such investigations or reviews the outcome of which would not, individually or in the aggregate, reasonably be likely to have a Company Material Adverse Effect. Except as would not, individually or in the aggregate, reasonably be likely to have a Company Material Adverse Effect, the Company and its Subsidiaries possess each permit, license, certification, approval, registration, consent, authorization, franchise, concession, variance, exemption and order issued or granted by a Governmental Entity (collectively, “Licenses”) necessary to conduct their respective businesses, since the Applicable Date have been in compliance with all terms and conditions of such Licenses, no such Licenses are subject to any actual or possible revocation, withdrawal, suspension, cancellation, termination or modification, and since the Applicable Date have not received written notice from any Governmental Entity alleging a conflict with or breach of any License. Notwithstanding the foregoing, this Section 5.1(j) shall not apply with respect to Taxes, which shall be covered exclusively by Section 5.1(n) or Environmental Laws, which shall be covered exclusively by Section 5.1(m).

  • Compliance with Laws Comply in all material respects with the requirements of all Laws and all orders, writs, injunctions and decrees applicable to it or to its business or property, except in such instances in which (a) such requirement of Law or order, writ, injunction or decree is being contested in good faith by appropriate proceedings diligently conducted; or (b) the failure to comply therewith could not reasonably be expected to have a Material Adverse Effect.

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