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.
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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. 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. (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. (b) GeneLink shall notify Licensee within three (3) business days of the commencement of any FDA or other regulatory authority (“Regulatory Authority”) inspection or notice of inspection of its facilities directly relating to the Products. GeneLink shall notify Licensee within three (3) business days of any FDA or other Regulatory Authority investigation relating to the Products. GeneLink shall provide to Licensee copies of any FDA Form 483s, Warning Letters, or the like from applicable Regulatory Authorities within five (5) business days of receipt, and shall provide to Licensee any proposed responses to 483s, Warning Letters, or the like for review and comment when directly related to the Products, and in advance of supplying them to the Regulatory Authority. GeneLink shall provide copies to Licensee of any subsequent responses to FDA Form 483 findings, or the like, relating to the Products within ten (10) business days of supplying them to the Regulatory Authority. GeneLink shall notify Licensee within three (3) business days of any Regulatory Authority request for Product samples or Product batch records. GeneLink shall notify Licensee of any requests for information, notices of violations or other communication from a Regulatory Aut...
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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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Related to Compliance with Laws; Manufacturing

  • 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 and Policies In carrying out the terms of this Agreement, both Parties shall comply with all applicable federal, state and local laws, regulations and rules, DSRIP Requirements, and the CNYCC Compliance Program.

  • 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 Laws and Rules Applicant shall comply with all statutes, regulations, and ordinances of all local, state and federal jurisdictions concerning the use of the Property. In addition, the City shall have the right to adopt reasonable rules concerning the use of the Property and Applicant shall comply with the rules.

  • 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 (i) Neither the Assuming Institution nor any of its Subsidiaries is in violation of any statute, regulation, order, decision, judgment or decree of, or any restriction imposed by, the United States of America, any State, municipality or other political subdivision or any agency of any of the foregoing, or any court or other tribunal having jurisdiction over the Assuming Institution or any of its Subsidiaries or any assets of any such Person, or any foreign government or agency thereof having such jurisdiction, with respect to the conduct of the business of the Assuming Institution or of any of its Subsidiaries, or the ownership of the properties of the Assuming Institution or any of its Subsidiaries, which, either individually or in the aggregate with all other such violations, would materially and adversely affect the business, operations or condition (financial or otherwise) of the Assuming Institution or the ability of the Assuming Institution to perform, satisfy or observe any obligation or condition under this Agreement. (ii) Neither the execution and delivery nor the performance by the Assuming Institution of this Agreement will result in any violation by the Assuming Institution of, or be in conflict with, any provision of any applicable law or regulation, or any order, writ or decree of any court or governmental authority.

  • Compliance with Laws; Licenses (a) The Company, each of the Retained Subsidiaries and the Retained Business since the Applicable Date has not been, and is 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, including the Export and Sanctions Regulations (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 expected to have a Company Material Adverse Effect. To the Knowledge of the Company, no investigation or review by any Governmental Entity with respect to the Company, the Retained Subsidiaries or the Retained Business is pending or, as of the date of this Agreement, 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 expected to have a Company Material Adverse Effect. Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, after giving effect to the Separation, the Company and the Retained 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 the Retained Business as it is conducted as of the date of this Agreement. (b) Section 3.10(b) of the Company Disclosure Letter sets forth a complete and accurate list, as of the date of this Agreement, of (A) each License that is issued or granted by the FCC to the Company or any of its Subsidiaries that is material to the conduct of the Retained Business as it is conducted as of the date of this Agreement (each, a “RemainCo FCC License”), (B) each License that is issued or granted by a Foreign Regulator to the Company or any of its Subsidiaries that is material to the conduct of the Retained Business as it is conducted as of the date of this Agreement (each, a “RemainCo Foreign License”), and (C) all Licenses (other than the RemainCo FCC Licenses and the RemainCo Foreign Licenses) issued or granted to the Company or any of its Subsidiaries that is material to the conduct of the Retained Business as it is conducted as of the date of this Agreement by any Governmental Entity, authorizing the Company or any of its Subsidiaries to provide broadcasting and/or audio-visual media services, and/or own, operate or install broadcasting and/or audio-visual media networks and facilities, including satellites, or to use radio frequencies, excluding, in each case, any License that is material to the conduct of the Retained Business as conducted as of the date of this Agreement solely because of an existing television programming distribution arrangement between the Retained Business and the SpinCo Business (collectively with the RemainCo FCC Licenses and the RemainCo Foreign Licenses, the “RemainCo Communications Licenses”). Each of the Company and its Subsidiaries is in compliance with the RemainCo Communications Licenses and the rules and regulations of the Governmental Entities issuing such RemainCo Communications Licenses, except for failures to comply that are, individually and in the aggregate, not material to the Retained Business, taken as a whole. There is not pending or, to the Knowledge of the Company, threatened before the FCC or a Foreign Regulator or any other Governmental Entity, any material proceeding, notice of violation, order of forfeiture, inquiry, administrative action, complaint or investigation (A) against the Company or any of its Subsidiaries relating to the Retained Business, (B) relating to any of the RemainCo Communications Licenses, including any such proceeding, notice, order, inquiry, action, complaint or investigation reasonably likely to result in the revocation, suspension, cancellation, rescission or modification of any material RemainCo Communications License or other impairment in any material respect of the operation of the Retained Business as it is conducted as of the date of this Agreement, except (x) proceedings to amend the Communications Laws not directed at the Company or its Subsidiaries or (y) proceedings of general applicability to the broadcasting and/or audio-visual media services industries or (C) that would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. Except for restrictions or conditions that appear on the face of the RemainCo Communications Licenses, and except for restrictions or conditions that pertain to the RemainCo FCC Licenses under generally applicable rules of the FCC, to the Knowledge of the Company, no RemainCo Communications License held by the Company or any Subsidiary of the Company is subject to any restriction or condition which would limit the operation of the Retained Business as it is conducted as of the date of this Agreement, except for failures to comply that individually or in the aggregate would not be materially adverse to the Retained Business taken as a whole. (c) Except as would not be materially adverse to the Retained Business taken as a whole: (i) The Company, its Subsidiaries and, to the Knowledge of the Company, their respective officers, directors, employees and agents are in compliance in with and since the Applicable Date have complied with: (A) the provisions of the U.S. Foreign Corrupt Practices Act of 1977, as amended (15 U.S.C. § 78dd-1, et seq.) (“FCPA”) to the extent applicable to the Company, its Subsidiaries and such officers, directors, employees and agents, and (B) the provisions of applicable anti-bribery, anti-corruption and anti-money laundering Laws of each jurisdiction in which the Company and its Subsidiaries operate or have operated. Since the Applicable Date, to the Knowledge of the Company, the Company, its Subsidiaries and/or their respective officers, directors, employees and agents have not paid, offered or promised to pay, or authorized or ratified the payment, directly or indirectly, of any monies or anything of value to any national, provincial, municipal or other Government Official or any political party or candidate for political office for the purpose of corruptly influencing any act or decision of such official or of the government to obtain or retain business, or direct business to any person or to secure any other improper benefit or advantage, in each case in violation of any of the FCPA or any Laws described in clause (B). (ii) The Company and its Subsidiaries have instituted and maintain policies and procedures reasonably designed to ensure compliance with the FCPA and other anti-bribery, anti-corruption and anti-money laundering Laws in each jurisdiction in which the Company and its Subsidiaries operate. (iii) Neither the Company nor any of its Subsidiaries are subject to any actual, pending civil, criminal, or administrative actions, suits, demands, claims, hearings, notices of violation, investigations, proceedings, demand letters, settlements, or enforcement actions, or made any voluntary disclosures to any Governmental Entity, involving the Company or any of its Subsidiaries relating to the FCPA or any other anti-bribery, anti-corruption or anti-money laundering Laws

  • 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.

  • Compliance with Laws and Regulations A. The Parties shall comply with all applicable laws and regulations including, but not limited to, safety; security; export control; environmental; and suspension and debarment laws and regulations. Access by a Partner to NASA facilities or property, or to a NASA Information Technology (IT) system or application, is contingent upon compliance with NASA security and safety policies and guidelines including, but not limited to, standards on badging, credentials, and facility and IT system/application access. B. With respect to any export control requirements: 1. The Parties will comply with all U.S. export control laws and regulations, including the International Traffic in Arms Regulations (ITAR), 22 C.F.R. Parts 120 through 130, and the Export Administration Regulations (EAR), 15 C.F.R. Parts 730 through 799, in performing work under this Agreement or any Annex to this Agreement. In the absence of available license exemptions or exceptions, the Partner shall be responsible for obtaining the appropriate licenses or other approvals, if required, for exports of hardware, technical data and software, or for the provision of technical assistance. 2. The Partner shall be responsible for obtaining export licenses, if required, before utilizing foreign persons in the performance of work under this Agreement or any Annex under this Agreement, including instances where the work is to be performed on-site at NASA and where the foreign person will have access to export-controlled technical data or software. 3. The Partner will be responsible for all regulatory record-keeping requirements associated with the use of licenses and license exemptions or exceptions. 4. The Partner will be responsible for ensuring that the provisions of this Article apply to its Related Entities. C. With respect to suspension and debarment requirements: 1. The Partner hereby certifies, to the best of its knowledge and belief, that it has complied, and shall comply, with 2 C.F.R. Part 180, Subpart C, as supplemented by 2 C.F.R. Part 1880, Subpart C. 2. The Partner shall include language and requirements equivalent to those set forth in subparagraph C.1., above, in any lower-tier covered transaction entered into under this Agreement.

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