Common use of Governmental Agencies Clause in Contracts

Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Products, regarding the Products if, in the opinion of that party’s counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

Appears in 4 contracts

Samples: Manufacturing Services Agreement (Orexigen Therapeutics, Inc.), Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.), Product Agreement (Horizon Pharma, Inc.)

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Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval Regulatory Approval for the Products, regarding the Products if, in the opinion of that party’s 's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

Appears in 4 contracts

Samples: Services Agreement (Evoke Pharma Inc), Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement (Indivior PLC)

Governmental Agencies. Subject to Section 7.87.7, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Products, regarding the such Products if, if in the opinion of that party’s 's counsel, the such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless; provided, however, that unless in the reasonable opinion of its counsel, counsel there is a legal prohibition against doing so, a such party will shall permit the other party to accompany and take part in any communications with the agency, and to receive copies of all such communications to and/or from the agency.

Appears in 2 contracts

Samples: Manufacturing Services Agreement (Critical Therapeutics Inc), Manufacturing Services Agreement (Critical Therapeutics Inc)

Governmental Agencies. Subject to Section 7.87.8 and Article 11, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval Regulatory Approval for the Productsapplicable Product, regarding the Products such Product if, in the opinion of that party’s 's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a each party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

Appears in 2 contracts

Samples: Product Agreement (Jazz Pharmaceuticals PLC), Product Agreement (Jazz Pharmaceuticals PLC)

Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Products, regarding the Products if, in the opinion of that party’s 's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

Appears in 2 contracts

Samples: Product Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Raptor Pharmaceutical Corp)

Governmental Agencies. Subject to Section 7.87.7, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Products, regarding the such Products if, if in the opinion of that party’s counsel, the such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless; provided, however, that unless in the reasonable opinion of its counsel, counsel there is a legal prohibition against doing so, a such party will shall permit the other party to accompany and take part in any communications with the agency, and to receive copies of all such communications from the agency.

Appears in 2 contracts

Samples: Manufacturing Services Agreement (Avanir Pharmaceuticals), Manufacturing Services Agreement (New River Pharmaceuticals Inc)

Governmental Agencies. Subject to Section 7.87.9, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval Regulatory Approval for the Products, regarding the Products if, in the opinion of that party’s counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

Appears in 1 contract

Samples: Product Agreement (Neurocrine Biosciences Inc)

Governmental Agencies. Subject to Section 7.8, each party may communicate with any Regulatory Authority or other governmental agency, or regulatory entity including but not limited to governmental agencies responsible for granting regulatory approval Regulatory Approval for the Products, regarding the Products if, in the opinion of that party’s counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against Unless prohibited from doing so, a each party will permit share with the other party to accompany and take part in any copies of communications with the agency, and agency as they are relevant to receive copies of all communications from the agencyother party’s activities.

Appears in 1 contract

Samples: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)

Governmental Agencies. Subject to Section 7.88(h), each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Products, regarding the Products if, in the opinion of that party’s counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Aptevo Therapeutics Inc.)

Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Products, regarding the such Products if, if in the opinion of that party’s counsel, the such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless; provided, however, that unless in the reasonable opinion of its counsel, counsel there is a legal prohibition against doing so, a such party will shall permit the other party to accompany and take part in any communications with the agency, and to receive copies of all such communications from the agency.

Appears in 1 contract

Samples: Product Agreement (Avadel Pharmaceuticals PLC)

Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Products, regarding the Products if, in the opinion of that party’s 's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.. ***Confidential Treatment Requested

Appears in 1 contract

Samples: Manufacturing Services Agreement (Horizon Pharma PLC)

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Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Products, regarding the Products if, in the opinion of that party’s 's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is Is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Egalet Corp)

Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Products, regarding the Products if, in the opinion of that party’s counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED Standard Form (PPI, April 2, 2010)

Appears in 1 contract

Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)

Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the ProductsRegulatory Authorities , regarding the Products if, in the opinion of that party’s 's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agencyagency and to review and provide comments on any responses to the communications.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Pozen Inc /Nc)

Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agencyagency regarding the Products, including including, but not limited to governmental agencies Regulatory Authorities responsible for granting regulatory approval Regulatory Approval for the Products, regarding the Products if, in the reasonable opinion of that party’s 's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulationApplicable Laws. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a Each party will permit shall promptly notify the other party of such communications regarding the Products, and upon request, shall provide copies to accompany and take part in the other party of any such written communications with the agency, and to receive copies of all communications from the agencygovernment agencies.

Appears in 1 contract

Samples: Product Agreement (TESARO, Inc.)

Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agencyAuthority, including but not limited to governmental agencies responsible for granting regulatory approval for the ProductsRegulatory Authorities, regarding the Products if, in the opinion of that this party’s 's counsel, the such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulationApplicable Laws. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Acorda Therapeutics Inc)

Governmental Agencies. Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval Regulatory Approval for the Products, regarding the Products if, in the opinion of that party’s counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

Appears in 1 contract

Samples: Product Agreement (ChemoCentryx, Inc.)

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