Manufacturing Practices. 7.2.1 Halozyme shall manufacture, or have manufactured, API under this Article 7 in conformity with the API Specifications and in accordance with all applicable laws and regulations. The API Specifications shall not be amended without the prior written consent of both parties. 7.2.2 Unless the parties otherwise mutually agree or except as otherwise contemplated by this Agreement, Halozyme shall manufacture, or have manufactured, API under this Article 7 in accordance with cGMP. 7.2.3 Subject to Section 7.2.1, Halozyme shall ***. 7.2.4 ViroPharma shall have the right, at its sole expense, to audit Halozyme and its CMO of PH20 Drug for compliance with applicable laws and regulations and GMP on reasonable notice during normal business hours and not more than once in each calendar year, subject to reasonable confidentiality obligations. 7.2.5 Halozyme shall provide ViroPharma with certificates of analysis for all API supplied hereunder based upon a reference standard established by Halozyme and reasonably acceptable to ViroPharma. 7.2.6 Upon the reasonable request of ViroPharma, Halozyme shall provide ViroPharma with such information, including analytical and manufacturing documentation, batch records for API and stability data, in each case requested by ViroPharma regarding quality control of API supplied under this Article 7. 7.2.7 All information disclosed or obtained pursuant to this Article 7 shall be Confidential Information of Halozyme.
Appears in 3 contracts
Sources: Collaboration and License Agreement, Licensing Agreement, Collaboration and License Agreement (Viropharma Inc)