Common use of Manufacturing Practices Clause in Contracts

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. Halozyme shall notify Intrexon in the event it agrees to modify the specifications for PH20 Drug being provided to any of its other licensees. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. 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 as it may be in effect at the time. 7.2.3 Subject to Section 7.2.1, Halozyme shall [*****]. 7.2.4 Intrexon 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 Intrexon with certificates of analysis for all API supplied hereunder based upon a reference standard established by Halozyme in accordance with all applicable rules and regulations and reasonably acceptable to Intrexon. 7.2.6 Upon the reasonable request of Intrexon, Halozyme shall provide Intrexon with such information, including analytical and manufacturing documentation, batch records for API and stability data, in each case requested by Intrexon 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.