CROSS CONTAMINATION. If ARIAD wishes to have a Third Party that is not an Approved Manufacturer as of the Effective Date become an Approved Manufacturer of API or Clinical Product or any intermediate of API or Clinical Product as set forth in Section 2.5(b), ARIAD shall either (a) advise the JMC that such Third Party is not producing, packaging, labeling, warehousing, quality control testing (including in-process, release and stability testing), releasing or shipping any chemical entity classified as “Restricted Category" at the facility at which it will Manufacture API or Clinical Product or any intermediate of API or Clinical Product, or (b) if "Restricted Category" chemical entities are used to produce, package, label, warehouse, quality control test (including in-process, release and stability testing), release or ship at the Facility at which it will Manufacture API or Clinical Product or any intermediate of API or Clinical Product, notify the JMC in writing and provide a declaration from the Third Party that such use (i) complies with all applicable cGMP requirements, (ii) will cause no potential problem of cross-contamination with API or Clinical Product, and (iii) will not violate any applicable Specified Regulatory Requirements that would prohibit such use in such facility. If requested, ARIAD will obtain from the Third Party and will provide to the JMC a summary of the Third Party’s procedures, controls, and cleaning methods that will be implemented to address any cross-contamination issues, as well as such other reasonable information (excluding any third party confidential information which the Third Party is not permitted to disclose after it has used reasonable efforts to obtain such permission) to allow the JMC to also assess whether the use at such facility of any chemical entity classified within the Restricted Category will potentially present any cross-contamination issue for the API or Clinical Product and could be in violation of Specified Regulatory Requirements. In the event the JMC identifies a potential problem of cross-contamination or with Specified Regulatory Requirements that would prohibit the activity, the JMC will meet to implement further measures (procedural or segregation) that may be necessary to address potential cross-contamination issues. Notwithstanding the foregoing, neither ARIAD nor its Approved Manufacturers shall manufacture, formulate or package API or Clinical Product in any facility that the JMC reasonably determines to present cross-contamination problems for API or Clinical Product. Any planned changes regarding the use of "Restricted Category" chemical entities within any Facility will be notified to MERCK through the agreed change control processes set forth in Section 8.4. "Restricted Categories" means any [***] or other [***] such as [***], or other [***] in the Facilities. The term “Live Agent” means a [***] a [***] that [***], including, but not limited to, [***].
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CROSS CONTAMINATION. If ARIAD MERCK wishes to have a Third Party that is not an Approved Manufacturer as of the Effective Date become an Approved Manufacturer of API Marketed Product or Clinical MERCK Product or any intermediate of API Marketed Product or Clinical MERCK Product as set forth in Section 2.5(b), ARIAD MERCK shall either (a) advise the JMC that such Third Party is not producing, packaging, labeling, warehousing, quality control testing (including in-process, release and stability testing), releasing or shipping any chemical entity classified as “Restricted Category" at the facility at which it will Manufacture API Marketed Product or Clinical MERCK Product or any intermediate of API Marketed Product or Clinical MERCK Product, or (b) if "Restricted Category" chemical entities are used to produce, package, label, warehouse, quality control test (including in-process, release and stability testing), release or ship at the Facility at which it will Manufacture API Marketed Product or Clinical MERCK Product or any intermediate of API Marketed Product or Clinical MERCK Product, notify the JMC in writing and provide a declaration from the Third Party that such use (i) complies with all applicable cGMP requirements, (ii) will cause no potential problem of cross-contamination with API Marketed Product or Clinical MERCK Product, and (iii) will not violate any applicable Specified Regulatory Requirements that would prohibit such use in such facility. If requested, ARIAD MERCK will obtain from the Third Party and will provide to the JMC a summary of the Third Party’s procedures, controls, and cleaning methods that will be implemented to address any cross-contamination issues, as well as such other reasonable information (excluding any third party confidential information which the Third Party is not permitted to disclose after it has used reasonable efforts to obtain such permission) to allow the JMC to also assess whether the use at such facility of any chemical entity classified within the Restricted Category will potentially present any cross-contamination issue for the API Marketed Product or Clinical MERCK Product and could be in violation of Specified Regulatory Requirements. In the event the JMC identifies a potential problem of cross-contamination or with Specified Regulatory Requirements Authority requirements that would prohibit the activity, the JMC will meet to implement further measures (procedural or segregation) that may be necessary to address potential cross-contamination issues. Notwithstanding the foregoing, neither ARIAD MERCK nor its Approved Manufacturers shall manufacture, formulate or package API Marketed Product or Clinical MERCK Product in any facility that the JMC reasonably determines to present cross-contamination problems for API Marketed Product or Clinical MERCK Product. Any planned changes regarding the use of "Restricted Category" chemical entities within any Facility will be notified to MERCK ARIAD through the agreed change control processes set forth in Section 8.4. "Restricted Categories" means any [***] or other [***] such as [***], or other [***] in the Facilities. The term “Live Agent” means a [***] a [***] that [***], including, but not limited to, [***], and [***].
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