CROSS CONTAMINATION Sample Clauses
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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 c...
CROSS CONTAMINATION. Sampling may result in unavoidable cross-contamination of subsurface areas, such as when a probe or boring penetrates through a contaminated area into an aquifer, underground stream, or other hydrous body not previously contaminated. Client acknowledges and understands that ARRO cannot, despite exercising due care, completely eliminate this risk. Because sampling is an essential element of the Phase II environmental services covered by this Agreement and can expose ARRO to considerable risks, Client agrees, to the maximum extent permitted by law, to waive any claim against ARRO and agrees to defend, indemnify, and hold ARRO harmless from any damage, claim, liability, or cost, including reasonable attorneys’ fees and costs of defense, for injury or loss which may arise out of or result from any cross-contamination allegedly caused by sampling or performance of services under this Agreement or related in any manner whatsoever to the existence, identification, release, or disposal of hazardous or toxic substances, except those damages, liabilities or costs arising directly from the sole negligence or willful misconduct of ARRO.
CROSS CONTAMINATION. NASTECH hereby declares that as of the date of execution of this AGREEMENT it is not producing, packaging, labeling, warehousing, quality control testing (including in-process, release and stability testing), releasing or shipping any chemical entity classified as penicillins or other beta-lactam antibiotics such as cephalosporins or carbapenems, steroids, hormones, alkaloids, controlled substances, LIVE AGENTS, cytotoxic drug substances, pesticides, herbicides, fungicides, or other toxic non-drug substances in the FACILITY. The term "LIVE AGENT" means a product containing a living organism that causes infectious disease, including, but not limited to, viruses, bacteria, rickettsia, fungi, and protozoa. In the event that NASTECH intends, during the course of this AGREEMENT, to produce, package, label, warehouse, quality control test (including in-process, release and stability testing), release or ship any chemical entity belonging to the classes of products listed above, NASTECH shall promptly notify MERCK in writing of its intention to do so in order to allow MERCK to consider any potential questions of cross-contamination or regulatory requirements. In the event MERCK identifies a potential problem of cross-contamination or regulatory requirements that would prohibit the activity, the parties will meet to resolve the problem. Notwithstanding the foregoing, NASTECH shall not manufacture, formulate or package products in the FACILITY that MERCK considers to present cross-contamination problems for PRODUCT.
CROSS CONTAMINATION. In order to minimize the risk of cross-contamination of Product with another product at the Lonza Facility, during the period of time that Lonza is processing any Bulk Drug in any of the existing bioreactors at the Lonza Facility, Lonza shall not introduce or process any other product in the fourth bioreactor after the process piping of such fourth bioreactor is connected to the existing bioreactors.
CROSS CONTAMINATION. NASTECH hereby declares that as of the date of execution of this AGREEMENT it is not producing, packaging, labeling, warehousing, quality control [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
CROSS CONTAMINATION. Prevent animal to animal transmission of infectious agents during collection of specimens by taking appropriate precautions in these studies. New pairs of disposable gloves and covers for work benches shall be required for each animal every time a specimen is collected. Clean/new protective barrier clothing as specified in 5b, above shall be required daily and on each different procedure. Separate sets of sterile instruments shall be required for collection of each specimen.
CROSS CONTAMINATION. Except as set forth on Schedule 6.13, SURMODICS hereby declares that as of the date of execution of this Agreement neither it nor its Contract Manufacturers is producing, packaging, labeling, warehousing, quality control testing (including in-process, release and stability testing), releasing or shipping any chemical entity classified as [*] In the event that SURMODICS or its Contract Manufacturers intends, during the course of this Agreement, to produce, package, label, warehouse, quality control test (including in-process, release and stability testing), release or ship any chemical entity belonging to the classes of products listed above, SURMODICS shall promptly notify MERCK in writing of its or its Contract Manufacturers’ intention to do so in order to allow MERCK to consider any potential questions relating to cross-contamination or Regulatory Authority requirements. SURMODICS acknowledges that MERCK has not had the opportunity to fully assess the matters disclosed on Schedule 6.13 and that further measures (procedural or segregation) beyond those described in Schedule 6.13 may be necessary to address potential cross-contamination issues relating to the I-vation Products. In the event MERCK identifies a potential problem of cross-contamination or with Regulatory Authority requirements that would prohibit the activity, [*]