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...
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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.
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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.
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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.
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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.]
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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.
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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, [*]
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Related to CROSS CONTAMINATION

  • Contamination The presence in, on or under land, air or water of a substance (whether a solid, liquid, gas, odour, heat, sound, vibration or radiation) at a concentration above the concentration at which the substance is normally present in, on or under land, air or water in the same locality, that presents a risk of Environmental Harm, including harm to human health or any other aspect of the Environment, or could otherwise give rise to a risk of non-compliance with any Statutory Requirement for the protection of the Environment.

  • Hazardous Materials; Remediation (a) If any material release or disposal of Hazardous Materials shall occur or shall have occurred on any real property or any other assets of any Borrower or any other Credit Party, such Credit Party will cause the prompt containment and removal of such Hazardous Materials and the remediation of such real property or other assets as is necessary to comply with all applicable Environmental Laws and Healthcare Laws and to preserve the value of such real property or other assets. Without limiting the generality of the foregoing, each Credit Party shall comply in all material respects with each Environmental Law and Healthcare Law requiring the performance at any real property by any Borrower or any other Credit Party of activities in response to the release or threatened release of a Hazardous Material. (b) Credit Parties will provide Agent within thirty (30) days after written demand therefor with a bond, letter of credit or similar financial assurance evidencing to the reasonable satisfaction of Agent that sufficient funds are available to pay the cost of removing, treating and disposing of any Hazardous Materials or Hazardous Materials Contamination and discharging any assessment which may be established on any property as a result thereof, such demand to be made, if at all, upon Agent’s reasonable business determination that the failure to remove, treat or dispose of any Hazardous Materials or Hazardous Materials Contamination, or the failure to discharge any such assessment could reasonably be expected to have a Material Adverse Effect.

  • Dangerous Materials Tenant shall not keep or have on the Premises any article or thing of a dangerous, flammable, or explosive character that might substantially increase the danger of fire on the Premises, or that might be considered hazardous by a responsible insurance company, unless the prior written consent of Landlord is obtained and proof of adequate insurance protection is provided by Tenant to Landlord.

  • Hazardous Material Contractor shall not permit any Hazardous Material (as defined below) to be located, used, incorporated into the Work or brought onto the Job Site in connection with the Work unless (i) absolutely necessary because no alternative is available, (ii) the precise nature and quantity of the Hazardous Material is specified in writing to Owner, (iii) the prior written approval of Owner is obtained, and (iv) Contractor complies with all Laws and prudent business practices concerning the Hazardous Material required. If Contractor encounters any material it reasonably believes to be Hazardous Material, or becomes aware of any incident involving Hazardous Material at the Job Site, Contractor shall immediately stop the Work in the area so affected and shall immediately report the same to Owner. Contractor shall also immediately notify Owner of any notice Contractor receives concerning the presence or use of Hazardous Material at the Job Site. Contractor shall be liable for all on and off-site disposal or transport of Hazardous Material (and shall sign any manifest for the transport or storage of such Hazardous Material), and for any discharge, release, injury to any person, or injury or damage to any property resulting from use of Hazardous Material in the performance of the Work. Contractor shall, at its expense, cause the removal of the Hazardous Material and remedy any associated problems in accordance with applicable Laws and prudent business practices. "Hazardous Material" shall mean (1) any Hazardous Material as defined under the Comprehensive Environmental Response, Compensation and Liability Act of 1980, the Resource Conservation and Recovery Act, or under any applicable state or local Laws, (2) any substance or matter that results in liability to any person or entity from discharge of or exposure to such substance or matter under any statutory or common law theory, (3) pesticides, asbestos, formaldehyde, polychlorinated biphenyl, solvents, petroleum and motor fuel hydrocarbon material, and (4) any other substance or matter that becomes subject to any federal, state or local agency order or requirement for removal, treatment or remedial action. To the extent permitted by Law, and without in any way limiting any other indemnity obligation under this Agreement, Contractor shall indemnify, defend (at Contractor's sole cost and with legal counsel acceptable to Owner) and hold Owner and their respective officers, directors, agents, employees, representatives, shareholders, partners, affiliates, successors and assigns harmless, from and against any and all claims, losses, costs or liabilities arising out of an incurred connection with removing or remediating any Hazardous Materials on or about the Job Site or transported on, to, from or about the Job Site by Contractor. This indemnity shall be effective during and after completion of the Work.

  • Hazardous Substance The term “Hazardous Substance” shall mean any hazardous or toxic substances, materials or wastes, or pollutants or contaminants as defined, listed or regulated by any Environmental Law or by common law decision including, without limitation, chlorinated solvents; petroleum products or by products; asbestos; and polychlorinated biphenyl.