Manufacturing Failure definition

Manufacturing Failure means (i) Emergent’s failure to Deliver at least fifty percent (50%) of the aggregate quantity of all Vials of Product with respect to all Binding Purchase Orders (exclusive of those Vials used as retain samples, those Vials used for the stability program as set forth in the Quality Agreement and those Vials Manufactured but not Delivered by agreement of the Parties) within a rolling twelve (12) month period in accordance with this Agreement (other than where such failure is due to a Force Majeure), provided that (a) Aptevo may only make the determination as to whether such failure has occurred during the prior twelve (12) months as of the end of a calendar quarter (i.e., as of March 31, June 30, September 30, or December 31, as applicable) and (b) Aptevo must provide Emergent notice in writing within fifteen (15) days of such determination; or (ii) a termination of this Agreement by Emergent pursuant to Section 9.2.5.
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Manufacturing Failure is defined in Section 5.12(e)(i).
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Manufacturing Failure means (i) Emergent’s failure to Deliver at least [****] of the aggregate quantity of all Vials of Product with respect to all Binding Purchase Orders (exclusive of those Vials used as retain samples, those Vials used for the stability program as set forth in the Quality Agreement and those Vials Manufactured but not Delivered by agreement of the Parties) within a rolling [****] period in accordance with this Agreement (other than where such failure is due to a Force Majeure), provided that (a) Aptevo may only make the determination as to whether such failure has occurred during the prior twelve [****] as of the [****] (i.e., as of [****], as applicable) and (b) Aptevo must provide Emergent notice in writing within [****] of such determination; or (ii) a termination of this Agreement by Emergent pursuant to Section 9.2.5.
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Examples of Manufacturing Failure in a sentence

  • Notwithstanding the foregoing, PII shall not be considered in material default under this Agreement if such material default results from a Licensed Product Manufacturing Failure.

  • Transcend, its Affiliates and their respective employees and agents shall not be entitled to the indemnities set forth in this Section 11.1 where the loss, damage or expense for which indemnification is sought was caused by a failure by Transcend to manufacture (or have manufactured) a Licensed Product in compliance with agreed-upon product specifications set forth in the Supply Agreement (a "Manufacturing Failure").

  • Should BI be found responsible for claims, losses or expenses caused by a Manufacturing Failure and not attributable to other causes for which BI is responsible, BI shall be entitled to indemnity from Transcend to the same extent as Transcend would be so entitled from BI under Section 11.1 above.

  • The Certificate of Analysis shall contain the following:• Product Lot Number• Weight in (lb/gal)• Ferric Chloride (%)• Percent (%) of Total Iron as Fe• Percent (%) of HCI• Percent (%) of Total Insoluble Matter• Specific Gravity• PH• Date of Manufacturing Failure to supply the required certificate of analysis may be grounds to reject the delivery or deliveries.

  • The Certificate of Analysis shall contain the following: Product Lot Number Weight in (lb./gal) Ferric Chloride (%) Percent (%) of Total Iron as Fe Percent (%) of HCI Percent (%) of Total Solids Specific Gravity PH Date of Manufacturing Failure to supply the required certificate of analysis may be grounds to reject the delivery or deliveries.

  • Productive work, according to Manufacturing Failure Hypothesis and the Performance of British Industry during the Long Boom’, Economic History Review, 56, 1 (2003) 1-­33.this new intellectual discourse, was at once noble, rational, and moral.

  • The Certificate of Analysis shall contain the following: • Product Lot Number • Percent (%) by weight active Chlorine • Viscosity • Specific Gravity • PH • Date of Manufacturing Failure to supply the required Certificate of Analysis at the time of each delivery may be grounds to reject said delivery.

  • Contractor shall obtain at Contractor’s expense the insurance specified in this section prior to performing under this Price Agreement and shall maintain it in full force and at its own expense throughout the duration of this Price Agreement and all warranty periods.

  • Collingwood may terminate this Agreement immediately, without penalty or further obligation to Ovamed, if Ovamed fails to achieve remediation within such [*******] period and Collingwood shall immediately be entitled to the Manufacturing Failure License.

  • The Bank may charge a special fee to the Client for taking measures described in point 4.3.8.3 of this section in the amount established in the Tariff book.

Related to Manufacturing Failure

  • Supply Failure shall have the meaning ascribed to it in Section 2.8.

  • Technical Failure means the discontinuation of Development or Commercialization of a Product for technical, scientific, medical or regulatory reasons, including, but, not limited to, unacceptable preclinical toxicity, demonstration of a side effect profile significantly worse than currently marketed products, or inability to manufacture in an acceptable purity or for an acceptable price.

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • Reporting Failure has the meaning set forth in Section 2.4.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Persistent Failure means any two (2) or more failures by the Supplier in any rolling period of twelve (12) months to comply with obligations in respect of the Contract Services under the Contract;

  • Listing Failure means the situation where the Bonds have not been listed on the corporate bond list of Nasdaq Stockholm (or any other Regulated Market) within sixty (60) calendar days after the Issue Date.

  • Consistent Failure means any of:

  • Service Level Failure means a failure to perform the Software Support Services fully in compliance with the Support Service Level Requirements.

  • MI Failure means when an MI report: a) contains any material errors or material omissions or a missing mandatory field; or b) is submitted using an incorrect MI reporting Template; or c) is not submitted by the reporting date(including where a Nil Return should have been filed);

  • Epidemic Failure means a series of repeating failures or defects resulting in at least a 0.5% failure rate for the same Product or Material during any twelve-month period.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Service Failure means a failure by the Contractor to provide the Services in accordance with any individual service level described above (measured on a monthly/quarterly/annual basis)

  • Manufacturing Process means any process for—

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Listing Failure Event means that: