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 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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Manufacturing Failure is defined in Section 5.12(e)(i).
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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.

  • 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.

  • If the Recall is contributed to by both CMC’s Manufacturing Failure and Customer Failure then CMC shall be liable for a proportion of the reasonable Commercial Supply Agreement – JUNE 2011 56 documented expenses actually and reasonably incurred by Customer in undertaking the Recall of those specific Products to the extent caused by CMC’s Manufacturing Failure subject to the provisions of Clause 12.10.

  • 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.

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

Related to Manufacturing Failure

  • Supply Failure has the meaning provided in Section 2.11.

  • Technical Failure means a failure of the court's hardware, software, and/or telecommunications facility which results in the impossibility of submitting a file electronically. Technical failure does not include malfunctioning of the equipment of the person submitting an e-file.

  • 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 all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • 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.

  • Automated drug dispensing system means a mechanical or electronic system that performs

  • 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 of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • 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.