Common use of QA Audit Clause in Contracts

QA Audit. During the Term, Lexicon will permit Symphony Icon’s representatives (such representatives to be identified by Symphony Icon in advance and reasonably acceptable to Lexicon and to enter into a confidentiality agreement with Lexicon) to examine and audit, during regular business hours, the work performed by Lexicon hereunder and the Lexicon facilities at which such work is conducted to determine that Lexicon Obligations are being conducted in accordance with the terms of the Agreement, the Development Plan and the Development Budget (“QA Audits”). Symphony Icon shall give Lexicon reasonable advance notice of such QA Audits specifying the scope of the audit. Symphony Icon shall reimburse Lexicon for its time associated with QA Audits; provided, however, that should a particular QA Audit reveal a material deficiency in Lexicon’s quality assurance procedures, then Lexicon will be responsible for all costs of such QA Audit, including Symphony Icon’s reasonable costs associated with such QA Audit, the work to be re-performed and the costs or expenses associated with curing such material deficiencies. Symphony Icon and Lexicon shall meet to discuss the results of the QA Audit and, if required, jointly agree upon any actions that will be required as a result of such QA Audit including defining material deficiencies to be addressed. Lexicon shall make commercially reasonable efforts to reconcile all such deficiencies found by Symphony Icon during such QA Audit.

Appears in 1 contract

Sources: Research and Development Agreement (Lexicon Pharmaceuticals, Inc./De)

QA Audit. During the Term, Lexicon Alexza will permit Symphony IconAllegro’s representatives (such representatives to be identified by Symphony Icon Allegro in advance and reasonably acceptable to Lexicon Alexza and to enter into a confidentiality agreement with LexiconAlexza) to examine and audit, during regular business hours, the work performed by Lexicon Alexza hereunder and the Lexicon Alexza facilities at which such work is conducted to determine that Lexicon Obligations are the project assignment is being conducted in accordance with the terms of the Agreement, the Development Plan and the Development Budget agreed upon services (“QA Audits”). Symphony Icon Allegro shall give Lexicon Alexza reasonable advance notice of such QA Audits specifying the scope of the audit. Symphony Icon Allegro shall reimburse Lexicon Alexza for its time associated with QA Audits; provided, however, that should a particular QA Audit reveal a material deficiency in LexiconAlexza’s quality assurance procedures, then Lexicon Alexza will be responsible for all costs of such QA Audit, including Symphony IconAllegro’s reasonable costs associated with such QA Audit, the work to be re-performed and the costs or expenses associated with curing such material deficiencies. Symphony Icon Allegro and Lexicon Alexza shall meet to discuss the results of the QA Audit and, if required, jointly agree upon any actions that will be required as a result of such QA Audit including defining material deficiencies to be addressed. Lexicon Alexza shall make commercially reasonable efforts to reconcile all such deficiencies found by Symphony Icon Allegro during such QA Audit.

Appears in 1 contract

Sources: Research and Development Agreement (Alexza Pharmaceuticals Inc.)

QA Audit. During the Term, Lexicon Isis will permit Symphony Icon’s representatives (GenIsis’ representatives, such representatives to be identified by Symphony Icon GenIsis in advance and reasonably acceptable to Lexicon and to enter into a confidentiality agreement with Lexicon) Isis, to examine and audit, during regular business hours, audit the work performed by Lexicon Isis hereunder and the Lexicon Isis facilities at which such work is conducted to determine that Lexicon Obligations are the project assignment is being conducted in accordance with the terms of the Agreement, the Development Plan and the Development Budget agreed upon services (“QA Audits”)) during regular business hours. Symphony Icon GenIsis shall give Lexicon Isis reasonable advance notice of such QA Audits specifying the scope of the audit. Symphony Icon GenIsis shall reimburse Lexicon Isis for its time associated with QA Audits; provided, however, that should a particular QA Audit reveal a material deficiency in Lexicon’s quality assurance proceduresdeficiency, then Lexicon Symphony GenIsis will not be responsible for all costs of such QA Audit, including Symphony Icon’s reasonable costs associated with such QA Audit, the work to be re-performed and or the costs or expenses associated with curing such any material deficiencies. Symphony Icon GenIsis and Lexicon Isis shall meet to discuss the results of the QA Audit and, if required, jointly agree upon any actions that will be required as a result of such QA Audit audits including defining material deficiencies to be addressed. Lexicon Isis shall make commercially reasonable efforts to reconcile all such deficiencies found by Symphony Icon GenIsis during such QA Audit.

Appears in 1 contract

Sources: Research and Development Agreement (Isis Pharmaceuticals Inc)

QA Audit. During the Term, Lexicon Exelixis will permit Symphony IconEvolution’s representatives (representatives, such representatives to be identified by Symphony Icon Evolution in advance and reasonably acceptable to Lexicon and Exelixis, to enter into a confidentiality agreement with Lexicon) to examine and audit, during regular business hours, audit the work performed by Lexicon Exelixis hereunder and the Lexicon Exelixis facilities at which such work is conducted to determine that Lexicon Obligations are the project assignment is being conducted in accordance with the terms of the Agreement, the Development Plan and the Development Budget agreed upon services (“QA Audits”), which review will last no more than eight (8) hours during regular business hours and will take place no more than once per year unless (i) there are significant changes to Exelixis’ Standard Operating Procedures, which may require additional QA Audits or (ii) the Development Committee determines additional QA Audits are necessary. Symphony Icon Evolution shall give Lexicon Exelixis reasonable advance notice of such QA Audits specifying the scope of the audit, which shall not include work that has previously undergone QA Audits. Symphony Icon Evolution shall reimburse Lexicon Exelixis for its time associated with QA Audits; provided, however, that should a particular QA Audit reveal a material deficiency in Lexicon’s quality assurance proceduresthe work performed, then Lexicon Symphony Evolution will not be responsible for all costs of such QA Audit, including Symphony Icon’s reasonable costs associated with such QA Audit, the work to be re-performed and or the costs or expenses associated with curing such any material deficiencies. Symphony Icon Evolution and Lexicon Exelixis shall meet to discuss the results of the QA Audit and, if required, jointly agree upon any actions that will be required as a result of such QA Audit audits including defining material deficiencies to be addressed. Lexicon Exelixis shall make commercially reasonable efforts to reconcile all such deficiencies found by Symphony Icon Evolution during such QA Audit.

Appears in 1 contract

Sources: Research and Development Agreement (Exelixis Inc)

QA Audit. During the Term, Lexicon Dynavax will permit Symphony IconDynamo’s representatives (representatives, such representatives to be identified by Symphony Icon Dynamo in advance and reasonably acceptable to Lexicon and to enter into a confidentiality agreement with Lexicon) Dynavax, to examine and audit, during regular business hours, audit the work performed by Lexicon Dynavax hereunder and the Lexicon Dynavax facilities at which such work is conducted to determine that Lexicon Obligations are the project assignment is being conducted in accordance with the terms of the Agreement, the Development Plan and the Development Budget agreed upon services (“QA Audits”)) during regular business hours. Symphony Icon Dynamo shall give Lexicon Dynavax reasonable advance notice of such QA Audits specifying the scope of the audit. Symphony Icon Dynamo shall reimburse Lexicon Dynavax for its time associated with QA Audits; provided, however, that should a particular QA Audit reveal a material deficiency in Lexicon’s quality assurance proceduresthe work performed, then Lexicon Symphony Dynamo will not be responsible for all costs of such QA Audit, including Symphony Icon’s reasonable costs associated with such QA Audit, the work to be re-performed and or the costs or expenses associated with curing such any material deficiencies. Symphony Icon [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Dynamo and Lexicon Dynavax shall meet to discuss the results of the QA Audit and, if required, jointly agree upon any actions that will be required as a result of such QA Audit audits including defining material deficiencies to be addressed. Lexicon Dynavax shall make commercially reasonable efforts to reconcile all such deficiencies found by Symphony Icon Dynamo during such QA Audit.

Appears in 1 contract

Sources: Research and Development Agreement (Dynavax Technologies Corp)