Product Technical Complaints and Recalls Sample Clauses

Product Technical Complaints and Recalls. (a) King shall have the sole authority and responsibility to respond to any regulatory agencies, including without limitation the FDA, to respond to Product Technical Complaints and medical complaints and to handle all returns, recalls or market withdrawals of the Product(s) in accordance with applicable law, at King’s cost and expense; provided, however, that if any such returns or recalls of Product samples are caused solely by actions or inactions by Wyeth constituting a breach of the provisions of this Agreement or a violation of applicable law, Wyeth, as King’s sole and exclusive remedy, shall bear all reasonable Direct Costs associated with such actions or in actions in connection therewith, provided, however that Wyeth shall have no obligation to reimburse King for any incidental or consequential damages incurred in connection therewith, including, without limitation, any lost profits. Prior to the Initiation Date, the AMC adopted a standard operating procedure (“SOP”) for handling Product Technical Complaints and medical inquiries received by Wyeth not otherwise specified in this Agreement for use during the Copromotion Period. (b) Each Party shall promptly (but in any case, not later than forty-eight (48) hours) notify the other Party in writing of any order, request or directive of a court or other governmental authority to recall or withdraw the Product. King shall be solely responsible for determining whether to issue a recall or withdrawal and for the cost and expense of any such recall or withdrawal of the Product. (c) Because the Product is manufactured by or on behalf of King and the underlying NDA is owned solely by King or an Affiliate of King, Wyeth shall send Product Technical Complaints (“PTC”) to King during the Term of the Agreement. If the PTC cannot be categorized as a B Complaint (meaning no actual or potential harm to patient), then the PTC will be categorized as an A Complaint. A Complaints shall be sent to King within [***] of receipt and B Complaints shall be sent within [***] of receipt, but no more than [***] from the receipt date by Wyeth. During the Copromotion Period King shall promptly notify Wyeth following receipt by King of any PTC’s.
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Product Technical Complaints and Recalls. Each party shall perform its responsibilities under the Safety Agreement in regards to product technical complaints and recalls.
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Product Technical Complaints and Recalls. (i) If Zogenix becomes aware of any Product Technical Complaint, Zogenix shall notify Valeant of such Product Technical Complaint promptly but not later than within [***] ([***]) business days. (ii) As between the Parties, Valeant shall have the sole authority and responsibility to respond to any governmental or regulatory authorities, including without limitation the FDA, in connection with Product Technical Complaints and medical complaints, and to handle all returns, recalls or market withdrawals of the Product in accordance with applicable law, at Valeant’s cost and expense. (iii) Each Party shall promptly (but in any case, not later than [***] ([***]) [***]) notify the other Party in writing via facsimile of any order, request or directive of a court or other governmental or regulatory authority to recall or withdraw the Product.
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Product Technical Complaints and Recalls. (i) If Santarus becomes aware of any Product Technical Complaint, Santarus shall notify Fleet of such Product Technical Complaint within [***] days. (ii) As between the parties, Fleet shall have the sole authority and responsibility to respond to any governmental or regulatory authorities, including without limitation the FDA, in connection with Product Technical Complaints and medical complaints, and to handle all returns, recalls or market withdrawals of the Product in accordance with applicable law, at Fleet’s sole cost and expense. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (iii) Each party shall promptly (but in any case, not later than [***]) notify the other party in writing via facsimile of any order, request or directive of a court or other governmental or regulatory authority to recall or withdraw the Product.
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Product Technical Complaints and Recalls. (i) If Santarus becomes aware of any Product Technical Complaint, Santarus shall notify Victory of such Product Technical Complaint within five (5) business days. (ii) As between the parties, Victory shall have the sole authority and responsibility to respond to any governmental or regulatory authorities, including without limitation the FDA, in connection with Product Technical Complaints and medical complaints, and to handle all returns, recalls or market withdrawals of the Product in accordance with applicable law, at Victory’s cost and expense. (iii) Each party shall promptly (but in any case, not later than forty-eight (48) hours) notify the other party in writing via facsimile of any order, request or directive of a court or other governmental or regulatory authority to recall or withdraw the Product.
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Product Technical Complaints and Recalls. (i) If DePuy Synthes becomes aware of any Product Technical Complaint, DePuy Synthes shall notify Pacira in writing of such Product Technical Complaint promptly but not later than within ten (10) business days to the extent DePuy Synthes is not legally prohibited from making such a notification. (ii) As between the Parties, Pacira shall have the sole authority and responsibility to respond to any governmental or regulatory authorities, including without limitation the FDA, in connection with Product Technical Complaints and medical complaints, and to make decisions regarding and handle all returns, recalls or market withdrawals of the Product subject to applicable law, at Pacira’s cost and expense (subject to the indemnification obligations of Section 10.1). (iii) Each Party shall promptly notify the other Party in writing via facsimile or email of any order, request or directive of a court or other governmental or regulatory authority to recall or withdraw the Product.
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Product Technical Complaints and Recalls a. If Co-Promotion Partner becomes aware of any Product Technical Complaint, Co-Promotion Partner shall submit a written report of such complaint, along with a sample of the Product involved in the complaint, if available, to Santarus within two (2) business days of receipt of such notice by Co-Promotion Partner; provided, however, that such time period relating to any such complaint involving tampering with the Product shall be one (1) business day. b. As between the parties, Santarus shall have the sole authority and responsibility to respond to any Governmental or Regulatory Authorities, including without limitation the FDA, in connection with Product Technical Complaints and medical complaints, and to handle all returns, recalls or market withdrawals of a Product in accordance with applicable law, at Santarus' cost and expense; provided, however, that to the extent any such returns or recalls of Product or Product samples are caused by actions or inactions by Co-Promotion Partner constituting a breach of the provisions of this Agreement or a violation of applicable law, rules or regulations, Co-Promotion Partner shall bear all reasonable costs associated with such actions or inactions in connection therewith. Santarus shall be under no liability whatsoever to compensate Co-Promotion Partner or make any other payment to Co-Promotion Partner for any decision to recall, initiate a market withdrawal or take any other corrective action with respect to the Products contemplated in this Section 6.5(b), unless such action results from a breach of the provisions of this Agreement or a violation of applicable laws, rules or regulations by Santarus. c. Each party shall promptly (but in any case, not later than forty-eight (48) hours) notify the other party in writing of any order, request or directive of a court or other Governmental or Regulatory Authority to recall or withdraw the Products.
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Product Technical Complaints and Recalls. If Zogenix becomes aware of any Product Technical Complaint, Zogenix shall notify Valeant of such Product Technical Complaint promptly but not later than within [***] ([***]) business days.
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Product Technical Complaints and Recalls 
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Related to Product Technical Complaints and Recalls

  • Product Complaints Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;

  • Product Claims The parties acknowledge that NCR Voyix, not Apple, is responsible for addressing any claims you or any third party relating to the Software or your possession and/or use of the Software, including, but not limited to: (a) product liability claims; (b) any claim that the Software fails to conform to any applicable legal or regulatory requirement; and (c) claims arising under consumer protection or similar legislation.

  • Licensed Patents 9.1.1 Oculis shall be responsible for and shall have the exclusive right with respect to, the preparation, filing, prosecution, protection, maintenance and enforcement of all Patent Rights in respect of the Licensed Technology in its discretion using its patent counsel. Oculis shall consult with Accure with respect thereto, supply Accure with a copy of the application as filed, together with notice of its filing date and serial number; and keep Accure advised of the status of actual and prospective Patent Right filings, including office actions, and keep Accure informed about and provide copies of all the relevant information exchanged between Oculis and the different Industrial or Intellectual Property Registration Offices regarding the prosecution, maintenance, defense and enforcement of the Licensed Patents. The cost and expense of filing, prosecuting, maintaining and enforcing all Licensed Patents shall be borne by Oculis. Accure shall, and hereby procures its personnel will, provide all requested information and perform all acts reasonably requested by Oculis in connection with the prosecution, maintenance, defense or enforcement of the Licensed Technology. Without limiting the foregoing, Accure and its Affiliates may not file for further Patent Rights relating to Licensed Technology. 9.1.2 Should Oculis not be interested in the prosecution, defense and maintenance of any or all of the Licensed Patents, and/or Xxxxxx decides not to pay all reasonable and necessary expenses with respect to the prosecution, defense or maintenance of any Licensed Patent before any upcoming deadline, Oculis shall give reasonable advance notice to Accure (no less than [***]), and subsequent to such notice Accure shall act as it deems appropriate in connection with the prosecution, defense and maintenance of the Licensed Patents at their discretion and at their own cost. As from such notification, Oculis shall not be responsible for costs associated with such Licensed Patents, and, where such notification is provided following such time as Xxxxxx assumes responsible for performing patenting matters as set forth above, Oculis shall not be responsible for the preparation, filing, prosecution, protection and maintenance of the mentioned Licensed Patents and such Patent Rights shall cease to be Licensed Patents and the provisions of Agreement shall be of no further effect with respect to such patent and/or country of the Territory.

  • Patent Rights The State and the U. S. Department of Transportation shall have the royalty free, nonexclusive and irrevocable right to use and to authorize others to use any patents developed by the Engineer under this contract.

  • Licensed Patent Rights The term “Licensed Patent Rights” shall mean rights arising out of or resulting from:

  • Product Recalls (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such action. The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).

  • Licensed Technology (a) LICENSOR is not aware of any interference, infringement, misappropriation, or other conflict with any intellectual property rights of third parties, and LICENSOR has never received any charge, complaint, claim, demand, or notice alleging any such interference, infringement, misappropriation, or violation (including any claim that LICENSOR must license or refrain from using any intellectual property rights of any third party). To the knowledge of LICENSOR, no third party has interfered with, infringed upon, misappropriated, or otherwise come into conflict with any of the LICENSED TECHNOLOGY. (b) Exhibit A identifies each patent or registration which has been issued to LICENSOR with respect to any of the LICENSED TECHNOLOGY and identifies each pending patent application or application for registration which LICENSOR has made with respect to any of the LICENSED TECHNOLOGY. LICENSEE acknowledges that LICENSOR has previously made available to LICENSEE correct and complete copies of all such patents, registrations and applications (as amended to-date) in LICENSOR’s possession and has made available to LICENSEE correct and complete copies of all other written documentation in LICENSOR’s possession evidencing ownership and prosecution (if applicable) of each such item. (c) Exhibit A identifies each item of LICENSED TECHNOLOGY that is assigned to LICENSOR or that LICENSOR uses pursuant to license, sublicense, agreement, or permission. LICENSOR has made available to LICENSEE correct and complete copies of all such licenses, sublicenses, agreements, patent prosecution files and permissions (as amended to-date) in LICENSOR’s possession. With respect to each item of LICENSED TECHNOLOGY required to be identified in Exhibit A and to the knowledge of LICENSOR: (i) the license, sublicense, agreement, or permission covering the item is legal, valid, binding, enforceable, and in full force and effect; (ii) the license, sublicense, agreement, or permission will continue to be legal, valid, binding, enforceable, and in full force and effect on identical terms following the consummation of the transactions contemplated hereby; (iii) no Party to the license, sublicense, agreement, or permission is in breach or default, and no event has occurred which with notice or lapse of time would constitute a breach or default or permit termination, modification, or acceleration thereunder; (iv) no party to the license, sublicense, agreement, or permission has repudiated any provision thereof; (v) the underlying item of LICENSED TECHNOLOGY is not subject to any outstanding lien or encumbrance, injunction, judgment, order, decree, ruling, or charge; (vi) no action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand is pending or is threatened which challenges the legality, validity, or enforceability of the underlying item of LICENSED TECHNOLOGY; and (vii) except as provided in Exhibit A, LICENSOR has not granted any license or similar right to the LICENSED TECHNOLOGY within the GENERAL FIELD or PARTHENOGENESIS FIELD.

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work. 4.12.2 Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams and other information furnished by the Contractor to illustrate a material, product or system for some portion of the Work. 4.12.3 Samples are physical examples which illustrate materials, equipment or workmanship and establish standards by which the Work will be judged. 4.12.4 The Contractor shall review, approve and submit, with reasonable promptness and in such sequence as to cause no delay in the Work or in the work of the State or any separate contractor, all Shop Drawings, Product Data and Samples required by the Contract Documents. 4.12.5 By approving and submitting Shop Drawings, Product Data and Samples, the Contractor represents that he / she has determined and verified all materials, field measurements, and field construction criteria related thereto, or will do so, and that he / she has checked and coordinated the information contained within such submittals with the requirements of the Work and of the Contract Documents. 4.12.6 The Contractor shall not be relieved of responsibility for any deviation from the requirements of the Contract Documents by the Architect's approval of Shop Drawings, Product Data or Samples under Subparagraph 2.2.7 of these General Conditions unless the Contractor has specifically informed the Architect and the State in writing of such deviation at the time of sub- mission and the Architect and the State has given written approval to the specific deviation. The Contractor shall not be relieved from responsibility for errors or omissions in the Shop Drawings, Product Data or Samples by the Architect's approval thereof. 4.12.7 The Contractor shall direct specific attention, in writing or on resubmitted Shop Drawings, Product Data or Samples, to revisions other than those requested by the Architect on previous submittals. 4.12.8 No portion of the Work requiring submission of a Shop Drawing, Product Data or Sample shall be commenced until the submittal has been approved by the Architect as provided in Subparagraph 2.2.7 of these General Conditions. All such portions of the Work shall be in accordance with approved submittals.

  • Product Data Illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by Developer to illustrate a material, product, or system for some portion of the Work.

  • Joint Patent Rights If not already established under the Research Collaboration Agreement, prior to either Party filing any Patent Right disclosing Joint Program Technology or Joint Probody Platform Improvements, the Parties shall establish a patent committee (the “Patent Committee”) comprised of at least one (1) representative of each Party for the purpose of facilitating the preparation, filing, prosecution, maintenance and defense of Joint Patent Rights. As agreed upon by the Parties, meetings of the Patent Committee may be face-to-face or may be conducted by teleconferences or videoconferences, from time to time as needed. The Patent Committee will be the forum through which the Parties coordinate their respective obligations to each other described in Sections 5.2.2 and 5.2.3 hereof and in this Section. In the event the Parties conceive or generate any Joint Program Technology or Joint Probody Platform Improvements, the Parties shall promptly meet to discuss and determine, based on mutual consent, whether to seek patent protection thereon, which Party will control filing, prosecution and maintenance of such patents and how to pay for the filing, prosecution and maintenance of such patents. It is presumed that ImmunoGen will control filing, prosecution and maintenance of Joint Patent Rights claiming Joint Program Technology or Joint Conjugation Probody Platform Improvements, and that CytomX will control filing, prosecution and maintenance of Joint Patent Rights claiming Joint Unconjugated Probody Platform Improvements. Neither Party will file any Joint Patent Right without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed. The Party controlling filing and prosecution of any such Joint Patent Right (a) shall keep the other Party informed regarding each Patent Right, (b) shall consider in good faith any recommendations made by the other Party in regard to the filing, prosecution or maintenance of any such Patent Right and (c) shall not unreasonably refuse to incorporate any recommendations made by the other Party in regard to such filing, prosecution or maintenance.

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