Product Technical Complaints and Recalls Sample Clauses

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.
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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 a. If Co-Promotion Partner becomes aware of any Product Technical Complaint concerning the Product, 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 Ligand 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.
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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 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. 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.
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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.
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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 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 AHPC constituting a breach of the provisions of this Agreement or a violation of applicable law, AHPC, as KING's sole remedy, shall bear all reasonable Direct Costs associated with such actions or in actions in connection therewith, provided, however that AHPC 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 shall adopt a standard operating procedure ("SOP") for handling Product Technical Complaints, medical inquiries and adverse event information received by AHPC not otherwise specified in this Agreement. The AMC shall revise the SOP from time to time during the Term as the AMC deems necessary.
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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.
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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.
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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 You acknowledge that Company, not an App Distributor, is responsible for addressing any claims of yours or any third party relating to the Company application or your possession and/or use of the Company application, including, but not limited to: (i) product liability claims; (ii) any claim that the Company application fails to conform to any applicable legal or regulatory requirement; and (iii) claims arising under consumer protection or similar legislation. (5)

  • Licensed Patents Licensee shall be responsible for all further patent prosecution with respect to the Licensed Patents and Licensed Technologies set out in Exhibit “A”. Licensee may select the patent agent for the prosecution of the Licensed Patents, subject to the approval of Licensor as the patent owner, which approval will not be unreasonably withheld. Licensee shall provide Licensor with copies of all relevant documentation related to the filing and prosecution of the Licensed Patents so that Licensor may be informed and apprised of and meaningfully consulted as to the continuing prosecution. Licensor shall keep all such documentation confidential. In the event the Licensee does not agree that any given patent application or patent should be filed, prosecuted or maintained (hereinafter referred to as a “Refused Licensed Patent”) in a particular jurisdiction(s) Licensee shall indicate such disagreement in writing (hereinafter “Refusal Notice”) and upon Licensor’s receipt of such Refusal Notice Licensor shall have the right unilaterally to make, prosecute and maintain such Refused Licensed * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Patent in such jurisdiction(s) in the name of its owners, at Licensor’s expense, and Licensee shall not have any rights or obligations to such Refused Licensed Patent in such jurisdiction(s); provided, however, that Licensee shall retain all of its ownership rights in any Refused Licensed Patent that is a Co-Owned Technology. In such case Licensor shall provide Licensee with copies of all relevant documentation related to the filing and prosecution of the Refused Licensed Patents so that Licensee may be informed and apprised of and be meaningfully consulted with as to the continuing prosecution. Licensor shall have no obligation to continue prosecution or maintenance of any Refused Licensed Patent and may abandon same without any prior notice or any obligation to Licensee. Both Licensee and Licensor shall make best efforts to respond promptly to any request from the other Party for input or assistance with respect to matters pertaining to the Licensed Patents. Licensee shall use reasonable efforts to amend any patent application to include claims reasonably requested by the other Party and required to protect the Licensed Technology. In addition to Licensee’s obligations pursuant to section 4.1 above, Licensee shall be solely responsible for all patent and legal costs relating to the Licensed Patents and Licensed Technology (excluding Refused Licensed Patents) from the Effective Date onward, including all costs relating to the transfer of the Licensed Patents to the new patent agents selected by Licensee and approved by Licensor. For any patent and legal costs relating to the Licensed Patents and Licensed Technology (excluding Refused Licensed Patents) paid by Licensor after the Effective Date (including, without limitation, those expenses related to patentability assessments and drafting, filing, prosecution, maintenance, and taxes (the “Patent Costs”)), Licensee shall promptly reimburse Licensor for such Patent Costs upon receipt of an invoice from Licensor for such expenses. For any work in progress with respect to the Licensed Patents for which the Patent Costs have not already been paid by Licensor to its patent firm prior to the transfer of the Licensed Patents to Licensee’s patent agent, Licensor will direct its patent firm to copy Licensee on all such invoices from said patent firm and Licensee will promptly pay said invoices directly to Licensor’s patent firm.

  • 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:

  • Responsibility for Patent Rights (a) University has primary responsibility at the expense of Company for the preparation, filing, prosecution, and maintenance of all Patent Rights, using patent counsel reasonably acceptable to Company. University shall consult with Company as to the preparation, filing, prosecution, and maintenance of all Patent Rights reasonably prior to any deadline or action with the United States Patent & Trademark Office or any foreign patent office and shall furnish Company with copies of relevant documents reasonably in advance of consultation. University shall consider in good faith any comments of Company on any patent filings for the Patent Rights.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Licensed Technology The term "Licensed Technology" shall mean the ------------------- Licensed Patents, plus all improvements thereto developed by Licensor, and all related data, know-how and technology.

  • Joint Patent Rights With respect to any potentially patentable Joint Invention, the Parties shall confer and agree upon which Party, if any, shall prepare, file, Prosecute (including any interferences, reissue proceedings, and other administrational proceedings) and Maintain patent applications covering such Joint Invention (any such patent application and any patents issuing therefrom a “Joint Patent Right”), at the responsible Party’s expense. It is the intention of the Parties that, unless otherwise agreed in writing, ATI would prepare, file, Prosecute and Maintain any Joint Patent Rights. The Party that Prosecutes a patent application in the Joint Patent Rights (the “Prosecuting Party”) shall provide the other Party reasonable opportunity to review and comment on such Prosecution efforts regarding the applicable Joint Patent Rights in the particular jurisdictions, and such other Party shall provide the Prosecuting Party reasonable assistance in such efforts. The Prosecuting Party shall provide the other Party with a copy of all material communications from any patent authority in the applicable jurisdictions regarding the Joint Patent Rights being Prosecuted by such Party, and shall provide drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses. In particular, each Party agrees to provide the other Party with all information necessary to enable the other Party to comply with the duty of candor/duty of disclosure requirements of any patent authority. Should ATI determine that it will no longer support the continued Prosecution or Maintenance of a particular Joint Patent Right in a country or jurisdiction, ATI shall provide Rigel with written notice of such determination at least thirty (30) Business Days prior to any deadline for taking action to avoid abandonment of such Joint Patent Right. Rigel shall have the right, but not ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 230.406 obligation, to file, Prosecute and Maintain such Joint Patent Rights in the applicable jurisdiction at Rigel’s expense.

  • Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.

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