Product Recall Management Sample Clauses

Product Recall Management. Collegium shall have the right to control and/or conduct any Product Recall of any Licensed Product Developed or Commercialized by or for it, any Affiliate thereof, or any Sublicensee in the Territory, subject to Section 12.01. The Product Recall shall be the sole responsibility of Collegium, its Affiliates, or Sublicensees, as applicable, and shall be carried out by Collegium, its Affiliates, or Sublicensees in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the affected Licensed Products and the goodwill and reputation of the Parties. Collegium, its Affiliates or Sublicensees, as applicable, shall maintain records of all sales and distribution of Licensed Products and customers in the Territory sufficient to reasonably adequately administer a Product Recall, for the period required by Applicable Law, and make such records available to BDSI or any designee thereof immediately upon request.
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Product Recall Management. Meda shall have the right to control and/or conduct any Product Recall in the Territory, subject to Section 12.01. The Product Recall shall be the sole responsibility of Meda or its Affiliates and shall be carried out by Meda or its Affiliates in as reasonable, prudent, and expeditious a manner as possible to preserve the goodwill and reputation of the Licensed Products and the goodwill and reputation of the Parties, provided that BDSI shall share any such Product Recall responsibilities to the extent assumed by BDSI pursuant to the Supply Agreement. Meda shall maintain records of all sales and distribution of Licensed Products and customers in the Territory sufficient to reasonably adequately administer a Product Recall, for the period required by Applicable Law, and make such records available to BDSI or any designee thereof immediately upon request.
Sample 1
Product Recall Management. Purdue shall have the right to control and/or conduct any Product Recall of any Licensed Product Commercialized or otherwise distributed by or for Purdue, any Affiliate thereof, or any Sublicensee in the Territory, subject to Section 12.01. Purdue will conduct such Product Recall in a Commercially Reasonable manner Confidential Treatment Requested by BioDelivery Sciences International, Inc. Confidential treatment requested with respect to certain portions hereof denoted with “***” determined by Purdue in its sole discretion and in compliance with all Applicable Law. Purdue, its Affiliates or Sublicensees, as applicable, shall maintain records of all sales and distribution of Licensed Products and customers in the Territory sufficient to reasonably adequately administer a Product Recall, for the period required by Applicable Law, and make such records available to BDSI or any designee thereof immediately upon request. BDSI shall cooperate, at, except as otherwise set forth in the Supply Agreement, Purdue’s expense, in the conduct of any Product Recall for such Licensed Product in the Territory as reasonably requested by Purdue. In the event Purdue notifies BDSI, or BDSI otherwise becomes aware, that Purdue, any Affiliate thereof, or any Sublicensee does not intend to undertake a Product Recall (i) in respect of any death or life-threatening Adverse Event associated with any Licensed Product or (ii) to comply with any Applicable Law with respect to any Licensed Product within, in either case, a reasonable period of time, or is unreasonably delayed in undertaking any such Product Recall, BDSI shall be entitled to do so without Purdue’s prior written consent, in which case Purdue shall cooperate (and cause its Affiliates and Sublicensees to cooperate) in the conduct of any such Product Recall as reasonably requested by BDSI.
Sample 1
Product Recall Management. Arius shall have the right to control and/or conduct any Product Recall in the Territory, subject to Section 13.01, with respect to any Product. The Product Recall shall be the sole responsibility of Arius or its Affiliate and shall be carried out by Arius or its Affiliate in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Arius shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Product Recall, for the period required by Applicable Law and make such records available to Arius Two immediately upon request.
Sample 1
Product Recall Management. Arius shall have the right to control and/or conduct any Product Recall in the Territory, subject to Section 12.01 with respect to any Product. The Product Recall shall be the sole responsibility of Arius or its Affiliate and shall be carried out by Arius or its Affiliate in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Arius and Arius Two (if applicable) shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Product Recall, for the period required by Applicable Law and make such records available to the other Party immediately upon request. ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “***”.
Sample 1

Related to Product Recall Management

  • 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.

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Quality Assurance Licensee agrees that all use of the Licensed Subject Matter shall be only upon the Products manufactured by or for Licensee in accordance with quality standards approved by Licensor prior to the commencement of manufacturing of the Products. Licensee shall submit for Licensor's sole and absolute approval the type of cereal, the name of cereal, the packaging design, advertising material, and all other materials to be used in connection with the Products subject to the sole and absolute approval of Licensor which shall not be unreasonably delayed or withheld.

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

  • Clinical Supply Takeda will provide to Licensee[***] the amount of TAK-385 Licensed Compound or TAK-385 Licensed Products needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan (estimated by Licensee as of the Effective Date to be [***]), solely to the extent that Takeda can supply such TAK-385 [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Licensed Compound or TAK-385 Licensed Products (a) from its supply of TAK-385 Licensed Compound or TAK-385 Licensed Products in existence as of the Effective Date and which supply can be used for its intended purposes without further re-processing (the “Initial Clinical Supply”) and (b) after retaining the amount needed by Takeda for Clinical Trials in the Takeda Territory. Takeda will also provide to Licensee, at [***] any additional supplies of TAK-385 Licensed Compound or TAK-385 Licensed Products in excess of the Initial Clinical Supply needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan. Within [***] days after the Effective Date, the Parties will enter into a manufacturing and supply agreement (the “Takeda Clinical Manufacturing and Supply Agreement”), which will govern the terms and conditions of the Manufacturing and supply of the TAK-385 Licensed Compound and TAK-385 Licensed Products (including the Initial Clinical Supply) by Takeda to Licensee for Development purposes, including the exact quantities and the timelines for delivery. The Parties will negotiate the terms and conditions of such Takeda Clinical Manufacturing and Supply Agreement in good faith for a period of [***] days (as may be extended upon agreement of the Parties). As part of the negotiation related to the Takeda Clinical Manufacturing and Supply Agreement, the Parties shall discuss in good faith the ability of Takeda to supply to Licensee [***]. If the Parties have not entered into a definitive agreement within such negotiation period, then the final terms and conditions of such agreement will be resolved in accordance with Section 8.2 (Arbitration for Failure to Agree).

  • Research Analyst Independence The Company acknowledges that the Underwriters’ research analysts and research departments are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriters’ research analysts may hold views and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of their respective investment banking divisions. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriters with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriters’ investment banking divisions. The Company acknowledges that each of the Underwriters is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short positions in debt or equity securities of the companies that may be the subject of the transactions contemplated by this Agreement.

  • Contract Management (a) Atlantic will appoint one individual with sufficient seniority, experience and authority to oversee the Atlantic's performance under this Agreement (the Atlantic "Contract Manager") and, for periods when any Contract Manager is absent due to illness or vacation, a deputy for him or her, who will be the primary point of contact for the Executive Officers. One of the Trust's trustees, PEO, PFO, or such other Person designated by the Board from time to time, shall be the Trust's "Contract Manager". The Contract Managers for each Party shall be responsible for the overall management of this Agreement. Subject to and as contemplated by this Agreement, the Contract Managers or their deputies will have the authority and be given the primary responsibility to:

  • Sales Force During the term of this Agreement, Licensee shall maintain a non-exclusive sales force suitable to carry out the purpose of this Agreement.

  • Marketing Services The Manager shall provide advice and assistance in the marketing of the Vessels, including the identification of potential customers, identification of Vessels available for charter opportunities and preparation of bids.

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