MANUFACTURING AND PRODUCT LIABILITY Sample Clauses

MANUFACTURING AND PRODUCT LIABILITY. 12.1 In the event that KRYPTON, subject to Section 5.5 above, elects GENTA JAGO, and GENTA JAGO expressly agrees to such manufacture, or any of its Affiliates shall manufacture Final Products, then the Parties agree to enter into good faith negotiations on and to use commercially reasonable efforts to execute in due time a respective Manufacturing and Supply Agreement, according to which GENTA JAGO or its Affiliates shall undertake to manufacture and supply Final Products in sufficient quantities to meet KRYPTON's requirements, at a sale price for such Final Products manufactured equal to GENTA JAGO's * In the event and for such period of time, that GENTA JAGO or its Affiliate manufactures and supplies Final Product under such Manufacturing and Supply Agreement, the Royalty Rate referred to in Section 14.1 below shall be *
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MANUFACTURING AND PRODUCT LIABILITY. 6.1 Subject to the exercise by Nitec of its rights under Section 6.2, Jagotec shall exclusively manufacture, package and supply, or have manufactured, packaged and supplied by an Affiliate, Product in bulk in accordance with the terms and conditions to be agreed upon in the Jagotec Manufacturing Agreement, which Jagotec Manufacturing Agreement shall contain provisions (i) that Nitec shall supply to Jagotec or its Affiliate free of charge all Active Drug in quantities required for such manufacturing of Product, and (ii) on manufacture and packaging of Product in bulk and reimbursement of cost at […***…] of Jago’s fully allocated manufacturing cost therefore (calculated in substantially the same manner as Jago’s other manufactured products of similar production process, run and complexity) as required by the Parties. If Jagotec wants to have the product manufactured, packed and supplied by an affiliate other than SkyePharma SAS, the costs of the manufacturing site change to such an affiliate (including but not limited to technical transfer, process validation, bioequivalence study and regulatory expenses) shall be borne by Skye. Furthermore, the Jagotec Manufacturing Agreement shall contain provisions on lead times, order quantity and supply and purchase obligations of such quantities ordered (or part thereof), as may be mutually agreed upon by the Parties and in the event of a failure by the Parties to agree by 31 March, 2005, each Party shall submit the matter to be resolved by an expert, to be appointed by ***Confidential Treatment Requested a single arbitrator appointed under ICC Rules. With the exception of the principles applied in calculating the fully allocated manufacturing cost referred to above, in relation to any particular proposed clause of the Jagotec Manufacturing Agreement on which the Parties are unable to agree, each Party shall propose terms, only one of which, subject to such amendments specified by the expert as shall be required to ensure that the Jagotec Manufacturing Agreement operates as a whole, shall be selected by the expert as the relevant clause of the Jagotec Manufacturing Agreement binding on the Parties. In the case of the principles applied in calculating the fully allocated manufacturing cost referred to above, the expert shall not be bound only to select terms proposed by one Party or the other as described above but shall be free to make such amendments to proposed terms as the expert shall think fit.
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MANUFACTURING AND PRODUCT LIABILITY. 12.1 In the event that KRYPTON, subject to Section 5.5 above, elects GENTA JAGO, and GENTA JAGO expressly agrees to such manufacture, or any of its Affiliates shall ------------- * Confidential treatment requested. The redacted material has been separately filed wit the Commission. manufacture Final Products, then the Parties agree to enter into good faith negotiations on and to use commercially reasonable efforts to execute in due time a respective Manufacturing and Supply Agreement, according to which GENTA JAGO or its Affiliates shall undertake to manufacture and supply Final Products in sufficient quantities to meet KRYPTON's requirements, at a sale price for such Final Products manufactured equal to GENTA JAGO's * In the event and for such period of time, that GENTA JAGO or its Affiliate manufactures and supplies Final Product under such Manufacturing and Supply Agreement, the Royalty Rate referred to in Section 14.1 below shall be *.
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Related to MANUFACTURING AND PRODUCT LIABILITY

  • Product Warranty and Product Liability Schedule 5.17 of the Disclosure Schedule contains a true, correct and complete copy of Company’s standard warranty or warranties for sales of Products (as defined below) and, except as stated therein, there are no warranties, commitments or obligations with respect to the return, repair or replacement of Products. Schedule 5.17 of the Disclosure Schedule contains a description of all product liability claims and similar claims, actions, litigation and other proceedings relating to Products which are presently pending or which to Company’s knowledge are threatened, or which have been asserted or commenced against Company within the last two (2) years, in which a party thereto either requests injunctive relief (whether temporary or permanent) or alleges damages in excess of $100,000.00 (whether or not covered by insurance). To the best of the Company’s knowledge, there are no defects in design, construction or manufacture of Products which would adversely affect performance or create an unusual risk of injury to persons or property. Except as set forth on Schedule 5.17, none of the Products has been the subject of any replacement, field fix, retrofit, modification or recall campaign other than in the ordinary course of business. The Products have been designed and manufactured so as to meet and comply with all governmental standards and specifications currently in effect, and have received all governmental approvals necessary to allow their sale and use. As used herein, the term “Products” means any and all products currently or at any time previously manufactured, distributed or sold by Company, or by any predecessor of Company under any brand name or xxxx under which products are or have been manufactured over the last three (3) years, distributed or sold by Company, in or through the Business. [*] = 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.

  • Product Warranty; Product Liability (a) Except as set forth on Company Disclosure Schedule 4.23, the products produced, sold or delivered by the Company in conducting the Business have been in all material respects in conformity with all product specifications and all applicable Laws. To the Company’s Knowledge, the Company has no material Liability for damages in connection therewith or any other customer or product obligations not reserved against on the Balance Sheet.

  • Product Liability and Recalls (a) Except a disclosed in Section 3.27 of the Disclosure Schedule or the Company SEC Documents to the Best Knowledge of the Company, there is no claim, or the basis of any claim, against the Company or any of this subsidiaries for injury to person or property of employees or any third parties suffered as a result of the sale of any product or performance of any service by the Company or any of its subsidiaries, including claims arising out of any alleged defective nature of its products or services, which could reasonably be expected to have a Material Adverse Effect on the Company.

  • Product Liability The Company has no Liability (and there is no basis for any present or future action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand against any of them giving rise to any Liability) arising out of any injury to individuals or property as a result of the ownership, possession, or use of any product manufactured, sold, leased, or delivered by the Company.

  • Product Liabilities There are no product recalls, trade disputes, product liabilities or product tampering claims now pending, threatened against or made by or affecting the Company or any of its directors, officers or employees or the businesses, assets or rights of the Company.

  • Products Liability There is no Action before any Governmental Authority involving Seller based upon breach of product warranty, strict liability in tort, negligent design, negligent manufacture of product, defects in design, manufacture, materials or workmanship, negligent provision of services, or any other allegation of liability, including or resulting in product recalls, arising from the materials, design, testing, manufacture, packaging, labeling (including instruction for use), documentation or sale of products (collectively, “Product Claims”; and, to the Knowledge of Seller, there is no basis for any such Product Claim. To the Knowledge of Seller, there are no material errors in any published technical documentation, specifications, manuals or user guides provided in the ordinary course of business to customers of the Business. There have been no material defects in design, manufacturing, materials or workmanship, including any failure to warn, or any breach of express or implied warranties or representations, which involve any product manufactured (or to be manufactured), shipped, sold, installed or delivered by or on behalf of Seller. There have been no product recalls by Seller with respect to any products manufactured (or to be manufactured), shipped, sold, installed or delivered by or on behalf of Seller, or to the Knowledge of Seller any investigation or consideration of or decision made by any Person or Governmental Authority concerning whether to undertake or not to undertake any recall. All manufacturing standards applied, testing procedures used, and product specifications disclosed to customers by Seller have complied in all material respects with all requirements established by any applicable Law or any Governmental Authority.

  • Product The term “

  • Product Warranty Each product manufactured, sold, leased, or delivered by the Company has been in conformity with all applicable contractual commitments and all express and implied warranties, and the Company has no Liability (and there is no basis for any present or future action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand against any of them giving rise to any Liability) for replacement or repair thereof or other damages in connection therewith, subject only to the reserve for product warranty claims set forth on the face of the balance sheet included in the Interim Financial Statements (rather than in any notes thereto) as adjusted for the passage of time through the Closing Date in accordance with the past custom and practice of the Company. No product manufactured, sold, leased, or delivered by the Company is subject to any guaranty, warranty, or other indemnity beyond the applicable standard terms and conditions of sale or lease. Section 4.22 of the Disclosure Schedule includes copies of the standard terms and conditions of sale or lease for the Company (containing applicable guaranty, warranty, and indemnity provisions).

  • 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.

  • Product Warranties Except as set forth in Schedule 3.15, (a) there are no warranties express or implied, written or oral, with respect to the Business and (b) there are no pending or threatened claims with respect to any such warranty, and Seller has no liability with respect to any such warranty, whether known or unknown, absolute, accrued, contingent or otherwise and whether due or to become due.

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