IMPAX Sample Clauses

IMPAX in its sole discretion, and at its cost, may perform periodic security audits of DAVA’s Product distribution system and will disclose its findings to XXXX. Except for cause, such security audits may be made no more than two times each calendar year, at reasonable times and on reasonable notice. XXXX will give IMPAX reasonable access and cooperation in connection with IMPAX’s security audits.
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IMPAX shall invoice WCH for the prices set forth in Exhibit B attached hereto, subject to adjustment as set forth in Sections 6.3.2, 6.3.3 and 6.3.4, for all Products delivered to WCH hereunder. All prices are inclusive of taxes, shipping costs to the point of delivery, customs duties and other charges.
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IMPAX. On August 7, 2003, IMPAX received an Accusation from the Department of Justice, Bureau of Narcotic Enforcement, State of California (“BNE”), alleging that we failed to maintain adequate controls to safeguard precursors from theft or loss regarding our pseudoephedrine product in January 2003. We contested the allegations in the Accusation and entered into discussions with the State of California, Department of Justice, to bring resolution to this matter. The Company has implemented a number of remedial measures aimed at improving the security and accountability of precursor substances used by the Company and regulated by the California Department of Justice, Bureau of Narcotic Enforcement. In March 2004, following a theft of pseudoephedrine from our facilities, the BNE filed an Amended Accusation, again alleging that the Company failed to maintain adequate controls to safeguard precursors from theft or loss regarding our pseudoephedrine product. In May 2004, a Notice of Hearing was received from BNE, which set the hearing of this matter, should one be necessary, for October 18 and October 19, 2004. On October 11, 2004 we entered into a Stipulation with the BNE regarding our California Precursor Business Permit #201, applicable to the our facility located at 00000 Xxx Xxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxx. Pursuant to the Stipulation, Permit #201 is provisionally suspended, with such suspension stayed, for a period of two (2) years, in which the Company must comply with the terms and conditions of the Stipulation. The Stipulation provides: “Upon successful completion of the terms of the Stipulation for the period of time in which it is in effect, the Company’s permit will be fully restored without having been suspended.” The Stipulation resolves both the original Accusation and the Amended Accusation. SOLVAY PHARMACEUTICALS V. IMPAX: THE CREON CASE On April 11, 2003, Solvay Pharmaceuticals, Inc., manufacturer of the Creon line pancreatic enzyme products, brought suit against the Company in the U.S. District Court for the District of Minnesota claiming that we have engaged in false advertising, unfair competition, and unfair trade practices under federal and Minnesota law in connection with the Company’s marketing and sale of its Lipram products. The suit seeks actual and consequential damages, including treble damages, attorneys’ fees, injunctive relief and declaratory judgments that would prohibit the substitution of Lipram for prescriptions of Creon. On June...
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IMPAX. THE OXYCODONE CASES On April 11, 2002, Purdue Pharma and related companies filed a complaint in the U.S. District Court for the Southern District of New York alleging that IMPAX's submission of ANDA No. 76-318 for 80 mg oxycodone tablets infringes three patents owned by Purdue. The Purdue patents are U.S. Patent Nos. 5,508,042, 5,549,912 and 5,656,295; all directed to controlled release opioid formulations. On September 19, 2002, Purdue filed a second Infringement Complaint regarding our 40 mg oxycodone generic product. On October 9, 2002, Purdue filed a third Infringement Complaint regarding our 10 mg and 20 mg oxycodone generic products. We filed its answer and counterclaims in each case on October 3, 2003. On November 25, 0000, Xxxxxx submitted their reply to our counterclaims. Purdue is seeking, among other things, a court order preventing us from manufacturing, using or selling any drug product that infringes the subject Purdue patents. Purdue previously sued Boehringer Ingelheim/Xxxxxx, Endo and Teva on the same patents. One or more of these defendants may resolve the invalidity issues surrounding the Purdue patents prior to when our case goes to trial. The Boehringer Ingelheim/Xxxxxx suit is stayed. The Endo action was tried in June 2003. In January 2004, the judge in the Endo action ruled that the three patents in suit, the same patents that Purdue has asserted against the Company, are unenforceable because they were inequitably procured and enjoined their enforcement. Purdue appealed that ruling to the Court of Appeals for the Federal Circuit. We were granted Summary Judgment on January 10, 2005, dismissing Purdue's charges of infringement and holding the patents to be unenforceable, based on the Endo decision. The Company commenced shipping Oxycodone 80mg in March 2005. On June 7, 2005, the Court of Appeals for the Federal Circuit affirmed the District Court's ruling that the patents in suit were unenforceable due to inequitable conduct. Purdue has stated that they intend to file a Petition for Re-hearing En Banc. If the Endo decision is ultimately reversed, and Purdue were to prevail in litigation against us, we would be liable for Purdue's damages, up to its lost profits from our infringing sales. If the infringement were found to be willful, our damages could be increased by up to three times. IMPAX V. AVENTIS PHARMACEUTICALS, INC.: THE RILUZOLE CASE In June 2002, we filed suit against Aventis Pharmaceuticals, Inc. in the U.S. District Court i...
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IMPAX. On August 7, 2003, IMPAX received an Accusation from the Department of Justice, Bureau of Narcotic Enforcement, State of California ("BNE"), alleging that we failed to maintain adequate controls to safeguard precursors from theft or loss regarding our pseudoephedrine product in January 2003. We contested the allegations in the Accusation and entered into discussions with the State of California, Department of Justice, to bring resolution to this matter. The Company has implemented a number of remedial measures aimed at improving the security and accountability of precursor substances used by the Company and regulated by the California Department of Justice, Bureau of Narcotic Enforcement. In March 2004, following a theft of pseudoephedrine from our facilities, the BNE filed an Amended Accusation, again alleging that the Company failed to maintain adequate controls to safeguard precursors from theft or loss regarding our pseudoephedrine product. In May 2004, a Notice of Hearing was received from BNE, which set the hearing of this matter, should one be necessary, for October 18 and October 19,
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IMPAX s manufacturing facilities conform, and shall continue to conform throughout the Term, in all respects to Applicable Law governing such facilities; and
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Related to IMPAX

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Licensee Licensee represents and warrants that:

  • Sublicensees Licensee shall have the full right (but not the obligation) to sublicense those rights granted to it under Section 2.1 to a Third Party (a “Sublicensee”); provided, however, that, prior to the payment of the first milestone pursuant to Section 7.2, Licensee may not grant any such sublicense to any contract research organization conducting Clinical Trials of Products or any Third Parties conducting contract Manufacturing activities without Licensee’s prior written notice (at least twenty (20) Business Days in advance) to Lilly, which shall include a description of the rights to be granted and the purpose therefor, the identity of the Third Party and the countries involved, and Lilly’s prior written consent, but such consent shall only be required (i) until such time as Licensee is the holder of record for the Regulatory Materials related to Taladegib and (ii) to the extent such organization is not performing services for Licensee as of the Effective Date; and provided further, that Licensee shall remain responsible for the performance by any of its Sublicensees. With respect to any Sublicensee granted a sublicense to any Commercialization rights hereunder, Licensee shall ensure that each of its Sublicensees accepts in writing all applicable terms and conditions of this Agreement, including the non-compete, reporting, audit, inspection and confidentiality provisions hereunder. Each Sublicensee shall also be prohibited from further sublicensing. For the avoidance of doubt, (a) Licensee will remain directly responsible for all amounts owed to Lilly under this Agreement, and (b) each Sublicensee is subject to the negative and restrictive covenants set forth in Sections 2.3.1 and 2.5, respectively. Licensee hereby expressly waives any requirement that Lilly exhaust any right, power or remedy, or proceed against a subcontractor, for any obligation or performance hereunder prior to proceeding directly against Licensee.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • Product Labeling The labeling of all Licensed Products sold or offered for sale under this Agreement shall expressly state that the Licensed Product is manufactured under a license from the Medicines Patent Pool.

  • Licensor any Person from whom a Grantor obtains the right to use any Intellectual Property. Lien: any Person’s interest in Property securing an obligation owed to, or a claim by, such Person, whether such interest is based on common law, statute or contract, including liens, security interests, pledges, hypothecations, statutory trusts, reservations, exceptions, encroachments, easements, rights-of-way, covenants, conditions, restrictions, leases, and other title exceptions and encumbrances affecting Property. Lien Waiver: an agreement, in form and substance satisfactory to Collateral Agent, by which (a) for any material Collateral located on leased premises, the lessor waives or subordinates any Lien it may have on the Collateral, and agrees to permit Collateral Agent to enter upon the premises and remove the Collateral or to use the premises to store or dispose of the Collateral; (b) for any Collateral held by a warehouseman, processor, shipper, customs broker or freight forwarder, such Person waives or subordinates any Lien it may have on the Collateral, agrees to hold any Documents in its possession relating to the Collateral as agent for Collateral Agent, and agrees to deliver the Collateral to Collateral Agent upon request; (c) for any Collateral held by a repairman, mechanic or bailee, such Person acknowledges Collateral Agent’s Lien, waives or subordinates any Lien it may have on the Collateral, and agrees to deliver the Collateral to Collateral Agent upon request; and (d) for any Collateral subject to a Licensor’s Intellectual Property rights, the Licensor grants to Collateral Agent the right, vis-à-vis such Licensor, to enforce Collateral Agent’s Liens with respect to the Collateral, including the right to dispose of it with the benefit of the Intellectual Property, whether or not a default exists under any applicable License.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

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