Buphenyl Sample Clauses

Buphenyl. As contemplated by Section 2(e)(ii) of the Agreement, Buphenyl is hereby added as a Product under the Agreement. The Product Launch Date of Buphenyl is June 1, 2013. Ammonul is not added as a Product under the Agreement.
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Buphenyl. If Hyperion exercises the Marketed Products Option, then following the FDA approval and commercial launch of HPN-100, Hyperion shall pay Ucyclyd a royalty on Net Sales of Buphenyl (or any other product for UCD that is promoted, distributed, marketed or sold, directly or indirectly by Hyperion in lieu of Buphenyl) for the treatment of UCD in patients in the United States in the age range that is outside the age range of the FDA-approved labeling for HPN-100. The royalty rate on such Net Sales shall be the same royalty rate for HPN-100 that is in effect at the time of calculation of the applicable royalty payment.

Related to Buphenyl

  • Asbestos Mortgagor shall not install nor permit to be installed in the Mortgaged Property asbestos or any asbestos-containing material (collectively, "ACM") except in compliance with any and all applicable present and future Environmental Laws respecting ACM. With respect to any ACM (including friable or non-friable asbestos or asbestos-containing materials regulated under any Environmental Law) discovered to be present in the Mortgaged Property at any time during the operation of this Mortgage, Mortgagor shall comply in all material respects with any and all applicable present and future Environmental Laws, all at Mortgagor's sole cost and expense Upon the occurrence and during the continuation of an Event of Default, Mortgagee may, but shall not be obligated to, in addition to any other remedies set forth herein, take, in substantial compliance with any applicable present and future Environmental Laws, whatever steps it deems reasonably necessary or appropriate to comply with any and all applicable present and future Environmental Laws. Any costs or expenses reasonably incurred by Mortgagee for such purpose shall be due within ten (10) days after demand and payable by Mortgagor and shall bear interest at the Default Rate. Mortgagor shall provide to Mortgagee and its agents and employees reasonable access to the Mortgaged Property and hereby specifically grants to Mortgagee a license to remove or encapsulate such ACM in substantial compliance with any applicable present and future Environmental Law if Mortgagor fails to do so and removal or encapsulation is required under any applicable present and future Environmental Law; provided, however, that nothing contained herein shall obligate Mortgagee to exercise any rights under such license. Mortgagor shall indemnify and hold Mortgagee harmless from and against all loss, cost, damage and expense (including, without limitation, reasonable attorneys' and consultants' fees) that Mortgagee may sustain as a result of the presence of any ACM and any removal or encapsulation thereof or compliance with any and all applicable present and future Environmental Laws other than such loss, cost, damage or expense, if any, to the extent it is caused solely by the gross negligence or willful misconduct of Mortgagee or its agents, contractors and subcontractors in performing any act or exercising its remedies under this Mortgage.

  • Product The term “

  • Products 1.1. The information (including but not limited to the quantity, rated hashrate, unit price (“Unit Price”), total price for one item (“Total Price (One Item)”), total price for all the items (“Total Purchase Price”) of Products to be purchased by Party B from Party A is as follows (“Products”):

  • Labeling Upon request, Lessee will xxxx the Equipment indicating Lessor's interest with labels provided by Lessor. Lessee will keep all Equipment free from any other marking or labeling which might be interpreted as a claim of ownership.

  • 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 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.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Radon Radon is a naturally occurring radioactive gas that, when it has accumulated in a building in sufficient quantities, may present health risks to persons who are exposed to it over time. Levels of radon that exceed federal and state guidelines have been found in buildings in Florida. Additional information regarding radon and radon testing may be obtained from your county public health unit.

  • Animals Except for guide, signal or service dogs in use by a blind, deaf or physically handicapped person or a watch dog used by the Tenant, no animals shall be allowed, even temporarily, anywhere in or on the Property without the Landlord’s prior written consent, which consent may be withheld, conditioned or delayed at the Landlord’s discretion.

  • Manufacture (a) Manufacturer shall only manufacture the specific number of Products as requested by Company and at no time shall manufacture excess goods or overruns. Manufacturer shall not sell any Products bearing the Trademarks to any third parties without the express written consent of Company.

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