Elan. Elan (or an Elan Affiliate) shall own, and shall be responsible at its own expense, for filing for and maintaining:
6.1.1 the DMF for the Product; and
6.1.2 all necessary manufacturing approvals to enable Elan (or its Affiliate) to manufacture and supply clinical supplies of Product pursuant to the Services Agreement and Bottled Product pursuant to the Commercial Manufacture and Supply Agreement;
6.1.3 all appropriate quotas from the US Drug Enforcement Agency to enable Elan to source and use the Compound to manufacture and supply clinical supplies of Product pursuant to the Services Agreement and Bottled Product pursuant to the Commercial Manufacture and Supply Agreement ; and
6.1.4 any necessary export or import licenses in relation to clinical supplies of Product manufactured and supplied by Elan pursuant to the Services Agreement and Bottled Product pursuant to the Commercial Manufacture and Supply Agreement (if Elan chooses to manufacture the Product outside the Territory).
Elan. Elan represents and warrants that it has the full right and authority, and has taken all necessary corporate action, to provide access to the Information, grant Amarin the exclusive Option and, if exercised, enter into the Assignment Agreement as set forth in this Agreement. Elan warrants that Elan’s entering into and performing this Agreement will not conflict with or create a default under any agreement or obligation binding on Elan or any of the assets or property which are the subject of this Agreement. Elan further warrants that:
(a) it is the sole owner or exclusive licensee of the Rights (with full right to grant the option and transfer and assign under any license agreement), without the necessity of obtaining any consents of third parties other than Xxxxxxx, and that such right, title and interest is unencumbered by any lien, charge, claim or encumbrance of any kind; and
(b) it is the sole owner or exclusive licensee (with the full right to sublicense under any license agreement, without the necessity of obtaining any consents except Xxxxxxx) of the patent(s) or patent applications in the Territory which claim fast-dissolving drug delivery systems which Xxxxxxx owns or under which Xxxxxxx is licensed with the right to sublicense (the “Patent Rights”); Exhibit A contains a complete and accurate listing of the Patent Rights (plus certain other patent rights outside of the Territory, to which Elan makes no representation or warranty) as of the date of the Xxxxxxx Agreement, which Elan has no reason to believe is inaccurate or incomplete; and to Elan’s knowledge, the Patent Rights are unencumbered by any lien, charge, claim or encumbrance of any kind.
(c) from now through the expiration or termination of this Agreement or the exercise of the Option, whichever first occurs, Elan shall not convey, sell, transfer, license, assign or encumber any interest in any of the Rights, including without limitation the Information or Patent Rights, or agree to do any of the foregoing.
Elan. EIS and/or RPI shall have the right to assign their rights and obligations hereunder to their Affiliates provided, however, that such assignment does not result in adverse tax consequences for any other Parties.
Elan. During the Term, ELAN shall not, and shall cause each of its Affiliates to not conduct any activity, either on its own, or with, for the benefit of, or sponsored by any Third Party, that is designed to research, develop or commercialize, or grant any license or other rights to any Third Party to utilize any Technology or Patent Rights Controlled by ELAN or any of its Affiliates for the purpose of researching, developing or commercializing, any Aptamer binding to a Program Target or any Aptamer Derived therefrom that binds specifically to the relevant Program Target, except as provided under this Agreement.
Elan. KNOW-HOW shall mean all knowledge, information, trade secrets, data and expertise owned or licensed by ELAN or to be developed by ELAN whether before or during the term of this Agreement relating to the PRODUCT, whether or not covered by any patent, copyright, design, trademark or other industrial or intellectual property rights. [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Elan. EIS and/or Acusphere shall have the right to assign their rights and obligations hereunder to their Affiliates provided, however, that such assignment does not result in adverse tax consequences for any other Parties.
Elan. Elan represents and warrants to Amarin as of the Termination Date as follows:
Elan. EIS and/or Athersys shall have the right to assign their rights and obligations hereunder to their respective Affiliates, PROVIDED, HOWEVER, that such assignment does not result in adverse tax consequences for any other parties PROVIDED, HOWEVER, that the assigning party shall remain liable for its obligations hereunder after such assignment
Elan. Draxis shall cooperate with Elan in taking reasonable and legally authorized steps to reduce or to eliminate such withholding or other taxes.
Elan. Elan shall not license, develop, manufacture or sell any oral dosage formulation (i) applying the Elan Intellectual Property to the Compound, (ii) applying the Elan Improvements to either constituent ingredient of the Compound as the sole active ingredient or (iii) applying the Elan Intellectual Property to hydralazine as the sole active ingredient: in the Territory during the Term;(provided, however, that to the extent EEA laws and regulations specifically so require, this restriction shall apply in the EEA for a period of five years beginning on the date of First Commercial Sale of the Product in the EEA, or such other maximum time period as EEA laws and regulations shall specifically so require).
