Auxilium Sample Clauses

Auxilium. Auxilium shall defend BTC at Auxilium’s cost and expense, and will indemnify and hold BTC and their respective directors, officers, employees, consultants, contractors, representatives, and agents harmless from and against any and all losses, costs, damages, fees, or expenses (including reasonable attorney’s fees and expenses) (“Losses”) incurred in connection with or arising out of any Third Party claim (a “Third Party Claim”) directly relating to (i) any material breach by Auxilium of its representations or warranties or obligations pursuant to this Agreement, (ii) any gross negligence or willful misconduct of Auxilium, its Affiliates, or their respective directors, officers, employees, contractors, consultants, agents, representatives, or Sublicensees in the exercise of any of Auxilium’ rights or the performance of any of Auxilium’ obligations under this Agreement, and (iii) the handling, packaging, storage, or Commercialization by Auxilium or any of its Affiliates or Sublicensees of any Product in the Territory (excluding all intellectual property infringement or related claims, which are covered in Section 12.2); provided that notwithstanding the foregoing, in all cases referred to in this Section 12.1, Auxilium shall have no liability to BTC for any Losses to the extent that such Losses were caused by any item for which BTC is required to indemnify Auxilium pursuant to Section 12.2.

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Auxilium. Auxilium shall indemnify and hold Distributor harmless from and against any and all loss, including, without limitation, court costs and reasonable attorneys’ fees and expenses regardless of outcome, arising out of any and all governmental or private actions based upon (i) a failure of the Product to meet the Specifications up to the expiry date marked on the Product, except where such failure is caused by improper storage and or handling of the Product after delivery to Distributor’s Warehouse or (ii) the quality of the Product or the proper and intended use of the Product, or (iii) alleged Product patent or Trademark infringement, except if, and to the extent that, any such loss is related in any way to the negligence or willful malfeasance of the Distributor.

Auxilium. Auxilium shall indemnify and hold Ipsen harmless from and against any and all loss, including, without limitation, court costs and reasonable attorneys’ fees and expenses regardless of outcome, arising out of any and all governmental or private actions based upon (i) design defects of the Product, (ii) labeling defects in countries where Auxilium or its Affiliates holds the Marketing Authorizations and (iii) Auxilium’s or its Affiliates’ gross negligence and willful malfeasance except if, and to the extent that, any such loss is related in any way to the gross negligence or willful malfeasance of the Ipsen or its Affiliates or Sub-licensee(s).

Auxilium. Auxilium hereby covenants that it shall not (and shall cause its Affiliates not to), during the Exclusivity Period, (i) develop (including submitting any applications for regulatory approval) or manufacture any pharmaceutical product consisting of the colG and colH collagenase gene sequences from Clostridium histolyticum and variants thereof, and their encoded proteins expressed either homologously or heterologously together with the isolated enzyme products used individually or in combination for use in the Field in the Territory or (ii) develop (including submitting any applications for regulatory approval), manufacture or commercialize any pharmaceutical product indicated for use in the Field in the Territory, in each case of (i) and (ii), either on its own, with or through any Affiliate, or in collaboration with a Third Party, and in each case other than with respect to the Development and Commercialization of the Product in the Field in the Territory pursuant to this Agreement. Notwithstanding the foregoing, the limitations set forth in this Section 2.5.2 shall not apply to any New Indication, subject to Section 2.6.

Auxilium. Auxilium shall indemnify and hold Ipsen harmless from and against ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. any and all loss, including, without limitation, court costs and reasonable attorneys’ fees and expenses regardless of outcome, arising out of any and all governmental or private actions based upon (i) Auxilium’s or its Affiliates’ gross negligence and willful malfeasance, (ii) a failure of the Product to meet the Specifications up to the expiry date marked on the Product, except where such failure is caused by improper storage and or handling of the Product after delivery to Xxxxx’x Warehouse; (iii) design defects of the Product; or (iii) labeling defects in countries where Auxilium or its Affiliates holds the Marketing Authorizations, except if, and to the extent that, any such loss is related in any way to the gross negligence or willful malfeasance of Ipsen, its Affiliates or Sub-licensee(s).

Auxilium. Auxilium hereby covenants that it shall not (and shall cause its Affiliates not to), during the Term, (i) develop (including submitting any applications for regulatory approval), manufacture or commercialize any collagenase-based pharmaceutical for use in the Field in the Territory or (ii) develop (including submitting any applications for regulatory approval), manufacture or commercialize any Competitive Product in the Territory, in each case of (i) and (ii), either on its own, with or through any Affiliate, or in collaboration with a Third Party, and in each case other than with respect to the Development and Commercialization of the Product in the Field in the Territory pursuant to this Agreement. Notwithstanding the foregoing, the limitations set forth in this Section 2.5.2 shall not apply to any New Indication, subject to Section 2.6.

Auxilium. Auxilium hereby covenants that it shall not (and shall cause its Affiliates not to), during the Term, develop (including submitting any applications for regulatory approval), manufacture or commercialize any Competitive Product in the Field in the Territory, either on its own, with or through any Affiliate, or in collaboration with a Third Party, and in each case other than with respect to the Development of Bulk Product and Commercialization of the Finished Product in the Field in the Territory pursuant to this Agreement. Notwithstanding the foregoing, the limitations set forth in this Section 2.5.2 shall not apply to any New Indication, subject to Section 2.6. Should Auxilium or its Affiliates, during the Term, develop (including submitting any applications for regulatory approval), manufacture or commercialize any Competitive Product in the Field, either Party may initiate discussions regarding the commercial viability of such Competitive Product in the Field in the Territory and should Auxilium, following such discussions, desire to develop or commercialize such Competitive Product in the Field in the Territory, Auxilium shall offer the exclusive rights to such Competitive Product in the Field in the Territory to Actelion, the details of which shall be negotiated in good faith between the Parties.

Auxilium. Auxilium hereby covenants that it shall not (and shall cause its Affiliates not to), during the Term manufacture or commercialize any Competitive Product in the Field in the Territory, either on its own, with or through any Affiliate, or in collaboration with a Third Party, and in each case other than with respect to the Development of Bulk Product and Commercialization of the Finished Product in the Field in the Territory pursuant to this Agreement. Notwithstanding the foregoing, the limitations set forth in this Section 2.5.2 shall not apply to any New Indication. Should Auxilium or its Affiliates, during the Term, develop (including submitting any applications for regulatory approval), manufacture or commercialize any Competitive Product in the Field, either Party may initiate discussions regarding the commercial viability of such Competitive Product in the Field in the Territory and should Auxilium, following such discussions, desire to develop or commercialize such Competitive Product in the Field in the Territory, Auxilium shall offer the exclusive rights to such Competitive Product in the Field in the Territory to Sobi, the details of which shall be negotiated in good faith between the Parties.

Auxilium. As from the Termination Date, and provided that the transitional obligations of the Parties described in this Termination Agreement are observed and performed by each Party during the Transition Period, and subject to Auxilium’s rights to indemnification pursuant to Section 17 of the License Agreement, Auxilium hereby releases and forever discharges Ipsen, any Affiliate, and its and their present and former shareholders, officers, directors, agents, employees, attorneys, successors, and assigns from any and all debts, liabilities, obligations, promises, covenants, contracts, endorsements, bonds, controversies, actions, causes of action, judgments, damages, expenses, claims and demands of any nature whatsoever, known or unknown, fixed or contingent, in law or in equity, which against Ipsen, Auxilium had, or now has, or hereafter can, shall or may have jointly, severally, or in the alternative, for, or by reason of, any matter or cause whatsoever arising from or related in any manner whatsoever to the License Agreement or Termination Agreement.

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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” means the individual or company that has entered into an Agreement with the Embassy. “Offer” means a response to a solicitation that, if accepted, would bind the offeror to perform the resultant Agreement.

Regulatory Materials (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply.

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.

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.

Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable. (b) To the extent a recall is required by applicable Law, or due to a potential safety hazard, non-compliance or Serial Defect, which is caused by Supplier, Supplier shall indemnify and hold Buyer harmless from all reasonable costs and expenses incurred in connection with any recall, repair, replacement or refund program, including all costs related to: (i) investigating and/or inspecting the affected goods; (ii) notifying Buyer’s customers; (iii) repairing, or where repair of the goods is impracticable or impossible, repurchasing or replacing the recalled goods; (iv) packing and shipping the recalled goods; and (v) media notification. Each party shall consult the other before making any statements to the public or a governmental agency relating to such recall, potential safety hazard, non- compliance or Serial Defect, except where such consultation would prevent timely notification required by Law.

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.

Regulatory Filing In the event that this Interconnection Service Agreement contains any terms that deviate materially from the form included in Attachment O of the Tariff, Transmission Provider shall file the Interconnection Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff within thirty days after execution. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix 2. An Interconnection Customer shall have the right, with respect to any Interconnection Service Agreement tendered to it, to request (a) dispute resolution under Section 12 of the Tariff or, if concerning the Regional Transmission Expansion Plan, consistent with Schedule 5 of the Operating Agreement, or (b) that Transmission Provider file the agreement unexecuted with the Commission. With the filing of any unexecuted Interconnection Service Agreement, Transmission Provider may, in its discretion, propose to FERC a resolution of any or all of the issues in dispute between or among the Interconnection Parties.

Product Recalls (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such action. The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).

Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

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