CONFIDENTIAL TREATMENT REQUESTED Sample Clauses

CONFIDENTIAL TREATMENT REQUESTED. Confidential portions of this document have been redacted and have been separately filed with the Commission.

CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Parties must expend for discovery; provided that the Arbitrator shall permit such discovery as he or she deems necessary to permit an equitable resolution of the dispute. The Parties shall use reasonable efforts to expedite the arbitration if requested by either Party. The Arbitrator shall, within fifteen (15) days after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The award shall be final and binding on the Parties and non-appealable, and judgment upon the award rendered by the Arbitrator may be entered in any court of competent jurisdiction. The proceedings and the final award shall be confidential. All arbitration proceedings must be completed within one hundred eighty (180) days of the date of the notice instituting arbitration proceedings provided by a Party to the other Party pursuant to Section 16.1 or as soon as practicable thereafter. The question of arbitrability and whether a claim, dispute or other matter in question would be barred by the applicable statute of limitations, which statute of limitations also shall apply to any claim or dispute subject to arbitration under this Agreement, shall be determined by binding arbitration pursuant to this Section 16.2. Each Party shall bear its own fees costs and expenses (including attorneys’ fees and expenses), arising out of the arbitration described in this Section 16.2, and shall pay an equal share of the fees, costs and expenses of the Arbitrator and all other general fees related to the arbitration; provided, however, that the Arbitrator shall be authorized to allocate fees and expenses in a way that bears a reasonable relationship to the outcome of the arbitration, with the Party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses. Unless the Parties otherwise agree in writing, during the period of time that any arbitration proceeding is pending under this Agreement, the Parties shall continue to comply with all those terms and provisions of this Agreement that ...

CONFIDENTIAL TREATMENT REQUESTED. Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk (“[***]”) to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.

CONFIDENTIAL TREATMENT REQUESTED. Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to omitted portions marked “***”.

CONFIDENTIAL TREATMENT REQUESTED waivers shall not have been obtained prior to the Closing and Buyer shall have waived the applicable condition to Closing with respect to such item(s), this Agreement shall not constitute a sale, assignment, transfer, conveyance or delivery, or any attempted sale, assignment, transfer, conveyance or delivery, thereof. Following the Closing, the parties shall use reasonable efforts and shall cooperate with each other, to obtain promptly such authorizations, approvals, consents or waivers. Pending such authorization, approval, consent or waiver, the parties shall cooperate with each other in any reasonable and lawful arrangements designed to provide to Buyer the benefits and liabilities of use of such Purchased Asset. Once such authorization, approval, consent or waiver for the sale, assignment, transfer, conveyance or delivery of a Purchased Asset not sold, assigned, transferred, conveyed or delivered at the Closing is obtained, Seller shall and shall cause its Affiliates to promptly assign, transfer, convey and deliver, or cause to be assigned, transferred, conveyed and delivered, such Purchased Asset to Buyer for no additional consideration. To the extent that any such Purchased Asset cannot be transferred or the full benefits and liabilities of use of any such Purchased Asset cannot be provided to Buyer following the Closing pursuant to this Section 6.9, then Buyer and Seller shall enter into such arrangements (including subleasing or subcontracting if permitted) designed to provide to Buyer the economic and operational equivalent of obtaining such authorization, approval, consent or waiver and the performance by Buyer of the obligations thereunder to the extent permitted by Law.

CONFIDENTIAL TREATMENT REQUESTED necessary to enable Alimera and/or its subcontractors to manufacture and perform quality testing on Medidur FA to satisfy Commercial Supply Requirements, all to the extent set forth in the CDS Development Budget and reimbursed pursuant to Section 3.1.2. CDS and/or its Permitted Subcontractors shall be responsible for the following activities in association therewith (to the extent set forth in the CDS Development Budget and any costs of which will be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, within ninety (90) days after the Amendment Effective Date, CDS shall provide to Alimera a Pharmaceutical Development Report, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant country.

CONFIDENTIAL TREATMENT REQUESTED. (g) ASTRA's obligation to pay royalty and other remunerations set out above in this Article 4.6 shall for each country and each separate Product remain in force for so long as ASTRA is the holder of a valid product patent protecting the respective Product or in case of a Product not protected by a valid product patent of ASTRA until * following the commercial launch of the Product in each country. (h) All payments due hereunder shall be payable in United States dollars. Conversion of foreign currency to U.S. dollars shall be made at the conversion rate existing in the United States (as reported by the Wall Street Journal) on the last working day of each royalty period. Such payments shall be without deduction of exchange, collection or other charges except charges of receiving bank * Late payments shall be subject to an interest charge of one and one half percent (1.5%) per month. (i) If transfer to U.S. dollars is subject to administrative authorization, ASTRA undertakes to file the transfer application with the competent authorities supported by all requisite documentation, and to apply its reasonable efforts to obtain such authorization and effect the remittance within the period laid down above. ASTRA further agrees to effect the transfer within thirty (30) days following the date on which authorization shall have been granted, provided that ASTRA shall not be obligated to pay before the date stipulated above. (j) If for any reason beyond the control of ASTRA the transfer of payments under this Section 4 are not effected within the period hereinabove provided or within such further period of time that GTC may allow, ASTRA shall settle such payments as soon as the impediment has ceased to exist. (k) In order to make possible the control of the calculations and payments provided for in this 4.6, the records of sales of Products entitling GTC to royalty and other payments under this 4.6 are open to inspection within two (2) years after the end of each calendar year by an independent certified public accountant engaged and paid by GTC and to whom ASTRA shall have no reasonable objection. Such accountant shall either confirm the accuracy of the statement by ASTRA or provide the necessary correction thereto but he shall not otherwise disclose any records or other information. In the event that any such inspection shows an under-reporting and underpayment ASTRA shall pay any additional sum that would have been payable to GTC had ASTRA reported correctly, plus...

CONFIDENTIAL TREATMENT REQUESTED. WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***”

CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. used by Magenta for the express purposes outlined in this Agreement and may not be disclosed or distributed in any form to any individual or entity without prior written approval of BTMB. Improper use and disclosure of Individually Identifying Data is a material breach of this Agreement and will subject Magenta to contract damages and possible liability to third parties injured by Magenta’s failure to comply with the requirements of this Section 13. In the event of an Individually Identifying Data breach, Magenta shall: (i) provide BTMB with the name and contact information for an employee of Magenta who shall serve as BTMB’s primary security contact [***]; (ii) notify BTMB of a Individually Identifying Data security breach as soon as practicable, but no later than [***] after Magenta becomes aware of it; and (iii) notify BTMB of any Individually Identifying Data security breaches by phone and e-mail via Magenta’s primary business contact with BTMB. The notification obligation shall include, to the extent possible, the identification of each individual whose unsecured Individually Identifying Data has been, or is reasonably believed by Magenta to have been, accessed, acquired, used, or disclosed during the Individually Identifying Data security breach. Additionally, at least annually, Magenta shall conduct site audits of the information technology and information security controls for all facilities used in complying with its obligations under this Agreement, including, but not limited to, obtaining a network-level vulnerability assessment performed by a recognized third-party audit firm based on the recognized industry best practices. Magenta shall be liable for any and all liabilities and damages caused by its breach of the obligations set forth in this Section.