Repligen and CRC shall not disparage each other or each other’s products, whether in public or private. Any factual statements contained in labeling approved by FDA or advertising submitted to FDA shall be expressly permitted and shall not constitute disparagement. Any such labeling or advertising shall be provided to either Party upon request of the other Party.
Repligen. Affiliates, and Sublicensees assume all risk of damage or injury to persons or property arising out of the clinical testing, manufacture, use, distribution or sale of the Licensed Products by them or authorized by them and shall hold harmless and indemnify UM, its officers and employees from and against any and all personal injury, property damage, product liability or similar claims, losses and liabilities arising out or Repligen's, Affiliates' or Sublicensees' (or any business associated of any of these) clinical testing, manufacture, use, distribution or sale of the Licensed Products, including reasonable attorneys fees and other costs or defense. UM shall, promptly upon receipt of any claim that may be subject to indemnification hereunder, give written notice to Repligen of such claim, and Repligen shall assume the defense thereof, including the employment of counsel reasonably satisfactory to UM. UM shall have the right to employ separate counsel in any such action and to participate in the defense thereof, but the fees and expenses thereof shall be at UM's expense. Repligen shall not be liable for any settlement of any such claim, action or proceeding effected without its written consent.
Repligen agrees to ensure that UM is fully reimbursed for the costs associated with prosecution and maintenance of Licensed Patents in the Licensed Field in accordance with this Agreement and the agreement made November 17, 1999 by and between the Parties and GI and attached hereto as Exhibit A. Repligen acknowledges and agrees that UM is to be reimbursed, in a matter *CONFIDENTIAL TREATMENT REQUESTED appropriately apportioned between GI and Repligen, for all expenses of all Licensed Patents. Unless and until otherwise arranged by the Parties and GI, Repligen shall reimburse all expenses related to US Applications 08/314,851, 08/475,741, and 08/385,194 and all related filings (including continuations, foreign equivalents, and resulting patents.
Repligen agrees to refrain from any business dealing relating to Licensed Products in which a significant purpose or result would be to lower UM's share of income or actual income resulting from this Agreement or the sale, use or commercialization of Licensed Products. This Section 8.13 shall not be construed in such a way as to (i) enlarge Repligen's obligations under Section 7.1 or (ii) provide any remedy to UM if Repligen terminates this Agreement under Section 13.4.
Repligen shall keep and it shall cause Affiliates and Sublicensees to keep, true and accurate records and books of account containing data reasonably required for the computation and verification of payments to be made as provided by this Agreement, which records and books shall be open for inspection upon reasonable notice during business hours by either UM auditor(s) or an independent certified accountant selected by UM, except one to whom Repligen has a reasonable objection, for the purpose of verifying the amount of payments due and payable. Said right of inspection may exercised not more than once in any calendar year, but will exist for four (4) years from the date of origination of any such record and this requirement and right of inspection shall survive any termination of this Agreement. UM shall be responsible for all expenses of its auditor(s) or independent accountants associated with such inspection. However, in the event that such inspection reveals an underpayment of royalties to UM in excess of ten percent (10%), then said inspection shall be at Repligen's expense and such underpayment shall become immediately due and payable to UM. If such inspection reveals an overpayment of royalties to UM, at Repligen's election, UM shall promptly reimburse Repligen to the extent of such overpayment or credit such overpayment against Repligen's next royalty payment to UM.
Repligen. Affiliates and Sublicensees shall make no statements, representations or warranties or accept any liabilities or responsibilities whatsoever to or with regard to any person or entity which are inconsistent with any disclaimer or limitation included in this Article XII.
Repligen agrees to develop a plan (“the * Plan”) to comply with best * practises according to those relevant portions of the guidelines published by * under the name * in relation to Biotech rPA. For this purpose Repligen has adopted an implementation program including the milestones set forth in Appendix 4 (the “* Milestones”). * CONFIDENTIAL TREATMENT REQUESTED Repligen will assume all the costs incurred in connection with implementing best * practises according to the * and any costs for the * Plan in excess hereof relating to GEHC specific requirements shall be shared as agreed on a case by case basis. Repligen and GEHC shall agree in advance on any costs which GEHC shall assume in this respect. GEHC shall have the right to carry out audits of the * Plan at Repligen on or in close connection to each of the milestones dates in Appendix 4 and thereafter on a regular basis. If any of the * Milestone is not timely met, and following GEHC written notice thereof, Repligen shall use its best efforts to remedy such failure as soon as possible and in each case within the remedy periods agreed in Appendix 4. If such a failure is not remedied within the agreed remedy periods then GEHC shall have the right to terminate this Amendment No. 1 with immediate effect upon a second written notice, unless the failure is of no significant importance to the overall quality of the * Plan. If this Amendment No. 1 is terminated pursuant to this Section 6.1, Amendment No. 1 to the License Agreement shall also immediately terminate and be of no further force or effect as specified in Section 2.4 of Amendment No. 1 to the License Agreement.
Repligen agrees to use its best efforts to bring one or more Licensed Products to the marketplace through a diligent program of development, production and distribution. For the purpose hereof, “best efforts” shall mean the usual practice followed by Repligen in pursuing commercialization of its products. Repligen shall be deemed to have satisfied its obligation under this Section 3 in each year that it expends (or its Sublicensees expend) at least $1,000,000 on the research, development or commercialization of Licensed Products.
Repligen s failure to perform in accordance with Section 3.1 shall be grounds for DFCI to terminate pursuant to Section 7.5 of this AGREEMENT. It is understood that termination shall be DFCI’s sole and exclusive remedy for any such failure to perform.
Repligen shall keep true books of account containing, an accurate record of all data necessary for the determination of the amounts payable under Article IV hereof. Said records shall be kept at Repligen’s principal place of business or the principal place of business of the appropriate division of Repligen to which this AGREEMENT relates. Said records shall be available for inspection at DFCI’s sole expense by a certified public accountant selected by DFCI and reasonably acceptable to Repligen during regular business hours for five (5) years following the end of the calendar year to which they pertain in order for DFCI to ascertain the correctness of any report and/or payment made under this AGREEMENT. There shall be no more than one (1) such inspection in any calendar year. The provisions of this Section 5.1 shall survive termination of this Agreement.
