Records; Audit Rights. Client will keep complete and accurate books and records relating to all amounts payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expenses.
Appears in 4 contracts
Samples: Development and License Agreement, Quality Agreement (Biohaven Pharmaceutical Holding Co Ltd.), Quality Agreement (Biohaven Pharmaceutical Holding Co Ltd.)
Records; Audit Rights. Client will Xxxxxx and its Affiliates and Sublicensees shall keep and maintain for [*****] years from the date of each Royalty Payment, Operating Income Payment and Sublicense Income Payment complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) by Xxxxxx and is achievement its Affiliates and Sublicensees of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseProduct, in sufficient detail to enable allow Royalty Payments, Operating Income Payments and Sublicense Income Payments to be determined accurately. Enanta shall have the calculation and verification right for a period of all payments payable [*****] years after receiving any such payment to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to inspect or audit, or to have appoint at its expense an independent certified public accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent Xxxxxx to prohibit inspect or audit the relevant records of Xxxxxx and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. Xxxxxx and its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent accounting firm certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from disclosing Client’s financial Enanta, solely to verify that Royalty Payments and proprietary information except as contemplated by this AgreementSublicense Income Payments were correctly accounted for or determined. Prior Enanta shall not exercise such inspection or audit right [*****]. All records made available for inspection or audit shall be deemed to disclosing the be Confidential Information of Xxxxxx. The results of any such audit to Catalenteach inspection or audit, if any, shall be binding on both Parties. In the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses event there was an underpayment by Client of Xxxxxx, Xxxxxx shall promptly (but in any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within event no later than [* * *****] days after the date Client receives the auditors’ final written report. Any fees and expenses Xxxxxx’x receipt of the independent accountant’s report so concluding) make payment to Enanta of any shortfall, together with the interest payment as provided in Section 6.5.5. In the event that there was an overpayment by Xxxxxx, Enanta shall promptly (but in any event no later than [*****] days after Enanta’s receipt of the independent accountant’s report so concluding) refund to Xxxxxx the excess amount. Enanta shall bear the full cost of such audit shall be paid by Catalent unless the such audit discloses an understatement underreporting by Client Xxxxxx of more than [* * *]% ****] of the aggregate amounts amount of Royalty Payment or Sublicense Income Payments payable to Catalent pursuant to this Agreement during such audit periodin any Calendar Year, in which case Client Xxxxxx shall bear the responsibility reimburse Enanta for any all costs incurred by Enanta in connection with such reasonable fees and expensesinspection or audit.
Appears in 4 contracts
Samples: Development and License Agreement (Enanta Pharmaceuticals Inc), Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc), Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc)
Records; Audit Rights. Client will Each of Shore and Santarus shall keep (and shall cause its Affiliates and shall require its sublicensees to keep) complete and accurate books and records relating that are necessary for the other Party to all amounts payable ascertain and verify the payments owed hereunder and Santarus’ expenditures to Catalent hereunder, sales of Products, its calculation of royalties Promote the Licensed Product required under Section 5.1(b). During the Term and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least a period [* * ***] years after thereafter, each of Shore and Santarus shall permit an independent, certified public accountant of nationally recognized standing appointed by the expiration of the year to which they relateother Party, at reasonable times and upon reasonable notice, but in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not no case more than once per calendar yearCalendar Year, Catalent to examine (but not copy) such records as may be necessary for the sole purpose of verifying the calculation and reporting of Net Sales and the correctness of any payment made under this Agreement for any period within the preceding [***] and of the amount of Santarus’ expenditures to Promote the Licensed Product during each Calendar Quarter as required under Section 5.1(b) hereof and compliance with any other terms and provisions of this Agreement; provided that each Party shall only be entitled to audit, one audit following expiration or to have an independent accountant audit, such books termination of this Agreement; and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination provided further that neither Party shall be limited permitted to pertinent Records for any year ending not audit the same period of time more than [* * *] years prior to the date of such requestonce. Before permitting such independent accounting firm to have access to such Records and personnelThe independent, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors certified public accountant will prepare and provide to Client each of Shore and Catalent Santarus a written report stating whether the royalty reports submitted and royalties paid, the expenditures to Promote the Licensed Product reported to Shore, or other payments made to Catalent for by either Party, as the audit period case may be, are correct or incorrect and the details of concerning any discrepancies. If Such accountant shall disclose to Shore or Santarus, as the case may be, only the amounts that the independent auditor believes to be due and payable hereunder to such Party, details concerning any discrepancy from the amount paid and the amount due, and shall disclose no other information revealed in such audit. Any and all records of a Party examined by such independent accountant shall be deemed such Party’s Confidential Information which may not be disclosed by said independent, certified public accountant to any Third Party, and such Party may require such accountant to enter into an audit discloses appropriate written agreement obligating it to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than the obligations set forth in ARTICLE 10. In the event there was an underpayment by Client either Party of any amounts paid pursuant to any provision of owed under this Agreement, such amounts Party shall promptly (but in no event later than [***] after its receipt of the independent auditor’s report so concluding) make payment to the other Party of any such shortfall. In the event that there was an overpayment by either Party hereunder, the other Party shall promptly (but in no event later than [***] after the other Party’s receipt of the independent auditor’s report so concluding) refund to Shore or Santarus, as the case may be, or credit to or against future royalties, at Santarus’ election, the excess amount. The expense of such audit shall be paid borne by the auditing Party; provided, however, that, if such audit establishes that the audited Party underpaid the auditing ***Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to Catalent within the omitted portions. Party by more than [* * ***] days after the date Client receives the auditors’ final written report. Any fees and expenses of the aggregate amount due hereunder for the period covered by such audit, or that expenditures to Promote the Licensed Product for a Calendar Quarter covered by such audit were less than the minimum spend required by Section 5.1(b), then the reasonable out-of-pocket expense of such audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expensesaudited Party.
Appears in 3 contracts
Samples: License Agreement, License Agreement (Salix Pharmaceuticals LTD), License Agreement (Santarus Inc)
Records; Audit Rights. Client will Each party shall keep complete and accurate books and records relating to all amounts payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters accuracy and completeness of all activities in questionconnection with this Agreement, including without limitation, inventory, shipping and delivery, storing, handling, transport, costs, sales, purchase and invoice records relating to the Product. Such access books and records shall include be preserved for a period not less than ten (10) years after they are created during and after the right Term. Either party may, upon not less than fifteen (15) business days advance written notice, audit all the books and records of Catalent the other party relating to this Agreement at a single United States location to verify the accuracy of such party's accounting. Any audit performed pursuant to this Section 3.8 shall be at expense of the party conducting such audit, unless it reveals a underpayment or overpayment of five per cent (5%) or more in favor of the independent accounting firm to interview Catalent’s personnel audited party for any Contract year, in which case the audited party shall reimburse the auditing party for the actual costs of such audit. Such audit may be performed by any employee of the requesting party as Catalent well as by any attorney or licensed certified public accountant designated by the requesting party, upon not less than fifteen (15) business days advance notice, during regular business hours, and in a manner that shall not unreasonably interfere with such independent accounting firm determines appropriateparty's normal business operations. Each party shall conduct no more than one (1) audit during any Contract Year, PROVIDED, HOWEVER, that such examination audit shall not be limited to the current Contract Year, but shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date period since the completion of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such the immediately preceding audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepanciesif any. If an audit discloses an reveals any underpayment by Client OMP to LifeCell, OMP shall pay LifeCell the amount of any amounts paid such [***] Material has been omitted pursuant to any provision a request for confidential treatment and such material has been filed separately with the Securities and Exchange Commission. underpayment within five (5) days of this Agreement, written notification of such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written reportunderpayment. Any fees and expenses of If the audit shall be paid by Catalent unless reveals that OMP has made an overpayment to LifeCell, the audit discloses an understatement by Client amount overpaid will be, at the option of more than [* * *]% of OMP, returned forthwith to OMP or credited to the aggregate amounts payable to Catalent pursuant to this Agreement during next such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expensespayment or payments due OMP from LifeCell.
Appears in 2 contracts
Samples: Promotion Agreement (Omp Inc), Promotion Agreement (Omp Inc)
Records; Audit Rights. Client will AstraZeneca shall (and shall use reasonable efforts to ensure that its Affiliates and Sublicensees shall) keep complete and accurate books maintain for [********] from the date of each payment of royalties hereunder (or such longer period as may be required by Applicable Law) records of AZ Net Sales by AstraZeneca, its Affiliates and Sublicensees (as the case may be) of each Product in sufficient detail to allow royalties to be determined accurately. Targacept shall have the right for a period of [********] after receiving any such payment to inspect or audit, or to appoint at its expense an independent certified public accountant reasonably acceptable to AstraZeneca to inspect or audit, the relevant records relating of AstraZeneca and its Affiliates to all amounts payable verify that the amount of such payment was correctly determined. AstraZeneca and its Affiliates shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from Targacept, solely to Catalent hereunder, verify that royalty payments hereunder were correctly determined. Such inspection or audit right shall not be exercised by Targacept more than [********] in any Calendar Year more than [********] with respect to sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to a particular Product in Section 4.1(D) for at least a particular period or more than [* * ********] years after the expiration end of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”)such period. Upon the written request and not more than once per calendar year, Catalent All records made available for inspection or audit shall be entitled deemed to audit, or to have an independent accountant audit, such books be Confidential Information of AstraZeneca and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to any such inspection or audit the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved accountant shall enter into a non-disclosure agreement in such audit, to sign to sign a confidentiality agreement form reasonably acceptable to Catalent to prohibit the independent AstraZeneca. The accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior shall disclose to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating Parties whether the payments made to Catalent for the audit period royalty reports are correct or incorrect and the specific details of concerning any discrepancies. If No other information shall be provided to Targacept. The results of each inspection or audit, if any, shall be binding on both Parties absent manifest error. In the event there was an underpayment by AstraZeneca hereunder, AstraZeneca shall promptly (but in any event no later than [********] after AstraZeneca’s receipt of the report so concluding) make payment to Targacept of any shortfall. In the event that there was an overpayment by AstraZeneca hereunder, Targacept shall promptly (but in any event no later than [********] after Targacept’s receipt of the independent accountant’s report so concluding) refund to AstraZeneca the excess amount. Targacept shall bear the full cost of such audit unless such audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client AstraZeneca of more than [* * *]% *******] of the aggregate amounts amount of royalties payable to Catalent pursuant to this Agreement during such audit periodin any Calendar Year, in which case Client AstraZeneca shall bear the responsibility reimburse Targacept for any all costs incurred by Targacept in connection with such reasonable fees and expensesinspection or audit.
Appears in 2 contracts
Samples: Collaborative Research and License Agreement (Targacept Inc), Collaborative Research and License Agreement (Targacept Inc)
Records; Audit Rights. Client will WCCI and its Affiliates and Sublicensees shall keep for three (3) years from the date of each payment of royalties complete and accurate books records of sales by WCCI and records relating to all amounts payable to Catalent hereunder, sales its Affiliates and Sublicensees of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseProduct, in sufficient detail to enable allow the calculation accruing royalties to be determined accurately. Paratek shall have the right for a period of three (3) years after receiving any such report or statement to appoint at its expense an independent certified public accountant (bound by written confidentiality obligations no less protective than those set forth in Article 6 hereof) reasonably acceptable to WCCI to inspect the relevant records of WCCI and verification its Affiliates and Sublicensees to verify such report or statement. WCCI and its Affiliates and Sublicensees shall each make its records available for inspection by such independent certified public accountant during their regular business hours at such place or places where such records are customarily kept, upon reasonable notice from Paratek, solely to verify the accuracy of all payments payable to Catalent hereunder (“Records”)the reports and payments. Upon the written request and Such inspection right shall not be exercised by Paratek more than once per calendar yearin any Calendar Year nor more than once with respect to sales of any Product in any given period. Paratek agrees to hold in strict confidence, Catalent and in accordance with Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. Article 6 hereof, all information concerning such payments and reports, and all information learned in the course of any audit or inspection, except to the extent necessary for Paratek to reveal such information in order to enforce its rights under this Agreement or if disclosure is required by law. The results of each inspection, if any, shall be entitled to auditbinding on both Parties, or to have an independent accountant auditabsent manifest error. Paratek shall pay for such inspections, such books and records. Client shall provide Catalent or such auditorsexcept that in the event there is any upward adjustment in the aggregate royalties, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records payable for any year ending not more than [* * *] years prior to the date of Calendar Year shown by such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client inspection of more than [* * *]% five percent (5%) of the aggregate amounts payable to Catalent pursuant to this Agreement during amount paid, WCCI shall pay for the reasonable costs of such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expensesinspection.
Appears in 2 contracts
Samples: Collaborative Research and License Agreement (Paratek Pharmaceuticals, Inc.), Collaborative Research and License Agreement (Paratek Pharmaceuticals Inc)
Records; Audit Rights. Client will keep complete and accurate books and records relating to all amounts payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(DSections 3.1(A) and 3.2(A) for at least [* * ***] years after the expiration of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once [***] per calendar year[***], Catalent shall be entitled to audit, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, the auditors with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records books and records of Client as may be reasonably necessary to verify the matters in question; provided, that such [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriateALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Each such examination auditors shall be limited to pertinent Records for any year ending not more than [* * *] years prior subject to the date obligations of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved confidentiality at least as strict as those set forth in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days an opportunity to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepanciesidentified. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * ***] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * ***]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit periodAgreement, in which case Client shall bear the responsibility for any such reasonable fees and expenses.
Appears in 2 contracts
Samples: Line Sale Agreement (Vaccinex, Inc.), Line Sale Agreement (Vaccinex, Inc.)
Records; Audit Rights. Client will Cara and its Affiliates and Sub-licensees shall keep and maintain, for [***] from the date of (x) each payment of royalties under this Agreement and (y) each milestone owed, complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) by Cara and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseits Affiliates and Sub-licensees, in sufficient detail to enable allow royalties and milestones on Net Sales to be determined accurately. All such records required to be maintained under this Section 6.7 shall include the calculation information contained in the reports required under Section 6.6. Enteris shall have the right for a period of [***] after receiving any such payments to appoint at its expense an independent certified public accountant reasonably acceptable to Cara to audit such records of Cara, or its Affiliates, to verify that the amount of any such payment was correctly determined. Cara and verification of all payments payable to Catalent hereunder (“Records”)its Affiliates shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] written notice from Enteris. Upon the written request and Such audit right shall not be exercised by Enteris more than once per calendar yearin any Calendar Year or more than once with respect to sales of a particular Product in a particular period or with respect to an individual milestone. All records CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Catalent MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED. made available for audit shall be entitled deemed to be Confidential Information of Cara. The results of each audit, or to have if any, shall be binding on both Parties absent manifest error. In the event there was an independent accountant auditunderpayment by Cara under this Agreement, such books and records. Client Cara shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Clientpromptly (but in any event no later than [***] after Cara’s relevant location and to such receipt of the pertinent Records report so concluding) make payment to Enteris of Client any shortfall together with interest as may be reasonably necessary to verify provided in Section 6.8 from the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or date such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior payment was due to the date paid in full. Enteris shall bear the full cost of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any audit unless such audit discloses a variance to Catalent, the auditors shall present Client with a preliminary report detriment of findings and provide Client with up to [* * *] days to respond to any questions raised Enteris of five percent 5% or issues identified (more from the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses amount of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, original payment calculation in which case Client Cara shall bear all reasonable cost of the responsibility for any performance of such reasonable fees and expensesaudit.
Appears in 1 contract
Samples: Non Exclusive License Agreement (Cara Therapeutics, Inc.)
Records; Audit Rights. Client will TG and its Affiliates, Sublicensees and Distributors shall keep and maintain for three (3) years from the date of each payment of royalties and/or Sublicense Royalties hereunder complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) by TG and is achievement its Affiliates, Sublicensees and Distributors of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseProduct, in sufficient detail to enable allow royalties and/or Sublicense Royalties to be accurately determined. LICENSOR shall have the calculation and verification right for a period of all payments payable three (3) years after receiving any such royalty payment to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have appoint at its expense an independent certified public accountant auditreasonably acceptable to TG to audit the relevant records of TG and its Affiliates, such books Sublicensees and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary Distributors to verify that the matters in question. Such access amount of each such payment was correctly determined; provided, that, (a) if requested by TG, LICENSOR shall include the right of Catalent or cause the independent accounting firm certified public accountant to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign enter into a confidentiality agreement reasonably acceptable to Catalent TG and (b) such independent certified public accountant may only disclose to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating LICENSOR whether the payments made to Catalent for the audit period royalties and/or Sublicense Royalties paid are correct or incorrect and the details of with respect to any discrepancies. If TG and its Affiliates, Sublicensees and Distributors shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon thirty (30) days written notice from LICENSOR. Such audit right shall not be exercised by LICENSOR more than once in any Calendar Year or more than once with respect to sales of a particular Product in a particular period. All records made available for audit shall be deemed to be Confidential Information of TG. The results of each audit, if any, shall be binding on both Parties absent manifest error. In the event there was an underpayment of royalties by TG hereunder, TG shall promptly (but in any event no later than thirty (30) days after TG’s receipt of the report so concluding) make payment to LICENSOR of any shortfall. LICENSOR shall bear the full cost of such audit unless such audit discloses an underpayment by Client TG of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of five percent (5%) or more than [* * *]% of the aggregate amounts amount of royalties and/or Sublicense Royalties payable to Catalent pursuant to this Agreement during such audit periodin any Calendar Year, in which case Client TG shall bear the responsibility reimburse LICENSOR for any all costs incurred by LICENSOR in connection with such reasonable fees and expensesaudit.
Appears in 1 contract
Samples: Exclusive License Agreement (Manhattan Pharmaceuticals Inc)
Records; Audit Rights. Client will AstraZeneca shall (and shall use reasonable efforts to ensure that its Affiliates and Sublicensees shall) keep complete and accurate books maintain for [********] from the date of each payment of royalties hereunder (or such longer period as may be required by Applicable Law) records of AZ Net Sales by AstraZeneca, its Affiliates and Sublicensees (as the case may be) of each Product in sufficient detail to allow royalties to be determined accurately. Targacept shall have the right for a period of [********] after receiving any such payment to inspect or audit, or to appoint at its expense an independent certified public accountant reasonably acceptable to AstraZeneca to inspect or audit, the relevant records relating of AstraZeneca and its Affiliates to all amounts payable verify that the amount of such payment was correctly determined. AstraZeneca and its Affiliates shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from Targacept, solely to Catalent hereunder, verify that royalty payments hereunder were correctly determined. Such inspection or audit right shall not be exercised by Targacept more than [********] in any Calendar Year more than [********] with respect to sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to a particular Product in Section 4.1(D) for at least a particular period or more than [* * ********] years after the expiration end of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”)such period. Upon the written request and not more than once per calendar year, Catalent All records made available for inspection or audit shall be entitled deemed to audit, or to have an independent accountant audit, such books be Confidential Information of AstraZeneca and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to any such inspection or audit the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved accountant shall enter into a non-disclosure agreement in such audit, to sign to sign a confidentiality agreement form reasonably acceptable to Catalent to prohibit the independent AstraZeneca. The accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior shall disclose to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating Parties whether the payments made to Catalent for the audit period royalty reports are correct or incorrect and the specific details of concerning any discrepancies. If an audit discloses No other information shall be provided to Targacept. The results of each inspection or audit, if any, shall be binding on both Parties absent manifest error. In the event there was an underpayment by Client of AstraZeneca hereunder, AstraZeneca shall promptly (but in any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within event no later than [* * ********] days after the date Client receives the auditors’ final written report. Any fees and expenses AstraZeneca’s receipt of the audit shall be paid by Catalent unless the audit discloses an understatement by Client report so concluding) make payment to Targacept of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expenses.any
Appears in 1 contract
Samples: Collaborative Research and License Agreement (Targacept Inc)
Records; Audit Rights. Client will MERCK and its Affiliates and Sublicensees shall keep and maintain for two years from the date of each payment of royalties hereunder complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including by MERCK and its Affiliates and Sublicensees of each Product, and the Cost of Goods Sold applicable to all relevant deductions) and is achievement Net Sales of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseProduct, in sufficient detail to enable allow royalties to be determined accurately. CARDIOME shall have the calculation right for a period of two (2) years after receiving any such payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK to audit the relevant records of MERCK and verification its Affiliates and Sublicensees to verify that the amount of all payments payable to Catalent hereunder such payment was correctly determined. MERCK and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon thirty (“Records”)30) days' written notice from CARDIOME. Upon the written request and Such audit right shall not be exercised by CARDIOME more than once per calendar year, Catalent in any Calendar Year or more than once with respect to sales of a particular Product in a particular period. All records made available for audit shall be entitled deemed to be Confidential Information of MERCK. The results of each audit, or to have if any, shall be binding on both Parties. In the event there was an independent accountant auditunderpayment by MERCK hereunder, such books and records. Client MERCK shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Clientpromptly (but in any event no later than thirty (30) days after MERCK’s relevant location and to such receipt of the pertinent Records report so concluding) make payment to CARDIOME of Client as may be reasonably necessary to verify any shortfall. CARDIOME shall bear the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date full cost of such request. Before permitting audit unless such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment underreporting by Client MERCK of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *Redacted - amount] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall total royalties payable in the audited period, as determined by the accountant to be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit periodcorrect, in which case Client MERCK shall bear the responsibility reimburse CARDIOME for any all costs incurred by CARDIOME in connection with such reasonable fees and expensesaudit.
Appears in 1 contract
Samples: Collaboration and License Agreement (Cardiome Pharma Corp)
Records; Audit Rights. Client will Biogen shall, and shall cause its Affiliates and permitted Sublicensees to, keep and maintain for three (3) years from the date of each payment under Section 4.5.1(a) (Royalty Rate) complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) of each Collaboration Product by Biogen, its Affiliates and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseits permitted Sublicensees, in sufficient detail to enable allow the calculation payments owing under Section 4.5.1(a) (Royalty Rate) to be determined accurately. Intec Pharma shall have the right for a period of three (3) years after receiving any such payment to appoint, at its expense, an independent certified public accountant reasonably acceptable to Biogen, to audit the relevant records of Biogen, its Affiliates and verification its permitted Sublicensees in order to verify that the amount of all payments payable to Catalent hereunder such payment was correctly determined. Biogen, its Affiliates and its permitted Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon thirty (“Records”)30) days written notice from Intec Pharma. Upon the written request and Such audit right shall not be exercised by Intec Pharma more than once per calendar year, Catalent in any Calendar Year. All records made available for audit shall be entitled deemed to auditbe Confidential Information of Biogen. If such independent certified public accountant correctly concludes that there was an underpayment by Biogen hereunder, or to have an independent accountant audit, such books and records. Client Biogen shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Clientpromptly (but in any event no later than forty-five (45) days after Intec Pharma’s relevant location and to such receipt of the pertinent Records report so concluding) make payment to Intec Pharma of Client as may be reasonably necessary to verify any shortfall. Intec Pharma shall bear the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date full cost of such request. Before permitting audit unless such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment underreporting by Client Biogen or its Affiliates or permitted Sublicensees of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% five percent (5%) of the aggregate amounts amount of royalties payable to Catalent pursuant to this Agreement during such audit periodin any Calendar Year, in which case Client Biogen shall bear the responsibility reimburse Intec Pharma for any all costs incurred by Intec Pharma in connection with such reasonable fees and expensesaudit. NOTE: PORTIONS OF THIS EXHIBIT ARE THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST BY THE REGISTRANT TO THE SECURITIES AND EXCHANGE COMMISSION (“COMMISSION”). SUCH PORTIONS HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE COMMISSION AND ARE MARKED WITH A “[***]” IN PLACE OF THE REDACTED LANGUAGE.
Appears in 1 contract
Samples: Note (Intec Pharma Ltd.)
Records; Audit Rights. Client will Cara and its Affiliates and Sub-licensees shall keep and maintain, for [***] from the date of (x) each payment of royalties under this Agreement and (y) each milestone owed, complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) by Cara and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseits Affiliates and Sub-licensees, in sufficient detail to enable allow royalties and milestones on Net Sales to be determined accurately. All such records required to be maintained under this Section 6.7 shall include the calculation information contained in the reports required under Section 6.6. Enteris shall have the right for a period of [***] after receiving any such payments to appoint at its expense an independent certified public accountant reasonably acceptable to Cara to audit such records of Cara, or its Affiliates, to verify that the amount of any such payment was correctly determined. Cara and verification of all payments payable to Catalent hereunder (“Records”)its Affiliates shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] written notice from Enteris. Upon the written request and Such audit right shall not be exercised by Enteris more than once per calendar year, Catalent in any Calendar Year or more than once with respect to sales of a particular Product in a particular period or with respect to an individual milestone. All records made available for audit shall be entitled deemed to be Confidential Information of Cara. The results of each audit, or to have if any, shall be binding on both Parties absent manifest error. In the event there was an independent accountant auditunderpayment by Cara under this Agreement, such books and records. Client Cara shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Clientpromptly (but in any event no later than [***] after Cara’s relevant location and to such receipt of the pertinent Records report so concluding) make payment to Enteris of Client any shortfall together with interest as may be reasonably necessary to verify provided in Section 6.8 from the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or date such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior payment was due to the date paid in full. Enteris shall bear the full cost of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any audit unless such audit discloses a variance to Catalent, the auditors shall present Client with a preliminary report detriment of findings and provide Client with up to [* * *] days to respond to any questions raised Enteris of five percent 5% or issues identified (more from the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses amount of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, original payment calculation in which case Client Cara shall bear all reasonable cost of the responsibility for any performance of such reasonable fees and expenses.audit. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED. - 28 -
Appears in 1 contract
Samples: Non Exclusive License Agreement (SWK Holdings Corp)
Records; Audit Rights. Client will For a period of [***] ([***]) years, sanofi-aventis shall keep and maintain, and shall require its respective Affiliates and Sublicensees to keep and maintain, such accurate and complete and accurate books and records relating to all amounts payable to Catalent in connection with the sale of Licensed Products hereunder, sales of Products, its as are necessary to allow the accurate calculation of royalties and Net Sales (including all relevant deductions) and is achievement consistent with generally accepted accounting principles of the milestone events referred royalties due to in Section 4.1(D) for at least [* * *] years after ImmunoGen, including any records required to calculate any royalty adjustments hereunder. Once per Calendar Year, ImmunoGen shall have the expiration of the year right to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have engage an independent accountant auditcertified public accounting firm of nationally recognized standing and reasonably acceptable to sanofi-aventis, such which shall have the right to examine in confidence the relevant books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location records of sanofi-aventis and to such of the pertinent Records of Client its respective Affiliates and Sublicensees as may be reasonably necessary to determine and/or verify the matters in questionamount of royalty payments due hereunder. Such access examination shall include be conducted, and sanofi-aventis shall make its records available, during normal business hours, after at least [***] ([***]) days prior written notice to sanofi-aventis, as applicable, and shall take place at the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or facility(ies) where such independent accounting firm determines appropriaterecords are maintained. Each such examination shall be limited to pertinent Records books and records for any year ending not more than [* * ***] years ([***]) months prior to the date of such requestrequest;provided, that, ImmunoGen shall not be permitted to audit the same period of time more than once. Before permitting such independent accounting firm to have access to such Records books and personnelrecords, Client sanofi-aventis may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement (in form and substance reasonably acceptable to Catalent each of the Parties) as to prohibit any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access, while conducting the audit under this paragraph. The ImmunoGen independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent each Party a written report stating whether the payments made to Catalent for the audit period royalty reports submitted and royalties paid are correct or incorrect and the specific details of concerning any discrepancies. If Such accounting firm may not reveal to ImmunoGen any information learned in the course of such audit other than the amount of any such discrepancies. ImmunoGen agrees to hold in strict confidence all information disclosed to it, except to the extent necessary for ImmunoGen to enforce its rights under this Agreement or if disclosure is required by law. In the event there was an underpayment by sanofi-aventis hereunder, sanofi-aventis shall promptly (but in no event later than [***] ([***]) days after such Party’s receipt of the independent auditor’s report so correctly concluding) make payment to ImmunoGen of any shortfall. In the event that there was an overpayment by sanofi-aventis hereunder, ImmunoGen shall promptly (but in no event later than [***] ([***]) days after ImmunoGen’s receipt of the independent auditor’s report so correctly concluding) refund to sanofi-aventis the excess amount. ImmunoGen shall bear the full cost of such audit unless such audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client sanofi-aventis of more than [* * ***] percent ([***]% %) of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit amount of royalties in any twelve (12) month period, in which case Client case, sanofi-aventis shall bear the responsibility reimburse ImmunoGen for any all costs incurred by ImmunoGen in connection with such reasonable fees examination and expensesaudit.
Appears in 1 contract
Samples: License Agreement (Immunogen Inc)
Records; Audit Rights. Client Each Party will keep complete keep, and accurate books and records relating to all amounts payable to Catalent hereunder, sales maintain for a period of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * **] years after following the expiration end of the year to which they relatea Calendar Year, in each case, accurate records in sufficient detail to enable royalties, Operating Profits (Losses), Research Costs, and Development Costs under this Agreement for such Calendar Year to be determined. In addition, Lexicon shall retain such records for such longer period of time as necessary to support an audit by Genentech of Research Costs and Development Costs reimbursable by Genentech upon exercise of an IND Opt-In or Phase II Opt-In pursuant to Section 4.6. A Party shall have the calculation and verification of all payments payable right, upon at least [**] prior written notice to Catalent hereunder (“Records”). Upon the written request and other Party, not more than once per calendar yearin any Calendar Year, Catalent through an independent certified public accountant acceptable to the other Party (which acceptance shall not be entitled to audit, or unreasonably refused) to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such those records of the pertinent Records of Client other Party as may be reasonably necessary to verify the matters in question. Such access shall include accuracy of the right royalty reports furnished by such other Party under this Agreement for the previous Calendar Years subject to audit hereunder, or for the verification of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date of such request. Before permitting such independent accounting firm to have access to such Records royalties, Operating Profits (Losses), Research Costs and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this AgreementDevelopment Costs. Prior to disclosing implementing an audit, the auditing Party agrees to submit an audit plan, including audit scope, to the other Party for approval (which shall not be unreasonably withheld). The independent certified public accountant will be instructed to provide an audit report containing its conclusions regarding the audit, and specifying whether the amounts paid were correct, and, if incorrect, the amount of any underpayment or overpayment. The independent certified public accountant further will be instructed to provide that audit report first to the Party being audited, and will be further instructed to redact any of that Party's proprietary information that is not relevant to the calculation of royalties, Operating Profits (Losses), Research Costs and/or Development Costs prior to providing that audit report to the other Party. That audit report shall be deemed to be Confidential Information of the Party subject to the audit, and used only for purposes germane to this Section. The Party being audited shall have the right, at its own expense, to have its own independent certified public accountant review and confirm the results of any such audit performed by the auditing Party's accountants. In the event that the Parties' accountants do not agree as to Catalentthe results of the audit, the auditors Parties agree that such accountants shall present Client with a preliminary report of findings and provide Client with up attempt in good faith to [* * *] days resolve any discrepancies between their results according to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect GAAP and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision terms of this Agreement. In the event that the Parties' accountants cannot resolve any discrepancies within a reasonable amount of time, such amounts dispute shall be paid resolved by the Parties pursuant to Catalent within Article 14:. The Party requesting an audit is solely responsible for all the expenses of an audit, unless the independent certified public accountant's report correctly shows any underpayment exceeding [* * **] days after of amounts due hereunder. If the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses independent certified public accountant's report correctly shows an understatement by Client underpayment of more than [* * **]% , the Party being audited shall be responsible for the reasonable expenses incurred by the auditing Party for the independent certified public accountant's services. If the independent certified public accountant's report correctly shows any underpayment, the Party being audited shall remit to the other Party within [**] after receipt of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expenses.report:
Appears in 1 contract
Records; Audit Rights. Client will Both Parties shall keep and maintain, and shall require their respective Affiliates and agents to keep and maintain accurate and complete and accurate books and records relating to all amounts payable to Catalent in connection with the reimbursement of Processed Tests hereunder, sales of Products, its as are necessary to allow the accurate calculation of royalties and Net Sales (including all relevant deductions) and is achievement consistent with generally accepted accounting principles of the milestone events referred payments due to in Section 4.1(D) for Interleukin under this Agreement. Either Party has the right to engage an independent certified public accounting firm reasonably acceptable to the other Party, at such Party’s own expense. Such firm shall have the right to examine the relevant books and records of the audited Party as may be reasonably necessary to determine and/or verify the amount of payments due hereunder. Such examination shall be conducted, and each Party shall make its records available, during normal business hours upon at least [* * *] years after thirty (30) days prior written notice, which shall take place at the expiration of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”)facility(ies) where such records are maintained. Upon the written request and Such audit rights shall not be exercised by either Party more than once per calendar year, Catalent shall be entitled to audit, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination audit shall be limited to pertinent Records books and records for any year ending not more than [* * *] years twenty four (24) months prior to the date of such request; provided, that, neither Party shall be permitted to audit the same period of time more than once. Before permitting such The independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent each Party a written report stating whether the reports submitted and payments made to Catalent for the audit period are correct or incorrect and the specific details concerning any discrepancies and may not reveal to either Party any information learned in the course of such audit other than the amount of any such discrepancies. If an audit discloses an underpayment Both Parties agrees to hold in strict confidence all information disclosed to it, except to the extent necessary for either Party to enforce its rights under this Agreement or if disclosure is required by Client Applicable Laws and Standards. Portions of any amounts paid this Exhibit, indicated by the mxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to any provision of this Agreement, such amounts shall be paid the Registrant’s application requesting confidential treatment pursuant to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses Rule 24b-2 of the audit shall be paid by Catalent unless the audit discloses an understatement by Client Securities Exchange Act of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period1934, in which case Client shall bear the responsibility for any such reasonable fees and expensesas amended.
Appears in 1 contract
Samples: Preferred Participation Agreement (Interleukin Genetics Inc)
Records; Audit Rights. Client will Oral DNA shall keep and maintain, and shall require its respective Affiliates and Sublicensees to keep and maintain, such accurate and complete and accurate books and records relating to all amounts payable to Catalent in connection with the sale of Licensed Products hereunder, sales of Products, its as are necessary to allow the accurate calculation of royalties and Net Sales (including all relevant deductions) and is achievement consistent with generally accepted accounting principles of the milestone events referred Product Payments due to in Section 4.1(D) for at least [* * *] years after ILI. ILI shall have the expiration of the year right to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have engage an independent accountant auditcertified public accounting firm reasonably acceptable to Oral DNA, such which shall have the right to audit the relevant books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such records of the pertinent Records of Client Oral DNA as may be reasonably necessary to determine and/or verify the matters in questionamount of Product Payments due hereunder. Such access examination shall include be conducted, and Oral DNA shall make its records available, during normal business hours upon at least fifteen (15) days prior written notice, which shall take place at the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or facility(ies) where such independent accounting firm determines appropriaterecords are maintained. Such audit rights shall not be exercised by ILI more than once per Calendar Year. Each such examination audit shall be limited to pertinent Records books and records for any year ending not more than [* * *] years thirty six (36) months prior to the date of such request; provided, that, ILI shall not be permitted to audit the same period of time more than once. Before permitting such The independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent each Party a written report stating whether the payments made to Catalent for the audit period reports submitted and Product Payments paid are correct or incorrect and the specific details concerning any discrepancies and may not reveal to ILI any information learned in the course of such audit other than the amount of any such discrepancies. If ILI agrees to hold in strict confidence all information disclosed to it, except to the extent necessary for ILI to enforce its rights under this Agreement or if disclosure is required by Applicable Laws. In the event there was an underpayment by Oral DNA hereunder, Oral DNA shall promptly (but in no event later than thirty (30) days after such Party’s receipt of the independent auditor’s report so correctly concluding) make payment to ILI of any shortfall. In the event that there was an overpayment by Oral DNA hereunder, ILI shall promptly (but in no event later than thirty (30) days after ILI’s receipt of the independent auditor’s report so correctly concluding) refund to Oral DNA the excess amount. ILI shall bear the full cost of such audit unless such audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client Oral DNA of more than [* * *]% five percent (5%) of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit amount of Product Payments in any twelve (12) month period, in which case Client case, Oral DNA shall bear reimburse ILI for all costs incurred by ILI in connection with such examination and audit. Portions of this Exhibit were omitted and have been filed separately with the responsibility for any such reasonable fees and expensesSecretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Appears in 1 contract
Samples: Non Exclusive License Agreement (Interleukin Genetics Inc)
Records; Audit Rights. Client During the term of this Agreement and for three (3) years thereafter (the "Audit Period"), Licensee will keep complete and accurate books records of Licensee's and records relating to all amounts any sublicensee's sales of Licensed Products and such other matters as may affect the determination of any amount payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each case, Licensor hereunder in sufficient detail to enable the calculation and verification of all payments Licensor to determine any amounts payable to Catalent hereunder Licensor under this Agreement. During the Audit Period, Licensor may engage a recognized accounting or audit firm reasonably acceptable to Licensee to act on its behalf, to audit and inspect the files, books and records of account of Licensee relating solely to the fees owed Licensor under the Agreement, upon ten (“Records”)10) days' prior written notice, during regular business hours and in such a manner to avoid unreasonable interference with normal business operations. Upon Such audit shall be solely at Licensor's expense unless it shows a shortage in the written request amount paid to Licensee of more than five percent (5%) for the period audited. Audits shall not be conducted with unreasonable frequency and not in no event shall be conducted more than once per calendar yeartwelve month period unless the immediately preceding audit showed a shortage in the amount paid to Licensee. Should any audit result in the discovery of any shortages, Catalent Licensee shall be entitled to auditpromptly pay any such shortages, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, together with access during normal business hours to appropriate space interest calculated at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior current prime rate back to the date of such requestthe incorrect payment. Before permitting such independent accounting firm to have access to such Records and personnelShould it be discovered that the Licensor was overpaid, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign then a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts correcting adjustment shall be paid to Catalent within [* * *] days after made at the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expensesnext scheduled Licensee payment.
Appears in 1 contract
Records; Audit Rights. Client will Biotest and its Affiliates and Sublicensees shall keep and maintain for [***] ([***]) years from the date of each payment of royalties hereunder complete and accurate books and records relating to of their respective Commercialization Expenses, as well as all amounts payable to Catalent hereunder, gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) by Biotest and is achievement its Affiliates and Sublicensees of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseLicensed Product, in sufficient detail to enable allow royalties to be determined accurately and ImmunoGen and its Affiliates and Sublicensees shall keep and maintain for [***] ([***]) years from the calculation date of each payment of Net Income Payments complete and verification accurate records of its Commercialization Expenses, as well as all gross sales and Net Sales of each Co-Developed Product in sufficient detail to allow Net Income Payments to be determined accurately. Each Party shall have the right for a period of [***] ([***]) years after receiving any such payment to appoint at its expense an independent certified public accountant reasonably acceptable to the other Party to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. inspect or audit the relevant records of such Party, its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. The Audited Party, its Affiliates and Sublicensees shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from the Auditing Party, solely to verify that Commercialization Expenses, royalty and Net Income payments payable to Catalent hereunder (“Records”)were correctly accounted for or determined. Upon Such inspection or audit right shall not be exercised by the written request and not Auditing Party more than once per calendar year, Catalent in any Calendar Year or more than once with respect to sales of a particular Licensed Product in a particular period. All records made available for inspection or audit shall be entitled deemed to be Confidential Information of the Audited Party. The results of each inspection or audit, or to have if any, shall be binding on both Parties. In the event there was an independent accountant auditunderpayment by the Audited Party hereunder, such books and records. Client the Audited Party shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Clientpromptly (but in any event no later than [***] ([***]) days after the Audited Party’s relevant location and to such receipt of the pertinent Records independent accountant’s report so concluding) make payment to the Auditing Party of Client as may be reasonably necessary to verify any shortfall. In the matters event that there was an overpayment by the Audited Party hereunder, the Auditing Party shall promptly (but in question. Such access shall include any event no later than [***] ([***]) days after the right Auditing Party’s receipt of Catalent or the independent accounting firm to interview Catalentaccountant’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior report so concluding) refund to the date Audited Party the excess amount. The Auditing Party shall bear the full cost of such request. Before permitting audit unless such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client Audited Party of more than [* * ***] percent ([***]% %) of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit periodamount of royalties or Net Income Payments payable, or Commercialization Expenses allocable, in any Calendar Year, in which case Client the Audited Party shall bear reimburse the responsibility Auditing Party for any all costs incurred by the Auditing Party in connection with such reasonable fees and expensesinspection or audit.
Appears in 1 contract
Samples: Collaborative Development and License Agreement (Immunogen Inc)
Records; Audit Rights. Client will ILI shall keep and maintain, and shall require its respective Affiliates and Sublicensees to keep and maintain, such accurate and complete and accurate books and records relating to all amounts payable to Catalent in connection with the providing of Additional Testing Services hereunder, sales of Products, its as are necessary to allow the accurate calculation of royalties and Net Sales (including all relevant deductions) and is achievement consistent with generally accepted accounting principles of the milestone events referred royalties due to in Section 4.1(D) for at least [* * *] years after Oral DNA, including any records required to calculate any royalty deductions or other adjustments hereunder. Oral DNA shall have the expiration of the year right to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have engage an independent accountant auditcertified public accounting firm reasonably acceptable to ILI, such which shall have the right to audit the relevant books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location records of ILI and to such of the pertinent Records of Client its respective Affiliates and Sublicensees as may be reasonably necessary to determine and/or verify the matters in questionamount of royalty payments due hereunder. Such access examination shall include be conducted, and ILI shall make its records available, during normal business hours upon at least fifteen (15) days prior written notice, which shall take place at the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or facility(ies) where such independent accounting firm determines appropriaterecords are maintained. Such audit rights shall not be exercised by Oral DNA more than once per Calendar Year. Each such examination audit shall be limited to pertinent Records books and records for any year ending not more than [* * *] years thirty-six (36) months prior to the date of such request; provided, that, Oral DNA shall not be permitted to audit the same period of time more than once. Before permitting such The independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent each Party a written report stating whether the payments made to Catalent for the audit period royalty reports submitted and royalties paid are correct or incorrect and the specific details concerning any discrepancies and may not reveal to Oral DNA any information learned in the course of such audit other than the amount of any such discrepancies. If Oral DNA agrees to hold in strict confidence all information disclosed to it, except to the extent necessary for Oral DNA to enforce its rights under this Agreement or if disclosure is required by Applicable Laws. In the event there was an underpayment by ILI hereunder, ILI shall promptly (but in no event later than thirty (30) days after such Party’s receipt of the independent auditor’s report so correctly concluding) make payment to Oral DNA of any shortfall. In the event that there was an overpayment by ILI hereunder, Oral DNA shall promptly (but in no event later than thirty (30) days after Oral DNA’s receipt of the independent auditor’s report so correctly concluding) refund to ILI the excess amount. Oral DNA shall bear the full cost of such audit unless such audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client ILI of more than [* * *]% five percent (5%) of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit amount of royalties in any twelve (12) month period, in which case Client case, ILI shall bear the responsibility reimburse Oral DNA for any all costs incurred by Oral DNA in connection with such reasonable fees examination and expensesaudit.
Appears in 1 contract
Samples: Non Exclusive License Agreement (Interleukin Genetics Inc)
Records; Audit Rights. Client will Each Party shall keep complete and accurate books maintain for three (3) years records of Development Costs and records relating Commercialization Costs incurred with respect to all amounts payable to Catalent hereunderthe Product, sales of Productsand, its calculation of royalties in ELAN's case, Operating Income (Loss), Sublicense Income, and Net Sales (including all relevant deductions) and is achievement or Opt Out Net Sales of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each case, Product in sufficient detail to enable tracking of such Development Costs, Commercialization Costs, Operating Income (Loss), Net Sales or Opt Out Net Sales and Sublicense Income and to allow confirmation of same by the calculation other Party. Each Party shall have the right for a period of ("deleted text") after such Development Costs and verification Commercialization Costs, Sublicense Income, Net Sales, Opt Out Net Sales or Operating Income (Loss) are incurred to appoint at its expense an independent certified public accountant reasonably acceptable to the other Party to audit the relevant records of all payments payable the other Party and its Affiliates to Catalent hereunder verify that the amounts of such Development Costs and Commercialization Costs, Operating Income (“Records”Loss), Sublicense Income, Opt Out Net Sales or Net Sales were correctly determined. Upon The audited Party and its Affiliates shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon ("deleted text") written notice from the written request auditing Party, solely to verify that such Development Costs and Commercialization Costs, Operating Income (Loss), Sublicense Income, Net Sales, or Opt Out Net Sales were correctly determined. Such audit right shall not be exercised by the auditing Party more than once per calendar year, Catalent in any Calendar Year and no period may be audited more than once. All records made available for audit shall be entitled deemed to be Confidential Information of the audited Party. The results of each audit, if any, shall be reported in writing to both Parties promptly (but in no event later than ("deleted text") after the audit and shall be binding on both Parties. In the event there was an error in the amount of Development Costs, Commercialization Costs, or to have an independent accountant auditOperating Income (Loss) reported by the audited Party hereunder, (a) if the amount of such books and records. Client costs or payments was over reported, the audited Party shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such promptly (but in any event no later than ("deleted text") after the audited Party's receipt of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior report so concluding) make payment to the date auditing Party of the amount required to achieve the appropriate sharing of such requestcosts and (b) if the amount of such costs, or income or loss was under reported, the auditing Party shall promptly (but in any event no later than ("deleted text") after the auditing Party's receipt of the report so concluding) make payment to the audited Party of the amount required to achieve the appropriate sharing of such costs or income or loss. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit The auditing Party shall bear the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results full cost of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an unless such audit discloses an under-payment by the audited Party of more than("deleted text") of the relevant amount of Development Costs and Commercialization Costs, Operating Income (Loss), or royalties in any Calendar Year, in which case the audited Party shall reimburse the auditing Party for all costs incurred by the auditing Party in connection with such audit. If the discrepancy is an under-payment of royalties to WARATAH, the amount of such underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent WARATAH within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses ("deleted text") of receiving a copy of the audit report. If the discrepancy is an over-payment of royalties to WARATAH, the amount of such over-payment of royalties shall be paid by Catalent unless to ELAN within ("deleted text") of receiving a copy of the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expensesreport.
Appears in 1 contract
Samples: Collaboration Agreement (Transition Therapeutics Inc.)
Records; Audit Rights. Client will For a period of [***] ([***]) years, sanofi-aventis shall keep and maintain, and shall require its respective Affiliates and Sublicensees to keep and maintain, such accurate and complete and accurate books and records relating to all amounts payable to Catalent in connection with the sale of Licensed Products hereunder, sales of Products, its as are necessary to allow the accurate calculation of royalties and Net Sales (including all relevant deductions) and is achievement consistent with generally accepted accounting principles of the milestone events referred royalties due to in Section 4.1(D) for at least [* * *] years after ImmunoGen, including any records required to calculate any royalty adjustments hereunder. Once per Calendar Year, ImmunoGen shall have the expiration of the year right to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have engage an independent accountant auditcertified public accounting firm of nationally recognized standing and reasonably acceptable to sanofi-aventis, such which shall have the right to examine in confidence the relevant books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location records of sanofi-aventis and to such of the pertinent Records of Client its respective Affiliates and Sublicensees as may be reasonably necessary to determine and/or verify the matters in questionamount of royalty payments due hereunder. Such access examination shall include be conducted, and sanofi-aventis shall make its records available, during normal business hours, after at least [***] ([***]) days prior written notice to sanofi-aventis, as applicable, and shall take place at the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or facility(ies) where such independent accounting firm determines appropriaterecords are maintained. Each such examination shall be limited to pertinent Records books and records for any year ending not more than [* * ***] years ([***]) months prior to the date of such request, provided, that, ImmunoGen shall not be permitted to audit the same period of time more than once. Before permitting such independent accounting firm to have access to such Records books and personnelrecords, Client sanofi-aventis may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement (in form and substance reasonably acceptable to Catalent each of the Parties) as to prohibit any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access, while conducting the audit under this paragraph. The ImmunoGen independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent each Party a written report stating whether the payments made to Catalent for the audit period royalty reports submitted and royalties paid are correct or incorrect and the specific details of concerning any discrepancies. If Such accounting firm may not reveal to ImmunoGen any information learned in the course of such audit other than the amount of any such discrepancies. ImmunoGen agrees to hold in strict confidence all information disclosed to it, except to the extent necessary for ImmunoGen to enforce its rights under this Agreement or if disclosure is required by law. In the event there was an underpayment by sanofi-aventis hereunder, sanofi-aventis shall promptly (but in no event later than [***] ([***]) days after such Party’s receipt of the independent auditor’s report so correctly concluding) make payment to ImmunoGen of any shortfall. In the event that there was an overpayment by sanofi-aventis hereunder, ImmunoGen shall promptly (but in no event later than [***] ([***]) days after ImmunoGen’s receipt of the independent auditor’s report so correctly concluding) refund to sanofi-aventis the excess amount. ImmunoGen shall bear the full cost of such audit unless such audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client sanofi-aventis of more than [* * ***] percent ([***]% %) of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit amount of royalties in any twelve (12) month period, in which case Client case, sanofi-aventis shall bear the responsibility reimburse ImmunoGen for any all costs incurred by ImmunoGen in connection with such reasonable fees examination and expensesaudit.
Appears in 1 contract