Common use of Access to Information; Regulatory Communications Clause in Contracts

Access to Information; Regulatory Communications. (a) Subject to currently existing contractual and legal restrictions applicable to the Company or Parent or any of Parent's Subsidiaries, each of Parent and the Company shall, and Parent shall cause each of its Subsidiaries to, afford to the accountants, counsel, financial advisors and other representatives of the other party hereto reasonable access to, and permit them to make such inspections as they may reasonably require of, during normal business hours during the period from the date of this Agreement through the Effective Time, all their respective properties, books, contracts, commitments and records (including, without limitation, the work papers of independent accountants, if available and subject to the consent of such independent accountants) and, during such period, Parent and the Company shall, and Parent shall cause each of its Subsidiaries to, furnish promptly to the other (i) a copy of each report, schedule, registration statement and other document filed by it during such period pursuant to the requirements of federal or state securities laws and (ii) all other information concerning its business, properties and personnel as the other may reasonably request. No investigation pursuant to this Section 5.3(a) shall affect any representation or warranty in this Agreement of any party hereto or any condition to the obligations of the parties hereto. (b) The Company (i) shall keep Parent promptly informed of (A) any communication (written or oral) with or from the FDA or the DEA and (B) any communications (written or oral) received from any Person relating to the Company Intellectual Property and (ii) shall not make any submissions to, or have discussions with, the FDA or the DEA without either the prior consultation or the inclusion of Parent; provided, however, that in the event the Company (i) -------- ------- is verbally contacted by the FDA and (ii) has made a good faith effort to include representatives of Parent in such discussion without success, then the Company shall be allowed to participate in such discussions without Parent and shall promptly inform Parent of the content of such discussions. Parent shall keep the Company promptly informed of any communications from the FDA or DEA relating to any of the drugs set forth in Schedule 5.3(b) of the Parent Disclosure Schedule,

Access to Information; Regulatory Communications. (a) Subject to currently existing contractual Novuspharma and legal restrictions applicable to the Company or Parent or any of Parent's Subsidiaries, each of Parent and the Company CTI shall, and Parent CTI shall cause each of its Subsidiaries subsidiaries to, afford to the other party, and the officers, employees, accountants, counsel, financial advisors and other representatives of the such other party hereto party, reasonable access toaccess, and permit them to make such inspections as they may reasonably require ofby giving one (1) day prior notice, during normal business hours during the period from the date of this Agreement through prior to the Effective Time, Time to all their respective properties, books, contracts, commitments commitments, personnel and records (including, without limitation, the work papers of independent accountants, if available and subject to the consent of such independent accountants) and, during such period, Parent Novuspharma and the Company CTI shall, and Parent CTI shall cause each of its Subsidiaries subsidiaries to, furnish promptly to the other party, (i) a copy of each report, schedule, registration statement and other document filed by it during such period pursuant to the requirements of United States federal or state or Italian securities laws laws, and (ii) all other information concerning its business, properties including product development efforts, properties, results of operations and personnel as the such other party may reasonably request. No investigation pursuant Each of Novuspharma and CTI will hold, and will cause its respective officers, employees, accountants, counsel, financial advisors and other representatives and affiliates to this Section 5.3(a) shall affect hold, any representation or warranty confidential information in this Agreement of any party hereto or any condition to accordance with the obligations of the parties heretoConfidentiality Agreement. (b) The Company CTI and Novuspharma shall notify and consult with each other promptly (i) shall keep Parent promptly informed after receipt of (A) any a communication (written or oral) with or from the FDA or the DEA and (B) any communications (written or oral) received from any Person relating Regulatory Agency and before giving any material submission to the Company Intellectual Property and such Regulatory Agency, (ii) shall not make after receipt of any submissions comments from any officials of any Governmental Entity in connection with filings made pursuant hereto, (iii) after receipt of any material request by any officials of any Governmental Entity for amendments or supplements to any filings made pursuant to, or have discussions information provided to comply in with, Applicable Laws, and (iv) prior to making any material change to a study protocol, the FDA addition of new trials, or a material change to the DEA without either the prior consultation development timeline for any of its product candidates or the inclusion of Parentprograms; provided, however, that in the event the Company either CTI or Novuspharma (ix) -------- ------- is verbally contacted by the FDA a Regulatory Agency, and (iiy) has made a good faith effort to include representatives of Parent the other party in such discussion without success, then the Company CTI or Novuspharma, as appropriate, shall be allowed to participate in such discussions without Parent the other party and shall promptly inform Parent the other party of the content of such discussions. Parent . (c) No information or knowledge obtained in any investigation or notification pursuant to this Section 5.2 shall keep affect or be deemed to modify any representation or warranty contained herein, the Company promptly informed of any communications from the FDA covenants or DEA relating to any agreements of the drugs set forth in Schedule 5.3(b) parties hereto or the conditions to the obligations of the Parent Disclosure Schedule,parties under this Agreement.

Access to Information; Regulatory Communications. (a) Subject to currently existing contractual and legal restrictions applicable to the Company or Parent or any of Parent's Subsidiaries, each of Parent and the Company shall, and Parent shall cause each of its Subsidiaries to, afford to the accountants, counsel, financial advisors and other representatives of the other party hereto reasonable access to, and permit them to make such inspections as they may reasonably require of, during normal business hours during the period from the date of this Agreement through the Effective Time, all their respective properties, books, contracts, commitments and records (including, without limitation, the work papers of independent accountants, if available and subject to the consent of such independent accountants) and, during such period, Parent and the Company shall, and Parent shall cause each of its Subsidiaries to, furnish promptly to the other (i) a copy of each report, schedule, registration statement and other document filed by it during such period pursuant to the requirements of federal or state securities laws and (ii) all other information concerning its business, properties and personnel as the other may reasonably request. No investigation pursuant to this Section 5.3(a) shall affect any representation or warranty in this Agreement of any party hereto or any condition to the obligations of the parties hereto. Notwithstanding the foregoing, the Company agrees to fully cooperate with Parent and its advisors in their investigation and evaluation of the Company Intellectual Property and the Company further agrees that such cooperation shall include, but not be limited to, the Company making available to Parent and its advisors those documents requested by Parent as well as scientific personnel of the Company who are familiar with the Company Intellectual Property. (b) The Company (i) shall keep Parent promptly informed of (A) any communication (written or oral) with or from the FDA or the DEA and (B) any communications (written or oral) received from any Person relating to the Company Intellectual Property and (ii) shall not make any submissions to, or have discussions with, the FDA or the DEA without either the prior consultation or the inclusion of Parent; provided, however, that in the event the Company (i) -------- ------- is verbally contacted by the FDA and (ii) has made a good faith effort to include representatives of Parent in such discussion without success, then the Company shall be allowed to participate in such discussions without Parent and shall promptly inform Parent of the content of such discussions. Parent shall keep the Company promptly informed of any communications from the FDA or DEA relating to any of the drugs set forth in Schedule 5.3(b) of the Parent Disclosure Schedule,.

Access to Information; Regulatory Communications. (a) Subject to currently existing contractual Novuspharma and legal restrictions applicable to the Company or Parent or any of Parent's Subsidiaries, each of Parent and the Company CTI shall, and Parent CTI shall cause each of its Subsidiaries subsidiaries to, afford to the other party, and the officers, employees, accountants, counsel, financial advisors and other representatives of the such other party hereto party, reasonable access toaccess, and permit them to make such inspections as they may reasonably require ofby giving one (1) day prior notice, during normal business hours during the period from the date of this Agreement through prior to the Effective Time, Time to all their respective properties, books, contracts, commitments commitments, personnel and records (including, without limitation, the work papers of independent accountants, if available and subject to the consent of such independent accountants) and, during such period, Parent Novuspharma and the Company CTI shall, and Parent CTI shall cause each of its Subsidiaries subsidiaries to, furnish promptly to the other party, (i) a copy of each report, schedule, registration statement and other document filed by it during such period pursuant to the requirements of United States federal or state or Italian securities laws laws, and (ii) all other information concerning its business, properties including product development efforts, properties, results of operations and personnel as the such other party may reasonably request. No investigation pursuant Each of Novuspharma and CTI will hold, and will cause its respective officers, employees, accountants, counsel, financial advisors and other representatives and affiliates to this Section 5.3(a) shall affect hold, any representation or warranty confidential information in this Agreement of any party hereto or any condition to accordance with the obligations of the parties heretoConfidentiality Agreement. (b) The Company CTI and Novuspharma shall notify and consult with each other promptly (i) shall keep Parent promptly informed after receipt of (A) any a communication (written or oral) with or from the FDA or the DEA and (B) any communications (written or oral) received from any Person relating Regulatory Agency and before giving any material submission to the Company Intellectual Property and such Regulatory Agency, (ii) shall not make after receipt of any submissions comments from any officials of any Governmental Entity in connection with filings made pursuant hereto, (iii) after 50 receipt of any material request by any officials of any Governmental Entity for amendments or supplements to any filings made pursuant to, or have discussions information provided to comply in with, Applicable Laws, and (iv) prior to making any material change to a study protocol, the FDA addition of new trials, or a material change to the DEA without either the prior consultation development timeline for any of its product candidates or the inclusion of Parentprograms; provided, however, that in the event the Company either CTI or Novuspharma (ix) -------- ------- is verbally contacted by the FDA a Regulatory Agency, and (iiy) has made a good faith effort to include representatives of Parent the other party in such discussion without success, then the Company CTI or Novuspharma, as appropriate, shall be allowed to participate in such discussions without Parent the other party and shall promptly inform Parent the other party of the content of such discussions. Parent . (c) No information or knowledge obtained in any investigation or notification pursuant to this Section 5.2 shall keep affect or be deemed to modify any representation or warranty contained herein, the Company promptly informed of any communications from the FDA covenants or DEA relating to any agreements of the drugs set forth in Schedule 5.3(b) parties hereto or the conditions to the obligations of the Parent Disclosure Schedule,parties under this Agreement.