Common use of Diligence Obligations Clause in Contracts

Diligence Obligations. (a) Subject to Section 2.5(b) below, Proprius agrees to use commercially reasonable efforts (directly and/or through one or more Affiliates and Sublicenses) to bring one or more initial Products to market in the Field in the Territory and, following first commercial sale, to promote such Initial Product(s) in the Field in the Territory during the Term. Without limiting the generality of the foregoing (but subject to Section 2.5(b)), Proprius shall achieve first commercial sale of an Initial Product by December 31, 2008. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale of an Initial Product by December 31, 2008, the parties shall discuss in good faith an appropriate extension of such deadline and/or other modification of such diligence milestone. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC shall have the right to convert Proprius’ license under Section 2.1 to a co-exclusive license upon written notice to Proprius. (b) Proprius’ diligence obligations under Section 2.5(a) are subject to ORGENTEC using commercially reasonable efforts to obtain U.S. Food and Drug Administration clearance or approval of its Anti-MCV (autoantibodies against mutated citrullinated vimentin) E XXXX technology by December 31, 2009. Proprius shall, if available and to the extent permitted by applicable laws and commercially reasonable, the protocols approved by the respective IRBs/ Ethic Committees of the institutions through which samples were collected, and any informed consents obtained by Proprius from sample donors, transfer (or cause to be transferred) available patient samples to ORGENTEC to support the FDA approval process. Proprius hereby grants to ORGENTEC, to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before or no later then December 31, 2009, Proprius has the right, at its own discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval process.

Diligence Obligations. (a) Subject Following the exercise of the Option to Section 2.5(b) belowContinue, Proprius agrees to Sanofi shall use commercially reasonable efforts Commercially Reasonable Efforts at its own cost and expense (directly and/or through one or more Affiliates and Sublicensesi) to bring Develop one or more initial Products to market (1) Program Product for one indication in the Field (and may Develop any additional Program Products or indications) and to seek and obtain Regulatory Approval for such Program Product for use in humans in each of the Major Countries, (ii) to Manufacture or have Manufactured Program Compound and Program Product for use in the Territory andDevelopment and Commercialization thereof, following first commercial saleand (iii) to Commercialize a Program Product for use in humans in each of the Major Countries. Sanofi shall perform, or cause its Affiliates or Third Party contractors to perform, its responsibilities under this Agreement, in compliance with this Agreement, all Applicable Laws, including, without limitation, then-current GLP, GCP and GMP. Further, Ardelyx acknowledges and agrees that nothing in this Section 4.3 is intended, or shall be construed, to promote require Sanofi to Develop or Commercialize a specific Program Product. In the event that Sanofi decides to discontinue the Development or Commercialization of a Program Product in favor of another Program Product, its obligations under this Section 4.3 shall cease with respect to such Initial Product(sinitial Program Product in favor of such other Program Product. Further, for clarity, for the purposes of this Section 4.3(a), Commercially Reasonable Efforts shall be determined [***], and Sanofi shall not be required to launch or otherwise commercialize a Program Product in any country of the Territory (including for clarity a Major Country) where Commercially Reasonable Efforts would not require it to do so. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) If Ardelyx at any time reasonably determines that a substantial delay has occurred in the Field in the Territory during the Term. Without limiting the generality Development of the foregoing (but subject to Section 2.5(b))a Program Product, Proprius shall achieve first commercial sale of an Initial Product by December 31, 2008. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale of an Initial Product by December 31, 2008, the parties shall discuss in good faith an appropriate extension of such deadline and/or other modification of such diligence milestone. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC Ardelyx shall have the right to convert Proprius’ license convene a meeting of the Senior Executives in order to discuss Ardelyx’s determination and Sanofi’s explanation therefor. The meeting shall be convened within [***] following Ardelyx’s written request therefor. Following such meeting, if Ardelyx believes that the substantial delay has occurred due to Sanofi’s failure to use Commercially Reasonable Efforts, Ardelyx shall, without further delay, have the right to proceed to exercise its rights under Section 2.1 to a co-exclusive license upon written notice to Proprius. 11.2(a) (b) Proprius’ diligence obligations under Section 2.5(a) are subject to ORGENTEC using commercially reasonable efforts to obtain U.S. Food the provisions set forth therein and Drug Administration clearance or approval of its Anti-MCV (autoantibodies against mutated citrullinated vimentin) E XXXX technology by December 31, 2009. Proprius shall, if available and to the extent permitted by applicable laws and commercially reasonable, the protocols approved by the respective IRBs/ Ethic Committees of the institutions through which samples were collected, and any informed consents obtained by Proprius from sample donors, transfer (or cause to be transferred) available patient samples to ORGENTEC to support the FDA approval process. Proprius hereby grants to ORGENTEC, to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before or no later then December 31, 2009, Proprius has the right, at its own discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval processArticle 13).

Diligence Obligations. (a) Subject to Section 2.5(b) below, Proprius agrees to AstraZeneca shall use commercially reasonable efforts Commercially Reasonable Efforts at its own cost and expense (directly and/or through one or more Affiliates and Sublicensesi) to bring one Develop a Licensed Product and to seek Regulatory Approval for such Licensed Product for use in humans in each of the Major Markets, (ii) Manufacture or more initial Products to market have Manufactured Licensed Compound and Licensed Product for use in the Field Development and Commercialization thereof, and (iii) to Commercialize a Licensed Product for use in humans in each of the Territory andMajor Markets. AstraZeneca shall perform, following first commercial saleor cause its Affiliates or Third Party contractors to perform, its responsibilities under this Agreement, and Ardelyx shall perform, or cause its Affiliates or Third Party contractors to perform the Assigned Activities, in each case, in compliance with this Agreement, all Applicable Laws, applicable FDA (or foreign equivalent) requirements, including, without limitation, then-current GLP, GCP and GMP. For the avoidance of doubt, AstraZeneca shall not be obligated to obtain Regulatory Approvals for, or Commercialize, more than one Licensed Product for use in humans in any Major Market. Further, Ardelyx acknowledges and agrees that nothing in this Section 4.4 is intended, or shall be construed, to promote require AstraZeneca to Develop or Commercialize a specific Licensed Product. In the event that AstraZeneca decides to discontinue the Development or Commercialization of a [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Licensed Product in favor of another Licensed Product, its obligations under this Section 4.4 shall cease with respect to such Initial Product(s) initial Licensed Product in the Field in the Territory during the Term. Without limiting the generality of the foregoing (but subject to Section 2.5(b)), Proprius shall achieve first commercial sale of an Initial Product by December 31, 2008. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale of an Initial Product by December 31, 2008, the parties shall discuss in good faith an appropriate extension favor of such deadline and/or other modification of such diligence milestoneLicensed Product. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC AstraZeneca shall have no other obligation, express or implied, to Exploit the right to convert Proprius’ license under Section 2.1 to a co-exclusive license upon written notice to PropriusLicensed Products. (b) Proprius’ diligence If Ardelyx at any time believes that AstraZeneca may be in material breach of its obligations under Section 2.5(a4.4(a), then Ardelyx may exercise its rights under Section 16.2(a) are or proceed directly to exercise its rights under Section 14.2(a) (subject to ORGENTEC using commercially reasonable efforts to obtain U.S. Food and Drug Administration clearance or approval of its Anti-MCV (autoantibodies against mutated citrullinated vimentin) E XXXX technology by December 31, 2009. Proprius shall, if available and to the extent permitted by applicable laws and commercially reasonable, the protocols approved by the respective IRBs/ Ethic Committees of the institutions through which samples were collected, and any informed consents obtained by Proprius from sample donors, transfer (or cause to be transferred) available patient samples to ORGENTEC to support the FDA approval process. Proprius hereby grants to ORGENTEC, to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before or no later then December 31, 2009, Proprius has the rightprovisions set forth therein), at its own Ardelyx’s sole discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval process.

Diligence Obligations. (a) Subject to Section 2.5(b) below, Proprius agrees to Licensee will use commercially reasonable efforts to develop, commercialize, market, promote, and sell Licensed Products for Friedreich’s Ataxia (directly and/or through one or more Affiliates and Sublicenses) to bring one or more initial Products to market in the Field in the Territory and, following first commercial sale, to promote such Initial Product(sSystemic) in the Field Commercial Field. Furthermore, if Licensee exercises the Commercial Option granted to Licensee under Section 2.3 with respect to Friedreich’s Ataxia (CNS), Licensee will use commercially reasonable efforts to develop, commercialize, market, promote, and sell Licensed Products for Friedreich’s Ataxia (CNS) in the Territory during the TermCommercial Field. Commercially reasonable efforts means efforts equivalent to those utilized by ****. Without limiting the generality of foregoing, Licensee will meet the foregoing following: (but subject to Section 2.5(b)), Proprius shall achieve first commercial sale a) acceptance by the FDA of an Initial Product Investigational New Drug application, or acceptance by December 31, 2008. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale the European Medicines Agency (or any successor entity thereto) of an Initial equivalent application, for a Licensed Product using AAVrh10 for Friedreich’s Ataxia (Systemic) by December 31, 2008, no later than **** after the parties shall discuss in good faith an appropriate extension of such deadline and/or other modification of such diligence milestoneEffective Date; and ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC shall have the right to convert Proprius’ license under Section 2.1 to a co-exclusive license upon written notice to PropriusCONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. (b) Proprius’ diligence obligations if Licensee exercises the Commercial Option granted to Licensee under Section 2.5(a2.3 with respect to Friedreich’s Ataxia (Systemic), acceptance by the FDA of an Investigational New Drug application, or acceptance by the European Medicines Agency (or any successor entity thereto) are subject to ORGENTEC of an equivalent application, for a Licensed Product using commercially reasonable efforts to obtain U.S. Food and Drug Administration clearance or approval the Specified Vector selected in the exercise of its Anti-MCV such Commercial Option for Friedreich’s Ataxia (autoantibodies against mutated citrullinated vimentinSystemic) E XXXX technology by December 31no later than **** after the Grant Date; provided, 2009. Proprius shallhowever, that, if available and Licensee expects not to the extent permitted by applicable laws and commercially reasonable, the protocols approved by the respective IRBs/ Ethic Committees achieve one of the institutions through which samples were collectedmilestones set forth in clause (a) or (b) on or before the specified deadline in such clause (a) or (b), Licensee may pay Licensor an extension fee of **** on or before such deadline and any informed consents obtained the relevant deadline in clause (a) or (b), as applicable, shall then be extended by Proprius from sample donorsan additional ****. Licensee will only be entitled to **** for **** of the milestones in clauses (a) and (b), transfer (or cause to be transferred) available patient samples to ORGENTEC to support the FDA approval process. Proprius hereby grants to ORGENTEC, to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before or no later then December 31, 2009, Proprius has the right, at its own discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval process****.

Diligence Obligations. (ai) Subject Buyer will use Commercially Reasonable Efforts to Develop and Commercialize a Royalty-Bearing Product. Such Development and Commercialization may be performed directly by Buyer or by subcontractors and Licensees. Not later than [***] days after each [***] anniversary of the Effective Date and lasting until the [***], Buyer shall provide the Representative with reasonably detailed written reports of [***], including without limitation an update of (i) [***], (ii) [***], (iii) [***], and (iv) [***] and Buyer shall make relevant personnel reasonably available to the Representative during normal business hours by phone to answer questions regarding the most recent report. Not later than [***] days after receipt of such reports from Buyer, Representative shall forward such reports to the Unitholders, which reports will be Confidential Information for purposes of Section 2.5(b) below6.2. The Company and the Unitholders acknowledge that any potential obligation to pay Milestone Payments, Proprius agrees Priority Review Voucher Payments, or Royalty Payments will not create any express or implied obligation for Buyer to use commercially reasonable efforts (directly and/or through one operate the Business in any particular manner in order to maximize such Milestone Payments, Priority Review Voucher Payments, or more Affiliates and Sublicenses) to bring one or more initial Products to market in the Field in the Territory and, following first commercial sale, to promote such Initial Product(s) in the Field in the Territory during the TermRoyalty Payments. Without limiting the generality of the foregoing (but subject foregoing, Buyer shall have no liability to Section 2.5(b))the Company or the Unitholders, Proprius shall achieve first commercial sale of an Initial Product by December 31, 2008. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale of an Initial Product by December 31, 2008and the Company, the parties Representative and the Unitholders shall discuss in good faith an appropriate extension not be entitled to make any claim for lost Milestone Payments, Priority Review Voucher Payments, or Royalty Payments if Buyer used Commercially Reasonable Efforts to Develop and Commercialize a Royalty-Bearing Product. Notwithstanding the foregoing, Buyer may cease to Develop or Commercialize any or all Royalty-Bearing Products, and thereafter shall comply with the provisions of such deadline and/or other modification of such diligence milestone. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC shall have the right to convert Proprius’ license under Section 2.1 to a co-exclusive license upon written notice to Proprius1.6(i) below. (bii) Proprius’ diligence obligations under Section 2.5(a) are subject From time to ORGENTEC using commercially reasonable efforts to obtain U.S. Food and Drug Administration clearance or approval time after the Closing, Buyer may publish information regarding the utility of its Anti-MCV (autoantibodies against mutated citrullinated vimentin) E XXXX technology by December 31, 2009. Proprius shall, if available and to the extent permitted by applicable laws and commercially reasonable, the protocols approved by the respective IRBs/ Ethic Committees of the institutions through which samples were collected, and any informed consents obtained by Proprius from sample donors, transfer (or cause to be transferred) available patient samples to ORGENTEC to support the FDA approval process. Proprius hereby grants to ORGENTEC, to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field Biomarkers in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before identification, testing, response, safety monitoring or no later then December 31treatment of Angelman Syndrome. (iii) EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE RESEARCH, 2009DEVELOPMENT, Proprius has the rightMANUFACTURE, at its own discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval processOR COMMERCIALIZATION OF ANY PRODUCT OR COMPONENT THEREOF WILL BE SUCCESSFUL.

Diligence Obligations. The parties agree that the following diligence obligations shall apply to Celldex's development and commercialization efforts with regard to a Product incorporating a Licensed Antibody for which it obtains an Exclusive Commercial License: 8.3.1 If upon the [*****] anniversary of the date that Celldex obtains an Exclusive Commercial License with respect to a Product, Celldex has not filed an IND for such Product in any country, Celldex shall pay Medarex a nonrefundable, noncreditable fee of [*****] per year to maintain such Exclusive Commercial License with respect to such Product until the earlier of (ai) Subject the date that Celldex files an IND for such Product in any country, (ii) the date Celldex terminates the Exclusive Commercial License with respect to such Product pursuant to Section 2.5(b4.3.3, or (iii) below, Proprius agrees to use commercially reasonable efforts (directly and/or through one or more Affiliates and Sublicenses) to bring one or more initial Products to market in the Field in the Territory and, following first commercial sale, to promote such Initial Product(s) in the Field in the Territory during the Term. Without limiting the generality [*****] anniversary of the foregoing date that Celldex obtains an Exclusive Commercial License with respect to such Product. 8.3.2 If upon the [*****] anniversary of the date that Celldex obtains an Exclusive Commercial License with respect to a Product, Celldex has not filed an IND for such Product in any country, all rights granted to Celldex hereunder with respect to such Product (but subject and corresponding Antibodies) shall revert to Medarex and the terms of Section 4.3.3 shall apply with respect to the applicable Exclusive Commercial License. 8.3.3 If upon the [*****] anniversary of the date that Celldex files an IND, if any, for such Product in any country, Celldex has not initiated a Phase II Clinical Trial with regard to such Product, Celldex shall pay a nonrefundable, noncreditable fee equal to [*****] with regard to such Product each year until such time as Celldex initiates a Phase II Clinical Trial with regard to such Product, unless Celldex terminates the Exclusive Commercial License with respect to such Product pursuant to Section 2.5(b)), Proprius shall achieve first commercial sale of an Initial Product by December 31, 20084.3.3. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale of an Initial Product by December 31, 2008, the parties shall discuss in good faith an appropriate extension of such deadline and/or other modification of such diligence milestone*****REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC shall have the right to convert Proprius’ license under Section 2.1 to a co-exclusive license upon written notice to PropriusCONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. (b) Proprius’ diligence obligations under Section 2.5(a) are subject to ORGENTEC using commercially reasonable efforts to obtain U.S. Food and Drug Administration clearance or approval of its Anti-MCV (autoantibodies against mutated citrullinated vimentin) E XXXX technology by December 31, 2009. Proprius shall, if available and to 8.3.4 If upon the extent permitted by applicable laws and commercially reasonable, the protocols approved by the respective IRBs/ Ethic Committees fifth anniversary of the institutions through which samples were collecteddate that Celldex initiates Phase II Clinical Trials for such Product, and any informed consents obtained by Proprius from sample donorsCelldex has not initiated a Phase III Clinical Trial with regard to such Product, transfer Celldex shall pay a nonrefundable, noncreditable fee equal to fifty percent (or cause 50%) of the milestone payment relating to be transferred) available patient samples Phase III Clinical Trials set forth in Section 5.4.1 with regard to ORGENTEC such Product each year until such time as Celldex initiates Phase III Clinical Trials with regard to support such Product, unless Celldex terminates the FDA approval process. Proprius hereby grants Exclusive Commercial License with respect to ORGENTEC, such Product pursuant to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before or no later then December 31, 2009, Proprius has the right, at its own discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval processSection 4.3.3.

Diligence Obligations. The parties agree that the following diligence obligations shall apply to Celldex’s development and commercialization efforts with regard to a Product incorporating a Licensed Antibody for which it obtains an Exclusive Commercial License: 8.3.1 If upon the [*****] anniversary of the date that Celldex obtains an Exclusive Commercial License with respect to a Product, Celldex has not filed an IND for such Product in any country, Celldex shall pay Medarex a nonrefundable, noncreditable fee of [*****] per year to maintain such Exclusive Commercial License with respect to such Product until the earlier of (ai) Subject the date that Celldex files an IND for such Product in any country, (ii) the date Celldex terminates the Exclusive Commercial License with respect to such Product pursuant to Section 2.5(b4.3.3, or (iii) below, Proprius agrees to use commercially reasonable efforts (directly and/or through one or more Affiliates and Sublicenses) to bring one or more initial Products to market in the Field in the Territory and, following first commercial sale, to promote such Initial Product(s) in the Field in the Territory during the Term. Without limiting the generality [*****] anniversary of the foregoing date that Celldex obtains an Exclusive Commercial License with respect to such Product. 8.3.2 If upon the [*****] anniversary of the date that Celldex obtains an Exclusive Commercial License with respect to a Product, Celldex has not filed an IND for such Product in any country, all rights granted to Celldex hereunder with respect to such Product (but subject and corresponding Antibodies) shall revert to Medarex and the terms of Section 4.3.3 shall apply with respect to the applicable Exclusive Commercial License. [*****] REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 8.3.3 If upon the [*****] anniversary of the date that Celldex files an IND, if any, for such Product in any country, Celldex has not initiated a Phase II Clinical Trial with regard to such Product, Celldex shall pay a nonrefundable, noncreditable fee equal to [*****] with regard to such Product each year until such time as Celldex initiates a Phase II Clinical Trial with regard to such Product, unless Celldex terminates the Exclusive Commercial License with respect to such Product pursuant to Section 2.5(b)), Proprius shall achieve first commercial sale of an Initial Product by December 31, 2008. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale of an Initial Product by December 31, 2008, the parties shall discuss in good faith an appropriate extension of such deadline and/or other modification of such diligence milestone. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC shall have the right to convert Proprius’ license under Section 2.1 to a co-exclusive license upon written notice to Proprius4.3.3. (b) Proprius’ diligence obligations under Section 2.5(a) are subject to ORGENTEC using commercially reasonable efforts to obtain U.S. Food and Drug Administration clearance or approval of its Anti-MCV (autoantibodies against mutated citrullinated vimentin) E XXXX technology by December 31, 2009. Proprius shall, if available and to 8.3.4 If upon the extent permitted by applicable laws and commercially reasonable, the protocols approved by the respective IRBs/ Ethic Committees [*****] anniversary of the institutions through which samples were collecteddate that Celldex initiates Phase II Clinical Trials for such Product, and any informed consents obtained by Proprius from sample donorsCelldex has not initiated a Phase III Clinical Trial with regard to such Product, transfer (or cause Celldex shall pay a nonrefundable, noncreditable fee equal to be transferred) available patient samples [*****] with regard to ORGENTEC such Product each year until such time as Celldex initiates Phase III Clinical Trials with regard to support such Product, unless Celldex terminates the FDA approval process. Proprius hereby grants Exclusive Commercial License with respect to ORGENTEC, such Product pursuant to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before or no later then December 31, 2009, Proprius has the right, at its own discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval processSection 4.3.3.

Diligence Obligations. (a) Subject to Section 2.5(b) below, Proprius agrees to BMS shall use commercially its best reasonable efforts to develop and market S-K Product(s) for commercial sale and distribution throughout the Territory pursuant to this Agreement, and to such end, BMS, its Affiliates or its Sub-sublicensees shall achieve the following objectives in accordance with the following schedule: (directly and/or through one or more Affiliates i) [XXX]. (ii) [XXX]. The Parties acknowledge that, subject to certain limitations set forth in Section 5.01 of the Xxxxx-Xxxxxxxxx/PROGENICS License Agreement, failure to achieve these objectives shall entitle Xxxxx-Xxxxxxxxx to terminate the license granted under the Xxxxx-Xxxxxxxxx/PROGENICS License Agreement and, thereby, the license granted under this Agreement. PROGENICS shall not unreasonably withhold its consent to, and Sublicenses) shall use all reasonable efforts to bring one or more initial Products to market obtain the consent of Xxxxx-Xxxxxxxxx to, any revision in the Field preceding schedule requested in writing by BMS and supported by evidence of technical difficulties or delays in the Territory and, following first commercial sale, to promote such Initial Product(s) in clinical studies or regulatory process that could not have been reasonably avoided. Notwithstanding the Field in the Territory during the Term. Without limiting the generality of the foregoing (but subject to Section 2.5(b)), Proprius shall achieve first commercial sale of an Initial Product by December 31, 2008. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale of an Initial Product by December 31, 2008foregoing, the parties Parties acknowledge that Xxxxx-Xxxxxxxxx shall discuss in good faith an appropriate extension of such deadline and/or other modification of such diligence milestone. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC shall not have the right to convert Proprius’ terminate the license granted under the Xxxxx-Xxxxxxxxx/PROGENICS License Agreement, and therefore PROGENICS shall not have a right to terminate the license granted under this Agreement, for the failure of BMS to meet a goal if such failure is a result of (i) causes beyond BMS's direct control; (ii) Xxxxx-Xxxxxxxxx'x or PROGENICS's failure to meet its obligations hereunder; (iii) infringement of Third Party patents; or (iv) actions or inactions of a federal or state agency whose approval is required for commercial sales. The Parties further acknowledge and agree that the milestones contained in this Section 2.1 5.1 were established on the assumption that the milestones would apply to a co-exclusive license upon written notice development of the GMK Vaccine. In the event that development of the GMK Vaccine is terminated due to Proprius. (b) Proprius’ diligence obligations under Section 2.5(a) are subject to ORGENTEC using commercially reasonable efforts to obtain U.S. Food and Drug Administration clearance safety or approval of its Anti-MCV (autoantibodies against mutated citrullinated vimentin) E XXXX technology by December 31, 2009. Proprius shall, if available and to the extent permitted by applicable laws and commercially reasonableefficacy reasons, the protocols approved by parties agree that the respective IRBs/ Ethic Committees of milestones set forth in this Section 5.1 shall not apply and the institutions through which samples were collected, and any informed consents obtained by Proprius from sample donors, transfer (or cause Parties will negotiate in good faith to be transferred) available patient samples to ORGENTEC to support the FDA approval process. Proprius hereby grants to ORGENTEC, to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before or no later then December 31, 2009, Proprius has the right, at its own discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval processestablish new milestones.

Diligence Obligations. (a) 9.1 Subject to Section 2.5(bthe remainder of this clause and compliance with Clause 2.6, Liverco shall use its commercially reasonable efforts to develop a Royalty Product one of each that is the subject of (i) below[**]; (ii) [**]; (iii) the Fabry Licence; and [**]; in each case until such time as the applicable Licence is terminated. Additionally, Proprius agrees where UCLB becomes entitled to exercise its right to terminate the FIX Licence under clause 9.5 (following expiry of the relevant date) but UCLB does not exercise such right and its right to terminate expires, then Liverco shall, from that point in time and thereafter, use its commercially reasonable efforts to develop a Royalty Product that is the subject of the FIX Licence (until such time as the FIX Licence is terminated), it being acknowledged that failure by Liverco (or if applicable a Sub-Licensee) to have met the First Target Date or Second Target Date (or extended Second Target Date pursuant to Clause 9.3) shall not be deemed a breach of commercially reasonable efforts. No obligations under this clause 9.1 shall apply with respect to any FIX Product where UCLB did not have a right to terminate under clause 9.5 unless any of the circumstances in Clause 9.6 apply. With respect to Liverco’s obligations to use commercially reasonable efforts (directly and/or through one or more Affiliates efforts, it is acknowledged that Liverco shall at its sole discretion have the right to determine the prioritisation of development of Royalty Products and Sublicenses) not be obliged to bring one or more initial Products to market in the Field in the Territory and, following first commercial sale, to promote such Initial Product(s) in the Field in the Territory develop a Royalty Product under each and every Program Licence at all times during the Termrelevant period. Without limiting It is recognised that in complying with the generality of the foregoing above, (but subject to Section 2.5(b)), Proprius shall achieve first commercial sale of an Initial Product by December 31, 2008. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale of an Initial Product by December 31, 2008, the parties shall discuss in good faith an appropriate extension of such deadline and/or other modification of such diligence milestone. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC i) Liverco shall have the right to convert Proprius’ license under Section 2.1 determine in its sole discretion the prioritisation, on a purely commercial basis, of the various Royalty Products for development, and that Liverco’s compliance with the foregoing shall be assessed on the basis of Liverco’s entire product development portfolio including the Royalty Products: and (ii) the performance of Liverco’s FIX Product in clinical trials will determine and influence the development of other Royalty Products, and (iii) until such time as a FIX Product has adequately advanced in clinical trials with robust data supporting a reasonable anticipation of that FIX Product achieving a Marketing Approval in Core Countries, Liverco is unlikely to have advanced the other Royalty Products. 9.2 Subject to clause 9.6, UCLB shall be entitled to terminate the FIX Licence if Liverco (or its Sub-Licensee) fails to [**] with respect to a coFIX Product (such specific FIX Product being the “First Iteration”) and fails to notify UCLB accordingly in writing by [**] (“First Target Date”). Any termination by UCLB under this Clause 9.2 shall only be effective if UCLB provides written notice of termination to Liverco by no later than [**]. 9.3 If Liverco (or its Sub-exclusive license Licensee) anticipates that it will fail to meet the First Target Date and yet Liverco or its Sub-Licensee plans to continue development of the First Iteration, it shall notify UCLB no later than the First Target Date. UCLB may decide to waive its right to terminate the FIX Licence under Clause 9.2. in which case UCLB shalt be entitled to extend the Second Target Date (as defined below) to cover the anticipated period of delay and if it is to do so, it must notify Liverco of a new Second Target Date within [**] of notice from Liverco under this Clause 9.3. 9.4 If Liverco or its Sub-Licensee decides to abandon development of the First Iteration it shall notify UCLB by the First Target Date. UCLB may decide to waive its right to terminate the FIX Licence under Clause 9.2 in which case the Parties hereby acknowledge that Liverco’s obligations to develop a FIX Product that is not the First Iteration shall be subject to the diligence obi igations set out in Clause 9.1. 9.5 Subject to clause 9.6, if Liverco (or its Sub-Licensee) fails to commence a [**] respect of the First Iteration (“[**]”) [**] (“Second Target Date”), or by the extended Second Target Date (as notified by UCLB pursuant to Clause 9.3) and fails to notify UCLB no later than the Second Target Date (or extended Second Target Date if applicable) that Liverco (or its Sub-Licensee) will not meet the Second Target Date (or extended Second Target Date if applicable) in relation the First Iteration, UCLB may terminate the FIX Licence by providing written notice of termination to Liverco by no later than [**] or where applicable, terminate the FIX Licence no later than [**] after expiry of the extended Second Target Date. The Parties hereby acknowledge that Liverco shall not be obliged to adhere to or comply with the diligence obligations set out in Clause 9.1 in respect of any FIX Product until such time that: (i) the Second Target Date or extended Second Target Date (if applicable) has passed; and (ii) UCLB had the right to terminate the FIX Licence but elected not to exercise such termination right and accordingly ceases to have a right to exercise its termination right in respect of the FIX Licence under, and in accordance with, this Clause 9.5. 9.6 In the event that any of the following circumstances arise: 9.6.1 AN has ceased to be CSO (as such terms is defined in the SSA) of Liverco; 9.6.2 AN is (i) an employee of Liverco, but has served notice of resignation notice or {ii) a consultant to Liverco, but has served notice to terminate his consultancy; 9.6.3 AN is an employee or consultant of Liverco, but under a termination notice served by Liverco; 9.6.4 AN is subject to any [**] initiated by Liverco which has concluded with [**]; 9.6.5 there have been unexpected regulatory hurdles in relation to the [**] that Liverco has or is requrred to overcome; 9.6.6 there has been unexpected and/or unfavourable clinical data arising from the [**] referred to in Clause 9.2; 9.6.7 there is a requirement by the Regulatory Authorties or ethics committee for Liverco or its Sub-Licensee to conduct additional clinical study(ies) before commencing the [**] using the First Iteration; and/or 9.6.8 there are ongoing, or have been, material difficulties in procuring satisfactory manufacturing and/or delivery of [**] including, without limitation, capacity availability, quality issues, yield issues, specification or stability issues, the Parties agree that the provisions of Clauses 9.2 to 9.5 shall cease to apply and thereafter Liverco’s diligence obligations set be limited to those in Clause 9.1 from such point onward. Should AN be subject to a [**] initiated by Liverco until such proceeding is finally concluded (or withdrawn) Liverco’s diligence obligations under this Clause 9 and UCLB’s right to terminate any licences under this Clause 9 shall be suspended, any time limits or deadlines on Liverco’s diligence shall be automatically extended by the period of time commencing with written notice [**] that are the subject of [**] and ending upon the final determination of such procedure (or its withdraw). 9.7 It is acknowledged that Exploitation by Liverco’s Affiliates and/or Sub-Licensees of any Royalty Product shall, for the purposes of this Clause 9, be considered activities of Liverco for assessing its use of commercially reasonable efforts under Clause 9.1, meeting the deadlines in Clauses 9.2 and 9.3 and otherwise the compliance with Clause 9. 9.8 With effect from [**] Liverco (and, in respect [**] after the provisions of both Clauses 9.2 and 9.3 cease to apply), thereafter by 31 March of each year, Liverco shall provide UCLB with a written report that will include a summary of its development timelines and major development steps in relation to the Royalty Products that were taken in the previous [**] and will include development timelines, budget and major development steps that Liverco anticipates shall be undertaken with respect to the Royalty Products for the following [**]. In addition to the foregoing, UCLB shall be entitled, if reasonable, to request details of FTE resource allocation and CRO costs incurred by Liverco. The foregoing obligation shall cease to apply with effect from the [**] of the Effective Date. 9.9 The parties acknowledge that the provisions of this Clause 9.9 shall only apply to the FIX Licence following UCLB having a right to terminate under Clause 9.5 and such right to terminate ceasing to have effect, following which the obligations in Clause 9.1 apply to the FIX Product. Without prejudice to the termination rights granted to UCLB under Clauses 9.2 and 9.5, non-compliance with this Clause 9 shall not result in a right to terminate this Agreement or any financial or equitable remedy (including any remedy in damages), but UCLB’s sole remedy for non-compliance shall be limited to the right to terminate those specific Program Licences granted under this Agreement in accordance with Clause 9.10. It is acknowledged that notwithstanding any delay in development of one or more Royalty Products, a breach of this Clause 9 may be remedied by Liverco subsequently undertaking activities to commence development of the applicable Royalty Product following UCLB’s written notice referred to below and as such a delay in development timeline is not an un-remediable breach. Prior to exercising any right of termination UCLB shall first be obliged to provide Liverco with a written notice setting out the basis for its allegation of breach by Liverco under this Clause 9, which notice shall set out the deficiencies by Liverco and set out a series of reasonable activities UCLB consider sufficient to remedy the breach. For the avoidance of doubt, UCLB’s list of suggested activities shall not be a definitive or minimum list of what is required to remedy any breach. Upon Liverco’s receipt of such notice, the Parties shall, promptly, in good faith and acting reasonably, (i) discuss ways for liverco to remedy or undertake activities in compliance with the obligations under this Clause 9 and (ii) agree a reasonabte period of time within which Liverco will be required to undertake such activities. If the Parties fail to agree the period which Liverco has to undertake the activities, Liverco shall have [**] from the date Liverco or UCLB serves written notice stating in its view that an agreement under (li) cannot be reached to comply with its obligations under this Clause 9 for the Royalty Product(s) in respect of which the breach has occurred. 9.10 Provided that Clause 9.9 has been complied with and the process set out therein followed, and provided that following [**] (or such other period agreed between the Parties) Liverco is still in breach of the same obligations under this Clause 9 in respect of the development of one or more Royalty Products that were the subject of the original breach notice under Clause 9.9, UCLB shall be entitled upon immediate written notice to Propriusterminate the Program Licence(s) granted, on a Program Licence by Program Licence basis, the Program Licence applicable to the Royalty Products where, in breach of its obligations hereunder in respect of such Royalty Products, Liverco has not met and has failed to remedy its diligence obligation under Clause 9.1 to develop such Royalty Products. (b) Proprius’ diligence obligations 9.11 Upon termination of a Program Licence by UCLB pursuant to Clause 9.2, 9.5 or 9.10, UCLB shall have the option to negotiate with Liverco to agree terms for a licence to those applicable Liverco Improvements Controlled by Liverco which are free of restrictions and encumbrances and which specifically relate to the Product licensed under Section 2.5(a) are subject the Program Licence that has been terminated. The foregoing right of UCLB to ORGENTEC using commercially reasonable efforts negotiate with Liverco for the Liverco Improvements shall expire [**] following notice of termination served under Clause 9.8. This Clause 9.9 shall survive the termination of this Agreement [**] from the date of termination during which UCLB shall have a right to obtain U.S. Food and Drug Administration clearance or approval of exercise its Anti-MCV (autoantibodies against mutated citrullinated vimentin) E XXXX technology by December 31, 2009. Proprius right under Clause 9.9. 9.12 Liverco shall, if available by written notice, promptly notify UCLB in the event that its Board takes any decision to permanently terminate development of Royalty Products under a particular Program Licence, whereupon Liverco shall have no further obligation to develop or Exploit any Royalty Product applicable to that Program Licence and to the extent permitted by applicable laws and commercially reasonable, the protocols approved by the respective IRBs/ Ethic Committees relevant Program Licence shall terminate as of the institutions through which samples were collected, date of Liverco’s written notice and any informed consents obtained by Proprius from sample donors, transfer (or cause to be transferred) available patient samples to ORGENTEC to support the FDA approval process. Proprius hereby grants to ORGENTEC, to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before or no later then December 31, 2009, Proprius has the right, at its own discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval processrelevant provisions of Clause 22 shall apply.