Common use of Development of Products Clause in Contracts

Development of Products. 4.1 During the Research Term, Orasense will diligently pursue the research and development of the Elan Intellectual Property, Isis Intellectual Property and Orasense Technology in accordance with the Research and Development Program. The objectives of this initial phase of the Research and Development Program will be (a) to develop the Oral Platform, and (b) to develop the Development Product. 4.2 The results of Orasense's research pursuant to the Research and Development Program shall be shared with Isis and, in the event Isis utilizes such data in connection with a product based upon the Development Candidate in a non-Oral formulation and includes such data in any regulatory submission and the use of such data substantially enhances such application, and a product which is the subject of such application is Commercialized, Isis agrees to negotiate in good faith reasonable compensation to Orasense for the use of such data. 4.3 Isis agrees to provide at Orasense's cost such amounts of the Isis Oligonucleotide Drugs designated by Isis as [...***...] and [...***...] as Orasense shall require for testing and research purposes only; provided however, that no clinical studies on humans may be performed utilizing [...***...]. 4.4 Orasense will diligently pursue the research, development and Commercialization of the Development Product and other Products in accordance with the Plan, this Agreement, the Elan License Agreement and the Development Agreement. 4.5 In the event the Management Committee, by unanimous vote of its members, shall determine that preclinical toxicology or pharmacology studies indicate that clinical trials of the Development Candidate should not be undertaken, or the Management Committee determines that development of the Development Candidate is not economically viable, Isis in good faith shall offer, and the Management Committee, by unanimous vote of its members shall approve, an Isis Oligonucleotide in pre-clinical development that it deems economically viable as a Substituted Development Candidate, subject to the agreement of the Participants, negotiating in good faith, to changes concerning the budget, Plan and funding of Orasense. 4.6 Except as otherwise provided herein, upon designation of an Isis Oligonucleotide as a Substituted Development Candidate, (i) all rights to the Development Candidate shall revert to Isis and (ii) all provisions contained herein other than in the preceding clause (i) relating to the Development Candidate shall be deemed to apply to the Substituted Development Candidate as if it were the Development Candidate. *CONFIDENTIAL TREATMENT REQUESTED

Development of Products. 4.1 During ​ “3.1Development Plan and Development Deadline Document. Upon selection of a Development Candidate, the Research TermJSC will meet to prepare a plan for the Development of such Development Candidate (such plan, Orasense will diligently pursue the research “Development Plan” for such Development Candidate”) and development to conduct a formal review of and prepare a comprehensive update to Exhibit SA-4A to the Second Amendment (the “Development Deadline Document”) that reflects anticipated activities directed towards Development and commercialization of such Development Candidate through Regulatory Approval in the United States, in each case taking into consideration available information concerning such Development Candidate, the interests of SMA patients, the intellectual property and regulatory landscape and the commercial potential of the Elan Intellectual Property, Isis Intellectual Property and Orasense Technology in accordance with the Research and Development ProgramCandidate. The objectives parties acknowledge and agree that Exhibit SA-4A takes into account many delays in Development and receipt of this initial phase Regulatory Approval that, while possible, are not anticipated as of the Research Second Amendment Effective Date to be likely; Company’s expectations, as of the Second Amendment Effective Date, of the activities required to obtain Regulatory Approval and its goal timelines for completing such activities are set forth in Exhibit SA-4B. When preparing the Development Program will be Plan and updating the Development Deadline Document for each Development Candidate, the JSC shall consider whether to obtain, (a) to develop “Orphan Product” designation from the Oral PlatformFDA, and (b) research funding from the FDA’s Office of Rare Diseases or other government agencies to develop the support human clinical trials conducted for such Development Product. 4.2 The results of Orasense's research pursuant to the Research and Development Program shall be shared with Isis andCandidate, in each case taking into consideration the event Isis utilizes such data protection of intellectual property rights and confidential information. The Development Plan shall set forth, in connection with a product based upon at least the Development Candidate level of detail included in a non-Oral formulation and includes such data in any regulatory submission and the use of such data substantially enhances such application, and a product which is Company’s or its Licensee’s plans for developing other preclinical or clinical (whichever reflects the subject of such application is Commercialized, Isis agrees to negotiate in good faith reasonable compensation to Orasense for the use of such data. 4.3 Isis agrees to provide at Orasense's cost such amounts of the Isis Oligonucleotide Drugs designated by Isis as [...***...] and [...***...] as Orasense shall require for testing and research purposes only; provided however, that no clinical studies on humans may be performed utilizing [...***...]. 4.4 Orasense will diligently pursue the research, development and Commercialization of the Development Product and other Products in accordance with the Plan, this Agreement, the Elan License Agreement and the Development Agreement. 4.5 In the event the Management Committee, by unanimous vote of its members, shall determine that preclinical toxicology or pharmacology studies indicate that clinical trials status of the Development Candidate should not at such time) pharmaceutical products, both major and minor Development activities planned to be undertakenconducted with respect to such Development Candidate by or on behalf of Company or its Affiliates or Licensees, the anticipated timeline for performing such activities, the goals of such activities and the anticipated timeline for achieving such goals. The Development Deadlines Document shall set forth the deadline by which each major Development activity must be performed by on behalf of Company or its Affiliates or Licensees if the Company wishes to avoid granting the Foundation the right to obtain a Reversionary License pursuant to Section 3.3 of the Agreement. No change can be made to any Development Plan or Development Deadline Document without the approval of the JSC unless such change is approved by the parties’ respective Chief Executive Officers pursuant to Second Amendment Section 5(d) or 5(e), is implemented by Baseball Arbitration ​ in accordance with Second Amendment Sections 5(d) and 17, or is approved by the Management Committee determines that development of the Development Candidate is not economically viable, Isis Foundation in good faith shall offer, and the Management Committee, by unanimous vote of its members shall approve, an Isis Oligonucleotide in pre-clinical development that it deems economically viable as a Substituted Development Candidate, subject to the agreement of the Participants, negotiating in good faith, to changes concerning the budget, Plan and funding of Orasense. 4.6 Except as otherwise provided herein, upon designation of an Isis Oligonucleotide as a Substituted Development Candidate, (i) all rights to the Development Candidate shall revert to Isis and (ii) all provisions contained herein other than in the preceding clause (i) relating to the Development Candidate shall be deemed to apply to the Substituted Development Candidate as if it were the Development Candidateaccordance with Second Amendment Section 9(b)(1). *CONFIDENTIAL TREATMENT REQUESTED​

Development of Products. 4.1 During the Research Term2.1 BLI shall, Orasense will diligently pursue the research and development of the Elan Intellectual Property, Isis Intellectual Property and Orasense Technology in accordance with the Research terms and Development Program. The objectives conditions of this initial phase of Agreement, use diligent efforts to (i) conduct toxicity studies, formulation development and clinical studies for, and pursue Regulatory Approval in the Research and Development Program will be (a) to develop Territory of, the Oral PlatformProducts other than the Additional Product, and (bii) conduct clinical testing for and pursue Regulatory Approval in the Territory of, the Additional Product, and to develop that end BLI, BCI and Polymer agree as follows: ENGAGEMENT OF BLI 2.2 Polymer hereby engages BLI to use diligent efforts to (i) conduct toxicity studies, formulation development and clinical studies for, and pursue Regulatory Approval in the Development Territory of, the Products other than the Additional Product, and (ii) conduct clinical testing for and pursue Regulatory Approval in the Territory of, the Additional Product, all in accordance with the terms of this Agreement. BLI hereby accepts that engagement. 4.2 The results of Orasense's research pursuant 2.3 BLI shall use diligent efforts to the Research (i) conduct toxicity studies, formulation development and Development Program shall be shared with Isis andclinical studies for, and pursue Regulatory Approval in the event Isis utilizes such data in connection with a product based upon Territory of, the Development Candidate in a non-Oral formulation and includes such data in any regulatory submission and Products other than the use of such data substantially enhances such applicationAdditional Product, and a product which is (ii) conduct clinical testing for and pursue Regulatory Approval in the subject of Territory of, the Additional Product and shall undertake such application is Commercialized, Isis agrees other activities as the parties may reasonably agree from time to negotiate in good faith reasonable compensation time. DEVELOPMENT WORK BY BCI 2.4 BLI hereby engages BCI to Orasense for the use of perform such data. 4.3 Isis agrees to provide at Orasense's cost such amounts of the Isis Oligonucleotide Drugs designated by Isis as [...***...] and [...***...] as Orasense shall require for testing and research purposes only; provided however, that no clinical studies on humans may be performed utilizing [...***...]. 4.4 Orasense will diligently pursue the research, development and Commercialization experimentation activities and such related tests and studies as BLI may from time to time during the Term of this Agreement delegate or assign to BCI. BCI agrees to perform such of the Development Product activities, tests and other Products in accordance studies as may be delegated or assigned to it by BLI. 2.5 Each of BLI and BCI agrees that Polymer may enforce the terms of this Agreement directly against BCI with respect to the Planperformance of any activity, test or study delegated or assigned to BCI by BLI as if Polymer had itself engaged BCI to carry out such activity, test or study. Polymer accepts the performance of any such activity, test or study by BCI as performance by BLI itself, and acknowledges that BCI may fulfil any of the obligations of BLI under this Agreement, . Each of BLI and BCI fully and unconditionally guarantees the Elan License Agreement and performance by the Development Agreement. 4.5 In the event the Management Committee, by unanimous vote other of its members, obligations under this Agreement. PRODUCT DEVELOPMENT PRIORITIES 2.6 Polymer and BLI shall determine that preclinical toxicology or pharmacology studies indicate that clinical trials of the Development Candidate should not be undertaken, or the Management Committee determines that development of the Development Candidate is not economically viable, Isis in good faith shall offer, and the Management Committee, by unanimous vote of its members shall approve, an Isis Oligonucleotide in pre-clinical development that it deems economically viable as a Substituted Development Candidate, subject to the agreement of the Participants, negotiating negotiate in good faith, as soon as reasonably possible after the Effective Date, to changes concerning determine the budgetrelative priorities for the Development of each of the Products. Biovail shall then develop budgets for each of the stages of Product Development for each Product, Plan consistent with these priorities. PRODUCT DEVELOPMENT PROGRAM 2.7 For each of the Products, BLI shall prepare and funding of Orasensesubmit to Polymer a Product Development Program consistent with the priorities and budgets established under paragraph 2.6. BLI shall diligently perform or cause BCI or any other qualified person to perform the tasks and activities set out in the Product Development Program. 4.6 Except as otherwise provided herein2.8 Each of BLI, upon designation of an Isis Oligonucleotide as a Substituted BCI and Polymer shall diligently carry out their respective obligations under the Product Development Candidate, (i) all rights Program and shall report any significant deviations therefrom to the Development Candidate Other in a timely manner. 2.9 BLI shall revert produce all information and data necessary to Isis and (ii) all provisions contained herein other than in the preceding clause (i) relating to the Development Candidate shall be deemed to apply to the Substituted Development Candidate as if it were the Development Candidate. *CONFIDENTIAL TREATMENT REQUESTEDfile any IND or NDA for any Product developed hereunder.